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.”
"Indeed, courts have also found, in the context of other medical devices, that attempting to separate the component parts of a medical device for purposes of preemption is not appropriate,” Ellison wrote. “Similarly, this Court cannot see the logic in holding that the ceramic components of the Trident System were PMA-approved for use with the acetabular shell, but that that acetabular shell itself was not PMA approved. … To require that a distinction be drawn between the approval process of the individual components of a system and the system itself, would, it seems, add a level of complication to the medical device approval process not anticipated by Congress, the FDA, or medical device manufacturers.”
Ellison’s decision to dismiss the case with prejudice seems to have been a difficult one.
"The Court recognizes and deeply regrets all that Plaintiff has suffered in this case. Were it not faced with such uniform and consistent legal precedent, this Court would have reasoned that these claims should be allowed to proceed in order to allow Plaintiff a meaningful opportunity to obtain redress for the pain he has endured,” Ellison wrote.