Requiem for a Remedy: The Law and Economics of Mutual Pharmaceutical v. Bartlett’s Over-Preemption

Robert C. Baker III

In Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court of the United States considered whether generic pharmaceutical manufacturers could be held strictly liable for unreasonably dangerous, defective drug designs when Food and Drug Administration (“FDA”) regulations prohibited the redesign of generic drugs. Extending the Court's impossibility preemption in PLIVA, Inc. v. Mensing, the Court preempted New Hampshire's “warning-based design-defect cause[s] of action” because generic manufacturers were unable to cure the defective design under federal law; dual compliance was “impossible.” In so holding, the Court rejected the compensatory focus of the First Circuit and Justice Sotomayor's dissent in favor of negligence-based, deterrence-centric tort policy. As a result, the manufacturers of eighty percent of the drug prescriptions dispensed in the United States are immune from most products liability while a victim's ability to recover hangs on a pharmacist's whim.