Smith & Nephew ($SNN) has had its own problems with metal hip replacements. But unlike Johnson & Johnson ($JNJ), the U.K. orthopedics giant has fared better lately in court. Harris Martin reported that a U.S. District Court judge threw out a patient's lawsuit alleging the company's metal hip replacement left her in pain, disabled and needing replacement surgery.
The issue at hand was an optional metal liner component for Smith & Nephew's R3 Acetabular system, which the company voluntarily recalled in June 2012 because of concerns over its performance and a high rate of revision surgeries. At that point, S&N said about 7,700 of the metal liners had been implanted in patients since 2007. The part was used in plaintiff Susan Simon's surgery and her lawsuit alleged that the part, combined with the hip replacement system, caused the resulting problems.
According to the story, Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York dismissed Simon's strict liability claim, in part because the liner had PMA approval and design defect claims over a PMA-approved device are preempted by the Medical Device Amendments of 1976. Surgeons used the optional liner with the R3 Acetabular System, which has 510(k) approval, but its approval did not include the liner in question.
The judge also said that Simon's attorneys did not properly argue that the product as designed was defective and injured her.
Simon had sued the company in the New York Supreme Court in February, but the case got shunted to federal court where S&N moved to dismiss the matter.
S&N's reconstructive implants have been hammered by regulatory problems and declining sales. The company has turned to job cuts and diversification in order to return to better health, focusing on wound care. The company snatched up wound-care giant Healthpoint for $782 million, a move that has helped improve revenue this year. Recently, the company also grabbed a 25% stake of its Brazilian wound-care distribution partner Politec Saúde, with an eye toward grabbing a greater stake in the Brazilian distribution of its growing wound-care product line.
- read the Harris Martin story (sub. req.)