Preemption Update: The Legal Landscape since Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008) Wendy Fleishman October 5, 2010 1
I. The Medical Device Amendments Act The Medical Device Amendments of 1976 ( MDA ), 21 U.S.C. 360c et seq., to the Federal Food, Drug and Cosmetic Act ( FDCA ), 21 U.S.C. 301 et seq., contain an express preemption clause stating that: no [s]tate or political subdivision... may establish or continue in effect with respect to a device intended for human use any requirement -- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. 360k(a) (1976) ( 360k(a) ) (emphasis added). II. Legal Challenges After Riegel In the Second Circuit, there were two reported decisions at the District Court level in two medical device cases where the District Courts dismissed claims as preempted and applied the logic of Riegel: Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 68 UCC Rep.Serv.2d 64, Prod.Liab.Rep. (CCH) P 18,192, E.D.N.Y., February 20, 2009 (NO. CIV.A.CV-07-1572 DGT) The District Court, Trager, J., held that: (1) recipient's negligence and recklessness, defective manufacturing, defective design, breaches of express and implied warranties, and failure to warn 2
claims were preempted by Medical Device Amendments (MDA) to Food, Drug and Cosmetic Act (FDCA), and (2) recipient's allegations failed to state violations of New York state General Business Law. Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, E.D.N.Y., December 28, 2009 (NO. CV 09-3264) The Plaintiff brought a cause of action in her amended complaint for negligence per se against Medtronic in connection with a pain pump. The cause of action alleges that Medtronic failed to manufacture the Medication Pump in a reasonable and prudent manner, and in accord with federally prescribed Current Good Manufacturing Practices ( CGMP's ). The Amended Complaint goes on to list eleven federal regulations alleged to have been violated in the manufacture of the Medication Pump. The District Court recognized that the Supreme Court held open the potential for parallel claims: The Court went on to hold that the MDA preemption provision does not bar a state from imposing a dam-ages remedy for a claim premised on the violation of federal law. In such a lawsuit, the plaintiff would seek damages for the violation of federal, and not state lawduties that the Court referred to as parallel to FDA requirements. Riegel, 128 S.Ct. at 1011. Thus, the court left open a narrow class of state court actions that could seek damages for injuries alleged to have been caused by federally regulated medical devices. Such lawsuits can be referred to as parallel actions. See *586 In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1152 (D.Minn.2009) (referring to narrow back door left open by Riegel ). The court turns to consider whether the Amended Complaint states such a claim. 677 F.Supp.2d 582, 586. Nonetheless, the District Court dismissed the action, on the grounds that the claims assserted by the plaintiff were only the broad statement of the federal manufacturing regulations, without specific violations asserted. The court wrote: The broad nature of the federal regulations relied upon also leads to the conclusion 3
that Plaintiff's claim cannot withstand the pleading requirements of Twombly. As noted, those standards require dismissal of complaints that do nothing more than engage ion a formulaic recitation of the elements of a cause of action... Twombly, 127 S.Ct. at 1965. Where, as here, the plaintiff has done nothing more that recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed. Id. at 588. In the Third Circuit In Williams v. Cyberonics, Slip Copy, 2010 WL 2982839, (Not Selected for publication in the Federal Reporter), C.A.3 (Pa.), July 30, 2010 (NO. 09-3800), users of medical device implanted into neck to stimulate nerves in order to treat depression brought action against device manufacturer, alleging strict liability for manufacturing defect, breach of warranty, fraudulent misrepresentation, and negligent misrepresentation. The United States District Court for the Eastern District of Pennsylvania, (Brody, J. 654 F.Supp.2d 301), granted manufacturer's motion for summary judgment, and users appealed. The U.S. Court of Appeals for the Third Circuit issued the ruling, saying the common law product liability for manufacturing defect and breach of warranty claims are preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The Third Circuit, however, said the device was given premarket approval after a rigorous review by the U.S. Food and Drug Administration as required by the MDA. The amendments, the Court said, were also specifically designed to preempt the claims advanced by the plaintiffs. The Court wrote: Appellants' allegations of strict products liability based on manufacturing defect and breach of warranty are pre-empted by the MDA. Generalized common law theories of liability, such as those advanced in appellants' complaint, are precisely the type of claims the MDA sought to preempt. See id. at 325 ( tort law, 4
