It's that analytical gaps are bridged by evidence and there was no evidence that therapeutic doses of Tylenol cause cirrhosis of the liver. Rather than simply saying so the court in Ratner v. McNeil-PPC, Inc. veered into the always unenlightening analytical gap width assessment:
"The plaintiff did not put forward any clinical or epidemiological data or peer reviewed studies showing that there is a causal link between the therapeutic use of acetaminophen and liver cirrhosis. Consequently, it was incumbent upon the plaintiff to set forth other scientific evidence based on accepted principles showing such a causal link. We find that the methodology employed by the plaintiff's experts, correlating long term, therapeutic acetaminophen use to the occurrence of liver cirrhosis, primarily based upon case studies, was fundamentally speculative (see Lewin v County of Suffolk, 18 AD3d 621), and that there was too great an analytical gap between the data and the opinion proffered. We emphasize that when an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community."
Why not just say "plaintiff's experts have no evidence that their theory is true"? In the court's defense it was struggling to reconcile its ruling with Zito v Zabarsky in which it had previously held that in the case of a "new drug" plaintiffs need not wait for evidence (e.g. epidemiology) as otherwise:
" [a] strict application of the Frye test may result in disenfranchising persons entitled to sue for the negligence of tortfeasors. With the plethora of new drugs entering the market, the first users of a new drug who sustain injury because of the dangerous properties of the drug or inappropriate treatment protocols will be barred from obtaining redress if the test were restrictively applied.
(I am here reminded of a benzene / CML case I once tried in which plaintiff's counsel in closing bellowed "Mr. Oliver says that not enough workers have gotten CML to prove benzene is the cause of their cancers. I hope when it's his turn to speak that he answers this question: How high must the bodies be stacked before his client will admit that benzene was the cause?")
Anyway, as you can see the court was confronted with its prior opinion in which it had held that a well conceived hypothesis, though lacking utterly any evidence to support it, was enough to get a "new drug" case to the jury. Thus its effort to distinguish the two cases via "Tylenol is not a new drug" (more to the point would have been "there's been ample opportunity to test your theory via retrospective epidemiological studies and yet still you have no evidence") and thereafter a retreat into the bushes of "analytical gaps".
Karl Popper said that science proceeds by conjecture and refutation. You think up a theory about how some aspect of nature works, determine what predictions follow from it, and then check to see if the predictions hold up. That last part is what's called evidence. Without it you're left with nothing but a more or less educated guess; and that isn't enough to warrant depriving a citizen of life, liberty or property. That's what Daubert was all about.
Finally, does it look to you like "deduction" has a different meaning in New York? Here it seems to refer simultaneously to the method by which a general rule is induced from observations and the method by which a causal association is inferred from the rule you've just induced, thus:
"Generally, deductive reasoning or extrapolation, even in the absence of medical texts or literature that support a plaintiff's theory of causation under identical circumstances, can be admissible if it is based upon more than mere theoretical speculation or scientific hunch (see Zito v Zabarsky, 28 AD3d at 46; see also Black's Law Dictionary [9th ed 2009] [defining "extrapolation" as "(t)he process of estimating an unknown value or quantity on the basis of the known range of variables" and "(t)he process of speculating about possible results, based on known facts"]). Deduction, extrapolation, drawing inferences from existing data, and analysis are not novel methodologies and are accepted stages of the scientific process.
For example, in Zito v Zabarsky (28 AD3d 42), this Court expressly recognized that extrapolation or deduction is warranted in instances where the theory pertains to a new drug."
Let me know. Thanks.
