Roche Vows Appeal After N.J. Accutane Cases Reinstated

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By Bruce Kaufman

Hoffmann-LaRoche Inc. must plan a new defense for 2,076 injury suits by Accutane users that were incorrectly dismissed by a New Jersey judge, a state appeals court ruled ( In re Accutane Litig. , 2017 BL 262267, N.J. Super. Ct. App. Div., No. A-4698-14T1, 7/28/17 ).

Roche told Bloomberg BNA July 31 it will ask the New Jersey Supreme Court to “take up this crucial issue, which has the potential to impact a broad range of lawsuits involving important public health issues.”

The multicounty product liability cases were restored because the trial judge in 2015 improperly barred two plaintiffs’ experts from testifying that ingestion of the acne drug caused the plaintiffs’ Crohn’s disease, the New Jersey Superior Court’s Appellate Division ruled July 28.

Crohn’s disease is a form of inflammatory bowel disease.

The reinstatement of statistician David Madigan and gastroenterologist Arthur Kornbluth is a blow to drug makers Hoffmann-LaRoche and Roche Labs, which hoped to be done with the suits but must now prepare for a trial.

Gatekeeping Function

Roche said it was disappointed that the appellate court is allowing the plaintiffs’ experts to “offer opinions that disregard this science, opinions which they themselves have only offered in lawsuits.”

“The medical and scientific communities have demonstrated that there is no link between Accutane and Crohn’s disease,” Roche said.

But the New Jersey appeals court said the trial court went beyond its “gatekeeping function” in determining the weight and credibility of the experts’ testimony, and in ruling the witnesses didn’t rely on scientific methodology.

The testimony, which mostly relied on observational studies, “should not have been barred because their analyses emphasized different evidence and produced different conclusions than those reached by the defense experts,” Judge Susan L. Reisner said.

Not Supported by the Record

The trial judge also said the experts were “hired guns” and were “on a mission” with their testimony.

The three-judge appeals panel said the trial judge’s “extreme negative reaction to plaintiffs’ witnesses” was not supported by the trial record.

The admissibility process is designed to “weed out `junk science,’ not to shield jurors from hearing expert testimony that is scientifically-based but unpersuasive to the trial judge, the appeals court said.

The ruling comes on the heels of an unpublished July 25 decision by a different appellate panel in the same court that reinstated 335 cases by plaintiffs who used Accutane after April 10, 2002, and alleged the drug caused ulcerative colitis, another form of inflammatory bowel disease.

A jury must decide if the post-2002 warnings, which said the drug was “associated with inflammatory bowel disease,” were adequate, the appeals court said.

But the appeals court affirmed judgment for Roche in suits by 197 plaintiffs from California, Colorado, Indiana, Maryland, Mississippi, New York, Texas, and Virginia. Under the law of those states, the warning was sufficient, it said (In re Accutane Litig., No. A-4760-14T1, 2017 BL 256585 (N.J. Super. Ct. App. Div. July 25, 2017).

Plaintiffs’ attorneys include Seeger Weiss; Lite, DePalma, Greenberg; and Weitz & Luxenberg. Defense attorneys include Covington & Burling, and Dughi Hewit & Domalewski.

To contact the reporter on this story: Bruce Kaufman in Washington at

To contact the editor responsible for this story: Steven Patrick at

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