While the focus of this blog is on product liability cases, we have had occasion to touch upon Lanham Act cases involving litigation between commercial competitors.  One reason is because Lanham Act cases provided significant early precedent for the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation

If there has been one regulatory constant over the years, it has been the FDA’s persistent position that off-label promotion is bad and that companies that engage in it are acting illegally.  Since we first encountered this agency attitude as relatively young lawyers in the 1990s, we’ve thought that this position was unconstitutional under the

For most of you, it has been a long time since you thought much about criminal law. Do you remember the hypothetical about the murder victim who perished on a desert hike and it was difficult to pinpoint the criminal(s) because one person had poisoned the water in the victim’s canteen, one had replaced the

Bexis vividly remembers how he first learned of 21 U.S.C. §337(a).  It was early 1995, and he had just joined the Danek Medical legal team in the early going of the Orthopedic Bone Screw MDL.  The plaintiffs’ complaints went on and on about “negligence per se” and purported violations of the FDCA.  Bexis figured that

Just in.  United States Supreme Court rules unanimously in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”), that the Third Circuit got it wrong in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, the majority opinion,