Hernia Mesh Lawsuit News Updates | TheLawFirm.com

Hernia Mesh Lawsuit News and Updates

The latest news and updates regarding hernia mesh devices, lawsuits and settlements.

Ethicon Mesh Lawsuit News: Next Wave Of Cases In Ethicon Pelvic Mesh MDL To Conclude Discovery By Early 2020, Judge’s Order Says

September 14, 2019
Author: Daniel Gala

On September 10, the judge overseeing federal multidistrict litigation (MDL) involving pelvic mesh implants made by Johnson & Johnson subsidiary Ethicon issued a pretrial order correcting a typographic error in the previously established discovery deadlines for the MDL’s next wave of cases. These deadlines show that the court anticipates having the bulk of the parties’ pretrial discovery concluded around the beginning of next year.

The MDL, based in the Southern District of West Virginia, has centralized federal products liability lawsuits involving Ethicon pelvic repair systems, with plaintiffs alleging that the products were defectively designed and that J&J and Ethicon failed to adequately disclose known risks associated with the mesh implants. The forthcoming wave of cases will be the MDL’s 13th, and it presently includes just under 100 cases, according to an attachment to the pretrial order.

Per the scheduling deadlines included in the September 10 pretrial docket control order, the deadline for depositions and the close of discovery for Wave 13 cases is December 13. Dispositive motions, Daubert motions, and their responses are to be concluded by the end of January 2020.

The long-running Ethicon pelvic mesh MDL dates back to February 2012 and is part of massive litigation over pelvic mesh devices that spans seven MDLs that collectively contain approximately 100,000 individual cases, making it one of the largest legal actions in the history of the United States. All seven pelvic mesh MDLs are taking place in the Southern District of West Virginia under US District Judge Joseph R. Goodwin.

According to the court’s list of member cases [https://www.wvsd.uscourts.gov/caselist/caseviewlist.aspx?mdl=2327], out of 40,549 total cases in the MDL, 38,108 had closed as of September 12, leaving roughly 2,400 yet to be resolved.

In addition to the thousands of lawsuits brought by patients alleging they were injured by Ethicon surgical mesh devices, Johnson & Johnson and Ethicon presently are in the midst of a trial over claims brought by the California Attorney General’s Office accusing the companies of violating the state’s anti-competition and false-advertising laws in their marketing of Ethicon's transvaginal mesh implants. California AG Xavier Becerra is seeking roughly $700 million in penalties, making it a bellwether of sorts as other state attorneys general consider bringing similar cases of their own. The San Diego-based trial presently is on hiatus as the judge takes a two-week vacation.

Sources:

United States District Court Southern District of West Virginia. (10 September 2019). Pretrial Order #346 (Docket Control Order - Ethicon, Inc. Wave 13 Cases). MDL 2327. In Re: Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation

Ethicon Mesh Lawsuit News: Woman Sues J&J, Ethicon Over Mesh Device Just Implanted In March

September 9, 2019
Author: Daniel Gala

A woman has sued Johnson & Johnson, its medical-device-making subsidiary Ethicon, and her doctor over a transvaginal mesh implant she just had implanted in March 2019, less than six months prior to the filing of the lawsuit.

The woman, identified only as J.S. to protect her private medical information, filed the suit August 30 in the Dallas County Court of Law, accusing the companies and her doctor of failing to warn of certain risks associated with what she alleges is a defective medical device.

J.S. says that she had the Ethicon Abbrevo device implanted on March 7, 2019 to treat her stress urinary incontinence, a common condition in aging women. The Abbrevo is a polypropylene transobturator sling similar to Ethicon’s TVT-O sling.

In addition to J&J and Ethicon, J.S. also is suing Dr. Charmaine K. Oladell, M.D., alleging that the doctor failed to warn her patient about “any problem or defect with the Abbrevo device or the extent or nature of the harm that might reasonability result” from its use, according to the complaint.

The lawsuit is just one of thousands filed against J&J and Ethicon over the companies’ various mesh devices. Although J.S.’s case was filed in Texas state court, thousands of federal Ethicon mesh cases have been centralized as multidistrict litigation (MDL) in the Southern District of West Virginia and the Northern District of Georgia.

While the Georgia MDL over Ethicon hernia mesh continues to make its way through pretrial proceedings, in the West Virginia pelvic mesh MDL, a master settlement agreement has been reached among the parties, and the MDL is in the process of winding down. According to the court’s list of member cases, as of September 7, nearly 33,000 cases out of a total of roughly 40,500 had closed.

In addition to the tens of thousands of products liability lawsuits over Ethicon mesh, J&J and Ethicon also are in the midst of a trial brought by the California Attorney General’s Office over allegations that the companies violated the state's false-advertising and anti-competition laws in their marketing of Ethicon transvaginal mesh implants. The company is seeking roughly $700 million in damages in the months-long trial that presently is on hold as the judge takes a two-week vacation.

With all the pending legal action over Ethicon’s allegedly defective mesh implants, the lawsuit filed by J.S. in Texas state court is just another reminder that J&J and Ethicon’s legal troubles are far from over.

Sources:

EIN Presswire. (5 September 2019). Johnson & Johnson Hit with Transvaginal Mesh Lawsuit in Dallas

United States District Court Southern District of West Virginia. (Accessed 7 September 2019). MDL 2327 Member List of Cases. In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

Sammon, J. (4 September 2019). Johnson & Johnson pelvic mesh trial on hold as judge takes vacation. Northern California Record

Ethicon Mesh Lawsuit News: $700m J&J, Ethicon Mesh Trial Brought By Calif. AG On Pause While Judge Takes Two-Week Vacation

September 5, 2019
Author: Daniel Gala

More than a month into a $700-million trial that is acting as a bellwether of sorts for similar lawsuits, the proceedings are taking a two-week pause as San Diego Superior Court Judge Eddie Sturgeon goes on a two-week vacation.

The high-stakes case involves claims brought by the California Attorney General against Johnson & Johnson and its subsidiary Ethicon over alleged violations of state laws governing anti-competitive behavior and false advertising. California AG Xavier Becerra is seeking nearly three-quarters-of-a-billion dollars in damages, asserting that the companies concealed known risks and overstated the benefits of Ethicon’s pelvic mesh implants.

“The trial has been postponed in California because the judge is on vacation,” said a spokeswoman for Ethicon, according to the Northern California Record.

The break comes mid-trial, with the California Attorney General’s Office having rested its case on August 19. Attorneys for J&J and Ethicon were in the midst of making their case when on August 29 they submitted a request for summary judgment, arguing that the state had failed to present facts sufficient to support its claims. Judge Sturgeon has yet to make a ruling on that request.

In addition to the case brought by the California AG, J&J and Ethicon face tens of thousands of products liability lawsuits over Ethicon’s mesh implants. In total, the makers of mesh implants have faced over 100,000 lawsuits in what collectively has amounted to one of the largest legal actions in the history of the United States. Federal lawsuits over Ethicon pelvic repair systems have been centralized as multidistrict litigation in the Southern District of West Virginia.

In April, the US Food and Drug Administration (FDA) banned from the US market all transvaginal mesh implants used in the treatment of pelvic organ prolapse (POP), a common condition in aging women. The nation’s chief pharmaceutical and medical-device watchdog found that “the manufacturers…have not demonstrated a reasonable assurance of safety and effectiveness for those devices.”

The California case is the first brought by a state AG against a maker of mesh implants to reach trial. Though the attorneys general for California and Washington state both filed similar lawsuits around the same time in 2016, Washington AG Bob Ferguson announced in April that his office had reached a $9.9-million settlement with J&J on the eve of trial.

In the press release announcing the California AG’s lawsuit in 2016, it was stated that “California co-led a multistate investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women.”

With so many other jurisdictions having participated in the initial investigation, it is highly likely that those attorneys general are watching the California case closely as they consider filing similar lawsuits of their own. But with Judge Eddie Sturgeon, who has been presiding over the jury-less bench trial, away on a two week vacation, all interested parties are left no choice but to wait patiently for his return.

Sources:

Sammon, J. (4 September 2019). Johnson & Johnson pelvic mesh trial on hold as judge takes vacation. Northern California Record

Washington State Office of the Attorney General. (4 September 2019). Johnson & Johnson will pay $9.9m for failing to disclose the risk of its surgical mesh devices. News Releases

California Office of the Attorney General. (24 May 2016). Attorney General Kamala D. Harris Files Lawsuit Against Johnson & Johnson for Deceptive Marketing of Surgical Mesh Products. Press Release

Ethicon Mesh Lawsuit News: J&J, Ethicon Say Judge Should Dismiss Calif. AG’s Mesh Claims For Lack of Evidence

September 3, 2019
Author: Daniel Gala

As a contentious trial between the California Attorney General’s Office and mega-conglomerate Johnson & Johnson winds toward its close, attorneys for J&J and its device-making subsidiary Ethicon have asked the presiding judge to dismiss the AG’s lawsuit for an alleged lack of facts supporting its claims.

“Ethicon is entitled to judgement,” an attorney for Johnson & Johnson argued before Judge Eddie Sturgeon on August 29, according to an account published by the Northern California Record.

With J&J and Ethicon having waived their right to a jury trial in favor of a bench trial, Judge Sturgeon will render the final verdict in the case, whether or not he decides to do so via summary judgment, as the defendants have urged.

Parties may file for summary judgment when they believe that the facts presented, even if taken as true for the sake of argument, fail to support the opposing party’s claims, making a certain outcome inevitable as a matter of law. In the instant case, J&J and Ethicon argue that the California AG’s office has failed to present factual evidence sufficient to support its allegations that the companies violated state anti-competition and false-advertising laws in their marketing of Ethicon mesh implants.

Specifically, attorneys with the office of California AG Xavier Becerra have argued that the companies explicitly chose not to include certain known risks in the mesh devices’ instructions for use (IFUs), thereby depriving doctors and patients of important information in making individual healthcare decisions. The state also has alleged that the companies improperly referred to the devices as “FDA approved” rather than “FDA cleared”, implying that the devices had undergone a level of regulatory scrutiny that they had not.

Attorneys for the defendant companies urged the court to find that the state had failed to adequately support these claims.

“The state has shown that a portion of the targeted consumers were misled,” said an attorney for the defense, per the Northern California Record. “If it’s only a few, it’s not actionable.”

The defense further sought to undermine the state’s claims by downplaying the significance of IFUs, saying that many doctors do not even read the IFUs, instead relying on their expert medical knowledge and other sources.

“The state has to show that doctors would forget their medical knowledge with the IFU,” an attorney for J&J contended, describing his side’s understanding of the applicable legal standard. “There is no evidence a California doctor read an IFU.”

An attorney for the California AG’s office later fought back against the defendants’ characterization of the case, maintaining the state’s position that the companies intentionally withheld important information from patients and doctors in order to boost sales.

“The company knew the dangers of the mesh, but did not include it in the marketing materials,” Daniel Osborn of the California Attorney General’s Office, argued. “A surgeon would not know the mesh itself could lead to chronic pain. [The risk of certain complications] is coming from the mesh [itself], not the [surgical] procedure [where the surgeon’s expertise lies].”

“J&J knew the risks but left out key risks,” Osborne summarized.

In April, the US Food and Drug Administration banned from the US market all transvaginal mesh implants used in the treatment of pelvic organ prolapse (POP), having determined that the devices’ safety and efficacy could not be established to the agency’s standards.

From 2008 to 2014, J&J and Ethicon sold 787,232 mesh implants in the United States, with more than 40,000 of the mesh devices having been sold in California, according a 2016 news release from the California Attorney General’s Office, announcing the filing of the instant lawsuit.

Surgical mesh implants also have been the subject of tens of thousands of products liability claims filed by patients who allege that they were inadequately warned as to serious risks association with the devices, including pain during sexual intercourse and other complications. Collectively, these lawsuits represent one of the largest legal actions in US history.

The California Attorney General’s lawsuit is the first case brought by a state AG against a maker of mesh implants to go to trial. In April, Washington state Attorney General Bob Ferguson settled similar claims with J&J on the eve of trial for $9.9 million.

California is seeking roughly $700 million in penalties, making it a near certainty that other state AGs are watching the trial closely while they consider filing similar lawsuits.

Sources:

Sammon, J. (30 August 2019). Johnson & Johnson attorneys ask court to toss state’s suit during pelvic mesh trial. Northern California Record

United States Food and Drug Administration (FDA). (16 April 2019). FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. FDA News Release

California Office of the Attorney General. (24 May 2016). Attorney General Kamala D. Harris Files Lawsuit Against Johnson & Johnson For Deceptive Marketing Of Surgical Mesh Products. Press Release

Washington State Office of the Attorney General. (22 April 2019). Johnson & Johnson Will Pay $9.9 Million For Failing To Disclose The Risk Of Its Surgical Mesh Devices. News Releases

Ethicon Mesh Lawsuit News: Ethicon Mesh Tested On Cadavers And Animals But Not Live Humans, J&J Witness Testifies At Calif. AG Trial

August 29, 2019
Author: Daniel Gala

The trial between California’s attorney general’s office and mega-conglomerate Johnson & Johnson over mesh implant devices made by J&J subsidiary Ethicon continued Monday, August 26, with J&J calling to the stand a product testing specialist from Ethicon, who claims her research showed the mesh devices at issue did not “rope and curl” under pressure, as the state of California has alleged. However, under cross-examination from attorneys for California, the witness conceded that her testing had been performed on cadavers and animals, not on live humans.

“Roping, curling, we didn’t see it,” testified Dr. Katrin Elbert, senior principal engineer for Ethicon, according to the Northern California Record. “We were applying loads and there was no permanent deformation. [The mesh under stress] went back to its original configuration.”

“We did 10 times [normal pressures exerted on the mesh] and still were not seeing deformation of the mesh.”

California has sued the companies seeking roughly $700 million in damages in the first case of its kind—brought by a state AG against a maker of surgical mesh implants—to reach trial. California accuses J&J and Ethicon of violating the state’s anti-competition and false-advertising laws by allegedly overstating the benefits and concealing risks associated with the mesh implants.

Through Dr. Elbert’s testimony, the defendant companies sought to demonstrate that, contrary to the state’s assertions, the devices in question had been adequately tested and proven safe.

“We have to make sure we’re in compliance,” Dr. Elbert said. “Our design control process is compliant with FDA regulations. As project lead, my job is to make sure we meet the requirements.”

Despite Dr. Elbert’s contention that the devices were adequately tested and proven safe, the United States Food and Drug Administration (FDA) announced in April that it was banning from the US market all transvaginal mesh implants used in the treatment of pelvic organ prolapse (POP), a common condition in aging women.

“The FDA has determined that the manufacturers [of transvaginal mesh implants used in the treatment of POP]…have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” read the FDA statement announcing the ban.

“[W]e couldn’t assure women that these devices were safe and effective long term,” the statement quoted Dr. Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, as saying. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions.”

During cross-examination, attorneys for the state’s AG’s office emphasized the lack of testing done on live human patients.

“That’s correct,” Dr. Elbert responded when asked if the devices had been tested exclusively on non-human animals and cadavers. However, Dr. Elbert countered that there was much to be learned from cadavers that translates to a live human body.

“[Testing on cadavers] does give us information that is absolutely relevant to the subsequent performance [of the mesh implants] in a live woman,” Dr. Elbert argued.

According to California’s Attorney General’s Office, from 2008 until 2014, Ethicon sold nearly 800,000 mesh implant devices, with upwards of 40,000 having been sold in California alone. The devices, including competing models manufactured by other companies, have been the subject of tens of thousands of products liability lawsuits, making the mesh lawsuits collectively one of the largest legal actions ever in the history of the United States.

With California seeking nearly three-quarters-of-a-billion dollars in penalties, other state AGs surely are watching the trial closely as they consider bringing similar cases of their own, particularly with nearly every state and the District of Columbia having joined California in its initial investigation.

When the California AG’s case originally was filed in 2016 by then-California Attorney General and now-US Senator and Democratic Party presidential candidate Kamala Harris, the office said in a statement that the lawsuit was the product of “a multi-state investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women.”

The participation of other jurisdictions in the initial investigation makes the California case a bellwether of sorts, with a victory for California making it more likely that other states will follow its lead, and a defeat likely having the opposite effect.

In April, Washington State attorney general announced on the eve of trial that he was settling his state’s mesh implant claims with J&J and Ethicon for $9.9 million.

Sources:

Sammon, J. (27 August 2019). Ethicon mesh engineer in Johnson & Johnson trial says no disfiguring shown in mesh during testing. Northern California Record

United States Food and Drug Administration (FDA). (16 April 2019). FDA takes action to protect women’s health, orders manufactures of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. FDA News Release

Washington State Office of the Attorney General. (22 April 2019). Johnson & Johnson Will Pay $9.9 Million For Failing To Disclose The Risk Of Its Surgical Mesh Devices. News Releases

Ethicon Mesh Lawsuit News: ‘Wonderful Performers’: Ethicon Mesh Designer Touts Benefits Of Now-Banned Devices At Calif. AG Trial

August 29, 2019
Author: Daniel Gala

The director of research and development for Johnson & Johnson subsidiary Ethicon took the stand August 28 in a trial brought by the California Attorney General’s Office alleging that J&J and Ethicon violated the state’s anti-competition and false-advertising laws in their marketing of now-banned transvaginal mesh implant devices. Testifying for the defendant companies, Ethicon employee Scott Ciarocca defended the transvaginal mesh devices that he helped to develop, at one point referring to the implants as “wonderful performers,” according to an account published by the Northern California Record.

“Our team overcame significant challenges and provided a really wonderful product to the market,” Ciarocca testified in San Diego Supreme Court of the Ethicon Prolift, one of the mesh devices at issue in the case.

The California Attorney General’s Office alleges that J&J and Ethicon intentionally downplayed the risks of Ethicon’s transvaginal mesh implants, including by failing to state certain known risks in the Instructions For Use (IFU). Doctors typically rely heavily on information provided in the IFUs to counsel patients on the potential risks and benefits of alternative courses of action.

Among the alleged risks that were not included in the IFUs at themes implants’ launch was dyspareunia, or pain during sexual intercourse. During cross examination, an attorney with the California AG’s office presented Ciarocca with a 2005 document requesting that such a risk be included in the IFUs.

“I propose to add the following to the new version of IFU: WARNING (in all caps), early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction, which may result in anatomical distortion of the vaginal cavity that can interfere with sexual intercourse,” attorney Daniel Osborn read in court, per the Northern California Record. “This must be taken into consideration when the procedure is planned in a sexually active woman.”

The attorney Osborn then asked Ciarocca if the requested warning made it into the IFU.

“The exact verbiage was not included in the IFU, correct,” he answered.

The trial, which began in mid-July, is well into its second month. With the defendants J&J and Ethicon having waived their right to a jury trial, Superior Court Judge Eddie Sturgeon will himself render the final verdict on the companies’ liability. California Attorney General Xavier Becerra is seeking roughly $700 million in penalties in the first case of its kind to be brought by a state AG against a manufacturer of transvaginal mesh implants.

In April, the United States Food and Drug Administration banned from the US market all transvaginal mesh implants used in the treatment of pelvic organ prolapse (POP), a common condition in aging women, particularly those who have given childbirth. The FDA banned the mesh implants after device makers failed to adequately demonstrate the devices’ safety and efficacy through clinical trials.

In addition to the lawsuit brought by the California AG, the makers of mesh implants face tens of thousands of lawsuits filed by patients who claim they were injured by the devices. Cumulatively, the surgical mesh products liability lawsuits represent one of the largest legal actions in US history.

Sources:

Sammon, J. (29 August 2019). Designer of J&J pelvic mesh product says sling was ‘wonderful performer’; State’s objection to description sustained by judge. Northern California Record

United States Food and Drug Administration (FDA). (16 April 2019). FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. FDA News Release

Ethicon Mesh Lawsuit News: ‘This Claim Is Meritless’: Philly Mesh Judge Urges Appeals Court To Uphold $41M Ethicon Verdict

August 27, 2019
Author: Daniel Gala

The Pennsylvania state court judge who denied defendants Johnson & Johnson and Ethicon’s efforts to have him recused from a case that resulted in a $41 million verdict against the companies has filed an opinion with the Pennsylvania Superior Court urging it to reject the companies’ bid to have the verdict overturned on appeal, The Legal Intelligencer reported August 23.

The case, Emmet v. Ethicon, is part of a mass tort program taking place in the Philadelphia Court of Common Pleas. Johnson & Johnson and its medical-device-making subsidiary Ethicon previously had tried to have Judge Kenneth Powell removed from the case, and any future Ethicon mesh trials, arguing that Judge Powell had a conflict of interest because his mother presently is involved in a lawsuit against J&J over the blood-thinner Xarelto.

The companies' efforts to have Judge Powell removed were rejected by both Judge Powell and supervising Judge Arnold New, and, in January, a Philadelphia jury returned a $41 million verdict for the plaintiff, including $15 million in compensatory damages, $25 million in punitive damages, and $1 million for loss of consortium.

Now, J&J and Ethicon are seeking to have that verdict overturned on appeal. In his 34-page opinion opposing such a move, Judge Powell does not mince words, calling the companies’ arguments “meritless”.

“Here, Ethicon has repeatedly attempted to seek recusal of the undersigned in an attempt to ‘judge-shop,’” Judge Powell wrote, per The Legal Intelligencer, arguing that Ethicon and J&J want him removed from the litigation because of a pretrial evidentiary ruling the defendants perceive as being unfavorable to them.

In a pretrial order on the admissibility of evidence, Judge Powell ruled that he would allow evidence pertaining to the device’s approval process at the US Food and Drug Administration (FDA), including information about the controversial 510(k) program. The 510(k) process allows new medical devices that are deemed substantially similar to approved devices to enter the market without undergoing the same level of scrutiny, including clinical trials, required of other new medical devices.

“Defendants are unhappy with this ruling [allowing evidence pertaining to the FDA approval process],” Judge Powell writes. "As such, they have tried to pursue any avenue of appellate review possible—even filing a King’s Bench motion (denied per curium) in the most recent pelvic mesh case in front of this court…to obtain recusal of the undersigned.”

In supporting his contention that that the appeal brought by J&J and Ethicon is “meritless”, Judge Powell cited what he says is clear and binding precedent from the United States Supreme Court as to the admissibility of such evidence.

“Ethicon chooses to ignore case law from the Supreme Court of the United States simply because it is not favorable to their claim,” Judge Powell argues. “For all of the above reasons, this case is meritless.”

The original lawsuit was filed by Suzanne Emmet and her husband Michael Emmet, who, according to their attorneys, both have suffered physical harm and mental anguish as a result of an allegedly defective Ethicon mesh implant. Originally implanted to treat Mrs. Emmet’s pelvic organ prolapse, the Ethicon mesh device eroded into Mrs. Emmet’s vagina, causing her to develop urinary incontinence and pain-inducing bladder contractions. Mrs. Emmet also reports suffering severe pain during sexual intercourse, and Mr. Emmet claims that he suffered a cut from the mesh device on his penis during intercourse, for which the jury awarded him the $1 million consortium claim.

“We are pleased that Judge Powell addressed each and every one of the stream of meritless allegations of error, which has been the consistent, predictable post-trial tactic by Johnson & Johnson following each of the nine jury verdicts where their mesh device products have been found defective by Pennsylvania juries,” the Emmets’ attorneys said in a statement quoted by The Legal Intelligencer.

In April, the FDA banned from the US market all transvaginal mesh implants used in the treatment of pelvic organ prolapse, which have been the subject of tens of thousands of lawsuits in the United States alone. In addition to the thousands of products liability claims, J&J and Ethicon also face a lawsuit,currently at trial, brought by the office of the California Attorney General Xavier Becerra, which seeks roughly $700 million in penalties over alleged violations of California’s false-advertising and anti-competition laws.

Sources:

Mitchell, M. (23 August 2019). Phila. Judge Stands by $41M Pelvic Mesh Verdict and His Refusal to Recuse. The Legal Intelligencer

Mitchell, M. (22 March 2019). Phila. Judge Declines to Bounce Colleague From Pelvic Mesh Trials. The Legal Intelligencer

Mitchell, M. (19 January 2019). Philadelphia Jury Awards $41M Verdict to Woman Who Needed 9 Surgeries to Fix Defective Pelvic Mesh. The Legal Intelligencer

United States Food and Drug Administration. (16 April 2019). FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. FDA News Release

Sammon, J. (23 August 2019). J&J attorneys tout mesh benefits through fact witnesses in pelvic mesh trial. Northern California Record

Bard Davol Mesh Lawsuit News: Judge Updates Bellwether Schedule For Davol, Bard Mesh MDL

August 26, 2019
Author: Daniel Gala

The judges overseeing multidistrict litigation (MDL) over surgical mesh implants made by medical-device-makers CR Bard, Inc. and Davol, Inc. issued on August 15 an order updating the pretrial schedule for three forthcoming bellwether trials, which will be the first to take place in the MDL.

According to the order signed by Chief United States District Judge Edmund A. Sargas, Jr. and United States Magistrate Judge Kimberly A. Jolson for the Southern District of Ohio’s Eastern Division, the first three bellwether trials presently are scheduled to commence July 13, September 14, and November 9, 2020.

The order further outlines the procedures by which the three bellwether cases will be selected from the bellwether trial pool.

The Davol/Bard MDL was created in August 2018 by order of the Judicial Panel on Multidistrict Litigation (JPML) to centralize federal claims over the companies’ polypropylene mesh devices.

“All of the actions share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections,” the JPML’s transfer order, dated August 6, 2018, states. “Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.”

More than 100,000 federal lawsuits have been filed nationwide on behalf of patients against the makers of surgical mesh implants, amounting collectively to one of the largest legal actions in United States history. Plaintiffs accuse the device makers of overstating the benefits and concealing the risks of the mesh devices, which, in their various forms, are used in the treatment of a number of conditions, from hernias to pelvic organ prolapse (POP) to urinary stress incontinence.

Sources:

United States District Court Southern District of Ohio Eastern Division. (15 August 2019). Case Management Order No. 10-A Amending Prior Case Management Order. No. 10 Bellwether Scheduling Order. Case No. 2:18-md-2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

United States Judicial Panel on Multidistrict Litigation (JPML). (6 August 2018). Transfer Order. MDL No. 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

Ethicon Mesh Lawsuit News: 'It’s A Huge Advancement In The Care Of Women,’ J&J Witness Says of Now-Banned Devices At Calif. AG / Ethicon Mesh Trial

August 26, 2019
Author: Daniel Gala

Despite all transvaginal mesh products having been banned from the US market by the Food and Drug Administration (FDA) in April, defendant Johnson & Johnson continues to assert the benefits of such devices in court, calling to the stand a witness who declared the implants “a huge advancement in the care of women” over a sustained objection by lawyers from the California Attorney General’s Office, per an account published August 22 by the Northern California Record.

As Johnson & Johnson and its medical-device-maker subsidiary Ethicon, Inc. defend themselves against claims that they violated the state’s anti-competition and false advertising laws, they called to the stand Dr. Bruce Kahn, a gynecologist at Scripps Clinic in San Diego, who defended the safety and efficacy of Ethicon’s transvaginal mesh implants, included the Prolift device.

“I don’t think I have a better option for surgical treatment of incontinence in my patients,” Dr. Kahn testified, referring to the mesh implants.

Dr. Kahn’s testimony contradicted that of experts presented during the state’s portion of the trial, who argued that the serious risks associated with the devices heavily outweighed their supposed benefits.

By contrast, lawyers for J&J and Ethicon sought to elicit from Dr. Kahn a characterization of the severity of the health problems the mesh devices were designed to treat and the device's efficacy in treating these conditions.

“[Out of 200 patients with follow-up] [t]here was one [with complications] that I known of,” Dr. Kahn said of his personal experience with the implants, per the Northern California Record.

While attorneys for the state AG’s office had sought to demonstrate the prevalence and severity of pain during sexual intercourse as a potential side effect of the mesh implants—a side effect the state says J&J and Ethicon did not adequately warn patients about—Dr. Kahn testified that in his experience, such a condition was rare, describing its occurrence as “[v]ery infrequent”.

With the defendants having foregone their right to a jury trial in favor of a bench trial, Superior Court Judge Eddie Sturgeon will render the final verdict in this case, which is expected to last several more weeks.