applied by juries under a negligence or strict-liability standard, is pre-empted by the MDA); Horn, 376 F.3d at 173 ( [I]t is firmly established that a requirement under 360k(a) can include legal requirements that arise out of state common-law damages actions. ). Success on appellants' breach of warranty claims would require them to show that the VNS Therapy System device was unsafe or ineffective despite the PMA process, thereby interfering with the requirements already established by the MDA, which has preempted safety and effectiveness determinations for a device. 21 U.S.C. 360k(a); see Riegel, 552 U.S. at 325 (holding that state law that requires a manufacturer's devices to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme ). Appellants also advance a strict products liability claim for a manufacturing defect based on the malfunction theory, which allows the trier-of-fact to infer a defect from the fact that the device malfunctioned. See Bruesewitz v. Wyeth Inc., 561 F.3d 233, 255 (3d Cir.2009), cert. granted, --- U.S. ----, 130 S.Ct. 1734, 176 L.Ed.2d 211 (2010) (stating that the malfunction theory permits a plaintiff to base a products liability claim on circumstantial evidence of a manufacturing defect. ). Although it is alleged that the VNS Therapy System stopped working for the Williamses and malfunctioned for Knight, appellants fail to explain how the device deviated from the FDA requirements. See Riegel, 552 U.S. at 330 (holding that strict liability claims under 360k are not preempted if premised on a violation of FDA regulations ); Horn, 376 F.3d at 179 (rejecting plaintiff's manufacturing defect claim because she did not assert[ ] that [defendant] has in any way failed to conform with the FDA requirements prescribed by its 5
PMA-nor that it deviated from, or violated, any of the FDA's federal statutes or regulations ). Rather, appellants seek to ground Cyberonics' liability on requirements that go beyond those established by the MDA. Accordingly, appellants' claims are preempted. III. CONTRARY DECISIONS: A. Breach of Warranty Claims Should Not Be Preempted As part of the PreMarket Approval ( PMA ) process, a manufacturer is required to submit a label for the FDA s review. Under the FDA regulatory scheme, once a device has received premarket approval, a manufacturer generally must obtain FDA approval before making any changes in the labeling, or any other attribute that would affect the device s safety or effectiveness. The important exception to that regulatory scheme is that the MDA allows a Special PMA Supplement Changes Being Effected ( CBE Supplement ) under 21 C.F.R. 814.39(d) (2008). A CBE Supplement permits a manufacturer to make [l]abeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association prior to FDA approval. 21 C.F.R. 814.39(d)(2)(i). A manufacturer is also allowed to make [l]abeling changes that delete misleading, false, or unsupported indications. 21 C.F.R. 814.39(d)(2)(iii). If these changes are not objected to by the FDA, they become accepted as part of the label. This CBE system is nearly identical to the CBE system applicable to pharmaceutical products. In Wyeth v. Levine, 129 S. Ct. at 1196, the United States Supreme Court, conducted a detailed review of that system and found that state law claims premised on the same are not preempted: There is an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency s approval. Among other things, this changes being effected (CBE) regulation provides that if a manufacturer is changing a label to add or strengthen a contraindication, warning, precaution, or adverse reaction or to add or strengthen an instruction about dosage and administration that is intended to increase the 6
safe use of the drug product, it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. 314.70(c)(6)(iii)(A), (C). Under both the MDA and the regulations applicable to pharmaceutical products, the manufacturer has a duty to update the label about adverse effects once there is a reasonable evidence of a causal association. 21 C.F.R. 814.39(d)(2)(i). That obligation is made explicit in the FDA s Conditions of Approval. Those conditions state: A PMA supplement must be submitted when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification (emphasis added). Therefore, an argument can be made that the failure to warn and the failure to follow the express instructions of the FDA in its approval is a parallel claim. B. Manufacturing Defect Claims Should Not Be Preempted In Purcel v. Advanced Bionics, 2008 WL 3874713 (N.D.Tex.2008), for example, the plaintiff successfully stated a parallel claim. There, it was alleged that a particular malfunction causing plaintiff's injury was the result of an unapproved supplier's modification of a component part of the regulated device. Purcel, 2008 WL 3874713 *1. The pleading with respect to the modification in Purcel alleged that defendant violated a particular federal specification referring to the device at issue. Similarly, in Rollins v. St. Jude Medical, 583 F.Supp.2d 790 (W.D.La.2008), the plaintiff stated a parallel claim where he was able to point to the alleged violation of premarketing packing requirements applicable to the particular medical device at issue. See Rollins, 583 F.Supp.2d at 800-01. In Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830 (S.D.In.2009), the patient sued the manufacturer of an artificial hip replacement device, asserting claims of strict liability for defective manufacture, negligent manufacture, breach of express warranty, breach of the implied warranty of fitness for a particular purpose, breach of the implied warranty of merchantability, and violations of the Indiana commercial fraud statute. The manufacturer moved to dismiss. The District Court, David F. Hamilton, Chief Judge, held that the patient's claims were 7
