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

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.