Wednesday, September 16, 2009

Better Late Than Never?

Everyone in the world - at least everyone who reads our blog - knows that the Supreme Court rejected preemption in Wyeth v. Levine, in large part because the regulatory history of Phenergan (as read by the majority) did not clearly establish a conflict between the plaintiff's warning defect claim and the FDA's regulatory determinations concerning that drug. It was only "intermittant" activity, and in any event the FDA's regulations allowed the defendant to change the warning whenever it wanted to. 129 S. Ct. at 1192, 1196-97. There was "no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of” IV-push versus IV-drip administration." Id. at 1199.

Well guess what?

Everything you thought you knew about Phenergan labelling, might not be true anymore. Today, the FDA announced that it's requiring a black box warning for Phenergan about precisely the same risk involved in Levine. That's the FDA's most serious warning - "passing attention," indeed. As the FDA's just issued press release begins:
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.
We have no idea how long this has been in the works. That doesn't mean that doing this earlier would have helped our side - it could have been quite prejudicial, depending on the timing of an earlier release. Still, the irony is so thick one can cut it with a knife.

A black box warning also has independent preemption implications. We discussed them in some detail here. The changes being effected procedure relied upon by the Supreme Court in Levine doesn't extend to black box warnings. The FDA's regulations so state. "If a boxed warning is required, its location shall be specified by the Food and Drug Administration.” 21 C.F.R.
§§201.80(e), 201.57(c).

So going forward, it seems that Phenergan's labeling for the risk at issue in Levine - now a black box - will be protected by the very preemption that the FDA's previous "no more than passing attention" did not permit.

According to the Levine opinion, this labeling process goes back to 1981. Better late than never, we suppose. But not for Ms. Levine.

1 comment:

Anonymous said...

Perhaps the greatest irony is that the new black box warning simply reiterates material that was in the label at the time Ms. Levine was treated. FDA has not accepted her position that intravenous administration of Phenergan should be banned and the "fault" for which Wyeth was held liable seems to be deficient display rather than lack of substantive information. Does this make sense?