ABA Health eSource
December 2008 Volume 5 Number 4

Should Drug and Device Manufacturers Be Immunized Against State Tort Law Liability If Their Products Have Been Approved By the FDA? No
By Marilyn Mann, 1 U.S. Securities and Exchange Commission, Washington, DC

I. Introduction

In the November 2008 issue of eSource, Jeffrey D. Zigler wrote 2 to oppose the enactment of federal legislation that would overturn a recent Supreme Court decision that held that the preemption clause of the Medical Device Amendments of 1976 3 bars common-law claims challenging the safety or efficacy of a medical device marketed in a form that has received pre-market approval from the Food and Drug Administration (FDA). 4 Mr. Zigler, a consultant to the medical device industry, argues that the legislation, the Medical Device Safety Act of 2008, 5 should be opposed because (1) the legislation would be disadvantageous to the medical device industry, 6 and (2) the FDA premarket approval process for medical devices sufficiently protects consumers. 7

The Supreme Court will soon determine whether FDA approval of a drug’s label preempts failure-to-warn claims under state law. 8 Because the Federal Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, does not contain a preemption clause, in Wyeth v. Levine the Court will decide whether preemption of state tort litigation is implied by the statute, even though it is not explicitly stated.

Below I argue that state tort litigation supports, rather than impedes, effective FDA regulation of drugs and medical devices. Because the public policy arguments against preemption of state tort law are similar in the case of drugs and devices, I address both of them together below.

II. State Tort Litigation Does Not Conflict with the FDA’s Authority

State tort litigation does not seek to replace the FDA as final decision-maker over drug or device labeling or safety information. For example, state failure-to-warn litigation challenges the manufacturer’s failure to warn about risks that were known at the time of plaintiff’s injury. It does not challenge the FDA’s original decision to approve the drug. Moreover, FDA approval by necessity is based on the agency’s assessment of the product’s benefits and risks at the time of approval. Pre-market clinical trials generally involve only a few thousand patients and last only a period of a year or less. Pre-approval testing generally is not able to detect safety problems that only develop over a long period of time, result from drug interactions, occur rarely, or affect groups that were excluded from the studies. Accordingly, FDA regulations permit revision of labeling as new information becomes available, including in some cases without FDA preapproval. 11 In addition, the manufacturer is permitted to communicate safety information in other ways (e.g., “Dear Doctor” letters) as soon as such information becomes available.

III. The FDA’s Post-Approval Monitoring System Cannot, By Itself, Adequately Safeguard Public Health

State tort litigation plays an important role in protecting consumers from dangerous products. By necessity, drugs and devices are approved on the basis of imperfect knowledge. Safety risks often become clear only after a drug or device has been approved and has been used by thousands, or even millions of people. Despite the FDA’s current pro-preemption position, 12 the agency cannot by itself perform the immense task of monitoring the safety of every one of the drugs and devices on the market. The FDA does not have sufficient access to safety information and other resources that would enable it to monitor on a daily basis the safety of every one of these products.

The argument that the FDA is capable of policing the market on its own 13 is called into question by recent history. Over the past several years, the agency has experienced numerous regulatory failures with recently approved products. In each of these cases, there was a considerable delay between the time when the manufacturer became aware of a serious hazard with its drug and when the manufacturer provided that information to the FDA. 14

In addition, the FDA resources for monitoring the safety of the thousands of drugs and devices that it has approved are limited. According to reports issued by the Institute of Medicine (IOM) and the Government Accountability Office (GAO), the FDA’s post-approval surveillance programs detect only a small fraction of all adverse drug events. 15 The current regulatory framework is focused on the evidence that is available to the agency before a product is approved. State tort litigation provides the FDA, the medical profession and the public with information that is not known and would not otherwise be available to the FDA.

IV. Conclusion

Preemption of state tort litigation would undermine the FDA’s mission of protecting the public from dangerous products. Congress should pass the Medical Device Safety Act of 2008 and, if the Supreme Court rules in favor of preemption in Wyeth v. Levine, similar legislation with respect to FDA regulation of drugs.

The ABA Health eSource invites comments from its readers. Reader articles will be published as we have room, especially where articles provide additional insights into topics previously addressed in The ABA Health eSource.

1 Marilyn Mann is a branch chief in the Division of Investment Management, U.S. Securities and Exchange Commission. The Commission disclaims responsibility for any private publication or statement of any Commission employee or Commissioner. This article expresses the author’s views and does not necessarily reflect those of the Commission, the Commissioners, or other members of the staff. Her email address is mannma@sec.gov.

