New Jersey Superior Court Judge Nelson Johnson issued two orders dismissing a total of 160 cases from 20 states against Hoffman-LaRoche Ltd. in Accutane product liability litigation that alleges the acne drug caused inflammatory bowel disease. At least 4,000 cases remain in the consolidated litigation, Case No. 271. The court:
- Granted summary judgment for the defendants in 86 cases from 35 jurisdictions because the plaintiff’s prescribing physicians are deceased on unable to be located.
- Similarly dismissed 74 cases from 16 jurisdictions for failure to show proximate cause.
The rulings turned on a doctrine in product liability law known as the “heeding presumption.” This is a rebuttable presumption that the recipient of an adequate warning in a failure-to-warn case would have heeded the warning. It holds that a physician would not have prescribed a drug if its warning had been adequate, and places the burden on the drug maker to prove that the doctor would have heeded a different warning.
The plaintiffs argued that the testimony of the missing physicians was not required to establish proximate cause because of the heeding presumption. They asserted that this presumption has been upheld in pharmaceutical failure to warn cases in 20 states. The plaintiffs argued that because the defendants did not present evidence to rebut the presumption, that the prescribing physicians would have heeded a stronger warning.
The defendants argued successfully that in a pharmaceutical products liability action alleging failure to warn, a plaintiff must show that a different warning would have altered their physician’s decision to prescribe the medication to satisfy proximate cause. However, there is no physician testimony.
“First, the heeding presumption does not eliminate Plaintiffs’ burden of proving a prima facie case,” the court stated.
The heeding presumption was rebutted because The American Academy of Dermatology (“AAD”) and The American Academy of Pediatrics (“AAP”) both issued statements approving the continued use of Accutane or isotrentinoin for the treatment of acne. The AAD’s statement confirmed the lack of association between isotrentinoin and inflammatory bowel disease and states that physicians should continue to prescribe the medicine while being aware of the risk, the court said.
“Accordingly, the Court finds that under New Jersey law, a heeding presumption does not apply in cases such as these, and even if it did, Defendants’ FDA approved warning carries a presumption of adequacy until rebutted by Plaintiffs.”