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From Products Liability Law Daily, June 23, 2014

Preemption decision in claim against medical device maker for disclosure violations stands

By Pamela C. Maloney, J.D.

A petition filed by a pump and catheter manufacturer asking the U.S. Supreme Court to review a decision by the U.S. Court of Appeals for the Ninth Circuit (sub nom. Stengel v. Medtronic, Inc.), which held that a state-law claim asserted by a patient in whom the device had been implanted was not impliedly or expressly preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) has been denied review. Thus, the Ninth Circuit decision remains standing (Medtronic, Inc. v. StengelDocket No. 12-1351, June 23, 2014).

Reasons for granting writ. Medtronic’s petition to the Supreme Court had noted that the federal courts of appeal have been divided regarding the applicability of both implied and express preemption under the MDA to state-law claims based on alleged violations of duties imposed by federal law. Regarding whether the MDA impliedly preempts state-law claims, the Ninth Circuit in this case and the Fifth Circuit in Hughes v Boston Scientific Corp., 632 F.3d 762 (2011) have said “no”; while the Sixth and Eighth Circuits have said “yes.” (See In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig (623 F.3d 1200, 1205-06 (8th Cir 2010); and Cupek v. Medtronic, 405 F.3d 421, 423-24 (6th Cir. 2005)). Medtronic also argued that the circuit courts also are split on whether the MDA expressly preempts state-law claims alleging a violation of a generalized, rather than a device-specific, federal requirement.

Finally, Medtronic had argued that the Ninth Circuit’s decision “would effectively eviscerate” the High Court’s earlier decisions in Riegel v. Medtronic, Inc. (552 U.S. 312 (2008)), and Buckman Co. v. Plaintiffs’ Legal Comm. (531 U.S. 341 (2001)). “A claim concerning a device that has received pre-market approval can avoid preemption only if it is based on a state-law duty that is both (1) independent of (Buckman), and (2) parallel to (Riegel), a duty imposed by federal law,” according to the petition. Medtronic had suggested that this case was an “ideal vehicle for addressing a recurring question of exceptional importance to device manufacturers and the public health

Question presented. The question presented by the petition was whether the MDA preempts a state-law claim alleging that a medical device manufacturer violated a duty under federal law to report adverse-event information to the FDA.

Attorneys: Thomas G. Cotter (Haralson, Miller, Pitt, Feldman & McAnally P.L.C.) for Richard Stengel and Mary Lou Stengel. Miguel A. Estrada (Gibson, Dunn & Crutcher LLP) for Medtronic, Inc.

Companies: Medtronic, Inc.

The case number is 12-1351 (petition for certiorari).

MainStory: TopStory PreemptionNews MedicalDevicesNews SupremeCourtNews

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