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The Levine Argument: More Early Returns

By James M. Beck and Mark Herrmann

We just received this reaction to today's argument in Wyeth v. Levine from someone else who attended. (We are not attributing this guest post to the reader who sent it, but these are not our words; we weren't there this morning.)

Quick reaction: I do not think we?ll see an 8-1 decision like in Riegel. The Justices took a much harder look at Wyeth, questioning in detail why it did not change its label and what its real ability was to do so based on risk information. The record of Wyeth's communications with the FDA is quite strong, but it did not appear clear enough for the Court to follow. Kneedler did a decent job but did not come across as too persuasive and could have represented FDA?s interest and history a bit stronger. Frederick switched his core theories at several points, and went off on tangents regarding misbranding and Wyeth?s failure in its duty to warn. 5-4, for Wyeth, is my prediction.

Full post as published by Drug and Device Law on November 03, 2008 (boomark / email).