On July 22, 2016, the Superior Court of New Jersey reversed two $9 million jury verdicts in cases involving the prescription acne drug Accutane. Plaintiffs alleged that Accutane caused them to develop inflammatory bowel disease (“IBd”) and that the labeling at the time failed to sufficiently warn them and their prescribing physicians of the risk of IBD from using the drug.

The evidence at trial was that both plaintiffs had stopped using Accutane by April 1998. The label in effect at the time of prescription warned that Accutane was “temporally associated” with IBD. In 2000, the manufacturer changed the warning by removing the term “temporally” and adding language about persistent IBD to read, “Accutane has been associated withinflammatory bowel disease . . . in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped.” Rossitto v. Hoffman-La Roche, 2016 WL 3943335, *14 (NJ Sup. Ct. July 22, 2016) (emphasis in original).

The trial court initially barred admission of the 2000 revised label as evidence of a subsequent remedial measure prohibited by Rule 407. However, after one of the defendant’s experts testified that removal of the word “temporally” from the label might weaken the warning, the trial court reversed itself and admitted the 2000 label into evidence for the purpose of impeaching the expert.

The New Jersey appellate court held trial court “seriously erred” in allowing evidence of the post-ingestion label. The RossittoCourt’s reasons for overturning the trial court included:

  • Even though the FDA played a role in proposing the 2000 label change, the change was not a mandated change and, therefore, constituted a voluntarily undertaken subsequent remedial measure.
  • The 2000 label change strengthened the warning regarding IBD and, “could easily have been viewed by the jurors as ‘smoking gun’ evidence, signifying that the Accutane label that had preceded the 2000 version was deficient.” Rossitto, *17.
  • The probative value of the label for impeachment was substantially overcome by the strong prejudice to the defendant.

The trial court further erred in refusing to allow all four of the defendant’s experts to testify on the critical subject of general causation, holding such testimony repetitive and unnecessarily duplicative. This error, coupled with trial court’s “ill-advised” admission of the post-ingestion label, “was of such a magnitude…to warrant relief” in the form of a new trial.

The full Rossitto decision can be found here.