Wyeth has filed its reply brief in the Levine case.

The reply stresses that this case is not a conventional failure to warn case, but an alleged failure to contraindicate case. Thus, plaintiff is directly challenging the FDA’s balancing of the risks and benefits of a labeled, warned-about indication. State law cannot obstruct federal regulation of pharmaceuticals by seeking to impose a different outcome to this balancing process than the one reached by the FDA.

When the FDA did address the risks and benefits of the particular method of drug delivery at issue, the agency told the defendant to use labeling which the state court jury held was inadequate under state law.

Wyeth also stressed what the case was not: no allegations of concealment from the agency or of failure to make a label change in response to any new risk information. The FDA had all the important information, and made a regulatory decision, which plaintiffs told the jury they could, and should, simply reject.

Note also an interesting discussion of CBE issues, with the arguments that this was not a CBE case, especially where methods of use are at issue, and that the FDA’s interpretation of the CBE is entitled to Auer– level deference. (As noted in a post by MassTortDefense, the CBE regulation was always intended to apply solely to new, emerging, significant information.) Finally the plaintiff’s argument that the defendant must prove that a CBE submission would have been unsuccessful before qualifying for preemption would create the untenable and frequently dis-approved situation in which juries are deciding hypothetical situations full of what-ifs.