The office of California Attorney General Xavier Becerra is seeking roughly $700 million in total penalties from the companies in the first case brought by a state AG against a maker of transvaginal mesh implants to reach trial.

Source:

Sammon, J. (22 August 2019). J&J witness says complications rate for mesh low, big success with women in Ethicon pelvic mesh trial. Northern California Record

Boston Scientific Mesh Settlement News: Court Approves Settlement Fund In Boston Scientific Mesh MDL

August 22, 2019
Author: Daniel Gala

In the latest sign that massive litigation involving approximately 100,000 cases spread across seven MDLs is continuing to wind down, the judge overseeing multidistrict litigation (MDL) over pelvic mesh implants made by Boston Scientific Corp. has approved a qualified settlement fund for clients represented by the law firm Wexler Wallace LLP, per an order issued August 16. The order appoints Wahlstrom & Associates as fund administrator, with Signature Bank to serve as escrow agent.

In recent months, the court has issued more than a dozen such orders approving the mechanisms for administering various settlement agreements reached between Boston Scientific and law firms representing plaintiffs.

As of August 21, 20,978 cases had closed out of 26,028 total in the Boston Scientific pelvic mesh MDL, leaving just over 5,000 active cases remaining, according to the court’s list of member cases. The long-running MDL has been ongoing since 2012 and is one of seven MDLs based in the Southern District of West Virginia, centralizing roughly 100,000 surgical mesh claims.

All bellwether trials in the Boston Scientific mesh MDL were canceled in February 2014.

According to Boston Scientific’s financial disclosures for the second quarter of 2019, the company has settled or is in the process of settling the vast majority of mesh claims.

“As of July 23, 2019, approximately 53,000 product liability cases or claims related to transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse have been asserted against us,” Boston Scientific reported to the US Securities and Exchange Commission (SEC). "As of July 23, 2019, we have entered into master settlement agreements in principle or are in the final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 52,000 cases and claims….Of the approximately 52,000 cases and claims, approximately 42,000 have me the conditions of the settlement and are final.”

Boston Scientific also faces thousands of state-court claims in Massachusetts, where “[o]ver 3,100 of the cases have been specially assigned to one judge in state court.”

When the United States Food and Drug Administration (FDA) banned all transvaginal mesh implants from the US market in April 2019, Boston Scientific—along with Coloplast—was one of only two device makers still selling such devices on the US market.

“All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing,” Boston Scientific further disclosed.

Sources:

United States District Court for the Southern District of West Virginia Charleston Division. (16 August 2019). Pretrial Order No. 214 (Order Re: Qualified Settlement Fund - Wexler Wallace LLP). MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair Systems Products Liability Litigation

United States District Court for the Southern District of West Virginia Charleston Division. (Accessed 21 August 2019). MDL 2326 Member List of Cases. MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair Systems Products Liability Litigation

Boston Scientific Corporation. (Filed 30 July 2019). Form 10-Q for the quarterly period ended June 30, 2019. Note I - Commitments and Contingencies. Product Liability Litigation. United States Securities and Exchange Commission (SEC)

Ethicon mesh lawsuit news update: State Rests Case In Calif. AG / Ethicon Mesh Trial

August 22, 2019
Author: Daniel Gala

The office of California Attorney General Xavier Becerra has concluded its case in a landmark trial over transvaginal mesh implants sold by Ethicon, Inc., a medical-device-making subsidiary of mega-conglomerate Johnson & Johnson, setting the stage for the defendant companies to begin making their arguments against the alleged violations of California’s anti-competition and false-advertising laws.

California concluded its portion of the trial by playing for the court videotaped depositions from two Ethicon employees, Dr. Aaron Kirkemo and Dr. Axel Arnaud, both of whom have held senior medical positions at the company. Both witnesses maintained under questioning that, while Ethicon’s transvaginal mesh products did pose risks to patients, the potential benefits outweighed those risks.

In a videotaped deposition dating back to 2013, then-associate director of Ethicon’s Medical Affairs Department Dr. Aaron Kirkemo explained that he had begun working for Ethicon in 1998 because he “really liked their products,” according to an account published by the Northern California Record.

“I liked the company and the folks I was working with,” Dr. Kirkemo said. “Some of the products at Ethicon were absolutely transformational for women. It positively changed women’s lives.”

Still, Dr. Kirkemo acknowledged that the mesh devices posed serious health risks, including the potential for intense pain during sexual intercourse.

“They’re talking about the potential of nerve injuries,” Dr. Kirkemo explained when asked about dyspareunia, or painful intercourse, per the Northern California Record. “They talk about if the wound doesn’t heal well, you know, that you could end up with exposure, an extrusion or erosion of the mesh, which would add inflammation, which would create a sore point down there which would cause pain with intercourse.”

However, Dr. Kirkemo defended Ethicon’s decision not to include such a risk in updates to the medical literature provided to healthcare professionals.

“When I got into the industry, I didn’t feel this portion [of the medical literature relating to dyspareunia] needed to be addressed on subsequent updates,” Dr. Kirkemo said, explaining that when he was in practice he believed the literature provided information sufficient for him to adequately counsel his patients.

In a separate videotaped deposition, Ethicon medical-device affairs director Dr. Axel Arnaud was asked about an email he had written in 2005 in which he suggested that the instructions for use (IFU) be amended to include a warning about the risk of painful intercourse, which can have a severe impact on the quality of life and personal relationships of sexually active women.

“It was no surprise that one of the possibilities was a complication called erosion,” Dr. Arnaud said on the recording when asked if this represented a new risk or one that had been known for some time. “From time to time, you might have more-important shrinkage that would lead to retraction, so no, it is nothing really new. I was asked to write this warning but there is nothing extraordinary in it.”

With California having rested its case, it is now Johnson & Johnson and Ethicon’s turn to present their own expert witnesses aimed at refuting the state’s claims that the companies improperly overplayed the benefits and downplayed the risks of the transvaginal mesh devices, including Ethicon’s Prolift.

In April, the United States Food and Drug Administration (FDA) banned all transvaginal mesh implants from the US market based on a lack of clinical data demonstrating their safety and efficacy. Meanwhile, mesh implants more broadly, including those used to repair hernias, have been the focus of one of the largest legal actions in US history with roughly 100,000 lawsuits involving numerous corporate defendants having been centralized in West Virginia federal court.

Source:

Sammon, J. (20 August 2019). Ethicon official argues benefits outweighed risks in pelvic mesh trial; State rests case. Northern California Record

United States Food and Drug Administration (FDA). (16 April 2019). FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. FDA Newsroom. Press Announcements

Ethicon mesh lawsuit news update: Med-Device Makers Alter Language In Scientific Studies, Expert Says At Calif. AG / J&J Mesh Trial

August 19, 2019
Author: Daniel Gala

Medical-device makers frequently influence the results and final wording of purportedly independent research examining the safety and efficacy of their devices, down to altering the wording of a study’s abstract, a professor at Georgetown University testified August 14 at a trial pitting the State of California against Johnson & Johnson and its medical-device-making subsidiary Ethicon. The office of California Attorney General Xavier Becerra accuses the companies of violating the state’s anti-competition and false-advertising laws with regards to vaginal mesh implants sold by Ethicon and is seeking roughly $700 million in penalties.

“[Mesh industry insiders] are hired just to write the last line of the abstract,” Dr. Adrian Fugh-Berman, professor of pharmaceutical and medical practices at Georgetown University School of Medicine, told the court, according to an account published by the Northern California Record.

Dr. Fugh-Berman’s statement was based on a report she prepared using confidential sources inside the industry. According to her sources, in at least one instance, industry insiders were responsible for removing a relevant fact, which may have cast the devices being studied in a negative light, from an article’s abstract. An abstract is a brief summary that many readers, including medical professionals, rely on to accurately reflect a study’s findings when they do not have time to read an entire paper.

In the example cited by Dr. Fugh-Berman, information that 34 percent of women in one test group and 51 percent in another had suffered from pain during intercourse after receiving a transvaginal mesh implant was removed from an article’s abstract.

“This [information] would be pretty important for physicians to see,” Dr. Fugh-Berman testified.

When asked if doctors can obtain objective knowledge about the safety and efficacy of medical devices by reading the medical literature, Dr. Fugh-Berman equivocated.

“[W]hen [the research] is co-opted by the [medical-device] industry, it’s not a reliable source,” Dr. Fugh-Berman responded, per the Northern California Record. “Studies not supportive of the marketing goals of the industry might not get published.”

According to Dr. Fugh-Berman, device makers pick and choose which studies to fund based on their chances of producing positive outcomes.

"[Medical-device makers] sponsor studies that are more likely to find favorable results,” she said. “These can be widely promoted and what reaches physicians can be pro-industry materials.”

During the professor’s testimony, attorney for the California AG’s office Jinsook Ohta used a chart to summarize Dr. Fugh-Berman’s findings as to the various techniques utilized by medical-device marketers to influence physicians, including: promoting studies with findings that coincide with pre-established marketing messages; attaching conditions, including the right to edit a paper’s language, to the funding of research; paying for the publication of favorable studies while suppressing negative ones; and refusing to provide funding for studies that may contradict the industry’s marketing themes.

Attorneys for J&J pushed back on the professor’s findings, questioning her reliance on confidential industry insiders and the credentials supporting her supposed “expertise” in the medical-device field.

“Her sample data [pertaining to medical devices] is very small. It’s speculative,” argued Ali Mojibi, an attorney for the Johnson & Johnson.

Superior Court Judge Eddie Sturgeon, presiding over the jury-less bench trial in San Diego Superior Court, dismissed J&J’s efforts to have Dr. Fugh-Berman barred as an expert witness, allowing her to testify.

The trial, expected to last approximately two months, has been ongoing for roughly one month.

Source:

Sammon, J. (15 August 2019). State witness in J&J pelvic mesh trial says doctors get doctored studies about mesh devices. Northern California Record

Ethicon mesh lawsuit news update: ‘I Never Learned That Fact, No’: Former Ethicon Sales Rep Says He Was Never Told Of Mesh Inflammation Risk At Calif. AG / J&J Trial

August 19, 2019
Author: Daniel Gala

As the State of California continued making its case against Johnson & Johnson and its medical-device-maker subsidiary Ethicon over allegations that the companies violated the state’s false-advertising and anti-competition laws with regards to Ethicon’s transvaginal mesh implants, lawyers for the state attorney general’s office played for the court the videotaped deposition of a former Ethicon sales rep and current product director, who confirmed under questioning that he was unaware of any risk of long-term inflammation associated with the medical devices he was responsible for selling to doctors.

The lack of such knowledge by the Ethicon sales team is central to the state’s claims that the companies systematically overplayed the benefits and downplayed the risks of Ethicon’s mesh implants, including its Prolift device, which is used in the treatment of pelvic organ prolapse (POP), a common condition in aging women, particularly those who have given birth.

When asked if he had been told during training about the risk of long-term inflammation caused by Ethicon’s mesh implants, the witness was unequivocal.

“I did not learn that fact, no,” Scott Jones, former Ethicon sales rep and current Ethicon product director, testified on the previously-recorded video, according to an account published by the Northern California Record based on a livestream of court proceedings made available by the Courtroom View Network.

“I had not heard that,” Jones repeated in response to a different question about whether he had been “trained there could be a more serious inflammatory reaction with TVT [tension-free vaginal tape],” echoing what would become a familiar refrain that the state hoped would underscore the inadequacy of Ethicon sales reps’ knowledge as to the risks of the very devices they were rewarded for selling doctors on the supposed benefits of.

When asked if his training as an Ethicon sales rep had covered the risks associated with serious inflammation:

“I had not heard that.”

When asked if infection could lead to erosion and exposure of the mesh:

“I’m not really sure if it could or not.”

When asked if he had been taught any such information by Ethicon:

“Not that I recall.”

When asked if he had “learned about the inflammatory reaction that’s initiated by Gynemesh and whether it can lead to erosion or exposure”?

“I’ve not learned that. I haven’t heard of the correlation between inflammation and erosion.”

The testimony is intended to support California’s seeking roughly $700 million in penalties from the defendant companies for their alleged violations of state law. It is the first lawsuit brought by a state attorney general against a maker of surgical mesh implants to reach trial, but with 46 states and the District of Columbia having participated in a multistate investigation, other state AGs certainly are watching the California case closely as they consider bringing similar claims.

The trial, which is expected to last approximately two months, is nearing the end of its first month.

Source:

Sammon, J. (14 August 2019). Ethicon director/sales rep says in J&J pelvic mesh trial that no major inflammatory warning given about mesh. Northern California Record

Ethicon mesh lawsuit news update: Attys For J&J, Calif. Exchange Barbs Over Ethicon Mesh Data

August 16, 2019
Author: Daniel Gala

As the closely-watched trial between the State of California and mega-conglomerate Johnson & Johnson over the company’s allegedly improper marketing of mesh-implant devices sold by its subsidiary Ethicon continued in San Diego Superior Court on Monday, August 12, attorneys for the two sides engaged in a tense exchange over the state’s characterization of data relied on by the defendant companies in gauging the safety and efficacy of Ethicon's mesh devices.

“They are saying fraudulent data is being supplied for the company to rely on,” protested attorney William Gage, representing J&J, according to an account published by the Northern California Record. “The allegations the state is making are not true.”

Jinsook Ohta, a lawyer with the office of California Attorney General Xavier Becerra, responded by arguing that the issue—raised by J&J on cross-examination—was outside the scope of the state’s direct examination, and therefore should not be allowed at that time.

“We are going way outside the scope of my examination. Mr. Gage is going way out on a limb,” Ohta told the court.

The exchange came during the third day of testimony by Dr. Piet Hinoul, global head for clinical and medical affairs of mesh products at Ethicon. The State of California is several weeks into presenting its case at the trial, which is expected to last about two months.

The lawsuit, originally filed in 2016 by the office of then-California AG Kamala Harris, accuses Johnson & Johnson and Ethicon of violating California’s false advertising and anti-competition laws. The state is seeking roughy $700 million in penalties for, among other things, inaccurately portraying Ethicon mesh products as “FDA approved” rather than “FDA cleared”.

With California seeking such significant financial penalties, other state AGs are watching the case closely as they weigh whether or not to bring similar claims under their state’s laws. The California case is the first filed by a state AG against a maker of mesh implants to reach trial. In April, Washington State AG Bob Ferguson settled a similar legal action for $9.9 million on the eve of trial.

In recent years, surgical mesh implants have been the subject of one of the largest legal actions in United States history, with more than 100,000 products liability lawsuits having been centralized across seven different MDLs (multidistrict litigation) taking place in US District Court in West Virginia. With that massive litigation finally winding down, the makers of surgical mesh devices now face the prospect of a slew of lawsuits filed by state attorneys general, particularly if the California case proves successful for AG Becerra’s office.

With the original May 2016 press release announcing the J&J/Ethicon lawsuit referencing “a multistate investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women”, other state AGs certainly are waiting in the wings, armed with the facts needed to bring cases of their own.

Sources:

Sammon, J. (13 August 2019). State attorneys quibble with defendants per FDA clearance of mesh products in J&J trial. Northern California Record

Office of the Attorney General of California. (24 May 2016). Attorney General Kamala D. Harris Files Lawsuit Against Johnson & Johnson for Deceptive Marketing of Surgical Mesh Products. Press Release

Ethicon mesh lawsuit news update: In Marketing Vaginal Mesh, Ethicon Spent More On Meals Than Training Events, Forensic Accountant Testifies

August 9, 2019
Author: Daniel Gala

Testifying for the State of California, which has sued Johnson & Johnson and its subsidiary Ethicon over their alleged improper marketing and anti-competitive practices with regards to Ethicon's transvaginal mesh implants, a forensic accountant said on August 6 that his analysis had revealed the companies spent more treating healthcare professionals to meals than on other marketing efforts, such as training events.

“[Spending on meals] was significantly higher than the professional education and training events that we saw,” certified forensic accountant and data analysis examiner Travis Armstrong testified in San Diego Superior Court, per the Northern California Record.

California is the first state to bring J&J and Ethicon to trial over claims that the companies violated state anti-competition and false advertising laws. California Attorney General Xavier Becerra is seeking roughly $700 million in penalties over allegations that the companies, among other things, inaccurately described Ethicon transvaginal mesh devices as “FDA approved” rather than “FDA cleared”.

Armstrong testified that, based on his analysis, between 2008 and 2015, Ethicon spent over $15,000 treating healthcare providers to meals during which its employees would pitch the benefits of transvaginal mesh implants such as Ethicon’s Prolift. This trumped the amount spent on other marketing efforts such as health-fair promotions.

Attorneys for the state further questioned Armstrong on the scope of Ethicon’s massive marketing effort. According to Armstrong’s analysis, in California alone, sales reps for Ethicon had nearly 43,000 marketing conversations promoting the company’s transvaginal mesh devices from 2008 to 2012. J&J and Ethicon also launched a supposedly informational website at www.pelvichealthsolutions.com, which attracted tens of thousands of visitors per year.

The lawsuit originally was filed in 2016 by then-California Attorney General Kamala Harris. In April, the US Food and Drug Administration (FDA) banned the sale of all trasvagifnal mesh implants from the United States market. Federal products liability claims over Ethicon pelvic mesh devices have been centralized in multidistrict litigation (MDL) in the Southern District of West Virginia.

Source:

Sammon, J. (7 August 2019). Accountant says in Johnson & Johnson trial that sales meals big selling feature for pelvic mesh. Northern California Record

Ethicon mesh lawsuit news update: Attys for Calif. Highlight Lack Of Warnings At J&J Ethicon Mesh Trial

August 9, 2019
Author: Daniel Gala

The global head for clinical and medical affairs of mesh products at Johnson & Johnson took the stand August 7 in a trial pitting the State of California against J&J and its subsidiary Ethicon over alleged improper marketing of Ethicon’s transvaginal mesh implants. The office of California Attorney General Xavier Becerra is seeking penalties of roughly $700 million in the case, which, as the first of its kind to reach trial, is acting as a bellwether of sorts, with other state AGs watching closely as they consider bringing similar claims.

The Northern California Record published the following exchange between attorney Jinsook Ohta, representing the State of California, and J&J’s Dr. Piet Hinoul, in which Ohta grilled Hinoul over a list of known risks posed by Ethicon’s mesh implants that the companies failed to include on the products’ warning labels.

First, Ohta asked if the warning labels for Ethicon’s mesh products mentioned “life-long erosion” or “re-occurrence”, two known complications of transvaginal mesh.

“Re-occurence and life-long [complications] are not cited,” J&J’s Dr. Hinoul responded.

California’s Ohta: “Does the warning say life-long dyspareunia [pain during sexual intercourse]?”

J&J’s Dr. Hinoul: “Not in those words, no.”

California’s Ohta: “Debilitating and life-changing?”

J&J’s Dr. Hinoul: “No.”

California’s Ohta: “Does it say the need for possible [mesh] removal?”

J&J’s Dr. Hinoul: “It’s does not.”

California’s Ohta: “Is life-long exposure included?”

J&J’s Dr. Hinoul: “I don’t see it, no.”

The questioning was intended to underscore California’s claims that J&J and Ethicon violated the state’s anti-competition and false-advertising laws by failing to adequately disclose to patients and their doctors the true risks associated with the companies’ transvaginal mesh implants.

The United States Food and Drug Administration (FDA) banned all transvaginal mesh devices from the US market in April of this year after the last two companies selling the devices, Boston Scientific and Coloplast, were deemed to have been unable to prove their devices’ safety and efficacy to the agency’s satisfaction.

On cross-examination by an attorney for Johnson & Johnson, Dr. Hinoul was asked whether any of the complications highlighted by the state had been mentioned in the FDA’s own warnings, referencing an FDA table, used from 2008 to 2010, listing adverse events associated with transvaginal mesh implants. The adverse events were not included, supporting J&J’s contention that it should not have been required to cite risks the FDA itself had not deemed it necessary to include in its own materials.

The trial is taking place in San Diego Superior Court. It is expected to last roughly two months.

Source:

Sammon, J. (8 August 2019). State attorneys argue J&J missed adequate label warnings in pelvic mesh trial. Northern California Record

Ethicon mesh lawsuit news update: Former FDA Commissioner Takes The Stand In Calif. AG Ethicon Mesh Trial

August 7, 2019
Author: Daniel Gala

A former commissioner for the United States Food and Drug Administration (FDA) was the latest witness to take the stand in what is expected to be a lengthy trial between the State of California and consumer-goods, pharmaceutical, and medical-device conglomerate Johnson & Johnson over transvaginal mesh implants sold by J&J subsidiary Ethicon, the Northern California Record reported August 6.

Dr. David Kessler, a San Francisco-based pediatrician and former FDA commissioner, explained under questioning the FDA’s approval process for medical devices, including the controversial 510K loophole that allows devices to enter the market with less scrutiny if a manufacturer can demonstrate that the new device is substantially equivalent to an existing approved device.

Among the State of California’s claims is the allegation that J&J and Ethicon engaged in false marketing of the Prolift transvaginal mesh implant by inaccurately referring to the device as “FDA approved” rather than “FDA cleared”. Though similar, the two phrases have vastly different legal meanings.

“The theory is, look, if [a similar device is] already on the market, and you don’t raise any new issues, [FDA] will let you go to market,” Dr. Kessler testified, according to the Northern California Record. “That’s the 510K standard that’s evolved over time.”

Kessler distinguished the 510K process from the far more stringent pre-market approval (PMA) process.

“If a product is found to be sub-equivalent [to a product already on the market], then it is cleared for marketing [by the FDA],” Dr. Kessler testified, clarifying that such a marketing clearance did not amount to independent verification by FDA that the product is safe and effective, a line J&J and Ethicon are accused of intentionally blurring in marketing their devices. On cross-examination, an attorney for Johnson & Johnson sought to portray Dr. Kessler as a professional expert witness who had amassed a fortune through paid testimony.

“You’ve been an expert witness 40 times, primarily on the plaintiff’s side?” J&J attorney William Gage asked. “As a litigation expert, you’ve earned millions from that work?”

Dr. Kessler answered affirmatively to both questions but clarified that he was not being paid to appear in the instant trial and instead viewed his testimony as a form of public service.

Originally filed in 2016 by then-California Attorney General and now-US Senator and Democratic Party presidential candidate Kamala Harris, the lawsuit has been carried forward by the office of current California AG Xavier Becerra. The first case of its kind to reach trial, the suit seeks roughly $700 million in penalties for alleged violations of the state’s anti-competition and false-advertising laws. In April, Washington State Attorney General Bob Ferguson settled similar claims on the eve of trial for $9.9 million.

Given its unprecedented nature and the size of the penalties sought, the case likely will act as a bellwether of sorts as other state AGs decide whether or not to bring similar claims.

Source:

Sammon, J. (6 August 2019). Former FDA commissioner says in J&J pelvic mesh trial that approval process based on raising of safety concerns. Northern California Record

Mesh lawsuit news update: Mesh MDL Judge Approves Allocation Of Almost $400 Million In Atty Fees, Finds Objections ‘Entirely Without Merit’

August 2, 2019
Author: Daniel Gala

The federal judge overseeing approximately 100,000 individual mesh lawsuits centralized into seven different MDLs has approved the allocation of attorney fees for common-benefit work performed by plaintiffs attorneys during the massive and long-running litigation, overriding the objections of four law firms. The ruling is the latest indication that the enormously large and complex legal proceedings, among the biggest in US history, finally is nearing its ultimate resolution.

In an order issued July 25, United States District Judge Joseph R. Goodwin approved the Fee and Cost Committee’s Final Written Recommendation for distribution of the common benefit fund, dismissing concerns raised by four law firms that continued to object to the terms of the proposed allocation. According to the order, a total of 94 firms have applied for common benefit compensation.

“The four remaining objectors focus upon the structure and results of the allocation process which they agreed to several years ago,” Judge Goodwin wrote for the Southern District of West Virginia Charleston Division. “The objectors have had many opportunities to object, including to the FCC, the External Review Specialist, and me. Having considered each of their objections, I find that they are entirely without merit. All the remaining objections [citations omitted] are DENIED.” (Emphasis in original.)

The allocation plan covers the disbursement of $366 million in attorney fees, according to Lexis Legal News.

The order states that the 94 firms seeking common benefit compensation claimed a total of almost one million hours “as time spent for the common benefit.” Following a thorough, multi-step review process, almost 700,000 total hours were approved by the Fee and Compensation Committee.

Earlier this year, the objecting law firms accused members of the Fee and Compensation Committee of improper self-dealing with regards to the allocation of common benefit funds, saying that committee members carved out more money for themselves and their firms than was appropriate under the circumstances.

Sources:

United States District Court Southern District of West Virginia. (25 July 2019). Pretrial Order #212 Memorandum and Opinion Order (Re: Allocation Order). MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair Systems Products Liability Litigation

Lexis Legal News. (30 July 2019). Pelvic Mesh MDL Judge Gives Final Approval to $366M Common Benefit Award

Law360. (29 March 2019). Pelvic Mesh MDL Fee Committee Accused of Self-Dealing

Ethicon Mesh lawsuit news update: ‘I Saw There Were Complaint Patterns’: Ethicon Medical Director For Safety Testifies At Calif. AG J&J Mesh Trial

August 2, 2019
Author: Daniel Gala

Dr. Meng Chen, former Ethicon medical director for safety surveillance, took the stand July 31 in a trial pitting the California Attorney General’s Office against medical-device-maker Ethicon, Inc. and its parent company Johnson & Johnson over claims that the companies violated the state's false advertising and anti-competition laws when they allegedly overstated the benefits and downplayed the risks of their transvaginal mesh implants, including Ethicon’s Prolift. Dr. Chen testified that she observed a pattern of similar complaints arising from recipients of Ethicon’s vaginal mesh implants and ultimately played a role in having the device’s instructions for use (IFU) changed to reflect this reality.

“It was very important to change the IFU,” Dr. Chen said before the court, according to the Northern California Record. The Ethicon Prolift IFU were changed in 2009. The device was introduced to the US market in 2005.

Dr. Chen further confirmed that she had encountered many patients who felt they had not been adequately warned about the risks associated with the devices, an issue central to the state’s claims.

“Patients did not feel there was adequate pre-op consent or risk/benefit assessment,” Dr. Chen wrote in a decade-old email read before the court, according to the Northern California Record. Dr. Chen had written the email after reviewing numerous patient complaints.

“From what I see each day, these patient experiences are not transitory at all,” Dr. Chen wrote in another email.

Under questioning from Deputy Attorney General for the California Department of Justice Daniel Osborn, Dr. Chen also testified that in one incident, the husband of a woman who had received a mesh implant ten weeks prior suffered cuts on his penis during sexual intercourse.

Initially filed in 2016 by then-California Attorney General and now-US Senator and Democratic Party presidential candidate Kamala Harris, the state’s lawsuit seeks roughly $700 million in penalties for J&J and Ethicon’s alleged violations of California law. Presently in its second week, the trial is expected to last multiple months.

The case is the first brought by a state AG against a maker of vaginal mesh implants to reach trial. In April, Washington State Attorney General Bob Ferguson settled similar claims for $9.9 million on the eve of trial. Given the significant monetary penalties California is seeking, other state AGs are likely to file similar claims if current California Attorney General Xavier Becerra’s office proves successful in collecting even a portion of the sum it says the companies should be ordered to pay.

Source:

Sammon, J. (1 August 2019). Ethicon complaint reviewer says in J&J trial that patients felt vaginal mesh instructions fell short of explaining risks. Northern California Record

Ethicon Mesh lawsuit news update: “Like Rebar In A Sidewalk, Once The Cement Is Dried”: Mesh-Removal Surgeon Testifies In Calif. AG Ethicon Trial

August 2, 2019
Author: Daniel Gala

A doctor with experience surgically removing problematic vaginal mesh implants in women continued his testimony for the State of California on Tuesday, July 30, describing in graphic detail the side effects his patients have experienced as a result of the devices, which were banned by the US Food and Drug Administration (FDA) earlier this year.

“[The mesh] is like rebar in a sidewalk, once the cement is dried,” pelvic reconstructive obstetrician and gynecological surgeon Dr. Michael Margolis testified for the State of California, according to the Northern California Record. “[The mesh] is cemented into the tissue. It’s glued in. The [vaginal sling’s] arms go off into surgical no-man’s land.”

