Here’s a preemption case that we’ll likely have an opportunity continue to follow. A magistrate in North Carolina federal court recently issued a report recommending dismissal, on the basis of preemption, of product liability claims concerning the product Gelfoam. Bradley v. Baxter Healthcare Corp., 2013 U.S. Dist. LEXIS 158935 (W.D.N.C. Oct. 18, 2013). Gelfoam is a medical device that can be used to control bleeding during surgery. It’s a class III device. You know what that means. Any claim that imposes requirements “different from or in addition to” requirements imposed by the FDCA or the FDA is preempted.
Now, it’s possible that the plaintiff could have stated a “parallel violation” claim. But not by simply pleading, as he did, that the defendant didn’t follow GMPs. Federal court pleadings need facts:
The conclusory allegations in the Complaint that Defendant failed to comply with 21 U.S.C. § 351 and the FDA’s Good Manufacturing Practice Requirements are insufficient to state a claim in federal court. See Twombly, 550 U.S. at 555, 127 S. Ct. at 1965.