Photo of Michelle Yeary

Last year we posted about two major decisions by the New Jersey Supreme Court finally chopping the Accutane inflammatory bowel disease (“IBD”) litigation down to size.  Our post here contains links to all of our posts over the years on the Accutane litigation.  The point of note is that to get to those two decisions took years.  In both situations, the trial court made terrific defense rulings on plaintiffs’ inadequate experts and the adequacy of the drug’s warnings.  Both of which were overturned by the Appellate Division only to be affirmed by the New Jersey Supreme Court.  So, when the trial court tossed out plaintiffs’ remaining experts back in 2017, we wondered if we were in for another lengthy roller coast ride through the New Jersey court system.  But this time we think the journey will conclude at the Appellate Division, and that’s a good development.

The latest Accutane decision can be found at In re Accutane Litigation, 2020 N.J. Super. Unpub. LEXIS 123 (N.J. App. Div. Jan. 17, 2020).  It is an appellate review of the trial court’s ruling excluding plaintiffs’ experts’ testimony on whether Accutane can cause ulcerative colitis.  Id. at *4.  As a result of that decision, the claims of over 3000 plaintiffs were dismissed.  Id.  The decision has been sitting for two years because the appellate court stayed its review until the New Jersey Supreme Court ruled on the earlier Daubert Accutane decision excluding plaintiffs’ experts on the issue of whether Accutane could cause Crohn’s disease.  As noted above, that decision was affirmed.  Because that decision was so instrumental to the ruling in the current decision, here’s a link to our post on that.

We called that NJ Supreme Court decision an “upgrade” to the state’s standards for the admission of expert testimony.  And we wholeheartedly approve of the decision to apply these upgrades to the current ruling even though there were handed down after the filing of the current appeal.  Id. at *6 (civil decisions are “presumed to apply retroactively”).  From just a practical standpoint, it would have been counterproductive for the appellate court to have reached a decision under the old standard just to be reversed on appeal, which would logically have been the outcome.

Which brings us to the substance of today’s decision.  It primarily reads like this – last time we had this issue the Supreme Court told us we got it wrong, so this time we’re going to do exactly what it did.  No argument from us.  Plaintiff’s ulcerative colitis experts were almost carbon copies of their Crohn’s disease experts.  Throughout the decision, the appellate court draws parallels between those experts and these.

Plaintiffs’ experts “disregarded the fundamentals of the scientific method,” by picking and choosing which studies to rely on in a way that “bespoke litigation-driven science.”  Id. at *13.  They elevated case reports well above their place at the “very bottom of the medical-evidence hierarchy.”  Id.  Similarly, they relied on anecdotal and animal studies over human epidemiology.  Id. at *15.  In fact, plaintiffs’ experts disregarded eight out of nine epidemiological studies “that ha[ve] found no association between Accutane and ulcerative colitis.”  Id. at *21-22.  Cherry-picking evidence to exclude that which contradicts you is not an accepted methodology under any circumstances.

Nor was the experts’ almost exclusive reliance on a portion of a study when the ultimate conclusion of the study was the absence of any link and the results of the portion relied on have never been replicated.  Id. at *24.  The court was unwilling to overlook that consistency of findings is “an important factor in making a judgment about causation.”  Id. at *25.

Plaintiffs’ experts claimed to be using the Bradford Hill guidelines to support their causation opinions.  However, Bradford-Hill can only be used “after an association between an agent and a particular disease has been determined to be present.”  Id. at *27.  The Bradford Hill criteria are used to determine if a known association “reflects true causality.”  They can’t be used to create an association not already evidenced by appropriate studies.  Id.  So, what plaintiffs’ experts were actually doing was “organiz[ing their] testimony to support a personal view that a causal association existed between Accutane and ulcerative colitis.”  Id. at *26.  Again, not a proper methodology.

Further, plaintiffs’ experts hid their conclusions from peer review.  Failure to publish or submit to peer-review does not disqualify an expert in and of itself.  But, upon examination the court concluded that the expert’s opinions lacked the “theoretical coherency” that would be required to pass the rigors of the peer-review process.  Id.  So, the failure to submit to that scrutiny, signifies “an expert who expressed a different set of opinions in the courtroom than he is willing to express to his colleagues.”  Id. at *17.   This, combined with selective reliance and indifference to the medical-evidence hierarchy, led the court to conclude that plaintiffs’ experts were not presenting objective science but rather litigation drive advocacy.  Id. at *18.

The bottom line is that the appellate court could find “little to distinguish” the experts the Supreme Court excluded and the current experts.  Id. at *28.  So, there was really very little left for the appellate court to do except affirm the trial court’s exclusion of these experts as well.  It’s simply the same quasi-science the Supreme Court already rejected.  This may finally be the wrap-up that this litigation has long been inching toward.