Medical Device Litigation

Hernia Mesh Litigation: What the Court and FDA Records Show

A factual overview of US hernia mesh litigation: the federal MDL against Davol and Bard, FDA device data, and the 2024 BD settlement announcement.

Surgical mesh used to reinforce tissue in hernia repair, the subject of consolidated federal product liability litigation
Surgical mesh used to reinforce tissue in hernia repair, the subject of consolidated federal product liability litigation
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Federal lawsuits alleging that polypropylene hernia mesh made by Davol Inc. and C.R. Bard Inc. (now part of Becton Dickinson, or BD) caused complications such as adhesions, organ damage, mesh migration and infection were consolidated into one federal proceeding in 2018. That proceeding is MDL 2846, assigned to Judge Edmund A. Sargus Jr. in the U.S. District Court for the Southern District of Ohio, and the Judicial Panel on Multidistrict Litigation (JPML) counted 23,324 actions pending there as of October 1, 2026. In October 2024 BD announced an agreement to resolve the vast majority of that litigation without admitting liability and without disclosing the terms. No court has found that any mesh product caused any individual patient’s injury.

What the litigation is about

Hernia repair is common. The FDA says as many as one million hernia repairs are performed each year in the United States and that most use surgical mesh, a device that reinforces weakened or damaged tissue (FDA, Surgical Mesh Used for Hernia Repair, accessed 2026-10-13).

The federal cases in MDL 2846 concern polypropylene mesh sold by Bard and its Davol subsidiary. The JPML created the proceeding on August 2, 2018, finding that the actions “share common factual questions arising out of allegations that defects in defendants’ polypropylene hernia mesh products can lead to complications when implanted in patients” (court page for MDL 2846, accessed 2026-10-13). An MDL is neither a trial nor a class action: it centralizes pretrial proceedings, mainly discovery, before one judge, and unresolved cases return to the districts where they were filed. That difference is set out in MDL versus class action, and hernia mesh sits inside the wider field covered by how mass tort litigation works. Other medical device litigation follows the same pattern, a marketed device followed by consolidated product claims, as in the Philips CPAP and ventilator recall litigation.

What is established vs. what is alleged

Established by the public record

  • The consolidation exists. The JPML created MDL 2846 on August 2, 2018 and transferred the cases to the Southern District of Ohio before Judge Sargus (court page).
  • Case counts are published. The JPML report dated October 1, 2026 lists 23,324 actions pending in MDL 2846 and 25,217 filed over its life, plus 2,479 pending actions in MDL 3029 (a separate hernia mesh proceeding involving Covidien) and 101 pending in MDL 2753 (Atrium Medical’s C-QUR mesh) (JPML report).
  • The FDA reviewed adverse event reports. It examined reports mentioning hernia mesh over 22 years and, filtered to specific hernia types, found over 55,000 of them. The FDA states that this surveillance system has limitations and that reports “alone are rarely able to confirm a direct cause and effect between an adverse event report and a specific medical device” (FDA Activities).
  • Product actions occurred. The FDA’s recall database records 2013 Class 2 recalls of Atrium’s C-QUR mesh lines, for additional instructions on use and storage because the coated mesh can adhere to its packaging liner in high humidity. The FDA-determined cause was package design or selection, not a clinical finding of defect. The recall was terminated on March 18, 2016 (FDA recall record).
  • One mesh line left the market. In May 2016 Ethicon, a Johnson & Johnson company, withdrew Physiomesh Flexible Composite Mesh for laparoscopic use from the global market after unpublished registry data from Germany and Denmark showed higher recurrence and reoperation rates than comparator meshes (TGA notice). That was a manufacturer market withdrawal, not an FDA finding about individual injuries.

Alleged in the complaints

Plaintiffs allege that polypropylene mesh is unsuitable for permanent implantation, that the resorbable coatings on some products fail earlier than intended, and that the manufacturers knew or should have known of the risks and failed to warn patients and surgeons adequately. The JPML’s transfer order describes those complications as allegations, and no such claim has been established by a judgment in the consolidated proceeding.

Where the claims stand procedurally

MDL 2846 remains active, and new federal suits can still be filed and transferred into it. The JPML’s October 1, 2026 count of 23,324 pending actions reflects a docket kept open while claims are reviewed and paid, not a schedule of imminent trials. Two other hernia mesh proceedings are active: MDL 3029, In re Covidien Hernia Mesh Products Liability Litigation (No. II), before Judge Patti B. Saris in the District of Massachusetts, and MDL 2753, before Judge Landya B. McCafferty in the District of New Hampshire. State-court proceedings run in parallel.

