Federal Kugel Mesh Hernia Patch Trial Set to StartMar 29, 2010 | Parker Waichman LLP
The first trial in the massive Kugel Mesh Hernia Patch multidistrict litigation is scheduled to start today. The first case set for trial is considered to be representative of the hundreds of cases pending in the multidistrict litigation. It is considered a bellwether, or test case, and could set a standard for other cases in the litigation.
The first trial will involve a lawsuit filed by John Whitfield of Missouri. Whitfield was implanted with the Kugel patch in 2004. His suit alleges that some of the rings broke under stress, and traveled through his body. As a result, Whitfield suffered a bowel obstruction, and had to have 22 cm of his intestine removed.
Whitfield’s lawsuit accuses Rhode Island-based Davol Inc. and its parent company, C.R. Bard, Inc. of negligence for failing to follow good manufacturing practices and failing to disclose the risk associated with the patches. It alleges that Davol continued to sell and distribute the Kugel patches after it knew or should have known they were failing.
When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems.
A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.
Just over 1,500 Kugel Mesh Hernia Patch lawsuits are currently pending in a multidistrict litigation in U.S. District Court in Rhode Island. Another 1,774 currently pending in Rhode Island Superior Court are scheduled to go to trial starting in July.