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Hernia Mesh Litigation Tracker

Each hernia mesh claim is filed as an individual lawsuit, not as part of a class action. But as often happens with mass torts, logistics and efficiency dictate that most cases filed in federal court will be filed and managed as part of a multi-district litigation (MDL).

Many thousands of hernia mesh lawsuits are pending across the country. Around 11,000 separate hernia mesh cases filed in the federal courts have been centralized for discovery and pretrial purposes into three MDLs.

Each hernia mesh MDL involves different products and manufacturers:

  1. MDL No. 2753 contains cases involving Atrium Medical Corporation’s C-QUR hernia mesh products. It is pending in the U.S. District Court for the District of New Hampshire.
  2. MDL No. 2782 contains cases involving Ethicon’s Physiomesh Flexible Composite product (“Physiomesh”). It is pending in the U.S. District Court for the Northern District of Georgia.
  3. MDL No. 2846 contains cases involving several polypropylene hernia mesh products made by C.R. Bard & Davol. It is pending in the U.S. District Court for the Southern District of Ohio.

There are also at least two major consolidated hernia mesh proceedings in state courts—a Multi-County Litigation in Atlantic County, New Jersey, against Ethicon, and nearly 2,000 consolidated cases pending in the Superior Court for Providence, Rhode Island, against C.R. Bard involving claimed injuries from Composix® Kugel® Mesh patches.

Litigation schedules are always unpredictable and change frequently for many different reasons. But the COVID-19 pandemic disrupted our court system and caused delays on a scale rarely seen. The federal courts and most state courts shut down in-person proceedings for much of 2020, and many still had not resumed normal operations by the summer of 2021. The extended closures or limited schedules have created severe backlogs of civil and criminal trials in every trial court (criminal cases have priority because the Constitution guarantees those accused a “speedy” trial). These backlogs wreaked havoc on court schedules and have contributed to unusual delays in the MDL trials. The Atrium MDL and the Bard/Davol MDL both had bellwether trials scheduled in 2020, which were delayed and now rescheduled for mid-to-late 2021; the Ethicon MDL also has bellwether trials scheduled for 2021. The first bellwether trial in the consolidated Rhode Island hernia mesh litigation was also pushed from 2020 into 2021. 

Atrium C-Qur Multi-District Litigation (MDL)

The Atrium MDL was the first of the ongoing major federal MDLs involving cases about defective hernia mesh. By late 2016, thirteen lawsuits were pending against the Atrium Medical Corporation in seven district courts. The plaintiffs in those cases claimed Atrium had defectively designed, manufactured, and labeled its C-Qur hernia mesh products and that those products had caused an allergic or inflammatory response that caused severe post-surgical complications, including bowel obstructions, hematoma, seromas, and fistulas.

Litigation Atrium Medical Corporation’s C-QUR Hernia Mesh Products Liability Litigation
MDL No. 2753
District District of New Hampshire

Assigned Judge            

Judge Landya B. McAfferty

 

On December 8, 2016, the Judicial Panel on Multidistrict Litigation (JPML) centralized the existing federal hernia mesh cases against Atrium for all pretrial purposes. The JPML order  transferred the cases to the U.S. District Court for the District of New Hampshire (Atrium’s home district) and assigned the MDL to Chief Judge Landya B. McCafferty:

In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation, 16-md-2753-LM (D. N.H.)

The Atrium MDL now includes more than 2,600 separate lawsuits. The MDL has moved through the general discovery phase, and the court and parties are preparing for the bellwether trials. The Court and parties have identified the first three bellwether cases to be tried: Barron v. Atrium Medical Corp., 1:17-cv-742-LM, Luna v. Atrium Medical Corp., 1:16-cv-372-LM, and Shumaker v. Atrium Medical Corp.,   1:17-cv-00741-LM.

On December 17, 2019, Judge McCafferty established procedures  for choosing the first two cases to be tried, and scheduled the first bellwether trial to begin on May 20, 2020.  On February 6, 2020, the parties moved to revise the pretrial schedule and push the first bellwether trial back to September 16, 2020.

Atrium moved to extend all pretrial deadlines and push the first bellwether trial back to January 2021, citing the effects of the pandemic on the availability of medical and regulatory experts and their ability to prepare for trial. Judge McCafferty extended some deadlines without changing the trial date but has eventually had to bow to reality and delay those trials. The Barron trial was scheduled to begin with jury selection on July 7, 2021, but less than two weeks before trial lawyers for Ms. Barron and Atrium told the Court the parties had agreed to settle the case. The court canceled the Barron trial dates and gave the parties thirty days (until July 26, 2021) to finalize the settlement. That deadline was later extended to August 9, 2021, and they did reach agreement. The Barron case was dismissed on August 12, 2021. 

All sides have agreed that the Luna case will be set for trial next, and then Shumaker, but the parties have not proposed, and the court has not set, any trial dates. The regular monthly status conferences set for August 12, September 9, and October 14, 2021, were all canceled because there have been no issues for the Court to decide.

