Hernia Mesh Lawsuit News and Updates 2020
The latest news and updates regarding hernia mesh devices, lawsuits and settlements.
Judge Approves Settlement Fund In Boston Scientific Mesh MDL
March 30, 2020
Author: Daniel Gala
Multidistrict litigation (MDL) over pelvic mesh made by Boston Scientific continues to wind down in the Southern District of West Virginia, with the court approving on March 26 the creation of a qualified settlement fund to administer the settlements of certain remaining plaintiffs. The long-running litigation—which has involved more than 26,000 total cases—still included more than 1,000 active cases as of March 28, according to the court’s list of member cases.
Originally formed in February 2012, the Boston Scientific pelvic mesh MDL centralized federal lawsuits alleging that Boston Scientific mesh devices designed to treat urinary stress incontinence and pelvic organ prolapse (POP)—two common conditions in aging women—were defectively designed and/or manufactured and caused serious, permanent injury in some recipients.
The Boston Scientific pelvic mesh MDL was just one of more than half-a-dozen pelvic mesh MDLs located in the Southern District of West Virginia. Collectively including more than 100,000 total cases, the West Virginia pelvic mesh MDLs have been one of the largest mass tort actions in the history of the United States.
Though settlement agreements have resolved many of these pelvic mesh cases, thousands remain, as evidenced by the 1,054 cases still active in the Boston Scientific mesh MDL.
In the March 26 pretrial order compelling the creation of a qualified settlement fund to “aid in the efficient processing and administration of a confidential settlement agreement” reached between Boston Scientific and an attorney representing multiple clients in the MDL, US District Judge Joseph R. Goodwin also approved the appointment of an escrow agent and administrator.
Issued March 26, the pretrial order also shows that the court is determined to push ahead with its winding down of Boston Scientific pelvic mesh litigation despite challenges created by the ongoing coronavirus pandemic.
Have you or a loved one suffered serious injury due to a pelvic mesh implant? If so, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation with a licensed attorney!
Sources:
United States District Court For The Southern District Of West Virginia Charleston Division. (26 March 2020). Pretrial Order #217 Order Re: Qualified Settlement Fund—Boston Scientific Corp. & Richard J. Plezia & Associates. MDL No. 2326. In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation
United States District Court For The Southern District West Virginia. (Accessed 28 March 2020). MDL 2326 Member List of Cases. MDL No. 2326. Boston Scientific Corp. Pelvic Repair System Products Liability Litigation
Ethicon Mesh Lawsuit News: J&J Urges Penn. Supreme Court To Overturn $12.5M Ethicon Mesh Verdict
March 15, 2020
Author: Daniel Gala
In oral arguments held March 10, multibillion-dollar mega-conglomerate Johnson & Johnson urged justices on the Pennsylvania Supreme Court to overturn a $12.5-million verdict in favor of a woman who sued J&J over an allegedly defective mesh implant made by its subsidiary Ethicon.
Lawyers for J&J and Ethicon argued that the Philadelphia Court of Common Pleas improperly exercised jurisdiction over the case, which was brought under Indiana law by an Indiana resident against the New Jersey-based defendants.
A Pennsylvania appellate court previously upheld the trial court’s exercise of jurisdiction over the case of Indiana resident Patricia Hammons, who claims that she has suffered serious injury as a result of the allegedly defective Ethicon Prolift mesh implant. Hammons claims that the Ethicon implant has required multiple additional surgeries and has made it too painful for her to have sexual intercourse.
In 2015, following a two-and-a-half-week trial, a Philadelphia-based jury found J&J and Ethicon liable in Hammons case, ordering the defendants to pay $5.5 million in compensatory damages and an additional $7 million in punitive damages.
“Every American depends on Johnson & Johnson to put safety ahead of selling,” Shanin Specter, a lawyer for Hammons, said at the time of the trial-court verdict, according The Philadelphia Inquirer. “They aren’t doing that, and they need to engage in some soul-searching.”
At trial, jurors heard evidence that J&J and Ethicon were aware even before they released Prolift mesh to the public in 2005 that the device was associated with side effects such as pain during sexual intercourse but failed to warn of such risks on the device’s label.
Jurors further heard Ethicon product engineer Scott Ciarrocca admit that, in designing Prolift mesh, the company made no provisions for how one might surgically remove the devices if necessary. Similarly, an expert testifying for the plaintiff Hammons described efforts to surgically remove the mesh implants as a “train wreck,” The Philadelphia Inquirer reported.
For its part, an Ethicon spokesperson at the time vowed that the company would appeal the verdict, with the March 10 oral arguments before the state supreme court demonstrating that, whatever the outcome, the defendant companies have made good on their promise to fight the jury’s decision as far as they could.
In addition to thousands of women who have sued J&J and Ethicon over the allegedly defective mesh implants, the vast majority of state attorneys general in the US also have threatened some form of legal action against the companies, claiming that their marketing practices violated state false-advertising and anti-competition laws by making false or misleading claims about the safety, efficacy, and FDA-approval status of the devices.
In January, a California state-court judge in San Diego ordered J&J and Ethicon to pay $344 million in penalties in the first such case brought by a state AG to reach trial.
If you or a loved one has suffered serious injury as a result of a surgical mesh implant, contact the experienced team of attorneys at TheLawFirm.com today for a free consultation with a licensed attorney!
