Photo of Rachel B. Weil

On our office bulletin board, we keep a post-it listing the states we have not yet visited.   We are down to ten, and we expected to cross Oregon off after a deposition last week. But our deponent moved from Bend, Oregon to St. George, Utah. We’ve been to Utah lots of times, and were annoyed at this development. And St. George is not easy to reach. The local airport is temporarily closed, and the closest major airport is in Las Vegas, 130 miles away. So we flew to Las Vegas and gritted our teeth for the drive. We needn’t have.   The drive is entirely on I-15, passing through Nevada and a tiny corner of Arizona before hitting Utah. It traverses the spectacular Virgin River Gorge – you should Google it – and was altogether a lovely surprise. The takeaway (spoiler alert – this is the clumsy transition to today’s case): “not new” doesn’t necessarily mean “not good.”

We warned you. Today’s case, actually from a few months ago, treads familiar ground: medical device preemption under Riegel, and Buckman preemption. But it is very good. In White v. Medtronic, Inc., 2019 WL 1339613 (E.D. Mich. Feb. 20, 2019), the plaintiff alleged that his now-deceased wife was injured by the defendant’s bone graft device, a Class III medical device.. The plaintiff alleged that the device was implanted in an “off-label” manner and asserted the usual litany of product liability claims. The defendant moved to dismiss, arguing that the plaintiff’s claims were preempted by the MDA.

The court explained that, under Riegel, the MDA expressly preempts any state law claims related to a Class III medical device (a device subject to premarket approval, or “PMA”) that impose a requirement that is “different from or in addition to” those imposed by the MDA. White, 2019 WL 1339613 at *2 (citation to Riegel omitted). Under Riegel’s two-pronged test, a state claim is preempted by the MDA when: 1) the federal government has established requirements applicable to the device in question; and 2) the state law claims, rather than asserting claims that parallel the federal requirements, seek to impose requirements that relate to safety and effectiveness and are different from, or in addition to, the federal requirements. White, 2019 WL 1339613 at *2 (citation to Riegel omitted). In addition, under Buckman, only the federal government can enforce the MDA and the FDCA, so claims are impliedly preempted to the extent that they are based on violations of either statute.

The first prong of the Riegel test was easily satisfied, as there was no dispute that the FDA had established requirements that applied to the defendant’s device. As such, the “critical question” was whether the state-law claims “invoke[d] requirements beyond those established by the federal government.” Id. at *3. “The short answer,” according to the court, was “they do.” Id.

Claims Grounded in Negligence and Failure to Warn

The plaintiff based a number of his claims on allegations that the defendant had failed to warn of risks associated with the bone graft device, including risks of implanting the device in the allegedly off-label manner in which it was implanted in the plaintiff’s wife.   But the plaintiff did not allege that the defendant failed to provide any of the warnings required by the FDA through the PMA process; rather, the claims were “premised on the theory that Defendants had a duty to provide warnings different from or in addition to” those FDA required. Id. at *4 (emphasis in original). As such, the MDA expressly preempted the warnings claims. Moreover, with respect to the negligence claims, the court held, “No negligence claims can be maintained as to [Class III] devices that complied with the FDA requirements because success on those claims requires a showing that the FDA requirements themselves were deficient. These claims cannot be presented to a jury because, if successful, they would be inconsistent with the federal requirements.” Id. (citation omitted).   This is true even if the claims come “in the guise of a general tort suit addressing only safety issues related to off-label uses,” id. at *5, because “off-label usage of medical devices is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering in the practice of medicine.” Id. (internal punctuation and citation omitted). Moreover, the claims related to off-label promotion didn’t “pass muster as parallel state torts” claims, because there is “no Michigan law duty to refrain from off-label promotion of a medical device.” Rather, “off-label promotion exists only as a creation of the FDCA scheme.” Id.   In addition, the court held, the plaintiff’s claims related to off-label use and failure to report adverse events were impliedly preempted under Buckman as impermissible attempts to enforce violations of the FDCA.

Other Preempted Claims

The plaintiff asserted breaches of express and implied warranties and violations of Michigan’s consumer protection statute. Like the warnings claims, the court held that these claims were preempted because the duties the claims sought to enforce “relate[d] to, and [were] potentially inconsistent with, the federal regulatory scheme.” Id. at *7. In addition, Michigan’s consumer protection statute contains a safe harbor for conduct regulated under state or federal statutory authority, which “of course [included] the FDCA and the MDA.” Id.   Finally, the court held that the plaintiff’s design and manufacturing defect claims were preempted because “PMA constitutes approval of the product’s design, testing, intended use, and manufacturing methods,” so permitting the claims to go forward would “in essence, impose [requirements] different from or in addition to that already approved by the FDA.” Id. (citations omitted).

Other Bases for Dismissal

The court went on to dismiss the plaintiff’s fraud claims for failure to satisfy Rule 9(b) and also as “fraud on the FDA claims” preempted under Buckman. In an interesting twist, the court added that the fraud claims – in essence, that the defendant made false statements about the safety of off-label use of the device or concealed information about the device to induce doctors to use the device – were not tied specifically to the plaintiff’s late wife or to her doctors. Instead, they “attempted to advance a ‘fraud on the market’ theory, with the ‘market’ being the medical community at large” that had “no place in a products liability case. . . .” Finally, the court held that, in any event, the plaintiff’s claims were time-barred.

We like this no-doubt-about-it defense victory.   We’ll keep you posted on similar decisions, and on our continuing  adventures as we cross states off of our post-it.