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This February, the U.S. Supreme Court rendered a decision holding that the Medical Device Amendments of 1976 pre-emption clause bars common-law claims against the safety or effectiveness of a medical device that has received Federal Drug Administration premarket approval. The opinion is captioned as Riegel v. Medtronic, Inc. The court ultimately decided that state actions in negligence and strict liability imposed additional “requirements” on manufacturers in violation of the MDA pre-emption clause. Justice Antonin Scalia wrote the majority opinion in which he was joined by Chief Justice John Roberts and Justices Anthony Kennedy, David Souter, Clarence Thomas, Stephen Breyer and Samuel Alito. Justice John Paul Stevens filed a separate concurring opinion and Justice Ruth Bader Ginsburg dissented. Factual Background and Procedural Posture In 1996, Charles Riegel underwent a coronary angioplasty procedure. His doctor inserted an Evergreen Balloon Catheter marketed by defendant Medtronic. His physician inflated the catheter beyond its stated burst pressure of eight atmospheres to 10 atmospheres. Riegel also had a heavily calcified coronary artery, a condition for which the device’s use was contraindicated. Upon inflation, the catheter burst and Riegel suffered severe injuries. The Riegels filed suit in the U.S. District Court for the Northern District of New York under claims of strict liability, breach of implied warranty and negligence. The court held that the MDA pre-empted the Riegels’ claims and dismissed the claims on summary judgment. The 2nd U.S. Circuit Court of Appeals affirmed. The U.S. Supreme Court granted certiorari. Majority Analysis The court began its analysis with the history of the MDA. Prior to its enactment, states had developed individual schemes for dealing with the approval of medical devices. The proliferation of medical devices brought numerous lawsuits for those devices that failed. Congress intervened in 1976 by passing the Medical Device Amendments. The MDA contained a pre-emption clause, which states, “[N]o 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 an requirement applicable to the device under this chapter.” The MDA established a process for premarket approval of new medical devices. Devices range in classification from I through III, class III devices receiving the greatest scrutiny from the FDA before approval. Under the MDA, however, many devices already on the market prior to the act’s passage were grandfathered in and did not need to go through the premarket approval process. Similarly, a new device “substantially equivalent” to a device exempt from premarket approval also did not need to go through the premarket approval process. The court then continued on to explain the “rigorous regime of premarket approval for new Class III devices.” Such process involved volumes of submissions by one seeking approval of a device. The FDA spends approximately 1,200 hours reviewing each application. If a device is approved, subsequent modifications to the device mandate that the revised device go back for re-approval by the FDA in a similar process to the initial approval. The Evergreen Balloon Catheter received premarket approval by the FDA in 1994 and subsequent modifications to its label were approved by the FDA in 1995 and 1996. The court then focused on the pre-emption language of the statute, noting that it only pre-empted state requirements differing from the MDA’s “requirements” under the MDA. In this regard, the court distinguished its prior ruling in the case of Medtronic, Inc. v. Lohr. In Lohr, the court held that the MDA did not pre-empt common law actions for devices approved through the substantial equivalence method. In Riegel, the court distinguished that holding by focusing on the word “requirements.” The court stated that devices getting premarket approval were put through individualized and rigorous tests by the FDA. Conversely, the substantial equivalence method is much less rigorous and individualized. Therefore, the court stated, it did not go through “requirements.” The court then looked at whether common law causes of action for negligence and strict liability impose requirements that are “different from” or “in addition to” those requirements under the MDA. The imposition of a “duty” under common law for a finding of liability subjects a manufacturer to requirements that a jury may deem unmet, yet do not appear in the MDA. In the absence of statutory language to the contrary, the court wrote that it was not its job to “speculate upon congressional motives.” The court stated if Congress meant for common law not to be pre-empted, it could have so written. The Riegels argued that even if the common law imposed “requirements,” that the requirements were not maintained “with respect to devices.” The court rejected this argument holding that the statutory text did not suggest that the pre-emption requirements apply only to the device at hand. The court recognized that the statute only pre-empted state requirements that are “different” or “in addition to” the MDA requirements. Therefore, common law claims based upon failure to meet the MDA, or claims “parallel to” the act, are not pre-empted. The court refused to hear any argument from the Riegels that their claims were parallel as this issue was not raised to the 2nd Circuit or in the certiorari briefs. The Dissent In her dissent, Ginsberg took a studied analysis of the passage of the MDA and its underlying purpose. She ultimately concluded that Congress did not intend to “effect a radical curtailment of state common-law suits” for consumers injured by devices. Ginsberg noted that there is a presumption against pre-emption unless there is clear showing by Congress that pre-emption is its intent. She further noted that where a statute has a pre-emption clause that is subject to more than one meaning, the presumption against pre-emption remains. Ginsberg focused on the fact that the MDA was a statute passed for the protection of consumers. Under her analysis, the absence of any remedy provision in the statute for consumers injured by approved devices is further credence to the fact that common law rights were not intended to be pre-empted. She argued that common law actions provided consumers with additional, necessary, protections. Under the court’s holding, consumers injured by defectively designed products that received FDA premarket approval were essentially without a remedy. Her analysis included former testimony of former chief counsel to the FDA in another case that the FDA’s view is that FDA product approval and state tort liability generally each act independently of one another, each providing different protections to consumers. Ginsberg also noted that the FDA provisions for food additives and drugs, although absent a pre-emption clause, still allowed common law negligence and strict liability to exist. Ginsberg stated the pre-emption clause only exists with medical devices because states had enacted their own premarket approval requirements prior to the passage of the MDA. No such schemes existed at the state level for drugs and food additives. The dissent further noted that the fact of receiving pre-market approval would still have relevance in a negligence suit. Such a showing could add to the defense in such a suit, or contradict a plaintiff’s liability theory. In all, she felt that the court’s holding was “at odds with the MDA’s central purpose: to protect consumer safety.” Stevens’ Concurring Opinion Stevens agreed with Ginsberg’s history of the MDA but ultimately believed that the court was limited to the statute’s actual text, which may not have fully represented the authors’ intent for the act. He further agreed that common law does create and define legal obligation, which can “unquestionably” be deemed as “requirements.” VASILIOS J. KALOGREDIS is president and founder of Kalogredis Sansweet Dearden & Burke, a health care law firm, and Professional Practice Consulting Inc., a health care consulting firm, in Wayne, Pa. Among his areas of expertise are group practice arrangements, practice sales and mergers, doctor contract drafting and negotiation, tax and retirement planning for physicians, joint ventures, fraud and abuse matters, and evaluation of practice options for physicians. He can be contacted at 800-688-8314 or by email at [email protected].

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