The recalled Kugel Mesh Hernia Patch, which has injured hundreds of people, has spawned countless lawsuits against its manufacturer, Davol Inc. and Davol’s parent company, C. R. Bard. Inc. So many in fact, that the Judicial Panel on Multidistrict Litigation of the United States Courts consolidated all federal cases regarding the defective Kugel Mesh Hernia Patch and transferred them to the District of Rhode Island for all pretrial proceedings. In doing so, the Panel has created Master Docket Number 1:07-md-01842-ML-LDA.
The Kugel Mesh Hernia Patch was supposed to offer hernia patients relief from an extremely painful condition. But by 2005, it was evident that something had gone terribly wrong with the device. That year, the Food & Drug Administration (FDA) began receiving many reports of failure with the Kugel Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quit 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.
Further investigation into the defective Kugel Mesh Hernia Patch revealed that Davol, Inc. had known about injuries associated with the recoil ring long before the FDA learned of them. According to an article in the New York Times this past March, Davol had received its first Kugel patch complaints in 2002. All of the reports involved injuries, some of them serious, caused by the X-large size patch. According to Davol’s parent company, C. R. Bard, Inc., it was determined that the “few” number of reports did not warrant public notification. But by 2005, Davol received 10 reports about ring breakage over a three month period. At that time, Davol tried blaming doctors for implanting the device improperly. But by the end of 2005, Davol concluded that it had been wrong about its assessment of Kugel patch problems. In December of that year, tests run by the company showed that the source of the problem was not doctor error, but failure of the ring weld on the device itself.
Following the Kugel Mesh Hernia Patch recalls, the FDA issued Davol a warning letter. The FDA said that it found serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products. The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugel Patch’s problems.
An FDA warning letter is a serious issue, and is evidence that Davol mishandled the safety issues surrounding its defective Kugel Mesh Hernia Patch. More information on Davol’s handling of the Kugel Mesh Hernia Patch recall will doubtless come to light as lawsuits against the company make their way through the courts.
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