Pa. pharmaceutical company sued over surgical implant defect

A Florida couple is suing a Pennsylvania pharmaceutical company for injuries the wife claims she sustained after she was surgically implanted with the company's device.

Philadelphia attorneys Thomas R. Kline, Lee B. Balefsky and Michelle L. Tiger, of the firm Kline & Specter PC, filed the product liability claim Sept. 23 at the Philadelphia Court of Common Pleas on behalf of Maggie and James McEwan of Live Oak, Fla.

The defendant named in the lawsuit is Endo Pharmaceuticals of Chadds Ford, Pa.

According to the complaint, Maggie McEwan had a synthetic mesh implanted in her pelvic region, which led to the development of a host of physical injuries as a result of alleged mesh erosion and hardening. The problems led to her developing problems urinating and necessitated more “dangerous and serious surgery,” the lawsuit claims.

Maggie McEwan claims through her suit that she has suffered physical pain and mental anguish, which has led to a diminished capacity for the enjoyment of life, a diminished quality of life, chronic debilitating pain and other damages.

The product liability lawsuit claims that Endo’s predecessor, American Medical Systems, had developed a technology to diagnose and treat conditions related to the pelvic health of men and women, but that the technology, a synthetic mesh, led to complications in those in which it was implanted.

The lawsuit states that between 2002 and the present, numerous reports have surfaced regarding the adverse effects of the product. Complaints have been filed by both physicians and patients. The most frequent complaints, the lawsuit states, have dealt with erosion, extrusion, infection, hardening of the mesh, chronic pain and worsening symptoms.

“Within months after the initial implant procedure, Plaintiff experienced complications from the defective mesh requiring additional medical care and treatment and/or surgical intervention,” the lawsuit states.

The lawsuit contains counts of strict product liability for both failure to warn, design defect and defective manufacture; negligence; 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 Law.

Maggie McEwan demands judgment against the defendant for general damages; medical, hospital and incidental expenses; loss of earnings; punitive and exemplary damages and other court relief.

James McEwan has a loss of consortium count in the lawsuit in which he seeks judgment against the defendant for general, special and punitive damages, in addition to court costs.

The plaintiffs are seeking a jury trial.

The case number is 110902656.