FDA Preamble preempts all failure to warn claims

Colacicco v. Apotex, Inc., -- F. Supp. 2d --, 2006 WL 1443357 (E.D. Pa.)

This decision against a plaintiff whose wife committed suicide after taking Paxil relies on the FDA's recent Preamble taking the position, contrary to some earlier statements, that state-law failure to warn tort claims are preempted by the FDCA. According to the argument advanced by the FDA and the defendants, FDA requirements provide both a floor and a ceiling, and extra warnings would cause the drug at issue to be misbranded.

The court also rejected specific state law claims, including a New York false advertising count, for various reasons. The court accepted the argument that, despite the existence of pervasive direct-to-consumer advertising, the learned intermediary doctrine precludes a prescription drug false advertising claim -- since only by fooling both doctor and patient can a drugmaker's false advertising succeed, and doctor-targeted ads aren't directed at consumers as the statute requires.

As my description indicates, I think the learned intermediary doctrine is ridiculous, especially in the age of DTC. The specific rationale is wrong, too: The ultimate intent of ads to doctors is to reach consumers. The consumer orientation requirement is designed to keep state false advertising laws from covering disputes between businesses and disuptes about individually negotiated contracts that don't affect anybody beyond the parties. It was not meant to provide a shield based on a particular business model -- especially when that business model now includes appeals to consumers, who usually get the drugs they ask for when they go to the doctor. (According to one study, 80% of consumers who saw a DTC ad and asked for the medicine received it.)

Though I'm not a preemption expert, what I really noticed about the opinion was its elucidation of the ways in which the FDA's position is a limit on the power of the federal courts to decide cases, not just on state law causes of action, as well as an enhancement of administrative/executive agency power. To what extent this fits into a larger administration strategy is a question for further debate.