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.
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
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.
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.
Cases involving Atrium C-CUR mesh products consolidated into an MDL in New Hampshire federal court. As of October 2017, 30 lawsuits were pending.
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.
People who developed serious complications following hernia mesh surgery filed lawsuits claiming the mesh was responsible for their injuries.
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.
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.
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.
|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|
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.
First 150 cases consolidated into MDL in Rhode Island federal court
Defense verdict for Bard in first bellwether trial of MDL
$1.5 million verdict for plaintiffs in second trial
Bard offers $184 million to settle 2,600 Kugel patch lawsuits
Kugel Hernia Mesh Patch MDL closed after 10 years
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.
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.
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.
FDA approves Atrium’s first C-QUR mesh products
Researchers find every C-QUR mesh in their study had increased rate of adhesions and immune system responses
FDA approves Ethicon’s Physiomesh Flexible Composite Mesh
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.
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.
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.
Two, large European hernia registries report higher than average failure rates for Physiomesh Flexible Composite Mesh.
Ethicon issues a “market withdrawal” of Physiomesh Flexible Composite Mesh products.
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.
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.
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