Tuesday, January 09, 2007

The apocalypse is upon us (overwarnings)

Over ten years ago, Lars Noah (now on the faculty of the University of Florida College of Law) wrote on the subject of product warnings. In his article, he noted that it was theoretically possible for a plaintiff to sue a defendant not just for failing to warn, but for the opposite -- for over-warning. Professor Noah noted that he was not aware of any such claim actually having been pursued and that "such an outcome is not to be encouraged." Lars Noah, "The Imperative to Warn: Disentangling the "Right to Know" from the "Need to Know" about Consumer Product Hazards," 11 Yale J. on Reg. 293, 379-80 & n.435 (1994).

We now read, at overlawyered.com, that, "In the Vioxx litigation, Mark Lanier has accused Merck of making too many warnings, and thus 'hiding' its warning of VIGOR cardiovascular data." Now we (or at least the one of us typing these words) are not involved in the Vioxx litigation, and we (or at least I) have not seen the trial transcripts. But if this description is right, the plaintiffs' bar is now seeking to impose a strict liability duty of perfection (and, perhaps, prescience) on the pharmaceutical industry. If manufacturers can be sued for both underwarning and overwarning, then a product label must identify the precise side effect that a particular patient will suffer and warn about that event, but not warn about too many other possible adverse events.

This is all the more reason for courts to rule in favor of preemption: Let the FDA dictate the appropriate terms of pharmaceutical and medical device labeling, analyzed before the fact and rationally, and then stand by those decisions. But don't let lay juries, in the presence of an injured plaintiff, decide after the fact whether the product manufacturer should be held liable for either -- take your pick -- giving too few warnings or giving too many.

If Mark Lanier's argument is as overlawyered.com describes it, that's this week's sign that the apocalypse is upon us.

1 comment:

pn said...

"The plaintiffs' bar (or at least one of its members)" is what you meant, I believe, to say.