Levine Appears Vindicated
The NY Times reports that the FDA will require stronger warnings about administering Phenergan via IV push:
Needless to say, this is a fascinating sequel to the Wyeth v. Levine case. The new warnings will apparently be what Diana Levine argued should have been on the label in the first place. The FDA reports the change is based on the number of cases it has received in which IV push administration led to gangrene and amputation--precisely what happened to Levine.
There is no suggestion that the label change was based on "new information" per se, but rather a few additional cases along with rethinking the older warning. The Vermont juries that twice upheld Levine agreed with her argument that Wyeth knew enough at the time of her injury, and had the authority, to make precisely such a change on its own (under the "Changes Being Effected" rules). While FDA would have had to agree, there are virtually no instances when it has not under such circumstances.
In an interesting closing, Gardiner Harris writes that this change may lend support to FDA's older position--pre-Bush administration--that civil liability and FDA regulation are overlapping, generally complementary, systems of consumer protection.