FDA general counsel under fire

As we noted May 24, trial lawyers are livid about the Food and Drug Administration’s program of filing amicus briefs in liability suits urging state courts not to second-guess the wording of warning labels which the agency had chosen to approve. The battle now seems to be escalating, and is being personalized into an attack […]

As we noted May 24, trial lawyers are livid about the Food and Drug Administration’s program of filing amicus briefs in liability suits urging state courts not to second-guess the wording of warning labels which the agency had chosen to approve. The battle now seems to be escalating, and is being personalized into an attack on the FDA’s respected general counsel, Dan Troy, who was the target of a press conference thrown the other day by Democratic Rep. Maurice Hinchey of New York. (“U.S. House Democrat Says Agency Aiding Drugmakers”, Bloomberg News, Jul. 13). Jonah Goldberg has more at National Review “The Corner”, as does Jonathan Adler (who excerpts an interesting Jun. 2003 speech by Mark McClellan to the Commonwealth Club in San Francisco discussing pharmaceutical liability).

The fundamental craziness at work here is that an agency like the FDA can spend years considering the best way to balance the risks associated with a drug (including the risk of scaring away patients who would benefit from it); it can decide to require thus-and-such a warning and not some other kind; then, after a drugmaker carefully adopts that exact warning, following the agency’s guidelines in each and every particular, trial lawyers claiming side effects can invite an open-ended series of juries, one at a time, to decide that some entirely different wording should have been used. They need only win occasionally for the game to work financially. Way back in 1988 my colleague Peter Huber explained it very well in his book Liability: The Legal Revolution and Its Consequences, whose relevant chapter was titled: “Knowledge of the Law is No Excuse”. Dan Troy is completely right to call the courts’ attention to the agency’s stake in this problem: let’s hope he outlasts his critics.

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