Big Pharma Wins in Another Supreme Court Accutane Decision

In re Accutane Litigation, 235 N.J. 229 (2018).  [Disclosure:  I argued this appeal, together with co-counsel, on behalf of the plaintiffs.  The opinions expressed in this post are mine alone, and are not attributable to or necessarily reflective of the views of other counsel for plaintiffs in the matter.]  Two months after the Supreme Court barred the experts for plaintiffs in this Multi-County Litigation who claimed that Accutane caused their Crohn’s Disease, striking the death knell for several thousand such cases, the Court yesterday doomed 532 more cases, granting summary judgment to defendants in all of them.

In an opinion by Justice Albin that applied de novo review to the legal issues presented, the Court ruled that plaintiffs did not sufficiently demonstrate that defendants’ warnings about Accutane after 2002 regarding inflammatory bowel disease were inadequate.  The Court applied New Jersey’s Product Liability Act, N.J.S.A. 2A:58C-4 (“NJPLA”), to all the cases, even those in which the plaintiffs lived, were prescribed and took Accutane, and were injured outside of New Jersey, and held that plaintiffs’ evidence did not rise to the level that the NJPLA requires in order to rebut its presumption of labeling adequacy where the FDA has approved the labeling.

The decision to apply the NJPLA to plaintiffs from all states was based on the idea, stated in Ginsberg v. Quest Diagnostics, Inc., 227 N.J. 7 (2016), that where there are many, potentially conflicting state laws at issue, it may be more efficient and manageable to apply one state’s law to everyone.  The laws of the 45 states from which the relevant universe of plaintiffs hailed were not uniform, and it would have been an “arduous and burdensome task” to apply the laws of each state, as t had done.  In the circumstances, the factors that comprise the “most significant relationship” test that governs choice of law did not lead to a clear result.  But once the Court applied “overarching principles” such as the needs of the interstate system, the need for certainty, predictability, and uniformity of result, and ease of determination and application of the law to be applied, the Court concluded that the NJPLA should govern globally.

Justice Albin then proceeded to examine plaintiffs’ evidence in support of their contention that they had overcome the NJLPA’s presumption of labeling adequacy.  He stated that the presumption of labeling adequacy can be rebutted only by clear and convincing evidence.  That is a standard “protective of responsible drug manufacturers,” which the Court found was the intent of the Legislature in adopting the NJPLA.  Analyzing plaintiffs’ proofs one by one, the Court concluded that they did not rise to the required level.

While recognizing that, in this summary judgment context, the evidentiary record needed to be viewed most favorably to plaintiffs, the Court minimized plaintiffs’ evidence in various ways.  Thus, the Court characterized plaintiffs’ proofs as “isolated examples … exhumed from the volumes of evidence” in the overall record.  But gold nuggets are no less golden merely because they are surrounded by other less than valuable materials.  The Court’s view (to shift to a different metaphor) did not fully take account of plaintiffs’  construction of a mosaic of evidence in their favor.

This was another bitter pill for Accutane plaintiffs to swallow.  But the NJPLA’s rebuttable presumption has been difficult to overcome, and this case turned out to be no different.