ABA Health eSource
November 2008 Volume 5 Number 3

Medical Device Safety Act Of 2008: Implications For Industry
by Jeffrey D. Zigler, 1 Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), Washington, DC

Jeffrey D. ZiglerBoth the Food and Drug Administration (FDA) and the medical device industry continue to battle the would-be champions of healthcare consumer protectionism in Congress. House Resolution 6381, dubbed the "Medical Device Safety Act of 2008," 2 represents the most current, as well as one of the most sweeping, legislative changes to the current regulatory environment for the industry today. As consultants to leading innovators of the medical device industry, acting as catalysts for their regulatory activity, and advocating before regulatory bodies tasked with enforcing Congress' will, firms like Musculoskeletal Clinical Regulatory Advisers (MCRA) in Washington, DC view this ongoing fight as one which industry professionals, manufacturers, and regulatory attorneys alike should all take notice.

The bill is itself quite brief, but would have significant impact on medical device manufacturers' ability to defend against state-level lawsuits based on federal pre-emption under the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act (FDCA). 3 Indeed, the bill's anti-pre-emption provision states that the federal FDCA would have "No Effect on Liability Under State Law."

The bill's proponents argue that patients should be able to hold negligent device manufacturers accountable for injuries caused by unsafe products, and that principles of federal pre-emption should not stand in their way. Some members of Congress posit that passing this bill would prevent manufacturers from receiving "total immunity" from any claims, "simply by virtue of receiving . . . [FDA] approval." 4 The reasons behind this bill are probably best understood when considered in light of the Bush administration's surge of rulemaking that is protective of pre-emption in many contexts other than just medical device regulation. 5

Legislative History and Recent Supreme Court Decisions

Congressmen Frank Pallone, Jr. [D-NJ] and Henry Waxman [D-CA] are sponsoring the bill, which may gain traction in the House as it enters the House Committee on Energy and Commerce, of which both are members. According to a June 26, 2008 press release, the bill "protects patients from dangerous and defective devices by correcting the [Supreme] Court's flawed interpretation of the [Medical Device Amendments]." 6 Rep. Pallone said in a statement that the Medical Device Safety Act of 2008 would reverse "an unfortunate Supreme Court decision that denied victims any legal recourse." 7 The case referenced in Congressman Pallone's statements is Riegel v. Medtronic, 8 an 8-1 decision that denied plaintiffs the ability to successfully argue state common law tort claims because they were pre-empted under federal law. 9

Following this decision, states cannot maintain requirements that are more stringent than federal standards. But the Medical Device Safety Act, if passed, would directly negate the Riegel decision, allowing product liability lawsuits to be pursued at the state level by individuals seeking damages for injuries alleged to have resulted from inadequate warnings as to medical devices provided by device manufacturers, even though such products had been reviewed by the FDA and met the agency's approval standards. The bill, if passed, would effectively overturn the Supreme Court's decision against this same attack on the FDA's authority in Riegel.

In Riegel, decided in February 2008, the Court determined "whether the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 U.S.C. § 360(k), bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the . . . [FDA]." 10 The device manufacturer's arguments in Riegel were based on the particular language in the Medical Device Amendments' built-in pre-emption clause, which was created to dispense with such arguments in the first place. 11 In other words, the Riegel Court was unwilling to undo what it believed to be Congress' original intent in construing this clause in favor of the federal Amendments. The Court held that the federal law creating the FDA's review-and-approval mechanisms under the Medical Device Amendments of 1976 "pre-empted," or overrided, all state law claims. 12 This was due largely to the fact that the FDA's formal Premarket Approval (PMA) processes were found to already be stringent enough, and sufficiently protected consumers across the nation. 13

Riegel was not the first time the Court has visited this issue. In 1996, twelve years before Riegel was decided, the Court heard arguments in Medtronic v. Lohr that a Florida state statute similarly pre-empted federal law establishing the § 510(k) process. 14 The Lohr Court determined that since the § 510(k) process "is focused on equivalence, not safety, substantial equivalence determinations provide little protection to the public."

