Hernia Mesh Lawsuit News and Updates
The latest news and updates regarding hernia mesh devices, lawsuits and settlements.
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.
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 3,000 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.
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.”
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.”
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 .
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.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
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!
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!
The Australian Broadcasting Corporation (ABC)
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.
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!
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!
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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