The Supreme Court's ruling in Merck Sharp & Dohme Corp. v. Albrecht continues to reverberate through pharmaceutical litigation, particularly in cases involving branded prescription drugs and failure-to-warn claims. The decision has prompted a re-examination of preemption defenses and the role of the U.S. Food and Drug Administration (FDA) in drug safety regulation.
Impact on Fosamax Litigation
The Fosamax multidistrict litigation (MDL) serves as a key example of the Albrecht decision's impact. The initial ruling against certain claims in the Fosamax MDL was reversed by the Supreme Court, leading to ongoing legal debate and reinterpretation. The Third Circuit's Fosamax II decision further complicates the landscape, highlighting the evolving understanding of preemption in these cases.
Preemption and the FDA's Role
The core of the legal debate centers on the concept of preemption, specifically whether federal law (in this case, FDA regulations) preempts state law claims. The Albrecht decision has raised questions about the evidence needed to establish conflict preemption, where it is argued that it was impossible for a drug manufacturer to comply with both federal and state law.
Different legal interpretations are emerging regarding the FDA's role in drug labeling and the extent to which manufacturers can be held liable for failing to warn about risks that were not explicitly mandated by the FDA. This includes assessing whether the manufacturer fully informed the FDA of the risks and whether the FDA would have approved a label change had it been proposed.
The ongoing legal discussions emphasize the need for a clear understanding of the FDA's regulatory authority and the evidence required to demonstrate that a drug manufacturer could not have independently strengthened its warning label without facing rejection from the agency. The Albrecht decision has thus created a complex legal environment requiring careful navigation by both pharmaceutical companies and plaintiffs.