Whereas the Riegel Court based its decision on the PMA process, the Lohr decision was based on the FDA's review of a medical device for substantial equivalency under the § 510(k) process. In clarifying the Lohr decision, the Riegel Court noted that PMA approval 1) was specific to individual devices, 2) was focused on safety, and 3) could only be achieved if the applicant sufficiently demonstrated to the FDA that the device in question offered "a reasonable assurance of safety and effectiveness." 15

Framing the Issue for the Industry

The Medical Device Safety Act of 2008, if passed, could create flurries of legislative and litigious activity at the state level, as tort claims would immediately be filed seeking what The Wall Street Journal termed "jackpot jury awards," and state laws unfavorable to the industry would be crafted in subsequent state legislative sessions. 16

To this point, The Wall Street Journal raised an interesting argument in a recent op-ed article, the notion that subjecting medical device manufacturers to both federal and state law claims amounts to a sort of "double-jeopardy," wherein manufacturers would ostensibly have to answer for their designs, claims, and warnings at both the federal and the state level. 17

The issue of states' rights and federalism is one that has been debated for many years, and today strikes at the very heart of the medical device industry: its members' freedom to innovate. If the Medical Device Safety Act of 2008 exits committee, and if its exposure in the House continues to increase, Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT) plan to introduce companion legislation in the Senate. If the bill does not die in committee, key members of the medical device industry need not only take notice, but perhaps active measures to re-frame the issue as one of federalism trumping states' rights, emphasizing the industry's (not to mention the economy's) need for uninhibited growth of small-to-midsize manufacturers' technological innovation.

1 Mr. Zigler has been an orthopedic medical device consultant with MCRA since September 2007, advising clients on reimbursement and regulatory matters. If you have any additional questions or comments on this article or a related matter, you may contact him at jzigler@mcra.com or (202) 552-5800.
2 Medical Device Safety Act of 2008, H.R. 6381, 110 th Congress, 2d Sess. (2008) ( Source: http://thomas.loc.gov) .
3 21 U.S.C. § 360(k).
4 House of Representatives floor statements made by Rep. Bruce Braley (D-IA), July 8, 2008, and by Rep. Anthony Weiner (D-NY), July 22, 2008 ( Source: http://thomas.loc.gov) .
5 Op Ed, " Bush Rule Changes Could Block Product-Safety Suits," Wall Street Journal, Oct. 15 2008, http://online.wsj.com/article/SB122403828537735379.html?mod=dist_smartbrief.
6 http://www.house.gov/list/press/nj06_pallone/pr_june26_medicaldevice.html.
7 http://www.newsinferno.com/archives/3357.
8 552 U.S. ___ (2008).
9 http://www.newsinferno.com/archives/3357.
10 552 U.S. ___ (2008).
11 Id.; AdvaMed, a medical device industry trade association, recently commented on the Amendments' express preemption clause, stating that " The Congress provided express preemption authority relative to FDA device approvals in 1976 because lawmakers recognized that a central, expert authority at the federal level would best serve the interests of public health and safety for all Americans...," http://medicaldesign.com/engineering-prototyping/regulatory/medical_device_safety_act_0207.
12 21 U.S.C. § 360k(a).
13 Although affecting all devices approved under FDA's PMA process, it should be noted that this decision remained silent on the issue of preemption of state laws for devices cleared under "510(k)" premarket notifications to the FDA.
14 518 U.S. 470 (1996); the "510(k)" process allows for an FDA application to be made, whereby clearance is obtained by applicants who can demonstrate their products' substantial equivalence to a predicate device(s).
15 552 U.S. ___ (2008).
16 http://www.medicalnewstoday.com/articles/118256.php.
17 Op Ed, "Device for Lawyers," Wall Street Journal, Aug. 13 2008, p. A16, http://online.wsj.com/article/SB121858631283235063.html.
18 Eighteen

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