Drugs

NJ Court Backs Accutane Case Dismissals

The New Jersey Supreme Court says 532 product liability claims against Roche alleging that the company inadequately warned of inflammatory bowel disease caused by Accutane should be dismissed. Of the 532 plaintiffs, 18 were New Jersey residents and 514 were residents of 44 other jurisdictions. The claims were designated as multicounty litigation and consolidated in one of New Jersey’s superior courts.

The state high court considered two questions: what law governs whether Roche’s label warnings were adequate and the adequacy of the warnings that FDA approved.

The trial court had granted summary judgment to Roche, concluding that the state Products Liability Act governed all the in-state and out-of-state claims, and holding that the plaintiffs failed to overcome the presumption of adequacy that attached to the labeling approved by FDA.

The appellate division reversed in part and affirmed in part, saying that each individual case had to be judged under the substantive law of the jurisdictions where each plaintiff was prescribed and took Accutane. It held that summary judgment should not have been granted in cases from 37 jurisdictions outside New Jersey because the adequacy of the Warnings could not be resolved as a matter of law and should be resolved by a jury.

The Supreme Court affirmed the cases that were granted summary judgment by the appellate division and reversed the cases in which the appeals court had reinstated action against Roche. The court held that New Jersey has the most significant interests, given the consolidation of the 532 cases there. And it said that the state’s interest in consistent, fair, and reliable outcomes could not be achieved by applying “a diverse quilt of laws to so many cases that share common issues of fact.” The court further held that the plaintiffs did not overcome the state law presumption of adequacy for medication warnings approved by FDA and said the warnings “provided physicians with adequate information to warn their patients of the risks of IBD.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome