Preemption and Regulatory Failure

This symposium was convened to address the growing and seemingly conflicting jurisprudence governing federal preemption of state damage actions. One way to evaluate the evolution of preemption law is to examine it through the lens of litigation under the preemption provision of the 1976 Medical Device Amendments ( MDA ) to the federal Food, Drug, and Cosmetic Act - a provision that in many respects is typical of express preemption provisions in regulatory statutes and has spawned a high volume of litigation. The question raised in cases under the MDA is whether the Act\u27s preemption provision nullifies state damage actions based on personal injuries caused by medical devices that are defective, poorly designed, or promoted in ways that do not alert patients (and physicians) to the risks that attend their use. The answer to that question depends on how one reads the MDA preemption provision

Lessons From a Story Untold: Nike v. Kasky Reconsidered

The Supreme Court\u27s recent dismissal, apparently on jurisdictional grounds, of the writ of certiorari it had granted to review Nike, Inc. v. Kasky has brought into sharp focus a number of critiques of the commercial speech doctrine - some new, some longstanding. At issue in Nike were communications Nike made to customers, newspaper editors, college presidents and athletic directors, and others responding to allegations that Nike had engaged in, or was complicit in, the mistreatment of foreign workers. Respondent Marc Kasky contended that Nike\u27s communications contained significant misstatements of fact and thus were actionable under California\u27s unfair competition and false advertising laws. Nike countered that, even if it had made factual misstatements, its communications were part of an ongoing public debate about the labor practices of multinational corporations generally and, for that reason, they were fully protected under the First Amendment. A sharply divided California Supreme Court rejected Nike\u27s theory, but the United States Supreme Court agreed to review Nike\u27s First Amendment claim. After full briefing and argument, a divided Court dismissed the writ as improvidently granted, much to the disappointment of Nike and its supporters who had forecast a Nike victory

Medical Device Safety Act of 2009: Hearing Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 111th Cong., May 12, 2009 (Statement of David C. Vladeck, Prof. of Law, Geo. U. L. Center)

I start with a brief history of the Medical Device Amendments of 1976 and explain why that history demonstrates that Congress quite clearly intended to preserve state liability law, not wipe it away. I will then turn to the Court\u27s ruling in Riegel and address why the Court\u27s wooden, textual approach to the Amendments -- which ignores their purpose -- led the Court to conclude, wrongly, that Congress intended the Amendments to preempt state liability claims for devices approved by FDA under the pre-market approval process. Next, I discuss the impact Riegel has had in the courts, resulting in the wholesale dismissal of device-related tort litigation and the denial of redress to thousands of patients injured by defective devices. Finally, I address the policy arguments against preemption and point out that the Court\u27s more recent decision in Wyeth v. Levine underscores the need for Congress to overturn Riegel

The Difficult Case of Direct-to-Consumer Drug Advertising

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise directly to consumers on television and other media. Justice Rehnquist argued that “there are sufficient dangers attending” the use of drugs “that they simply may not be promoted in the same manner as hair creams, deodorants, and toothpaste.” Today drugs are promoted in much the same way as other products. Drug companies devote forty percent of their advertising expenditures — over $4 billion per year — to DTC ads. The average American views as many as 16 hours of prescription drug ads per year, far exceeding the average time spent with a primary care physician. The question is whether proposals before Congress to limit or ban DTC advertising would pass constitutional muster. The article canvasses the arguments in some detail and concludes that legislation restricting DTC advertising to enable the FDA to assess the risks of a drug might withstand constitutional attack, but that an all-out ban on DTC advertising would not likely be sustained. The point of this discussion is to illustrate the complexity of commercial speech questions and to demonstrate that Professor Shiffrin was correct when he observed that “the commercial speech problem is in fact many problems,” and that “the small questions [it poses] will not go away.

A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. The article next explains why the agency’s view that it is capable of singlehandedly regulating the safety of drugs is unrealistic. The agency does not have the resources to perform the Herculean task of monitoring the performance of every drug on the market. Both the Institute of Medicine and the Government Accountability Office have explained the shortcomings in the FDA’s recent performance, and they express doubt that the FDA is in capable of facing an increasingly challenging future. The article then explains how state damages litigation helps uncover and assess risks that are not apparent to the agency during a drug’s approval process, and why this “feedback loop” enables the agency to better do its job. FDA approval of drugs is based on clinical trials that involve, at most, a few thousand patients and last a year or so. These trials cannot detect risks that are relatively rare, affect vulnerable sub-populations, or have long latency periods. For this reason, most serious adverse effects do not become evident until a drug is used in larger population groups for periods in excess of one year. Time and again, failure-to-warn litigation has brought to light information that would not otherwise be available to the FDA, to doctors, to other health care providers, and to consumers. And failure-to-warn litigation often has preceded and clearly influenced FDA decisions to modify labeling, and, at times, to withdraw drugs from the market