We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can't help ourselves. Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is an ever-present possibility. To be sure, there is no shortage of litigation alleging that drug and device companies have violated state law duties, so we don't want to overstate matters. Regardless, federal preemption remains the bright shiny object from which we cannot avert our gaze.
Federal preemption demands our attention also because it is so often misunderstood and/or misapplied. We have said at times that some judges are hostile to preemption, and that might be true for some of the obviously result-oriented opinions that we review. It is more likely that courts confront the many branches of preemption and the spider web of cases applying preemption in its various flavors, and they just get it wrong. God only knows that the authorities are not always clear.
This is a long lead-in to a recent case that got preemption wrong on so many levels that we're not completely sure what to make of it. In Tryan v. Ulthera, Inc., No. 2:17-cv-02036, 2018 U.S. Dist. LEXIS 140111 (E.D. Cal. Aug. 17, 2018), the plaintiffs sued the manufacturer of a medical device that uses ultrasound to tighten skin and reduce wrinkles on the face, neck, and chest. The FDA cleared the device for marketing through the 510(k) premarket notification process, which is different from the more rigorous premarket approval (or "PMA") process that some other devices go through. The plaintiffs' beef was that the manufacturer represented that the device was "FDA approved" (as opposed to "FDA cleared") in violation of FDA regulations. Id. at **2-4.
The case seems fairly straightforward. Plaintiffs based their claims on an alleged violation of the Food Drug & Cosmetic Act ("FDCA") and its regulations. Moreover, the plaintiffs did not allege any complication with their procedures, or even that the device did not work exactly as it was supposed to. Instead, they alleged that had they known the device was not FDA approved, and that it was merely FDA cleared, they would have paid less for the therapy or considered alternative treatments. Id. at *4.
Whatever you think of those allegations and the likelihood that any consumer would draw any distinction between "FDA cleared" and "FDA approved," these plaintiffs were suing because of a violation of the FDCA, which runs directly into implied preemption under Buckman and 28 U.S.C. § 337(a). Whether the device was FDA "approved," "cleared," or whatever, without the FDCA, there would be no FDA action at all. Buckman is the Supreme Court case that held that state-law claims conflicting with the FDCA are impliedly preempted, and Section 337 mandates that only the federal government can enforce the FDCA. Whenever a purported state-law cause of action includes as a "critical" element some sort of FDCA violation, it runs afoul of § 337(a) and is therefore impliedly preempted under Buckman. Buckman involved a 510(k) device, so device categories do not affect implied preemption.
The manufacturer therefore justifiable moved to dismiss on implied preemption, and in denying the motion, the district court got off on the wrong foot, and it got worse from there. The district court began its discussion with the express preemption clause of the Medical Device Amendments, which expressly preempts any state law requirement which is "different from or in addition to" federal requirements. Id. at *10. This is a valid legal principle as far as it goes, but it is completely irrelevant to this case: The defendant did not assert that federal law expressly preempted the plaintiffs' claims. The defendant asserted implied preemption, under which federal law preempts state law where the state law conflicts with federal law or stands as an obstacle.
You might ask what difference that would make? Well, it makes a big difference, because in its next breath, the district court invoked the questionable and often-misunderstood "parallel claim" exception to preemption. As the "exception" goes, because the MDA's express preemption clause preempts state-law requirements that are "different from or in addition to" federal requirements, claims based on state-law duties that "parallel" federal requirements are not preempted.
We can debate whether the "parallel claim" exception is a good idea or whether federal authorities actually support its existence. One thing, however, is certain:
There is no parallel claim exception to implied preemption.
The district court's introduction of express preemption at the outset of its opinion was therefore no harmless error. It started the opinion down a legal path from which the opinion would never recover, as the court forced the plaintiffs' allegations into an "exception" that does not exist. For example, the district court noted with approval that the plaintiffs alleged that California law "incorporates and mirrors the FDCA." Id. at *11. In the context of implied preemption, that observation alone should have been the death knell of this case because it acknowledged in plain terms that the plaintiffs were suing to enforce the FDCA. We know from Buckman and section 337(a) that such actions are not allowed. The "mirroring" of California law matters only in food cases, to which a statutory exception to section 337(a) applies. That exception does not apply to medical devices (or drugs), which we detailed here.
Unfortunately, the district court misapprehended this point again and again. It noted the "linkage" between state and federal law and cited the plaintiffs' use of federal "regulatory and statutory violations" as the predicates for their state-law claims. Id. The court noted that California statutes adopt federal regulations as state-law standards. Id. The court observed that California law prohibits false and misleading advertising. And why is it misleading to say a Class II medical device cleared through the premarket notification process is "FDA approved"? Because such a statement allegedly violates federal regulations. All paths lead back to the plaintiffs suing to enforce the FDCA, which is the epitome of implied preemption.
The district court also wrongly cited federal law in support of its opinion. It relied on Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), to describe the FDA's 510(k) process. Id. at **5-6. The court certainly is not alone in citing Lohr on this point, but as we have explained here and here, Lohr understates and marginalizes the 510(k) process' focus on safety and efficacy and was outdated even before it was published. The district court also stated that "FDCA regulations appear to directly preclude preemption," but once again the cited regulation defines the scope of the Medical Device Amendment's express preemption provision. That provision did not apply, nor did the defendants argue that it should. Id. at *13.
Finally, the court observed that 510(k) clearance does not preempt "state statutes of general application." Id. at **13-14. Of course the mere fact of 510(k) clearance does not create a blanket of preemption over "statutes of general application," and we highly doubt the defendant argued that it did. However, when the plaintiffs is claiming that a medical device manufacturer violation a state statute of any kind because its conduct violated the FDCA, that's implied preemption, and that is exactly what the plaintiffs alleged here.
In the end, we have a class action alleging that "FDA approved" and "FDA cleared" are different enough to consumers that the law should require awarding damages to patients who allege no injury and for whom the device may have worked exactly as advertised. We are not so sure, nor are we sure that this order will survive an appeal.
This article is presented for informational purposes only and is not intended to constitute legal advice.
