October 5, 2018

NJ Supreme Court Ends Accutane Cases in a Significant Opinion Addressing Adequacy of Warning in Pharmaceutical Product Liability Litigation


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:

  1. Establish "deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects from FDA"; 1
  2. Demonstrate "economically driven manipulation of the regulatory process";2 or
  3. Present "clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal association between the use of the drug and 'a clinically significant hazard' and that the manufacturer failed to update the label accordingly."3

New Jersey courts had previously recognized the first two ways to overcome the presumption. But the third one is new. It tracks the standards for updating a label under FDA regulations, but also requires plaintiffs to come forward with evidence that is "so clear, direct, weighty in terms of quality, and convincing as to cause [one] to come to a clear conviction of the truth of the precise facts in issue."4 How lower courts will apply this standard in future cases will be closely watched.

The court left no question that the presumption can be powerful. Applying the standards to the facts of the case, the court held that plaintiffs had failed to meet their burden and dismissed the cases without remanding for further proceedings. The court explained that plaintiffs' "isolated examples" of post-marketing adverse event reports and internal company documents failed to establish clear and convincing evidence that Accutane "causes" IBD.5 The FDA-approved Accutane label—which "informed physicians that it was possible—though not proven" that Accutane caused IBD—was adequate as a matter of law.6

© Arnold & Porter Kaye Scholer LLP 2018 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. Accutane II, slip op. at 56 (citing Perez v. Wyeth Labs., Inc., 161 NJ 1, 25 (1999)).

  2. Accutane II, slip op. at 5, 20 (citing McDarby v Merck & Co., 401 NJ Super. 10, 63 (App. Div. 2008), where a manufacturer disclosed risks to FDA but deliberately delayed amending its label "despite the universal opinions of the FDA's advisory committee and medical reviewers—and indeed, initially, the FDA regulators, themselves—that a warning was appropriate")).

  3. Accutane II, slip op. at 62.

  4. Id.

  5. Id. at 67.

  6. Id. at 66.

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