Dr. Margolis, of El Camino Hospital in Los Gatos, California, also described the excruciating pain caused by the mesh implants.

“It’s called the chandelier,” he told the court, per the Northern California Record. “The pain can be so bad the patient jumps off the table and hangs from the chandelier. It’s really severe pain.”

Beyond pain and the inability to completely remove an implanted mesh device, Dr. Margolis testified about yet more side effects suffered by his patients, risks the State of California accuses J&J and Ethicon of downplaying when marketing the products to patients and doctors.

“There is an increased risk of immediate post-operative infection,” Dr. Margolis explained, adding that other potential complications included the twisting of vaginal slings and mesh erosion, both of which also can result in severe chronic pain.

The lawsuit is the first brought by a state attorney general against a manufacturer of vaginal mesh implants to reach trial, making it a bellwether of sorts as other state AGs consider whether or not to file similar suits. Superior Court Judge Eddie Sturgeon is presiding over the jury-less bench trial, which is taking place in San Diego.

Originally filed in 2016 by then-California Attorney General and now-US Senator and Democratic Party presidential candidate Kamala Harris and carried forward by the office of current California AG Xavier Becerra, the lawsuit accuses multi-billion-dollar conglomerate Johnson & Johnson and its wholly owned subsidiary Ethicon of “false and deceptive marketing of its surgical mesh products for women,” according to a press release issued by the California AG’s office at the time of the case’s original filing.

The lawsuit is the culmination of a multistate investigation that involved the attorneys general of 46 states and the District of Columbia, according to the California AG’s office. In April, the State of Washington was on the eve of trial when its attorney general announced a roughly $10 Million settlement to resolve the state’s claims.

The California suit is seeking approximately $700 million in penalties against J&J and Ethicon, making it highly likely that other states will follow California’s lead and file similar claims if the trial proves successful. On the other hand, if California loses, it will become less likely that other state AG’s will attempt vaginal mesh lawsuits of their own.

J&J and Ethicon also face thousands of products liability claims filed by individual plaintiffs. Since 2012, federal products liability lawsuits over Ethicon pelvic repair devices have been centralized as multidistrict litigation (MDL) in the Southern District of West Virginia.

Approximately 42,000 Ethicon pelvic mesh implants were sold from 2008 through 2014.

Sources:

Sammon, J. (31 July 2019). Surgeon talks complications, infection rates of pelvic mesh in J&J mesh trial. Northern California Record

Sammon, J. (30 July 2019). Pelvic surgeon outlines risks of mesh, difficulty of removal in J&J mesh trial. Northern California Record

State of California Office of the Attorney General. (24 May 2016). Attorney General Kamala D. Harris Files Lawsuit Against Johnson & Johnson for Deceptive Marketing of Surgical Mesh Products. Press Release

Washington State Office of the Attorney General. (22 April 2019). Johnson & Johnson Will Pay $9.9 Million For Failing to Disclose the Risk of Its Surgical Mesh Devices. News Releases

United States District Court Southern District of West Virginia. (Last Updated: 28 July 2019). MDL 2327. Ethicon, Inc. Pelvic Repair System Products Liability Litigation. Court Website

Ethicon Mesh lawsuit news update: Ethicon Sales Rep Takes The Stand In Calif. AG J&J Mesh Trial

July 29, 2019
Author: Daniel Gala

A sales manager for Johnson & Johnson’s wholly owned subsidiary Ethicon took the stand this week as the trial over claims that the companies violated California’s unfair competition and false advertising laws with regards to the Ethicon Prolift vaginal mesh implant continued in San Diego. The State of California is seeking roughly $700 million in penalties in the first case brought by a state AG against the makers of vaginal mesh implants to reach trial.

Ethicon division sales manager Michele Garrison faced questioning from California Deputy Attorney General Laurel Carnes, who probed into J&J and Ethicon’s sales practices with regards to the Prolift vaginal mesh implant at issue in the case.

In an unusual move, Judge Eddie Sturgeon posed his own question at one point in the proceedings, a move even the judge conceded was abnormal for him. Judge Sturgeon sought clarity on whether Ethicon sales reps actually would be present in the operating room during implant surgery.

“So you were in an operating room with a doctor and he would stop and ask you a question?” Judge Sturgeon asked, according to an account published by the Northern California Record.

“Sometimes, yes,” Garrison responded.

With the case being a bench trial, Judge Sturgeon is the ultimate finder of fact. In a jury trial, jurors fulfill that role.

Under questioning, Garrison explained the intensive training that Ethicon sales reps undergo, including roleplaying activities. Deputy Attorney General Carnes also elicited responses detailing Ethicon’s incentive structure, which encouraged higher sales. The state displayed a chart showing bonuses reaching into the thousands of dollars based on sales incentives. It also showed that a sales rep had been recognized as a “slam dunk winner.”

“Growth of sales was always a component (of compensation),” Garrison testified.

Attorneys for the State of California also showed the court a promotional video from a 2011 Ethicon sales conference, which employed military imagery and a high-energy soundtrack.

“Carnes played a video for the court that was shown to Ethicon sales reps at a 2011 national sales meeting,” reported the Northern California Record. “The video portrayed a commando team descending in a helicopter as though on an anti-terrorism mission to the sound of rock music followed by soundbites with doctors touting the benefits of mesh implants.”

“A statement appeared telling doctors, ‘you will be exposed to the latest weaponry (mesh implants).’”

Earlier this year, the United States Food and Drug Administration (FDA) banned vaginal mesh implants from the US market. The devices, such as the Ethicon Prolift at issue in the California AG’s case, were designed to treat pelvic organ prolapse and urinary stress incontinence, both common medical conditions in aging women. Instead, the vaginal mesh implants have been associated with a host of painful and debilitating side effects.

Between 2008 and 2014, over 40,000 women received Ethicon Prolift implants alone.

The lawsuit brought by the California Attorney General’s Office–originally filed in 2016 by then-California AG and now-US Senator and Democratic Party presidential candidate Kamala Harris–alleges that Johnson & Johnson and Ethicon violated the state’s unfair competition and marketing laws by improperly overplaying the benefits and underplaying the risks of Prolift mesh implants.

With the case being the first of its kind to reach trial, much hinges on its ultimate outcome. If California is successful, other state AGs are likely to follow suit with similar cases. If J&J and Ethicon prevail, California’s lawsuit could be the first and last of its kind.

Source:

Sammon, J. (25 July 2019). During trial over vaginal mesh, Ethicon sales manager says reps not pushy. Northern California Record

Ethicon Mesh lawsuit news update: The Risks Are Downplayed Or Not Mentioned At All,’ Marketing Expert Testifies At Ethicon Mesh Trial

July 24, 2019
Author: Daniel Gala

As the first trial brought by a state attorney general against consumer-goods, pharmaceutical, and medical-device conglomerate Johnson & Johnson and its wholly-owned subsidiary Ethicon over allegedly defective surgical mesh implants proceeded through its first week, attorneys for the State of California called to the stand a professor of psychiatry who testified that a “reasonable consumer would be misled” by the marketing information provided by the defendant companies.

The lawsuit, which seeks roughly $700 billion in penalties, accuses the companies of violating state laws in what California Attorney General Xavier Becerra has said are deceptive marketing practices that downplayed the risks while exaggerating the efficacy of the Ethicon Prolift vaginal mesh device, which was used in the treatment of pelvic organ prolapse and urinary stress incontinence. Approximately 42,000 of the devices were implanted into women from 2008 to 2014.

According to Dr. Anthony Pratkanis, professor of psychiatry at University of California Santa Cruz, J&J and Ethicon used marketing to increase sales.

“Johnson & Johnson tried to create demand by raising awareness and prompting patients to seek treatments from doctors using the J&J mesh,” Dr. Pratkanis testified, as quoted by the Northern California Record.

Dr. Pratkanis said that J&J and Ethicon sought to instill certain notions in consumers through the use of marketing techniques such as buzz words, imagery, and social consensus.

“They are used to reinforce patient acceptance,” Dr. Pratkanis said of the techniques. “If everybody’s doing it, it must be right.”

While California is the first state to bring such a case to trial, approximately 100,000 federal lawsuits over surgical mesh implants have been filed in the United States alone. Most of these cases have been consolidated into multidistrict litigation (MDL) taking place in the Southern District of West Virginia.

Washington State had filed a lawsuit similar to California's, but Washington Attorney General Bob Ferguson announced on the eve of trial that his office had settled the claims for $9.9 million. California’s lawsuit was originally filed in 2016 by then-California Attorney General and now-US Senator and Democratic Party presidential candidate Kamala Harris.

Earlier this year, the Food and Drug Administration (FDA) banned the use of all transvaginal mesh implants in the US.

Source:

Sammon, J. (22 July 2019). Marketing expert testifies for state: J&J minimizes mesh implant risk in selling. Northern California Record

Ethicon Mesh lawsuit news update: At Calif. Ethicon Mesh Trial, Doctor Describes Pelvic Mesh Flaws In Gruesome Detail

July 19, 2019
Author: Daniel Gala

As the first case brought by a state attorney general over Ethicon mesh to reach trial proceeded through its first week, an expert witness for the State of California described in gruesome detail the manner in which mesh implants respond within the human body and the potential side effects that may occur as a result. In the lawsuit, the State of California, acting through Attorney General Xavier Becerra, is seeking nearly $1 billion in penalties over alleged violations of state law relating to accusations that mega-conglomerate Johnson & Johnson and its wholly owned subsidiary Ethicon mislead doctors and patients about the risks involved with the companies’ Prolift mesh implant.

“Mesh can rope and curl,” Dr. Bruce A. Rosenzweig, gynecologist and urinary tract specialist at Rush University Medical Center in Chicago, told the court when questioned by an attorney from the state AG’s office, according to a July 18 report by the Northern California Record. “[Particles that have broken off of mesh implants] stick through the vagina, leading to pain, or can migrate to other areas of the body where they should not be.”

Dr. Rosenzweig further testified in the jury-less bench trial that a 2011 study of similar devices had discovered that 42% of the women studied suffered from complications and that one-fifth of those complications were what researchers considered “serious.”

While Dr. Rosenzweig did concede under questioning that J&J and Ethicon had included information regarding such potential risks in the marketing materials for the Prolift device, he said the companies had not stated that these risks were a result of the design of the device itself.

“Did the company disclose the risk (of complications) in marketing materials?” an attorney asked Dr. Rosenzweig, according to an account published by the Northern California Record.

“Yes,” Dr. Rosenzweig responded.

“Did it say it was caused by the properties of the mesh itself?” an attorney asked.

“No,” Dr. Rosezweig responded.

Regardless of the outcome, the California AG’s case, taking place in California Superior Court in San Diego, is likely to be a harbinger of things to come. If California is successful in seeking some or all of the roughly $700 million in penalties it is seeking, other state attorneys general are likely to follow suit. However, if California is unsuccessful, it could mean the end of such lawsuits.

In April, on the eve of trial, Washington State Attorney General Bob Ferguson announced a $9.9 million settlement on similar claims brought on behalf of his state.

Source:

Sammon, J. (18 July 2019). Doctor says mesh can disfigure, causing women acute pain in J&J trial. Northern California Record

Ethicon Mesh lawsuit news update: Ethicon Mesh Trial Pitting Calif. AG Against J&J Begins In San Diego

July 17, 2019
Author: Daniel Gala

An attorney representing the People of the State of California began delivering opening remarks Monday, July 15, as a lawsuit brought against mega-conglomerate Johnson & Johnson by the California Attorney General’s Office became the first filed by a state AG over Ethicon surgical mesh to go to trial. Whether or not other state AGs follow suit will depend a great deal on the outcome of the California case.

“Your honor, we are here today because Johnson & Johnson and its wholly-owned subsidiaries Ethicon, Inc. and Ethicon U.S. LLC misrepresented to doctors and misrepresented to patients the dangerous properties of their mesh material, that leads to serious complications,” attorney Jinsook Ohta, representing the People of the State of California, told the court, according to video available on the Courtroom View Network. “They did this despite the fact that the company knew the risks, they went ahead and mislead the public and ignored the internal warning signs that they could have heeded to stop their deceptive marketing behavior.”

Originally filed in May 2016 by then-California Attorney General and now-United States Senator and Democratic Party presidential candidate Kamala Harris, the lawsuit accuses Johnson & Johnson and its subsidiary Ethicon of violating the state’s unfair competition law by having engaged in “unfair or fraudulent acts or practices” that “include, but are not limited to, material misrepresentations and/or omissions by Defendants regarding the safety and efficacy of surgical mesh for pelvic floor repair,” according to the 2016 Complaint.

The state’s allegations of fraud include accusations that “J&J has misleadingly touted that its products are ‘FDA approved,’ even though J&J’s surgical mesh devices were merely ‘cleared’ by the FDA under the 510(k) equivalency process” and that “J&J misrepresented the safety of its surgical mesh products by failing to disclose the known risks and complications to doctors and patients, which would have been material information in considering treatment options,” per the complaint.

In court Monday, the attorney for California, Ohta, began walking the court through the history and function of J&J transvaginal mesh devices used in the treatment of urinary stress incontinence and pelvic organ prolapse in women. According to Ohta, instead of using a mesh material specifically designed for use on the sensitive tissue of the vaginal wall, J&J and Ethicon used pre-existing mesh material intended for the treatment of hernias.

While the State of California is seeking the payment of hundreds of millions of dollars in penalties for the allegedly fraudulent misrepresentations, Attorney General for the State of Washington Bob Ferguson recently settled his state’s claims on the eve of trial for under $10 million, making the California trial a bellwether pivotal to the prospect of future cases.

The complex, sure-to-be-contentious trial is expected to last approximately two months.

Sources:

Courtroom View Network. (15 July 2019). Demo Clip_California v. Ethicon 07/15/19 AM (OPENINGS). CVN.com

Superior Court of the State of California for the County of San Diego. (Filed 24 May 2016). Complaint for Permanent Injunction, Civil Penalties, and Other Equitable Relief. The People of the State of California v. Johnson & Johnson, a New Jersey Corporation; Ethicon, Inc., a New Jersey Corporation, and Does 1 through 100, inclusive

Ethicon Mesh lawsuit news update: J&J, Calif. AG Prepare For Trial Over Nearly $1 Billion In Ethicon Mesh Penalties

July 15, 2019
Author: Daniel Gala

On Monday, July 15, the California attorney general and multibillion-dollar-conglomerate Johnson & Johnson will square off in what is expected to be a lengthy and highly contentious trial over claims that the company and its medical-device unit Ethicon Inc. falsely marketed polypropylene mesh devices used in the treatment of pelvic organ prolapse and stress urinary incontinence to the state’s female residents and their doctors.

While the case may be the first mesh case brought by a state AG against J&J to reach trial, if successful, it is unlikely to be the last.

The California AG’s lawsuit dates back more than three years to when now-US Senator and Democratic Party presidential candidate and then-California Attorney General Kamala Harris brought the claims following “a multistate investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women,” according to a May 2016 press release from the California AG’s office.

“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” then-Attorney General Harris said at the time of the lawsuit’s filing.“Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.”

Despite the vast majority of states and the District of Columbia having been involved in the multistate investigation, California Attorney General Xavier Becerra is the first state AG to bring claims resulting from that investigation to trial.

In April, Washington State Attorney General Bob Ferguson announced on the day his state’s trial with J&J was set to begin that the parties had reached a settlement under which the company would pay roughly $10 million to “avoid going to trial for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices.”

The California trial involves far larger sums, with Attorney General Becerra seeking nearly $1 billion in penalties under the California Unfair Competition Law and False Advertising Law. The state alleges that J&J engaged in over 190,000 “targeted representations” as defined under California law, with the state seeking $5,000 in penalties per representation, according to Law360 . This makes the total penalties sought roughly $960 million.

Whatever the outcome, experts anticipate the trial being a harbinger of things to come. While a victory for the state likely would encourage other state AG’s to follow suit, or at least give them greater leverage in reaching their own settlements, a loss for California also could lead other states to back down in their enforcement efforts.

“If this is something that can really gain traction and be successful and deliver a large payout, other states will pursue it,” Amy Alderfer, a mass tort defense attorney, told Law360 before adding, “If California is not successful, coupled with that fairly anemic settlement in Washington state, I don’t know if you’re going to see a lot more of these.”

Source:

Siegal, D. (12 July 2019). Breaking Down J&J And California’s $1B Pelvic Mesh Trial. Law360

State of California Department of Justice. Office of the Attorney General. (24 May 2016). Attorney General Kamala D. Harris Files Lawsuit Against Johnson & Johnson for Deceptive Marketing of Surgical Mesh Products. Press Release

Washington State Office of the Attorney General. (22 April 2019). Johnson & Johnson Will Pay $9.9 Million For Failing To Disclose The Risk Of Its Surgical Mesh Devices. News Releases

Mesh lawsuit news update: Now-Sealed Complaint Alleges Massive Fraud By Plaintiffs Attorneys In Mesh MDLs

July 4, 2019
Author: Daniel Gala

In a now-sealed complaint filed June 13 in the US District Court for the Southern District of Texas, attorneys representing four women who were formerly plaintiffs in historically large multidistrict litigation (MDL) over transvaginal mesh (TVM) implants allege massive fraud by the women’s former attorneys. The facts asserted in the complaint outline a complex and far-reaching scheme of self-dealing and profit maximization, oftentimes in apparent violation of the attorneys’ and law firms’ fiduciary duty to their clients.

The previously public complaint, sealed by order of US District Judge Andrew Hanen on July 2 but posted online by Reuters, further alleges that the improprieties may have impacted hundreds if not thousands of cases handled by the defendants. The alleged improprieties include such egregious failures as not filing numerous of their clients’ lawsuits until after the statute of limitations had lapsed, rendering those claims time-barred, and then attempting to cover up this fact by lumping the time-barred claims in with valid claims in an aggregate settlement agreement.

The facts asserted center around defendant law firm Clark, Love & Hutson, G.P. (CLH), which, along with a closely affiliated firm, represented approximately 26,000 women in the transvaginal mesh (TVM) MDLs. One of the largest legal actions in the history of the United States, the TVM litigation included roughly 100,000 individual claims spread across multiple MDLs, all located in the US District Court for the Southern District of West Virginia and presided over by US District Judge Joseph R. Goodwin.

The transvaginal mesh MDLs have lasted for years and, though terms of any settlement agreements have largely remained confidential, it is broadly accepted based on financial disclosures and other information that medical device companies have paid billions of dollars to settle claims of serious injury caused by their TVM implants.

According to the complaint, Clark, Love & Hutson, along with the Lee & Murphy Law Firm (LM), the named partners of which are former CLH attorneys, worked together to capitalize on these cases by bringing in as many clients as possible. The firms specialized in handling tens of thousands of mass tort cases per year.

“CLH focuses on mass torts, particularly those involving pharmaceutical drugs and medical devices,” the complaint states. “CLH typically handles a docket of 40,000 to 50,000 individual plaintiffs (or entities) a year.”

CLH manages this massive caseload with a typical staff of three named partners along with a team of eight to ten associate attorneys and in association with the Lee & Murphy Law Firm (LM). The complaint accuses the firms and the member attorneys of seeking to extract every bit of value possible from their clients cases by engaging in a number of schemes.

Litigation & Records Services (LRS)

To begin with, the complaint alleges that the attorneys at CLH and LM formed their own litigation services company in order to charge their clients extra for services normally included within attorneys fees. This company was formed by CLH and LM and staffed with the law firms’ own people, according to the complaint, being little more than a shell to extract additional profits.

“On information and belief, in order to save on these substantial costs [of litigation support services] and increase their own profits on clients’ cases, CLH and LM formed their own litigation support team, Litigation & Records Services (“LRS”),” the complaint alleges. “By forming LRS, CLH and LM were able to collect attorneys’ fees and then also charge for additional back office support, data entry, records retrieval, and medical review services, which would normally be included as part of the work covered by attorneys’ fees. In other words, LRS enable CLH and LM to share in additional payments to the clients above and beyond the attorneys’ fees.”

Using television advertisements urging recipients of TVM implants with potential claims to call a 1-800 number, the firms were able to attract tens of thousands of clients.

“All told, CLH and LM signed up, and were retained by, over 26,000 TVM clients,” reads the complaint [emphasis in original].

The “Lien Machine”

One of the most nefarious allegations contained in the complaint involves its description of the so-called “lien machine”, a complex scheme that involved lawyers, doctors, and medical lenders all manipulating their clients, patients, and customers in an effort to render their legal claims more valuable and to extract a bigger portion of any eventual recovery.

“To increase the value [of the women’s TVM claims], upon information and belief, Defendants contacted clients who had not had their TVM implants surgically removed and convinced them to have a consultation with a pre-determined doctor who, in turn, would attempt to convince the clients to undergo a revision surgery,” the complaint asserts. “At first glance, it would appear that Defendants were performing a good deed for their clients. However, what Defendants were attempting to do was to significantly increase the value of its entire portfolio of clients in anticipation of an aggregate settlement for the purpose of increasing Defendants’ attorney’s fees.”

The complaint continues: “The revision surgeries came at an exorbitant cost, however, which created what has been referred to as the ‘Lien Machine.’”

As asserted, the Lien Machine operates as follows: First, attorneys push their clients to have revision surgery from a doctor with whom the lawyer or law firm already has an existing relationship. In order to pay for the surgery, it is arranged that the doctor will sell the bill for the surgery to a “private surgical funder”, an entity that purchases patient debt from doctors’ offices and makes its money by collecting on that debt. In the case of the Lien Machine, the arrangement is set up in such a way that the private surgical funder will have the right to extract the cost of the procedure from any eventual recovery for the patient/plaintiff.

In the process, the complaint alleges, the doctors and private surgical funders have charged patients many time the normal rate for the revision surgeries.

“While private insurers typically pay doctors just $6,000.00 for the same surgery, MedStar would acquire the surgical bill, which had been pumped up to $37,000.00,” the complaint asserts.

The complaint spells out how, given the volume of clients the defendant law firms and lawyers were handling, they stood to recover millions of dollars in additional attorneys fees by urging their clients to enter the “Lien Machine”.

The Lessons To Be Learned

Mass torts involving tens of thousands of cases and millions if not billions of dollars in potential damages will inevitably attract unscrupulous attorneys and law firms who are drawn to the cases out of greed and not out of a motivation to seek the justice their clients deserve. Unfortunately, the legal landscape is laden with profit-driven attorneys such as these, who end up victimizing their clients a second time after they already have suffered so much.

That’s why your choice of attorney is pivotal to the ultimate success of your case. You need someone who sees you as a human being and who you can trust to stand up for you and fight for your rights, not someone who simply views you as another case among thousands.

Sources:

Frankel, A. (2 July 2019). Judge seals ex-clients’ fraud complaint against co-lead counsel in pelvic mesh case. Reuters

United States District Court for the Southern District of Texas Houston Division. (13 June 2019). Complaint. Case 4:19-cv-02148. Tammy Alvarado, Clara Redmond, Tammy Haga, and Amy Ruminski, Plaintiffs, v. Clark, Love & Hutson, G.P., Lee & Murphy Law Firm, G.P., Clayton A. Clark, Clayton A. Clark, Esq., PC, Scott A. Love, Scott A. Love, PC, Shelley Hutson, Hutson Law Firm, P.C., James Lee, Jr., James Lee Law Firm, PC, and Erin Murphy. Posted by Reuters

Mesh lawsuit news update: Law Firm Accused Of Fraud in Pelvic-Mesh MDLs Has Complaint Against It Sealed

July 3, 2019
Author: Daniel Gala

On Monday, July 2, following an order by U.S. District Judge Andrew Hanen, copies of a class action complaint filed against law firm Clark, Love & Hutson, G.P. and others suddenly disappeared from legal-document services like Westlaw and Pacer. The disappearance was a result of Judge Hanen’s approval of a motion by the defendant law firm requesting that the complaint against it be sealed.

Even the motion to seal the complaint is itself under seal, according to Reuters legal reporter Alison Frankel. Frankel, who obtained a copy of the original complaint prior to its being placed under seal, has posted a copy here.

The class action complaint was brought by former clients of Clark, Love & Hutson, as well as several other law firms and individual attorneys, who accuse the law firms and lawyers of bungling their representation in lawsuits over allegedly defective transvaginal mesh (TVM) implants, specifically by failing to file their clients’ claims within the statute of limitations, impacting the amount of their eventual recovery.

“This case involves the Defendants’ breach of the fiduciary duties owed by them to their clients in connection with their failure to disclose that they failed to timely file cases within the statue of limitations for hundreds, and potentially thousands of clients,” the complaint alleges.

In addition to Clark, Love & Hutson, other named defendants included in the complaint are the Lee & Murphy Law Firm, G.P.; Clayton A. Clark (as an individual); Clayton A. Clark, Esq., PC; Scott A. Love (as an individual); Scott A. Love, PC; Shelly Hutson (as an individual); Hutson Law Firm, PC; and Erin Murphy (as an individual).

The complaint accuses the defendants of failing to meet statutory deadlines for hundreds if not thousands of their clients complaints, then attempting to conceal this fact from their clients by rolling all of the cases— including those that were time-barred and those that were not—into a massive global settlement.

“Defendants, lawyers who were handling approximately 26,000 individual cases just with respect to TVM [transvaginal mesh] alone, missed the statute of limitations filing deadlines for hundreds, and potentially thousands of cases, and then, rather than disclosing that problem, included those time-barred cases in aggregate settlements totaling nearly a billion dollars,” the complaint alleges.

“Defendants did this without telling Plaintiffs, and upon information and belief, without telling any of their participating clients—either (a) the clients who claims were being barred by the statute of limitations or (b) those clients whose claims were not subject to such a defense,” the complaint continues. “As a result, the Plaintiffs and Defendants’ TVM clients participated in the settlements without understanding that the aggregate settlement included many time-barred claims.”

The class action complaint seeks to recover not only the attorneys fees extracted from the clients’ settlements—amounting 40% of the settlement amount—but also to “recoup damages for the value of [the clients’] claims had they been timely filed and properly handled by Defendants.”

The complaint places the value of each of those claims at $20.9 million.

While, given the allegations, it is no wonder why the defendant law firms and lawyers would want the complaint hidden from public view, according to reporting by Reuters’ Frankel, it is rare for courts to grant such requests in cases featuring claims levied against legal representatives because of the significant public interest involved when the allegations are related to the attorneys’ fulfillment of their fiduciary duty to clients.

“It’s very unusual for judges to seal allegations against law firms, according to Kevin Rosen of Gibson, Dunn & Crutcher and Paul Koning of Koning Rubarts, who both frequently represent law firm defendants,” Frankel writes. “It’s still more unusual, Koning said, for a law firm defendant’s sealing motion itself to be filed under seal. There’s an obvious public interest in allegations that law firms have breached their duty to clients, Koning said.”

One reason Judge Hanen may have agreed to seal the complaint is because it contains specific information about the amount of money received by the plaintiffs pursuant to confidential settlements with the makers of transvaginal mesh implants.

For example, the complaint reveals that plaintiff Tammy Alvarado received a gross settlement of $137,943.00, of which she received $48,448.10. Plaintiff Clara Redmond received a gross settlement of $123,066, of which she received $68,597.09. Plaintiff Tammy Haga received a gross settlement of $98,000, of which she received $55,419.92. And plaintiff Amy Ruminski received a net recovery of approximately $11,000.

According to Frankel’s report for Reuters, attorneys for the defendant law firms and lawyers said their clients were dismayed that the women’s attorneys had breached the confidentiality of those agreements by including such details in the complaint.

Dale Jefferson, representing the law firm Clark, Love & Hetson, told Reuters that his client was “shocked” that the plaintiffs’ attorneys had including the confidential information in a public filing, accusing opposing counsel of having “deliberately engaged in shady behavior” and having “walked their clients into contempt for breaching the agreements” confidentiality terms.

“There was absolutely no reason for these plaintiffs lawyers to do what they did,” Jefferson said, per Reuters, adding that the information easily could have been redacted from the complaint or included in separate exhibits that were filed under seal.

However, professor Elizabeth Burch of the University of Georgia, who also spoke to Reuters, disagreed, arguing that for “accusations about lawyers (who were in leadership positions no less) breaching their fiduciary duties to clients in one of the biggest proceedings in history” the public interest in transparency should prevail.

