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Hernia Mesh Lawsuits: Physiomesh, C-QUR

Thousands of people have filed lawsuits over the past decade blaming hernia mesh for severe complications. Hernia mesh lawsuits have already resulted in at least one verdict of $1.5 million and a settlement worth $184 million, even as people continue to file new lawsuits.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

If you had a hernia mesh surgery and suffered one of the following complications, you may be entitled to compensation.

  • Mesh Migration
  • Bowel Obstruction
  • Perforation
  • Seroma
  • Hernia Recurrence
  • Abscess
Suffering from complications related to Hernia Mesh?

Number of LawsuitsMore than 2,000

Plaintiff InjuriesWrongful death; infections; organ damage; autoimmune problems; adhesions; bowel obstructions

DefendantsAtrium Medical Corp.; Ethicon; Johnson & Johnson; C.R. Bard, Davol Inc.

Litigation Status Active

SettlementBard settled about 2,000 Kugel hernia patch cases for $184 million

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Written by , on December 22, 2016

Edited on November 10, 2017

Fast Facts

  • Past lawsuits against Bard Davol hernia mesh netted a $184 million settlement
  • Atrium C-QUR and Ethicon Physiomesh are blamed for serious complications in new lawsuits
  • Hundreds of lawsuits have been filed in the latest round of hernia mesh cases

More than 250 hernia mesh lawsuits had been combined into two new multidistrict litigations (MDLs) in federal court. MDLs allow cases to move more quickly and efficiently through the legal system. Lawyers expect hundreds more could be added before the cases go to trial.

People filing lawsuits claim Ethicon’s Physiomesh Flexible Composite products and Atrium C-QUR hernia mesh were not properly designed and caused serious internal injuries, allowed hernias to recur or other complications.

Status of Current Hernia Mesh Lawsuits

As of October 2017, there were 266 lawsuits pending in the latest federal MDLs against two hernia mesh manufacturers. The lawsuits had been combined in separate MDLs within seven months of each other.

  • December 2016

    Cases involving Atrium C-CUR mesh products consolidated into an MDL in New Hampshire federal court. As of October 2017, 30 lawsuits were pending.

  • June 2017

    Lawsuits over Ethicon’s Physiomesh Flexible composite Hernia Mesh were consolidated into an MDL in Georgia federal court. As of October 2017, 236 lawsuits were pending.

One of the earliest lawsuits in the current round of hernia mesh cases was originally filed in Illinois federal court and was set to go to trial in early 2018. But that case, Huff v. Ethicon, was transferred to the MDL in Georgia in June 2017, and the original trial date was canceled.

Neither MDL judge has set any trial dates yet for lawsuits in the multidistrict litigations. Attorneys expect hundreds of additional lawsuits may be filed by the time they do schedule trials.

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Why People File Hernia Mesh Lawsuits

People who developed serious complications following hernia mesh surgery filed lawsuits claiming the mesh was responsible for their injuries.

INJURIES LISTED IN HERNIA MESH LAWSUITS INCLUDE:

  • Adherence (becoming stuck to internal tissue)
  • Bowel obstruction
  • Infection
  • Mesh failure
  • Migration (moving from where it was implanted)
  • Perforation of organs or tissues
  • Seromas (pockets of fluid) that require surgery

People filing C-QUR hernia mesh lawsuits also claim the products’ fish oil-derived coating led to “allergic or inflammatory” responses that caused further complications.

Accusations Against Hernia Mesh Manufacturers

People filing C-QUR and Physiomesh lawsuits claim hernia mesh manufacturers knew or should have known their products were defective, but failed to warn people of the complications.

HERNIA MESH LAWSUITS ACCUSE DEVICE MAKERS OF SEVERAL COUNTS OF NEGLIGENCE, INCLUDING:

  • Manufacturing a defective product
  • Failing to adequately test hernia mesh
  • Failing to warn the public about the risks of mesh
  • Intentionally, knowingly and recklessly concealing information about the defective mesh
  • Intentionally misrepresenting the quality and safety of hernia mesh
  • Negligently designing and marketing unsafe hernia mesh

Hernia Mesh Manufacturers Being Sued

At least four manufacturers and 19 different products are embroiled in the latest wave of hernia mesh lawsuits. While Atrium and Ethicon products have been combined into MDLs, patients receiving Bard or Covidien mesh products have also brought individual lawsuits against those companies alleging complications.

