Pennsylvania Record

Tuesday, October 15, 2019

Pa.-based Endo Pharmaceuticals and Minnesota's American Medical Systems face product liability claim over pelvic mesh device

By Jon Campisi | Aug 7, 2012

An Ohio woman has filed a product liability complaint against Pennsylvania-based Endo

Pharmaceuticals and Minnesota-based American Medical Systems over claims that she became injured after having been implanted with a device manufactured and sold by the defendants that is used to treat pelvic issues.

Pensacola, Fla. attorney James D. Barger, of the firm Aylstock, Witkin, Kreis & Overholtz, filed the civil action Aug. 6 at the U.S. District Court in Philadelphia on behalf of Connie C. Pinkerton, who claims she sustained a variety of injuries as a result of having had the Elevate Prolapse Repair System implanted in her body during a surgery performed at Akron City Hospital in Akron, Ohio during an unspecified date.

The product had been implanted in the plaintiff to treat her pelvic organ prolapse and/or stress urinary incontinence, the suit states.

As a result of having had the product surgically placed in her body, Pinkerton has experienced physical and mental pain and suffering, she has sustained permanent injury and physical deformity, she has undergone and will have to undergo corrective surgery or surgeries, and she has suffered financial and economic loss, the complaint alleges.

The lawsuit claims that emerging scientific evidence suggests that the material used in the defendants’ pelvic mesh products is biologically incompatible with human tissue and promotes an immune response in a large number of patients who undergo surgery involving the implantation of the product.

The immune response, the lawsuit claims, promotes “degradation of the pelvic tissue and can contribute to the formation of severe adverse reactions to the mesh.”

The mesh can migrate with the surrounding tissues causing what the complaint calls “irreparable damage” to the tissue as well as nerve endings, the latter of which will not regenerate and can lead to debilitating neuromas suffered by patients such as the plaintiff in this case.

The complaint accuses the defendants of underreporting and withholding information about the dangers of their pelvic mesh product, as well as intentionally misleading the Food and Drug Administration, the medical community, patients and the public at large about the problems associated with the product.

The defendants are accused in the lawsuit of failing to perform or rely on proper and adequate testing and research in order to determine and evaluate the risks and benefits of the medical devices that are subject of the litigation.

In this particular case, the suit claims that the plaintiff was “induced to, and did, use the Medical Device thereby sustaining severe and permanent personal injuries and damages.”

“Defendants intentionally failed to inform the public, including Plaintiff, of the high failure rate, including erosion, the difficulty of removing the Medical Device, and the risk of permanent injury,” the lawsuit states. “Defendants chose to over-promote the safety, efficacy and benefits of the Medical Device instead.”

The suit claims that had Pinkerton known the true facts about the dangers of the product, she would have never undergone the surgery to have the device implanted in her body in the first place.

The lawsuit contains counts of negligence, strict liability-manufacturing defect, strict liability-failure to warn, and breach of express and implied warranties.

Pinkerton seeks compensatory and punitive damages in excess of $75,000, costs, attorney’s fees, interest and other court relief.

A jury trial has been demanded.


The federal case number is 2:12-cv-04415-PD. 

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