Ratner v. McNeil-PPC, Inc., 2010 NY Slip Op 20023 (N.Y. Sup. Ct. 1/19/2010)

• Decision Date: 19 January 2010
• Docket Number: 48820/02
• Citation: 2010 NY Slip Op 20023
• Court: New York Supreme Court
• Parties: MARGALIT RATNER, Plaintiff, v. McNEIL-PPC, INC., Defendant,

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2010 NY Slip Op 20023

MARGALIT RATNER, Plaintiff, v. McNEIL-PPC, INC., Defendant,

48820/02

Supreme Court, Kings County.

Decided January 19, 2010.

LEON RUCHELSMAN, J.

The defendant has filed a motion seeking to preclude the expert testimony offered by the plaintiff and for summary judgement pursuant to CPLR §3212 on the grounds that the plaintiff cannot succeed on the claims alleged. The plaintiff opposes the motion seeking preclusion and has cross moved seeking summary judgement arguing that there is no dispute that the plaintiff is entitled to judgement. Papers were submitted by both parties and arguments held. After reviewing the papers of the parties, including the medical affidavits submitted this court now makes the following determination.

Background

This lawsuit was filed against the defendant the makers of Tylenol alleging that normal dosage ingestion of Tylenol and specifically, acetaminophen, a significant component of Tylenol caused her to develop cirrhosis of the liver which required a liver transplant in 2004. Following the exchange of significant medical discovery both parties move seeking summary judgement. The defendant presents essentially two arguments why the case should be dismissed. The first is that the plaintiff did not suffer from cirrhosis of the liver and that any case reports connecting cirrhosis and ingestion of acetaminophen, even if true and scientifically sound, are completely irrelevant. Moreover, the defendant argues that there is no scientifically acceptable evidence linking cirrhosis and acetaminophen and the plaintiff will simply be unable to prove this necessary causative element at trial. The plaintiff disputes both of these contentions and argues that the medical evidence submitted sufficiently demonstrates the causal link between acetaminophen and cirrhosis and that at least a Frye hearing should be held to further explore the issue.

Conclusions of Law

Summary Judgment may be granted where the movant establishes sufficient evidence which would compel the court to grant judgment in his or her favor as a matter of law (Zuckerman v. City of New York, 49 NY2d 997, 427 NYS2d 998, [1980]). Summary Judgment would thus be appropriate where no right of action exists foreclosing the continuation of the lawsuit.

It is well settled that expert testimony which involves novel scientific theories or techniques will be admissible at trial only upon a showing that such theories and such techniques are generally accepted within the scientific community (Frye v. United States, 293 F. 1013 (D.C. Cir., 1923). As the court explained in People v. Wesley, 83 NY2d 417, 611 NYS2d 97 [1994] "the test pursuant to Frye v United States (293 F 1013) poses the more elemental question of whether the accepted techniques, when properly performed, generate results accepted as reliable within the scientific community generally". Thus, the conclusion reached need not be a consensus opinion since "general acceptance does not necessarily mean that a majority of the scientists involved subscribe to the conclusion. Rather it means that those espousing the theory or opinion have followed generally accepted scientific principles and methodology in evaluating clinical data to reach their conclusions" (Zito v. Zabarsky, 28 AD3d 42, 812 NYS2d 535 [2d Dept., 2006]).

These principles are equally applicable in cases such as the one at bar which concern a plaintiff attempting to prove that a certain drug caused a certain medical condition. To permit the medical expert evidence necessary to prove causation the plaintiff must submit relevant scientific data or studies showing such causal link (Hooks v. Court Street Medical P.C., 15 AD3d 544, 790 NYS2d 679 [2d Dept., 2005]). Therefore, in Blackwell v. Wyeth, 971 A2d 235, 408 Md. 575 [Court of Appeals of Maryland, 2009] the court excluded expert testimony linking certain vaccines with autism finding that the tests conducted to prove that causal connection were methodologically flawed and unreliable. Similarly, inRuggiero v. Warner-Lambert Co., 424 F.3d 249 [2d Cir., 2005], the court did not permit expert testimony seeking to establish a causal link between the ingestion of the drug Rezulin and cirrhosis of the liver since the court found there was no evidence to support such a link. The court held that the only link consisted of the plaintiff's doctor's opinion based upon a differential diagnosis, in other words a process of elimination identifying the most likely cause from a list of possible causes. The court concluded that basis was insufficient to permit introduction of that medical testimony.¹

