The U.S. Supreme court refused to hear an appeal by Stryker Corp. (NYSE:SYK) in a product liability lawsuit filed over its recalled Trident hip implant.
The Kalamazoo, Mich.-based orthopedics giant wanted the Supremes to hear its appeal of a lower court’s ruling that Margaret Bausch’s state lawsuit was not preempted by federal rules. The U.S. Appeals Court for the 7th Circuit ruled in December 2010 that Bausch could press her suit, despite a 2008 Supreme Court decision establishing preemption, because her state suit presents a "parallel claim" that Stryker violated FDA rules.
Bausch was implanted with the Trident device in March 2007, six days after the federal watchdog agency warned Stryker about problems at the Cork, Ireland, plant where here implant was made. Stryker subsequently recalled hip and knee implants made at the plant.
The preemption doctrine, enshrined into law in the Supremes’ 2008 decision in Riegel v. Medtronic, holds that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval. But the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.
The 7th Circuit judges found that the Supreme Court "made clear" in Riegel that FDA rules protect medical device manufacturers from liability "to the extent that it has complied with federal law, but it does not extend protection from liability where the claim is based on a violation of federal law. In other words, where state law is parallel to federal
law, [the FDA rule] does not preempt the claim," according to court documents.
"Nothing in the more recent Riegel case calls into question the ability of a patient to sue a Class III device manufacturer under state law for violations of federal law. In fact, the Riegel court went out of its way to explain that such claims are not preempted," according to the documents. "Just as a plaintiff in an auto accident may use the other driver’s speeding violation as evidence of negligence, plaintiff Bausch claims that she was injured by Stryker’s violations of federal law in manufacturing the device implanted in her hip. It remains to be seen whether she can prove those allegations, including causation and damages. But if she can prove those allegations of harm caused by violations of federal law, her claims under state law would not impose on defendants any requirement ‘different from, or in addition to, any requirement’ imposed
by federal law. Her claims are not preempted."
Stryker’s petition for a certiori from the high court was denied yesterday.