Sources:

Frankel, A. (2 July 2019). Judge seals ex-clients’ fraud complaint against co-lead counsel in pelvic mesh case. Reuters

United States District Court for the Southern District of Texas Houston Division. (13 June 2019). Complaint. Case 4:19-cv-02148. Tammy Alvarado, Clara Redmond, Tammy Haga, and Amy Ruminski, Plaintiffs, v. Clark, Love & Hutson, G.P., Lee & Murphy Law Firm, G.P., Clayton A. Clark, Clayton A. Clark, Esq., PC, Scott

Ethicon lawsuit news update: For 9th Time, Jury Finds J&J Liable In Philly Mesh Mass Tort

July 1, 2019
Author: Daniel Gala

For the ninth time, a Pennsylvania state-court jury has found Johnson & Johnson liable for injuries suffered by the recipient of a pelvic-mesh implant made by J&J unit Ethicon Inc., awarding a woman $500,000 in damages as part of a mass tort program taking place in the Philadelphia Court of Common Pleas. While the verdict added to plaintiffs’ winning record in the program, the amount of damages awarded was markedly lower than in other cases.

“We are pleased that this is the ninth time in these vaginal mesh cases that Johnson & Johnson has been found to have acted wrongfully,” Elia Robertson, an attorney representing the plaintiff, told Law360.

The verdict, announced June 28, was in favor of plaintiff Linda Dunfee, but the six-figure damages award was significantly lower than that in other cases, with nearly $350 million in total damages having been awarded thus far in the Ethicon mesh mass tort program.

Dunfee originally sued the companies in October 2015, alleging that the health complications she suffered following implantation of Ethicon ProLift surgical mesh have made it too painful for her to engage in sexual intercourse with her husband. Dunfee also was forced to undergo surgery to remove portions of the ProLift implant that had become embedded in her tissue.

Dunfee’s attorneys argued that ProLift was defectively designed because the rigid materials utilized were ill-suited for implantation into the soft tissues of the pelvic region.

“If there were a museum for defective products, this thing would be in the lobby front and center,” an attorney for Dunfee argued in court, as quoted by Law360.

Despite the plaintiff having prevailed on design defects and other claims in nine of the 11 cases brought to trial thus far, J&J and Ethicon continue to argue that their medical devices are not to blame for the plaintiffs’ injuries and the resulting debilitating pain.

“Just because Ms. Dunfee experienced an erosion and pain with sex following her ProLift procedure does not mean she’s entitled to money,” a lawyer for Ethicon told jurors during closing arguments, according to Law360.

The company even went so far as to release a follow-up statement in which it said the product had worked exactly as intended.

“While Ethicon empathizes with women who experience medical complications, this verdict is inconsistent with the science and with Ethicon’s actions,” the statement read, per Law360. “In this case, ProLift worked as intended and effectively addressed the pelvic organ prolapse.”

Source:

Fair, M. (28 June 2019). J&J Hit With $500K Verdict In Latest Philly Mesh Case. Law360

Bard Mesh Lawsuit News: Parties Agree To Medical Examination Rules For First Bellwethers In Bard, Davol Mesh MDL

June 28, 2019
Author: Daniel Gala

As multidistrict litigation (MDL) involving alleged defects to hernia mesh manufactured by Davol, Inc. and C.R. Bard Inc. continues to make its way through pretrial discovery proceedings toward the first bellwether trials, the parties have agreed to procedures governing medical examinations for and the collection of specimens from potential bellwether plaintiffs, according to a case management order issued June 14. .

“It is the intention of the Parties that all Material that has not previously been analyzed or tested, be preserved in a manner that permits the Parties equal access to and analysis of the Material,” states Case Management Order No. 19, signed by Chief United States District Judge Edmund A. Sargus, Jr. and United States Magistrate Judge Kimberly A. Jolson. “With one exception, the Parties will not interfere with or circumvent the analysis and preservation of the Materials by the Facilities to which any of the Plaintiffs’ treating physicians have sent or will send the Materials in the usual course of business. The exception is where, in the usual course of business, the Facility would destroy the Materials.” .

The order defines “Materials” to include “any and all gross and microscopic material purported to contain mesh or any other tissue excised or explanted from Plaintiff, including but not limited to, any pathology evidence, mesh explants, history slides, paraffin blocks containing tissue, loose mesh, mesh and tissue, dry mesh, and gross specimens.” .

The order spells out the manner in which certain materials are to be handled by the parties and by professional custodians, with pains taken to ensure that, to the extent practicable, the parties have equal accident to the evidence. Where the parties are unable to come to terms among themselves as to the division of certain evidence, the order instructs that they are to meet and confer in an attempt to reach agreement, seeking the court’s intervention if necessary. .

However, the order also makes clear that the parties in no way have waived their right to contest the manner in which the evidence has been preserved. .

“Nothing in this Order shall be construed to preclude a Party from challenging the method of preservation of any Materials,” Paragraph X to the order states in full. .

The massive MDL, established by an August 6, 2018 Transfer Order issued by the Judicial Panel on Multidistrict Litigation (JPML), centralized federal products liability claims against Davol and Bard. .

“All of the actions share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections,” the JPML’s transfer order states. .

Sources: .

United States District Court Southern District of Ohio Eastern Division. (14 June 2019). Case Management Order No. 19 (Stipulated Pathology Examination and Division Protocol for Bellwether Pool Cases). MDL 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation. Court website .

United States Judicial Panel on Multidistrict Litigation. (6 August 2018). Transfer Order. MDL No. 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation. Court website

Bard Mesh Lawsuit News: CR Bard Wins Dismissal Of Claims By Arguing Pelvic Mesh Is “Unavoidably Unsafe”; Judge Asks For Immediate Appeal

June 27, 2019
Author: Daniel Gala

Attorneys for medical-device maker C.R. Bard Inc. won dismissal of a woman’s strict liability claims on Tuesday, June 26 after having successfully argued that Pennsylvania state law exempts products that are “unavoidably unsafe” from such claims and that Bard’s pelvic mesh implants qualify as such products.

However, citing a lack of clear precedent by either the Pennsylvania Supreme Court or the Third Circuit Court of Appeals, the federal district judge making the ruling certified the matter for immediate appeal.

“Recognizing that the strict liability claim for a manufacturing defect is open to debate and is a controlling question of law, the court certified this question to the Third Circuit for interlocutory appeal,” US District Judge Eduardo Robreno explained, according to Law360 .

Plaintiff Sarah Rosenberg sued CR Bard after she suffered severe complications due to a Bard pelvic mesh device she had surgically implanted in November 2012 to treat urinary stress incontinence. Instead of treating her condition, the mesh sawed through the surrounding tissue, causing intense pain and serious tissue damage. Rosenberg says the pain has left her unable to have sexual intercourse.

Rosenberg sued in November 2018, with attorneys for Bard arguing that her strict liability claims should be dismissed based on a comment to a 2014 Pennsylvania Supreme Court decision. The comment references a portion of the Restatement (Second) of Torts, which holds that most strict liability claims should not apply to the makers of “unavoidably unsafe products”, specifically naming products that “cannot be sold except to physicians or under the prescription of physicians”, as quoted by Law360.

Judge Robreno agreed that, based on the comment, it is logical that such exemptions should apply to the makers of medical devices.

“[The comment’s] plain language appears to include prescription medical devices because ‘prescription’ medical devices, by definition, are products that require a physician’s prescription, just as ‘prescription’ drugs also, by definition, require a physician’s prescription,” Judge Robreno said, per Law360.

However, in his certification for immediate appeal, Judge Robreno noted the lack of clear appellate precedent on the issue despite a lower-court split in rulings. Out of 14 previous similar cases cited by the judge, in nine instances the court had allowed strict liability claims to proceed while in 5 cases the court had tossed them.

“There is substantial ground for difference of opinion as to whether, notwithstanding the adoption of [the comment], there remains a carve-out for strict liability manufacturing defect claims for prescription medical devices,” Judge Robreno said, according to Law360.

Source:

Fair, M. (27 June 2019). Judge Asks 3rd Circ. To Probe Pa. Device Defect Claim. Law360

Ethicon Mesh Lawsuit News: J&J Files Opening Brief In Pa. Supreme Court Appeal of $12.5M Mesh Verdict

June 26, 2019
Author: Daniel Gala

On Friday, June 21, consumer-goods, medical-device, and pharmaceutical mega-conglomerate Johnson & Johnson filed the opening brief in its appeal to the Pennsylvania Supreme Court of a $12.5-million verdict handed down by a Philadelphia-based jury that found the company and its unit Ethicon Inc. liable for injuries sustained by a woman as a result of an Ethicon pelvic-mesh device she had surgically implanted in 2009.

In the appeal, Johnson & Johnson has argued that the Philadelphia Court of Common Pleas lacked jurisdiction over the case because the lower-court plaintiff is a resident of Indiana and the defendants lack the requisite legal connections to the state, as well.

The outcome of J&J’s appeal to the state high court potentially has ramifications for other cases filed as part of an ongoing mass tort program taking place in Pennsylvania state court in Philadelphia. Attorneys representing J&J repeatedly have challenged that court’s authority to exercise jurisdiction over cases involving out-of-state plaintiffs, saying such lawsuits should not be a part of the program.

The mass tort program already has resulted in several multi-million-dollar jury verdicts against J&J and Ethicon. Two of these cases featured out-of-state plaintiffs and potentially may be affected by the supreme court’s ruling.

In its brief to the Pennsylvania Supreme Court, J&J argued that the lawsuit’s connections to the state of Pennsylvania are tenuous and fail to meet the legal standards required for the courts of that state properly to exercise jurisdiction over the case. According to J&J, the lawsuit’s only connections to Pennsylvania are that a manufacturer of the mesh in question and a doctor who tested it are based there.

J&J argues that this amounts to an insufficient basis for establishing jurisdiction.

“If that were sufficient for jurisdiction, then the due process clause, the principles of federalism that animate it, and the statutes of this commonwealth would be essentially meaningless and would impose no restraint at all on the type of case that may be brought in our courts,” attorneys for J&J say in their brief, according to Law360.

The original lawsuit was filed by plaintiff Patricia Hammons, who received an Ethicon Prolift pelvic-mesh implant in 2009 and subsequently suffered severe side effects and debilitating pain when the implant became embedded in her bladder. Hammons said the condition had left her unable to have sex with her husband.

A Philadelphia jury awarded Hammons $5.5 million in compensatory damages and $7 million in punitive damages. The Philadelphia Superior Court later upheld the verdict on appeal by J&J, saying that the plaintiff had demonstrated that J&J and Ethicon possessed business ties to the state adequate to support the court’s exercise of jurisdiction.

J&J vehemently disagreed, leading to the instant appeal.

“Specific jurisdiction can exist over a cause of action only to the extent the specific cause of action arose out of defendants’ conduct in Pennsylvania. There was no such cause of action here,” the company argued to the state high court, per Law 360. “It is not enough to show, as the Superior Court thought, that there are acts in Pennsylvania that are ‘affiliated’ with the case or in some small way related to the case as a whole.”

An attorney for Hammons expressed confidence in the ultimate outcome of J&J’s appeal, pointing out the conglomerate’s losing track record on the issue.

“There is clearly an adequate nexus between the harm caused to Ms. Hammons and Pennsylvania given Ethicon’s decisions to engage in significant activities in Pennsylvania related to pelvic mesh including acts related to mesh design, production and marketing,” Shanin Specter, an attorney for Hammons, told Law360. “That’s why J&J is zero for four on the jurisdictional issue. We are confident that the Supreme Court will uphold the Superior Court’s unanimous decision affirming the trial court.”

Source:

Salvatore, C. (24 June 2019). Mesh Case Has Weak Ties To Pa., J&J Tells State Justices. Law360

Mesh News: New Meta-Study Shows ‘Jury Is Still Out’ On Long-Term Safety Of Mesh Implants

June 24, 2019
Author: Daniel Gala

With the makers of surgical mesh implants facing tens of thousands of products liability lawsuits and billions of dollars in settlements and damages in the United States alone, the long-term safety of such devices, including those still on the market today, remains an open question, according to a recently published meta-analysis of 175 clinical studies that appeared June 5 in the BMJ (formerly the British Medical Journal).

“Based on our findings, the jury is still out on the long-term risks of vaginal mesh for stress urinary incontinence,” Dawn Craig of Newcastle University in the UK, one of the study’s co-authors, told Reuters via email.

The meta-analysis examined “175 randomised [sic] controlled trials assessing a total of 21 598 women” with the intention of “compar[ing] the effectiveness and safety of surgical interventions for women with stress urinary incontinence,” according to the study’s abstract.

While the researchers did find that the various surgical methods examined showed signs of short-term efficacy in the treatment of urinary stress incontinence, a common condition that affects more than 10% of women, they also concluded that “[d]ata on long term effectiveness and adverse events are, however, limited.”

This lack of data is due in large part to a dearth of long-term studies on the safety and efficacy of mesh implants.

“We do not have good long-term follow up data for any of these surgeries as the trials analyzed lasted up to five years at most and mesh can cause problems many years after insertion,” Rufus Cartwright of Oxford University Hospitals NHS Trust, co-author of a BMJ editorial published alongside the meta-analysis, told Reuters.

Given the many thousands of lawsuits filed by patients around the world who claim that they have suffered severe injuries as a result of defectively designed surgical mesh implants, one might hope that medical-device regulators would begin to approach the devices with greater scrutiny, at least requiring long-term studies to demonstrate the devices are safe and effective over the course of the many years they are intended to remain in a patient’s body. Particularly in the United States, where the FDA recently banned all transvaginal mesh implants after allowing them on the market for years based on extremely limited or nonexistent clinical data, one might hope that this recent meta-analysis would be ringing alarm bells.

Sources:

Rapaport, L. (13 June 2019). Mesh implants work for bladder leakage, long-term safety unclear. Reuters

Craig, D. et al. (5 June 2019). Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomized controlled trials. BMJ (Formerly British Medical Journal)

Carter, E. et al. (5 June 2019). Surgical interventions for stress urinary incontinence. BMJ (Formerly British Medical Journal)

Mesh Lawsuit Settlement News: Judge Appoints Settlement Master in Boston Scientific Mesh MDL

June 18, 2019
Author: Daniel Gala

In the latest sign that long-running multidistrict litigation (MDL) over pelvic mesh devices made by Boston Scientific Corp. is winding down, the presiding judge issued June 12 an order appointing a settlement master to oversee the execution of a confidential settlement agreement reached between the defendants and Johnson Law Group, which is representing a number of plaintiffs in the MDL.

In the order, US District Judge Joseph R. Goodwin, writing for the Southern District of West Virginia Charleston Division, approved Johnson Law Group’s request on behalf of its clients to appoint as settlement master Archer Systems/Matthew W. Frazier “to assist in the administration and implementation” of the settlement agreement.

As such, the court explicitly grants Archer Systems/Matthew W. Frazier “the authority to…determine that the calculation, allocation, division, and distribution of settlement payments among the claimants pursuant to the terms of the Settlement Agreement provides for fair and reasonable compensation for each client based on the facts and circumstances of this litigation.”

Additionally, the settlement master is authorized to “[s]erve as an arbitrator in binding arbitration for any insurance companies or other third-parties who agree in writing with Plaintiffs’ Counsel to submit any disputes regarding whether or not health care coverage and reimbursement claims fall within the scope of the litigation and [are] therefore subject to insurance liens or subrogation rights.” In such disputes, the settlement master is further authorized to determine “the amount of such liens under terms of the applicable agreements.”

Finally, the order also grants the settlement master the authority to act “as mediator of claims if jointly requested by Plaintiff’s Counsel” and defendants. Beyond the explicit authorizations contained in the June 12 order, additional duties of the settlement master are to be spelled out in greater detail in the confidential settlement agreement itself. The order does not state how many cases potentially are covered by the settlement between the defendants and Johnson Law Group.

In total, the Boston Scientific Mesh MDL, which has been ongoing since February 2012, has included 26,026 cases, of which 17,636 had closed as of June 18, according to the court’s list of member cases. This leaves over 8,000 cases, or nearly one-third of the total, yet to be resolved.

Sources:

United States District Court for the Southern District of West Virginia Charleston Division. (12 June 2019). Pretrial Order #211 (Order Appointing Archer Systems/Matthew W. Frazier As Settlement Master For Private Settlement Agreement Between Boston Scientific And Certain Plaintiffs’ Counsel). MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation. Court Website

United States District Court for the Southern District of West Virginia Charleston Division. (Accessed 18 June 2019). MDL 2326 Member List of Cases. MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

Mesh Lawsuit Settlement News: Court Approves Qualified Settlement Fund, Appoints Settlement Master For Covidien Mesh Claims

June 18, 2019
Author: Daniel Gala

In a pair of orders issued June 12 order #1; order#2 , the judge overseeing federal multidistrict litigation (MDL) over pelvic-mesh implants approved a qualified settlement fund and appointed a settlement master to oversee the resolution of claims brought by certain plaintiffs against the medical-device maker Covidien. The orders are the latest sign that the long-running litigation, which has been ongoing since 2010 and has involved over 15,700 total cases, continues to near its resolution, albeit slowly.

Pursuant to an unopposed motion by the plaintiffs, US District Judge Joseph R. Goodwin named Randi S. Ellis “Settlement Master for the administration of the settlement reached between Plaintiffs’ Counsel and Covidien, related to the implantation of Covidien Pelvic Repair Products.” The duties of the settlement master are to be “set forth in the Settlement Agreement.”

Significantly, Pretrial Order #307, appointing the Settlement Master, defines the party “Covidien” to include “Covidien LP, Tyco Healthcare Group LP, Covidien Inc., Covidien plc, United States Surgical Corporation, Sofradim Production, Tissue Science Laboratories, Limited, Medtronic, Inc., and Medtronic plc (“Covidien”), but not C.R. Bard, Inc.” (italics added)

Of the 15,753 total cases in the MDL, 13,685 had closed as of June 17, according to the court’s list of member cases. This leaves 2,068 cases, or about 13% of the total, still active. It was not immediately clear how many of these remaining cases would be covered by the Covidien settlement.

Writing for the US District Court for the Southern District of West Virginia Charleston Division, Judge Goodwin in Pretrial Order #306 named the Garretson Resolution Group as fund administrator, with CIBC Bank, USA, to serve as custodian of the qualified settlement fund. The MDL centralized federal products liability claims involving alleged defects to mesh pelvic repair systems designed and sold by C.R. Bard, Inc. and Covidien, among other defendants. Plaintiffs have brought tens of thousands of federal cases in the United States alone alleging injuries caused by surgical mesh implants.

Sources:

United States District Court For The Southern District of West Virginia Charleston Division. (12 June 2019). Pretrial Order #307 (Order Appointing Randi S. Ellis As Settlement Master For Settlement Agreement Between Covidien And Certain Plaintiffs’ Counsel). MDL No. 2187. In Re: C.R. Bard, Inc. Pelvic Repair Systems. Court Website

United States District Court For The Southern District of West Virginia Charleston Division. (12 June 2019). Pretrial Order #306 (Order Establishing Qualified Settlement Fund – Napoli Shkolnik). MDL No. 2187. In Re: C.R. Bard, Inc. Pelvic Repair Systems. Court Website

United States District Court For The Southern District of West Virginia Charleston Division. (Accessed 17 June 2019). MDL 2187 Member List Of Cases. MDL No. 2187. In Re: C.R. Bard, Inc. Pelvic Repair Systems. Court Website

Mesh Lawsuit Update: Class Action Accuses Law Firms Of Stealing Settlement Funds From Mesh Plaintiffs

June 13, 2019
Author: Daniel Gala

In yet another stunning example of the importance of choosing a legal team you can trust, a proposed class action lawsuit has accused multiple law firms of stealing settlement proceeds from clients the firms were representing as plaintiffs in surgical mesh litigation taking place in New Jersey state court. The proposed class action lawsuit was filed in New Jersey’s Bergen County Superior Court.

Made public June 12, the class action accuses the defendant law firms of extracting legal fees and expenses from the settlements of nearly 1,500 pelvic mesh plaintiffs based on retainer agreements that either did not exist or which were legally invalid.

“The defendants were negligent in that their conduct fell below and breached the applicable standard of care, because they failed to ensure that all the cases were retained, filed, litigated, settled, and disbursed in accordance with New Jersey law,” the complaint alleges, according to Law360 .

The defendant law firms include New Jersey-based Nagel Rice LLP and the Texas-based firms Potts Law Firm, Bailey Cowan Heckaman PLLC, Junell & Associates PLLC, and Burnett Law Firm. The complaint also named Houston-based attorney Annie McAdams as defendant.

“On information and belief, defendants performed very little, if any, actual legal services of value on behalf of the plaintiff and the proposed class members, thus entitling defendants to little or no recovery in quantum merit,” the complaint claims, as quoted by Law360.

A hearing is scheduled for July 11 at which Superior Court Judge Rachelle Lea Harz will hear arguments as to whether the defendant law firms should be required to hand over certain documents demanded by the plaintiffs, including “a full accounting” of all retainer agreements and all funds deducted from the plaintiffs’ settlements.

The defendants struck back publicly against the claims contained in the proposed class action. Attorney Annie McAdams, named as a defendant, represented Debbie Gore in pelvic-mesh litigation in New Jersey. Gore is now named plaintiff in the class-action complaint.

“This is the first I have heard Ms. Gore was unsatisfied,” McAdams said, per Law360. “Ms. Gore chose to accept her settlement. If she was unhappy and did not want [to] accept the settlement, I would still be fighting for her today, as I continue to handle many cases that have not resolved. It is unfortunate victims like Ms. Gore are being exploited in this manner.”

The complaint alleges numerous violations of New Jersey law pertaining to attorney retainer agreements, including improper fee-sharing among attorneys without the client’s explicit consent. Plaintiffs further claim that contingency-fee provisions contained within the agreements also violated New Jersey law. New Jersey law limits contingency fees to one-third of proceeds up to $750,000, with progressively smaller percentages allowable on figures exceeding that amount. Gore’s contingency agreement with defendants allegedly called for the attorneys to receive 40% of any recovery plus expenses.

The 1,450 cases referenced in the complaint were part of multicounty litigation (MCL) taking place in New Jersey state court. The MCL centralized New Jersey state court claims against Johnson & Johnson and C.R. Bard over pelvic mesh implants sold by the companies and their subsidiaries.

Source:

Wichert, B. (12 June 2019). NJ, Texas Firms Unlawfully Pocketed Mesh Funds, Suit Says. Law360

Mesh Lawsuit Update: Investor Lawsuit Accuses Boston Scientific Of Using Counterfeit Resin In Mesh Implants

June 5, 2019
Author: Daniel Gala

A class action lawsuit filed on behalf of investors in Boston Scientific Corporation has accused the company’s officers of repeatedly and over a period of years making materially false and misleading statements to investors about relevant business operations, including Boston Scientific’s use of counterfeit resin from China in certain of its surgical mesh implants, a shareholders alert distributed by the law firm representing the prospective class stated.

According to the alert, shareholders who held Boston Scientific securities between February 26, 2015 and April 16, 2019 have until June 24, 2019 to file their claims to become class members.

The class action complaint accuses Boston Scientific and certain of its officers of violating federal securities law in misleading investors for years as to the true state of the company’s surgical mesh implant business, including the safety of its devices and the likelihood of a regulatory crackdown such as the total ban instituted on the US market in April 2019.

“The complaint alleges that through the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies,” the shareholder alert states.

For years, Boston Scientific deceived shareholders as to the true level of risk involved in its surgical mesh business, failing to give investors a true picture of its sustainability, or lack thereof.

In one of the more striking examples alleged in the complaint, shareholders accuse Boston Scientific officers of exposing the company to liability by using counterfeit resin from China in its surgical mesh products.

“Separately, the Company had sold vaginal mesh implants containing counterfeit or adulterated resin products imported from China,” the shareholder alert claims, adding elsewhere that this alleged practice had led to the filing of a putative class action lawsuit in FY2015.

However, the final blow to Boston Scientific’s transvaginal mesh business came on April 16, 2019, when the United States Food and Drug Administration FDA ordered a stop to all sale and distribution of transvaginal surgical mesh implants that previously had been approved for the treatment of pelvic organ prolapse. Such devices had represented a key aspect of Boston Scientific’s business in the crucial US market.

Prior to banning all such devices in the United States, the FDA had given companies an opportunity to keep their products on the market by engaging in clinical trials to prove their devices’ safety and efficacy. Despite hundreds of such devices previously having been permitted to enter the US market through a regulatory loophole that did not require them to undergo clinical trials in humans prior to approval, only two companies—Boston Scientific and Coloplast—decided to put their transvaginal mesh devices up for scientific scrutiny rather than simply pulling them from the market.

And, according to the FDA, neither Boston Scientific nor Coloplast managed to meet the agency’s standards for approval, leading to the April 16 ban.

Boston Scientific continues to face tens of thousands of products liability lawsuits brought by patients claiming to have been injured by the allegedly faulty devices. Federal products liability claims in the United States have been centralized as multidistrict litigation (MDL) in the Southern District of West Virginia Charleston Division.

Sources:

Bronstein, Gewirtz & Grossman, LLC. (5 June 2019). SHAREHOLDER ALERT - Boston Scientific Corporation (BSX) Bronstein, Gewirtz & Grossman, LLC Announces Class Action and Lead Plaintiff Deadline: June 24, 2019. BGandG.com

United States Food and Drug Administration (FDA). (Updated 16 April 2019). Urogynecological Mesh Implants. FDA Website

United States Food and Drug Administration (FDA). (Updated 16 April 2019). FDA’s Activities: Urogynecological Surgical Mesh. FDA Website

Ethicon Mesh Lawsuit Settlement Update: Judge In Ethicon Pelvic Mesh MDL Okays Settlement Fund

May 30, 2019
Author: Daniel Gala

On May 24, the judge presiding over multidistrict litigation (MDL) involving allegedly defective pelvic-mesh devices sold by Johnson & Johnson unit Ethicon Inc. approved the creation of a settlement fund for plaintiffs who are clients of the law firm Douglas & London, P.C., which has reached a confidential settlement agreement with Ethicon, according to court documents.

Granting a May 17 motion by Douglas & London seeking court approval of the settlement fund, the May 24 order names the Garretson Resolution Group, Inc. as fund administrator and Deutsche Bank as escrow agent.

“All settlements reached by and between Ethicon and Plaintiffs in state or federal litigation or Claimants who are represented by Douglas & London pursuant to the Master Settlement Agreement dated December 3, 2018, shall be paid into the DOUGLAS & LONDON-ETHICON Qualified Settlement Fund,” Judge Joseph R. Goodwin wrote for the United States District Court for the Southern District of West Virginia, adding later, “[D]isbursements from the DOUGLAS & LONDON-ETHICON Qualified Settlement Fund shall be made pursuant to the terms of the Master Settlement Agreement and Escrow Agreement, which include provisions for payments into the MDL No. 2327 Fund.”

The December 2018 master settlement agreement marked the beginning of the end for the long-running MDL, which dates back to early 2012. The MDL centralized federal products liability claims in the United States over Ethicon’s pelvic repair system, as well as claims against the makers of other pelvic-mesh devices. As of May 29, out of 40,546 total cases in the MDL, 27,704 had been closed, according to the court’s list of member cases.

The massive litigation essentially involved multiple MDLs rolled into one, all overseen by District Judge Goodwin in the Southern District of West Virginia. In addition to Ethicon, medical-device makers American Medical Systems (AMS), Boston Scientific, C.R. Bard, and Coloplast also faced allegations that their pelvic-mesh devices, designed to treat pelvic organ prolapse and urinary stress incontinence in women, were riskier than originally disclosed and caused serious injuries in some patients.

Sources:

United States District Court Southern District of West Virginia. (24 May 2019). Pretrial Order #339 (Order Re: Qualified Settlement Fund – Douglas & London, P.C.). MDL No. 2327. In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation. Court website

United States District Court Southern District of West Virginia. (Accessed 29 May 2019). MDL 2327 Member List of Cases. MDL No. 2327. In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation. Court website

Ethicon Mesh Lawsuit Update: Appellate Court Pushes Back On J&J, Ethicon Appeal of $20M Mesh Award

May 23, 2019
Author: Daniel Gala

On Tuesday, May 21, a panel for the Seventh Circuit Court of Appeals heard arguments from attorneys for Johnson & Johnson and its unit Ethicon, who argued that a $20 million mesh verdict should be overturned because, they say, the lower-court judge erred in not allowing the jury to hear evidence that the United States Food and Drug Administration (FDA), the nation’s chief regulator of medical devices and pharmaceuticals, found the device in question to be safe and effective. “Excluding the FDA evidence in this case is equivalent to dropping a soldier in the middle of a battlefield with no weapon or even shoes,” argued attorney Lisa Blatt, representing Ethicon.