Sources:
Raymond, N. (10 March 2020). Case to Watch: J&J to ask Pennsylvania top court to toss $12.5 million verdict. Reuters. Westlaw News
Law360. (10 March 2020). Pa. Had No Role In Out-Of-State Mesh Case, Justices Told
The Philadelphia Inquirer
Bloomberg news
Ethicon Mesh Lawsuit News: NJ Appeals Court Says Woman Can’t Prove Maker Of Mesh Implant, Upholds Dismissal
March 13, 2020
Author: Daniel Gala
An appellate panel in New Jersey has confirmed a lower court ruling dismissing the case of a woman and her husband who had sued Johnson & Johnson and its subsidiary Ethicon over an allegedly defective mesh implant, agreeing in a March 6 decision that the plaintiff had failed to prove which company had made the implant she received.
In 2014, Deborah Kline and her husband filed a complaint in New Jersey state court claiming that she suffered serious injury as a result of Ethicon polypropylene hernia repair mesh, culminating in her having the device surgically removed six years after it was implanted. However, the trial court subsequently tossed out her case, granting J&J’s motion for summary judgment, which had argued that Kline could not adequately prove what company had manufactured the specific hernia mesh she personally received.
Kline appealed the ruling, arguing that the trial court failed to allow her to present certain evidence that would have proven the mesh to have been made by Ethicon. For example, Kline argued that her surgeon’s post-operation report describes the implant as “Prolene mesh,” an Ethicon product, though the surgeon says he used the term generically.
Judge Nelson C. Johnson, the lower court judge, also blocked further discovery by Kline’s lawyers, such as a request to depose a corporate executive who they say might have knowledge of the device’s manufacturer. Judge Johnson, however, found that Kline’s attorneys, having had the preserved mesh device in their possession for several years, already had been given adequate time to investigate.
“While Ethicon empathizes with any patient who experiences medical complications, the court appropriately dismissed the case because it lacked a basic prerequisite of demonstrating evidence that the product was produced by Ethicon,” Ethicon said in a statement quoted in part by MassDevice.
Across the United States, tens of thousands of plaintiffs have sued the makers of surgical mesh implants, alleging that the devices were defectively designed and manufactured, resulting in serious—and in some cases permanent—injury along with sky-high medical bills. The resulting litigation has involved so many cases that it has become one of the largest mass tort actions in the history of the US.
If you or a loved one has suffered serious harm as a result of a surgical mesh implant, contact the team of experienced attorneys at TheLawFirm.com today for a free legal consultation!
Sources:
Law360. (6 March 2020). J&J Escapes Suit After Couple Can’t ID Pelvic Mesh Maker
Crotti, N. (9 March 2020). J&J’s Ethicon wins lawsuit over hernia mesh. MassDevice
Harris Martin Publishing. (10 March 2020). N.J. Panel Upholds Award of Summary Judgment to J&J, Ethicon in Hernia Mesh Case
Boston Scientific Mesh Lawsuit Verdict: Canadian Mesh Implant Recipients To Receive $21.5M In Settlement
March 10, 2020
Author: Daniel Gala
Plaintiffs in a Canadian class-action lawsuit over pelvic mesh designed and sold by Boston Scientific have settled their claims for a reported total of $21.5 million, the Associated Press reported March 4.
The settlement took an important step forward when Ontario Superior Court Justice Paul Perell approved the proposed class definition and methods for contacting class members. It is anticipated that the justice will give the deal his final approval in June.
The class, which contains roughly 325 women, accuses Boston Scientific of selling defective and unsafe devices while failing to adequately warn patients and doctors about the significant risks associated with the pelvic-mesh implants. Justice Perell certified the class of plaintiffs in February 2017.
“There is some basis in fact that the polypropylene mesh in each of Boston Scientific’s transvaginal mesh devices has a clinically significant deficiency,” Justice Perell ruled at the time. “Boston Scientific’s arguments based on the alleged multiplicity of differences between the products, patients, and the complications, do not negate the commonality of the proposed common issues.”
Along with Boston Scientific, a number of other medical-device makers cumulatively have faced thousands of lawsuits over similar mesh implants, which are intended to treat pelvic organ prolapse and stress urinary incontinence, two common conditions in aging women.
The devices and the procedures to surgically implant them have become commonplace, with approximately 25,000 women receiving mesh implants each year in Canada alone, according to the AP.
However, as the mesh devices have been implanted in a growing number of women, the prevalence of devastating side effects has become more and more apparent, leading to an almost unprecedented number of legal claims.
In the United States, multiple MDLs (multidistrict litigation) have been formed to centralize pretrial proceedings in the staggering number of pelvic mesh cases. Cumulatively containing more than 100,000 cases, pelvic mesh litigation has grown into one of the largest mass tort actions in the history of the US.
Tragically, the experience of the lead plaintiff in the Canadian class action is representative of the nightmare thousands of women have lived as a result of having received pelvic mesh implants. Susan Vester received a Boston Scientific mesh implant in January 2010 to treat incontinence. Subsequently, she alleges that the device has made it difficult for her to walk; has caused urinary issues; and has made it painful for her to have sexual intercourse with her husband and co-plaintiff.
Many women have resorted to undergoing additional surgeries in an effort to remove the problematic devices and alleviate some of their debilitating side effects. However, even after surgery, many of these women have been told that removal of the entire device is impossible and that they will have to live with the effects for the rest of their lives.
For its part, Boston Scientific has maintained that the side effects experienced by plaintiffs like Vester are a result of the patients’ own preexisting medical conditions rather than a flaw in the devices themselves. As part of the settlement, Boston Scientific will not admit to any wrongdoing, though the company did pull its pelvic mesh implants from markets worldwide in July 2018.
An attorney representing the lead plaintiff Vester expressed satisfaction with the settlement, under which plaintiffs will receive compensation on a sliding scale based on the extent of their injuries.
“This agreement will enable members of the class to receive compensation for the injuries they allege,” said Daniel Bach, an attorney representing the Vesters, according to the AP .
