A recent New Jersey Supreme Court decision that dismissed more than 500 cases alleging Hoffmann-LaRoche’s Accutane acne medicine caused chronic bowel disease is being praised as a victory for the business community by Trenton-based New Jersey Civil Justice Institute, a legal advocacy group.
This appeal arises from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc.
Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs alleged Accutane caused them to develop inflammatory bowel disease and that Roche failed to give adequate label warnings to advise them of the known risks of the medication.
A statement given NJBIZ by Dr. Gottlieb Keller, general counsel for Roche, said the September 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 of 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.”
Alida Kass, president of the New Jersey Civil Justice Institute, said she was pleased to see the court affirm the strength of New Jersey’s presumption of adequacy for U.S. Food and Drug Administration-approved warnings, which require a heightened standard of “clear and convincing” evidence that a label warning is inadequate, and a finding that Roche’s warnings were adequate as a matter of law.
“The decision affirms the primacy of the federal regulatory process in adequacy of warnings and ensures that our state’s pharmaceutical companies will continue to enjoy the protection from unmeritorious product-liability litigation,” Kass said.