However, the judges on the appellate panel appeared to push back on these arguments, saying that such a ruling would place the Seventh Circuit in conflict with other federal appeals courts.

“We would be running upstream against other circuits reversing on that ground,” U.S. Circuit Judge Diane S. Sykes responded, per Law360 . “Federal law did not prohibit your client from redesigning this implant to be safer and submitting a request for a safer design.”

Ethicon further argued that medical-device makers owe a duty only to doctors who use their devices, for those doctors are the company’s true customers. Doctors, in turn, owe a duty of care to their patients. Therefore, attorney Blatt argued for the device maker, plaintiff’s injured by medical devices actually should be seeking legal recourse against their doctor, not the device maker, in the form of a medical malpractice lawsuit. “There’s no dispute surgeons unquestionably knew these side effects could occur,” Ethicon lawyer Blatt told the court, according to Law360. “No one stopped [the lower-court plaintiff] from suing her doctor.”

However, an attorney representing Barbara Kaiser, who sued J&J and Ethicon over injuries she claims she suffered because of an Ethicon Prolift mesh implant, countered that Kaiser’s doctor had testified at trial that he and other surgeons had been unaware at the time of the true extent of the risks posed by such devices. “This is competent testimony from an experienced surgeon,” Mark Miller, representing the lower-court plaintiff, argued, per Law360, adding elsewhere that the Ethicon Prolift implant “ruined [his client’s] life.”

In March 2018, an Indiana jury originally awarded Kaiser $35 million, $10 million in compensatory damages and $25 million in punitive damages. The trial court later reduced this amount to $15 million, finding the original amount unreasonable. J&J and Ethicon have argued on appeal that any award of punitive damages in the case were unwarranted, as the plaintiff failed to demonstrate wrongdoing with clear and convincing evidence, the legal standard for such a finding.

Sources:

Bott, Celeste. (21 May 2019). J&J Tells 7th Circ. Missing FDA Evidence Dooms $20M Verdict. Law360

Field, E. (9 March 2018). Johnson & Johnson Hit With $35M Verdict In Pelvic Mesh Trial. Law360

Ethicon Mesh Lawsuit Update: In Another Philly Mesh Loss, J&J and Ethicon Ordered To Pay $80M

May 22, 2019
Author: Daniel Gala

In the latest trial to take place as part of a mass tort program in the Philadelphia Court of Common Pleas, a jury returned another verdict in favor of the plaintiff and against medical-device, pharmaceutical, and consumer-goods conglomerate Johnson & Johnson over pelvic mesh implants sold by J&J unit Ethicon Inc. The verdict, which came down on Friday, May 17, included $80 million in damages, $50 million of which is punitive damages, Law360 reported

Out of ten trials concluded in the Philadelphia mass tort program thus far, the jury has returned a verdict in favor of the plaintiff in eight. Cumulatively, J&J and Ethicon have been ordered to pay hundreds of millions of dollars in damages.

The instant case involved plaintiff Patricia “Jill” Mesigian, who sued over an Ethicon Prolift mesh implant she received in September 2008 to treat pelvic organ prolapse. Mesigian’s medical records indicate that she subsequently suffered from vaginal bleeding, which was found to be caused by the mesh implant sawing through her vagina. Mesigian underwent four additional surgeries in an effort to remedy the problem, and also twice underwent treatment where chemical burns were used to remove scar tissue in the affected area.

Aside from the physical pain and disability, an attorney for Mesigian told jurors that the ordeal had severely impacted her personal life, as well, making it virtually impossible for her to be intimate with her husband.

“The last time Jill tried to have sex with the man she loves was six months ago, and it felt like her vagina was being ripped in barbed wire, and she was being torn apart,” Thomas Kline, representing the plaintiff, told jurors during closing remarks, per Law360, quoting court transcripts.

Attorneys for J&J had argued that Mesigian had exceeded statutory time limits in bringing her original claim in February 2014 and that her own preexisting medical conditions had caused her health problems, not their client’s mesh device, which was pulled from the market in 2012.

J&J unit Ethicon voiced directly its displeasure with the verdict.

“While Ethicon empathizes with women who experience medical complications, this verdict and the damages awarded are inconsistent with the science and Ethicon’s actions,” read a statement released by the defendant device maker following the verdict, quoted in part by Law360. “We believe the evidence showed Ethicon’s Prolift device was properly designed and that Ethicon acted appropriately and responsible in the research, development and marketing of the product.”

Source:

Fair, M. (17 May 2019). J&J Hit With $80M Verdict In Philly Mesh Case. Law360

Mesh Lawsuit Update: Philly Inquirer Exposé Shows Shocking Scope Of Transvaginal Mesh Crisis In US

May 17, 2019
Author: Daniel Gala

“When I grew up, you trusted your doctors. And I’m a trusting person. I think most women are,” Manchester, Pennsylvania resident Ella Ebaugh, who has suffered severe complications after receiving multiple mesh implants sold by a unit of medical-device, pharmaceutical, and consumer-goods conglomerate Johnson & Johnson, told the Philadelphia Inquirer in a report published May 15. “J&J manipulated the data. They knew these risks and didn’t disclose them to doctors or patients. As a patient, you can do your research. But how do we know they’re telling the truth?”

With a mass tort program for claims against Johnson & Johnson and its unit Ethicon over the companies’ pelvic mesh implants being centralized in the Philadelphia Court of Common Pleas, the city’s paper of record published May 15 an in-depth examination of the public health crisis posed by the devices, which were pulled from the US market last month over safety concerns, but only after being implanted in hundreds of thousands of women across the nation.

According to the Philadelphia Inquirer, pelvic mesh “has become one of the biggest mass torts in U.S. history. Medical device makers are paying nearly $8 billion to settle the claims of more than 100,000 women who suffered complications including pain, organ damage, infection, and incontinence.”

While makers of the mesh implants have had to face injured plaintiffs in court, the US Food and Drug Administration (FDA) increasingly is coming under fire for what critics say is a failure to properly study the safety and efficacy of the products before approving them for sale on the US market. From 2002 to 2013, the FDA approved more than 100 different transvaginal mesh devices for the treatment of pelvic organ prolapse, a common condition in aging women.

However, as evidence of the serious risks associated with the mesh implants mounted, the FDA released in 2008 warnings that “vaginal mesh products could contract, break, and ‘erode’ into organs, causing infection, pain, vaginal scarring, urinary retention or incontinence, recurring prolapse, and more,” according to The Inquirer.

Finally, the FDA required manufacturers of transvaginal mesh devices who wished to continue selling their products in the US to conduct clinical trials to prove the devices’ safety. Such trials had not been required prior to the devices’ initial approval, which has been criticized as a key example of the FDA’s failure to exercise proper oversight to ensure patient safety.

Despite the FDA having approved over 100 transvaginal mesh products for sale in the US, only two manufacturers proceeded with the newly mandated clinical trials. The remainder of the manufacturers chose simply to withdraw their products from the market rather than face the scrutiny of scientific rigor, though the devices collectively already had been implanted in hundreds of thousands, if not millions, of women around the globe.

And the two companies that did attempt clinical trials? Boston Scientific and Coloplast both failed to demonstrate “a reasonable assurance of safety and effectiveness of these devices,” according to the FDA, which ordered those devices withdrawn from the market, as well.

Sources:

McCullough, Mary. (15 May 2019). Pelvic mesh is under fire. What should women with prolapsed organs do? The Inquirer

United States Food and Drug Administration (FDA). (16 April 2019). Urogynecologic Surgical Mesh Implants. FDA Website

Bard Mesh Lawsuit Update: Plaintiffs And Defendants Spar Over Production Deadlines In Davol / Bard Mesh MDL

May 17, 2019
Author: Daniel Gala

On May 6, the judges presiding over multidistrict litigation (MDL) involving surgical mesh devices sold by Davol and C.R. Bard issued an order aimed at refereeing an ongoing dispute between plaintiffs and the defendant companies over the production deadlines for over 200 previously identified custodians. While Davol and Bard sought to push the production deadline back to late September, plaintiffs countered with an early August deadline, accusing defendants of failing to comply with the court’s established schedule, potentially delaying the opening of the MDL’s first trial.

In a May 6 order signed by United States Chief District Judge Edmund A. Sargus, Jr. and United States Magistrate Judge Kimberly A. Jolson for the Southern District of Ohio Eastern Division, the court sought to split the difference while maintaining the scheduled start date for the first trial.

“Defendants shall substantially complete the production of documents for all remaining custodians on or before August 29, 2019,” the order states, setting a deadline that falls part way between the August 9 deadline requested by plaintiffs and the September 27 date proposed by defendants. “Any supplemental production for the remaining custodians shall be complete on or before September 12, 2019.”

Production will continue to take place on a rolling basis, with defendants producing new materials every two weeks.

In a previous filing quoted in the May 6 order, the Plaintiffs Steering Committee (“PSC”) had argued that the defendants’ request “threatens to derail the pretrial schedule that was carefully negotiated with the Parties and ignores the firm trial date that was long ago ordered by this Court.”

The court concluded the order with a threat to defendants should they fail to meet the revised production deadlines.

“To the extent Defendants do not comply with these deadlines or do not otherwise act in good faith, the Court is inclined to consider, among other things, cost-sharing measures to alleviate the burden on the PSC [Plaintiffs’ Steering Committee] and to ensure the case proceeds consistent with the deadlines set forth in CMO 10,” the judges wrote.

The MDL has centralized federal products liability claims involving polypropylene hernia mesh products sold by medical-device-makers Davol, Inc. and C.R. Bard, Inc.

According to the August 2018 Transfer Order issued by the Judicial Panel on Multidistrict Litigation (JPML), which established the MDL, “All of the actions share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections.”

The MDL’s next in-person status conference is scheduled for June 25.

Sources:

United States District Court Southern District of Ohio Eastern Division. (6 May 2019). Order. MDL 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

Judicial Panel on Multidistrict Litigation (JPML). (6 August 2018). Transfer Order. MDL 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

Mesh Lawsuit Update: NY Times Editorial Board Excoriates FDA Over Pelvic Mesh, Medical Device Oversight

May 14, 2019
Author: Daniel Gala

The New York Times Editorial Board did something May 4 that unfortunately is all too much of a rarity among for-profit, corporate news outlets: it published a piece clearly outlining the safety issues pertaining to pelvic mesh implants and did not mince words in holding the United States Food and Drug Administration (FDA) to account for its failure to properly oversee the devices over the course of decades.

“When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products—medical devices that have been on the market for decades—the collective response from tens of thousands of women harmed by the products sounded something like this: Duh,” begins the Op Ed, attributed to The Times Editorial Board.

The piece then proceeds to outline the horrifying scope of the problem and the utter lack of pre-approval FDA oversight:

The mesh, which is used to hold pelvic organs in place when muscles become too weak to do the job, has long been tied to life-altering injuries, including nearly 80 deaths as of 2018. In the past decade, seven companies have spent a collective $8 billion to resolve more than 100,000 patient claims—making litigation over vaginal mesh (or pelvic mesh, as it is sometimes called) one of the largest mass cases in United States history. As those lawsuits have made clear, most of these devices were approved for market with nearly no clinical data.

The Editorial Board further argues that the issue is not limited to the FDA’s regulatory oversight of pelvic mesh, which is merely representative of a much larger issue.

“It seems incredible that products meant for inside the human body would be used on patients without any proof of safety or efficacy,” The Editorial Board writes [https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html]. “But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.”

While none of this will come as much of a surprise to regular readers of TheLawFirm.com, The New York Times Op Ed is significant, and not just given the breadth of The Times’ potential audience. All too often, for-profit news organizations show a hesitancy to report or comment on the massive issues afflicting the medical device and pharmaceutical industries for fear of running afoul of the corporate advertisers their business models rely on.

There is hope that the Times editorial represents a turning of the tides.

“In the past decade, nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices, many approved with little to no clinical testing, according to a global investigation by the International Consortium of Investigative Journalists,” the Editorial Board states.

Given the epidemic scale of the public health crisis now facing the nation over under-regulated medical devices, perhaps even the for-profit media can no longer turn a blind eye to the malfeasance of this multibillion-dollar-per-year industry.

Source:

The Editorial Board. (4 May 2019). 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. The New York Times

Mesh Lawsuit Update: Judge Approves Settlement Fund In Boston Scientific Mesh MDL

May 8, 2019
Author: Daniel Gala

In an order issued May 7, the judge presiding over multidistrict litigation (MDL) involving mesh pelvic repair systems sold by Boston Scientific Corp. approved the creation of a qualified settlement fund to administer claims pursuant to a confidential settlement agreement reached in June 2018. The court further appointed the Garretson Resolution Group, Inc. as fund administrator and CIBC Bank, USA as custodian of the fund.

The order is the most recent sign that the long-running MDL, which dates back to February 2012, continues to near its ultimate resolution. In all, the massive products liability litigation contained a total of 26,026 cases, with 17,636 having closed as of May 8, according to the court’s list of member cases.

The qualified settlement approved in the May 7 order will apply only to plaintiffs who were clients of Johnson Becker, LLC at the time the confidential settlement agreement was executed. It was unclear from the order and the court’s list of member cases exactly how many lawsuits would be resolved through the settlement fund.

Over 8,000 active products liability lawsuits remain centralized in the MDL, which is taking place in the United States District Court for the Southern District of West Virginia. The more than 26,000 total cases were brought by plaintiffs alleging pelvic mesh devices sold by Boston Scientific were defectively designed, causing serious permanent injuries.

Sources:

United States District Court Southern District of West Virginia. (7 May 2019). Pretrial Order #209 Qualified Settlement Fund Order – Johnson Becker, LLC. MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

United States District Court Southern District of West Virginia. (Accessed 8 May 2019). MDL 2326 Member List of Cases. MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

Ethicon PhysioMesh Lawsuit Update: J&J Quarterly Filing Gives Snapshot Of Ethicon Mesh Litigation

May 4, 2019
Author: Daniel Gala

On May 1, consumer-goods, pharmaceutical, and medical-device conglomerate Johnson & Johnson issued its quarterly filing with the United States Securities and Exchange Commission (SEC), and, while Wall Street focuses on the numbers, the document also contains mandatory disclosures about legal threats facing the company. Of the many serious products liability issues facing Johnson & Johnson, among the most significant are those posed by surgical mesh implants sold by J&J unit Ethicon, Inc.

According to J&J’s Form 10-Q for the three months ended March 31, 2019, as of that date, approximately 29,500 plaintiffs had “direct claims in pending lawsuits” against J&J and Ethicon over the companies’ pelvic meshes used in the treatment of stress urinary incontinence and pelvic organ prolapse. The companies faced an additional 2,700 active lawsuits over Ethicon PHYSIOMESH Flexible composite mesh.

Federal claims in the United States over Ethicon pelvic mesh devices have been centralized as multidistrict litigation (MDL) in the Southern District of West Virginia. According to the J&J quarterly filing, “The Company has settled or otherwise resolved a majority of the United States cases.”

Additionally, thousands of lawsuits have been filed in the US over Ethicon PHYSIOMESH hernia mesh, which was pulled from markets worldwide in June 2016. While an MDL has been established in the Northern District of Virginia to handle federal PHYSIOMESH products liability cases, a “multicounty litigation (MCL) has also been formed in New Jersey state court and assigned to Atlantic County for cases pending in New Jersey.”

J&J reports that new cases continue to be filed over both Ethicon pelvic mesh and PHYSIOMESH devices.

Source:

Johnson & Johnson. (Filed 1 May 2019). Form 10-Q For The Three Months Ended March 31, 2019. United States Securities and Exchange Commission (SEC). Commitments and Contingencies Disclosure. Legal Proceedings. Product Liability

Mesh Lawsuit Update: Parent-Subsidiary Relationship Not Enough For Mesh Liability, Judge Rules

May 1, 2019
Author: Daniel Gala

Although Endo Pharmaceuticals Inc. has owned American Medical Systems Inc. as a wholly-owned subsidiary for over half a decade, that link is not enough to hold Endo responsible for American Medical’s allegedly defective surgical mesh products, a federal judge in Pennsylvania declared April 29, tossing out a woman’s claims against the parent company.

The ruling came in a lawsuit brought by an Oregon woman and her husband, who allege that the American Medical pelvic mesh the woman had surgically implanted was defective, resulting in serious injury.

Although some claims against American Medical were allowed to stand, the court dismissed the plaintiffs’ strict liability and failure to warn claims against the medical-device maker, along with all claims against its parent Endo Pharmaceuticals.

“We cannot hold Endo liable merely because it purchased American Medical and now holds American Medical as a wholly-owned subsidiary,” U.S. District Judge Mark A. Kearney’s order read, according to Law360. “The parent-subsidiary relationship is insufficient to hold Endo liable for the acts of its subsidiary. We cannot apply successor liability for a more fundamental reason as well. The original entity—American Medical—still exists.”

Attorneys for the plaintiffs had argued that Endo assumed all of American Medical’s liabilities when Endo purchased the company in 2011.

The court disagreed, finding that, “Nowhere has [plaintiffs] Mr. and Mrs. Buck alleged Endo expressly assumed American Medical’s liabilities.”

“Endo only purchased American Medical’s liabilities in the sense it became the owner of American Medical,” Judge Kearney wrote, per Law360. “The corporate form shields Endo from American Medical’s liabilities.”

With regards to the dismissal of the plaintiffs’ strict liability and failure to warn claims against American Medical, the court ruled that under Pennsylvania law, which all parties agreed governed in the case, such claims are presently barred, pending a ruling to the contrary by the Pennsylvania high court.

“While the Pennsylvania Supreme Court has not yet ruled on the issue, numerous courts in our Circuit applying Pennsylvania law hold a plaintiff cannot bring strict liability design defect or failure to warn claims for a defective medical device,” Judge Kearny wrote, according to Law360.

The case will now proceed on the remaining claims against American Medical.

Source:

Santoni, M. (29 April 2019). Endo Not Liable In Pa. For Defective Mesh Made By Subsidiary. Law360

Mesh Lawsuit Update: Boston Scientific Discloses Over 50,000 Mesh Lawsuits in Quarterly Filing

April 30, 2019
Author: Daniel Gala

The bad news for Boston Scientific seems to just keep coming.

In its mandatory quarterly report to the United States Securities and Exchange Commission (SEC), filed April 29, 2019, medical-device-maker Boston Scientific Corporation gave investors, regulators, and other observers an update on the staggering scope of litigation facing the company over its transvaginal surgical mesh products, disclosing that over 50,000 claims have been filed over the devices, which the FDA prohibited from the US market in a recent announcements.

“On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered that all manufacturers of surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse stop selling and distributing their products in the United States immediately,” states Boston Scientific’s Form 10-Q for the first quarter of 2019.

With Boston Scientific having been one of two remaining sellers of such devices in the United States, the FDA announcement resulted in a precipitous drop in the company’s share price, as it fell almost three dollars, or nearly 8%, on the news, according to Law360 [https://www.law360.com/articles/1153164/investor-sues-boston-scientific-over-fda-s-mesh-product-pull], which further reported that the decline in share price already has resulted in at least one investor lawsuit, filed April 24.

“Despite years of denials by Boston Scientific in response to questions concerning the safety of its vaginal mesh products, the apparent full extent of the company’s misstatements was revealed on April 16 [with the FDA announcement],” said Steve Klein, who filed the investor lawsuit against Boston Scientific, per Law360 .

According to Boston Scientific’s disclosures, as of April 23, the company had reached terms in principal on master settlement agreements that would resolve roughly 51,000 of the approximately 53,000 claims the company faces over its vaginal mesh implants. Of these 51,000 claims, “approximately 41,000 have met the conditions of the settlement and are final,” the filing reports.

The company’s transvaginal surgical mesh products originally were intended to treat urinary stress incontinence and pelvic organ prolapse in women. However, by 2016, the FDA had reclassified the devices as high risk, ultimately leading to the April 2019 announcement that the products no longer would be available legally on the US market.

Sources:

Boston Scientific Corporation. (Filed 29 April 2019). Form 10-Q. 3 Months Ended March 31, 2019. Note I – Commitments And Contingencies. Product Liability Litigation. United States Securities and Exchange Commission (SEC)e

United States Food and Drug Administration (FDA). (16 April 2019). Urogynecologic Surgical Mesh Implants. FDA Website

Seal, D. (24 April 2019). Investor Sues Boston Scientific Over FDA’s Mesh Product Pull. Law360

Bard Mesh Lawsuit Update: Davol, Bard Mesh MDL Growing By 80-100 Cases Per Week, Plaintiffs Say

April 27, 2019
Author: Daniel Gala

Multidistrict litigation (MDL) over polypropylene hernia mesh implants manufactured by Davol, Inc. and C.R. Bard, Inc. continues to grow rapidly, at a rate of roughly 80-100 new cases per week, the Plaintiffs’ Steering Committee has reported to the court, according to a pretrial order issued April 19. The order, which memorialized the contents of an April 17 status conference, further stated that 1,720 cases have been filed with the MDL to date.

Located in the Southern District of Ohio, the MDL has centralized cases involving products liability claims against medical device makers C.R. Bard and Davol, alleging that their polypropylene hernia mesh products were defectively designed, marketed, and sold.

The MDL was created in August 2018 by transfer order of the Judicial Panel on Multidistrict Litigation (JPML), which stated that, “All of the actions share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections.”

The April 19 pretrial order shows that, while pretrial proceedings continue, the litigation still remains in its early stages. Among the other items discussed were document production by the defendants, who were ordered to provide a definitive date by which they will have completed production, and defendants’ motion to compel plaintiffs’ interrogatories, which was denied.

The next status conference is scheduled for June 5, 2019.

Source:

United States District Court Southern District of Ohio Eastern Division. (19 April 2019). Pretrial Order No. 8: April 17, 2019 Status Conference. MDL 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

Mesh Lawsuit Verdict Update: One Week After Win, Jury Says J&J and Ethicon Must Pay $120M In Mesh Suit

April 25, 2019
Author: Daniel Gala

Exactly a week after Johnson & Johnson and its medical-device-maker subsidiary Ethicon were claiming vindication following a Philadelphia-based jury’s finding them not liable for a plaintiff’s injuries, the companies were hit April 24 with the biggest monetary verdict yet in a mass tort program over allegedly defective mesh implants sold by Ethicon. The $120 million verdict more than doubled the mass tort program’s previous high of $57.1 million and raised the total damages awarded in favor of plaintiffs to over a quarter of a billion dollars.

The most recent verdict was in favor of plaintiff Susan McFarland, who had alleged that the Ethicon TVT-O mesh device she had surgically implanted in 2008 to treat urinary stress incontinence had caused her years of debilitating pain that had required follow-up surgery and left her unable to have sexual intercourse with her husband.

The road to April 24’s nine-figure verdict had been a long one for Ms. McFarland. Her first trial, held in the fall of 2018, resulted in a mistrial when jurors deadlocked. And the instant trial was postponed for nearly a month while an expert witness for the defense recovered from a heart attack.

The verdict appeared to affirm the observations of some outside legal experts who had suggested following last week’s verdict in favor of J&J and Ethicon that the problem for the plaintiff in that case had been that her injuries had not been tied directly enough to the surgical mesh implant and had not lent themselves to the same sort of graphic, vivid descriptions as those suffered by other plaintiffs.

Other plaintiffs, tragically, like Ms. McFarland.

“When the mesh shrinks, it becomes tense and rigid, and then this rigid mesh can cut through the vaginal wall. It’s like a saw,” attorney Tracie Palmer, representing the plaintiff Ms. McFarland, told jurors during closing arguments before urging them to get the companies’ attention by hitting them where it hurts: the balance sheet.

“I can’t tell you how much money to award to stop Johnson & Johnson from hurting other women, that’s your decision to make, but I’d ask you to make it count, and not let Johnson & Johnson and Ethicon brush Susan off their shoulders like a piece of lint,” Palmer said, according to Law360.

Apparently, the jury listened, delivering the first nine-figure verdict of the mass tort program and essentially reversing whatever momentum J&J and Ethicon thought they had gained following last week’s short-lived victory. 


Following the verdict, an Ethicon spokesperson said the company would appeal.

“While we empathize with women who experience medical complications, this verdict and the damages awarded are inconsistent with the science, Ethicon’s actions, and previous verdicts related to our TVT-O product, which continues to be the gold standard of treatment for stress urinary incontinence,” Ethicon spokeswoman Mindy Tinsley told Law360.

Out of ten trials to be completed in the Ethicon mesh mass tort program, which is taking place in the Philadelphia Court of Common Pleas, seven now have resulted in verdicts for the plaintiff, with over $270 million having been awarded in the process.

Collectively, Johnson & Johnson are estimated to be worth approximately $60 billion.

Source:

Fair, M. (24 April 2019). Philly Jury Slams J&J With $120M Award In Mesh Injury Case. Law360

Mesh Lawsuit Settlement Update: J&J, Ethicon Settle State of WA Mesh Claims

April 24, 2019
Author: Daniel Gala

On Monday, April 22, the same day that a trial was scheduled to begin between Johnson & Johnson and the state of Washington, the two sides announced they had agreed to terms resolving claims over allegedly deceptive marketing practices related to surgical mesh implants sold by J&J subsidiary Ethicon. Johnson & Johnson will pay nearly $10 million to settle the claims, according to Law360.

“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways,” read a statement released by Washington Attorney General Bob Ferguson, announcing the deal. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct—and look forward to providing millions of dollars in relief to assist those who were harmed.”

Meanwhile, Ethicon acknowledged the agreement while seeking to minimize the damage to its reputation, saying in its own statement that, “Ethicon’s devices for the treatment of incontinence are recognized as the standard of care by surgeons and medical professional societies in Washington and around the world,” per Law360.

According to the Washington attorney general’s office, approximately 14,000 Washingtonian women have received surgical mesh implants made my Johnson & Johnson and its subsidiaries, with hundreds having suffered significant injury as a result, including chronic pain, recurring infections, urinary and defecatory dysfunction, and the inability to have sexual intercourse.

Ferguson, the Washington attorney general, said in his statement that the money recovered from J&J would go toward compensating these victims. The settlement does not prevent individual patients from filing their own lawsuits against the companies, as tens of thousands of women across the United States and around the globe already have.

AG Ferguson’s lawsuit, originally filed in May 2016, accused Johnson & Johnson of knowingly downplaying the risks associated with the surgical mesh devices, which, in many cases, according to the complaint, are permanent and irreversible.

Source:

Siegal, D. (22 April 2019). J&J Settles Wash. AG’s Pelvic Mesh Case Just Before Trial. Law360

Ethicon Mesh Lawsuit Update: J&J, Ethicon Philly Mesh Win Shows Outer Bounds Of Successful Claims, Observers Say

April 21, 2019
Author: Daniel Gala

Plaintiffs who claim to have suffered less serious injuries as a result of allegedly defective mesh implants may have a more difficult time succeeding at trial than plaintiffs whose injuries have been more severe and are more graphic, legal observers are saying in the aftermath of a recent trial win by Johnson & Johnson and its device-making subsidiary Ethicon, Inc.

That trial, part of a mass tort program taking place in the Philadelphia Court of Common Pleas, involved claims brought by a woman who had an Ethicon TVT-Secur mesh device surgically implanted in 2008 to treat a mild case of stress urinary incontinence (SUI). Rather than her condition improving, the plaintiff alleges that her SUI continued to worsen, and she began suffering from other complications, including vaginal pain that has made it impossible for her to have sexual intercourse.

Despite the jury’s finding that Ethicon had been negligent in designing, manufacturing, and selling of the TVT-Secur mesh, it did not conclude that Ethicon’s negligence had caused the plaintiff’s alleged injuries.

The trial was the ninth to be completed as part of the Philadelphia mass tort program. Six of the previous trials had resulted in verdicts for the plaintiff, with Ethicon being ordered to pay nearly $150 million in total damages.

