NJ Supreme Court Ends Accutane Cases In A Significant Opinion Addressing Adequacy Of Warning In Pharmaceutical Product Liability Litigation

Author:Ms Jocelyn A. Wiesner, Matthew Eisenstein, Jessica D. Jones and Upnit Kaur Bhatti
Profession:Arnold & Porter

On October 3, 2018, the New Jersey Supreme Court ended more than 500 product liability lawsuits involving the drug Accutane in a decision that reaffirmed and broadly applied New Jersey's presumption that FDA-approved labels are adequate to warn of pharmaceutical side effects. In re: Accutane Litig. (A-26/27-17) (079933) (N.J. Oct. 3, 2018) (Accutane II). The decision comes on the heels of another victory for Roche in the Supreme Court, which two months ago adopted Daubert as the standard for admissibility of expert testimony in New Jersey.

The Accutane II appeal involved 532 plaintiffs in a consolidated multicounty litigation (MCL) that included 514 plaintiffs from 44 states other than New Jersey. Plaintiffs alleged that Roche did not adequately warn that Accutane caused inflammatory bowel disease (IBD). Accutane's label listed IBD as a possible side effect, but plaintiffs claimed that the warning should have been stronger.

Extension of New Jersey Law. In an analysis that could have a broad impact on other product liability cases challenging the adequacy of drug labels of New Jersey pharmaceutical manufacturers, the court extended New Jersey's adequacy presumption to the failure to warn claims of the 514 nonresident plaintiffs. Although the court considered a number of factors, it focused on administrative efficiency, since an MCL judge could not be expected to master the laws of 44 states, and applying those laws could lead to more errors, more appeals, and greater delays in resolving cases. The court also pointed to concerns of predictability and uniformity, given the risk of disparate outcomes among similarly situated plaintiffs.

Clarification of Adequacy Presumption. The court's decision also clarified New Jersey's presumption of the adequacy of FDA-approved labels and showed that the presumption has teeth by reversing the lower appellate court and dismissing the cases on the record before it as a matter of law.

The court identified three ways in which plaintiffs could overcome New Jersey's "rebuttable presumption" that a drug label approved by the FDA contains an adequate warning about the risks of the product. A plaintiff could:

Establish "deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects from FDA"; 1 Demonstrate "economically driven manipulation of the regulatory process";2 or Present "clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired...

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