Handout photo.

A federal appeals court heard oral arguments last week in a case that could carve out more guidance on whether state law claims involving labels on pharmaceuticals are pre-empted.

To argue the case on Oct. 3 before the U.S. Court of Appeals for the Ninth Circuit, both sides brought in appellate heavyweights from Washington D.C.: David Frederick of Kellogg Hansen Todd Figel & Frederick for the plaintiffs and Kannon Shanmugam of Williams & Connolly for the defendants, which include Merck Sharp & Dohme Corp. and Eli Lilly and Co.

At issue is the “clear evidence” standard that the U.S. Supreme Court set forth in its 2009 decision in Wyeth v. Levine. The high court found that federal regulatory approval of a drug didn't shield manufacturers from state law claims without “clear evidence” that the FDA would “not have approved” changes to product labels.