Ethicon MDL

The Ethicon MDL has grown to include more than 3,700 separate cases claiming that Ethicon, Inc. (the manufacturer) and its parent company Johnson & Johnson defectively designed, manufactured, and labeled the PHYSIOMESH Flexible Composite Mesh (“the Physiomesh”)1, which then injured the plaintiffs after their surgeries.

Litigation Ethicon’s PHYSIOMESH Flexible Products Liability Litigation    
MDL No. 2782
District Northern District of Georgia
Assigned Judge             Judge Richard W. Story

 

By late spring 2017, more than 70 lawsuits were pending against Ethicon in 36 federal district courts claiming the Physiomesh had injured the plaintiffs. Those cases alleged that defects in the product could and often did lead to severe complications, including hernias through the mesh, recurring hernias, ruptured hernias, and the mesh deforming inside the abdomen (which can damage the surrounding tissue and organs). More specifically, many cases allege that the multi-layer coating kept the mesh from being adequately incorporated into the body and that the polypropylene in the mesh could not withstand normal abdominal forces.

On June 2, 2017, the Judicial Panel on Multidistrict Litigation centralized the federal Physiomesh cases into an MDL for pretrial proceedings. The JPML order transferred the cases to the Northern District of Georgia and assigned the MDL to Judge Richard W. Story:

In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL No. 2782 (N.D. Ga.)

The Ethicon MDL has completed the general discovery phase, and the parties have designated four individual cases to be the first Ethicon bellwether trials:

  • Crumbley v. Ethicon, Inc. and Johnson & Johnson, 1:18-cv-00748
  • Guffey v. Ethicon, Inc. and Johnson & Johnson, 1:18-cv-00402
  • Bovian v. Ethicon, Inc. and Johnson & Johnson, 1:17-cv-04840
  • Smith v. Ethicon, Inc. and Johnson & Johnson, 1:17-cv-05031

Each bellwether trial is expected to take 2-3 weeks. Judge Story originally ordered the first bellwether trial to begin on November 2, 2020, and the second to begin on February 22, 2021. After months of pandemic-related delays, the first bellwether trial was scheduled to begin on March 18, 2021 and the second on June 7, 2021, with a third, consolidated, bellwether trial to begin on September 13, 2021. But the Court had to delay the first bellwether trial (Crumbley) temporarily due to the plaintiff’s March 2021 surgery, and in late April 2021 scheduled limited supplemental discovery and set the trial to begin on September 13, 2021. In May 2021, the Court delayed the second bellwether trial (Guffey) indefinitely and stayed the schedules for all other trial pool cases. The Crumbley and Guffey cases apparently continued to move forward, as the parties in Crumbley filed a dozen standard pre-trial motions on July 14, 2021.

But the Court’s indefinite stay order was a sign that the two sides were involved in serious settlement negotiations. On September 20, 2021, court filings by the plaintiffs’ counsel announced the parties had agreed to a global settlement of all claims against the Ethicon Physiomesh Flexible Composite Mesh products filed by May 13, 2021, in both the federal MDL and the New Jersey multi-county litigation discussed below. The plaintiffs requested that Judge Story appoint an experienced Special Master to help implement the global settlement agreement and also establish a Qualified Settlement Fund. The court granted both of those motions and issued the requested orders that same day.

All other details of the settlement remain confidential; the parties filed the supporting documents “under seal” with the court’s approval.

Consolidated Ethicon Physiomesh State Cases

On July 17, 2018, the Supreme Court of New Jersey (Ethicon’s home state) designated all cases filed in the New Jersey state courts alleging injuries from Physiomesh part of a multi-county litigation or “MCL”. (This state court procedure is the New Jersey version of an MDL). The Court assigned the Physiomesh MCL to Atlantic County, New Jersey for centralized case management; it is currently assigned to Superior Court Judge John C. Porto. All cases filed in the MCL by May 13, 2021 are part of the global settlement agreement.

Bard/Davol MDL

The Bard/Davol MDL includes more than 4,800 cases claiming that many polypropylene hernia mesh products made and sold by C.R. Bard (now Bard Medical) and its subsidiary Davol, Inc., (or Bard Davol) were defectively designed, manufactured, and labeled and then injured the plaintiffs after their surgeries

Litigation C.R. Bard & Davol Polyproplyene Hernia Mesh Products Liability Litgation    
MDL No. 2846
District Southern District of Ohio
Assigned Judge             Judge Edmund A. Sargus

 

By mid-2018 at least 53 hernia mesh lawsuits were pending against Bard and Davol in 21 federal district courts (and at least 69 potential “tag-along” cases had been identified) claiming injuries from one of their many polypropylene hernia mesh products. Those cases alleged that, due at least in part to the polypropylene material, defendants’ hernia mesh products could and often did cause severe complications when implanted, including adhesions, damage to organs, inflammatory and allergic responses, immune systems rejecting the mesh as a foreign body, migrating mesh, and infections.

On August 2, 2018, the Judicial Panel on Multidistrict Litigation centralized the cases against the Bard/Davol polypropylene hernia mesh products into an MDL for coordinated or consolidated pretrial proceedings. The JPML’s order transferred the cases to the Southern District of Ohio and assigned them to Judge Edmund A. Sargus:

In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2:18-md-2846 (S.D. Oh.)

