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:
Plaintiff contends that . . . [defendant] made negligent misrepresentations regarding the clinical study he was enrolled in. But, he offers no facts in support of this assertion to establish a violation. Instead, Plaintiff sets forth a laundry list of general regulations . . . that [defendant] allegedly violated. These conclusory allegations amount to the same type of “magic words” or blanket claims that [applicable precedent] expressly prohibits. These assertions . . . seek to impose requirements that are different from, or in addition to, the requirements imposed by the FDA. As a result, the Court must hold that these claims are expressly preempted.
Id. at *6 (citations omitted).
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.
[Plaintiff] cites no facts showing that . . . in obtaining Plaintiff's informed consent, [the surgeon] “was acting as [defendant’s] agent”. . . . Plaintiff’s breach of contract claim is both insufficient under state law and also preempted by federal post-approval study requirements, which obligate the physician “investigator,” not the manufacturer, to obtain the patient's informed consent.
Id. at *6 (citing 21 C.F.R. §812.100). The misrepresentation claim included an alleged promise of ten years of free followup care, however:
[T]his Study was dictated by federal statute. Because this claim attempts to create requirements not imposed by federal law, it is expressly preempted. . . . Even if federal requirements prohibited Plaintiff’s termination from the study due to relocation of his physician, a termination does not violate a Florida state law tort duty, as would be necessary to sufficiently allege a “genuinely equivalent” parallel claim. Plaintiff does not cite to, and the Court is unaware of, any Florida law that requires a manufacturer to pay for postsurgical monitoring.
Id. at *7 (citing 21 C.F.R. §814.82(a)(2)). Thus, it didn’t matter if plaintiff’s reading of the extensive federal regulations concerning clinical trials was right or not. The claim fell because of the state-law side of the “parallel violation” track – where there wasn’t any pre-existing state-law duty for the alleged violation to be parallel to. Mink stands for the proposition that participation in post-approval clinical trials doesn’t provide any extra basis for a plaintiff avoiding Riegel preemption.
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:
This change does not affect the analysis here because preemption analysis focuses on how the product came to market, not its current classification. Preemption necessarily looks backward (to the time of PMA) rather than forward because retroactive second-guessing on the FDA’s decision-making would interfere with the PMA process. Thus, [the device] is still treated as having PMA approval for the purposes of MDA preemption analysis.
Allen, 2015 WL 6637232, at *2 (citations and quotation marks omitted). That’s also the right result. When we looked at downclassification a few years ago, every case to address it had found no effect on preemption.
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:
Component parts, like the [device], are considered to have the same PMA approval as the device of which they are a component. Thus both [devices at issue] are considered to have PMA approval for the purposes of MDA preemption analysis.
Id. at *3.
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:
Similarly, Mensing does not require dismissal of [plaintiff’s] claims based on the generic drug manufacturers’ failure to suspend or withdraw sales of a “misbranded” drug. [Plaintiff] alleged that the generic drug was misbranded because the generic drug manufacturers failed to, inter alia, include information that they were required to include, namely the 2004 update. She alleged that Georgia law prohibits drug manufacturers from selling misbranded drugs, and that state law parallels federal law in that regard.
2015 WL 7431346, at *3. Supposedly, this tying of misbranding to updating means that it “not impossible for the generic drug manufacturers to simultaneously comply with both state and federal law.” Id. This rationale is an attempt to fix at least the warning causation problems with duty-to-update claims, since if the very presence of the product on the market is the tort, then a learned intermediary’s reliance on its warnings doesn’t matter.
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.
We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. . . . Adopting the . . . stop-selling rationale would mean that not only [Mensing], but also the vast majority—if not all—of the cases in which the Court has found impossibility pre-emption, were wrongly decided. Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.
Id. at 2477-78 (citations and quotation marks omitted).
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.