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As attorneys that represent individuals who were injured by Smith and Nephew’s Birmingham Hip Resurfacing System, we wanted to report that a federal judge in Chicago has ruled that the Birmingham Hip Resurfacing System is not preempted by the medical device amendments to the Food, Drug and Cosmetic Act.  Judge John H. Lefkow of the United States District Court for the Northern District of Illinois followed a recent preemption ruling by another district judge in the case of Elmore v. Smith and Nephew, No. 1:12-cv-08347.  In so holding, Judge Lefkow concluded that Tillman’s allegations of quality control issues are not expressly preempted by the MDA.  “The same alleged violations were considered recently by the Court in Elmore v. Smith and Nephew, Inc.. .” the Judge noted.  “There, the Court rejected Smith and Nephew’s identical arguments that the claims are expressly preempted on two grounds:  (1) a medical device manufacturer’s required adherence to CGMP does not end once [pre-marked approval] is granted” and (2) the claims alleged are sufficiently parallel to the federal requirements.”

Judge Lefko agreed on the Elmore’s analysis and held that Mr. Tillman’s claims were based on alleged violations of CGMP and did not impose any additional or different requirements from federal ones and are thus not expressly preempted.  Nevertheless, the Judge did state that to the extent Mr. Tillman asserted a claim that the hip replacement system designed by the FDA was defective, that claim would be preempted.  However, any decision on that issue should await further discovery.  It should also be noted that Mr. Tillman will have to show that he was harmed by the alleged violations but at this stage, his claims survived an implied preemption analysis thus permitting the case to move forward.

If you have been injured by a Smith and Nephew Birmingham Hip Resurfacing System, please contact us as soon as possible so that our team of medical device lawyers can assist you.

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