Is it still news when Medtronic wins a preemption motion for one of its PMA devices?  We think so, so we’ll tell our readers about Stengel v. Medtronic, Inc., No. CV 10-318-TUC-RCC, slip op. (N.D. Ariz. Nov. 9, 2010).
The product was a Class III pain pump that received initial PMA in 1988 and was modified through a couple of PMA supplements about a decade later.
It’s pretty clear that the plaintiff’s attorney did not know what s/he was getting into when bringing the suit.  The complaint simply alleged run-of-the-mill state-law torts for “strict liability, negligence, and breaches of express and implied warranties.”  Slip op. at 4.  None of them even purported to impose the “same” duty on the defendant, so all were preempted as a matter of course.  Id.  That’s like shooting fish in a barrel.
The Riegel decision is more than two years old at this point.  Somebody out there seriously needs some CLE.
So the plaintiff in Stengel proposes to amend the complaint – but “alleges the same four causes of action.”  Slip op. at 4.  Only now, the plaintiff throws in some boilerplate that “Defendant failed to warn/inform the FDA and medical physicians” about the relevant risk.  Id.  In short, the plaintiff tried to put forward some sort of parallel violation claim.
Didn’t work because plaintiff didn’t, or couldn’t (it hardly matters) show that the purported claims were anything more than statutorily prohibited attempts to raise private claims that the defendant violated the FDCA.  You can’t do that.  21 U.S.C. § 337(a) “makes clear that the United States is the only party that has standing to bring such a claim.”  Slip op. at 4 (in case you haven’t figured out, page 4 is the most important page of this opinion).  The plaintiff failed to explain how these new purported claims were in fact creatures of state, rather than federal, law.  Slip op. at 5 (“any state law claims not subject to express preemption must rest on conduct that is actionable even if the federal law did not exist”).  That’s the thing about “parallel” claims – there must in fact be two parallel legal tracks.  In Stengel there wasn’t.
Finally, the plaintiff tried to claim that the defendant’s submission of a public record – the FDA’s PMA – turned a motion to dismiss into a summary judgment motion under Rule 56(f), apparently in an attempt to get discovery.  Discovery of what, we’re not sure.  The court held: (1) submission of a public record subject to judicial notice did not convert the motion, and (2) “additional discovery is futile because Plaintiff’s claims are preempted and additional discovery will not remedy that.”  Slip op. at 5.
Congratulations to Mike Brown and Ginger Pigott of Reed Smith for winning Stengel and thanks to blog subscriber Lisa Baird for passing it along to us.