If you or a loved one has experienced serious injury as a result of a pelvic mesh implant, contact the team of experienced attorneys at TheLawFirm.com today for a free legal consultation!
Source:
Perkel, C. (4 March 2020). Women with transvaginal mesh implants to share $21.5 million in settlement. Associated Press
Ethicon Mesh Lawsuit Verdict: J&J Must Pay $1.7M To Three Lead Plaintiffs In Australia Ethicon Mesh Class Action, Judge Rules
March 4, 2020
Author: Daniel Gala
Multibillion-dollar conglomerate Johnson & Johnson has been ordered to pay $1.7 million to three Australian women on allegations that the company misinformed doctors and patients about the risks associated with surgical mesh implants made by J&J subsidiary Ethicon.
The ruling, issued by the Federal Court of Australia on March 3, involved the three lead plaintiffs in a class-action lawsuit that includes a total of 1,350 women. In November 2019, the same court found J&J and Ethicon liable on the plaintiffs’ claims, with Judge Anna Katzman’s decision describing information the companies provided to doctors and patients as “inaccurate” and finding that it contained “false misrepresentations,” the BBC reported at the time.
“The risks were known, not insignificant and on Ethicon’s own admission, serious harm could ensue if they eventuated,” Judge Katzman’s November 2019 decision found.
The original claimant, Julie Davis, said following the November verdict that J&J and Ethicon “treated women essentially like guinea pigs, lied about it and done nothing to help.”
However unequivocal Judge Katzman’s earlier findings, her prior ruling was silent on the amount of compensation J&J and Ethicon owed the women who had paid for the companies’ lies with their health and well-being.
The court’s March 3 ruling on compensation due to the class action’s three lead plaintiffs is the first indication of the court’s thinking with regards to damages. The three plaintiffs received different amounts ranging from A$555,555 to A$1.28 million (approximately US$365,000 to US$840,000), Reuters reported.
Now that damages for the lead plaintiffs have been determined, the court next will consider which issues are common to all class members, a key step in determining the damages applicable to the more than 1,300 other plaintiffs in the case.
J&J and Ethicon continue to face thousands of lawsuits around the world over Ethicon surgical mesh implants used in the treatment of pelvic organ prolapse and stress urinary incontinence, two common conditions in aging women. Patients have accused the companies of downplaying the significant risks such devices pose while overstating their supposed benefits.
Many pelvic mesh plaintiffs allege that the Ethicon devices have caused them permanent, debilitating pain that has forever altered their lives—for example, by making it impossible to have sexual intercourse—while failing to remedy the initial conditions for which the mesh was implanted, if not making those conditions worse. In more serious cases, women have attempted to have the mesh removed surgically to no avail, with their doctors telling them they will be forced to live with some or all of the mesh embedded in their bodies for the rest of their lives.
In the United States, federal products liability lawsuits over Ethicon pelvic mesh implants have been centralized as multidistrict litigation (MDL) in the Southern District of West Virginia. Having included a total of more than 40,500 cases, as of February 27, 2020, only about 2,400 active cases remained, according to the court’s list of member cases.
“The MDL Court is remanding cases for trial to the jurisdictions where the case was originally filed and additional pelvic mesh lawsuits have been filed, and remain, outside the MDL,” Johnson & Johnson disclosed in its annual report, filed February 18.
In addition to individual plaintiffs, that vast majority of state attorneys general in the US have either brought or threatened legal action against J&J and Ethicon over allegations of falsely marketing Ethicon's pelvic mesh devices. In October, the attorneys general of 41 states plus the District of Columbia announced that they had reached a roughly $117 million settlement with J&J and Ethicon on the AGs’ pelvic mesh claims, with the office of Connecticut Attorney General heralding the agreement as “the fourth largest consumer protection health fraud multistate settlement in U.S. history” in a statement released at the time.
“Health and safety must come before profits,” New York Attorney General James said her own statement. “While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger.”
California, to date the only state to bring pelvic mesh claims against J&J and Ethicon to trial, was awarded $344 million in a verdict delivered in early February.
Outside the US, Australia is hardly the only country where Johnson & Johnson and Ethicon face significant legal action over Ethicon’s pelvic mesh.
“[C]lass Actions and individual personal injury cases or claims have been commenced in various countries outside the United States, 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,” J&J’s annual report disclosed.
Sources:
Reuters. (3 March 2020). J&J ordered to pay $1.7 million to three Australian women in pelvic mesh class action
BBC News. (21 November 2019). Johnson & Johnson loses vaginal mesh class action
United States District Court Southern District of West Virginia. (Accessed 27 February 2020). MDL 2327 List of Member Cases. MDL 2327. In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation
Johnson & Johnson. (Filed 18 February 2020). Form 10-K for the fiscal year ended December 29, 2019. Notes to Financial Statements. Commitments and Contingencies Disclosure [Abstract]. Legal Proceedings. Product Liability
New York Department of Justice Office of Attorney General Letitia James. (17 October 2014). Johnson & Johnson And Subsidiary To Pay $117 Million Settlement After Endangering Women’s Health. Press Releases
Ethicon Mesh Lawsuit Update: J&J Annual Filing Provides Updates On Various Ethicon Mesh Litigation
February 27, 2020
Author: Daniel Gala
On February 18, multi-billion-dollar medical-device, pharmaceutical, and consumer-goods mega-conglomerate Johnson & Johnson filed its annual report for fiscal year 2019. In addition to the abundance of financial information covering J&J’s assortment of businesses and products, the Form 10-K also provided an update on the numerous legal entanglements the company presently finds itself in.
