Richard Stengel v. Medtronic Incorporated

I. Background

Congress enacted the MDA to extend the coverage of the Food, Drug, and Cosmetic Act (“FDCA”) to medical devices. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). The MDA divides medical devices into three classes according to user risk. Class I devices pose the least risk; Class III devices pose the most. See id. at 316–17; see also 21 U.S.C. § 360c(a)(1). Class I devices are subject to “general controls” such as labeling requirements. Id. § 360c(a)(1)(A); Riegel, 552 U.S. at 316. Class II devices are subject not only to “general controls,” but also to “special controls” such as “performance standards, postmarket surveillance, [and]

STENGEL V . MEDTRONIC, INC.

patient registries.” 21 U.S.C. § 360c(a)(1)(B); Riegel, 552 U.S. at 316–17. If a device cannot be determined to provide a reasonable assurance of safety and effectiveness under Class I or II controls and is either marketed as a life- supporting device or may cause an unreasonable risk of illness or injury, it is a Class III device. A Class III device is subject to a pre-market approval process of the FDA. 21 U.S.C. § 360c(a)(1)(C); Riegel, 552 U.S. at 317. The Medtronic pain…

Opinion by Judge W. FLETCHER; Concurrence by Judge WATFORD.

*1226 OPINION

Plaintiffs Richard and Mary Lou Stengel sued Medtronic under state law when a medical device manufactured by Medtronic rendered Richard permanently paraplegic. Medtronic moved to dismiss the Stengels’ complaint, contending that the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”) preempted their state-law claims. The Stengels moved to amend their complaint to add a new state-law negligence claim. That claim alleged that Medtronic had violated a state-law duty of care by failing to report known risks associated with use of its medical device to the Food and Drug Administration (“FDA”). The MDA required Medtronic to report those risks to the FDA. Medtronic contended that the MDA also preempted the Stengels’ new negligence claim.

The district court held that the MDA preempted all of the Stengels’ claims, including the new negligence claim. Stengel v. Medtronic, Inc., No. CV 10-318-TUC-RCC, 2010 WL 4483970 , at *3-4 (D.Ariz. Nov. 9, 2010). It denied the Stengels’ motion to amend the complaint and dismissed their suit under Federal Rule of Civil Procedure 12(b)(6). Id. The…

concurring:

While I join Judge Fletcher’s opinion, I write separately to provide a few additional thoughts as to why the state law failure-to-warn claim alleged in the proposed amended complaint is not preempted.

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. Regulations issued by the Food and Drug Administration (FDA) permitted Medtronic to issue such post-sale warnings, even without receiving prior approval from the FDA, but those regulations did not require such warnings. See 21 C.F.R. § 814.39 (d). As a result, any attempt to predicate the Stengels’ claim on an alleged state law duty to warn doctors directly would have been expressly preempted under 21 U.S.C. § 360k, which forbids state-imposed requirements that are “different from, or in addition to” the requirements imposed by federal law. See McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.2005)…