Monday, November 3, 2008

Oral Argument in Wyeth v. Levine

The Supreme Court heard oral arguments today in Wyeth v. Levine, the case involving drug manufacturer Wyeth's federal preemption defense against a state tort claim.  SCOTUSwiki has an excellent overview here.  (Thank you.)  I've posted on related issues here and here.

The issue in the case is whether FDA's drug labelling requirement preempts--by conflict preemption--a state tort claim against a drug manufacturer for failure to warn of the dangers of its drug.  (The Federal Food, Drug, and Cosmetic Act has no express preemption provision, making this case different than last term's Riegel v. Medtronic, in which the Court held that federal law expressly preempted state claims against manufacturers of FDA-approved medical devices.)

The Constitutional and Administrative Law Scholar's amicus brief has a good argument (argument II, running from pages 18 to 26 of the brief, not the pdf).  This is well worth a look.

The oral argument transcript provides some nice back-and-forth (as you'd expect); look at the respondent's argument, starting on page 24, for exchanges that home in on the issues particularly well.  Much of the oral argument focused on whether Wyeth had new information about the drug--information that the FDA did not consider in its original action directing Wyeth's label (whether acquired before or after the original FDA action).  In other words:  Did Wyeth sit on information about the drug's harmful effects--even as the FDA failed to consider that information--and take advantage of the FDA's more lenient labelling requirement?  It did, respondent argues, and therefore the FDA labelling requirement does not preempt state tort claims for failure to warn. 

Wyeth's brief is here; Levine's brief is here; the government's amicus brief (supporting Wyeth and preemption) is here.

SDS

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