These legal challenges include tens of thousands of lawsuits filed against J&J and its subsidiary Ethicon over Ethicon’s allegedly dangerous surgical mesh devices. In addition to class action and individual lawsuits, multidistrict litigation (MDL) and multicounty litigation (MCL) have been formed to centralize pretrial proceedings in litigation relating to a number of Ethicon mesh products. Here is an update on litigation involving each device, as disclosed by J&J:
Ethicon Pelvic Mesh Devices For SUI And POP
Johnson & Johnson and Ethicon have faced collectively tens of thousands of lawsuits over allegedly defective Ethicon mesh devices. Among the devices that have proven most problematic are mesh implants designed to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), two common conditions in aging women.
"Claims for personal injury have been made against Ethicon, Inc. (Ethicon) and Johnson & Johnson arising out of Ethicon’s pelvic mesh devices used to treat stress urinary incontinence and pelvic organ prolapse," J&J’s annual report discloses. "The Company continues to receive information with respect to potential costs and additional cases."
Federal Ethicon pelvic mesh cases have been centralized as multidistrict litigation (MDL) in the Southern District of West Virginia. According to J&J, having centralized the lawsuits for pretrial proceedings, the MDL judge now is at the point of sending Ethicon pelvic mesh cases back to their home districts for resolution.
"The MDL Court is remanding cases for trial to the jurisdictions where the case was originally filed and additional pelvic mesh lawsuits have been filed, and remain, outside the MDL," J&J discloses.
Though J&J’s Form 10-K does not state a specific number of cases involved in the Ethicon MDL in the Southern District of West Virginia, according to the court’s list of member cases, as of February 27, 2020, 38,119 cases had closed out of a total of 40,551, leaving just over 2,400 active cases.
While J&J claims to have "settled or otherwise resolved a majority of the United States cases" with "the estimated costs associated with these settlements and the remaining cases…reflected in the Company’s accruals," J&J and Ethicon continue to face significant legal challenges from Ethicon pelvic mesh cases filed elsewhere around the globe.
"Class Actions and individual personal injury cases or claims have been commenced in various countries outside the United States, 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,” J&J’s Form 10-K says.
J&J further discloses a recent win for Ethicon pelvic mesh plaintiffs in an Australian class action case, with the full costs to the company yet to be known.
“In November 2019, the Federal Court of Australia issued a judgment regarding its findings with respect to liability in relation to the three Lead Applicants and generally in relation to the design, manufacture, pre and post-market assessment and testing, and supply and promotion of the devices in Australia used to treat stress urinary incontinence and pelvic organ prolapse,” J&J’s annual report says. “Orders determining the damages amounts to be awarded to the three Lead Applicants are expected in the first quarter of 2020.”
“Ethicon Pelvic Mesh Devices For SUI And POP” Sources:
Johnson & Johnson. (Filed 18 February 2020). Form 10-K for the fiscal year ended December 29, 2019. Notes to Financial Statements. Commitments and Contingencies Disclosure [Abstract]. Legal Proceedings. Product Liability.
J&J’s annual report discloses
United States District Court Southern District of West Virginia. (Accessed 27 February 2020). MDL 2327 List of Member Cases. MDL 2327. In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation
Ethicon Physiomesh
Ethicon’s Physiomesh Flexible Composite Mesh was recalled from markets worldwide in June 2016, but the J&J and Ethicon continue to face significant legal action over the alleged injuries the device caused to thousands of plaintiffs. Federal personal injury claims involving Ethicon Physiomesh have been centralized as multidistrict litigation (MDL) in the Northern District of Georgia, and, in New Jersey, Multicounty litigation (MCL) has been formed to handle state court Physiomesh claims.
Additionally, J&J’s quarterly filing discloses that other federal Physiomesh cases have been included in an MDL in the Southern District of Ohio.
While J&J’s annual filing does not provide the number of cases presently involved in the Georgia Physiomesh MDL, according to the court’s list of member cases, the MDL contained 2,697 active cases as of February 24, 2020.
“Ethicon Physiomesh” Sources:
Johnson & Johnson. (Filed 18 February 2020). Form 10-K for the fiscal year ended December 29, 2019. Notes to Financial Statements. Commitments and Contingencies Disclosure [Abstract]. Legal Proceedings. Product Liability.
United States District Court Northern District of Georgia. (Updated 24 February 2020). Member Case List for 1:17-md-2782. MDL 2782. In Re: Ethicon Physiomesh Flexible Composite Mesh Products Liability Litigation
Ethicon Proceed and Proceed Ventral Patch
Johnson & Johnson further discloses that it faces a number of lawsuits over Ethicon Proceed and Proceed Ventral Patch devices. In New Jersey, multicounty litigation (MCL) was formed in March 2019 to centralize state court claims in Atlantic County Superior Court.
“Additional [Proceed] cases have been filed in various federal and state courts in the US, and in jurisdictions outside the US,” J&J’s annual filing says.
No MDL yet has been established to centralize federal Proceed and Proceed Ventral Patch Cases.
“Ethicon Proceed and Proceed Ventral Patch” Source:
Johnson & Johnson. (Filed 18 February 2020). Form 10-K for the fiscal year ended December 29, 2019. Notes to Financial Statements. Commitments and Contingencies Disclosure [Abstract]. Legal Proceedings. Product Liability.
Ethicon Prolene Polypropylene Hernia Mesh System
According to J&J in January 2020, the New Jersey Supreme Court granted the request of 107 plaintiffs suing J&J and Ethicon over Ethicon’s Prolene Polypropylene Hernia Mesh System, forming multicounty litigation (MCL) in the Atlantic County Superior Court to centralize their claims.
