Law

Thus, it’s not surprising that plaintiffs’ lawyers fight preemption tooth and nail.  That’s their job.  They are just as ethically bound to represent their clients zealously within the boundaries of the law as we are.  Thus they pick every preemption nit they can find.

That’s what we’re on about today.  We’re discussing some recent decisions that address some lesser-known – but equally deadly − preemption arguments. 

The first of these cases is Mink v. Smith & Nephew, Inc., ___ F. Supp.3d ___, 2015 WL 7356285 (S.D. Fla. Nov. 19, 2015), and as to Mink we’d like to give a shout out to Dave Walz of Carlton Fields, who sent us the decision, and the rest of the successful defense team, Ed Gerecke (also CFJB) and Doug Moore and Dave O’Quinn at Irwin Fritche.  Mink involved PMA medical device preemption under the rubric of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Our PMA preemption scorecard now lists over 300 decisions, but Mink is the first one in which the plaintiff was a participant in an FDA-mandated post-approval clinical trial.

The Mink plaintiff’s status as a both a clinical trial participant and a user of a PMA device predictably produced unusual attempts to avoid preemption.  Here’s the first:  plaintiff “allege[d] that [manufacturer] breached an express or implied warranty by [] failing to honor the bargain that [plaintiff] would continue as a [post-approval] Study participant.”  2015 WL 7356285, at *2.  Here’s the second:  plaintiff brought “claims for breach of contract . . . and negligent misrepresentation,” both of which alleged that the manufacturer “failed to comply with the terms of the Consent to Participate Form by terminating him as a Study participant and declining to transfer [plaintiff] to another approved doctor to continue the Study.”  Id.

Nice try; no cigar.  As to the first claim, the court mentioned that, among the numerous preemptive FDA requirements applicable to PMA devices were that “a PMA applicant [must] produce comprehensive data from which the FDA can make a reasonable determination of the device’s safety and effectiveness, including the human clinical trials,” and that, as to such trials, “Class III devices are also subject to post-approval reporting requirements, including informing the FDA of new studies.”  2015 WL 7356285, at *4.  The presence of these FDA requirements was enough to bring the post-approval trial within the scope of the statute’s “different from or in addition to” express preemption clause, which was all she wrote:

The contract and misrepresentation claims based on the defendant’s alleged promise of free follow-up care to the plaintiff as a study participant fared no better.  The consent form allegedly constituting the contract was presented by the implanting physician.

In case anyone’s interested, Mink also addressed more widely seen, non-study-related claims, which were also preempted.  Id. at *8.

The second unusual preemption case was Allen v. Zimmer Holdings, Inc., 2015 WL 6637232 (D. Nev. Oct. 30, 2015), also involving PMA medical devices.  The outstanding feature of Allen was the regulatory pedigree of “one of the products at issue here, [which] was developed prior to the MDA and went through the FDA’s New Drug Application (“NDA”) process.”  Id. at *2.  The Medical Device Amendments were enacted in 1976.  After “the MDA came into effect, devices [that] had been treated as drugs prior to the amendments . . ., were automatically reclassified as Class III medical devices.  The MDA provided that these devices were deemed to have PMA approval if they had gone through the NDA approval process.”  Id. (citing 21 U.S.C. §§360j(l)(1), 360j(l)(3)(A).

Allen thus involved a device that had been used for decades.  Given its prolonged, successful use, it is not surprising that, after a while, “the FDA re-classified [it] as a Class II medical device.”  Id.

Thus, the preemption analysis in Allen involved two unusual aspects:  first, that the device was what’s called a “transitional device,” that is, dating from before 1976; and second, that the device had been downclassified from Class III to Class II.

The first issue, the device’s status as a pre-1976 transitional device, required little additional explication beyond what the Medical Device Amendments provided – that they are treated as PMA.  “Because the products at issue are deemed to have PMA approval, requirements are imposed under the MDA, and the first prong of the Riegel test is met.”  Id. at *4.  From there on out, standard preemption analysis applied – vague allegations and failure to flesh out any “parallel” claim doomed the plaintiff’s allegations.  Id.  Although Allen didn’t cite any cases for that result, it’s squarely in the mainstream, as a prior post of ours collecting transitional device preemption caselaw points out.

The court also took care of the second issue, downclassification:

Finally, the court pointed out that, in the context of this plaintiff’s surgery, the device at issue was effectively the component of the larger device system that had been implanted.  Component part status also didn’t undercut preemption:

As with Mink, Allen also contains more mundane preemption analysis – pleading and a discussion of express warranties – for those interested in yet another citation on those points.

Finally, because not everything is skittles and beer, here’s a new and unfortunate twist on the generic drug preemption concept of “duty to update.”  PLIVA, Inc. v. Dement, ___ S.E.2d ___, 2015 WL 7431346 (Ga. App. Nov. 20, 2015).

We’ve said before that duty to update claims, even putting aside preemption, are lousy claims on the merits.  Medical causation is hard to prove because the period without updating is often only a fraction of total use of the drug.  Warning causation is hard to prove because prescribing physicians often don’t read generic warnings, updated or not.  The plaintiff in Dement managed to slip through preemption a duty-to-update claim tied to a “misbranding” allegation:

However, the court in Dement provided neither a rationale nor precedent for that statement, because there is none.  The plaintiff-side’s simultaneous compliance argument in an ordinary duty-to-update argument is decent, as long as one ignores that “updating” is an FDCA requirement that can’t be privately enforced under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  But, putting Buckman aside, the update-based claim described above isn’t a demand to change warnings, but a demand to “suspend or withdraw sales.”  That’s barred under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), not because of simultaneous compliance issues, but because the so-called “stop-selling” argument simply proves too much – it would do away with preemption altogether.  “[A]dopting [a] stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law.”  Id. at 2470.

So Dement took the rationale for one type of duty-to-update claim (warning-based), and applied it to a new and completely different type of claim (misbranding/stop-selling based), while totally ignoring the real reason why the Supreme Court broadly rejected the stop-selling argument as “revolutionary” in Bartlett.  It’s like adding two plus a brick and getting moldy Thanksgiving leftovers – the novel duty to update equation in Dement simply doesn’t add up.