Court of Appeals for the First Circuit issues controversial opinion in generic drug case

Last week, the Court of Appeals for the First Circuit issued an opinion in a case called Bartlett v. v. Mutual Pharmaceutical Co. recognizing a design defect claim in a case involving a generic drug.  The defendants argued the claim was preempted.  You can read the full opinion here.

What makes the case controversial is the question of whether the decision is contrary to the holding in PLIVA v Mensing, the US Supreme Court decision holding that inadequate warnings cases against generic drug manufacturers are preempted because federal law requires the warnings for generic drugs to be identical to those of branded drugs.  Not surprisingly, the Drug and Device blog has taken the position that the opinion is simply wrong (although they use stronger language).  You can read their comments here and here.

For previous posts on Mensing and related issues go here, here, here, here, here, here, here, here, here, and here.