The Wyeth Case

This morning, the U.S. Supreme Court will hear oral arguments in a case that could give a boost to the Bush Administration’s backdoor “tort reform” efforts – an increasingly transparent effort to shield industry from litigation over defective products. The issue in Wyeth v. Levine is whether the Food and Drug Administration’s labeling requirements preempt state tort law.

Here are the facts of the case: Eight years ago, professional guitarist Diana Levine went to a clinic with a migraine and received an injection of Phenargen, an anti-nausea medicine. The drug’s label cautioned that one method for administering the drug – the so-called “Push IV” method of direct injection into a vein – was risky because of the danger that the drug could be injected into an artery instead of a vein. But the label did not instruct doctors not to use the technique. Indeed, the manufacturer, Wyeth, knew well that the potential hazards of direct injection were serious: if the drug hit a artery – as it did in Levine’s arm – it could kill tissue, forcing amputation or worse. Nevertheless, rather than instructing health care providers to use the safer intravenous drip method, Wyeth’s label only cautioned care. The worst happened, and Levine’s arm had to be amputated. She sued Wyeth over its failure to provide adequate warning of the dangers of the drug.

In court, Wyeth argued that because its label had been approved by the FDA, it could not be sued under state tort law. Indeed, Wyeth further maintains that it could not legally have distributed the drug with any additional labeling information, without prior approval from FDA. Not only were medical professionals adequately warned, the company maintains, but warning them more explicitly would have violated the law.

The argument that Wyeth cannot be sued for using an FDA-approved label relies on a misreading of the law – but it is a misreading the Bush Administration has promoted, and toward which the Supreme Court majority has shown some sympathy. The relevant law is the Federal Food, Drug and Cosmetic Act, which gives FDA authority to approve drugs for use in the market. Nothing in the now 70-year-old statute suggests that it preempts state tort laws, and FDA has long expressed the view that it did not. Neither has Congress seen fit to expand FFDCA law to preempt tort laws. In fact, when Congress debated the 1938 Act, it considered creating a federal claim for damages, but was dissuaded at least in part on the argument that state law already permitted such actions.

That made good policy sense then, and still does today. The FDA is underfunded and overextended. Its information is imperfect, reliant as it is on industry to identify relevant safety issues and to provide data on them. Simply put, manufacturers know more about their products than the FDA does or ever will. Those that choose to hide or avoid taking action to protect consumers from hazards their products pose ought not be able to hide behind the FDA’s skirts. As the House Oversight and Government Reform recently reported, FDA’s own scientific staff argued strongly against the political leadership’s new position because it wrongly assumes that the staff will spot erroneous or misleading information on labels before the agency approves them.

Civil litigation creates a powerful disincentive for such corporate misbehavior. It helps hold manufacturers accountable and provides victims with an opportunity to receive some compensation for the harm done to them.

In the case of Wyeth vs. Levine, for example, Ms. Levine’s career as a guitarist is effectively over because Wyeth made a decision not to issue a stronger warning label. Contrary to its assertions in court, it is not only permitted but required to provide additional warnings to doctors when it learns that its products have such possible adverse consequences; it must seek approval concurrently.

That notwithstanding, FDA now takes the position that its label approvals preempt state tort laws. If regulatory agencies were perfect, common law liability might be unnecessary. A long record clearly indicates otherwise. And, more specifically, if FDA were perfect, Wyeth’s label would have carried an adequate warning.

Ms. Levine deserves compensation. Wyeth deserves to be held accountable. Americans deserve the protection from such corporate irresponsibility that litigation helps provide.