A decision by New Jersey’s Appellate Division to reinstate 2,100 Accutane lawsuits has spurred a renewed effort by business groups to persuade New Jersey to adopt the Daubert standard of expert opinion admissibility. The Appellate Division, an intermediate appellate court, concluded that a trial judge improperly excluded the proposed testimony of plaintiffs’ experts to establish that Accutane causes Crohn’s disease.
If the New Jersey Supreme Court decides to review the Appellate Division’s decision, it may decide whether to adopt the Daubert standard. Given the Appellate Division’s analysis of the expert evidence, however, it is not clear that changing the standard would change the outcome. While lawyers for the business community tend to dismiss any expert testimony against a corporate defendant as being based on “junk science,” the expert evidence in the Accutane litigation might well satisfy the Daubert standard.
About 2,100 New Jersey lawsuits allege that the prescription acne drug Accutane, manufactured by Hoffman-La Roche Inc. and Roche Laboratories Inc., caused the plaintiffs to develop IBD, a condition that manifests itself as Crohn’s Disease or ulcerative colitis.
Accutane was first marketed in the 1980s and was withdrawn from the market in 2009. Hoffman-La Roche denies that the drug is dangerous. It asserts that it stopped selling Accutane for “business reasons,” not for safety reasons. The “business reasons” undoubtedly related to the millions of dollars that Hoffman-La Roche has paid to plaintiffs who alleged that they were injured by a dangerous drug.
The manufacturers have had some litigation success, both in winning cases at trial and in convincing appellate courts to overturn jury verdicts that were returned in favor of plaintiffs. Their appellate arguments have primarily focused on the claim that expert evidence was either inadmissible or insufficient to sustain the jury verdict.
The New Jersey lawsuits were consolidated in 2003. As they slowly worked their way through the system, plaintiffs relied on a variety of evidence to prove that Accutane caused IBD, including “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.”
No epidemiological studies were available until two studies were published in 2009 and 2010. Neither study found a statistically significant increased risk of developing Crohn’s disease from the use of Accutane. One of the studies found that ulcerative colitis is associated with exposure to the drug. Other studies with conflicting results were eventually published.
Although experimental studies are the “gold standard” of epidemiological studies, none of the studies were experimental. That is, they were not the kind of study in which a test group is given a drug and the control group is not. Experimental studies cannot ethically be conducted when the studied drug might be dangerous.
The studies of Accutane were observational studies that either compared people with IBD to people without IBD to determine whether one group was more likely to have taken Accutane, or compared people who took Accutane to people who didn’t to determine whether one group was more likely to develop IBD.
Dr. Kornbluth’s Expert Opinion
The trial court excluded the testimony of two plaintiffs’ experts. The first, Dr. Asher Kornbluth, is board-certified in gastroenterology. He is a professor of medicine at Mount Sinai, the preeminent hospital for IBD, and has specialized in Crohn’s disease for 27 years. His expertise was not challenged.
Dr. Kornbluth concluded that Accutane can cause Crohn’s disease in humans. He based that conclusion on his personal experience in treating thousands of patients with the disease and on a variety of studies and articles. He considered animal studies, medical reports showing that the resumption of Accutane use worsened the disease, and side effects caused by related drugs. Dr. Kornbluth determined that a strong association between Accutane and Crohn’s disease is confirmed by scientific articles, MedWatch reports, and causality assessments.
Dr. Kornbluth placed less reliance on epidemiological studies, concluding that most of them have been fundamentally flawed. He nevertheless found some evidence in those studies that pointed to a positive association between the drug and Crohn’s disease.
Recognizing that an association does not prove causation, Dr. Kornbluth relied on the Bradford Hill criteria to determine whether a causal link exists. The criteria for causation are widely used in the scientific community, although the application of those criteria in any particular case might be disputed. Dr. Kornbluth concluded that the Bradford Hill criteria supported the conclusion that Accutane causes Crohn’s disease.
Dr. Madigan’s Expert Opinion
Dr. David Madigan is a statistician who has substantial experience with biostatistics. He explained why, in his opinion, the epidemiological studies upon which Hoffman-La Roche relied were biased in favor of finding the absence of a causal link between Accutane ingestion and Crohn’s disease.
He criticized the studies for failing to observe patients for a sufficient period of time after their Accutane use to detect whether those patients developed Crohn’s disease. He also concluded that, for reasons such as insufficient sample size, the studies had insufficient statistical “power” to find a statistically significant association of Accutane use with Crohn’s disease if one existed. He also concluded that using a “meta-analysis” to account for small sample sizes would be inappropriate because a meta-analysis of several biased studies does not make bias disappear.
Finally, Madigan conducted a “disproportionality” analysis of drugs in the FDA database, using techniques that are routinely used by the FDA to flag potentially dangerous drugs. He found that taking Accutane, as opposed to other drugs, was associated with an increased risk of developing Crohn’s disease. He also noted that a similar disproportionality analysis conducted on the World Health Organization database found that people who took Accutane were nineteen times more likely to develop Crohn’s disease than people who did not.
The experts for Hoffman-La Roche disagreed with Drs. Kornbluth and Madigan. They concluded that the epidemiological studies should be given greater weight than the other evidence because they were scientifically sound and a “higher level” of evidence. Notably, one of those experts admitted that during her expert testimony in a different case, she used the same methodology that she faulted Dr. Kornbluth for using in this case.
Appellate Court’s Decision
According to the appellate court, the issue was “whether Kornbluth’s causation testimony and Madigan’s statistical analysis testimony was sufficiently reliable in the field of scientific research to be admitted.” New Jersey law uses a variation of the Frye standard that requires an expert’s scientific theory to be generally accepted in the scientific community, while relaxing the standard in toxic tort cases. In those cases, “a scientific theory of causation that has not yet reached general acceptance may be found to be sufficiently reliable if it is based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.”
Applying that standard, the Court of Appeal rejected the trial court’s description of Madigan as “an expert on a mission” and its criticism of Kornbluth’s approach as “being less convincing than [the defendants’ expert’s] analysis as to causation.” The appellate court concluded that both experts employed a methodology and used data that would be reasonably relied upon by experts in their fields, and faulted the trial judge for making credibility determinations that should be left to the jury.
Will the Supreme Court Adopt Daubert?
Hoffman-La Roche asked the New Jersey Supreme Court to review the appellate court’s decision. A number of business groups have filed amicus briefs in support of that request, seizing the opportunity to persuade New Jersey’s highest court to adopt the Daubert standard.
The business community tends to see Daubert as a business-friendly standard for evaluating expert testimony. Business groups have long advocated the Daubert standard as a way to prevent juries from relying on “junk science” offered by plaintiffs.
Yet the Appellate Division acknowledged and addressed the importance of applying a standard that excludes junk science. The court said that the purpose of reviewing expert testimony for reliability “is to weed out ‘junk science,’ not to shield jurors from hearing expert testimony that is scientifically-based but unpersuasive to the trial judge.” That analysis is perfectly consistent with Daubert.
In fact, it isn’t clear that the New Jersey rule differs greatly from the Daubert standard. The heart of both rules is the reliability of the expert’s methodology, as opposed to the expert’s credibility. The Appellate Division’s analysis focused on the reliability of the experts’ methodologies. The analysis probably would not have been significantly different if the court had applied the Daubert standard.
As is often the case in battles about Daubert, rhetoric about “junk science” may have little to do with the expert testimony that courts are asked to admit or exclude. Whatever the groups that filed amicus briefs may hope to achieve, it seems clear that the specific facts of the case before the court have nothing to do with junk science.