In a case involving 532 product liability claims filed against Hoffman-La-Roche, the New Jersey Supreme Court held that New Jersey Choice of Law Rules mandated that New Jersey law apply to claims which arose in multiple states, and defendants were entitled to dismissal of all 532 claims based on the New Jersey Product Liability Act’s defense of the rebuttable presumption of adequacy of an FDA-approved label warning.  In re: Accutane Litigation, - N.J. – (2018).

In re: Accutane involved 532 product liability claims filed against defendant Hoffman-La-Roche, Inc. and Roche Laboratories, Inc. The plaintiffs argued that the defendants had failed to warn them that Accutane could cause inflammatory bowel disease (IBD).  The 532 plaintiffs included residents of 44 jurisdictions in addition to the New Jersey plaintiffs.

Defendants argued that New Jersey law should apply to all claims.  The Supreme Court agreed. The court employed the Restatements most significant relationship test and found that New Jersey law should apply.

While normally, there is a presumption that the law of the state where the injury occurred applies, that presumption may be overcome if some other state has a more significant relationship with the parties and the occurrence based on an assessment of each state’s contacts.  The court noted that applying a single standard to govern the adequacy of the label warnings in 532 individual cases would ensure predictable and uniform results and that administrative ease and efficiency favor the application of New Jersey law.

The court then dismissed all plaintiffs’ claims.  The FDA had approved the warning labels and pursuant to N.J.S.A. 2A:58C-4, a rebuttable presumption arises that the warning or instruction is adequate when it has been approved by the FDA.  The court held that the plaintiffs had not met their burden of overcoming the presumption by presenting clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal relationship between the use of the drug and a clinically significant hazard and that the manufacturer failed to update the label accordingly.