A federal judge in Tennessee ruled that preemption does not apply in the case of a product liability lawsuit over an allegedly defective Stryker Corp. (NYSE:SYK) hip implant.
Marty Phillips sued Stryker in November 2009, more than three years after receiving a Trident hip implant, according to court documents. In July 2008, Phillips began experiencing increased pain in the hip, "including popping sensations," according to the documents. In September 2009 X-rays revealed that the device had failed due to the loosening of the implant’s acetabular shell; Phillips’ doctor recommended that he undergo revision surgery to correct the failure.
The lawsuit alleged that Stryker "failed to comply with [Food & Drug Administration] regulations in manufacturing the Trident System," according to the documents. The claim hinges on an interpretation of a 2008 U.S. Supreme Court 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.
But preemption does not apply if the plaintiff can prove that the claims under state law parallel FDA requirements. Judge Thomas Varlan of the U.S. District Court for Eastern Tennessee decided June 3 that Phillips’ claim satisfies that requirement, ruling that preemption does not apply because Stryker failed to comply with federal regulations in manufacturing the implant. The company issued a recall of the device in 2008, following FDA criticism of manufacturing procedures at the Cork, Ireland, plant where the implants were made.
"Plaintiff advances several theories of state
common law liability to link those compliance failures to the ultimate failure of the device
implanted in his hip. These state law claims, which “parallel” federal requirements, thus
survive preemption," Varlan wrote. "They also contain sufficient
factual matter, accepted as true, to state a plausible claim for relief."
The decision comes on the heels of a series of wins for Stryker in other liability lawsuits over allegedly defective Trident implants. A federal judge in Texas tossed a similar case in May, finding that preemption did apply; later that month a federal judge in Alabama dismissed another Trident lawsuit after the plaintiff failed to muster enough expert testimony to bolster her case.