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1 Number 522 July 18, 2006 Client Alert Latham & Watkins Litigation Department Second Circuit Finds State Common Law Claims Involving FDA Premarket Approved Medical Devices Preempted Riegel is a significant decision for medical device manufacturers because it increases the number of states in which common law claims involving premarket approved devices are foreclosed. The Second Circuit recently joined the Third, Fifth, Sixth, Seventh and Eighth Circuits in holding that Section 360k(a) of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC 301, et seq., preempts certain state common law tort claims regarding medical devices that have entered the market through the Food and Drug Administration s premarket approval (PMA) process. See Riegel v. Medtronic Inc., 2006 WL , Case No CV (2d Cir. May 16, 2006). Consistent with the majority of Circuit Courts that have considered the issue, the Second Circuit found that product liability claims alleging liability as to a PMA-approved device regardless of the manufacturer s adherence to the PMA process such as claims for strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing and sale claims impose different requirements on a manufacturer than those imposed by the FDA, and are therefore preempted. By contrast, product liability claims seeking damages based on a manufacturer s alleged departure from the PMA approval standards, such as negligent manufacturing, do not fall within the scope of the FDCA s preemption provision. The Medical Device Amendments Premarket Approval The Medical Device Amendments to the FDCA were enacted in 1976 to provide for the safety and effectiveness of medical devices intended for human use. The Amendments group medical devices into three categories Classes I, II and III. Class I and II devices, ranging from elastic bandages to powered wheelchairs, are subject to fewer FDA controls than Class III devices. Class III devices are those that either present[] a potential unreasonable risk of illness or injury or are for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health. 21 USC 360c(a)(1)(C)(ii). Devices that are classified as Class III devices must be approved by the FDA before being marketed. The two most common avenues for obtaining FDA approval of Class III medical devices are the 510(k) process and PMA. The 510(k) process applies to devices shown to be substantially equivalent to devices that entered the market prior to the 1976 Medical Device Amendments and were not subject to FDA approval if a manufacturer Latham & Watkins operates as a limited liability partnership worldwide with an affiliate in the United Kingdom and Italy, where the practice is conducted through an affiliated multinational partnership. Copyright 2006 Latham & Watkins. All Rights Reserved.

2 establishes that a new device is substantially equivalent to one that is already on the market, the manufacturer may market the new device without going through the lengthy premarket approval process. If no substantial equivalent exists for a new device, the 510(k) process is not an option, and the device must obtain premarket approval. The PMA process requires a manufacturer to submit a detailed PMA application to the FDA containing, among other things: reports of all clinical and non-clinical studies of the safety and effectiveness of the device; a statement of the device s components; ingredients, properties and principles of operation of the device; a description of the methods used in the manufacture and processing of the device; details regarding any marketing of the device; information about performance standards; samples of proposed labeling; and any other information requested by the FDA. 21 CFR After reviewing the PMA application, the FDA has authority to approve, deny, or impose modifications the FDA may issue: an approval order indicating that the device meets the requirements for approval under the FDCA; an approvable letter informing the manufacturer that it believes the device will be approved if the manufacturer agrees to certain conditions; a not approvable letter describing the deficiencies in the application; or an order denying approval. 21 CFR (c). Once the FDA approves a PMA application, the applicant must comply with the approval order, which contains conditions to approval. 21 CFR In addition, any subsequent changes that may affect the safety or effectiveness of the device must be submitted to the FDA for approval, through a PMA supplement. 21 CFR (a). Section 360k(a) In addition to setting forth the procedure for obtaining premarket approval of medical devices, the Medical Device Amendments contain an express preemption clause, which states, in relevant part: [N]o state or political subdivision of a State 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 USC 360k(a). The Act does not define the term requirement, making it unclear whether Congress intended the provision to preempt state common law claims. The FDA s regulations on preemption provide that state requirements are preempted only when the FDA has established specific requirements applicable to a particular device. The Supreme Court considered the scope of Section 360k(a) in 1996 in Medtronic, Inc. v. Lohr, 518 US 470 (1996). Medtronic v. Lohr In Lohr, the Supreme Court considered whether Section 360k(a) preempts state common law claims involving medical devices that have entered the market through the 510(k) notification process. The plaintiff in Lohr brought claims for negligence and strict liability against Number 522 July 18, 2006

