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Defense Wins First Kugel Mesh Hernia Patch Trial

Apr 16, 2010 | Parker Waichman LLP

Davol, Inc. and C.R. Bard, Inc. have scored a victory in the first Kugel Mesh Hernia Patch to go to trial in the multidistrict litigation currently underway in U.S. District Court in Rhode Island.

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 – the agency’s most urgent recall – of the Kugel Mesh X-Large Patch. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

The first lawsuit in the multidistrict litigation was brought by John Whitfield of Missouri. who was implanted with the Kugel patch in 2004. Three years later, the patch failed, and Whitfield had to have 22 cm of his intestine removed in order to save his life.

The Rhode Island jury found the defendants negligent in the design of the Kugel patch, but ruled that the plaintiff did not prove that the negligent design directly caused or contributed to the damages he suffered.

Whitfield’s lawsuit was one of four “bellwether”, or test cases, slated for trial in the multidistrict litigation. The second bellwether case will go to trial in June.

Around 1,300 other lawsuits involving the Kugel Mesh Hernia Patch are pending in the multidistrict litigation currently underway 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.

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