"Ethicon Prolene Polypropylene Hernia Mesh System” Source:
Johnson & Johnson. (Filed 18 February 2020). Form 10-K for the fiscal year ended December 29, 2019. Notes to Financial Statements. Commitments and Contingencies Disclosure [Abstract]. Legal Proceedings. Product Liability
Conclusion
Despite already having been embroiled in years of litigation over allegedly defective Ethicon surgical mesh devices, J&J and Ethicon’s legal woes show no sign of dissipating any time soon. For every case that is resolved, it seems another plaintiff takes its place, as an increasing number of people who have been injured by poorly designed Ethicon devices continue to seek out the justice and compensation they deserve.
If you or a loved one has suffered serious injury due to an Ethicon mesh implant, contact the expert team of attorneys at TheLawFirm.com now for a free consultation!
Ethicon Mesh Lawsuit News: ‘We Were Treated Like Guinea Pigs’: Victims In Australia Mesh Class Action Say No Amount Of Money Can Compensate For Loss
February 20, 2020
Author: Daniel Gala
Months after an Australian judge delivered a landmark verdict in favor of more than 1,300 women who had sued Johnson & Johnson and its subsidiary Ethicon over allegedly defective vaginal mesh implants, plaintiffs are eagerly awaiting their payouts, which are expected to provide at least some help for the hundreds of women who have seen their lives and their careers upended due to the adverse effects of the Ethicon devices.
Still, many plaintiffs in the seven-year-long class-action suit say that the money they are likely to receive will amount to a relative pittance compared to the financial losses and other harms they have endured.
“If it was in the tens of millions it might go some of the way to making me feel like I’d been seen, heard, and there was a modicum of justice,” 49-year-old Justine Watson told Buzzfeed News, referring to the amount of money she will receive as compensation for her injuries.
The average payout for surgical mesh claims in the United States is approximately $100,000.
Watson had Ethicon mesh surgically implanted in 2010. She alleges that complications from the device have cost her more than $100,000 in medical expenses, as well as her career as a counselor and psychotherapist, which garnered her an income of roughly $100,000 annually.
“Ten years at $100,000 is a million bucks,” she said, calculating her lost income.
“I’ve had to borrow from friends and use my very meagre inheritance from my mum’s estate,” Watson described. “I’m not going to be able to give my children anything.”
The pain and suffering Watson endured as a result of the Ethicon mesh was so great she even attempted to take her own life. When she travelled to the United States in a desperate attempt to have the device removed by a world-renowned specialist, she even cited the country’s "Do Not Resuscitate” laws as an advantage of having the surgery performed there.
“The beauty of America is you can sign a ‘Do Not Resuscitate’ [order],” Watson said. “I was like, ‘Well, if you can’t get every single piece of this thing out of me then I’m not going to get well again.’”
Watson’s situation is hardly unique. Kim Blieschke, a paramedic from southern Australia, has had her life upended since she had Ethicon mesh surgically implanted in 2006 to treat pelvic organ prolapse (POP), a common condition in aging women, particularly those that have gone through childbirth.
“My body will never ever be the same again and no amount of surgery will ever fix that,” Blieschke told BuzzFeed. “I don’t think any figure that Johnson & Johnson come up with will cover the pain and suffering.”
Blieschke calculates that she has incurred from $300,000 to $400,000 in medical costs as a result of the Ethicon mesh implant. In addition to undergoing multiple surgeries aimed at remedying her situation, she also has endured debilitating chronic pain for fourteen years and counting.
Like the pain, some of Blieschke’s medical costs will be ongoing, probably for the rest of her life. One of the device’s side effects has been incontinence, and Blieschke’s estimates she spends $50 per week on incontinence aids such as pads and catheters. Additionally, she says she pays roughly $150 per month on pain medications. These costs have added up at a time when Blieschke also has suffered from lost income caused by her medical challenges.
“I’ve had 14 years using all of my long service leave, all my sick leave,” she said. “I’d say I’ve had close to two-and-a-half years off all up.”
A third plaintiff in the Australian class action says she has experienced similar travails. The woman, who requested anonymity in order to maintain her medical privacy, received the life-altering mesh implant as a supposed remedy for a mild case of stress urinary incontinence (SUI), another common condition in women of a certain age. The mesh implantation was performed as an adjunct to a hysterectomy, but it was the mesh that would have the more lasting impact on her everyday life. Rather than relieve her mild SUI, the woman says the mesh made her condition worse, in addition to causing her a host of other health problems, including debilitating pain.
Even the woman’s husband was physically injured by the Ethicon mesh.
“I want back [to the medical facility] after being cleared to have sex because my husband’s penis got stabbed during sex as the mesh was poking out of my vagina,” she said.
As part of the judge’s November verdict, each class member will have her medical expenses paid for by defendants J&J and Ethicon. However, not all of that money will go directly to victims, as government and private insurers will receive reimbursement for some of the funds they expended on treatments resulting from the devices. Victims are understandably wary that the amount they ultimately receive will be anything comparable to the losses they have suffered.
Buzzfeed reports that the case’s next hearing is scheduled for March 3.
Sources:
Rushton, G. (12 February 2020). Pelvic Mesh Victims Waiting For Their Payout Say No Dollar Amount Will Be Enough. Buzzfeed News
Rushton, G. (20 November 2019). Hundreds of Women Just Won a Landmark Case Against Johnson & Johnson Over Pelvic Mesh Implants. Buzzfeed News
Ethicon Mesh Lawsuit News: ‘This Abuse of Trust Is Particularly Egregious’ - Judge Orders J&J To Pay $344 Million In Landmark Calif. Mesh Case
February 5, 2020
Author: Daniel Gala
After months of waiting, a San Diego-based judge finally delivered on Thursday, January 30 a landmark verdict in a widely-watched case brought by the California attorney general’s office against multi-billion-dollar mega-conglomerate Johnson & Johnson and its subsidiary Ethicon over allegedly improper practices relating to the companies’ surgical mesh implants.
