Will Wyeth v. Levine Inhibit Pharmaceutical Innovation?

In a provocative thought piece appearing in the Wall Street Journal on March 9, 2009, L. Gordon Crovitz predicts that the United States Supreme Court decision in Wyeth v. Levine will usher in an era of increased prices for drug and create a disincentive for new product innovation. Mr. Crovitz compares the American legal culture behind the Court’s decision to the Luddites that smashed mechanized looms in England at the beginning of the Industrial Age in 19th century England.  He also suggests that the decision’s logic may lead product manufacturers to "carry 50 different warnings, one for each state, updated by local juries from time to time."  Despite his misgivings about the decision, it is not likely that any product manufacturers, drug makers or otherwise, are likely to start tailoring their warning on a state by state basis.  As a practical matter, products are sold nationally, often through distributors, and it would be virtually impossible to  ensure that product warnings for Texas purchasers ended up in Texas and that product warnings intended for California purchasers ended up in California.  Moreover, from a jury standpoint, nothing would please a plaintiff’s lawyer more than to be able to argue that the manufacturer provided a less strict warning for the product in the jurisdiction where his client’s accident occurred. 

The title of Mr. Crovitz’ piece, "The Supreme Court and the Tyranny of Lawyers" is suggestive of the revolutionary’s rant in Shakepeare’s Henry VI, "The first we do, let’s kill all the lawyers". But however much we may disagree with the Supreme Court’s decision in Wyeth v. Levine, it may be overly simplistic to attribute the holding to our "legalistic culture".  Short of an act of Congress, which some believe may be under active consideration, the defense of express preemption should continue to play an important role in FDA regulation. It would be a grave mistake to undermine the regulatory authority of the FDA by removing that defense to a strict liability personal injury claim. 

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