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accutane Tannen Maury/ Bloomberg News

The New Jersey Supreme Court on Wednesday said plaintiff expert testimony in a mass tort case alleging that the pharmaceutical giant Hoffmann-La Roche’s anti-acne drug Accutane led to development of Crohn’s disease was properly excluded.

The unanimous ruling, a reversal of the Appellate Division, is a major victory for Hoffmann-La Roche, which was defending more than 2,100 Accutane lawsuits in New Jersey, all of which were consolidated in Atlantic County. It reinstates the decision on admissibility originally issued by Superior Court Judge Nelson Johnson, who rejected the testimony of the plaintiffs’ experts.

It’s a broader victory, though, for business groups and others that had pushed the court to update its standard on the admissibility of expert evidence in products litigation.

“Our analysis of the record lead to a clear result: The trial court properly excluded plaintiffs’ expert testimony,” Justice Jaynee LaVecchia wrote for the court.

“In this matter, the trial court did not abuse its discretion in its evidentiary ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts,” she said.

In the ruling, the court adopted the standard set by the U.S. Supreme Court’s 1993 decision, Daubert v. Merrell Dow Pharmaceuticals, which sets a high standard for the use of experts in products liability cases—more stringent than New Jersey’s Rule of Evidence 702. New Jersey currently follows the more relaxed standard set in the 2002 interpretation of evidence rule 702 in Kemp ex rel. Wright v. State.

“We now reconcile our standard … with the federal Daubert standard to incorporate its factors for civil cases,” LaVecchia said.

In Daubert, the U.S. Supreme Court said trial courts should serve as gatekeepers for determining the admissibility of expert testimony. “Properly exercised, the gatekeeping function prevents the jury’s exposure to unsound science through compelling voice of an expert,” LaVecchia said.

In implementing the Daubert standard going forward, “we expect the trial court to assess both the methodology used by the expert to arrive at an opinion and the underlying data used in the formation of the opinion,” the court said.

“Methodology, in all its parts, is the focus of the reliability assessment, not outcome,” LaVecchia wrote. “It is not for a trial court to bless new ‘inspired’ science theory; the goal is to permit the jury to hear reliable science to support the expert opinion.”

Hoffmann-La Roche’s attorney, Paul Schmidt of Covington & Burling in Washington, D.C., referred a request for comment to a company representative.

The company issued a statement from its general counsel, Dr. Gottlieb Keller.

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.”

“We are gratified that the Supreme Court endorsed exclusion of experts whose “novel theory of causation” “flies in the face of consistent findings of no causal association,” Keller said.

Neither Bruce Greenberg of Newark’s Lite DePalma Greenberg, nor David Buchanan of Seeger Weiss in New York, the lead plaintiff attorneys, returned calls seeking comment.

On appeal were Johnson’s rulings barring testimony from Arthur Kornbluth, a gastroenterology expert for the plaintiffs, and biostatistician David Madigan, an epidemiological expert for the plaintiffs in the litigation, which included 2,174 individual suits. Both Kornbluth and Madigan were critical of a series of eight epidemiological studies that showed users of Accutane were not at increased risk of developing Crohn’s disease. Kornbluth and Madigan said they favored other studies on the subject, including some in which dogs developed bowel problems after being administered Accutane. Johnson said Kornbluth’s “contrived reasoning is not supported by the scientific community as a reliable basis for making causal determinations,” and said his testimony was “replete with what can be described as convenient assumptions.” Johnson said Madigan’s opinions were conclusion-driven, rather than methodology-based.

A year ago, the Appellate Division ruled that the plaintiff expert testimony was improperly excluded by Johnson. The court reversed an order barring expert testimony by the plaintiffs’ experts, and another order dismissing  2,174 cases. The panel, consisting of Judges Susan Reisner, Ellen Koblitz and Thomas Sumners Jr., said Johnson wrongly concluded that the plaintiffs’ experts ignored the epidemiological studies in favor of less reliable evidence.

“The experts did not ignore the studies. Rather, in extensive and detailed testimony, they opined that most of the studies were unreliable, and they explained in considerable detail the reasons for those opinions,” Reisner wrote for the court in the July 2017 decision. The judge’s duty was “to weed out ‘junk science,’ not to shield jurors from hearing expert testimony that is scientifically-based but unpersuasive to the trial judge,” Reisner said.

That decision came roughly a week after a different panel of the Appellate Division reinstated a different set of 335 cases on other grounds.

Michael Booth

Trenton Bureau Chief New Jersey Law Journal American Lawyer Media mbooth@alm.com Twitter: @mboothnjlj

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