Following a contentious trial that began in July 2019, California Superior Court Judge Eddie Sturgeon has ordered J&J to pay $344 million in penalties, a substantial sum that still falls far short of the more than $800 million sought by the state.
At issue are Ethicon surgical mesh implants designed to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), two common conditions in aging women. The devices have come under fire for their propensity to cause permanent debilitating injury in recipients and for the companies’ failure to adequately disclose such risks to patients and doctors, leading to tens of thousands of lawsuits around the world.
In his scalding 88-page decision, Judge Sturgeon found that that the state had adequately demonstrated that the defendant companies acted in violation California laws governing business competition and the marketing of medical devices.
“When a medical device manufacturer chooses to affirmatively advertise its products, California’s Unfair Competition Law and False Advertising Law require it to do so truthfully, thereby deterring deceptive and misleading advertising. This is equally true whether the manufacturer targets doctors or patients,” Judge Sturgeon summarized in his overview. “The Court concludes that the People of the State of California (‘Plaintiff’) have proven by a preponderance of the evidence that Defendants deceptively marketed their pelvic mesh products in the state of California and that their marketing was likely to deceive reasonable doctors and reasonable lay consumers, including potential patients and their friends and family, about the risks and dangers of these products.”
In total, the court awarded the state $343,993,750 in damages.
J&J said it would appeal the decision, likely pushing back final resolution of the case for a matter of years.
Damning Evidentiary Findings: ‘The Nature and Seriousness of the Misconduct Were Grave’
Judge Sturgeon’s highly-anticipated decision takes great pains to document the court’s evidentiary findings, describing J&J and Ethicon’s misconduct, and its subsequent impact on thousands of women and their families, in striking, and sometimes passionate, detail.
“Pelvic mesh products are meant to be permanently implanted in the human body for life and carry the potential to cause debilitating, chronic pain and destroy patients’ sexual, urinary, and defecatory functions—consequences that go to the very core of personal identity, dignity, and quality of daily life,” the judge wrote. “Despite having this knowledge from the launch, J&J chose, willfully and knowingly, to withhold this crucial information from physicians and patients and to deceive them about the balance of risks and benefits associated with pelvic mesh.”
To illustrate his points, Judge Sturgeon uses the examples of actual individuals who have had their lives forever altered by the defendants’ conduct.
“J&J’s deception had real consequences for real people,” Judge Sturgeon wrote before quoting one of the defendants’ thousands of victims. “California resident and TVT Abbrevo [a form of Ethicon pelvic mesh] patient Colleen Perry testified that ‘there are many times that I, myself, feel like damaged goods; that because of the mesh surgery and because of the vaginal pain and the painful sex that a decision that I made ruined everything…it is devastating.’”
Injunctive Relief: ‘Defendants Have Been Deceiving Physicians—Including Their Own Witnesses—For Years’
In addition to the roughly $344 million in damages, Judge Sturgeon also granted the state’s request for injunctive relief preventing the companies from improperly marketing the offending products in the future.
“The Court finds there is a reasonable probability that J&J could market its transvaginal mesh products deceptively in the future absent an injunction barring it from doing so,” Judge Sturgeon’s decision says. “Injunctive terms prohibiting J&J from making deceptive or misleading claims regarding any SUI [Stress Urinary Incontinence] and POP [Pelvic Organ Prolapse] mesh product is therefore warranted and necessary.”
The court also granted injunctions forcing J&J to share the risks associated with the devices.
“Furthermore, injunctive terms affirmatively requiring J&J to disclose significant risks and complications associated with its pelvic mesh products are necessary to alleviate the deception and confusion caused by J&J’s years of untrue, misleading, and incomplete marketing statements,” Judge Sturgeon wrote. “As discussed above, the evidence shows that Defendants have been deceiving physicians—including their own witnesses—for years, with the result that physicians have been unable to adequately counsel patients regarding the risks and benefits of pelvic mesh implants.”
A Landmark Verdict In The First Case Of Its Kind To Reach Trial
While dozens of state attorneys general have sued J&J and Ethicon over allegedly improper marketing practices relating to the companies’ pelvic mesh implants, the California case was the first such case to reach trial. In October 2019, 41 states and the District of Columbia announced a $116.9 million settlement with J&J and Ethicon on mesh-related claims, but, under the agreement, the companies did not admit to any wrongdoing.
The verdict rendered by Judge Sturgeon, however, explicitly determined that the companies had engaged in culpable behavior, a distinction highlighted by California Attorney General Xavier Becerra, who, in a statement quoted in part by the New York Times heralded the verdict as the first time a court officially has found that J&J and Ethicon “did indeed engage in illegal false and deceptive business practices.”
“J&J knew the dangers but put its profits ahead of the health of millions of women,” the statement also said, per the Wall Street Journal. “Today we achieved justice for the women forever scarred by this dishonesty.”
That justice—likely to be further delayed by J&J’s imminent appeal—certainly has been a long time coming. The office of then-California Attorney General Kamala Harris originally filed the state’s lawsuit in 2016.
Regardless of the outcome of the California case, many women whose lives have been forever altered by allegedly defective surgical mesh implants made by J&J and Ethicon will continue to find that, for them, adequate justice remains elusive. Tens of thousands of active lawsuits over surgical mesh implants made by Ethicon and other medical-device makers remain pending in what collectively amounts to one of the largest mass tort actions in the history of the United States.