The October 2024 settlement announcement

On October 2, 2024, BD announced an agreement to resolve the vast majority of its existing hernia litigation. Its statement says the agreement covers cases in both the Rhode Island consolidated litigation and the federal MDL in Ohio, the terms are confidential, the amount falls within BD’s existing product litigation reserve, and payment will occur over a multi-year period. It states that the settlement “does not include any admission of liability or wrongdoing” and that BD “continues to dispute the allegations in these matters” (BD press release).

Because the terms were not disclosed, no per-case amount, total value or eligibility standard can be verified from the public record. An official settlement administration notice is the only source that states binding terms.

Key dates

  • July 19, 2013 (initiated), August 9, 2013 (posted): Atrium Medical’s Class 2 recall of C-QUR mesh lines; terminated March 18, 2016 (FDA recall record).
  • May 2016: Ethicon withdraws Physiomesh Flexible Composite Mesh for laparoscopic use from the global market (TGA notice).
  • August 2, 2018: The JPML creates MDL 2846 in the Southern District of Ohio (court page for MDL 2846).
  • October 2, 2024: BD announces an agreement to resolve the vast majority of its hernia litigation, with no admission of liability (BD press release).
  • October 1, 2026: The JPML reports 23,324 actions pending and 25,217 total in MDL 2846 (JPML report).

What this does not establish

The public record shows no judicial finding that a hernia mesh product caused a particular patient’s injury, and no finding of liability or wrongdoing by Bard, Davol or BD. The FDA’s adverse event database is a reporting system, not a causation finding. The C-QUR recall was classified as a packaging and instruction issue. The BD agreement is a company announcement whose terms are confidential and which expressly disclaims any admission. A pending case count says nothing about how many claims are meritorious.

Frequently asked questions

Is hernia mesh litigation a class action?

No. The federal cases are consolidated for pretrial purposes as MDL 2846. In an MDL each plaintiff keeps an individual case; in a class action one case is litigated for a defined group. See MDL versus class action.

Has any court ruled that hernia mesh causes injury?

Not in the consolidated proceeding, on the record reviewed here. The JPML’s transfer order describes the complications as allegations. Individual cases can end in verdicts, but none is treated as a general finding about a product.

What does the FDA say about mesh complications?

The FDA lists pain, infection, hernia recurrence, adhesion, obstruction, bleeding, fistula, seroma and perforation as the most common adverse events in hernia repair, with or without mesh, adding mesh migration or shrinkage for repairs that use mesh. It cautions that adverse event reports rarely confirm cause and effect on their own.

Does the 2024 BD announcement mean all claims were settled?

No. BD described the agreement as resolving the vast majority of its existing litigation and said it would defend cases not resolved by it; the terms are confidential.

Can new hernia mesh cases still be filed?

The MDL remained active in the JPML’s October 1, 2026 report, and federal suits can be filed into it. Deadlines depend on state law and the facts; statute of limitations rules for injury claims explains how they generally work.

Sources

  1. U.S. District Court for the Southern District of Ohio - “Introduction - MDL 2846” (link, accessed 2026-10-13)
  2. United States Judicial Panel on Multidistrict Litigation - “MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending” (link, accessed 2026-10-13)
  3. U.S. Food and Drug Administration - “Surgical Mesh for Hernia Repair: FDA Activities” (link, accessed 2026-10-13)
  4. U.S. Food and Drug Administration - “Surgical Mesh Used for Hernia Repair” (link, accessed 2026-10-13)
  5. U.S. Food and Drug Administration - “Class 2 Device Recall CQUR Edge Mesh (Recall Z-1937-2013)” (link, accessed 2026-10-13)
  6. Therapeutic Goods Administration, Australian Government - “Ethicon Physiomesh Flexible Composite Mesh” (link, accessed 2026-10-13)
  7. Becton, Dickinson and Company (filed with the U.S. Securities and Exchange Commission) - “BD Reaches Agreement to Resolve Vast Majority of Hernia Litigation” (link, accessed 2026-10-13)

CollectiveClaim.us publishes general legal information. This article is not legal advice and does not create an attorney–client relationship. Court records and agency actions change; verify current status with the court or agency before relying on it.

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