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Commentary: A Cure for What Ails the FDA

Publication Date: 
June 26, 2007
The American Lawyer
Peter Schuck

In the American Lawyer, Yale Law Professor Peter Schuck discusses the work of Professor Robert Rabin:

Still, some leading analysts with no ideological axes to grind support the status quo. Robert Rabin, a pre-eminent torts scholar at Stanford Law School and the co-editor of a leading torts casebook, has published a prominent defense of the traditional rule. He also argues that products failing to comply with FDA regulations are per se defective.

Let me explain why I and some other torts scholars reject Rabin's characteristically careful analysis and instead favor a federal statutory qualified regulatory compliance defense. Rabin's first argument invokes the value of state autonomy in tort law. Absent express federal pre-emption, he contends, this value militates against any regulatory compliance defense. But because the market for pharmaceuticals is national and international, the interest in nationally uniform rules is correspondingly greater than in other tort areas, like medical malpractice or workplace injuries. When the FDA acts within its unified, comprehensive system of drug regulation, its approval should usually pre-empt state tort liability.

For this reason, Rabin's next argument -- that a regulatory compliance defense would leave a "compensation gap" for injured plaintiffs -- misses a fundamental point about tort law that he has actually emphasized in his other work comparing social insurance to tort liability. Congress has authorized the FDA to determine the socially optimal level of drug safety and information, taking other factors into account. If, as I maintain, a properly labeled, FDA-approved drug is thereby not defective, tort compensation -- as distinct from no-fault compensation for injured consumers that Congress might authorize, as it has for certain childhood vaccines -- is simply inappropriate.

Rabin doubts that tort liability in such situations would deter manufacturers. Tell that to Merrill Dow Pharmaceuticals, whose safe and effective drug for treating morning sickness, Bendectin, was driven from the market by a few jury awards wholly inconsistent with the findings of objective scientists -- and indeed of most other Bendectin juries. Tell it to the breast implant manufacturers that paid more than $4 billion to settle lawsuits based on specious claims that this widely used product caused autoimmune disease. (A decade later, the FDA is allowing the product to be remarketed.) Tell it to Merck & Co. Inc., which withdrew Vioxx, the best nonsteroidal pain reliever for many (but not all) arthritis sufferers, partly out of fear of tens of thousands of tort claims alleging that it increased the risk of heart failure. So far, most Vioxx juries have found it safe and the labeling adequate, but some have not. In early March, a New Jersey jury awarded $20 million (plus possible punitive damages) to the family of a heart attack victim who had used Vioxx for two months. A few weeks later, an Illinois jury exonerated Vioxx in the case of a longtime user. Because the plaintiffs had different risk factors, these verdicts are not necessarily inconsistent -- but they could be. We'll never know what each of these juries was thinking. My larger point, however, is that this is no way to regulate drugs.

Rabin also observes, correctly, that many drug-related risks become apparent only when adverse drug reactions come to the FDA's attention -- after it has approved a drug -- and also notes that manufacturers might knowingly submit false or incomplete information to the agency. But these troubling possibilities, far from refuting the case for a carefully limited regulatory compliance defense, suggest only what those limits should be.