However, the recent victory for the defendant companies has shown that there is an outer limit to juries’ willingness to find J&J and Ethicon responsible for a plaintiff’s injuries, legal observers say.

“It’s a signal to the plaintiffs that not every case is going to be a winner,” Philadelphia lawyer Alan Klein told Law360. “This may be an important moment for plaintiffs to go back and look at their portfolio of cases and weed out the ones that are not as likely to be successful.”

Other attorneys also cited the form and extent of the particular plaintiff’s injuries as a potential reason for the jury’s verdict.

“The fact that the jury didn’t hear about a graphic removal surgery or that the product had actually worn through the patient’s tissue likely made it a lot easier to appreciate the alternative causes of the symptoms and to recognize that nobody is guaranteed a perfect outcome,” said lawyer Peter Goss, per Law360.

Approximately 90 active cases against Johnson & Johnson and Ethicon are still pending as part of the Philadelphia mass tort program.

Sources:

Fair, M. (19 April 2019). J&J Win Shows Potential Limit To Mesh Injury Claims. Law360

Fair, M. (17 April 2019). J&J Dodges Pelvic Mesh Claims In Philadelphia Trial. Law360

FDA Transvaginal Mesh Lawsuit Update: FDA Bans Last Remaining Transvaginal POP Mesh Devices In US

April 18, 2019
Author: Daniel Gala

It took a Philadelphia jury less than a full day of deliberations to find Johnson & Johnson and its medical-device-making subsidiary Ethicon, Inc. not liable on claims that an Ethicon pelvic mesh implant had caused the plaintiff’s condition to worsen and resulted in other lifelong harms, Law360 has reported. The verdict was not a total win for the defendant companies, though, as the jury did conclude that Ethicon had been negligent in its designing, marketing, and selling of the device.

On Wednesday, April 17, just one day after closing arguments had concluded, the jury returned the verdict finding that Ethicon had been negligent in designing, marketing, and selling the TVT-Secur mesh implant but rejecting claims that Ethicon’s negligence had been the cause of the plaintiffs injuries.

The plaintiff, Malgorzata Krolikowski, had Ethicon TVT-Secur vaginal mesh implanted in October 2008 to treat a mild case of urinary stress incontinence. She alleges that over the years, rather than improving, her condition worsened and that she has suffered from other complications including pain during sexual intercourse.

At trial, attorneys for J&J and Ethicon argued that the companies were not responsible for the device’s failing to completely cure Ms. Krolikowski’s condition and pointed to other medical reasons for why she suffered from pain during intercourse.

Ms. Krolikowski’s lawyers countered that Ethicon and Johnson & Johnson has been motivated by money in rushing an unsafe medical device to market despite concerning data coming from the companies’ own research.

“Obviously, we’re disappointed, but we respect the jury’s decision,” Colin Burke, a lawyer for the plaintiff Ms. Krolikowski, told Law360, adding, “They found that the defendants, Ethicon and Johnson & Johnson, were negligent. We had the evidence to prove that.”

The trial was the ninth to take place as part of a mass tort program being conducting in the Philadelphia Court of Common Pleas. Juries had found Ethicon and Johnson & Johnson liable in six of the previous verdicts, ordering the companies to pay nearly $150 million in total damages.

Ethicon TVT-Secur mesh implants have been off the market in the United States since 2012.

Source:

Fair, M. (17 April 2019). BREAKING: J&J Dodges Pelvic Mesh Claims In Philadelphia Trial. Law360

Ethicon Mesh Lawsuit Update: Jury Finds Ethicon Negligent But Not Liable In Ninth Philly Mesh Trial

April 17, 2019
Author: Daniel Gala

It took a Philadelphia jury less than a full day of deliberations to find Johnson & Johnson and its medical-device-making subsidiary Ethicon, Inc. not liable on claims that an Ethicon pelvic mesh implant had caused the plaintiff’s condition to worsen and resulted in other lifelong harms, Law360 has reported. The verdict was not a total win for the defendant companies, though, as the jury did conclude that Ethicon had been negligent in its designing, marketing, and selling of the device.

On Wednesday, April 17, just one day after closing arguments had concluded, the jury returned the verdict finding that Ethicon had been negligent in designing, marketing, and selling the TVT-Secur mesh implant but rejecting claims that Ethicon’s negligence had been the cause of the plaintiffs injuries.

The plaintiff, Malgorzata Krolikowski, had Ethicon TVT-Secur vaginal mesh implanted in October 2008 to treat a mild case of urinary stress incontinence. She alleges that over the years, rather than improving, her condition worsened and that she has suffered from other complications including pain during sexual intercourse.

At trial, attorneys for J&J and Ethicon argued that the companies were not responsible for the device’s failing to completely cure Ms. Krolikowski’s condition and pointed to other medical reasons for why she suffered from pain during intercourse.

Ms. Krolikowski’s lawyers countered that Ethicon and Johnson & Johnson has been motivated by money in rushing an unsafe medical device to market despite concerning data coming from the companies’ own research.

“Obviously, we’re disappointed, but we respect the jury’s decision,” Colin Burke, a lawyer for the plaintiff Ms. Krolikowski, told Law360, adding, “They found that the defendants, Ethicon and Johnson & Johnson, were negligent. We had the evidence to prove that.”

The trial was the ninth to take place as part of a mass tort program being conducting in the Philadelphia Court of Common Pleas. Juries had found Ethicon and Johnson & Johnson liable in six of the previous verdicts, ordering the companies to pay nearly $150 million in total damages.

Ethicon TVT-Secur mesh implants have been off the market in the United States since 2012.

Source:

Fair, M. (17 April 2019). BREAKING: J&J Dodges Pelvic Mesh Claims In Philadelphia Trial. Law360

Ethicon Mesh Lawsuit Update: Jury Hears Closing Arguments In Ninth Philly Mesh Trial

April 17, 2019
Author: Daniel Gala

On Tuesday, April 16, a Philadelphia jury heard closing arguments in a trial over claims that a woman suffered permanent, life-altering harm as a result of a pelvic mesh implant sold by Johnson & Johnson unit Ethicon, Inc. The case is the ninth involving Ethicon mesh to go to trial in the Philadelphia Court of Common Pleas as part of a mass tort program, with Ethicon and Johnson & Johnson already having been ordered to pay over $100 million in damages.

“They had the opportunity to do the right thing and they chose not to, and it wasn’t an accident,” attorney Colin Burke, representing plaintiff Malgorzata Krolikowski, told the jury in reference to the defendant companies, per Law360. “They made deliberate and intentional decisions. They showed what they were really about, and it wasn’t the health and safety of women like Ms. Krolikowski.”

According to Burke, 31 female patients were implanted with Ethicon’s TVT-Secur surgical mesh device prior to its being released in September 2006. Of those women, Burke told the jury that 60% suffered from at least one complication post-surgery and that 30%, or almost one-third, of the devices had failed, even though the women were only monitored for five weeks and the devices are intended to be implanted permanently.

In a move Burke described as “a business decision,” Ethicon and Johnson & Johnson decided to proceed with the release regardless.

“Why did they rush this product to market without proper testing?” Burke asked the jury rhetorically, per Law360. “We know why: money.”

The TVT in Ethicon TVT-Secur stands for transvaginal tape. The plaintiff, Ms. Krolikowski, had the device surgically implanted in October 2008 to treat a mild case of urinary stress incontinence, which she says continued to worsen over the years, despite the mesh implant. Worse yet, she began suffering from other complications, including pain during sexual intercourse.

Lawyers representing the defendants argued that the plaintiff had failed to demonstrate that the surgical mesh device caused her later injuries, saying that the companies should not be held liable simply because their device failed to completely cure the plaintiff’s condition.

“If I’m taking aspirin for a headache and the headache doesn’t completely cure the headache, you wouldn’t say the aspirin caused the headache,” asserted attorney Sean Gallagher, representing defendant Ethicon.

Juries have found Johnson & Johnson and Ethicon liable in six of the nine previous Ethicon mesh trials that have been part of the Philadelphia mass tort action, awarding plaintiffs a total of nearly $150 million in damages.

With the jury deliberations beginning following closing arguments, a verdict in the case is expected at any time.

Source:

Fair, M. (16 April 2019). J&J’s Rush To Market Made Mesh Patients Suffer, Jury Told. Law360

Mesh Lawsuit Update: Despite Safety Concerns, Hernia Mesh Market Projected To Grow By Billions

April 16, 2019
Author: Daniel Gala

Despite tens of thousands of lawsuits in the United States and an ongoing ban in England, the global demand for surgical mesh devices is expected to continue its strong fiscal growth well into the coming decade, according to a new report by MarketWatch, details of which were released April 9. MarketWatch projects that the hernia repair devices market in particular will see sustained growth of nearly 10%, reaching almost $10 billion annually by 2025.

The report did not list safety concerns or device efficacy among its “restraining factors of Global Hernia Repair Devices Market,” instead focusing on high cost and a lack of adequately trained professionals to perform the complex procedures.

Among the factors cited as driving the growth of the hernia mesh market, the report, somewhat circularly, identified “[r]ising demand for advanced mesh” as well as an aging population globally and the “[g]rowth of medical tourism in emerging countries.”

The rise of medical tourism raises the specter of patients traveling overseas for procedures that may not only be less expensive than at home but which may even be banned in a patient’s home country.

Numerous makers of various surgical mesh devices face lawsuits around the globe, with patients alleging that they have suffered severe, sometimes permanent harm as a result of having a mesh device surgically implanted. Surgical mesh implants are used in the treatment of hernias, as well as pelvic organ prolapse and stress urinary incontinence (SUI) in women.

Since July 2018, England has imposed a “pause” on surgeries implanting surgical mesh devices designed to treat SUI and pelvic organ prolapse, and, in the United States, tens of thousands of federal lawsuits have been brought against the makers of surgical mesh devices, with the companies having been ordered to pay billions of dollars in damages.

Despite these safety concerns, the MarketWatch report projects a compound annual growth rate (CAGR) of 8.5% through 2025, at which point the global hernia repair devices market is expected to top $9.5 billion.

Source:

Press Release. (9 April 2019). Hernia Repair Devices Market to Grow US$9.5 Billion by 2025. MarketWatch

Mesh Lawsuit Verdict Update: NHS England Extends “Pause” On Mesh Implant Surgeries

April 14, 2019
Author: Daniel Gala

The National Health Service (NHS) in England has issued an extension of its “pause to the use of vaginal mesh,” according to an NHS letter issued March 29 and subsequently released updated guidelines issued April 2. The extension of the restrictions, which first were enacted in July 2018, demonstrates that the safety of surgical mesh implants continues to be of concern to patients and healthcare professionals around the globe.

The decision to extend the restrictions first was announced in a March 29 letter sent from two NHS directors to “Regional Directors, Trust Medical Directors, and clinicians involved in the care of patients with stress urinary incontinence and pelvic organ prolapse.”

“We are now writing to confirm that the pause and period of high restriction is being extended,” reads the letter, signed by Stephen Powis, National Medical Director of NHS England, and Kathy McLean, Executive Medical Director and Chief Operating Officer of NHS Improvement, adding that the restrictions will remain in place until the conditions outlined in the original July 2018 letter instituting the “pause” have been met.

These conditions include creating a national database to track every procedure involving the treatment of stress urinary incontinence (SUI) and associated complications in England; only allowing “appropriately trained” surgeons to perform procedures for the treatment of SUI; and creating a system for identifying and accrediting “specialist centres [sic] for SUI mesh procedures” including removal procedures and care for other adverse effects.

On April 2, the National Institute for Health and Care Excellence (NICE) expanded on the letter’s contents by issuing updated guidelines related to the treatment of SUI and pelvic organ prolapse in women. These guidelines reiterated that the “pause” was being extended pending further progress in ensuring the safety of women receiving surgical mesh implants.

“In July 2018, the Government announced a period of ‘high vigilance restriction’ on the use of a group of procedures, including vaginally inserted mesh and tape to treat stress urinary incontinence and pelvic organ prolapse, in England,” an introduction to the updated guidelines states. “At the time of publication of this updated NICE guideline, the high vigilance restriction period has been extended and, until it ends, professionals should continue to follow its requirements.”

Source:

National Institute For Health and Care Excellent (NICE). (2 April 2019). Urinary incontinence and pelvic organ prolapse in women: management. Nice guideline NG123

National Health Service (NHS) Improvement and National Health Service (NHS) England. (29 March 2019). EXTENSION OF PAUSE TO THE USE OF VAGINAL MESH. NHS website

Ethicon Mesh Lawsuit Verdict Update: PA Appellate Court Upholds $13.5M Ethicon Mesh Verdict

April 12, 2019
Author: Daniel Gala

Consumer-goods, pharmaceutical, and medical-device conglomerate Johnson & Johnson and its subsidiary Ethicon have lost their appeal of a $13.5 million verdict in favor of a woman who alleged she has suffered life-long harm as a result of a surgical mesh implant sold by Ethicon.

On Thursday, April 11, a state appellate court in Pennsylvania issued its decision upholding the award, rejecting the companies’ arguments that the verdict should be overturned for a lack of evidence to support the jury’s findings, for the original claims’ having violated the applicable statute of limitations, and for the lower court’s lack of proper jurisdiction to hear those claims.

An appellate panel for Pennsylvania Superior Court rejected the appeal on all grounds.

In finding a sufficient factual basis to support the trial jury’s verdict in favor of the plaintiff, the appellate judges pointed to evidence that Ethicon had been aware of certain risks at the time the plaintiff received her implant but had failed to adequately warn patients and doctors.

“Ethicon’s IFU [Instructions For Use] provided no warning about the risks of foreign body reaction, fibrotic bridging, mesh shrinkage, vaginal scarring, vaginal perforation, nerve damage, chronic pain, dyspareunia or complications requiring mesh removal,” the decision reads, per Law360, listing many of the health risks associated with Ethicon’s vaginal mesh implants.

The appeal stems from the case of Sharon Carlino of New Jersey, who, in 2005, had Ethicon transvaginal tape (TVT) implanted to treat urinary stress incontinence. Since that time, Carlino alleges that she has dealt with a host of serious complications, including multiple corrective surgeries, chronic pain, and an inability to have vaginal intercourse with her husband.

In February 2016, a Philadelphia-based jury sided with Carlino, leading to the instant appeal.

“This brave woman has been horribly injured by Johnson & Johnson’s vaginal mesh product,” an attorney for Carlino said in a statement quoted by Law360. “Unfortunately, they’re still making and selling [the vaginal mesh product] for permanent implantation. We hope J&J will get the message and take this product off the market for the health and safety of America’s women.”

Source: Lidgett, A. (11 April 2019). Pa. Panel Backs Woman’s $13.5M J&J Mesh Injury Award. Law360

Ethicon Mesh Lawsuit Update: PA Supreme Court To Hear Jurisdictional Arguments On Ethicon Mesh Cases

April 11, 2019
Author: Daniel Gala

Johnson & Johnson and its subsidiary Ethicon have taken their fight to keep out-of-state plaintiffs from suing them in Pennsylvania state court all the way to the state’s supreme court, with the high court agreeing on April 10 to hear the defendant companies’ appeal of previous rulings that have allowed non-Pennsylvania-based plaintiffs to participate in an ongoing mass tort program taking place in the Philadelphia Court of Common Pleas.

The appeal granted is narrow in scope, with the Pennsylvania Supreme Court only agreeing to hear arguments on 14th Amendment Due Process issues, according to the order.

“[T]he Petition for Allowance of Appeal is granted, limited to the issue set forth below,” the order reads. “The issue as stated by Petitioner is: Whether the Due Process Clause of the Fourteenth Amendment to the United States Constitution…precludes Pennsylvania from asserting personal jurisdiction over two New Jersey companies in a case brought by an Indiana resident asserting claims under the Indiana Product Liability Act.”

Appeals on all other issues were expressly denied.

To date, juries have awarded out-of-state plaintiffs over $45 million in verdicts resulting from three different trials that were part of the Philadelphia-based Ethicon mass tort program. Dozens of additional cases from out-of-state plaintiffs remain, meaning potentially hundreds of millions of dollars hinge on the outcome of the Pennyslvania Supreme Court’s findings as to the standing of non-Pennyslvania-based plaintiffs.

The mass tort program stems from allegations that surgical mesh implants sold by J&J subsidiary Ethicon, Inc. were defectively designed and manufactured and that the defendant companies failed to adequately warn consumers of the risks inherent in the devices. Plaintiffs allege that they have suffered harms such as life-long pain, permanent injury, and the inability to have sexual intercourse as a result of having Ethicon mesh devices surgically implanted, oftentimes to treat urinary stress incontinence or pelvic organ prolapse.

Source:

Supreme Court of Pennsylvania Eastern District. (10 April 2019). Petition for Allowance of Appeal from the Order of the Superior Court. No. 111 EM 2018 Hammons v. Ethicon, Inc. et al., No. 112 EM 2018 Carlino v. Ethicon, Inc. et al

Mesh Lawsuit Update: Fee Committee Chairman Fires Back Against Self-Dealing Allegations In Mesh MDLs

April 10, 2019
Author: Daniel Gala

The chairman of the fee and cost committee overseeing the distribution of an estimated $550 million in legal fees and expenses fired back against allegations of self-dealing and other improprieties that have been leveled against him by other plaintiffs’ attorneys involved in the litigation, filing on April 8 a response defending the committee’s disbursement plan against the objections raised by four different law firms.

“The objectors focus much of their objections on attacking the FCC [Fees and Costs Committee] and its members and the external review specialist and complaining of information they were allegedly not provided about other firms’ submissions,” chairman Henry Garrard III wrote in the committee’s response, emphasizing that only four law firms out of 94 applicant firms presently object to the proposed allocations, which Garrard argues speaks to their lack of merit.

“An appropriate starting point for consideration of the four remaining objections is the simple fact that there are only four remaining objectors,” the filing states, adding later, “The same rules and the same analysis were applied to every one of the 94 firms. The fact that the other 90 firms have no objection to the recommended allocation when they participated in the same process and had access to the same information about their submissions from the FCC is telling.”

The four objecting law firms have explicitly accused the fees and costs committee of self-dealing, with Kline & Specter PC claiming in an objection filed March 26 that the allocation plan amounted to a “mass taking” by the committees member, according to Law360.

Another objector, Anderson Law Offices LLC of Ohio, pointed out that the committee had assigned the firms of its members two-thirds of the allocated funds, leaving the remaining third to cover 79 other law firms that had provided common benefit work during the long-running litigation.

“By definition, this is self-dealing pure and simple,” Anderson Law Offices asserted in its filing, per Law360.

The massive sum to be allocated—with outside estimates ranging from one-third to over one-half billion dollars—covers common-benefit fees and expenses from seven different MDLs involving various surgical mesh pelvic repair systems sold by defendants C.R. Bard; American Medical Systems; Boston Scientific; Johnson & Johnson unit Ethicon, Inc.; Coloplast; Cook Medical; and Neomedic. In all, the seven MDLs have included a total of over 50,000 individual cases.

Sources:

United States District Court Southern District of West Virginia Charleston Division. (8 April 2019). Common Benefit Fee and Cost Committee’s Omnibus Response To The Objections To The Recommended Allocations Of The External Review Specialist. MDL Nos. 2187, 2325, 2326, 2327, 2387, 2440, 2511

Strickler, Andrew. (29 March 2019). Pelvic Mesh MDL Fee Committee Accused of Self-Dealing. Law360

Ethicon Mesh Lawsuit Verdict Update: 7th Circuit Hears J&J, Ethicon Appeal of $20M Mesh Verdict

April 6, 2019
Author: Daniel Gala

On Thursday, April 4, attorneys representing a woman awarded $20 million over injuries incurred as a result of a surgical mesh implant sold by Ethicon, Inc. argued before the Seventh Circuit Court of Appeals that the court should toss out an appeal by Ethicon and its parent company Johnson & Johnson, asserting that “[n]umerous courts have rejected Ethicon’s argument” and that the Seventh Circuit should do the same, according to Law360.

“Ethicon is sending up yet another ‘trial balloon’ on appeal,” attorneys for the lower-court plaintiff proclaimed, per Law360, adding later, “Ethicon has an insurmountable hill to climb on appeal.”

Central to Johnson & Johnson’s and Ethicon’s appeal is the argument that the federal laws governing United States Food and Drug Administration (FDA) approval of medical devices supersede state design-defect tort law, such as the Indiana state law at issue in the instant case. Otherwise, the companies’ contend, in an argument previously rejected by other courts, they are caught in a legal catch-22 in which they will be in violation of either state or federal law.

Attorneys for the lower-court plaintiff Barbara Kaiser, who in 2009 was implanted with an Ethicon Prolift polypropylene mesh device to treat her pelvic organ prolapse, countered that there is no precedent supporting J&J’s and Ethicon’s argument.

“Ethicon must establish that the FDA’s §510(k) market-clearance process preempts all state tort law—something no court has ever held,” attorneys for Kaiser told the Seventh Circuit, per Law360.

In March 2018, a jury awarded Kaiser $35 million after finding that the Ethicon surgical mesh implant had caused her lifelong injury, including additional surgeries, bladder spasms, pain, and the inability of having sexual intercourse. The verdict consisted of $10 million in compensatory damages and $25 million in punitive damages, with the punitive award later being reduced to $10 million.

Source:

Salvatore, C. (5 April 2019). J&J’s Mesh Appeal Nothing But a ‘Trial Balloon,’ 7th Cir. Told. Law360

Bard Mesh Lawsuit Update: Judge Issues Privilege Log Rules In Bard Mesh MDL

April 5, 2019
Author: Daniel Gala

As multidistrict litigation (MDL) in Ohio over surgical mesh sold by C.R. Bard and Davol continues to make its way through pretrial proceedings, the judge overseeing the MDL issued on April 3 an order laying out the ground rules governing claims of privilege with regards to discovery documents.

“This Order is entered to set forth the protocol that shall govern the procedures going forward for withholding documents from discovery based on a claim of attorney client privilege, joint defense privilege, work product protection or any other privilege or claim of protection of responsive document that would otherwise be subject to discovery,” Chief United States District Judge Edmund A. Sargas, Jr. and United States Magistrate Judge Kimberly A. Jolson wrote for the Southern District of Ohio.

Producing parties have 30 days from the production deadline to provide privilege logs that include separate, detailed entries for each document for which privilege is claimed. Receiving parties then have 75 days after having been provided with a privilege log to contest any claims contained therein.

According to the Judicial Panel on Multidistrict Litigation (JPML), which created the Bard/Davol MDL by order issued August 6, 2018, all cases in the centralized litigation “share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections.”

The next status conference is scheduled for April 17.

Sources:

United States District Court Southern District of Ohio Eastern Division. (3 April 2019). Case Management Order No. 17 Regarding Privilege Log Protocol. Case No. 2:18-md-2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

United States Judicial Panel on Multidistrict Litigation. (6 August 2018). Transfer Order. MDL No. 2846. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

Ethicon Mesh Lawsuit Update: J&J, Ethicon Lose Bid To Bar Out-Of-State Plaintiffs From Philly Mesh Trials

April 4, 2019
Author: Daniel Gala

On Wednesday, April 3, a three-judge panel in Philadelphia rejected an effort by conglomerate Johnson & Johnson and its device-making subsidiary Ethicon to bar out-of-state defendants from joining a mass tort program taking place in Pennsylvania state court, Law360 reported. The bid was the latest attempt by the defendant companies to reverse a June 2017 decision finding that Ethicon’s business ties to Pennsylvania were sufficient for out-of-state plaintiffs to join the Ethicon mesh mass tort litigation program.

In making their argument before the Pennsylvania Superior Court panel, Johnson & Johnson and Ethicon relied on the 2017 United States Supreme Court decision in Bristol-Myers Squibb Co. v. Superior Court of California, which made it more difficult for plaintiffs to sue companies in venues other than where the alleged injury occurred or where the defendant is headquartered.

However, the panel rejected the defendants’ reliance on that precedent, finding the facts in the instant case to be substantially similar to those in a prior case in which J&J and Ethicon also failed to have an out-of-state plaintiff’s claims dismissed for lack of jurisdiction.

“Ethicon’s direct oversight of the knitting of the mesh in Pennsylvania, coupled with its reliance on clinical studies performed by a Pennsylvania gynecologist, is sufficient to bring Ethicon within the jurisdiction of the commonwealth,” the panel wrote, denying the companies’ latest bid to have out-of-state plaintiffs barred from the mass tort program.

The reasoning behind the panel’s ruling coincided with an earlier decision by Judge Arnold New, who is overseeing the Ethicon mesh mass tort program in Philadelphia. In that decision, Judge New noted that Ethicon had engaged a Pennsylvania-based manufacturer, Secant Medical Inc., to sew the surgical mesh implants at issue, making for sufficient contacts within the state to overcome the jurisdictional challenge.

J&J and Ethicon presently have petitioned the Pennsylvania Supreme Court to consider their jurisdictional arguments, but it is unclear at this time whether the court will take up those issues. Approximately 70 cases featuring out-of-state defendants would be impacted should the companies prevail.

Source:

LaSusa, M. (3 April 2019). Pa. Superior Court Clears Way For Out-Of-State Mesh Cases. Law360

Mesh Lawsuit Update: Attorneys For Mesh Plaintiffs Contest Fee Committee Plan in W. Va MDL

March 31, 2019
Author: Daniel Gala

Attorneys from several different law firms representing plaintiffs in long-running multidistrict litigation (MDL) over surgical mesh implants made by Boston Scientific Corp. have accused the MDL’s fee committee of self-dealing, filing formal motions with the Southern District of West Virginia alleging that the committee’s leaders had improperly assigned themselves and their firms the bulk of common benefit attorneys’ fees awarded in the MDL. The filings also claim that committee leaders used ethically dubious means to apply pressure on reluctant parties, including the committee chair, in efforts to persuade them to agree to the committee’s proposed fee allocations, Law360 reported March 29.

At issue are approximately $336 million in attorneys’ fees set aside for attorneys who have provided common-benefit work during the seven-year-old complex litigation. Common benefit fees are awarded to legal counsel that have conducted work that is considered to be of benefit to all cases in the MDL, rather than simply the attorneys’ own cases.

In one alleged incident, lawyer Bryan Aylstock is accused of threatening to have an attorney from his firm who sits on the fee committee vote against the committee’s fee plan unless committee chair Henry Garrard agreed to give up $10 million worth of fees allocated to Garrard’s firm.

A filing by the law firm Mazie Slater Katz & Freeman quoted the retired judge appointed by the court to oversee the allocation plan as being “‘sickened’ and ‘angered’ by this conduct, which he described as Mr. Aylstock pressuring [Garrard] when he was particularly vulnerable,” according to Law360.

Kline & Specter PC, another firm contesting its allocation of the common benefit fees, was blunt in its assessment of the performance of retired judge Daniel Stack in overseeing the allocations.

“Mr. Stack’s methodology, if one exists, is severely flawed,” Law360 quoted the firm as saying, adding that the fee committee was perpetrating a “mass taking” that it accused the retired judge of “rubber stamping.”

The West Virginia-based MDL centralized federal products liability cases over surgical mesh implants made by Boston Scientific Corp., with the complex litigation ultimately spawning seven different MDLs involving more than 50,000 individual lawsuits.

Sources:

Strickler, A. (29 March 2019). Pelvic Mesh MDL Fee Committee Accused of Self-Dealing

Ethicon Physiomesh Lawsuit Update: Judge Denies J&J Motion For Mesh Mistrial Over Expert Witness’s Inability to Appear

March 29, 2019
Author: Daniel Gala

The Philadelphia judge overseeing a trial involving surgical mesh designed, manufactured, and sold by Johnson & Johnson subsidiary Ethicon has denied a motion filed by the defendant companies seeking a mistrial on the basis that one of their expert witnesses will be unable to appear due to a medical emergency, Law360 reported. March 28. Instead Judge Kenneth Powell of the Philadelphia Court of Common Pleas announced that the trial would be stayed pending the witness’s being cleared by his medical team, a delay that is expected to last at least a month.

Attorneys for Johnson & Johnson and Ethicon had argued in a motion filed March 25 that the judge should declare a mistrial after Dr. Robert Rogers, who had been scheduled to testify as an expert witness for the defense, suffered a heart attack. Dr. Rogers is not expected to be able to take the stand until late April at the soonest, although court documents suggest that Dr. Rogers will continue to see some of his own patients in the interim.

