Thursday, December 17, 2009
Interesting new case about generic drugs
The Court of Appeals for the Eighth Circuit recently decided an interesting case that presented the following two questions: (1) can a brand name manufacturer be liable for an alleged inadequate warning on a generic drug, where the plaintiff never used the brand name product? and (2) are warning claims against generic manufacturers preempted by the FDCA requirement that generic drugs have the same labeling as their brand name bioequivalents. The court said NO to both questions. The case is Mensing v. Wyeth, Inc., No. 08-3850 (8th Cir. Nov. 27, 2009) (available here). Both holdings make sense to me. Although there is at least one case out there that decides the first question in the affirmative (Wyeth v. Conte -- see here and here), it is difficult to justify that result and I believe most, if not all, other courts that have addressed the issue have rejected the analysis in that case. The holding on the issue of preemption is more controversial, but not surprising. The defendant's argument was based on Bush-era FDA statements in the Federal Register that had no force of law. As, the Drug & Device Law Blog points out, "[t]he beating that the FDA's 2006 preemption preamble took in Levine pretty much presaged the same treatment for these other FDA statements about "sameness" and the ability of generic manufacturers to alter their warnings." For a long comment on this case, check out the Drug & Device Law Blog's post here.