Texas judge rules preemption in hip implant suit against Stryker

April 21, 2010 by MassDevice staff

A federal judge in Texas tossed a lawsuit filed against Stryker Corp. and its Howmedica Osteonics subsidiary over an allegedly faulty hip implant, ruling that federal law preempts the suit at the state level.

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A federal judge in Texas tossed a lawsuit against Stryker Corp. (NYSE:SYK) and its Howmedica Osteonics subsidiary over an allegedly defective hip implant, ruling that federal law preempts the suit.

Egon Lewkut sued in the U.S. District Court for Southern Texas late last year, alleging that the Stryker Trident right hip prosthesis he was implanted with in November 2006 "contained impurities, residues and bacteria," according to court documents. Lewkut had revision surgery in January 2009 and alleged that the pain in his thigh, groin and hip was caused by the loosening of the implant's acetabular shell because of "residues that remained on the shell after manufacturing and
packaging," according to the documents.

In February, Judge Keith Ellison granted Stryker's motion to be dismissed from the case, leaving Howmedica as the sole defendant. In an April 16 ruling, Ellison decided to dismiss the case entirely, citing the U.S. Supreme Court's decision in Riegel vs. Medtronic. In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law, provided that the device was cleared via the more-rigorous pre-market approval process rather than via the 510(k) predicate device protocol.

Ellison's decision hinged on whether the acetabular shell component of the device — which Stryker recalled in January 2008 — was included in the PMA for the entire Trident device, or whether it was cleared via the 510(k) process. Citing decisions in cases involving both the Trident implant and other devices, Ellison wrote that "several courts have now explicitly or implicitly reached the conclusion that, when the Trident System was approved in 2003, all of its components were deemed to have undergone the PMA process."

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