Plaintiff Testifies in Kugel Mesh Hernia Patch Trial

A federal jury in Rhode Island heard testimony from the plaintiff in the first <"">Kugel Mesh Hernia Patch lawsuit to come to come to trial since the devices were recalled in 2005. The lawsuit is one of more than 1,000 pending in a multidistrict litigation currently underway before Chief U.S. District Judge Mary M. Lisi.

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.

The first trial the multidistrict litigation involves a lawsuit filed by John Whitfield of Missouri. Whitfield was implanted with the Kugel patch in 2004. 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.

A few weeks after receiving his Kugel patch, Whitfield returned to his doctor, complaining that his abdomen was bulging. But his doctor told him that his experience was normal. Then, three years later, 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.

Weeks later, Whitfield learned that the patch had been recalled. “It made me angry that this was put out there,” he told the court, adding “I went through it all for something that shouldn’t have been on the market.”

The Whitfield lawsuit 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.

In addition to the Kugel Mesh lawsuits filed in the multidistrict litigation, another 1,774 currently pending in Rhode Island Superior Court are scheduled to go to trial starting in July.

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