Capretz & Associates Announces Lawsuit Filed Today in Federal Court against Encore, the Manufacturer of an Allegedly Faulty Knee Replacement Device, and the State College, PA, Surgeon Who Implanted It

Business Wire, Oct 23, 2006

Plaintiff Reportedly Heard Her Surgically Repaired Knee 'Clunking'

SCRANTON, Pa. -- Capretz & Associates announced that a West Virginia husband and wife filed a lawsuit today in U.S. District Court, Middle District of Pennsylvania, against a State College, PA, orthopedic surgeon and an Austin, TX, company that manufactured an allegedly defective knee replacement device the doctor implanted in both knees of the 63-year-old woman.

The lawsuit filed on behalf of Camilla and Michael Hendrix of White Sulphur Springs, WV, alleges that both the physician, Dr. Kenneth L. Cherry, MD, and the manufacturer, Encore Medical Corporation, knew the device called a polyethylene tibial insert was defective and had the potential of breaking, resulting in significant pain and immobility and requiring replacement surgery. Dr. Cherry is an owner of University Orthopedics & Sport Medicine of College Park, which is also named as a defendant. He implanted several of the Encore knee implants in his patients.

The complaint alleges that Encore violated Pennsylvania's unfair trade practices and consumer protection laws, and accuses Dr. Cherry of medical battery, stating that, "As the treating orthopedic physician for Plaintiff Camilla Hendrix, Defendant Kenneth L. Cherry was required to provide (her) with all material information necessary ... to determine whether to proceed with the implantation of the Encore orthopedic knee devices which Defendant Kenneth L. Cherry knew were dangerous and defective ..."

According to the complaint filed on behalf of the Hendrixes by the law firm of Capretz & Associates, Newport Beach, CA, which specializes in medical device cases, Dr. Cherry surgically replaced both of Mrs. Hendrix's knees with Encore polyethylene tibial inserts in May 1999. In 2003, the complaint states that Mrs. Hendrix began suffering from the "feeling of instability" in her right knee and that the Encore device was surgically replaced in November, during which it was discovered that the device's tibial post that anchors it to the recipient's bone, had broken. Her claim for the injury of the right knee was satisfactorily resolved between the parties although it appears she may need additional surgery to remove the scarring from the first operation.

But, according to the newly filed complaint, Mrs. Hendrix began having swelling and "excruciating pain" in her left knee earlier this year, and reportedly began to hear a "clunking" sound in the knee. Dr. Cherry determined that the post of the Encore polyethylene tibial insert in that knee also fractured, requiring replacement surgery and several months of rehabilitation for Mrs. Hendrix.

"As a direct and proximate result of the sudden and premature breakage of her left polyethylene tibial insert and the need to undergo a surgical procedure to revise the product's failure, Mrs. Hendrix has suffered and will continue to suffer physical pain, mental anguish, and loss of enjoyment of life. In addition, Mrs. Hendrix and her husband, Michael Hendrix, have suffered and will continue to suffer loss of consortium," the complaint states.

A bigger issue, according to Atty. James T. Capretz, who is representing the Hendrixes, is that both Encore and Dr. Cherry knew or should have known as early as 1995 that the polyethylene tibial insert was faulty when problems with it began surfacing with the Federal Food & Drug Administration. "Nevertheless, Encore continued to manufacture and market the insert, and orthopedic surgeons such as Dr. Cherry continued to implant it in patients, even though they should have stopped using the faulty device when the problems initially arose," Capretz said.

The complaint states that "At no time was Plaintiff, Camilla Hendrix, ever informed by either the Encore Defendants or the Medical Provider Defendants of the potential or actual problems with the defective Encore orthopedic prosthetic knee device or of any conflicts of interest."

The complaint further states that prior to May 1999 when Dr. Cherry implanted the Encore devices in Mrs. Hendrix, he "had performed multiple revision procedures to correct problems which developed with Encore prosthetic knee devices previously implanted on several patients for whom he and other physicians at University Orthopedics were the primary implanting physicians and upon whom defective Encore orthopedic knee devices were implanted ... Therefore he knew or should have known that the Encore orthopedic knee device was dangerous and defective ..."

"Because neither Encore nor the attending physicians tried to inform people who had the knee device of the inherent problems with the product, we believe it's possible that there could be many other Encore knee replacement patients in Pennsylvania and surrounding states that could have the faulty device in them and they don't even know it," Capretz said. "Their knee replacements are ticking time bombs."