Supreme Court Clears Path for Medical Device Manufacturers but Leaves Dangerous Stones Unturned

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In the Medical Device Amendments of 1976 (MDA)1 to the Food, Drug and Cosmetics Act (FDCA), the U.S. Congress initiated testing and Federal Drug Administration (FDA) approval of medical devices2 Under the regulatory scheme of the MDA, Class III (high risk)3 medical devices are required to undergo a stringent pre-market approval process by the FDA to ensure that valid scientific evidence exists to support the safety and efficacy of the device for its intended uses.   This pre-market approval (PMA) process requires the applicant to demonstrate a “reasonable assurance” that the device is both “safe . . . [and] effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.”4

The MDA also contains a clause that preempts state law personal injury suits against manufacturers of medical devices that underwent the PMA process.  Prior to the U.S. Supreme Court’s February 2008 decision in Riegel v. Medtronic5, however, courts declined to give effect to the MDA’s preemption clause.  As a consequence, lawsuits alleging personal injury from FDA approved medical devices have cost the medical devices industry billions of dollars in damages awards, liability insurance, legal settlements, and fees spent defending lawsuits that should never have been allowed to proceed.  Although Justice Stevens writes in his concurrence in Riegel that “[t]here is nothing in the preenactment history of the MDA suggesting that Congress thought state tort remedies had impeded the development of medical devices,”6 the real-world impact of lawsuits on the medical device industry says otherwise. 

The tort industry that arose has had the unintended effect of retarding the advancement of medical device technology in the United States because of the risks and costs inherent in developing a new device, putting it through the FDA required PMA process, and then being faced with unpredictable litigation in state courts nationwide.7  “As a practical matter, complying with the FDA’s detailed regulatory regime in the shadow of 50 States’ tort regimes will dramatically increase the burdens facing potential applicants--burdens not contemplated by Congress in enacting the FDCA and the MDA.”8

Trying to navigate the tangle of state tort laws “generates substantial costs of compliance and . . . uncertainty and economic inefficiency.  The uncertainty may force manufacturers to forgo development, production, and marketing of otherwise valuable products that might expose them to unpredictable risk.  This risk, in turn, may negatively affect the variety of products available to consumers.”9

Research and development of new medical devices has consequently been slow, with many manufacturers preferring to create or update devices that are “substantially equivalent”10 to pre-amendment devices, rather than to create entirely new devices that would be subject to the FDA’s rigorous pre-market approval process, and potential targets of expensive litigation under the tort regimes of the different states.  Such pre-amendment devices have established records of safety and efficacy and well-understood risk profiles, substantially reducing the risk of prospective litigation.  As a consequence, fewer than 5% of medical devices in use today have undergone pre-market approval as new devices created since 1976.


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1 21 U.S.C. § 360(k)(a). Return to cited sentence

2 Medical devices include instruments, apparatuses, machines and implants that are intended for use to diagnose, cure, treat or prevent disease, or to affect the structure or any function of the body.  21 U.S.C.  § 321(h). Return to cited sentence

3 “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Return to cited sentence

4 21 U.S.C. § 360(e)(d)(2)(A) and (B). Return to cited sentence

5 Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1012 (2008). Return to cited sentence

6 Id. at 1012. Return to cited sentence

7 “There are four major barriers to innovation that are responsible for hindering the development of new medical technologies in the United States: (1) unpredictable and inappropriately focused U.S. regulatory practices, (2) controls on the export of unapproved devices, (3) restrictive reimbursement policies, and (4) the effects of widespread product liability lawsuits.”  William W. George, Medical Technology and Competitiveness in the World Market: Reinventing the Environment for Innovation, 50 Food & Drug L. J. 477, 479 (1995) Return to cited sentence

8 Buckman v. Plaintiff’s Legal Cmte., 531 U.S. 341, 350 (2001). Return to cited sentence

9 Michael Ena, Choice of Law and Predictability of Decisions in Products Liability Cases, 34 Fordham Urban L.J. 1417, 1418-19 (Oct. 2007). Return to cited sentence

10 21 U.S.C. § 510(k) permits commercial distribution, without completion of the PMA process, of medical devices that are “substantially equivalent to” devices in commercial distribution prior to the effective date of the MDA. Return to cited sentence