Accutane Plaintiffs Overcome the “Super-Presumption” That FDA-Approved Warnings About Drugs are Adequate

In re Accutane Litig., 2017 WL 3138003 (App. Div. July 25, 2017).  [Disclosure:  I argued for the successful plaintiffs in one of these two consolidated appeals, the one that involved the NJPLA.]  The New Jersey Product Liability Act, N.J.S.A. 2A:58C-4 (“NJPLA”), creates a presumption, which the Supreme Court has labeled a “virtually dispositive” “super-presumption,” that a manufacturer’s warning regarding a drug is adequate if that warning has been approved by the federal Food and Drug Administration.  The Supreme Court and the Appellate Division have, however, established at least two exceptions to that principle.  First, “evidence of a deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects” will overcome the presumption.  Second, “substantial evidence of economically-driven manipulation of the post-market regulatory process” will also defeat the presumption.

The Accutane Litigation was designated by the Supreme Court as a mass tort case in 2005 and has been hotly litigated ever since.  The matter encompasses many thousands of cases, all of which involve allegations that Accutane, a drug manufactured by Hoffmann-LaRoche, causes inflammatory bowel disease (“IBD”), in the forms of Crohn’s disease and ulcerative colitis.  The appellate courts have seen a number of Accutane cases, including (most recently) McCarrell v. Hoffmann-LaRoche, Inc., 227 N.J. 569 (2017), a landmark statute of limitations decision that was discussed here.

Today’s decision by the Appellate Division (Judges Fisher, Ostrer, and Moynihan) involved the adequacy of post-2002 warnings regarding IBD.  Because the plaintiffs in this mass tort hail from 45 states, there were questions as to whether the NJPLA or the home state of each plaintiff applied.  The Law Division, applying the NJPLA, granted defendants’ motion for summary judgment, finding the warnings adequate as a matter of law under the “super-presumption.”  That court went on to rule, however, that if the NJPLA did not apply across the board, and the home states of the plaintiffs applied instead, summary judgment was appropriate under the laws of a number of states and inappropriate under a number of others.

Plaintiffs appealed both aspects of the Law Division’s ruling, and defendants cross-appealed as to those states where the Law Division denied summary judgment.  In an extraordinary 100-page opinion, the panel today reversed the summary judgment under the NJPLA and, ruling that the home state laws of the various plaintiffs governed their claims, affirmed that part of the Law Division ruling that had denied summary judgment in a number of states, but reversed summary judgment as to all but eight other states.  As to the NJPLA, the panel found that plaintiffs had adduced enough evidence to present a jury question as to both of the exceptions to the presumption: deliberate concealment and manipulation of the regulatory process.  The Appellate Division then grouped the remaining states, analyzed their laws, and ruled as to the appropriateness of summary judgment as to plaintiffs in those states.

Judge Higbee, the original mass tort judge who handled this litigation for many years until her promotion to the Appellate Division, had been presented with a similar motion under the NJPLA by defendants, and had found that there were fact issues for trial.  The current judge, on essentially the same motion, reached the opposite result.  The Appellate Division today, on the specific facts here, expressly agreed with Judge Higbee’s ruling, even as the panel ruled that the law of the case doctrine did not preclude the current Law Division judge from revisiting the issue.

This fact-intensive decision, largely a win for plaintiffs, is worth reading in full.  It establishes, as to New Jersey law, that the exceptions to the presumption of adequacy have vitality on appropriate facts.  The opinion also discusses choice of law, and analyzes the law of dozens of other states in the area of warnings regarding pharmaceutical products.  It represents a prodigious effort by the panel.