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Kugel Mesh Hernia Patch Lawsuits Head to Court in Rhode Island

Oct 26, 2007 | Parker Waichman LLP

Kugel Mesh Hernia Patch lawsuits stemming from Davol, Inc’s 2005 recall of the defective medical device are shining a spotlight on the US District Court in Providence, Rhode Island that will decide many of the Kugel Patch cases.  Recently, 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 and possible settlement.   It is the first time that the US District Court in the small state has been given such a task by the Judicial Panel.

The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968.  Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters.   According to the Providence Journal, the judicial panel has consolidated and transferred more than 100 Kugel Mesh Hernia Patch lawsuits to the US District Court in Rhode Island, and that number is expected to climb as more than 100,000 people were implanted with the defective Kugel Mesh Hernia Patch. Davol Inc, the maker of the Kugel Mesh Hernia Patch, has its corporate headquarters in Cranston, Rhode Island.

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.  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 Food & Drug Administration (FDA) issued a Class I recall, its most serious type of recall, of the Bard Composix Kugel Mesh X-Large Patch.  Doctors where warned to stop using that version of the Kugel Mesh Hernia Patch, and  patients who received the patch were told 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.

Following the Kugel Mesh Hernia Patch recalls, the FDA issued Davol a warning letter that cited serious problems at Davol’s Cranston headquarters.   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.

Now, hundreds of people are suing Davol over their Kugel Mesh Hernia Patch injuries.  They claim that Davol took too long to issue the Kugel Mesh Hernia Patch recall, allowing the device to seriously injure far more people.   This past March, the New York Times published an article that backed up those claims.  According the New York Times, Davol had received its first Kugel patch complaints in 2002, but it was determined that the “few” number of reports did not warrant public notification.   But in 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 in December of that year, tests run by the company showed that the source of the Kugel Mesh Hernia Patch problems was not doctor error, but failure of the ring weld on the device itself.

Now, it will be up to the US District Court in Rhode Island to decide if Davol was negligent in informing patients and physicians of problems with the Kugel Mesh Hernia Patch. 

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