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  • BIOETHICS FORUM ESSAY

Safety First – Or Safety Preempted?

According to the World Street Journal, the Food and Drug Administration is about to launch a new effort – appropriately dubbed “Safety First” – to enhance its capacity to oversee the safety of already approved drugs. Given the host of drug-safety problems revealed in recent years, from Vioxx to Avandia, as well as the ongoing investigation of at least 21 deaths tied to heparin imported by Baxter International from China, the announcement of the Safety First program appears timely. Unfortunately, any progress it may promote, and its details have yet to be made public, may be undermined by another less-heralded FDA project: the preemption of lawsuits against drug-makers.

For decades, individuals who have felt that they were harmed due to unsafe drugs have been able to sue drug manufacturers under a variety of claims, most typically for inadequate labeling of the risks associated with the drug. Such lawsuits generally depend on state common law, which has long been thought a part of the states’ traditional power to protect the health and safety of their citizens. Few thought that such lawsuits were incompatible with the FDA’s regulatory efforts. Indeed, for decades the FDA did not make such a claim.

In the last several years, however, spurred by Supreme Court rulings in other product liability cases, drug companies and their advocates have begun to suggest that the FDA’s approval process for drugs preempt, or barred, state lawsuits. According to preemption advocates, the FDA’s decision to regulate a drug or approve its label constitutes a carefully calibrated determination of the drug’s costs and benefits which may be undermined by any court finding of liability against a manufacturer that has complied with the FDA. Hence private litigation conflicts with and must be displaced by FDA regulations.

In the early years of the Bush Administration, the FDA adopted this view and began to express it to courts in amicus briefs. Then in 2006, in a preamble to new drug labeling regulations, the FDA firmly asserted that its regulations preempted private law suits alleging that drug companies had inadequately warned the public of a drug’s risk.

Although the Supreme Court will not rule decisively on the issue until next term, lower courts have split on the issue. Moreover, there are strong reasons to believe that several of the Supreme Court justices will be receptive to the FDA’s position. For example, last month in Riegel v. Medtronic, Inc., the Court decided 8-1 that lawsuits cannot be brought against unsafe medical devices that are subject to FDA premarketing approval. In its decision the Court noted that the plaintiff had argued that because state lawsuits have long been brought about drugs, lawsuits should be likewise be allowed against medical devices approved by the FDA. The Court accepted the comparison between the two types of lawsuits but questioned the plaintiff’s conclusion. As the Court saw it, the similarities between drugs and medical devices could as well suggest that drug cases should be preempted.

A more telling indication that some justices may be prepared to preempt tort litigation against drug companies derived from the Court’s decision in Warner-Lambert Company v. Kent.In that relatively narrow case, which did not pose the broad question of whether or not state tort litigation against drug companies is preempted, the Second Circuit Court of Appeals upheld a Michigan statute that barred claims against drug makers except when the drug company committed fraud on the FDA. With only eight justices hearing the case, the Court divided 4-4, thereby affirming without opinion the lower court. Chief Justice Roberts, who to date has shown himself to be a firm supporter of federal authority, did not participate in the decision. Had he done so, the outcome may well have been different.

According to Linda Greenhouse of the New York Times, during oral arguments in Warner-Lambert, Justice Breyer asked who was better equipped to protect public safety, “[a]n expert agency on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?”

In a perfect world, the answer to Justice Breyer’s question would be obvious. As he suggests, jurors are often ill equipped to assess the complex epidemiological and medical evidence critical to drug cases. Nor are jurors charged with looking at the big picture. They are rightly focused on the harm caused to the individual plaintiff sitting before them. That bias may lead jurors to find liability even if a drug’s overall benefits exceed its harm. And perhaps, although empirical support for the point is surprisingly thin, such liability may deter drug companies from investing in and marketing beneficial products.

But as the frequent headlines about lapses in drug safety make clear, we do not live in a perfect world. Far from it. As the 2006 Institute of Medicine report The Future of Drug Safety: Promoting and Protecting the Health of the Public revealed, the FDA is ill-equipped to assure the safety of the drugs that are on the market. The recently enacted Food and Drug Amendments Act of 2007 may help, but it is far from clear that it will do the trick, especially if the courthouse door is slammed. For despite all of the imperfections of litigation, it may give the FDA more help than hindrance. This is in part because the evidence amassed through the civil discovery process can help bring information to the FDA’s attention that it would otherwise never receive. Moreover, the fear of litigation can prompt manufacturers to cooperate with the FDA and accept broader and more energetic regulatory oversight.

Litigation is an expensive and clumsy tool for protecting the public’s health. It is also an inefficient way to compensate people who have been injured. But in our very imperfect world, it is the only means we have of doing the latter. And it is one of the most potent methods we have of pressuring industries and the agencies that regulate them to do the former. Perhaps someday preemption may make sense, but only if and when safety has truly been put first.

Published on: March 6, 2008
Published in: Health and Health Care, Medical Error & Malpractice Reform

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