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Court Expands Kugel Mesh Hernia Patch Litigation

Jan 28, 2008 | Parker Waichman Alonso LLP

The maker of the defective Kugel Mesh Hernia Patch will now have to face even more lawsuits over faulty hernia patches.  Earlier this month, a Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc’s defective mesh patches, even those that were not involved in the original Kugel Mesh Hernia Patch recall.

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.

In April 2007, the FDA issued a warning to Davol after an inspection of its Rhode Island headquarters uncovered serious problems with the quality assurance programs used in the manufacture of the Kugel Mesh Patch. Among the problems cited during the inspection where those found in the system Davol used to track complaints. The FDA said that the system was so inadequate that Davol was unable to conduct timely complaint investigations. The FDA said that the lack of these procedures was to blame for Davol’s delays in dealing with the Kugel Mesh Patch problems.

The defective Kugel Mesh Hernia Patch spawned so many lawsuits against Davol and Bard, that last fall, 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.

Now it appears that the quality problems the FDA found at Davol did not impact only Kugel Mesh patch memory recall.   The FDA has received reports about problems connected with other Davol patches since at least 2000, and many lawyers involved in Kugel Patch litigation have heard complaints from people injured by some of Davol’s other hernia devices.  For that reason, the Federal Court in Rhode Island has agreed to expand the Kugel Mesh proceedings to include any lawsuits that involve an injury caused by Davol patches not included in the Kugel recall, or that do not involve problems with the memory recoil ring.