Prescription Drug Products Liability Litigation and Punitive Damages Preemption

Abstract

In Wyeth v. Levine, the Supreme Court held that FDA-approval of the brand name prescription drug Phenergan not preempt state common law claims seeking compensatory damages for injuries allegedly caused by the drug. (1) The holding was informed by the fact that Congress, in enacting the Food, Drug, and Cosmetic Act (FDCA), did not provide a federal remedy for consumers harmed by unsafe or ineffective and instead [e]vidently ... determined that widely available state rights of action provided appropriate relief for injured consumers. (2) This reasoning--that allegedly injured plaintiffs should have judicial recourse to compensation has been a consistent theme in Supreme Court arguments opposing preemption of state tort claims involving FDA-approved products. (3) Levine not address the separate question whether a brand name prescription drug manufacturer may be subject to punitive damages under state law related to the marketing of an FDA-approved drug. However, the question of punitive damages preemption in prescription drug litigation has arisen post-Levine in the context of state tort reform statutes that bar punitive damages against FDA-compliant drug manufacturers absent evidence that the manufacturer had defrauded the FDA. In this context, most courts have followed the Supreme Court's reasoning in Buckman v. Plaintiff, Legal Committee (4) and have held that punitive damages claims are preempted because the required showing of fraud on the FDA would impermissibly frustrate the federal statutory scheme in which the FDA is granted plenary power to police such misconduct. (5) While these opinions are limited on their face to the particular state statutes under which they arise, the rulings have a potential national impact, both because of: (1) choice of law rules that call for the application of a defendant manufacturer's home state law to punitive damages claims arising from injuries taking place in other states; and (2) the legal reasoning supporting the preemption holdings in some of these cases, which would apply more broadly to punitive damages awards in prescription drug product liability litigation even in the absence of state tort reform statutes. The broader significance of this emerging body of prescription drug punitive damages preemption case law is demonstrated in a recent opinion secured by Novartis Pharmaceutical Corporation (NPC) in one of the cases being defended in the Aredia[R] and Zometa[R] MDL products liability litigation. (6) In Zimmerman v. Novartis Pharmaceutical, a Maryland plaintiff brought suit against NPC (headquartered in New Jersey), alleging that her doctor's prescription of the FDA-approved drugs Aredia[R] and Zometa[R] for prevention of skeletal complications associated with her metastatic breast cancer to bone had caused a jaw condition known as osteonecrosis of the jaw. Applying the Second Restatement's significant relationship standard, the court held that while Maryland law governed the plaintiffs claims for compensatory damages arising from her use of the drugs and injury in Maryland, New Jersey law governed the plaintiffs claim for punitive damages because the alleged defendant misconduct at issue took place in New Jersey. (7) The court then held that plaintiffs claim for punitive damages was preempted by a New Jersey state statute that bars punitive damages in claims involving FDA-approved drugs absent evidence that the defendants had engaged in fraud on the FDA. (8) In this article, we analyze the Zimmerman court's reasoning in support of both the choice-of-law and preemption parts of its ruling and then discuss what Zimmerman may portend for the broader application of preemption to punitive damages claims involving FDA-approved prescription drugs throughout the country. I. The Zimmerman Court's Punitive Damages Preemption Analysis Zimmerman was originally filed in the middle district of Tennessee, where the Aredia[R] and Zometa[R] MDL is situated, and was remanded to the district court of Maryland for case-specific pretrial proceedings and trial on July 27, 2011. …