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. More than 12,000 separate hernia mesh cases filed in the federal courts have been centralized for discovery and pretrial purposes into four 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.
4. MDL No. 3029 contains cases involving various Covidien hernia mesh products. It is pending in the U.S. District Court for the District of Massachusetts.

There are also consolidated hernia mesh proceedings in state courts — including a Multi-County Litigation in Atlantic County, New Jersey, against Ethicon, a coordinated proceeding in the Massachusetts state courts with more than 4,700 cases against Covidien, 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 late 2021. The extended closures or limited schedules created severe backlogs of civil and criminal trials in every trial court (criminal cases have priority because the Constitution guarantees the accused a “speedy” trial). These backlogs wreaked havoc on court schedules and have contributed to unusual delays in the MDL trials. The bellwether trials in the Atrium MDL, the Bard/Davol MDL, and the Ethicon   MDL were all significantly delayed by the pandemic. The newly formed Covidien MDL has not been so affected yet.

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 agreed that the Luna case would be set for trial next, and then Shumaker, but the parties did not propose, and the court did not set, any trial dates. The regular monthly status conferences set for August through October 2021, were all canceled because there have been no issues for the Court to decide.

This extended period of silence and apparent inactivity in a complicated MDL suggested that the parties were having settlement talks behind the scenes.  And on December 9, 2021, the curtain opened up and the Plaintiffs’ counsel filed five motions with the defendants’ agreement. The first motion asked the Court to stay all deadlines in the MDL while the parties finalized a proposed settlement. The other motions sought appointment of a Special Master to assist with certain settlement issues, a qualified protective order governing the disclosure of confidential information, and other procedural matters. The next day, Plaintiffs’ counsel filed another agreed motion to establish a Qualified Settlement Fund.  On December 20, 2021, the Court granted those motions.   

On February 7, 2022, Judge McCafferty issued an order scheduling a public video hearing on March 17, 2022, so that individual plaintiffs could ask, and the lead plaintiffs’ counsel could answer, questions about the settlement process and its progress. The court allowed plaintiffs to submit questions online in advance, which the Court screened and read to the lead plaintiffs’ counsel at the hearing. The Court noted that it might schedule additional hearings as the settlement process progressed.

In March of 2022, the Plaintiffs’ counsel filed another motion related to the details of settlement and payment, including many documents to be filed under seal. In April of 2022, the court agreed to seal the documents as requested, and there has been no further public activity in the MDL.

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 was 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 proposed settlement remained confidential; the parties filed the supporting documents “under seal” with the court’s approval.  The court’s docket remained quiet for months as the two sides apparently worked with the appointed Special Master to hammer out the many details and complicated procedures required to resolve and process thousands of cases from the MDL. On June 22, 2022, Plaintiffs filed an Unopposed Motion asking the court to issue a “qualified” Protective Order allowing the plaintiffs’ confidential medical and identifying information to be shared as needed to resolve liens and other claims for reimbursement of medical benefits. The Court granted the motion and issued the protective order on that same day. The Motion refers to a confidential Master Settlement Agreement, which, combined with the details about resolving liens and other third-party claims, strongly suggests that at least this round of Physiomesh litigation has ended.

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.

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 the 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 December 21, 2021, Judge Sargus denied Mr. Johns’ motion for a new trial.

On October 14, 2021, Judge Sargus granted summary judgment for Bard on Mr. Milanesi’s claims based on strict liability for alleged manufacturing defects and on negligence per se, but allowed the claims alleging design defect, failure to warn, fraud, misrepresentation, gross negligence and punitive damages to continue on to trial.

After disposing of literally dozens of pre-trial motions seeking to exclude evidence (44), Judge Sargus issued Case Management Order (29-C) on January 11, 2022,  amending the deadlines for the pretrial filings in the Milanesi case, which had been pushed back to March 21, 2022.

The Milanesi trial began on March 21, 2022, and ran for 18 trial days, ending on April 15, 2022, with a verdict for the plaintiffs. The jury awarded the plaintiff $250,000 on the design defect claim (and awarded his wife $5,000 for loss of consortium). Both sides have filed post-trial motions, with Bard seeking to overturn the jury verdict through its Motion for Judgment as a Matter of Law, and Milanesi moving for a new trial on damages (or in the alternative, simply a new trial).

On May 27, 2022, Defendants filed a Motion for Entry of a Docket Control Order. A Docket Control Order would require the plaintiffs’ lawyers to make certain certifications about every case they file in the MDL. Bard claims that the MDL is expanding significantly, but that many of the new cases seem to lack merit and it doesn’t have the time or ability to investigate and screen those out. Both sides have briefed that motion.

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 until 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.