[Drug and Device Law] Far from Dumbo: Md. Fla. Gets "Parallel Claim" Case Right
This is the time of year when our thoughts start migrating southward. We can see all those birds’ nests in our suddenly denuded poplar trees. The driveway is a skating rink of damp leaves. The baseboards in our home now gurgle from the operation of an ancient oil heating system.
Over the last two weeks our posts leaned against a pair of intemperate blasts from a Vermont federal court. The results were dreary and/or indecipherable. Thus, it is with some relief that we bask in the warm glow of a nice, straightforward decision from the happiest place on Earth, the federal court in Orlando. In Stanifer v. Corin USA Ltd, Inc., 2014 U.S. Dist. LEXIS 158587 (M.D. Fla. Nov. 10, 2014), a hip resurfacing system was implanted into the body of the plaintiff during a right hip arthroplasty procedure. Subsequent failure of the system allegedly caused the plaintiff to suffer a revision left total hip arthroplasty and surgical removal of the system. The plaintiff filed a lawsuit in state court seeking to recover “damages and losses” from the defendants based on state law strict liability claims for breach of warranty, manufacturing defect, and design defect. After removal of the action to federal court, the defendants moved to dismiss the claims based on federal preemption.
The hip system was a class III device, and therefore subject to the PMA process and the attendant federal preemption. After the Supreme Court’s decision in Reigel, a plaintiff injured due to use of a Class III PMA device can escape preemption only by asserting a “parallel” state law claim. As readers of this blog likely know, we think of the parallel claim exception as something crazy and made-up, like a fairy tale or a Johnny Depp movie. Luckily, the Stanifer case is governed by the law of the Eleventh Circuit, a place that knows how to deal with such things. The Stanifer court embraced Eleventh Circuit precedent to the effect that plaintiffs cannot effectively state a “parallel claim” absent allegations that the defendant violated a “particular federal specification.” Ah – we are far from the windy incoherence of Vermont (or Chicago – the Bausch case still stands as the babbling zenith of parallel claim doofus-prudence).
But for a moment the plaintiff in Stanifer tried to take the court through the looking glass, ludicrously arguing that the fact that the hip system went through the PMA process could not be applied during the motion to dismiss stage, since that was beyond the pleadings. The court held fast to reality, invoking Fed. R. Evid. 201, which provides that a court may take judicial notice of an adjudicative fact “at any stage of the proceeding” if it “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” The public records of the FDA, including the FDA website, enjoy such accuracy, so the plaintiff was stuck. There was simply no question that all of the plaintiff’s claims would impose requirements that differ from the FDA PMA, and that preemption therefore applied.
At that point, perhaps momentarily seized by an attack of conscience, candor, or common-sense, the plaintiff had to admit that it had not alleged a “parallel” defect, so it was reduced to requesting leave to amend the complaint and also to obtain discovery to determine “the circumstances surrounding the exact nature of the manufacturing defect,” “the facts presented by” the defendants, and whether the defendants complied with PMA requirements. Such discovery, of course, offers all the horrors of the Haunted Mansion at Disney World. Or maybe even the Aerosmith Rock and Roller Coaster. Or the Twilight Zone Tower of Terror ride where you drop several stories in two sphincter-clenching seconds. Or, most scary of all, that torture cruise called It’s a Small World.
The court did the right thing by dismissing the complaint. It also did the predictable, annoying, soft-headed, inevitable thing by, in an “abundance of caution,” permitting the plaintiffs “one opportunity” to amend the complaint, if it could be done in accordance with the obligations under Rule 11 without discovery to determine “the circumstances surrounding the exact nature of the manufacturing defect.” The court also noted that the plaintiff had not managed to cite any Florida private cause of action for enforcing the FDCA, so there is more than one reason to believe that the Stanifer case is history. Unlike with Pirates of the Caribbean, we foresee no sequels.
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Posted By Steve McConnell to Drug and Device Law at 11/19/2014 07:30:00 AM --
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