What's the point of spilling virtual ink on Daniels-Feasel v. Forest Pharms., Inc., 2023 U.S. App. LEXIS 19448 (2d Cir. July 28, 2023), an unpublished Second Circuit decision? Well, the well-esteemed (at least by us) Washington Legal Foundation thought the decision was significant. It had filed an amicus brief with the Second Circuit and its post-decision press release headline was "In WLF Success, Second Circuit Affirms Exclusion of an unreliable Causation Evidence in Pharmaceutical Case." Plus, the case involves some lawyers we know and respect. We even have grudging respect for the main plaintiff expert, Dr. Moye, who is charming and formidable. In addition, we blogged about the district court order here. And in our Best of 2022 wrap-up, we said we were eagerly awaiting the outcome of the Daniels-Feasel decision. Now the wait is over, and it was well worth it.
The case was filed by six women who claimed that using an SSRI antidepressant while pregnant caused them to bear children who developed autism spectrum disorder. By now most sentient beings are aware that the information environment abounds with junk science about possible causes of autism. When plaintiff lawyers enter the debate, count on the science to get even junkier, though adorned with Ph.D's and vague babbling about Bradford-Hill criteria.
In Daniels-Feasel, the plaintiffs proffered expert opinions by three experts. Dr. Moye employed epidemiology in support of his general causation opinion that the antidepressant could cause autism. (In our mind's eye and ear we can see Dr. Moye turn to the jury with a wry smile and hear him say "Epidemiology is a big word for a simple concept: counting people." Warning to fellow defense hacks: jurors usually like Dr. Moye. A lot.) The other two plaintiff experts discussed biological plausibility. The district court ruled that the three plaintiffs experts flunked the Rule 702 analysis and then granted summary judgment to the defendant because the absence of admissible expert testimony on general causation sunk the case.
In appellate land, the first issue is standard of review. Rulings on admissibility of experts, assuming the lower court at least pretends to embrace the right standard, are reviewed for abuse of discretion. In practice, that means reversals are relatively rare. By contrast, summary judgments are reviewed de novo, meaning that the appellate court does not give any deference to the lower court. The appellate court looks at summary judgment with fresh eyes.
The Second Circuit held that the district court's conclusions that the plaintiff general causation expert misapplied the Bradford/Hill factors and cherry-picked data were not an abuse of discretion. The plaintiff expert purported to apply a "weight of the evidence" analysis which, like a judicial balancing test, means the deciders can justify whatever outcome they prefer. Here, the plaintiff expert applied exclusion/inclusion criteria inconsistently depending on the study result. Dr. Moye chucked the null outcome studies for lack of "compliance validation," meaning maybe some women in the study who were prescribed SSRIs did not actually take them, but that selfsame issue resided in some of the studies the plaintiff expert relied upon to show a statistically significant association. That is classic cherry-picking. Similarly, the plaintiff expert omitted inconvenient meta-analysis results for methodological reasons that were specious. Finally, the plaintiff expert's weighting of the various Bradford-Hill criteria looked like another fuzzy exercise in situational science.
In short, the district court in Daniels-Feasel met its responsibility as gate-keeper. When the gate slammed shut on the plaintiff epidemiology testimony, the plaintiffs could not prove general causation, and summary judgment was warranted.
The other two experts did not furnish general causation opinions, but focused only on biological plausibility. (At least one of those plaintiff experts was someone who shows up in a large chunk of mass torts. Have zoology degree, will travel.) Even if those expert opinions were admissible, the plaintiffs could not prove causation. The case was gone anyway, so the Second Circuit saw no need to address those other experts. Thus, the Daniels-Feasel decision turns out to be well-reasoned, defense-friendly, and efficient. What more could a defense-hack want?
Originally Published by Drug & Device Law
This article is presented for informational purposes only and is not intended to constitute legal advice.
