This is our second go round with Vardouniotis v. Pfizer, Inc., Case No. 152029/2019 (N.Y. Sup.).  When we posted about the court’s decision on defendant’s motion to dismiss, we were resigned to shrug our shoulders and accept that “nothing’s perfect.”  It’s two years later and we’re still shrugging.

After the court allowed plaintiff’s negligence; gross negligence; willful, wanton and malicious misconduct; breach of implied warranty; and unjust enrichment causes of action to proceed, fact and expert discovery moved forward, including the production of plaintiff’s voluminous medical records.  Vardouniotis, 2024 WL 3345021, *4 (N.Y. Sup. Jul. 8, 2024).  Plaintiff claimed her 11-day use of Chantix caused her to develop a movement disorder.  The opinion details the treatment plaintiff sought for this condition including seeing ten different neurologists and undergoing multiple diagnostic tests like MRIs, EEGs, EMGs, and nerve conduction studies—none of which found a neurological basis for plaintiff’s abnormal movements.  Id. at *1-2.  Nor did any of plaintiff’s treaters diagnose a cause for plaintiff’s abnormal moments other than psychogenic or malingering.  Id. at *2.  Except one—the one she sought out because he had co-authored an article reporting two cases of movement disorders after use of Chantix.  The one who became plaintiff’s only causation expert.    

On general causation, plaintiff’s expert’s theory was that Chantix caused “excessive dopamine transmission” that can result in movement disorders.  Id. at *9.  His opinion was based on three studies, but none “draw a causal connection between” Chantix and any movement disorders.  Two of the studies do not address plaintiff’s claimed injury, and the third is about the risks of dopamine release caused by smoking, not by Chantix.  Id.  Moreover, “proof of a risk, even an increased risk, does not constitute proof of causation.”  Id. 

Plaintiff’s expert had “no controlled clinical studies, epidemiological data, or peer reviewed studies demonstrating a causal link” between defendant’s drug and any movement disorder.  Instead, he relied on five case reports.  However, “case reports are not generally accepted in the scientific community on questions of causation.” Id.   Indeed, three of the case reports here were “circumspect regarding causation,” and another attributed the patient’s movement disorder to stopping smoking, not to the effects of Chantix.  Id. at *10.  Finally, plaintiff’s expert cited an article summarizing post-market adverse event reports.  But the article itself did not reach any causation conclusion and specifically warned that “adverse event reports in themselves do not establish a causal link to the drug.”  Id.  Therefore, plaintiff’s general causation evidence was not based on a generally accepted methodology and was excluded. 

While the court’s ruling on general causation disposed of plaintiff’s expert’s specific causation opinion as well, the court conducted a separate specific cause analysis.  To reach his specific cause opinion, plaintiff’s expert relied on his own treatment and examination of plaintiff, and the medical records and testimony of her primary care doctor and her pain management doctor.  He chose not to review the medical records of the nine other treating neurologists, her multiple diagnostic tests, her numerous emergency room visits and hospitalizations, or any of her other medical providers.  Id. at *11.  All records that largely question whether plaintiff actually has any injury at all.  He disregarded “numerous and repeated notations by various treatment providers linking the plaintiff’s complaints of abnormal movements, and her efforts to obtain opioid medication as a treatment for her purported condition, to her suspected opioid use disorder and malingering.”  Id. 

Plaintiff tried to argue that the difference of opinion between her expert and her other treaters was an issue for the jury, but that missed the point.  “[T]he issue is not that other doctors reached a different diagnosis, but that [plaintiff’s expert] ignores and fails to specifically address those inconsistent diagnoses and the findings upon which they were based.”  In other words, plaintiff’s expert chose to ignore the overwhelming medical evidence that contradicted his litigation-driven opinion and made no attempt to rule out the findings of those other treaters as possible causes.  

And then plaintiff doubled down by submitting an affidavit from her expert asserting that he did not need to review the other treaters’ records because “those doctors are simply inferior physicians whose findings may be summarily discounted.”  Id. at *12.   Another mortal struck down by hubris. 

Without expert causation evidence, general or specific, defendant moved for summary judgment—which we think should have been a gimme.  And while the court agreed that plaintiff needs expert evidence on this type of complex causation issue, the court was unwilling to accept defendant’s assertion that the excluded expert was plaintiff’s only expert on causation.  Id. at *6, 12.  One would think that if plaintiff had such additional evidence, she would have proffered it in opposition to the motion.  So, while we are left shrugging our shoulders for now, we assume the dismissal on causation has merely been kicked down the road a bit.