Wyeth v. Levine Followup

     This Federal Preemption case was heard this morning, involving the i.v. push therapy of a drug that is manufactured by Wyeth. As I have previously blogged (blog), Wyeth was arguing that it should be immune from suit because its drug had been approved by the FDA and such approval should remove any responsibility for injury. The Associated Press (AP article) described the arguments by the counsel and Justices. It seems that the Justices focused on the warning label and how Wyeth knew that the warning was inadequate and that they should have gone back to the FDA for a different label. According to the AP article, Wyeth's counsel responded that the FDA could have changed the warning, because it also knew about the issues that were not listed in the warning.

     This case has been broadcast as the Court's opportunity to take up drug company immunity. However, according to the reported arguments (Wall Street Journal) there is a potential that such immunity may not be exactly reached, if the Justices place their focus on warning instead of immunity. Notwithstanding, the Presidential and Congressional elections may have an impact. There are bills that have already been introduced that would serve to overturn any immunity that would be granted to the drug manufacturers, based upon any FDA defense. For such bills to possibly get passed, it is expected that the Democrats would have to control the House,Senate and President, to get the necessary votes and signature. This will be a sidebar issue as the tally of votes comes in.