Federal lawsuit filed over synthetic pelvic mesh implant

Jon Campisi Dec. 16, 2011, 12:12pm

A Texas couple who alleges that the wife sustained injuries after having had a synthetic pelvic mesh product implanted into her body has filed a federal product liability complaint against two companies involved in the design and manufacture of the allegedly defective product.

Lancaster, Pa. attorney Dianne M. Nast and Kansas City, MO lawyers Thomas P. Cartmell jointly filed the civil action Dec. 14 at federal court in Philadelphia on behalf of Carolyn and John McHaney of Arlington, TX.

The defendants named in the lawsuit are Pennsylvania-based Endo Pharmaceuticals and Delaware-based American Medical Systems, Inc.

According to the complaint, Carolyn McHaney suffered physical injuries after being implanted with transvaginal synthetic mesh for pelvic organ prolapsed and/or stress urinary incontinence.

The product, which was sold under the name AMS Miniarc Sling, was designed and manufactured by the defendants, who have since merged and specialize in the production of urogynecological medical devices.

The defendants’ technology is designed to treat the pelvic health of both men and women, the suit claims.

Without getting into specifics, the suit states that Carolyn McHaney has a condition that required surgical intervention for repair, and she therefore underwent a pelvic mesh implant.

The procedure led to McHaney developing “complications” from the defective mesh, something that required additional medical care and treatment and/or surgical intervention, the suit claims.

The complaint alleges that during the past decade, physicians and patients have issued numerous reports regarding the “adverse events” related to the synthetic mesh system.

The most frequent complaints, the suit states, were erosion, extrusion, infection, hardening of the mesh, chronic pain and other problems.

“Published studies have shown a high rate of mesh erosion accompanied by worsening symptoms,” the lawsuit states.

The suit goes on to claim that Endo and its predecessor, AMS, “knew that the subject synthetic mesh system was not safe for the patients for whom it was prescribed and implanted because the mesh eroded and otherwise malfunctioned, and therefore failed to operate in a safe and continuous manner, causing injuries from erosion, extrusion, infection, sepsis, chronic foreign body invasion, dense adhesions and worsening symptoms.”

The suit claims that the product can even lead to life-threatening complications such as hemorrhage and even permanent disfigurement.

“As of the filing of this complaint, Mrs. McHaney is more likely than not to have continuing procedures relating to injuries suffered from the defective device,” the lawsuit states.

The lawsuit contains counts of strict product liability-failure to warn, strict liability-defective design, strict liability-defective manufacture, negligence, negligence per se, breach of implied warranty, breach of express warranty, fraud, fraud by concealment, negligent misrepresentation, and violations of Pennsylvania’s Unfair Trade Practices and Consumer Protection Laws.

The suit also contains a loss of consortium count on the part of McHaney’s husband.

The couple seeks general damages, punitive damages, medical and hospitalization costs, compensation for loss of earnings and earning capacity, exemplary damages and other court relief.

A jury trial has been demanded.

The federal case number is 2:11-cv-07637-AB.

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