Arguing that there is no ripe circuit conflict and that "(t)ort claims based on a manufacturer’s failure to update its product’s labeling to account for new safety information ordinarily are not impliedly preempted" the Department of Justice in the Solicitor General's amicus brief has opposed Medtronic's petition for certiorari in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Ariz. 2013. The Ninth Circuit held en banc that a post-sale failure to warn claim is not impliedly pre-empted by the Medical Device Amendments because the Arizona tort claim is "parallel" to the FDCA and does not constitute an additional "requirement".
The product at issue - an implanted pump that delivers pain medication to the spine - caused permanent paraplegia to Richard Stengel. Medtronic failed to report its knowledge of the complication (acquired post-FDA approval). That, said the Circuit presented no conflict with federal law, i.e. it is a "parallel claim" - a thicket that Brian Wolfman and Anne King have lucidly described: Mutual Pharmaceutical Co. v. Bartlett and Its Implications (November 5, 2013). The United States Law Week (BNA), Vol. 82, pp. 1-18, 2013.
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