Thursday, January 19, 2006
This WSJ Law Blog entry is interesting, if for no other reason as a reminder of what is certainly true: even if the FDA's position prevails (hardly a certainty), there remain a number of suits available to bring in drug cases. Preemption would, indeed, make the doorway narrower, but not shut it entirely.
Preemption would also increase efforts to show fraud on the FDA or the equivalent, as a way to get around the preemption in the first place. In many pharma claims, in many jurisdictions, there may be enough evidence that a sympathetic judge might decide that preemption didn't apply, or at least to allow the jury to consider the fraud on the FDA claim.
Update: The NYT article does a decent job of summarizing the rest of the rule. In short form, it seeks to improve the accessibility of the package insert to physicians, with a "Highlights" section and the like. It does not impose any similar additions to the patient PI.