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Medtronic Uses Preemption in Medtronic Infuse Case, Again

Jan 11, 2016

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While a shallow analysis of the Supreme Court’s action in denying certiorari made it seem as if Medtronic had finally succeeded in preventing the litigation of hundreds of cases across the country claiming serious injuries due to its Infuse® Bone Graft Device, that was not the case at all.

Medtronic argued in the Caplinger case that federal law and the Supreme Court’s prior decisions in cases such as Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs’ Legal Committee, 532 U.S. 341 (2001) barred any private right of action against manufacturers of such devices; that they prohibited states from protecting their citizens under the doctrine of “preemption.” But an examination of the Caplinger case reveals that the only issue actually before the Supreme Court was limited to how victims pleaded their cases, rather than the merits of their claims. As the United States Court of Appeals for the Tenth Circuit said (whose opinion was subject to the potential review by the Supreme Court), nothing the Supreme Court has said in the past regarding this area of the law has been especially clear. “How,” asked the Court of Appeals, “are we supposed to apply all these competing instructions [from the Supreme Court]? It’s ‘no easy task.’” Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1340 (10th Cir. 2015). The Tenth Circuit then limited its ruling in Caplinger, held that preemption would only apply where a plaintiff failed to adequately plead state causes of action which paralleled federal statutory or regulatory violations, something which the plaintiff in Caplinger had failed to do [“It’s where the problems begin,” said the Tenth Circuit. 784 F.3d at 1340.]

What was left undecided by the Tenth Circuit, and thus never presented to the Supreme Court was, what happens when an individual injured by the Medtronic Bone Graft Device does plead his case properly, making an appropriate claim that there were no federal requirements covering the device as used or that state law only parallels existing federal law, rather than preempting it? The answer to that question had come earlier in a Ninth Circuit matter, Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013). In Stengel, the Ninth Circuit Court of Appeals, in an unusual en banc proceeding where not just three, but all the judges of the Circuit participated, upheld the amended complaint of a plaintiff against a Medtronic medical device because it did properly plead a state-law duty that paralleled a federal-law duty. The Supreme Court had said that such pleading would be sufficient to avoid preemption. In upholding such a pleading, the Ninth Circuit noted that it joined both the Fifth and Seventh Circuits which had reached the same conclusion. 704 F.3d at 1223. The Supreme Court then refused Medtronic’s request to have it review the Stengel case. Significantly, though, before denying Medtronic that review of Stengel, the Court invited the Solicitor General of the United States to “express the views of the United States.” Medtronic, Inc. v. Stengel, 134 S.Ct. 375 (2013). The Solicitor General urged the Supreme Court to deny any review of the Stengel opinion rejecting preemption and the Court did just that in June 2014. 134 S.Ct. 2839 (2014)

With the Stengel decision firmly in hand, the Supreme Court’s denial of review in Caplinger has limited effect, pertaining only to those cases which have been pleaded incorrectly. All other cases against Medtronic, whose complaints resemble those in Stengel, will continue unabated.

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