The Device Is Subject Of FDA Recall
Many patients who received a Kugel Hernia Patch during a surgical repair have suffered serious abdominal injuries caused by a defect in the device. These side effects, including bowel obstructions, bowel perforations, and chronic enteric fistulae have caused major health problems for many, and in some cases, death.
The Kugel Hernia Patch was introduced in smaller sizes in 2001 by manufacturer Davol, Inc. (a subsidiary of C.R. Bard, Inc.). However, when the company brought to market the Kugel large sized and extra-large sized patches, significant problems were reported by patients and physicians. Numerous patients were experiencing major intestinal injuries as result of breakages in the memory recoil ring around the mesh patch.
These devices were designed to be folded for insertion at the hernia site, but to spring back to an open, flat position once behind the opening in the abdominal wall. The folding and re-opening of the product is dependent upon the flexible memory recoil ring around the perimeter of the mesh.
Davol, Inc. first insisted that the concerns about the product were invalid, blaming the broken rings and subsequent injuries on surgeons who used the device. But their own testing later revealed that the breakages were almost always occurring at the point where the ring was welded together. This, along with an FDA investigation, led to three product recalls, the first of which (December 2005) only included the large and extra-large sized oval patches.
After FDA officials inspected the facilities where the mesh patches were manufactured, they noted that Davol didn’t have an adequate system for tracking reported problems with the product. The agency also criticized the company for allegedly downplaying the extent of the problems with the Kugel Hernia Patch. As a result, the hernia mesh recall was expanded to include other models of the device in March 2006 and January 2007.
Many of the patients who are injured by a broken Kugel Hernia Patch incur major medical expenses, require additional surgeries, and experience severe pain and suffering. Some of these individuals have begun the process of seeking compensation from the product’s manufacturer. Their attorneys have argued that the company was negligent in that they were slow to recall the Kugel Hernia Patches when problems became apparent, and that their minimization of the scope of the problem contributed to numerous injuries and in some cases, deaths.
More than 2,000 such cases have been filed to date, and have been consolidated in the U.S. District Court in the District of Rhode Island. This is a process whereby cases which hinge on the same questions of law and fact can be placed under one judge in one district during the pretrial phase. However, each case remains an individual lawsuit, and if not resolved during through pretrial litigation, is remanded back to the court where it was originally filed for trial.
Plaintiff’s attorneys often specialize in a particular type of litigation, and given the broad impact of the Kugel Hernia Patch defects, some are focused in this area. A mesh patch lawyer can answer your questions about how defective product lawsuits work, and evaluated your case to determine whether you might benefit from such an action.
Legal Tube is the perfect tool to help consumers identify the legal professional who best meets their needs.
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