not preempted under the express preemption clause of the Medical Device Amendments of 1976 (MDA). Hofts' negligence and strict liability claims (Counts I and IV of his Amended Complaint) stem from his allegations that Howmedica defectively manufactured the Trident by violating the FDA's manufacturing requirements. The Court wrote: Here it is clear that Hofts bases his tort claims on his allegations that Howmedica failed to meet the FDA's requirements, not on allegations that Howmedica failed to depart from or exceed those requirements. A jury could find that Howmedica breached the duty of care it owed to Hofts by failing to adhere to the FDA's manufacturing requirements without imposing different or additional requirements. See Lohr, 518 U.S. at 495, 116 S.Ct. 2240. Similarly, on Hofts' strict liability claim, a jury could find that Howmedica's deviation from the FDA's manufacturing requirements was unreasonably dangerous without imposing different or additional requirements. If supported by the evidence, these results would be entirely consistent with the legal presumption that the FDA got it right in setting those requirements. A jury verdict could simply enforce those same federal requirements. The only state law requirements implicit in Hofts' tort claims are thus identical or parallel to the FDA's federal requirements under Riegel, so that Hofts' state tort claims are not preempted under section 360k(a). 597 F.Supp.2d 830, 836. In addition, the Court found that Hofts express breach of warranty claims were also not preempted. C. Product Liability Claims involving a Medical Device that was Approved Pursuant to a 510(k) Should Not Be Preempted Riegel, and its progeny all address Class III medical devices that have been approved pursuant to the PMA process. 8
Medical Device Amendments (MDA) classify medical devices in three categories based on risk to public: devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by general controls; potentially more harmful devices are designated Class II and may be marketed without advance approval, but their manufacturers must comply with federal performance regulations known as special controls; and devices that either present potential unreasonable risk of illness or injury, or which are purported or represented to be for use in supporting or sustaining human life or for use which is of substantial importance in preventing impairment of human health, are designated Class III and must obtain premarket approval (PMA). Federal Food, Drug, and Cosmetic Act, 513(a)(1)(A, B, C), as amended, 21 U.S.C.A. 360c(a)(1)(A, B, C). Two important exceptions exist to premarket approval (PMA) requirement for Class III medical devices under Medical Device Amendments (MDA): first, grandfathering provision allows pre-1976 devices to remain on market without Food and Drug Administration (FDA) approval until such time as FDA initiates and completes requisite PMA, and second, to prevent manufacturers of grandfathered devices from monopolizing market while new devices clear PMA hurdle and to ensure that improvements to existing devices can be rapidly introduced into market, MDA also permits devices that are substantially equivalent to preexisting devices to avoid PMA process. Federal Food, Drug, and Cosmetic Act, 515(b)(1)(A, B), as amended, 21 U.S.C.A. 360e(b)(1)(A, B); 21 C.F.R. 814.1(c)(1). While Class III medical devices which are substantially equivalent to devices already approved may be marketed under Medical Device Amendments (MDA) without rigorous premarket approval (PMA) review, such new devices, as well as all new Class I and Class II devices, are subject to limited form of review under which every manufacturer intending to market new device is required to submit premarket notification to Food and Drug Administration (FDA); if FDA concludes that the device is substantially equivalent to preexisting device, it can be marketed without further regulatory analysis. Federal Food, Drug, and Cosmetic Act, 510(k), as amended, 21 U.S.C.A. 360(k). Where a device has been approved pursuant to a 510(k) approval, there is no submission of detailed clinical studies and related scientific 9
analysis. Under Medtronic v. Lohr, 518 U.S. 470, 116 S.Ct. 2240 (1996), the Supreme Court held that state law defective design claims asserted against manufacturer of pacemaker which was Class III device under Medical Device Amendments (MDA), and which was marketed as device substantially equivalent to devices already on market, were not preempted under MDA; Food and Drug Administration (FDA) in approving device based on substantial equivalency did not require pacemaker to take any particular form for any particular reason, and simply allowed pacemaker to be marketed without running gauntlet of premarket approval (PMA) process under MDA. Federal Food, Drug, and Cosmetic Act, 510(k), as amended, 21 U.S.C.A. 360(k). 895594.1 10