The long list of polypropylene Bard/Davol hernia mesh products at issue in this MDL includes at least the following products:

  • 3D Max & 3D Max-Lite
  • Composix, Composix E/X, Composix Kugel & Composix L/P
  • Kugel Patch
  • Marlex
  • PerFix Plug & PerFix Light Plug
  • Pre-shaped Mesh
  • Spermatex
  • Sepramesh
  • Ventralex & Ventralex ST
  • Ventralight
  • Ventrio & Ventrio ST
  • Visilex

On January 24, 2020, Judge Sargus selected the first three bellwether cases for the Bard/Davol MDL and scheduled those trials:

  • Johns v. C.R. Bard, Inc., et al., 2:18-cv-01509-EAS-KAJ (S.D. Oh.). This case (which Defendants had proposed) involves the Ventralight™ ST product and was originally set for trial beginning May 11, 2020.
  • Milanesi et al. v. C.R. Bard., Inc., et al., 2:18-cv-01320-EAS-KAJ (S.D. Oh.). This case (which plaintiffs had proposed) involves the Ventralex™ product and was originally set for trial beginning July 13, 2020.
  • Stinson v. Davol, Inc, et al., 2:18-cv-01022- EAS-KAJ (S.D. Oh.). This case (which plaintiffs had proposed) involves the PerFix™ Plug and was originally set for trial beginning September 14, 2020.

Two months later, on March 24, 2020, the court rescheduled the first two bellwether trials, which have since been rescheduled multiple times. The Johns trial was set to begin on August 2, 2021, and the court scheduled the Milanesi trial to begin on January 10, 2022.  On June 10, 2021, the court restated that the Stinson case will be the third bellwether trial, and designated Miller v. Davol, Inc., 2:18-cv-01443-EAS-KAJ (S.D. Oh.) as the fourth. The Miller case involves the Bard 3D Max. No trial dates have been set for Stinson or Miller.

Trial in the Johns case began as scheduled on August 2, 2021 and ran for 21 trial days, ending on September 8, 2021 with a jury verdict in favor of C.R. Bard.

On September 29, 2021, Judge Sargus issued Case Management Order (29-A) setting deadlines for the pretrial filings in the Milanesi case.

Beyond the ongoing federal hernia mesh MDL, the Superior Court for Providence, Rhode Island is also managing a consolidated state proceeding involving thousands of cases filed against Bard/Davol polypropylene hernia mesh:

IN RE: DAVOL/ C.R. BARD HERNIA MESH, Case No. PC-2017-1929, (Providence/Bristol Cty. Sup. Ct).

In May 2017, the Providence trial court—sitting in the city where Davol, Inc., was founded in 1874 and still Bard’s hometown—established “a multi-case management coordinated proceeding for all subsequent filings alleging personal injuries from Davol /C.R. Bard hernia mesh products.” Most of these state cases involve the Ventralex and Composix E/X products. The first bellwether trial in the state litigation, involving the Ventralex product, was delayed from 2020 and scheduled to begin on April 6, 2021.

Plaintiffs may not usually be eager to do legal battle on a defendant’s home ground, but they know the Providence court has jurisdiction over Bard & Davol. And Rhode Island law offers plaintiffs other advantages. The state proceedings appear to have grown so large because Rhode Island applies the “discovery rule” to personal injury cases involving dangerous drugs and medical devices. Under that rule, Rhode Island’s standard three-year statute of limitations does not begin to run until the plaintiff “knew or reasonably should have known” of their injury. Rhode Island also has no statute of repose cutting off a plaintiff’s ability to bring a claim. As a result, many injured plaintiffs who may have missed their home state’s deadline to file suit filed in Rhode Island instead.

Covidien Lawsuits

Individual lawsuits have also been filed against Covidien (now Medtronic Minimally Invasive Therapies), its parent company Medtronic PLC, and other related entities. There are currently no consolidated litigations involving Covidien products. By early 2020, the total number of cases (more than 150 state and federal cases combined) was large enough that Covidien requested that the Joint Panel on Multidistrict Litigation centralize all federal cases against it into an MDL and transfer them to the Southern District of New York. Some plaintiffs opposed consolidation. The JPML denied Covidien’s motion in an order issued August 7, 2020.

The Panel ruled Covidien had not shown that the benefits of an MDL would outweigh the delays caused by the transfers and the burdens on the plaintiffs in cases that had been ongoing for two to three years. The Panel also held that the twelve federal cases against Covidien pending in nine districts were not numerous enough to show that consolidation would greatly benefit the court system. Covidien argued that roughly 130 other hernia mesh cases were pending against it in state courts, but the Panel noted that it saw no evidence many of those cases would be removed to federal court, and that its consolidation decisions are fact-specific and can’t be based on speculation.

  

End Notes

  • The similarly-named PHYSIOMESH™ Open Flexible Composite Mesh Device is not at issue in the Ethicon MDL. 

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