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New Jersey Judge Excludes Expert Witness Testimony in Accutane Lawsuit

A New Jersey judge struck a blow to thousands of pending cases against the manufacturer of Accutane this week by denying plaintiffs use of an expert witness connecting the drug to Crohn’s disease.  Finding that the expert testimony failed to meet the standards of reliable scientific analysis, Atlantic County Superior Court Judge Nelson Johnson prevented plaintiffs from using a key expert in their Accutane lawsuit.

Plaintiffs Allege Accutane Causes Crohn’s Disease

By February of this year, more than 6,700 lawsuits against Accutane’s manufacturer Roche Laboratories were combined and heard by Judge Johnson.  Plaintiffs across the country claim that the acne medication posed several harmful side effects including depression, birth defects, ulcerative colitis, and inflammatory bowel disease (IBD).  Crohn’s disease is a chronic gastrointestinal type of IBD with symptoms ranging from severe diarrhea, fatigue, abdominal pain, rectal bleeding, and weight loss.  Crohn’s disease can lead to cancer, bowel perforation, and other life-threatening health complications.

According to plaintiffs, Accutane increased the risk of Crohn’s disease, and Roche Laboratories failed to provide adequate warning about the drug’s side effects.  In order to support allegations, the plaintiffs submitted reports by two expert witnesses who advanced research that claimed to connect the acne drug to Crohn’s.

Accutane Plaintiffs turn to Expert Witnesses

At issue before Judge Johnson were the expert witness reports from Dr. Arthur Kornbluth, a professor at the Mount Sinai Medical School, and David Madigan, a statistics professor at Columbia University.  Dr. Kornbluth and Madigan compiled and interpreted information from hundreds of studies, reports, and treatises from relevant scientific literature in order to present Judge Johnson with a consolidated report that weeds through the existing work on Accutane and presents an argument that the drug increases the risk of Crohn’s disease.

According to the expert witness report from Kornbluth and Madigan, there are several unreliable studies on the effects of Accutane that downplay its negative side effects.  The two experts discounted these works, and highlighted a selection of other studies and statistical data that point to a connection between the acne medication and IBD complications including Crohn’s.

New Jersey Judge Dismisses Accutane Plaintiffs’ Expert Reports

Acknowledging that Kornbluth and Madigan were accomplished experts in the field, Judge Johnson nonetheless found their report to fall short of the “sound and well-founded methodology” that is expected of expert witnesses in defective drug litigation.  Of primary concern to Judge Johnson was the experts’ reliance on a small selection of available studies on the connection between isotretinoin, the active ingredient in Accutane, and IBD.  Johnson, who personally reviewed 400 documents the two expert witnesses relied on, pointed out that the studies Kornbluth and Madigan looked to were small samples of the available research.  Finding that the plaintiffs’ experts dismissed larger studies that did not point to a connection between Accutane and Crohn’s, Judge Johnson excluded the experts for selectively presenting research and being “willing to contort the facts and torture the logic associated with plaintiffs’ hypothesis.”

Throughout his opinion, Judge Johnson remained true to the role of judges as gatekeepers of expert witness scientific reports by focusing less on the conclusions reach by Kornbluth and Madigan, and more on the methodological process which the experts used.  Johnson found that the research presented by the Accutane experts selectively focused on reports that bolstered their conclusions and was therefore limited in its scope.  Concluding that the Kornbluth and Madigan were driven more by conclusions than by sound scientific research, Judge Johnson excluded their testimony, effectively pumping the brakes on thousands of Accutane lawsuits.