Reached an agreement to settle most of the personal injury lawsuits involving the defective device. Nearly six years after the first Composix Kugel Mesh Hernia Patch recall was announced by the U.S. Food & Drug Administration (FDA), C.R. Bard says it has reached an agreement to settle most of the personal injury lawsuits involving the defective device.
According to its most recent quarterly filing with the Securities and Exchange Commission (SEC), the company will take a $184 million charge to cover the cost of the Kugel Mesh Hernia Patch settlements.
C.R. Bard and its Davol Inc. subsidiary face over 3,500 lawsuits involving the Kugel Mesh Hernia Patch. More than 1,300 are pending in a multidistrict litigation in the U.S. District Court for the District of Rhode Island, where two cases have already been tried.
Though the jury in the first trial found the Kugel Mesh Hernia Patch had been negligently designed, it determined that the plaintiff had not proven that the design of the device had caused or contributed to his injuries. The second trial ended with a $1.5 million verdict for the plaintiffs.
C.R. Bard faces another 1,700 lawsuits n Rhode Island Superior Court
In addition to the federal multidistrict litigation, C.R. Bard faces another 1,700 lawsuits n Rhode Island Superior Court.
The settlement agreement announced in C.R. Bard’s quarterly filing does not cover any potential class action lawsuits. The company could face at least two in the U.S. and four in Canada, though none have been certified.
The first Kugel Mesh Hernia Patch recall was issued in December 2005, after the FDA received reports of the device’s recoil ring breaking, which in some cases caused bowel perforations and other serious problems. Additional Class I recalls were issued in 2006 and 2007.