2 Jeffrey D. Zigler, Medical Device Safety Act of 2008: Implications For Industry, ABA Health eSource, November 2008, http://www.abanet.org/health/esource/Volume5/03/zigler.html.

3 21 U.S.C. § 360k(a).

4 Riegel v. Medtronic, 552 U.S. __, 128 S. Ct. 999 (2008).

5 Medical Device Safety Act of 2008, H.R. 6381, 110 th Congress, 2d Sess. (2008) (Source: http://thomas.loc.gov/cgi-bin/query/D?c110:1:./temp/~c1104NyGvO::).

6 While I do not necessarily agree that state tort litigation, or the threat thereof, would negatively impact the future of the medical device industry, this issue is beyond the scope of this article.

7 Mr. Zigler does not state this point directly, but his views are clear from his characterization of the sponsors of the Medical Device Safety Act of 2008 as “would-be champions of healthcare consumer protectionism” and his approval of what he states was the basis for the Supreme Court’s decision in Riegel v. Medtronic: the Court’s recognition that Congress, in enacting the preemption clause of the Medical Device Amendments of 1976, had concluded that the FDA’s pre-approval process was already “stringent enough, and sufficiently protected consumers.” However, I believe Mr. Zigler misconstrues the basis for the Court’s decision, which was based on the language of the preemption clause, not on Congressional intent.

8 Wyeth v. Levine, cert. granted 128 S. Ct. 1118 (2008).

9 I claim no originality for the ideas expressed in this article, as the ground has already been well-plowed by many others. See, e.g., David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s Efforts To Preempt Failure-To-Warn Claims, 96 Geo. L.J. 461 (2008); Leonard H. Glantz and George J. Annas, The FDA, Preemption, and the Supreme Court, NEJM 358;18:1883-85 (2008); Gregory D. Curfman, Stephen Morrissey, and Jeffrey M. Drazen, Why Doctors Should Worry About Preemption, NEJM 359;1:1-3 (2008); Brief for Donald Kennedy and David Kessler as Amici Curiae in Support of Respondent, Wyeth v. Levine, No. 06-1249.

10 To obtain approval for a new drug, a manufacturer must submit a new drug application (NDA) for the FDA’s review. 21 U.S.C. § 355. An NDA must include all information bearing on a drug’s safety and effectiveness, including the results of animal testing, pharmacological studies, and full reports of all clinical trials performed on human subjects. Premarket human trials often involve only a few thousand subjects, and the conditions of the study are carefully controlled, with subjects who take other drugs or have other diseases excluded. These conditions often differ dramatically from those under which a drug is used once it is approved.

11 Importantly, FDA regulations provide that “labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” 21 C.F.R. § 201.80(e); see also 21 C.F.R. § 201.57(c)(6)(i).

12 Until 2002, the FDA recognized that state tort litigation served as an important adjunct to the agency’s own efforts. Kessler & Vladeck, supra note 8, at 483-86. Currently, the FDA takes a pro-preemption position. See, e.g., Brief for United States as Amicus Curiae in Support of Petitioner, Wyeth v. Levine, No. 06-1249.

13 See, e.g., Petitioner’s Brief, Brief for United States as Amicus Curiae in Support of Petitioner, Wyeth v. Levine, No. 06-1249.

14 See, e.g., McDarby v. Merck, 949 A.2d 223, 241-44 (N.J. App. Div. 2008) (Merck delayed reporting information on Vioxx’s cardiovascular risks to FDA); Alex Berenson & Gardiner Harris, Pfizer Says 1999 Trials Revealed Risks With Celebrex, N.Y. Times, Feb. 1, 2005, at A1 (Pfizer withheld from FDA for two years study showing cardiovascular risks with Celebrex); Gardiner Harris & Eric Koli, Lucrative Drug, Danger Signals and the FDA, N.Y. Times, June 10, 2005 (discussing delays in reporting safety information on Propulsid); Denise Grady, FDA Reviews Accusations About Diabetes Drug, N.Y. Times, Mar. 16, 2000 (company failed to submit safety data on Rezulin to FDA).

15 IOM, The Future of Drug Safety, Promoting and Protecting the Health of the Public 51, 53 (2006); GAO, Drug Safety: Improvement Needed in FDA’s Postmarket Decision-Making and Oversight Process 18 (2006).


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