If you or a loved one has suffered serious harm as a result of a surgical mesh implant, contact the experienced team of attorneys at TheLawFirm.com today for a free legal consultation!
Sources:
Superior Court of the State of California County of San Diego Central Branch. (30 January 2020). Statement of Decision. Case No. 37-2016-00017229-CU-MC-CTL. The People of the State of California, Plaintiff, v. Johnson & Johnson, et al., Defendants
Loftus, P. (30 January 2020). Judge Orders J&J to Pay $344 Million in Pelvic Mesh Lawsuit. Wall Street Journal
Goldstein, M. (30 January 2020). Johnson & Johnson Is Told to Pay $344 Million in Pelvic Mesh Suit. The New York Times
Ethicon Mesh Lawsuit News: Federal Appeals Court Upholds $35M Ethicon Mesh Verdict
January 22, 2020
Author: Daniel Gala
The Seventh Circuit Court of Appeals has rejected an attempt by Johnson & Johnson and its device-making subsidiary Ethicon to overturn a $35 million pelvic-mesh verdict, allowing the award to stand in a decision filed January 14.
In its 42-page decision, a three-judge panel writing for the Seventh Circuit affirmed the trial court verdict, including the award of both compensatory and punitive damages, in the case of plaintiff Barbara Kaiser, who sued J&J and Ethicon over the Prolift pelvic mesh device she had surgically implanted.
Rejecting what the panel described as Ethicon’s “flurry of arguments” for why the verdict should be overturned or, in the least, why a new trial should be granted, the court of appeals allowed to stand jury verdicts for the plaintiff “on both design-defect and failure-to-warn theories of liability” awarding “$10 million in compensatory damages and $25 million in punitive damages.”
The facts of the case, as described by the appellate panel, bear similarities with many of the tens of thousands of surgical mesh lawsuits that have been filed in the United States alone.
Indiana resident Barbara Kaiser suffers from pelvic-organ prolapse, a non-life-threatening condition common in aging women. In 2009, when Kaiser was 60 years old, at the recommendation of her doctor, she had an Ethicon Prolift device surgically implanted in an attempt to address this condition.
Soon thereafter, the problems began.
“In September 2011 Kaiser reported pelvic pain to her physician, who attributed the problem to Prolift ‘bunching,’” the appellate panel describes. “Kaiser’s complications gradually worsened. In October 2013 she complained of severe pelvic pain and bladder spasms. After determining that the Prolift was the likely source of these problems, Kaiser’s physician recommended surgery to remove the device. In November [plaintiff’s surgeon] Dr. Bales performed a corrective procedure by using clamps and scissors to remove the vaginal tissue surrounding the mesh. But he was only able to remove part of the device. He informed Kaiser that her pain was likely permanent.”
The Ethicon Prolift MDL
Kaiser then sued J&J and Ethicon as part of massive, 28,000-case multidistrict litigation (MDL) taking place in the Southern District of West Virginia. Collectively, the multiple surgical mesh MDLs centralized there amounted to one of the largest mass tort actions in the history of the United States, containing more than 100,000 total cases.
While the case was part of the West Virginia MDL, “Kaiser and Ethicon agreed that Indiana law applied, and the MDL judge construed two counts in Kaiser’s complaint as alleging design-defect and failure-to-warn claims under the Indiana Product Liability Act (‘IPLA’ or ‘the Act’),” the panel summarizes. “The judge rejected Ethicon’s argument that the federal regulatory scheme preempted Indiana law. He then dismissed Kaiser’s other claims as nonrecognizable under the Act and transferred the case to the Northern District of Indiana,” where a jury returned the above-referenced verdict in favor of the plaintiff Kaiser.
The Appeal
On appeal, J&J and Ethicon’s main argument still hinged on their already-rejected contention that federal law supersedes Indiana law with regards to medical devices.
This argument is based on the firmly established principle of constitutional law dictating that, where federal and state law come into direct conflict, federal law governs.
As the appellate panel explains, a “direct conflict exists where ‘it is impossible for a private party to comply with both state and federal requirements.’”
For its part, “Ethicon maintains that it is impossible for it to comply with both the federal regulatory scheme for medical devices…and the requirements of the IPLA [Indiana Product Liability Act].”
However, just like the MDL court and the Indiana district court before it, the Seventh Circuit appellate panel dismisses this argument, concluding, “Nothing in the [federal] 510(k) regulatory scheme prevented Ethicon from complying with the IPLA’s standard of care before seeking a 510(k) clearance on Prolift.”
The Seventh Circuit panel also rejects Ethicon’s secondary arguments that “Kaiser’s claims fall short under Indiana law in multiple respects, or at the very least a new trial is warranted based on evidentiary and instructional errors by the district judge.”
Conclusion
The case of Barbara Kaiser offers an informative case study in how an individual plaintiff has proceeded through the massive surgical-mesh litigation, which has spanned multiple MDLs over a number of years. Though it took years, Kaiser was able to effectively navigate her case through the MDL—overcoming an attempt by Ethicon to have all her claims dismissed—and back to Indiana federal court, where a jury found in her favor and ordered the defendants to pay $35 million in damages.
If you or a loved one has suffered serious injury as a result of a surgical mesh implant, contact the experience team of lawyers at TheLawFirm.com now for a free consultation!
Source:
United States Court of Appeals For The Seventh Circuit. (14 January 2020). Decision. No. 18-2944. Barbara Kaiser, Plaintiff-Appellee, v. Johnson & Johnson and Ethicon, Inc., Defendants-Appellants. Appeal from the United States District Court for the Northern District of Indiana, Hammond Division. No. 2:17-cv-00114
Mesh Lawsuit News: Kentucky Judge Tosses 13 Claims In Ethicon Mesh Suit, Allows 4 To Proceed
January 13, 2020
Author: Daniel Gala
In an order filed January 9, a federal judge in Kentucky granted in part and denied in part a motion by Johnson & Johnson and its subsidiary Ethicon to dismiss a lawsuit filed by a woman claiming that she has suffered serious, permanent injuries due to an Ethicon pelvic mesh implant she received in 2006.