Hernia Mesh Makers and Products in Current Lawsuits

Manufacturer Models Involved in Lawsuits
Atrium C-QUR Mesh C-QUR Edge Mesh V-Patch
C-QUR Lite Mesh V-Patch C-QUR OVT Mesh
C-QUR RPM Mesh C-QUR TacShield
C-QUR V-Patch C-QUR Mosaic
Bard PerFix Mesh 3DMax Mesh
Ventralex Patch Ventralex ST Mesh
Sepramesh IP Composite Mesh Composix E/X Mesh
Covidien Parietex Surgical Mesh Parietex Composite Mesh
Parietex ProGrip Mesh
Ethicon Physiomesh Flexible Composite Meshh

Previous Hernia Mesh Verdicts and Settlements

Various models of Bard Davol’s Kugel Patch were among of the first hernia-mesh devices involved in multidistrict litigation. Bard first recalled the patch in 2005 because it could cause bowel perforations and fistulas. The first lawsuits followed soon after. Eventually, plaintiffs filed over 3,000 cases against C.R. Bard, Inc., and its subsidiaries for the design, manufacture, and use of specific hernia mesh devices.

  • June 2007

    First 150 cases consolidated into MDL in Rhode Island federal court

  • April 2010

    Defense verdict for Bard in first bellwether trial of MDL

  • August 2010

    $1.5 million verdict for plaintiffs in second trial

  • June 2011

    Bard offers $184 million to settle 2,600 Kugel patch lawsuits

  • September 2017

    Kugel Hernia Mesh Patch MDL closed after 10 years

Hernia Mesh Class Action Lawsuit

The latest series of hernia mesh lawsuits in the U.S. involve multidistrict litigations (MDLs). These differ from class action lawsuits in a few important ways.

Class Action Lawsuits

These involve a few people filing a single lawsuit over a common injury or injuries. Only people who suffered those injuries are eligible to collect any portion of the verdict or settlement. Usually, everyone in the class receives a proportionate share of awards or settlements.

Multidistrict Litigations (MDLs)

These start as multiple lawsuits filed by several – even hundreds or thousands – of people in federal courts. These are combined to speed them through much of the pre-trial portions of the case more quickly and less expensively. They tend to be more flexible on the range of injuries allowed and settlement payments may be based on each type of injury.

Canadian law is somewhat different, and at least two brands of hernia mesh have been entangled in that country’s version of class action litigation in recent years.

2014

Bard Davol agreed to $1.375 million settlement for hernia mesh class action lawsuit over its Kugel Patch

2017

Lawyers begin seeking class action certification for people harmed by Ethicon’s Physiomesh

Clinical Studies, FDA Actions on Hernia Mesh

Scientific studies have questioned the effectiveness of some hernia mesh and companies have pulled products off the market after high failure rates were reported. The FDA has even sent a warning to at least one company over its manufacturing and quality control process at a hernia mesh manufacturing plant.”Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market”a FDA statement; April 4, 2017.

Timeline of hernia mesh studies and FDA actions

  • 2006

    FDA approves Atrium’s first C-QUR mesh products

  • 2009

    Researchers find every C-QUR mesh in their study had increased rate of adhesions and immune system responses

  • 2010

    FDA approves Ethicon’s Physiomesh Flexible Composite Mesh

  • 2012

    FDA issues a warning letter to Atrium Medical noting that there were complaints of infections from the mesh that were not properly addressed or documented and Atrium’s sterilization process may have been inadequate.

  • 2015

    Federal court grants FDAan injunction against Atrium to stop distribution and manufacturing of medical devices from the company’s Hudson, New Hampshire plant until it complied with certain provisions of the Federal Food, Drug, and Cosmetic Act.

