The New Jersey Supreme Court has ruled that plaintiff expert testimony was properly excluded in a mass tort case alleging that the anti-acne drug Accutane causes severe gastrointestinal problems. In doing so, New Jersey became the most recent state to have adopted the federal government’s Daubert standard as the law governing when to admit expert testimony into evidence.
The Accutane Lawsuits
Over 2,100 New Jersey plaintiffs sued Hoffman-La Roche Inc., alleging that its prescription anti-acne drug Accutane caused them to develop severe gastrointestinal problems. Accutane was introduced to the market in the1980s and taken off the market in 2009. Hoffman-La Roche denied that Accutane is dangerous and said that it stopped selling Accutane for “business reasons.” Litigation surrounding the marketing of a dangerous drug is the kind of “business reason” that generally results in a decision to stop marketing the drug.
These lawsuits were consolidated in 2003. The plaintiffs introduced experts and studies to show that Accutane caused IBD, which becomes Crohn’s disease or ulcerative colitis. The trial court excluded the testimony of two of the plaintiffs’ experts, Dr. Asher Kornbluth and Dr. David Madigan. Dr. Kornbluth is a board-certified gastroenterologist and professor of medicine at Mount Sinai who opined that the Bradford Hill criteria supported the conclusion that Accutane causes Crohn’s disease. Dr. Madigan is a statistician with experience in biostatistics who opined that taking Accutane was associated with an increased risk of developing Crohn’s disease.
The Appellate Division ruled that the trial court had improperly excluded the testimony of Dr. Kornbluth and Dr. Madigan. In reversing the trial court, the panel of judges said that the trial court had been wrong to conclude that the experts had ignored epidemiological studies in favor of less reliable evidence. The panel stated that it was the judge’s duty “to weed out ‘junk science,’ not to shield jurors from hearing expert testimony that is scientifically-based but unpersuasive to the trial judge.”
Hoffman-La Roche appealed the ruling to the New Jersey Supreme Court and urged the court to adopt the Daubert standard set by the U.S. Supreme Court’s 1993 decision, Daubert v. Merrell Dow Pharmaceuticals.
The Daubert Standard
The Daubert Standard is a standard used by trial court judges to determine whether a proposed expert’s testimony is based on reasoning or methodology that is scientifically valid and can be properly applied to the facts at issue. Under the Daubert standard, a judge will consider the following factors to determine whether a methodology is valid: (1) whether the theory or technique in question can be and has been tested; (2) whether it has been subjected to peer review and publication; (3) its known or potential error rate; (4) the existence and maintenance of standards controlling its operation; and (5) whether it has attracted widespread acceptance within a relevant scientific community.
The Supreme Court’s Ruling
A unanimous New Jersey Supreme Court said that the trial court did not abuse its discretion in excluding the plaintiffs’ experts. In doing so, the court adopted the federal Daubert standard. The Daubert standard sets a high standard for the use of experts in product liability cases.
General counsel for Hoffman-La Roche, Dr. Gottlieb Keller, said, “Today’s decision is a victory for patient health and for good science. As the American Medical Associate aptly said in this case, ‘Patients, physicians, and our system justice all suffer when courts permit outlier experts to confuse juries with disproven theories based on scientifically unsound methodologies that contradict peer-reviewed medical studies.’” On the other hand, the court’s ruling raises the question whether justice suffers when judges substitute their own view of the evidence for a view that a jury might reasonably take.