Friday, July 27, 2012

Full Ninth Circuit To Review Failure-to-Warn Preemption Ruling

The Ninth Circuit this week ordered en banc review of the split three-judge panel decision that the FDA reporting requirements preempted a state-law failure-to-warn claim in Stengel v. Medtronic.  

The order means that the full Ninth Circuit will review the panel ruling and possibly reverse it, allowing the plaintiffs' state-law failure-to-warn claim to go forward.  It also means that the case is all the more likely to ultimately attract the attention of the Supreme Court.  (There's already a minor circuit split.)

The core issue--the one that divided the three-judge panel--is whether the plaintiffs' failure-to-warn claim is sufficiently independent of the FDA's requirement that a medical device manufacturer discover and report to the FDA any complaints about the product's performance and any adverse health consequences attributable to the product.  If so--that is, if the state failure-to-warn claim stands on its own, independent of FDA reporting requirements--it's likely not preempted.  But if the failure-to-warn claim derives from the FDA requirement, it may be preempted.

The dispute turns on three principal cases: Medtronic v. Lohr (1996); Buckman Co. v. Plaintiffs' Legal Committee (2001); and Riegel v. Medtronic (2008).  

The panel majority said that the case is governed by Buckman.  In Buckman, the Court ruled that the FDCA preempted a state-law fraud-on-the-FDA claim, because the claim derived exclusively from a requirement owed to the FDA (and not directly to the plaintiffs).  The Court distinguished Lohr, which held that the FDCA did not preempt certain negligence claims that paralleled FDCA requirements, writing that "the [Lohr] claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements," whereas the Buckman fraud claims "exist solely by virtue of the FDCA disclosure requirements."  Op. at 4094.  

The dissent argued that the plaintiffs' failure-to-warn claim was an independent, preexisting state-law cause of action that did not derive exclusively from FDCA reporting requirements--that it looked more like the independent, but parallel, claim in Lohr than the FDCA-derived claim in Buckman.  The dissent argued that Riegel only reinforced the Lohr holding.

SDS

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