Instead of declaring a mistrial multiple weeks into the proceedings, Judge Powell instead said that he will postpone the remainder of the trial, which began in early March, until Dr. Rogers is well enough to testify.

An attorney for plaintiff Susan McFarland, who alleges that the Ethicon TVT-O pelvic mesh sling she had surgically implanted to treat urinary stress incontinence has left her with permanent scarring and chronic pain, seemed pleased with the judge’s decision, although her side had suggested that Dr. Rogers, who apparently will continue to see some of his own patients as he recovers, should be subjected to videotaped depositions, which then could be played in front of jury.

“This arrangement allowed us to avoid mistrial,” commented Tracie Palmer of Kline and Specter PC, per Law360.

Johnson & Johnson expressed greater dissatisfaction with the ruling.

“Given the length of the delay and the inherent uncertainty of recovery and treatment, we cannot see how this trial can continue in a manner that would be fair to the jury, the court, Ms. McFarland, and Dr. Rogers and his family,” the defendant company said in a statement quoted by Law360.

The case is part of an Ethicon mesh litigation program presently taking place in the Philadelphia Court of Common Pleas. J&J and Ethicon previously have made numerous attempts to have Judge Powell removed from the case, alleging the appearance of impropriety because Judge Powell’s mother has a lawsuit pending against Janssen Pharmaceuticals, which was, until a recent sale, also a subsidiary of Johnson & Johnson.

Source:

Fair, M. (28 March 2019). J&J Can’t Get Pa. Mesh Mistrial Over Expert’s Heart Attack. Law360

Ethicon Physiomesh Lawsuit Update: Jury Hears Opening Remarks In New Philly Ethicon Mesh Trial

March 27, 2019
Author: Daniel Gala

Over the course of March 25 and 26, a Philadelphia jury heard opening remarks from both sides as a new trial began featuring a woman who claims that a mesh surgical implant designed and sold by Johnson & Johnson subsidiary Ethicon, Inc. has caused her lifelong pain while denying her the potential for physical intimacy, Law360 has reported. The trial is the ninth in an Ethicon mesh litigation program taking place in the Philadelphia Court of Common Pleas.

Meanwhile, Law360 also reported that Judge Arnold L. New, who is overseeing the Ethicon mesh litigation program, issued an order March 22 denying yet another effort by J&J and Ethicon to have Judge Kenneth Powell removed from a different case on alleged conflict of interest grounds.

The defendant companies have argued that Judge Powell’s involvement in the mesh litigation gives the appearance of impropriety because Judge Powell’s mother presently is suing a different J&J subsidiary, Janssen Pharmaceuticals, over its drug Xarelto. Despite filing numerous motions in multiple forums arguing to that effect and requesting Judge Powell’s reassignment, J&J and Ethicon have been consistently rebuffed by authorities ranging from Judge Powell himself to the Philadelphia Supreme Court and now the judge overseeing the mesh litigation program.

In the new case, opening arguments for which began Monday, March 25, the jury heard first from attorneys for the plaintiff, who asserted that Philadelphia-area resident Malgorzata Krolikowski had suffered a range of devastating health and personal complications since having Ethicon TVT-O mesh surgically implanted approximately a decade ago. Attorney Elia Robertson of Kline and Specter PC told jurors that Ms. Krolikowski continued to suffer from worsening urinary incontinence and that the Ethicon device had made it impossible for her to engage in sexual intercourse, depriving her of the ability to have normal human intimacy.

“What Ms. Krolikowski wants now is a normal life,” Robertson said before the court, according to Law360 . “She wants to be able to do her job without leaking, she wants to not have to change a pad five times a day, and most of all, like all of us, what she wants is companionship. The defendants have taken that away from her.”

Attorneys for the defendant medical device makers countered that the Ethicon TVT-O mesh should not be blamed for all of the plaintiff’s ailments, which Andrea La’Verne Edney of Butler Snow LLP attributed to other causes, among them Ms. Krolikowski’s allegedly abnormally positioned uterus.

“Just because a device doesn’t work and cure 100 percent doesn’t mean it was a defective device,” Edney argued, per Law360.

Sources:

Penton, K. (25 March 2019). Philly Judge Won’t Boot Colleague From J&J Mesh Dispute. Law360

Fair, M. (25 March 2019). Faulty Mesh Worsened Woman’s Incontinence, Pa. Jury Hears. Law360

Fair, M. (26 March 2019). ‘Imperfect’ Treatment Result Not J&J Mesh’s Fault, Jury Told. Law360

Ethicon Physiomesh Lawsuit Update: Ethicon Physiomesh MDL Continues to Grow, Passes 1900 Cases

March 26, 2019
Author: Daniel Gala

Multidistrict litigation (MDL) over Physiomesh surgical mesh implants sold by Johnson & Johnson subsidiary Ethicon Inc. continues to grow, passing 1,900 individual claims, according to an update to the court’s list of member cases released March 25.

With the total cases now numbering 1,912, the MDL has added 14 cases in the last week alone, or two new cases per day.

The MDL, taking place in the Northern District of Georgia, involves products liability claims over Ethicon Physiomesh Flexible Composite Hernia Mesh, including allegations that Johnson & Johnson and Ethicon defectively designed, manufactured, and labeled the device, resulting in injury to the plaintiffs. tively designed, manufactured, and labeled the device, resulting in injury to the plaintiffs.

The MDL does not include claims over Ethicon Physiomesh Open Flexible Composite Mesh. tively designed, manufactured, and labeled the device, resulting in injury to the plaintiffs.

Source:

United States District Court Northern District of Georgia. (25 March 2019). Member Case List for 1:17-md-2782. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation

Atrium Mesh Lawsuit Update: Atrium Agrees To Waive Venue, Service Objections In C-Qur Mesh MDL

March 25, 2019
Author: Daniel Gala

Medical-device maker Atrium Medical Corporation and other defendants facing lawsuits over their surgical mesh products in multidistrict litigation (MDL) taking place in New Hampshire have agreed to waive any objections regarding improper venue and formal service of process related to the MDL, according to an order issued March 14 by the judge overseeing the litigation.

“In order to eliminate disputes over service of process, Defendants agree that they will waive formal service of process in cases in this MDL,” United States District Judge Landya McCafferty wrote in the Second Amended Case Management Order No. 2., stating elsewhere that defendants also “agreed to waive any objection to improper venue for actions filed directly in this MDL.”

The move will help facilitate the filing of new claims directly in MDL 2753 In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation. Plaintiffs seeking to take advantage of the order by avoiding formal service of process and/or by filing their claim directly in the MDL still will have to file waiver requests with the defendants.

“Service is deemed effective as of the date Defendants file the waiver,” Judge McCafferty ordered.

Despite agreeing not to contest cases on the basis of venue, defendants still “reserve the right to object to the inclusion of any such action in this MDL,” the order states.

The order, the first to be issued in the Atrium C-Qur mesh MDL in nearly a month, shows that the parties and the court continue to coordinate on the ground rules and logistics of the complex litigation. Aside from Atrium, other defendants in the MDL include Maquet Cardiovascular, LLC; Maquet Cardiovascular US Sales, LLC; Getinge AB; and Getinge USA.

As of March 19, 2019, the MDL contained over 1,100 individual cases arising out of 22 different districts, spanning the United States from Florida to Arizona, according to TheLawFirm.com’s review of the court’s list of member cases. The vast majority of the cases, totaling over 1,000, were filed with the District of New Hampshire, home venue for the MDL.

According to the transfer order issued by the Judicial Panel on Multidistrict Litigation (JPML) in 2016, which established the Atrium C-Qur MDL, “All the actions [in the MDL] share common factual questions arising out of allegations that the defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications.”

Further, “All the actions involve factual questions relating to whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh.”

Sources:

United States District Court for the District of New Hampshire. (14 March 2019). Second Amended Case Management Order No. 2 (Direct Filing and Waiver of Service). MDL No. 2753 In Re: Atrium Medical Corp. C-Qur Products Liability Litigation

United States District Court for the District of New Hampshire. (Updated 19 March 2019). Attachment A: Listing of Individual Cases as of March 19, 2019. MDL No. 2753 In Re: Atrium Medical Corp. C-Qur Products Liability Litigation

United States Judicial Panel on Multidistrict Litigation. (8 December 2016). Transfer Order. MDL 2753 In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation

Bard Mesh Lawsuit Update: Judge Approves Covidien Settlement In W. Va. Pelvic Mesh MDL

March 22, 2019
Author: Daniel Gala

By an order entered March 18, the federal judge overseeing multidistrict litigation (MDL) over surgically implanted pelvic repair systems approved a proposed settlement agreement previously submitted by plaintiffs represented by the firm Andrus Wagstaff, P.C. and defendant medical-device-maker Covidien. The order is the latest sign that the near decade-long MDL continues to wind down.

In Pretrial Order #303, United States District Judge Joseph R. Goodwin, writing for the Southern District of West Virginia, also established a qualified settlement fund and appointed Providio MediSolutions, LLC as fund administrator.

The court’s list of member cases includes seven individual cases within the pelvic repair system MDL that name Covidien entities as defendants, all of which originated in Massachusetts federal court. It is unclear from the list how many of these plaintiffs are represented by Andrus Wagstaff, the firm involved in the Covidien settlement.

Overall, the MDL has included 15,753 cases, of which 13,685 had closed as of March 21, 2019.

The approval of the proposed settlement agreement follows a March 14 order reappointing the MDL’s Common Benefit Fee and Cost Committee to review attorneys’ common benefit time and expense submissions since December 21, 2016, another indication that the MDL is nearing final resolution.

The MDL centralized actions brought against makers of so-called pelvic repair systems, which utilize surgical mesh implants in the treatment of a number of ailments. The lawsuits accused the companies, including C.R. Bard, Inc. and Covidien, of defectively designing, manufacturing, and marketing the devices, as well as failure to warn.

Sources:

United States District Court for the Southern District of West Virginia Charleston Division. (18 March 2019). Pretrial Order #303 (Order Re: Approval of Qualified Settlement Fund – Covidien – Andrus Wagstaff). MDL No. 2187 In Re: C.R. Bard, Inc. Pelvic Repair Systems Products Liability Litigation

United States District Court for the Southern District of West Virginia Charleston Division. (14 March 2019). Pretrial Order #302 (Order Reappointing Common Benefit Fee and Cost Committee). MDL No. 2187 In Re: C.R. Bard, Inc. Pelvic Repair Systems Products Liability Litigation

Bard Mesh Lawsuit Update: 3,000 Case Filings Expected in Ohio Mesh MDL By End of Year

March 22, 2019
Author: Daniel Gala

The plaintiffs’ steering committee for multidistrict hernia mesh litigation presently taking place in the Southern District of Ohio expects 3000 cases to be filed by the end of 2019, according to a court order detailing the contents of a March 6 status conference. The order also spelled out details and deadlines regarding the ongoing pretrial discovery process, including the parties’ submissions for bellwether trials.

The centralized cases involve products liability claims against medical-device makers C.R. Bard, Inc. and Davol, Inc. over the companies’ polypropylene hernia mesh products, alleging that their implantation can result in dangerous and painful complications and that the defendants failed to adequately warn plaintiffs of the risks involved. The medical complications linked to the mesh implants include inflammation, allergic reactions, adhesion, and damage to internal organs.

The relatively new multidistrict litigation (MDL) was formed by order of the Judicial Panel on Multidistrict Litigation (JPML) on August 2, 2018. At the time, the JPML was considering whether approximately 50 actions across 23 districts should be centralized. That the plaintiffs’ steering committee now expects 3,000 such cases by the end of 2019 demonstrates the large number of patients who claim to have been negatively impacted by defendants’ hernia mesh implants, as well as the expectation that the litigation will rapidly expand.

The next status conference is scheduled to be held April 17.

Sources:

United States District Court for the Southern District of Ohio Eastern Division. (8 March 2019). Pretrial Order No. 7 March 6, 2019 Status Conference. In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

United States Judicial Panel on Multidistrict Litigation. (2 August 2018). Transfer Order. MDL No. 2846 In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation

Atrium Mesh Lawsuit Update: Atrium Agrees To Waive Venue, Service Objections In C-Qur Mesh MDL

March 21, 2019
Author: Daniel Gala

Medical-device maker Atrium Medical Corporation and other defendants facing lawsuits over their surgical mesh products in multidistrict litigation (MDL) taking place in New Hampshire have agreed to waive any objections regarding improper venue and formal service of process related to the MDL, according to an order issued March 14 by the judge overseeing the litigation.

“In order to eliminate disputes over service of process, Defendants agree that they will waive formal service of process in cases in this MDL,” United States District Judge Landya McCafferty wrote in the Second Amended Case Management Order No. 2., stating elsewhere that defendants also “agreed to waive any objection to improper venue for actions filed directly in this MDL.”

The move will help facilitate the filing of new claims directly in MDL 2753 In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation. Plaintiffs seeking to take advantage of the order by avoiding formal service of process and/or by filing their claim directly in the MDL still will have to file waiver requests with the defendants.

“Service is deemed effective as of the date Defendants file the waiver,” Judge McCafferty ordered.

Despite agreeing not to contest cases on the basis of venue, defendants still “reserve the right to object to the inclusion of any such action in this MDL,” the order states.

The order, the first to be issued in the Atrium C-Qur mesh MDL in nearly a month, shows that the parties and the court continue to coordinate on the ground rules and logistics of the complex litigation. Aside from Atrium, other defendants in the MDL include Maquet Cardiovascular, LLC; Maquet Cardiovascular US Sales, LLC; Getinge AB; and Getinge USA.

As of March 19, 2019, the MDL contained over 1,100 individual cases arising out of 22 different districts, spanning the United States from Florida to Arizona, according to TheLawFirm.com’s review of the court’s list of member cases. The vast majority of the cases, totaling over 1,000, were filed with the District of New Hampshire, home venue for the MDL.

According to the transfer order issued by the Judicial Panel on Multidistrict Litigation (JPML) in 2016, which established the Atrium C-Qur MDL, “All the actions [in the MDL] share common factual questions arising out of allegations that the defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications.”

Further, “All the actions involve factual questions relating to whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh.”

Sources:

United States District Court for the District of New Hampshire. (14 March 2019). Second Amended Case Management Order No. 2 (Direct Filing and Waiver of Service). MDL No. 2753 In Re: Atrium Medical Corp. C-Qur Products Liability Litigation

United States District Court for the District of New Hampshire. (Updated 19 March 2019). Attachment A: Listing of Individual Cases as of March 19, 2019. MDL No. 2753 In Re: Atrium Medical Corp. C-Qur Products Liability Litigation

United States Judicial Panel on Multidistrict Litigation. (8 December 2016). Transfer Order. MDL 2753 In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation

Ethicon Mesh Lawsuit Update: J&J, Ethicon Continue Efforts To Remove Judge From Philly Mesh Trial

March 20, 2019
Author: Daniel Gala

Despite repeated rejections, including one handed down by the Philadelphia Supreme Court earlier this month, Johnson & Johnson and its subsidiary Ethicon Inc. have continued in their efforts to have a judge barred from presiding over cases involving the defendant companies’ surgical mesh implants, including a trial that began last week, alleging the appearance of impropriety. In its latest attempt, J&J and Ethicon have filed a motion with the judge overseeing the mass tort litigation over Ethicon’s pelvic mesh implants, Law360 has reported.

Meanwhile, attorneys representing women who claim to have suffered debilitating injury as a result of Ethicon’s pelvic mesh implants have blasted the companies’ attempts to have Judge Kenneth Powell reassigned from the cases, saying the defendants are merely seeking a more favorable jurist for their side.

“Ethicon has filed these…motions [to have Judge Powell reassigned] in a blatant effort at judge-shopping and attempting to receive special treatment,” the plaintiffs’ attorneys said, per Law360.

According to arguments repeatedly put forth by J&J and Ethicon, including three motions denied directly by Judge Powell himself during trials he presided over, the judge should be reassigned from any cases involving Johnson & Johnson and its subsidiaries because his mother presently is involved in a lawsuit against J&J unit Janssen Pharmaceuticals over its anticoagulant medication Xarelto. Like the Ethicon pelvic mesh trials Judge Powell has presided over, his mother’s Xarelto case also is taking place in Philadelphia County.

J&J and Ethicon claim that they were unaware of Judge Powell’s potential conflict during the first trial he oversaw, a lack of disclosure that they claim resulted in the “appearance of impropriety.”

For his part, Judge Powell has maintained that he was unaware at the time of this first trial that his mother’s lawsuit was against a J&J subsidiary and that the situation has no bearing on his ability to be impartial. Attorneys for the plaintiffs agree.

“This motion has already been denied by two judges of the [Philadelphia County] Court of Common Pleas and rejected by the Supreme Court of Pennsylvania,” Shanin Specter, an attorney for the plaintiffs, said, per Law360. “In another example of judge-shopping by this defendant, Johnson & Johnson now seeks a different ruling from a 10th judge. It should be denied again.”

Source:

Fair, M. (18 March 2019). Mesh Victims Slam J&J’s ‘Judge-Shopping’ In Pa. Recusal Bid. Law360

Ethicon Mesh Lawsuit Update: Jury Hears Opening Arguments In Latest Philly Ethicon Mesh Trial

March 16, 2019
Author: Daniel Gala

After Johnson & Johnson and its subsidiary Ethicon Inc. failed in their last-ditch effort to have the judge assigned to their forthcoming case removed over an alleged conflict, opening statements began in the latest trial in a Philadelphia mass tort action featuring claims that plaintiffs suffered serious, life-altering injuries due to defects with Ethicon's surgical mesh device .

The opening arguments in the instant case, which involves plaintiff Susan McFarland’s allegations that Ethicon’s TVT-O pelvic mesh device has caused her debilitating pain and injury since she had it surgically installed over a decade ago, are highly reminiscent of those presented previously in similar trials, with an attorney for the plaintiff describing in visceral detail the manner in which the Ethicon device “sawed away” at McFarland’s vaginal tissue, and attorneys representing the defendant companies insisting that the injuries were a result of the body’s natural aging processes. 

“Why is a woman’s body being blamed for doing what it’s supposed to do when there’s a piece of plastic permanently implanted in it?” Tracie Palmer, an attorney for the plaintiff, told the court, per Law360 arguing that the nature of her client’s injuries show that the mesh implant played a significant role in causing the damage. 

Additionally, Palmer accused Ethicon and J&J of cutting corners in order to get the TVT-O to market as soon as possible, saying that the companies did not hold a single clinical trial to study patient safety before offering the device to consumers. 

“They put profits before patients, and women like Mrs. McFarland are the ones who’ve had to pay the price,” Law360 quoted Palmer as saying. “They acted unreasonably as the manufacturer of a medical device meant to remain in a woman’s body forever.”

Of eight previous trials held as part of the Ethicon mass tort action taking place in the Philadelphia Court of Common Pleas, six have resulted in awards for the plaintiff, totaling $150 million in damages. McFarland’s case presently is on retrial after a previous trial resulted in a deadlocked jury. 

As in similar cases, attorneys for the defendant companies sought to downplay the connection between their clients’ products and the patients’ injuries. 

“In a court of law, belief is not enough. Belief is not evidence,” Kate Skagerberg, an attorney for Ethicon, argued . “What is evidence is the testimony of Ms. McFarland’s own doctor, who will tell you that vaginal atrophy is the reason for the concerns that she complains about in this lawsuit.”

The week before the trial was set to begin, defendants Johnson & Johnson and Ethicon had petitioned the Pennsylvania Supreme Court seeking to have the judge assigned to the case removed, arguing that he was conflicted because his mother was suing J&J subsidiary Janssen Pharmaceuticals in an otherwise unrelated case also taking place in Philadelphia County. The Supreme Court of Pennsylvania denied the companies’ motion. 

Stay tuned to TheLawFirm.com for the latest updates on pelvic mesh lawsuits

Source: 

Fair, M. (13 March 2019). Retrial Jury Hears J&J Mesh Not To Blame For Woman's Pain. Law360

Ethicon Mesh Lawsuit Update: Ethicon, J&J Lose Bid To Have Judge Reassigned in Philly Mesh Trial

March 13, 2019
Author: Daniel Gala

Following repeated fruitless efforts by Johnson & Johnson and its subsidiary Ethicon Inc. to have a judge removed from overseeing trials involving the companies’ pelvic mesh products, the Pennsylvania Supreme Court handed the defendant medical device makers yet another loss on the issue, denying their last-minute bid to have Judge Kenneth Powell reassigned from a case set to begin as soon as the issue was resolved, Law360 has reported.

J&J and Ethicon repeatedly have alleged that Judge Powell should not be involved in mass tort litigation taking place in Philadelphia County because the judge’s mother presently is the plaintiff in a separate lawsuit against a different Johnson & Johnson subsidiary. In a ruling released March 12, the Pennsylvania Supreme Court denied the defendants’ latest effort, effectively paving the way for Judge Powell to preside over the forthcoming retrial of a women who accuses the companies of design defects and a failure to adequately warn patients of the risks of Ethicon’s surgical mesh implants. 

An attorney for the plaintiff held little back in his criticism of the companies’ efforts to have Judge Powell removed from the case. 

“Johnson & Johnson is a bully, a felon and a mass tortfeasor,” Shanin Specter, representing the plaintiff in the upcoming trial, told Law360. “Their contemptible motion was beyond the bounds of fair advocacy. It disparaged one of the most highly regarded trial judges in Pennsylvania and was an assault on the independence of the judiciary.”

The forthcoming trial features plaintiff Susan McFarland, who alleges that she has suffered serious injuries as a result of an Ethicon surgical mesh device that she had implanted in order to treat urinary stress incontinence. In a previous trial, jurors failed to reach a verdict, resulting in the retrial.

The trial will be the eighth such case J&J and Ethicon have faced in Philadelphia County in recent years. Six of the previous cases have resulted in damages for the plaintiffs.

Judge Powell’s mother reportedly is suing Johnson & Johnson, also in Philadelphia County, over the medication Xarelto, which is sold by J&J subsidiary Janssen Pharmaceuticals. 

Source: 

Law360 has reported

Ethicon Mesh Lawsuit Update: Ethicon seeks Judge Reassignment In Pelvic mesh tort

March 9, 2019
Author: Daniel Gala

On March 7, Johnson & Johnson unit Ethicon Inc. filed a motion seeking reassignment of a judge involved in mass tort litigation over the company’s pelvic mesh devices, saying that the judge should recuse himself because his mother has a separate lawsuit pending against Johnson & Johnson, Law360 reported. The judge in question already has overseen four cases in the Ethicon pelvic mesh litigation and was scheduled to preside over a fifth beginning Monday, March 11.

Ethicon says it previously had sought the recusal of Judge Kenneth J. Powell, Jr. in multiple trials but that the judge had denied its motions. The new request for a reassignment order has been filed with a different judge, Judge Arnold L. New.

In response to the defendants’ previous efforts to have Judge Powell removed from other trials, attorneys for the plaintiffs have accused Ethicon and Johnson & Johnson of “judge shopping”.

The mass tort litigation taking place in Philadelphia County involves claims brought by female plaintiffs who allege that Ethicon’s pelvic mesh implants were negligently designed and that the company had failed to provide adequate warnings of the devices’ risks, including the potential for permanent injury.

Most recently, Judge Powell oversaw a trial that concluded in January 2019 and which resulted in a $41 million verdict against Ethicon and Johnson & Johnson. That trial was the eighth overall to be completed in the Philadelphia mass tort action. Six have resulted in a jury verdict for the plaintiff.

Sources:

O’Sullivan, J. (8 March 2019). J&J Wants Philly Judge Booted From Further Mesh Trials. Law360

Fair, M. (26 November 2018). Pa. Mesh Judge Won’t Recuse Over Mom’s Case Against J&J. Law360

Ethicon Mesh Lawsuit Update: Judge Approves Settlement Fund In Ethicon Pelvic Repair MDL

March 6, 2019
Author: Daniel Gala

On February 28, the judge overseeing multidistrict litigation (MDL) involving products liability claims against Johnson & Johnson subsidiary Ethicon Inc. over the company’s pelvic repair system granted an unopposed motion governing the administration of a confidential settlement agreement reached among the parties.

In Pretrial Order #331, District Judge Joseph R. Goodwin established a qualified settlement fund and appointed Archer Systems, LLC as fund administrator, pursuant to the terms of the parties’ master settlement agreement, their escrow agreement, and the unopposed motion.

The terms of the master settlement agreement, including any financial payouts, have not been disclosed publicly.

The (MDL) over Ethicon’s pelvic repair system, a surgical mesh medical device, has been ongoing in the Southern District of Georgia since February 2012. According to the court’s Member List of Cases, as of February 28, 2019, the MDL had included a total of 40,545 cases, of which 26,497 had been closed, meaning over 14,000 cases remained open.

Despite several cases having been selected as bellwether trials, from 2013 through 2017, the court website shows these cases to have been repeatedly postponed, with none ever going to trial.

However, with Judge Goodwin’s order approving the administration of the settlement agreement, it appears this long-running litigation may finally be nearing an end.

Sources:

Pretrial Order #331 (Order Re: Qualified Settlement Fund—Johnson Law Group). (Entered 28 February 2019). MDL Docket No. 2327. In Re: Ethicon Inc. Pelvic Repair System Products Liability Litigation. United States District Court for the Southern District of West Virginia Charleston Division

Member List of Cases. (Accessed 5 March 2019). MDL Docket No. 2327. In Re: Ethicon Inc. Pelvic Repair System Products Liability Litigation. United States District Court for the Southern District of West Virginia Charleston Division

Bellwether Trials and other trials. (Last Updated 23 February 2017). MDL Docket No. 2327. In Re: Ethicon Inc. Pelvic Repair System Products Liability Litigation. United States District Court for the Southern District of West Virginia Charleston Division

ETHICON MESH LAWSUIT UPDATE: Almost 2000 mesh cases remain active in mdl over ethicon physiomesh flexible composix mesh

March 5, 2019
Author: Daniel Gala

As of March 5, 2019, nearly 2,000 cases remained active in multidistrict litigation (MDL) over Ethicon PHYSIOMESH Flexible Composite Mesh, according to the court’s Member Case Listing. The MDL is located in the United States District Court for the Northern District of Georgia and is being overseen by US District Judge Richard W. Story.

The exact number of cases in the Member Case Listing as of February 25 was 1,857. A review of the list by TheLawFirm.com has revealed that the vast majority of plaintiffs are individuals while at least two—VRM MSP Recovery Partners, LLC and MSP Recovery Claims, Series LLC—appear to be business entities.

“This litigation involves claims that a particular hernia mesh product was allegedly defectively designed, manufactured, and labeled by Ethicon, Inc. and/or Johnson & Johnson and caused personal injuries to plaintiffs,” the case summary on the court’s website reads. “The specific device at issue in this litigation is PHYSIOMESH Flexible Composite Mesh. This litigation does not involve PHYSIOMESH Open Flexible Composite Mesh Device.”

The court’s most recent publicly available order, Practice and Procedure Order No. 15 signed by Judge Story on January 17, continued to pave the way for the Initial Discovery Pool as the MDL winds its way toward its first bellwether trials. The order calls for discovery in the first trials to be completed by summer 2019.

“Absent an Order from the Court to the contrary or agreement by the parties, all corporate and case-specific discovery for the Trial Cases shall be completed by July 1, 2019,” the order states.

Sources:
Member Case List for 1:17-md-2782. (25 February 2019). MDL Docket No. 2782. In Re: Ethicon PHYSIOMESH Flexible Composite Hernia Mesh Products Liability Litigation. United States District Court for the Northern District of Georgia

Practice and Procedure Order No. 15. (17 January 2019). MDL Docket No. 2782. In Re: Ethicon PHYSIOMESH Flexible Composite Hernia Mesh Products Liability Litigation. United States District Court for the Northern District of Georgia

Case Summary. (Last Accessed 26 February 2019). MDL Docket No. 2782. In Re: Ethicon PHYSIOMESH Flexible Composite Hernia Mesh Products Liability Litigation. United States District Court for the Northern District of Georgia

Bard Mesh Lawsuit Update: Showing Urgency To Resolve Remaining Cases, Judge Clarifies Procedures For Dismissing Settled Cases in CR Bard Mesh MDL

February 28, 2019
Author: Daniel Gala

In a pretrial order entered February 26, 2019, the judge overseeing multidistrict litigation (MDL) involving products liability claims against C.R.Bard, Inc. over its pelvic repair system clarified the proper proceedings for having individual cases dismissed from the litigation. The order represents the court’s latest effort to push along the large number of cases that have either settled completely or entered a settlement model but which remain on the court’s inactive docket.

