FDA Healthcare Tort Litigation Environmental February Supreme Court Finds

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					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
   For more information, contact:
                                    devices.
             Mark S. Brown          The plaintiffs, the Riegels, brought a lawsuit against a medical device
             (202) 626-5443
                                    manufacturer, Medtronic, Inc., for events that occurred concerning
         mbrown@kslaw.com
                                    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
           tdavis@kslaw.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
          nguest@kslaw.com          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.
              (202) 661-7816
          ntaylor@kslaw.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;
               King & Spalding
                                    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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