3 Medtronic after a pacemaker equipped with the company s Model 2011 pacemaker lead failed and the plaintiff was required to undergo emergency surgery. The Justices unanimously agreed that the plaintiffs design defect claims were not preempted because the 510(k) process merely establishes whether a new device is substantially equivalent to a pre-1976 device and does not, therefore, impose any pre-empting federal requirements on the new device. Lohr, 518 US at 494, 507, 513. With respect to the plaintiffs manufacturing and labeling claims, however, the Court was divided. Justices Stevens, Kennedy, Souter, Ginsburg, and Breyer (writing separately) concluded that these claims were not preempted because the FDA manufacturing and labeling requirements that covered the device at issue were general, rather than device-specific. In other words, these Justices held that Section 360k(a) s reference to requirements applicable under the Act means that only devicespecific FDA requirements can give rise to preemption. Lohr, 518 US at 500. Justices Rehnquist, O Connor, Scalia and Thomas disagreed, concluding that any FDA requirements, whether general or device-specific, give rise to preemption. Id. at The Justices also disagreed on the broader question of whether common law duties may ever constitute requirements for purposes of preemption under Section 360k(a). Although Justices Stevens, Kennedy, Souter and Ginsburg declined to decide this issue, they made their opinion clear that few, if any, common law duties have been preempted by the provision and that it would be rare, indeed to find such a state action that falls within the statute s parameters. Id. at As to the state claims at issue in Lohr, they held that they were not specifically developed with respect to medical devices, and did not therefore constitute requirements under the preemption provision. By contrast, Justices O Connor, Rehnquist, Scalia and Thomas found that, as with state statutes and regulations, common law actions do impose requirements on manufacturers, and are preempted by Section 360k(a) to the extent they are different from, or in addition to, FDCA requirements applicable to a device. Id. at 512. While Justice Breyer declined to join Justice O Connor s decision, he agreed that the word requirement may be read as including the legal requirements that grow out of the application, in particular circumstances, of a State s tort law. Id. at 504. Post-Lohr Preemption of Claims Involving PMA Devices Although the Lohr Court did not address the preemption of state claims involving devices entering the market through the PMA process, the majority of courts that have addressed this question since Lohr have relied on the Court s interpretation of Section 360k(a) in holding that such claims are preempted. The Third, Fifth, Sixth, Seventh and Eighth Circuits have all held that approval through the PMA process, unlike the 510(k) process, amounts to a federal device-specific requirement, and that common law tort actions alleging liability as to a premarket approved device regardless of the manufacturer s adherence to the PMA process conflict with that requirement, and are therefore preempted. See Horn v. Thoratec Corp., 376 F.3d 163, (3d Cir. 2004); Martin v. Medtronic, Inc., 254 F.3d 573, (5th Cir. 2001); Brooks v. Howmedica, Inc., 273 F.3d 785, (8th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216, (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902, (7th Cir. 1997). The Eleventh Circuit is the only exception. In Goodlin v. Medtronic Inc., 3 Number 522 July 18, 2006

4 the Court concluded that the PMA process represents nothing more than a finding by the FDA that the manufacturer s proposal to market a device has reasonably assured the FDA of the device s safety and effectiveness, and does not provide any indication of what (if any) specific substantive requirements the FDA may have applied to reach its determination. Thus, the Court in Goodlin held that state claims involving PMA devices are not preempted because premarket approval does not constitute a federal requirement within the meaning of Section 360k(a). See Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1377 (11 th Cir. 1999). Riegel v. Medtronic The Second Circuit considered the same issue in Riegel, and joined the majority in holding that state claims relating to PMA approved devices may be preempted. Factual and Procedural Background The device at issue in Riegel was Medtronic s Evergreen Balloon Catheter, a device used to open clogged arteries during angioplasties performed on patients with coronary heart disease. The FDA originally approved the catheter as a medical device through the PMA process on August 30, PMA supplements relating to the product s labeling were approved on April 27, 1995 and April 18, On May 10, 1996, Plaintiff Charles Riegel underwent a percutaneous transluminal coronary angioplasty, during which his physician used Medtronic s catheter. The physician inserted the catheter into a damaged artery multiple times before it burst, and Mr. Riegel lost consciousness and was required to undergo emergency coronary bypass surgery. Mr. Riegel survived the incident, but claimed in his complaint that he suffered severe and permanent personal injuries and disabilities. Mr. Riegel and his wife sued Medtronic in the Northern District of New York for negligence in the design, testing, inspection, manufacture, distribution, labeling, marketing and sale of the Evergreen Balloon Catheter; strict liability; breach of express warranty; breach of implied warranty; and loss of consortium. Medtronic moved for summary judgment on all claims on the ground that they were preempted by Section 360k(a) of the Medical Device Amendments to the FDCA. On March 14, 2002, the District Court granted Medtronic s motion with respect to the strict liability, breach of implied warranty, and most of the negligence claims, but the Court let stand the Riegels breach of express warranty and negligent manufacturing claims. After discovery, Medtronic moved for summary judgment on the remaining claims. On December 2, 2003, the District Court granted Medtronic s motion, holding that Medtronic was entitled to judgment as a matter of law on each claim. The Riegels appealed both the District Court s March 14, 2002 and December 2, 2003 decisions. Relying on the stringent premarket approval process, the explicit preemption provision of the Medical Device Amendments, and the Supreme Court s decision in Medtronic v. Lohr, the Second Circuit affirmed both orders, and entered summary judgment on all claims. Interpretation and Application of Lohr Writing for the majority, Judge Pooler interpreted Lohr as setting forth two main principles for determining whether a common law tort action involving a medical device is preempted by Section 360k(a) of the Medical Device Amendments. First, the court must consider whether there are any devicespecific federal requirements covering Number 522 July 18, 2006

