26 February 2019, by Colleen M. McElroy, Brendan Krasinski
The Arizona Supreme Court blazed a new trail in December when it unanimously rejected the Ninth Circuit's key holding in Stengel v. Medtronic, 704 F.3d 1224 (9th Cir. 2013) – "that the [Medical Device Amendments] did not expressly or impliedly preempt plaintiffs' Arizona common law failure-to-warn claim based on Medtronic's alleged failure to submit adverse event reports to the FDA." Conklin v. Medtronic, 431 P.3d 571, 578-79 (Ariz. 2018) (citing Stengel, 704 F.3d at 1226, 1233). The Arizona high court's decision is the first instance in which a state supreme court rejected Stengel and may bode well for defendants arguing that state law "failure-to-warn" claims are preempted by the Medical Device Amendments.
In Stengel, the plaintiffs claimed that Medtronic's alleged failure to submit adverse event reports to the FDA with respect to its Class III pain pump and catheter devices created a viable common law failure-to-warn claim.
Class III medical devices are subject to rigorous federal regulatory and pre-market approval (PMA) processes. Once approved, those devices remain subject to federal duties imposed by the Medical Device Amendments (MDA) to the Food Drug and Cosmetic Act (FDCA) - one of which is the duty to report, in certain situations, adverse events to the FDA. The MDA's regulatory requirements are extensive and include a preemption provision that bars states from imposing requirements "different from" or in "addition to" any requirement set forth in the MDA which relates to the safety or effectiveness of the device or to any matter otherwise applicable to the device under the MDA. See 21 U.S.C.A. § 360k (a). In contrast, some courts have determined that if a state-based law is neither "different from" nor "adds to" an MDA requirement, it creates a "parallel" claim that remains viable when levied against defendants. See Stengel, 704 F.3d at 1230 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, at 495 (1996)). The MDA's preemption provision and its contested application to state law was at issue in Stengel.
In Stengel, the Ninth Circuit held that the MDA did not expressly or impliedly preempt the plaintiffs' state-based claim. Stengel, 704 F.3d at 1226. The court reasoned that, because Arizona law "contemplated a warning to a third party such as the FDA" and that, "[u]nder Arizona law, a warning to a third party satisfies a manufacturer's duty to warn . . . if there is reasonable assurance that the information will reach those whose safety depends on their having it," the plaintiffs properly alleged a parallel Arizona failure-to-warn claim. See Stengel, 704 F.3d at 1233.
Five years later, the Arizona Supreme Court in Conklin held that the Ninth Circuit got it wrong – the "it" being Arizona law. As the Arizona Supreme Court explained, the Ninth Circuit's holding in Stengel "was based on the unsupported premises that 'Arizona law contemplates a warning to a third party such as the FDA' and that '[u]nder Arizona law, a warning to a third party satisfies a manufacturer's duty if, given the nature of the warning and the relationship of the third party, there is 'reasonable assurance that the information will reach those whose safety depends on their having it.'" Conklin, 431 P.3d 579. But "[n]either premise comports with Arizona law." Id.
The court emphasized that, although Arizona "case law contemplates that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party, such as a learned intermediary [,] the FDA is not a learned intermediary or other relevant third party in that analysis." Id. at 579 (emphasis in original). The court went on to note that it was "not aware of any case that supports the proposition that a manufacturer is independently required under Arizona law to warn a governmental regulatory body." Id. (emphasis in original). Because no independent duty to submit averse event reports to the FDA exists under Arizona law, the court held that Conklin's failure to warn claim "at bottom, is an attempt to enforce a federal law requirement," and "that claim is impliedly preempted under the MDA." Id. at 578.
In light of Conklin, any Stengel claims brought on behalf of Arizona plaintiffs should be subject to dismissal.
But the potential impact of Conklin is far broader. Defendant manufacturers should now consider aggressively pursuing dismissal of Stengel claims brought by residents of states that do not (1) impose a duty on drug or device manufacturers to submit adverse event reports to the FDA or (2) otherwise contemplate that manufacturers can satisfy their duty to warn end users by submitting adverse event reports to the FDA. To our knowledge, that potentially covers every one of the 50 states.
Conklin also suggests an additional basis for challenging Stengel claims. Although the Arizona Supreme Court punted on the issue, it did raise a question as to whether submission of an adverse event report to FDA ever could constitute a legitimate "warning" in the context of a duty to consumers.See Id. at 576-77 (describing adverse event reports as "one of the least reliable sources" of information and explaining that even the FDA's website includes a disclaimer that states adverse event reports do "not necessarily reflect a conclusion by the party submitting the report or by [the] FDA").
A few years, ago the Southern District of Ohio took a more direct approach to the issue, finding that "adverse-event reports are not warnings. Although the FDA 'may disclose' adverse-event reports, it is not required to do so . . . thus, adverse-event reports, unlike the warnings on a device label, 'are not automatically made public.'"Aaron at 1005 (emphasis in original) (internal citations omitted). Defendants may also want to consider briefing this issue in parallel with arguments regarding lack of state law duties.
The Arizona Supreme Court's bold decision in Conklin creates a promising foothold for defendants seeking to dismiss state-based failure-to-warn claims involving PMA devices. With some hard work from the defense bar, perhaps in the coming years we will see the impact of Stengel'scontroversial holding erode.
An earlier version of this article appeared on Law360 on February 25, 2019.Back to news landing page