Jon Campisi Jun. 6, 2013, 1:02pm


An Indiana woman has filed suit in a Pennsylvania state court over injuries she allegedly sustained as a result of having had an apparently defective pelvic mesh implant device surgically placed in her body.

Attorneys Thomas R. Kline, Lee B. Balefsky and Michelle L. Tiger, of the Philadelphia law firm Kline & Specter P.C., filed a civil action May 31 at the Philadelphia Court of Common Pleas on behalf of Washington, IN resident Patricia L. Hammons, who claims the medical device she had placed inside of her body back in the spring of 2009 to treat her stress pelvic floor prolapse actually ended up harming, not helping, her.

The lawsuit claims that Hammons sustained injuries such as mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain, and recurrent urinary incontinence.

The defendants named in the complaint are Johnson & Johnson; Ethicon Inc., which does business as Ethicon Women’s Health and Urology; Gynecare; and Secant Medical Inc.

Secant is based in Bucks County, Pa. while the other defendants are all based out of neighboring New Jersey.

In the complaint, the defendants are accused of continuing to manufacture, sell, market, label, and distribute the Prolift pelvic mesh implant, which is designed to treat female medical conditions such as pelvic organ prolapse and stress urinary incontinence, despite warnings that the medical device had been the subject of problems among the medical community and the consuming public.

Contrary to the defendants’ representations through marketing campaigns, the pelvic mesh product in reality can experience a high failure rate, cause injury and complications in patients who have had the device implanted in their bodies, and have on occasion caused “severe and irreversible injuries,” including significant and permanent damage, the complaint reads.

“The J&J Defendants in particular have consistently underreported and withheld information about the propensity of the [sic] their Pelvic Mesh Products and/or their Mesh Components to fail and to cause injury and complications, and have misrepresented the efficacy and safety of their Pelvic Mesh Products and/or their Mesh Components, through various means and media, actively and intentionally misleading the [U.S. Food and Drug Administration], the medical community, patients and the public at large,” the lawsuit states.

The defendants, the suit says, have individually or jointly failed to perform or rely upon proper and adequate testing and research in order to determine and evaluate the risks and benefits of the pelvic mesh products and their components.

Like other pelvic mesh implant product liability lawsuits, the Hammons complaint alleges that the mesh products “create risks to the health and safety of the patients that are far more significant and devastating than the risks posed by other products and procedures available to treat the corresponding medical conditions,” and which outweigh the utility of the defendants’ product.

The companies are accused of intentionally and recklessly designing, manufacturing, marketing, selling, and/or distributing the medical device with “wanton and willful disregard for the rights and health of the Plaintiffs and others, and with malice, placing their economic interests above the health and safety” of the public.

The lawsuit contains counts of strict liability, negligence, negligent misrepresentation, common law fraud, negligent infliction of emotional distress, breach of implied and express warranties, gross negligence, and violations of consumer protection laws.

The plaintiff sustained economic losses and other damages are a result of her injuries, the suit states.

Hammons seeks damages in excess of $50,000 and other court relief.

A jury trial has been demanded.

 

The case ID number is 130503913.

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