Stengel v. Medtronic: The 9th Circuit Switches Sides on Medical Device Preemption

ReedGuest Commentary

by Matthew A. Reed, Sedgwick LLP

Mr. Reed is an associate in the firm’s Los Angeles office and author of a November 2012 WLF Legal Backgrounder, What’s The Implication? Courts And The Scope Of Implied Medical Device Preemption

Overview

The expansive view of Buckman implied preemption lost an important ally last week.  In Stengel v. Medtronic Inc., — F.3d —, 2013 WL 106144 (9th Cir. Jan. 10, 2013), the en banc Ninth Circuit held, contrary to a previous ruling by its 3-judge panel, that Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), did not impliedly preempt a state-law failure-to-warn claim predicated on alleged regulatory violations.  The legal grounding for the court’s preemption analysis in reaching that conclusion is difficult to discern.  The overarching message, however, is not: Buckman is now construed quite narrowly in the Ninth Circuit.

Background

In Stengel, plaintiffs brought four state tort law claims involving Medtronic’s Class III, premarket-approved pain pump, alleging it had caused Richard Stengel’s paralysis.  Medtronic moved to dismiss those claims as expressly preempted by the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act (“FDCA”).  While that motion was pending, the Stengels sought to amend their complaint by alleging that each cause of action was triggered by Medtronic’s failure to report injury information to the FDA, as required by FDA regulations.  The district court granted Medtronic’s motion under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the original claims asserted violations of state tort law with no allegation that Medtronic violated FDA regulations, and thus the state claims were different from or additional to FDCA requirements.  Conversely, it denied the Stengels’ motion to amend as a matter of law, because the new claims alleging regulatory violations were impliedly preempted under Buckman.

On appeal, the three-judge panel briefly affirmed express preemption on Riegel grounds.  676 F.3d 1159, 1162 (9th Cir. 2012).  The bulk of its opinion was devoted to applying Buckman implied preemption.   Buckman held that state law claims alleging fraud on the FDA were impliedly preempted because they interfered with the federal regulatory scheme.  The Stengels’ “failure to warn” claims, the Ninth Circuit held, were no different because they hinged on allegations that the defendant mislead the FDA – whether by commission or omission:  “The policing of such conduct in both instances is committed exclusively to the federal government, and recognizing a state cause of action based on such conduct would conflict with the statutory scheme established by Congress.”

The Stengels claimed Buckman was satisfied because its conflict avoidance rationale required only the preemption of state claims alleging FDCA violations the FDA had not previously determined, whereas the FDA had issued a warning letter finding the same violations they alleged.  The Ninth Circuit disagreed, finding Buckman was not only concerned with “avoid[ing] jurors second-guessing the FDA’s decision making: it was also based on the idea that state fraud-on-the-FDA claims would exert an extraneous pull on the scheme established by Congress, in which the FDA was supposed to enforce the FDCA’s disclosure requirements.”  Thus, failure-to-warn claims based on misleading the FDA were impliedly preempted because they “threaten to skew the delicate balance of statutory objectives sought to be achieved by the FDA.”

Stengel En Banc: All Preemption is (More or Less) One

The en banc Ninth Circuit, by contrast, acknowledged implied preemption, but only as a mostly indistinct component of single preemption analysis.  Thus, Stengel began by asserting, without caveat, that “[t]here is a presumption against federal preemption of state laws that operate in traditional state domains.”  That presumption applies to express preemption, but not implied preemption, which, Buckman noted, arises from the “exclusively federal” relationship between a federal regulatory agency and its regulated entities.  531 U.S. at 347-48.  As such, it does not implicate “traditional state domains” or the presumption against federal preemption they carry.

Stengel included Buckman as one of three Supreme Court MDA preemption cases, but claimed they all stood for the rule that the “MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.”  But that is only the express preemption standard.  Riegel 552 U.S. at 330.  It is not the rule of Buckman, which dealt solely with implied preemption.  531 U.S. at 348 n.2.

The en banc court’s minimization of Buckman extended to its interpretation of Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Stengel characterized Lohr as “an across-the-board holding” that the MDA did not expressly or impliedly preempt state law negligence actions (thus implying that Buckman’s later implied preemption finding must be limited to its facts).  But Lohr was, by its own characterization, solely an express preemption case.  518 U.S. at 484 (stating its task as “interpreting a statutory provision that expressly preempts state law”).  As such, it does not address implied preemption or thereby limit Buckman.

Stengel’s analysis of Buckman itself is baffling.  It distinguished Buckman from Lohr by asserting the Buckman plaintiffs “alleged no state-law claim,” despite earlier acknowledging that they did.  It also asserted they were “concerned exclusively with the alleged fraud on the FDA that had occurred as part of [the FDA pre-market] approval process,” which, Stengel asserted, Buckman characterized as “wholly federal” and thus naturally amenable to the exclusive application of federal law.  But the Buckman characterization actually referred to “the relationship between a federal agency and the entity it regulates,” not the just FDA approval process.

Stengel’s analysis thus does not seem to support its exemption of the Stengels’ claim from implied preemption on the ground that “[i]t is a state law claim that is independent of the FDA’s pre-market approval process that was at issue in Buckman.”  To complicate matters, Stengel’s seven-judge concurrence seemed instead to distinguish Buckman, as the Fifth and Seventh Circuits have, because it only preempted “fraud-on-the-FDA” claims, raising a question as to which opinion’s Buckman analysis controls.  Whatever the answer, the practical reality – that Buckman implied preemption is now essentially limited to its facts in the Ninth Circuit – remains the same.  So does the Sixth and Eighth Circuits’ opposition to that view, preserving the circuit split that could trigger Supreme Court review.

4 thoughts on “Stengel v. Medtronic: The 9th Circuit Switches Sides on Medical Device Preemption

  1. In this posting, the author says:

    “The legal grounding for the court’s preemption analysis in reaching that conclusion is difficult to discern.”

    From reading the Opinion, I discerned that the legal grounding has to do the parallel claims doctrine. According to the en banc Ninth Circuit, the Supreme Court, in several device preemption cases going back to Medronic v. Lohr, held that claims that were “parallel” to Federal claims were not preempted. Here, the court ruled that the state law claims asserted by the plaintiff were in fact “parallel” to the Federal violations asserted.

    As for Buckman preemption, the Court said the state law claims here were distiguishable from Buckman because there “fraud on the FDA” was only theory for liability whereas here a traditional state law claim had been asserted.

    I am not commenting on the correctness of the decision in Stengel, only that the court did spell out its legal grounding. So, with respect, I disagree with the author on this point.

    Arnie Friede
    Arnie@FriedeFDALaw.com

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