The ‘Business Case of the Century’

On Monday, the Supreme Court will hear the case of Wyeth v. Levine, which the U.S. Chamber of Commerce has called the "business case of the century." A Vermont woman who had to have an arm amputated after a nausea drug was improperly administered sued the drug’s manufacturer, Wyeth (she also sued the clinic, physician, and physician's assistant, but these parties settled). She won in state court, and Wyeth sought review in the U.S. Supreme Court under the theory of "preemption" — that states cannot regulate (by statute or common law) in fields, like pharmaceuticals, where the federal government already does. Here the FDA had approved Wyeth's label, but Wyeth did not change that label to conform to Vermont's particular (and stronger) laws.

I don't know whether this is the "business" case of the century, but it may well be that for the pharmaceutical industry. The outcome turns on a close reading of the statute — as Dan Troy and Becky Wood detailed in the most recent Cato Supreme Court Review, the Court is much more likely to endorse "explicit" rather than "implicit" preemption — but everyone (especially patients) will be better off if the Court upholds FDA preemption here. The courts should not be micro-managing what goes on labels or we will end up with the "overwarning" problems that defeat the labels' purpose. Moreover, litigation is a blunt regulatory instrument that tends to skew the FDA's already warped incentives to give too much weight to rare side-effects at the cost of prohibiting or suppressing useful drugs. These incentives, and the related litigation costs, ultimately affect the development of new drugs.