Again, in Shepard v. Barnard, 949 So2d 232, 32 Fla L. Weekly D217 [District Court of Appeal of Florida, 2007] the court refused to permit expert testimony linking the drug Verteporfin with photoallergy. In that case the only evidence linking the two was the testimony of the doctor who based his opinion solely upon the "temporal relationship" between ingesting the drug and contracting the illness. The court held such scientific evidence failed to satisfy the Frye standard and excluded the evidence.New York cases likewise exclude scientific evidence where the methodology or techniques utilized are not accepted within the scientific community. InSelig v. Pfizer, Inc., 290 AD2d 319, 735 NYS2d 549 [1st Dept., 2002] the court excluded testimony demonstrating a link between the drug Viagra and heart attacks. The court found that studies were not conducted with Viagra itself but a similar drug with important medical differences. Moreover, a study submitted on the subject did not draw any conclusions about the connection between Viagra and cardiac failure, only that further study was required. The court held such medical information insufficient to demonstrate causality and consequently the medical evidence was excluded. Similarly, inKaczor v. Vanchem, Inc., 262 AD2d 1041, 691 NYS2d 831 [4th Dept., 1999] the court excluded expert testimony that chemical exposure caused chronic fatigue syndrome. The only evidence supporting such a link between the two was evidence from a doctor that fumes from chemical exposure causes increased liver enzyme levels which can cause chronic fatigue syndrome and that plaintiff had such increases in liver enzyme levels after the incident with the fumes. However, the doctor did not offer any basis to substantiate the assertion that high enzyme levels are caused by chemical fumes. Without any basis the evidence was excluded. Once again, inLewin v. County of Suffolk, 18 AD3d 621, 795 NYS2d 659 [2d Dept., 2005] the court excluded expert testimony attempting to link certain pesticides with birth defects. The court noted that the methodology used by the experts were speculative.

While the particular deficiencies which prompted the courts to exclude the expert evidence varied from case to case there was one overarching principle that underscored them all. In all the cases the methods utilized by the experts were not accepted within the scientific community and hence did not satisfy the Frye test.

These cases must be contrasted with those that held expert testimony admissible under Frye seeking to prove that a certain drug caused a specific injury. Thus, in Rodriguez ex rel. Posso-Rodriguez v. Feinstein, 793 So2d 1057, 26 Fla. L. Weekly D813 [District Court of Appeal, 2001] the court permitted expert testimony linking exposure to certain drugs in utero as a cause of birth defects. Specifically, in that case the defendant prescribed the anti-fungal drug Sporanox to treat a toenail fungus infection to a pregnant woman. When the child was born with an eye defect the doctor was sued for malpractice. Expert evidence was sought to be introduced linking ingestion of Sporanox as a cause for the birth defects. The conclusion of the three experts was based upon seven factors enumerated by the court. They included"(1) the timing and duration of the exposure to the drug; (2) the lingering effect of the drug in the system even after the patient stops taking it due to the drug's lipophilic aspect (attraction to the fatty tissue); (3) the drug's molecular weight which is small enough to be transferred through the placenta; (4) the Federal Drug Administration's classification of the drug as a category C drug, teratogenic in animals; (5) the manufacturer's package insert which warns against taking this particular drug during pregnancy; (6) animal studies which have shown the drug to cause birth defects; and (7) the statistical increase in birth defects according to FDA adverse reaction reports." The court concluded that the scientific views expressed by plaintiff's experts were accepted within the scientific community and the fact the conclusions differed from those of defendant's experts did not mean they were unreliable. Thus, the court admitted the expert testimony.

However, an important clarification of the Frye standard was developed in Nonnon v. City of New York, 32 AD3d 91, 819 NYS2d 705 [1st Dept., 2006] and cases which followed. In that case the court conceded that epidemiological studies were not novel and hence did not require Frye analysis. The court defined epidemiology as "a science which focuses on the question of general causation (i.e., is the [landfill] capable of causing disease?) rather than that of specific causation (i.e., did [the landfill] cause disease in a particular individual?)" (internal quotations and citations omitted). Thus, "this field of science is the primary generally accepted methodology for demonstrating a causal relation between a chemical compound and a set of symptoms or a disease" (internal quotations and citations omitted). The court found that the experts engaged in standard scientific procedure and methodology and reached acceptable conclusions. Therefore, the court permitted expert evidence linking carcinogens found at a land fill causing injuries to plaintiffs. In Marso v. Novack, 42 AD3d 377, 840 NYS2d 53 [1st...