  • 2016

    Study published in JAMA finds that while mesh reduces chances of hernia recurrences within 5 years of surgery, benefits are often offset by mesh complications.

  • 2016

    Two, large European hernia registries report higher than average failure rates for Physiomesh Flexible Composite Mesh.

  • 2016

    Ethicon issues a “market withdrawal” of Physiomesh Flexible Composite Mesh products.

  • 2016

    Study finds recalled mesh is responsible for some of the most serious complications.

The FDA has different definitions for recalls and market withdrawals. The FDA considers a market withdrawal as cases where there were no grounds for the agency to take legal action against a manufacturer. In those cases, the company simply removes the product from the market or corrects the violation.

Author

Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.


Hide Sources

  1. James and Kimberly Brown vs Atrium Medical Corporation. (2017, January 9.) U.S. District Court of New Hampshire. Retrieved from https://45ijagbx6du4albwj3e23cj1-wpengine.netdna-ssl.com/wp-content/uploads/https-ecf-nhd-uscourts-gov-doc1-11711835179.pdf
  2. Lexis Legal News. (2017, September 9). Kugel Hernia Mesh Patch MDL Closed Sept. 15 After 10 Years. Retrieved from https://www.lexislegalnews.com/articles/20550/kugel-hernia-mesh-patch-mdl-closed-sept-15-after-10-years
  3. Matthew Huff vs. Ethicon, Inc. (2016, April 1) U.S. District Court, Southern District of Illinois. Retrieved from https://18vtbxct6zl2lh5x8psdj8p7-wpengine.netdna-ssl.com/wp-content/uploads/2016-04-01-Complaint.pdf
  4. The Internet Archive. (2016, May 25). Ethicon Physimesh Flexible Composite Mesh. Retrieved from https://archive.org/stream/EthiconPhysiomeshRecall/ethicon%20physiomesh%20recall_djvu.txt
  5. U.S. Food and Drug Administration. (2017, April 4). Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  6. Science Daily. (2016, October 18). Study finds mixed results for use of mesh for hernia repair. Retrieved from https://www.sciencedaily.com/releases/2016/10/161018094928.htm
  7. Kokotovic, D. et al. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. Retrieved from http://jamanetwork.com/journals/jama/fullarticle/2565771
  8. U.S. Judicial Panel on Multidistrict Litigation (2017, September 15). MDL Statistics Report – Distribution of Pending MDL Dockets by District. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-September-15-2017.pdf
  9. U.S. Food and Drug Administration. (2012, October 11). Warning Letter CMS # 363780. Retrieved from https://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm325084.htm
  10. U.S. Food and Drug Administration (2015, Feb. 4). Federal judge approves consent decree with Maquet Holding B.V. & Co [Press release]. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm432925.htm
  11. IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation. (2016, December 8). Transfer Order, MDL No. 2753. U.S. Panel on Multidistrict Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  12. IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. (2017, June 2). Transfer Order, MDL No. 2782. U.S. Panel on Multidistrict Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2782-Initial_Transfer-05-17.pdf
  13. Judicial Panel on Multidistrict Litigation. (2016, December 8). IN RE: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation; MDL No. 2753. Retrieved from: http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  14. U.S. Department of Justice. (2015, February 3). District Court Enters Permanent Injunction Against New Hampshire Company and Senior Executives to Stop Distribution of Adulterated and Misbranded Products. Retrieved from: https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-new-hampshire-company-and-senior
  15. Schreinemacher, M.H., et al. (2009, March). Degradation of Mesh Coatings and Intraperitoneal Adhesion Formation in an Experimental Model. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/19224521
  16. FDA. (2010, April 9). 510(k) Premarket Notification; Physiomesh. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093932
  17. FDA. (2006, March 31). 510(k) Premarket Notification; Atrium C-QUR. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050311
  18. Ethicon. (2016, May 25). Urgent: Field Safety Notice; Ethicon Physiomesh Flexible Composite Mesh (All Product Codes). Retrieved from: https://www.swissmedic.ch/recalllists_dl/13779/Vk_20160525_11_e1.pdf

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