First Composix Kugel Patch Trial Ends in Defense Verdict for Davol and Bard

  • Written by: Staff Writers

A Rhode Island jury has returned a defense verdict in the first trial out of about 3,000 product liability lawsuits filed over the Composix Kugel hernia patch.

The hernia patch lawsuit trial involved claims brought by plaintiff John Whitfield against Davol, Inc. and C.R. Bard, Inc., alleging that he suffered severe internal injuries as a result of problems with the companies’ Composix Kugel patch.

During a hernia repair surgery in January 2004, doctors implanted a Composix Kugel patch in Whitfield. At some point after the surgery, the hernia patch allegedly broke inside his body and caused Whitfield to develop multiple and severe injuries when it became intertwined with his hernia. Whitfield alleged that the patch caused bowel obstructions, severe abdominal pain and swelling, nausea, sickness, permanent bowel disfigurement, and other problems.

Following more than two weeks of trial, a jury in the U.S. District Court for the District of Rhode Island rejected Whitfield’s claim, returning a defense verdict. Although the jury found that the plaintiff established that Davol and Bard were negligent in the design of the Composix Kugel patch, they indicated that he did not prove that his damages were directly caused by or contributed to by the negligent design.

Whitfield’s trial was the first out of about 3,000 product liability lawsuits that have been filed against Davol and Bard over problems with different variations of the Composix Kugel patch, many of which have been recalled. All of the Kugel lawsuits involve allegations that the patch was defectively designed and that the manufacturers failed to warn patients and doctors about the health risks associated with the product.

Between 2005 and 2007, three separate Kugel patch recalls were issued for different sizes and models of the hernia mesh. The recalls were issued because of problems with a plastic ring in the mesh that was prone to break, potentially causing bowel perforations, chronic intestinal fistula and other internal injuries that often require additional surgery to remove the mesh.

There are more than 1,300 other Kugel lawsuits pending in the U.S. District Court for the District of Rhode Island, where all federal lawsuits have been centralized under Chief Judge Mary M. Lisi as part of a multidistrict litigation, or MDL. Another 1,774 lawsuits over the Composix Kugel patch have been centralized at the state level in Rhode Island Superior Court under Presiding Justice Alice B. Gibney.

Whitfield’s case was selected as one of four “bellwether” Kugel patch trials that were selected from the federal MDL for early trials. The parties and the court selected the four cases to gauge how juries will respond to evidence and witness testimony that may be presented in other cases throughout the Kugel mesh litigation.

The next lawsuit scheduled to go to trial is a claim filed by Christopher Thorpe, of North Carolina, and his wife, Laure, which is expected to begin June 9, 2010. Thorpe claims to have suffered an abdominal wall abscess and fistula allegedly caused by a broken Kugel patch ring. Eventually, doctors determined that the broken ring had become stained with bile and caused Thorpe to become septic. Thorpe required numerous surgeries to repair the damage and the lawsuit claims he continues to suffer physical pain.

According to earlier reports, there have been a handful of Kugel mesh settlements confidentially reached in individual cases. The outcome of the remaining bellwether Kugel trials could impact how the other cases are resolved, potentially resulting in an attempt to reach a global settlement of the litigation.

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  1. Robert Reply

    I am shocked. I have been living with this for 8 years. My doctor just last week pulled more mesh out of my side. After 12 plus surgurys what was it causing my problems?

  2. Allen Reply

    With politions and the FDA taking pay-offs and the lawyers for this case doing secret settlments before the trial, how can we believe these “Bellwether cases” can be trusted ? C.R.Bard has no shame in there game.

  3. Jeanette Reply

    My mom died as a result of this patch, all these companies are worried about is there bottom line they are supposed to help people my mother had faith this would help her I watch her suffer for weeks while infectous feeces leaked out of her body through one of her last surgery incisions we watched her die her 4 grandchildren watched her die the youngest being only 6 years old, my son was born 3 years after her death they stole her from him, they should pay, to me the death penality would be nice thats what they gave my mom.They know what they did read the recall on the fda website its in plain english, my moms 15 year old granddaughter has and she gets it, why cant they.

  4. Denise Reply

    As a (disabled) nurse practitioner who has been seriously harmed by medical mesh, I find it impossible to believe that the jury did not find that this mesh product caused this man’s injuries especially since they decided that “the companies were negligent in the design”. What? This doesn’t make sense! Mesh causes SERIOUS injuries and sometimes death, even without the “broken ring”. Our FDA (which is HIGHLY influenced by industry) has allowed medical mesh products to be on the market for use in the general public because of the 510(k) CLEARANCE (NOT approval) process. Mesh was “grandfathered” in when the 510(k) started so NO CLINICAL TRIALS are done on humans BEFORE it’s use in the general public. New meshes come on the market by saying they are “substantially similar” to mesh already cleared. This includes new ways of putting it in such as by using the ring or “mesh kits” used female pelvic surgery. MEDICAL MESH IS A BAD, BAD PRODUCT! NONE of us had INFORMED CONSENT because Big Pharm has lied to us and not been forthcoming in admitting all of the serious problems and complications from mesh. They are being found out as time goes on and more patients are being harmed every day. Disgusting!

  5. Gena Reply

    Does anyone have a good attorney for the Bard Composix E/X mesh?

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