FDA/Healthcare | Tort Litigation & Environmental
February 26, 2008
Supreme Court Finds MDA Preemption Clause Bars
Common Law Claims Which Challenge the Safety or
Effectiveness of PMA Medical Devices
On February 20, 2008, the U.S. Supreme Court in Riegel v. Medtronic,—
S.Ct.—, 2008 WL 440744 (2008), ruled that the Medical Device
Amendment of 1976 (MDA), 21 U.S.C. § 360k, preemption clause bars
common law claims which challenge the safety or effectiveness of Food
and Drug Administration (FDA) premarket approved (PMA) medical
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Mark S. Brown The plaintiffs, the Riegels, brought a lawsuit against a medical device
manufacturer, Medtronic, Inc., for events that occurred concerning
Medtronic’s medical device—Evergreen Balloon Catheter. Id. at *5.
Todd P. Davis The device is a Class III device that received PMA approval from FDA
(404) 572-3589 in 1994 (with additional supplemental approvals in 1995 and 1996 for
email@example.com changes to its labeling).
Nathan A. Guest The plaintiffs’ claims alleged: (1) the medical device was “designed,
(202) 661-7941 labeled, and manufactured in a manner that violated New York common
firstname.lastname@example.org law, and [the] defects caused Riegel to suffer severe and permanent
injuries;” (2) strict liability; (3) breach of implied warranty; (4) negligent
Nicole R. Taylor manufacturing; and (5) loss of consortium. Id.
email@example.com The United States District Court for the Northern District of New York
held that: “the MDA pre-empted Riegel’s claims of strict liability;
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breach of implied warranty; and negligence in the design, testing,
Atlanta, GA inspection, distribution, labeling, marketing, and sale of the catheter.”
1180 Peachtree Street, NE Additionally, the court held that, “the MDA preempted a negligent
Atlanta, GA 30309-3521 manufacturing claim insofar as it was not premised on the theory that
Phone: (404) 572-3589
Fax: (404) 572-5100 Medtronic violated federal law.” Finally, the court determined that, “the
MDA preempted Donna Riegel’s claim for loss of consortium to the
Washington, DC extent it was derivative of the pre-empted claims.” Id. (citations omitted).
1700 Pennsylvania Avenue, NW
Washington, DC 20006-4706 The United States Court of Appeals for the Second Circuit affirmed the
Tel: (202) 737-0500
Fax: (202) 626-3737 District Court’s dismissal of Riegel’s claims. It concluded that
“Medtronic was ‘clearly subject to the federal, device-specific
www.kslaw.com requirement of adhering to the standards contained in its individual,
federally approved’ premarket approval application. The Riegel’s claims
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FDA/Healthcare | Tort Litigation & Environmental
were pre-empted because they ‘would, if successful, impose state requirements that differed from, or added to’ the
device-specific requirements.” Id. (citations omitted).
Justice Scalia delivered the opinion of the Supreme Court, affirming the judgment of the Court of Appeals.
Justice Scalia’s analysis focused on two questions:
(1) “Since the MDA expressly pre-empts only state requirements ‘different from, or in addition to, any
requirement applicable … to the device’ under federal law, § 360k(a)(1), we must determine whether the
Federal Government has established requirements applicable to Medtronic’s catheter.” Id. This language
relates only to whether the device in question remains within the scope of its cleared PMA.
(2) If yes, then the Court must determine “whether the Riegels’ common law claims are based upon New
York requirements with respect to the device that are ‘different from, or in addition to’ the federal ones,
and that relate to safety and effectiveness. § 360k(a).” Id.
With respect to the first question, the Court found that the case differed from Medtronic, Inc. v. Lohr, 518 U.S.
470 (1996). In Lohr, the Supreme Court rejected the manufacturer’s assertion that medical devices approved
under FDA’s §510(k) process imposed device-specific “requirements.” Id. at *6. In contrast, in this case, the
Supreme Court found PMA-approved medical devices, like Medtronic’s catheter, imposed device-specific
“requirements.” The Court found that “premarket approval is specific to individual devices,” and “FDA requires a
device that has received premarket approval to be made with almost no deviations from the specifications in its
approval application, for the reason that the FDA has determined that the approved form provides a reasonable
assurance of safety and effectiveness.” Id.
With respect to the second question, the Court found that “common-law causes of action for negligence and strict
liability do impose ‘requirement[s]’ and would be preempted by federal requirements specific to a medical
device.” Id. (citing Lohr 510 U.S. at 512, 503-505).
Accordingly, the Court found that the MDA preemption clause bars common law claims against PMA-approved
medical devices. The Court also recognized that the MDA preemption clause “would pre-empt a jury
determination that the FDA-approved labeling for a pacemaker violated a state common law requirement for
additional warnings.” Id. at *9. However, the Court emphasized that “[s]tate requirements are pre-empted under
the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal
law. §360k(a)(1).” Id. The Court’s preemption ruling extends only to claims challenging the safety or
effectiveness of the device marketed in a form that received PMA approval.
The Supreme Court heard oral argument in Warner-Lambert Co. v. Kent on February 25, 2008, and will hear oral
argument in Wyeth v. Levine in the fall of 2008.
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This alert provides a general summary of recent legal developments. It is not intended to be and should not be relied upon as legal advice.
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