Whereas defendants J&J and Ethicon had sought dismissal of all counts, Chief Judge Danny C. Reeves of the Eastern District of Kentucky allowed four of the lawsuits’ counts to proceed while dismissing 13, many on the basis of those claims being time-barred by the applicable statute of limitations. (The plaintiffs also had voluntarily agreed to no longer pursue one of their lawsuit’s 18 claims.)
The lawsuit, originally filed in May 2012 by wife and husband plaintiffs Jenesta Cutter and Larry Cutter, was transferred within weeks of its filing to multidistrict litigation (MDL) taking place in the Southern District of West Virginia, where it remained for more than five years before being remanded back to the Eastern District of Kentucky in November 2017, according to court documents.
The January 9 order was in response to a motion for summary judgment originally filed by J&J and Ethicon in July 2016, which the parties now “have indicated” is “ripe for consideration.”
The Lawsuit
As filed in 2012, the Cutters’ original complaint contained ten counts including defective manufacture and design and failure to warn. However, while the Cutters’ case was included in the Ethicon mesh MDL, it adopted a second amended complaint based on the MDL’s short-form complaint, which contained a total of 18 counts.
Each of the Cutters’ claims stem from an Ethicon Pro-Lift mesh implant that Jenesta Cutter had surgically implanted in June 2006. Prior to her surgery, plaintiffs allege that Jenesta and her treating physician had been “exposed” to an “advertising and marketing campaign directed by Ethicon” which “misrepresented the efficacy and safety of the Products, through various means and media, actively and intentionally misleading the FDA, the medical community, patients and the public at large.”
“Plaintiff and her physician, either through direct promotional contact with Ethicon Sales Representatives, Lab Faculty, through word-of-mouth with other health care providers, and/or promotional materials, received the information Ethicon intended Plaintiff and her physician to receive and view, to wit: that the Pelvic Mesh Products were safe and effective for use in the treatment of pelvic organ prolapse and stress urinary incontinence,” argues the original complaint.
Following the surgery, Jenesta began to suffer from a series of serious health problems she alleges were caused by the Ethicon implant, including “severe and debilitating pain, mesh erosion, and exposure/extrusion/protrusion.”
In an effort to alleviate these problems, Jenesta underwent subsequent surgeries in 2008 and 2010, ultimately suing J&J and Ethicon in 2012.
The Judge’s Ruling
Pursuant to Chief Judge Reeves’ January 9 order, the Cutters’ lawsuit will be allowed to proceed but in a significantly reduced capacity, with only four of the 18 counts surviving the defendants’ motion for summary judgment.
The four surviving claims include fraudulent concealment, negligent infliction of emotional distress, unjust enrichment, and the violation of consumer protection laws.
On these four counts, Chief Judge Reeves found that “the defendants…have not met their summary judgment burden for dismissal.”
However, with regards to 13 other counts, the judge found that the defendants had met their burden to have the claims dismissed as a matter of law. Seven of these claims were tossed, at least in part, for having been barred by the applicable statute of limitations. These included counts based on negligence, strict liability (failure to warn), strict liability (defective product), strict liability (design defect), gross negligence, breach of implied warranty, and breach of express warranty.
(The two breach of warranty claims also were dismissed for a lack of privity, and the strict liability [failure to warn] claim also was dismissed for lacking a proximate cause.)
Additionally, two counts (punitive damages; discovery rule and tolling) were dismissed for not constituting “a separate cause of action”, and three (common law fraud; constructive fraud; negligent misrepresentation) were tossed for lack of an affirmative material representation.
Conclusion
Despite each case having its own particular set of facts relating to the lives of real human beings who are seeking justice for their injuries, the Cutters’ Ethicon mesh lawsuit is representative of tens of thousands of cases that are all too similar in their descriptions of personal tragedies that plaintiffs say were foreseeable and preventable but for the profit-driven actions of J&J and Ethicon, who allegedly failed to warn patients and physicians about known risks relating to the mesh devices.
If you or a loved one has suffered serious injury as a result of a surgical mesh implant, contact the attorneys at TheLawFirm.com today for a free consultation!
Sources:
United States District Court Eastern District of Kentucky Central Division (at Lexington). (9 January 2020). Memorandum Opinion And Order. Case: 5:19-cv-00443-DCR. Jenesta Cutter and Larry Cutter, Plaintiffs, vs. Ethicon, Inc., Ethicon Women’s Health And Urology, a Division of Ethicon, Inc., Gynecare, and Johnson & Johnson, Defendant(s)
United States District Court Eastern District of Kentucky Central Division (at Lexington). (14 May 2012). Complaint And Demand For Jury Trial. Case: 5:19-cv-00443-DCR. Jenesta Cutter and Larry Cutter, Plaintiffs, vs. Ethicon, Inc., Ethicon Women’s Health And Urology, a Division of Ethicon, Inc., Gynecare, and Johnson & Johnson, Defendant(s)
United States District Court Eastern District of Kentucky Central Division (at Lexington). (13 September 2012). Second Amended Short Form Complaint. Case: 5:19-cv-00443-DCR. Jenesta Cutter and Larry Cutter, Plaintiffs, vs. Ethicon, Inc., Ethicon Women’s Health And Urology, a Division of Ethicon, Inc., Gynecare, and Johnson & Johnson, Defendant(s)
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.
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