FDA Preemption and Albrecht’s Progeny

Jamie Kendall, Brad Welsh & Paul Devastey

ABSTRACT

In product liability cases, manufacturers have argued for years that failure-to-warn claims involving FDA-approved drugs should be preempted by federal law because manufacturers lack the ability to add certain warnings to an approved product label. In Merck v. Albrecht, the United States Supreme Court confirmed that preemption is a question of law properly decided by courts and provided additional guidance on theframework required for manufacturers to successfully raise this defense. This Article examines how courts have applied this framework post-Albrecht and explores what
potential litigants can do to better prepare to either raise a preemption defense or
defend against it.