Overview
In August 2016, the New Jersey Appellate Division overturned two major verdicts totaling $18 million against pharmaceutical manufacturer Hoffman-La Roche, finding that the trial judge committed prejudicial errors during the 2012 proceedings in Atlantic County Superior Court. The decision had significant implications for the approximately 3,000 Accutane-related cases still pending nationwide at the time, the majority of which were centralized in New Jersey’s mass tort docket.
Background of the Cases
Plaintiffs Kathleen Rossitto (New Jersey) and Riley Dean Wilkinson (Utah) developed ulcerative colitis, a form of inflammatory bowel disease (IBD), after using Accutane as minors in the mid-to-late 1990s. They filed separate lawsuits that were consolidated for trial before Superior Court Judge Carol Higbee in Atlantic County.
At trial, the central dispute was whether Accutane’s warning label adequately disclosed the risk of IBD. Hoffman-La Roche had revised the label in 2000 to add stronger language about gastrointestinal symptoms — a fact that became the focal point of the appellate dispute.
The Trial Errors
Judge Higbee initially excluded the 2000 revised label from evidence. Twenty-nine days later, however, she allowed the plaintiff’s counsel to use the revised label to impeach the credibility of Hoffman-La Roche’s former Chief Medical Officer, Dr. Russell Ellison. The jury was instructed that the label was admitted solely for impeachment purposes — not to prove that the original warning was inadequate.
The Appellate Division found this sequence problematic for two reasons. First, the court held that Judge Higbee was not permitted to “stray” from her original ruling excluding the label. Second, the probative value of the label’s admission was “substantially outweighed by the danger of unfair prejudice to the defense” — the standard under N.J.R.E. 403.
The appellate court also noted that Judge Higbee’s limitation on the number of defense expert witnesses, while insufficient on its own to warrant reversal, “added a degree of concern” about the overall fairness of the trial.
The Broader Impact
The reversal affected not only Rossitto and Wilkinson but also the broader Accutane litigation landscape. Two other plaintiffs in the same consolidated trial had received “no-cause” verdicts from the jury. At the time of the appellate decision, Hoffman-La Roche had defeated plaintiffs at two additional trials, while seven other trials had returned verdicts for plaintiffs that were on appeal.
Mass tort litigation requires careful attention to trial procedure. When judges err in admitting or excluding evidence, the resulting appeals can delay resolution for years — a reality that affects plaintiffs seeking compensation and defendants seeking closure alike.
Key Takeaways
- The Appellate Division overturned $18 million in Accutane verdicts due to prejudicial evidentiary errors
- Trial judges must be consistent in their evidentiary rulings to avoid reversal
- The decision affected thousands of pending Accutane cases in New Jersey’s mass tort docket
- Under N.J.R.E. 403, evidence with unfairly prejudicial effect should be excluded
- Mass tort plaintiffs should prepare for lengthy appellate processes in pharmaceutical litigation
Reviewed by Britt J. Simon, Esq., Managing Partner — Simon Law Group, LLC — May 2026
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