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Walls v. Medtronic, Inc.

United States District Court, E.D. Pennsylvania

December 16, 2019

MEDTRONIC, INC., et al., Defendants.


          Gerald Austin McHugh United States District Judge.

         This is a product liability action brought by Plaintiff Edward Walls and his wife against Medtronic, Inc., Medtronic USA, Inc., and Physio-Control, Inc. Plaintiffs allege that two Activa deep brain stimulators and one deep brain stimulator lead-surgically implanted in Mr. Walls to treat neurological disorders-were defective, lacked adequate instructions and warnings, and were negligently designed and produced.

         Defendants move to dismiss, asserting that because the devices were subject to a full Premarket Approval (PMA) process by the Food and Drug Administration (FDA) under the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 360c et seq., Plaintiffs' claims are therefore preempted pursuant to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). In their response, Plaintiffs have failed to overcome the obstacles presented by Riegel. The Complaint will therefore be dismissed, though such dismissal is without prejudice to Plaintiffs' ability to assert claims that might be consistent with the federal statutory scheme.

         I. BACKGROUND

         A. Statutory and Regulatory Framework for Medical Devices

         When Congress passed the Medical Device Amendments to the FDCA, it created a comprehensive “regime of detailed federal oversight.” Riegel, 552 U.S. at 316. Congress also specified in the MDA that no state may impose “any requirement” relating to the safety or effectiveness of a medical device that “is different from, or in addition to, any requirement applicable . . . to the device” under federal law. 21 U.S.C. § 360k(a).

         The MDA also “established various levels of oversight for medical devices, depending on the risks they present.”[1] Riegel, 552 U.S. at 317. Devices that are “purported or represented to be for a use in supporting or sustaining human life” or “present a potential unreasonable risk of illness or injury” are designated “Class III” devices. 21 U.S.C. § 360c(a)(1)(C)(ii). Except for devices “substantially equivalent” to one that is already exempt, any new Class III device must receive premarket approval from the FDA, which is the most stringent form of FDA review for devices. Riegel, 552 U.S. at 317 (internal citations and quotation marks omitted). Obtaining “[p]remarket approval is a ‘rigorous' process.” Id. (internal citation omitted). The FDA “grants premarket approval only if it finds there is a ‘reasonable assurance' of the device's ‘safety and effectiveness.'” Id. at 318 (quoting 21 U.S.C. § 360e(d)).

         B. The Premarket Approval Process

         As described by the Second Circuit in Riegel, a manufacturer seeking premarket approval must submit:

a detailed PMA application that contains full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, ingredients, properties, and principles of operation of the device; a full description of the methods used in the manufacture and processing of the device; information about performance standards of the device; samples of the device; specimens of the proposed labeling for the device; and any other relevant information.

Riegel v. Medtronic, Inc., 451 F.3d 104, 109 (2d Cir. 2006) (citing 21 U.S.C. § 360e(c)), aff'd, 552 U.S. 312 (2008).

         The Premarket Approval process involves “‘weigh[ing] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.'” Riegel, 552 U.S. at 318 (quoting 21 U.S.C. § 360c(a)(2)(C)). It includes review of a device's proposed labeling to “evaluate … safety and effectiveness under the conditions of use set forth on the label, ” id. (citing § 360c(a)(2)(B)), and “determine that the proposed labeling is neither false nor misleading, ” Id. (citing § 360e(d)(1)(A)). If the FDA concludes that a device's proposed design, manufacturing methods, or labeling needs revision, it can require such revisions before approval. Id. at 319 (citing 21 C.F.R. § 814.44(e)).

         Even after approval, a Class III device remains subject to scrutiny after reaching the market. “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). Any change in the device requires a PMA Supplement, which is subject to the same rigorous standards as an initial PMA application. Id. (citing 21 C.F.R. § 814.39(c)); see also Kemp v. Medtronic, Inc., 231 F.3d 216, 222 (6th Cir. 2000).

         Defendants here cite to and attach FDA records accessible online that demonstrate their products were subject to a full Class III Premarket Approval process. Def. Mot. to Dismiss, Ex. I. ECF 3-2, at 1-16. Plaintiffs have not questioned the validity of those records, and I am satisfied that it is proper for me to take judicial notice of them. Federal ...

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