5 the device at issue. If so, the court must determine whether the liability-creating premises of the plaintiff s state-law tort claims impose requirements that are different from or in addition to those federal requirements. Riegel, at *10. The majority in Riegel concluded that approval through the PMA process, unlike the 510(k) process, amounts to a federal device-specific requirement. The Court emphasized that the PMA process requires a manufacturer to provide reasonable assurance of a device s safety and effectiveness and denotes FDA approval of a new device, neither of which is the case for the 510(k) process. In addition, the PMA process expressly gives the FDA the authority to require a device to take a particular form in order to be approved as safe and effective. Once the device has been approved, the manufacturer cannot make any changes that might affect its safety and effectiveness without further FDA approval. Thus, the Court concluded that a device that has gone through the PMA process is subject to the federal, device-specific requirement of adhering to the standards contained in its individual, federally approved PMA. Riegel, at *12. Having determined that the catheter at issue in Riegel was subject to a federal device-specific requirement within the meaning of Section 360k(a), the Court proceeded to consider whether the Riegels claims would, if successful, result in state requirements that differed from or were greater than the PMA standards. The Court concluded that claims for strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing and sale constitute state requirements for purposes of preemption under Section 360k(a). In reaching its decision, the majority emphasized that the liability-creating premise of all of these claims is that the Evergreen Balloon Catheter itself, in its present PMA-approved form, is in some way defective and therefore requires modification. Riegel at *15. A jury verdict in the Riegels favor on any of these claims would represent a finding that the [catheter] had not adhered to the various state common law duties implicated by those claims, e.g., that its design did not comport with the duty of due care or that its labeling did not comport with the duty to warn, which would differ from the FDA s approval of the device as safe and effective. Thus, the Court held that each of these claims fell within the parameters of Section 360k(a). However, the Court reached the opposite result with respect to the Riegels negligent manufacturing claim. Because the negligent manufacturing claim was based on the allegation that the particular catheter deployed during the Plaintiff s angioplasty was not manufactured in accordance with the PMA-approved standards, the Court found that it did not impose additional requirements on Medtronic. If the Riegels negligent manufacturing claim was successful, Medtronic would merely be required to compensate them for deviating from the PMA standards. The Court summarized its holding as follows: [T]ort claims that are premised on a manufacturer s deviation from the standards set forth in the device s approved PMA application such as the Riegels negligent manufacturing claim are in no way preempted. Only those claims that allege liability despite a PMA-approved device s adherence to those standards are, pursuant to this decision, preempted. Riegel, at *17. Conclusion Riegel is a significant decision for medical device manufacturers because it increases the number of states in which common law claims involving Number 522 July 18, 2006

6 premarket approved devices are foreclosed. Although the vast majority of medical devices entering the market today do so through the 510(k) notification process, new devices for which Section 510(k) is not an option must be approved through the PMA process, which is lengthy and rigorous and requires a tremendous investment of time and resources. Manufacturers that invest the manpower in preparing and submitting a premarket approval application need to have assurance that they will not be subject to state common law liability after adhering to the FDA s stringent PMA process. Although Riegel does not eliminate all state law claims, it significantly reduces the number of such claims available to plaintiffs, and it further solidifies the validity and effectiveness of preemption as a defense. Office locations: Brussels Chicago Frankfurt Hamburg Hong Kong London Los Angeles Milan Moscow Munich New Jersey New York Northern Virginia Orange County Paris San Diego San Francisco Shanghai Silicon Valley Singapore Tokyo Washington, D.C. Client Alert is published by Latham & Watkins as a news reporting service to clients and other friends. The information contained in this publication should not be construed as legal advice. Should further analysis or explanation of the subject matter be required, please contact the attorneys listed below or the attorney whom you normally consult. A complete list of our Client Alerts can be found on our Web site at If you wish to update your contact details or customize the information you receive from Latham & Watkins, please visit to subscribe to our global client mailings program. If you have any questions about this Client Alert, please contact Allen M. Gardner or Marguerite M. Sullivan of the Washington, D.C. office or any of the following attorneys. Brussels Jean Paul Poitras +32 (0) Chicago Juli Wilson Marshall Frankfurt Bernd-Wilhelm Schmitz Hamburg Ulrich Börger Hong Kong Joseph A. Bevash London John A. Hull David L. Mulliken Los Angeles Daniel S. Schecter Milan David Miles Moscow Anya Goldin Munich Jörg Kirchner New Jersey Alan E. Kraus New York James V. Kearney Northern Virginia Eric L. Bernthal Orange County Jon D. Anderson Paris Patrick Dunaud +33 (0) San Diego Robert M. Howard San Francisco James K. Lynch Stephen Stublarec Peter A. Wald Shanghai Rowland Cheng Silicon Valley Patrick E. Gibbs Singapore Mark A. Nelson Tokyo Bernard E. Nelson Washington, D.C. Allen M. Gardner Marguerite M. Sullivan Number 522 July 18, 2006