Products Liability Law Reporter

A federal district court held that the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §301 et seq., does not preempt negligent misrepresentation, consumer protection, and design defect claims arising out of a patient’s use of and overdose of a powerful painkiller.

Michael Kelley suffered from lower back pain, knee pain, and carpal tunnel syndrome. His pain management physician allegedly prescribed off-label use of Subsys, a powerful painkiller and fentanyl spray that is typically used to treat cancer pain. Several years later, Kelley suffered respiratory failure from an accidental Subsys overdose. He required resuscitation and was hospitalized with serious medical problems, including multiorgan failure. Kelley and his wife sued Insys Therapeutics, Inc., Insys Pharma, Inc., and Insys Manufacturing, LLC, which manufactured Subsys, alleging statutory and common law strict liability claims, common law negligence, negligent misrepresentation, fraud, false advertising, and unjust enrichment. The plaintiffs also alleged violation of the Ohio Consumer Sales Practices Act, and Kelley’s wife sought damages for loss of consortium and negligent infliction of emotional distress.

The defendants moved to dismiss.

The district court granted in part and denied in part. The court noted that the FDCA regulates prescription drugs and impliedly preempts state law claims alleging violation of the act. Citing case law, the court found that any claim based solely on off-label promotion is impliedly preempted; however, not all claims involving off-label promotion are preempted. If independent state law grounds support such claims, the court said, the FDCA does not preempt them.

Applying these principles here, the court concluded that the FDCA preempts the plaintiffs’ negligence and strict liability-inadequate warning claims. The statute preempts the plaintiffs’ negligence claim because it seeks recovery for an off-label promotion. Similarly, the plaintiffs’ assertion that the defendants failed to provide proper information to the FDA regarding the safety of Subsys constitutes a fraud-on-the-FDA claim, which the FDCA clearly preempts.

The court found that the FDCA does not preempt the plaintiffs’ negligent misrepresentation, fraud, consumer protection, and false advertising claims. These rely on an independent assertion that the defendants promoted Subsys in a fraudulent way, the court said, adding that the claims also allege more than off-label promotion, specifically that the defendants willfully deceived as to Subsys’s health risks, among other things. Similarly, the FDCA does not preempt the plaintiffs’ design defect claims, the court said. The claims alleged that Subsys was defective because it was unsafe when used for on- or off-label purposes, the court noted. Therefore, the FDCA does not preempt these claims because they allege more than off-label promotion.

Concluding that the plaintiffs’ active misrepresentation claims may proceed, and that Kelley’s wife may pursue emotional distress damages that are derivative of the plaintiffs’ viable claims, the court dismissed with prejudice and denied dismissal consistent with its order.

Citation: Kelley v. Insys Therapeutics, Inc., 2019 WL 329600 (N.D. Ohio Jan. 25, 2019).

Plaintiff counsel: AAJ member Dennis Mulvihill, Cleveland; and AAJ members Jacob Gebelle, Richard Schulte, and Stephen Behnke, all of Vandalia, Ohio.

Comment: In Rinder v. Merck Sharp & Dohme Corp., 2019 WL 319497 (Ill. App. Ct. Jan. 23, 2019), four plaintiffs whose family members died of pancreatic cancer allegedly caused by the diabetes drug Januvia sued Merck Sharp & Dhome Corp., alleging it failed to warn that using the drug led to the increased risk of pancreatic cancer. The defendant moved for summary judgment, arguing the plaintiffs’ failure to warn claims were preempted by federal law. The company argued that under federal statutes and regulations controlling the labeling of pharmaceutical drugs, the FDA would have rejected any attempt to add such a warning to Januvia’s label. The trial court ruled that a jury should decide the issue and denied the defendant’s motion. The trial court then certified to the appellate court the question whether a judge or jury should decide when a defendant has presented the necessary clear evidence. The appellate court held that the issue should be decided by a jury. Among other things, the court found that determining the existence of clear evidence is a question of mixed law and fact and an application of a task often undertaken by juries, which often decide what would have happened absent allegedly wrongful conduct. AAJ member Kenneth J. Brennan, Edwardsville, Ill., represented the plaintiffs.