When we first reported on Stengel back in 2010, it was simply another PMA preemption win. Earlier this year, we were excited when the Ninth Circuit upheld that decision. We ended that post with the thought: “What Riegel giveth (parallel violation claim), Buckman taketh away – at least when the allegation is based solely on FDA disclosure requirements (and except in the Fifth Circuit).” Unfortunately, today we need to amend that statement to “except in the Fifth and Ninth Circuits.” Yuck.
Finally, Plaintiffs alleged that Medtronic failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations. . . . [T]hese claims are simply an attempt by private parties to enforce the MDA, claims foreclosed by § 337(a) as construed in Buckman.
Arizona law contemplates a warning to a third party such as the FDA. Under 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.” Anguiano v. E.I. DuPont de Nemours & Co., 808 F.Supp. 719, 723 (D.Ariz.1992), aff'd 44 F.3d 806 (9th Cir.1995).
Giving to the third person through whom the chattel is supplied all the information necessary to its safe use is not in all cases sufficient to relieve the supplier from liability. It is merely a means by which this information is to be conveyed to those who are to use the chattel. The question remains whether this method gives a reasonable assurance that the information will reach those whose safety depends upon their having it.
Given the Supreme Court's preemption decisions in this area, the Stengels faced a dilemma in framing their failure-to-warn claim. The most direct way to state the claim would be to allege that under Arizona law Medtronic owed a post-sale duty to warn doctors when it learned of adverse events in which the medical device at issue here caused a death or serious injury. . . . [A]ny attempt to predicate the Stengels' claim on an alleged state law duty to warn doctors directly would have been expressly preempted.. . .[Therefore], they predicate their claim on Medtronic's reporting duty to the FDA, as they must to avoid express preemption.