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Hernia patch suits head to court Monday -The Providence Journal 03/29/2010 - The first of more than 3,000 lawsuits accusing a Cranston company of manufacturing and marketing faulty hernia repair patches will head to trial Monday in U.S. District Court. The trial marks the first time lawsuits filed nationwide are being handled in federal court in Rhode Island under a program that has centralized such high-profile litigation as that involving asbestos, breast implants and the arthritis drug Vioxx. The Judicial Panel on Multidistrict Litigation, which coordinates related federal cases and chooses the judge to oversee pretrial proceedings, agreed to transfer to Rhode Island all suits brought against Cranston-based Davol Inc. over its Composix Kugel Mesh hernia patch. In all, 1,335 suits filed in federal courts elsewhere have been sent to Rhode Island. Another 182 cases were filed directly in the Ocean State, according to David DiMarzio, clerk of the court. All — and more come in weekly — will be handled by Chief U.S. Judge Mary M. Lisi. In addition, 1,774 cases involving the patches are being overseen by Presiding Justice Alice B. Gibney in state Superior Court. The first of those trials is slated for July. The case heading to trial before Judge Lisi involves a John Whitfield, a Missouri man who had a Kugel Mesh patch surgically implanted in Jan. 26, 2004. Whitfield is suing Davol and its parent company, C.R. Bard, Inc. The case targets patches manufactured by Davol from 2001 to 2006. Invented by Dr. Robert Kugel, the mesh patches are folded in half and inserted behind a hernia through a small incision, the suit says. The patches include a “memory recoil ring” that redeploys once inside the abdomen. The suit alleges that some of the rings broke under stress. As a result, the rings came loose and traveled inside the body, causing stomach pain, intestinal blockages, bowel perforations and even death. The FDA ordered a recall for a variety of Kugel Mesh patches, indicating the agency believes product is dangerous or defective, the suit says. In Whitfield’s case, his lawyer said, the faulty patch caused a bowel obstruction in which 22 cm of his intestine had to be removed. Whitfield is accusing the company of negligence for failing to follow good manufacturing practices and failing to disclose the risk associated with the patches. He alleges the company continues to sell and distribute the product after it knew or should have known they were failing. He is seeking unspecified damages for economic losses and pain and suffering. “It’s our position that the blockage never should have happened,” he said. Davol denied the allegations in court documents, arguing the patch was not defective, but that it had not been used as intended. The misuse of the product or failure to follow instructions by Whitfield, the company wrote, barred him from filing suit as does the fact that the patches were marketed with warnings, cautions and instructions. The company noted that it voluntarily recalled Composix Kugel Mesh patches in 2005, 2006, and 2007. The company denies it should have known that bodily injury was likely or that it operated with disregard for the safety of others. A lawyer for the company declined to comment on the case. “Both sides agreed it would be meaningful to try,” Whitfield’s attorney said, adding “It gives us a chance to see how judges rule on certain types of evidence.” Each case, however, he said, will be handled individually. “When we’re done with that, we’ll take the next one.” He asked the judicial panel three years ago to move the cases to Rhode Island. Lawyers for the companies h | ||
