Composix Kugel Hernia Patch Lawsuit Ends In Summary Judgment For Manufacturer

A federal judge has granted summary judgment in favor of the makers of the Composix Kugel hernia patch in a product liability lawsuit, after excluding the plaintiffs causation expert testimony. 

The case was filed by Norma Olmo and her husband, Nelson, in October 2013, alleging that C.R. Bard, Inc. and Davol, Inc. manufactured and sold a defective hernia repair patch, which folded up inside of her body and eroded into her bowels.

Olma had an extra-large Bard Composix Kugel patch implanted in August 2005, which featured two memory recoil rings designed to provide stability for the device. However, several years after the hernia patch was implanted, Olma began experiencing severe abdominal pain and underwent hernia repair surgery.

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At that time, it was discovered that the Composix Kugel patch had lost fixation and folded under, causing the mesh to eroded into the bowel. While the surgeon did not observe any buckling of the explanted hernia patch, or determine whether a ring break had occurred, the hospital discarded the product and no photographs were taken for expert examination.

In an order (PDF) issued on April 10, U.S. District Judge James Cohn granted the manufacturers’ motion for summary judgment after excluding the expert that would testify on behalf of the plaintiff, to provide evidence that Olma’s injuries were caused by the design of the mesh and lack of adequate warnings about the Composix Kugel hernia patch risks.

The court determined that since plaintiff’s experts never examined the explanted patch or performed any testing on it, reliable testimony could not be provided about the amount of deformation necessary to cause Olmo’s injuries.

This week, Olma filed a notice of appeal (PDF), challenging the district courts final judgment to the U.S. Court of Appeals for the Eleventh Circuit.

In recent years, Bard and Davol have faced thousands of hernia patch lawsuits over problems with Composix Kugel products, most involving allegations that the memory recoil ring around the perimeter of the mesh broke, resulting in serious internal injuries.

In 2011, C.R. Bard agreed to Kugel mesh settlements that resulted about 2,600 cases, paying about $70,000 to each plaintiff. However, the agreement left about 1,000 claims unsettled, and also did not address claims like Olmo’s, which was filed in later years.


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