Defense Claims Victory in First Kugel Mesh Hernia Patch Trial

The first federal <"">Kugel Mesh Hernia Patch trial has ended in a verdict for the defendants, Davol, Inc. and C.R. Bard, Inc. 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.

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.

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 after receiving his patch, Whitfield was admitted to the emergency with nausea and vomiting. That’s when a CT scan discovered that Whitfield’s Kugel patch had folded over and became affixed to the bowel, causing an obstruction. To save his life, Whitfield had to have 22 cm of his intestine removed.

His lawsuit had accused Davol and Bard of negligence for failing to follow good manufacturing practices and failing to disclose the risk associated with the patches. It further alleged that Davol continued to sell and distribute the Kugel patches after it knew or should have known they were failing.

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.

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.

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