The Philadelphia Personal Injury Law Blog

Pelvic Mesh Manufacturer Endo Pharma Faces Products Liability

There are products that we hear about recalls and think, "so what?" or "who cares?" because the recall seems to be for a product that people should know could be used in a dangerous manner. Then there are those products, like some cars, that we learn are practically death traps that we would have no idea about unless there was a recall.

This products liability claim might lead to the recall of a product that is little known and the dangers of are just being discovered. We're talking about the pelvic mesh, also known as transvaginal or vaginal mesh, that is used to help treat pelvic organ prolapse. The suit is being brought by Connie Pinkerton of Ohio against Endo Pharmaceuticals, a Pennsylvania based pharmaceutical company, and Minnesota-based American Medical Systems, according to The Pennsylvania Record.

A products liability claim is based on a defective product. A product can be defective in its manufacture, design, or warnings. Medical device products liability is based on the same fundamentals as any other products liability case, but has the added complexity of needing medical experts and dealing with the hurdle of FDA approval.

Here, the claim is that the design was defective because it caused a person’s immune system to attack it, causing pain and physical deformity, requiring new surgery to fix. Further, there is a claim that the companies tricked the FDA into approving the device.

The biggest question will probably be whether there were adequate warnings of the possible harm before the device’s use. If the warnings were adequate and Pinkerton consented to the risks, then she might not have a claim. However, if she can prove that the pelvic mesh is dangerous for any use, she will likely succeed in her claim against Endo Pharmaceuticals.

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