The February 26 order follows a more detailed pretrial order entered February 4 in which the court explicitly laid out its frustration that so many otherwise resolved cases were remaining on the inactive docket.

“Despite representations in inactive docket orders proposed by the parties and entered by the court, that the cases on Exhibit A have been settled or entered into a settlement model,” US District Judge Joseph R. Goodwin lamented in the earlier order, “and despite repeated warnings by the court that cases will not remain on the inactive docket indefinitely, the number of cases on the inactive docket remains in the thousands.”

Exhibit A lists 398 cases that have resided on the inactive docket since as far back as July 2017.

The repeated orders show Judge Goodwin’s urgency to clear the inactive docket and push the overall litigation toward resolution. Having commenced in October 2010, the MDL is nearing a decade old. The most recent of four bellwether trials began back in 2015.

The cases involve product liability claims that surgical mesh devices manufactured by CR Bard, Inc. were defectively designed and featured risks that were inadequately disclosed to patients, resulting in serious injury to the plaintiffs.

According to the court’s Member List of Cases, the MDL has included a total of 15,753 cases. With 13,658 cases having been closed, that leaves nearly 2,100 still pending resolution.

From his recent orders, Judge Goodwin appears eager to have these remaining cases dealt with as soon as possible, and understandably so.

Sources:

Pretrial Order #300 Order Re: Procedure for Filing Motions to Dismiss Individual Cases. (Entered February 26, 2019). MDL 2187. United States District Court for the Southern District of West Virginia Charleston Division

Pretrial Order #299 Docket Control Order – C.R. Bard Wave 9 Cases. (Entered February 4, 2019). MDsL 2187. United States District Court for the Southern District of West Virginia Charleston Division

Ethicon Mesh Lawsuit Update: Court chides parties for ‘Inefficiencies’ in dismissing settled cases in ethicon mesh mdl

February 28, 2019
Author: Daniel Gala

In a pretrial order issued February 21, 2019, the judge overseeing multidistrict litigation (MDL) over surgical mesh products manufactured and sold by Johnson & Johnson subsidiary Ethicon, Inc. maligned “inefficiencies” in having cases that already have been settled and paid dismissed with prejudice by the court, as is the standard practice in such litigation. The order clarifies the process for having such cases dismissed and reiterates the importance of engaging in this process in a timely manner. 

“When a settlement of an individual plaintiff’s case occurs, the parties in that case are obligated (as in any litigation) to arrange for the case to be promptly dismissed with prejudice,” wrote US District Judge William R. Goodwin in Pretrial Order #328. “It has come to the court’s attention that there have been inefficiencies and delays in the process of dismissal of settled cases, which the court now addresses in this Order.”

With Johnson & Johnson reporting in a recent filing with the US Securities and Exchange Commission (SEC) that most of the Ethicon-mesh cases in the United States have been settled, the judge’s order appears to be a further sign that litigation over Ethicon’s pelvic repair system is beginning to wind down, at least in the United States. 

“The Company has settled or otherwise resolved a majority of the United States cases and the costs associated with these settlements are reflected in the Company's accruals,” Johnson & Johnson’s annual filing stated among its legal disclosures. 

However, J&J and Ethicon continue to face ongoing litigation outside the US. 

“[C]lass actions and individual personal injury cases or claims have been commenced in various countries outside of the United States,” Johnson & Johnson disclosed in its Form 10-K filing for the 12 months ended December 30, 2018, “including claims and cases in the United Kingdom, the Netherlands and Belgium, and class actions in Israel, Australia and Canada, seeking damages for alleged injury resulting from Ethicon's pelvic mesh devices. In Australia, a trial of class action issues has been completed and the parties are awaiting a decision.”

Check back in with TheLawFirm.com for the latest updates on Ethicon surgical mesh litigation. 

Sources:
Pretrial Order #328 (Order Re: Dismissed and Settled Cases). (21 February 2019). MDL 2327 IN RE: ETHICON, INC. PELVIC REPAIR SYSTEMS PRODUCTS LIABILITY LITIGATION. United States District Court for the Southern District of West Virginia Charleston Division

Johnson & Johnson Corporation. (20 February 2019). Form 10-K for 12 months ended Dec. 30, 2018. Notes to Financial Statements. Commitments and Contingencies Disclosure. Legal Proceedings. Product Liability. United States Securities and Exchange Commission (SEC)

Mesh Lawsuit Update: Boston Scientific Discloses Resolution in 10,000s of Mesh Cases

February 24, 2019
Author: Daniel Gala

Facing upwards of 50,000 active lawsuits over harms allegedly caused by its surgical mesh implants, Boston Scientific Corp. revealed in its annual financial filings to the United States Securities and Exchange Commission (SEC) that it is nearing settlement in the vast majority of such cases, a review of the company’s disclosures posted February 19, 2019 has revealed.

“As of February 5, 2019, approximately 53,000 product liability cases or claims related to transvaginal surgical mesh products designed to treat stress and pelvic organ prolapse have been asserted against us,” Boston Scientific’s Form 10-K for the 12 months ended December 31, 2018 reported. “The pending cases are in various state courts in the U.S. and include eight putative class actions.”

However, the company added that, also as of February 5, 2019, it had “entered into master settlement agreements in principal or [was] in the final stages of entering into one with certain plaintiffs’ counsel to resolve an aggregate of approximately 50,000 cases and claims.” Further, out of “the approximately 50,000 cases and claims, approximately 35,500 have met the conditions of the settlement and are final,” with all such agreements being “entered into solely by way of compromise and without any admission or concession by [Boston Scientific] of any liability or wrongdoing.”

Since 2012, many of the transvaginal surgical mesh cases brought against Boston Scientific in the United States had been consolidated as multidistrict litigation (MDL) taking place in the Southern District of West Virginia. According to the company’s filings, it also faced lawsuits outside the US, including “fewer than 25 cases in Canada” including “one certified and three putative class actions,” as well as fewer than 25 cases in the United Kingdom.

Boston Scientific’s disclosures describe the company’s being sued by plaintiffs asserting “design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims.” The exact terms of the settlement agreements, including any financial payouts, were not reported in the company’s “Product Liability Litigation” disclosures, though Boston Scientific did disclose that it has “established a product liability accrual for known and estimated future cases and claims.”

Sources:
Boston Scientific Corporation. (19 February 2019). Form 10-K. Note J - Commitments and Contingencies. Product Liability Litigation. United States Security and Exchange Commission

Mesh Lawsuit Update: Judge Issues amended case management order in ethicon pjysiomesh mdl

February 8, 2019
Author: Daniel Gala

With the deadline for both sides to submit cases for expert discovery fast approaching, the total number of individual plaintiffs in a Multi District Litigation (MDL) over Ethicon PHYSIOMESH implants has grown to nearly 1,800, court documents reveal. Additionally, according to an amended discovery order issued January 17, the court also has set the date of the first bellwether trial for February 3, 2020.

Practice and Procedure Order No. 15, signed by District Judge Richard W. Story on January 17, 2019, reaffirms and amends slightly a previous proposed discovery, scheduling, and case management order. According to the order, the parties have until April 15 to select five cases each on which expert discovery will proceed, with all expert discovery scheduled to be completed by October 14, paving the way for the first bellwether trials to begin.

Although the Ethicon PHYSIOMESH MDL continues to proceed apace, the first trial still remains roughly a year away, with the order stating that the “Court will set the first trial for February 3, 2020.”

This all takes place as the number of total cases in the MDL continues to grow. According to the Member Case List updated February 4, 2019, the US District Court for the Northern District of Georgia listed 1,794 total cases involving individuals suing over harms allegedly caused by Ethicon PHYSIOMESH.

In the MDL’s Master Long Form Complaint , plaintiffs allege a number of design and manufacturing defects with Ethicon PHYSIOMESH Flexible Composite Mesh implants, including that the device’s “multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”

Additionally, the complaint claims that defendants Ethicon and its parent company Johnson & Johnson “knew or should have known of the lack of bioincompatibility of the multi-layer coating of the Physiomesh prior to introducing it into the stream of commerce,” ultimately arguing that the “manufacturing and design defects associated with the Physiomesh were directly and proximately related to the injuries related to plaintiffs.

Sources:
Practice and Procedure Order No. 15 (Amended Proposed Discovery, Scheduling and Case Management Order – Initial Discovery Pool). MDL Docket No. 2782. 17 January 2019
Member Case List for 1:17-md-2782. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. MDL Docket No. 2782. 4 February 2019
Master Long Form Complaint. In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. MDL Docket No. 2782. 6 September 2017

Mesh Lawsuit Update: Judge Says W. VA Pelvic Mesh MDLs “Virtually Unprecedented in Size”, Have Yielded $7.25 Billion in Awards

February 7, 2019
Author: Daniel Gala

In a rare court order involving more than half-a-dozen different multidistrict litigations (MDLs) presently taking place in the Southern District of West Virginia, a district judge offered insight into the massive scale of the ongoing MDLs, including that the total number of plaintiffs number in the six figures and that the cumulative awards to date top $7 billion.

The order, entered January 30, calls for common benefit attorneys to receive 5% percent of all settlements and judgements associated with seven hernia-mesh-related multidistrict litigations (MDLs) presently taking place in the Charleston Division of the Southern District of West Virginia. Among the MDLs covered by the order are ongoing products liability litigation over pelvic repair systems manufactured by Ethicon, Inc. and CR Bard, Inc.

With different MDLs typically proceeding more or less independently of one another, the order impacting multiple MDLs provides unique insight into the massive scale of surgical mesh litigation presently facing the Southern District of West Virginia. According to Pretrial Order #327, signed by District Judge Joseph R. Goodwin, the seven pelvic-mesh-related MDLs represent “one of the largest multidistrict litigation proceedings in this country’s history” with “over 104,000 individual plaintiffs suing numerous defendants who manufactured many different pelvic mesh products.”

According to the court, over the course of these seven pelvic mesh MDLs, although many cases remain open, “[t]ens of thousands of cases have been resolved, for a total sum to date of $7.25 billion.”

The massive scope of the litigation, in terms both of the number of plaintiffs involved and the number of surgical mesh products implicated, demonstrates that the alleged dangers associated with hernia mesh devices are not limited to a single design or manufacturer. What began with 36 plaintiffs suing over a single hernia mesh device has since ballooned into what the court says is litigation “virtually unprecedented in size and scope.”

According to the Common Benefit Fee and Cost Committee (FCC), which petitioned the court for the 5% award, to date, common benefit counsel have worked approximately 900,000 hours over the nine-plus years of ongoing litigation, of which nearly 700,000 hours qualified as being for the common benefit.

Source:
Pretrial Order #327. In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation. MDL No. 2327. 30 January 2019

Bard Mesh Lawsuit Update: Davol and Bard Must Hand Over Communications with Foreign Regulators, Court in Mesh MDL Rules

February 5, 2019
Author: Daniel Gala

Davol, Inc. and C.R. Bard, Inc. must turn over to plaintiffs official communications with six foreign regulators regarding the safety and labeling of the companies’ polypropylene hernia mesh products, the judge and magistrate judge overseeing multidistrict litigation (MDL) involving the devices ruled in an Opinion and Order issued January 28.

The ruling, signed by Chief District Judge Edmund A. Sargus, Jr. and Magistrate Judge Kimberly A. Jolson of the Eastern Division of the Southern District of Ohio, granted in part and denied in part a motion previously filed by plaintiffs, who requested “that the Court compel Defendants to produce foreign regulatory materials relating to polypropylene surgical mesh” as part of the pretrial discovery process. According to the opinion, plaintiffs later narrowed the request to include only communications pertaining to safety and labeling.

While the Order and Opinion broadly grants the plaintiffs’ request for communications with the foreign regulatory bodies, the court sought to address the defendant companies’ proportionality concerns by limiting the scope to the polypropylene hernia mesh products named in the Master Long Form Complaint and by instructing the parties to meet and confer regarding the applicable time period, an important issue the order does not resolve but which must be settled before Davol and Bard actually produce any of the documents in question.

The foreign regulatory bodies covered by the Opinion and Order include the Scientific Committees of the European Commission; the Medicines and Healthcare Products Regulatory Agency (MHRA), including Health Facilities Scotland (HFS) and the United Kingdom’s National Health Services (NHS); Germany’s Federal Institute for Drugs and Medical Devices (BfArM); Health Canada; Australia’s Therapeutic Goods Administration (TGA); and Japan’s Pharmaceuticals & Medical Devices Agency (PMDA).

Defendants Davol and Bard had argued that the production of its communications with these foreign regulatory bodies was unwarranted because they were irrelevant to the issues at hand and because such production would prove overly burdensome to the defendants and their subsidiaries. While the Order and Opinion shows that the court largely disagreed with the defendants’ arguments, the defendants did succeed in having the production request narrowed to include only products named in the Master Long Form Complaint and in obtaining a further opportunity to confer with plaintiffs over the relevant time period.

Source:
Opinion and Order. In Re: Davol, Inc. / C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation. No. 2:18-md-2846. US District Court for the Southern District of Ohio Eastern Division. 28 January 2019

Mesh Lawsuit Update: Johnson & Johnson considers ethicon physiomesh cases among 'most significant,' disclosure says

November 2, 2018

Johnson & Johnson considers lawsuits over surgical mesh manufactured by its subsidiary Ethicon, Inc. to be among the “most significant” product liability cases facing the conglomerate, according to a recent filing with the United States Securities and Exchange Commission (SEC). Johnson & Johnson reported that as of September 30, it faced approximately 37,400 lawsuits over pelvic mesh in the United States alone.  



Despite the massive number of hernia mesh lawsuits remaining, Johnson & Johnson claims that it “has settled or otherwise resolved a majority of the United States cases.” The pelvic-mesh devices, used in the treatment of stress urinary incontinence and pelvic organ prolapse, also have been the subject of patient-filed lawsuits in the United Kingdom, the Netherlands, and Belgium, with class-action suits ongoing in Israel, Canada, and Australia. (Johnson & Johnson says it expects a decision in the Australia class-action case sometime this year.) 



Johnson & Johnson separately reports 1,500 active lawsuits over Ethicon’s PhysioMesh Flexible Composite Mesh, which is used in hernia-repair surgery. According to J&J’s quarterly report, federal Ethicon PhysioMesh cases have been consolidated in multidistrict litigation (MDL) in the Northern District of Georgia, and a number of New Jersey state-court suits have been centralized in multicounty litigation (MCL) in that state. 



“Following a June 2016 worldwide market withdrawal of ETHICON PHYSIOMESH Flexible Composite Mesh, claims for personal injury have been made against Ethicon, Inc.,” Johnson & Johnson’s disclosure states. “Product liability lawsuits continue to be filed, and the Company continues to receive information with respect to potential costs and the anticipated number of cases.” 



“The Company has established accruals with respect to product liability litigation associated with ETHICON PHYSIOMESH Flexible Composite Mesh,” the PhysioMesh disclosure concludes, meaning that, from an accounting standpoint, Johnson & Johnson already has set money aside to pay out over Ethicon PhysioMesh claims. 



If you or a loved one has suffered serious injury following implantation of a surgical-mesh device, contact the experienced team of lawyers at TheLawFirm.com right away for a free legal consultation with a licensed attorney!

Source: 
Product Liability. 
Legal Proceedings. Commitments and Contingencies Disclosure. 
United States Securities and Exchange Commission (SEC) Form 10-Q. 
September 30, 2018. Filed October 31, 2018. 

Mesh Lawsuit Update: Judge denies covidien attempt to toss mesh lawsuit over time limit

October 31, 2018

A federal judge on October 25 rejected an attempt by medical-device maker Covidien LP to have a surgical mesh lawsuits dismissed outright for having been filed after the statutory time limit expired, instead granting the plaintiffs time to amend their complaint and argue why their claims should be permitted to proceed. 



Federal District Court Judge Yvette Kane allowed plaintiffs Ronald Soutner and his wife, Janelle, an opportunity to file an amended complaint in which the couple could provide more information to assist the court in its determination as to when the statutory clock began counting on the couple’s claims. 



The Soutners sued Covidien after Ronald suffered severe complications from the implantation of Covidien Parietex ProGrip mesh in conjunction with hernia-repair surgery he underwent in late 2011. According to the Soutners’ complaint, which includes a total of ten legal claims, the Covidien mesh caused inflammation so severe that the mesh and portions of the surrounding tissue, including the vas deferens, had to be surgically removed about two years later. The Soutners originally sued in October 2017. 



“In light of the nature of the parties’ dispute, the court believes it appropriate to allow plaintiffs to file a second amended complaint including additional facts that would be useful to a determination of when the applicable limitations period began, and whether the plaintiffs exercised reasonable diligence,” Judge Kane’s order read, according to Law360. 



Lawyers for Covidien had argued that the statutory countdown on the Soutners’ claims began with Ronald’s second surgery in 2013 and that the couple missed this window when they waited until fall 2017 to sue. The Soutners now will have the chance to argue why they could not reasonably have known that Ronald’s injuries were the result of Covidien’s conduct at that time. 



“[At the time of Ronald’s second surgery, the Soutners] could not have discovered through due diligence that their injuries were caused by another party’s conduct,” Judge Kane wrote, stating the Soutners’ position. 



The Soutners’ case reiterates once again the importance of seeking expert legal advice right away if you or a loved one ever suffers harm as a result of a medical device or prescription drug. Big Pharma and billion-dollar device makers have lobbied hard for laws that allow injured patients only a short period of time to file their legal claims. Don’t delay! Contact the experienced lawyers at TheLawFirm.com right away for a free legal consultation with a licensed attorney!

Source: 
Law360

Mesh Lawsuit Update: Johnson & Johnson Appeals $20 Million Mesh Verdict

October 23, 2018

A little more than a decade ago, New Jersey resident Peggy Engleman, like millions of Americans, was suffering from stress urinary incontinence, a common condition that particularly afflicts women who have been pregnant and given childbirth. In the hopes of relieving her symptoms, in June 2007, Peggy Engleman underwent surgery during which she had TVT-Secur mesh manufactured by Johnson & Johnson subsidiary Ethicon implanted into her pelvic region.

Unfortunately, rather than relieving her symptoms and allowing Ms. Engleman to return to her normal lifestyle, the TVT-Secur mesh began causing complications only a month later, when it was discovered that a portion of the mesh had become exposed in Ms. Engleman’s vagina, causing her a great deal of pain and discomfort. Ms. Engleman underwent subsequent operations in September 2007, February 2008, and December 2013 in an effort to address the chronic pain. Although portions of the original Ethicon TVT-Secur mesh were removed with each subsequent surgery, doctors still found pieces that had eroded into her vagina during the December 2013 operation, Ms. Engleman’s fourth surgery involving the mesh implant.

In April 2014, Ms. Engleman saw a television ad for a law firm taking on surgical mesh claims just like hers. She sued, and, following a three-week trial in April 2018, a Pennsylvania jury delivered a verdict in her favor, ordering Ethicon to pay $2.5 million in compensatory damages and $17.5 million in punitive damages.

Now, however, Johnson & Johnson and Ethicon are seeking to have that verdict dismissed, arguing before a three-judge appellate panel on October 17 that Ms. Engleman’s claims should be tossed out because she did not file her suit until after the two-year statute of limitations had expired. The appeal revives what was a major issue at trial: When should the two-year countdown begin?

Before the appellate panel, attorneys for the defendant companies continued to argue, as the jury explicitly rejected at trial, that the two-year period should begin in 2007 when Ms. Engleman first became aware of the issues with her Ethicon mesh implant.

At least one of the judges sitting on the panel appeared to express skepticism over such an argument, with Judge Alice Beck Debow saying to an attorney for the defense, “Everything you’re telling us now, the jury heard that and they found there was no statute of limitations violation,” according to Law360.

Ms. Engleman’s case is part of a pelvic mesh mass tort program taking place in Pennsylvania state court in Philadelphia County. At the time of the April 2018 verdict, Law360 reported that 183 other cases remained pending as part of the program.

Ms. Engleman was the third plaintiff in the Philadelphia mass tort program to prevail on similar claims against Johnson & Johnson and Ethicon. In 2015, a jury awarded a woman from Indiana $12.5 million, and, in 2016, a New Jersey woman received $13.5 million. (In September 2018, the judge overseeing a subsequent case announced that the jury had deadlocked, resulting in a mistrial. Though the jurors were able to agree that Ethicon had been negligent in designing the mesh implant, they were unable to reach a consensus as to whether that negligence was the cause of the plaintiff’s alleged injuries.)

This case shows once again how important it is to file your legal claim as early as possible! If you or a loved one has been injured by a problematic mesh implant or other defective medical device, contact the experienced attorneys at TheLawFirm.com right away for a free legal consultation with a licensed attorney!

Mesh Lawsuit Update: Australian Health Minister Issues National Apology over Mesh Implants

October 23, 2018

“On behalf of the Australian Government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantations, which have led to horrific outcomes,” Australian Health Minister Greg Hunt said in a videotaped national apology released October 10 “This has been an issue over some decades in many cases, and on our time, on our watch, that [sic.] we both recognize the problem, and we’re moving to take sweeping action to repair it.”

The apology came nearly a year after Australia, in November 2017, banned transvaginal mesh products used in the treatment of pelvic organ prolapse and over six months after the conclusion of a parliamentary report looking into the devices. The statement by the Health Minister accompanied the release by the Australian government of its policy response to the parliamentary report, which includes measures such as permanent funding through Australian Medicare for the removal and treatment of pelvic mesh implants. The government also says it will work with states and territories to conduct a national audit of mesh implants and to create voluntary registries of mesh implant recipients that would track complications and other data.

According to the Australian Broadcasting Corporation (ABC), Health Minister Hunt has stated his support for requiring healthcare professionals to report all side effects for all implantable medical devices, though he says making such reporting mandatory would exceed the legal powers of the federal government.

Senator Derryn Hinch, representing Victoria as a member of Derryn Hinch’s Justice Party, was one of the main proponents of the parliamentary investigation into transvaginal mesh implants. He has dubbed the circumstances surrounding the mesh implants “one of the biggest medical scandals” in his country’s history.

Many Australian women, some of whom participated in the parliamentary investigation, say they were not taken seriously by their healthcare providers when they reported feeling intense pain and other symptoms following implantation of a transvaginal mesh device.

“Women are still not being believed by their doctors,” Australian mother Joanne Villani told ABC News, who said she still experiences chronic symptoms from her mesh implant over a decade after the initial surgery. “Doctors are still implanting mesh and telling women it’s new mesh, and it is the same mesh…I would like mesh to be banned until it’s been shown to be safe. If it’s not shown to be safe, then it should never be used again.”

If you or a loved one has suffered from complications due to the implantation of a surgical mesh device, contact the experienced lawyers at TheLawFirm.com now for a free legal consultation with a licensed attorney!

Source:
The Australian Broadcasting Corporation (ABC)
The Guardian
Parliament of Australia – Standing Committees on Community Affairs

Mesh Lawsuit Update: Parent Company Allocates $200 Million for Atrium Mesh Claims in U.S, Canada

October 19, 2018

Late in the evening on Sunday, October 14, Swedish medical conglomerate Getinge stunned financial analysts around the globe when it announced that it had allocated some $200 million in anticipated costs to cover allegations in the United States and Canada over surgical mesh manufactured by its subsidiary Atrium Medical Corp. Morgan Stanley estimated that the $200-million set-aside represents approximately eight percent of Getinge’s entire equity value.

The sheer size of the financial provision, which senior Getinge executives say should cover all costs associated with the Atrium mesh claims, suggests that the companies’ liability may be greater than previously anticipated, prompting a slide in its stock price.

“The [$200 million] provision today materially exceeded our expectation,” a Morgan Stanley analyst told clients, according to Bloomberg.

Presently, approximately 900 lawsuits have been filed over Atrium’s polypropylene mesh, with patients alleging they suffered serious complications after having the device surgically implanted to repair hernias and other pelvic-area conditions. The first trials are expected to take place in 2019.

Despite Getinge’s assurances that “the claims are being vigorously defended,” the $200 million set-aside shows the company’s true feelings about the strength of its legal position.

Stay tuned to TheLawFirm.com for the latest updates on surgical mesh lawsuits.

Source:
Bloomberg

Mesh Lawsuit Update: Judge Orders Creation of Settlement Fund in Ethicon Mesh MDL

October 15, 2018

In an order issued September 14, the judge in charge of federal multidistrict litigation (MDL) over pelvic-repair systems manufactured by Ethicon, Inc. authorized the creation of a qualified settlement fund and assigned a fund administrator to oversee it. The move marks the potential start of winding down the litigation, which has been ongoing for over six years and continues to include tens of thousands of active cases.

Pretrial Order #318 was issued by US District Court Judge Joseph R. Goodwin in response to an Unopposed Motion for Approval of Qualified Settlement Fund, which had been filed September 13 by a law firm representing numerous plaintiffs in the MDL. Lawyers from Milstein, Jackson, Fairchild & Wade LLP had requested creation of the qualified settlement fund to facilitate the efficient processing of a confidential settlement agreement they reached with the defendant companies, including Ethicon and, presumably, its parent company Johnson & Johnson.

From the bench at the US District Court for the Southern District of West Virginia, Judge Goodwin appointed as fund administrator the company Archer Systems, LLC, which has been “given the authority to conduct any and all activities necessary to administer” the settlement fund.

Terms of the confidential settlement agreement were not disclosed in the court order, nor were the number of plaintiffs covered by the agreement. According to the MDL’s Member List of Cases, as of October 13, 2018, the MDL included 40,398 total cases, of which 16,536 had been closed, leaving 23,862 active cases remaining.

If you or a loved one has been injured by a defective medical device, contact TheLawFirm.com right away for a free legal consultation with a licensed attorney!

Source:
MDL Docket No. 2327 Website

Mesh Lawsuit Update: Jury Finds Negligence But Deadlocks on Connection to Injuries in Philly Ethicon Mesh Case

September 28, 2018

The jury has deadlocked in the seventh Philadelphia-based trial over alleged defects to pelvic mesh manufactured and distributed by Ethicon Inc., causing the judge to declare a mistrial, Law360 reported September 24.

The case involved plaintiff Susan McFarland, who originally sued Ethicon in July 2013 over injuries allegedly caused by its TVT-O pelvic mesh, which McFarland had implanted in 2008 to treat stress urinary incontinence. However, rather than relieve her symptoms, McFarland contends that defects in the TVT-O design have caused her permanent injuries, including the inability to have sexual intercourse with her husband.

While the jury reported to Judge Michael Erdos that it was able to reach agreement that there had been negligence on the part of the defendant Ethicon, the jurors were hopelessly deadlocked when it came to whether the Ethicon’s negligence was the cause of the plaintiff’s injuries.

According to Law360, the jury initially informed Judge Erdos of the deadlock on Friday, September 21, but the judge asked the jury to reconvene for one more day of deliberations to see if its members could agree on a verdict. On Monday, the judge finally relinquishing, dismissing the panel.

“There seems no reasonable hope that a verdict of 10 jurors or more can be reached,” Judge Erdos conceded before the court prior to addressing the jurors directly. “Everyone stood by their convictions and that’s the most we can ask of you.”

Of the six previous Philadelphia-based trials over Ethicon pelvic mesh, the juries in five have sided with the plaintiffs, resulting in over $105 million in total damages.

If you or a loved one has been injured by defective surgical mesh, hernia mesh, or pelvic mesh, contact the experienced team of attorneys at TheLawFirm.com today for a free consultation with a licensed attorney!

Source:
Law360

Do you qualify for a hernia mesh lawsuit?

Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article. 

Related Articles

About The Law Firm

picture of the lawfirm.com logo and staff members

About TheLawFirm.com (TLF)

TheLawFirm.com is a group of award winning attorneys, paralegals and associates from the legal profession who’s main goal is to educate and represent their clients with the utmost expertise, respect and trust.

We also work closely with a large group of experts from the medical profession so we can draw upon their expertise, in order to present as much accurate information relating to various mass tort and personal injury lawsuits as we can.