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.
Id. at *6-7.  And so the magistrate recommended dismissal.
But this may not be over.  The plaintiff may file objections to the magistrate’s report (though we’re not sure how he could possibly win with such allegations).  Id. at *8.  Or he may file a proper motion to amend his complaint, something that he improperly tried to do in his response papers.  Id. *7-8.  If he does either of those things successfully, we may have future opinions in this case to follow.
One thing, though.  While the court determined that the plaintiff hadn’t properly stated a parallel violation claim, it also stated that, generally, “a plaintiff may maintain a suit based on violations of FDA regulations.” This isn’t exactly so.  Private plaintiffs CANNOT enforce FDA regulations.  The FDCA says that and so does lots of caselaw that we’ve discussed here. Rather, to survive, plaintiff’s parallel violation claims must be based on a true and existing state law, not one mused into existence for purposes of this particular litigation, that places requirements on the defendant that parallel FDA requirements.  If no such state law already exists or if the state law’s requirements don’t parallel the FDA’s, then the court will, once again, have to recommend dismissal of any amended complaint. Until then . . .