A New Jersey state judge recently issued two orders dismissing 160 consolidated cases claiming that the acne drug Accutane caused inflammatory bowel disease on the basis of prescriber testimony.
In the first order, the court granted summary judgment for defendants in 86 cases due to the lack of testimony from plaintiffs' prescribing physicians, who were either deceased or could not be located. See Order Granting Motion for Summary Judgment Based on Lack of Proximate Cause Because Plaintiffs' Prescribers are Deceased or Unable to be Located. In Re: Accutane Litig., Civ. No. 271 (MCL), N.J. Super. Ct. Law Div. (entered Oct. 12, 2015). The ruling turned on the "heeding presumption," a rebuttable presumption that instructs the jury that had an adequate warning been given, the recipient of the warning (in the context of a prescription drug case, the prescriber) would have heeded it. Coffman v. Keene Corp., 133 N.J. 581, 601 (N.J. 1993); In re Diet Drug Litigation, 384 N.J. Super. 525, 544-45 (Law. Div. 2006) (extending the presumption to pharmaceutical litigation). Plaintiffs argued that under that presumption, the burden shifted to Defendants to show that the doctors would have still prescribed the drug. The court disagreed. It reasoned that under both New Jersey law and the law of certain of the plaintiffs' residences, the heeding presumption did not apply to cases where the risk was warned against, even if the adequacy of that warning was in dispute. In some states, moreover, the court found that the heeding presumption did not apply at all in pharmaceutical cases. The court further determined that, even if the heeding presumption did apply, Defendants rebutted given statements from the medical community recommending the continued use of Accutane.
The second ruling applied to 74 plaintiffs whose prescribing doctors testified that they still would have prescribed Accutane had the warning been different. See Order Granting Summary Judgment Based on Lack of Proximate Cause, In Re: Accutane Litig., Civ. No. 271 (MCL), N.J. Super. Ct. Law Div. (entered Oct. 12, 2015) (Order II). Analyzing each prescribing doctor's testimony, the court ruled that the learned intermediary doctrine required dismissal because plaintiffs failed to prove that a different warning would have changed their doctors' prescribing decisions. The court further rejected plaintiffs' argument that plaintiffs' own testimony that they would not have taken the drug if adequately warned defeated summary judgment. Order II at 3 (citing Rossitto, Wilkinson v. Hoffma[n] La Roche Inc., Nos. A-1236T1, A-1237-13T1, slip op., 58-62 (July 22, 2016)). The court reasoned that plaintiffs' argument, if accepted, would effectively gut the learned intermediary doctrine.
The Accutane rulings represent an important re-affirmance of the principle that it is squarely plaintiffs' burden to prove causation by showing that a different warning would have changed the prescribing doctor's prescription decision.