Ratner v. McNeil-PPC, Inc.

CourtNew York Supreme Court Appellate Division
Citation91 A.D.3d 63,2011 N.Y. Slip Op. 08575,933 N.Y.S.2d 323
PartiesMargalit RATNER, appellant, v. McNEIL–PPC, INC., respondent.
Decision Date22 November 2011

2011 N.Y. Slip Op. 08575
91 A.D.3d 63
933 N.Y.S.2d 323

Margalit RATNER, appellant,
McNEIL–PPC, INC., respondent.

Supreme Court, Appellate Division, Second Department, New York.

Nov. 22, 2011.

[933 N.Y.S.2d 324]

Weitz & Luxenberg, P.C., New York, N.Y. (Alani Golanski, Paul Pennock, and Lawrence Goldhirsch of counsel), for appellant.

Dechert LLP, New York, N.Y. (Robert W. Sparks, Debra D. O'Gorman, Patrick G. Broderick, Michael E. Planell, and Rose L. Amandola of counsel), for respondent.


[933 N.Y.S.2d 325]


[91 A.D.3d 64] This case involves the admissibility, pursuant to Frye v. United States, 293 F. 1013, of a plaintiff's experts' assertion that there is a causal connection between the plaintiff's ingestion of a ubiquitous over-the-counter medication and her subsequent development of a disease. Specifically, we consider a novel theory of medical causation concerning the relationship between the long-term use of acetaminophen and the development of liver cirrhosis, where such theory is primarily, if not exclusively, supported by extrapolation from a few observational case studies. For the reasons discussed below, we conclude that the Supreme Court properly granted the defendant's motion to preclude the plaintiff's expert testimony relating to the plaintiff's theory of medical causation and for summary judgment dismissing the amended complaint.

The plaintiff testified at her deposition that beginning in 1985, she ingested Tylenol and Extra Strength Tylenol as needed in order to relieve migraine headaches. Tylenol is an over-the-counter analgesic which contains acetaminophen as its sole active ingredient. The plaintiff asserts that her usage never exceeded the maximum recommended dosage. In 1997 the plaintiff underwent a liver biopsy based upon symptoms of “portal hypertension,” which did not show established cirrhosis.

[91 A.D.3d 65] In 2001 a magnetic resonance imaging exam indicated that the plaintiff had “micronodular cirrhosis.” In July 2004 the plaintiff underwent liver transplant surgery. Thereafter, the plaintiff was diagnosed with “incomplete septal cirrhosis” (hereinafter ISC), a condition that reflected either an ongoing injury or a regression of liver scarring. In addition, the plaintiff was diagnosed with “hepatoportal sclerosis” (hereinafter HPS), a relatively uncommon liver condition which can lead to the shrinking of the liver and the development of “portal hypertension.”

The plaintiff commenced this action against the defendant, which manufactures and sells Tylenol. In the amended complaint, the plaintiff sought to recover damages for negligence, failure to warn, defective design, breach of implied and express warranties, and a violation of the General Business Law.

Expert Disclosures

During discovery, the plaintiff disclosed that the following experts were prepared to testify on her behalf: Douglas Dieterich, Neil Theise, Gerald M. Rosen, and Suzanne Parisian. The plaintiff further revealed that two of her experts were prepared to set forth the theory that acetaminophen caused her liver cirrhosis. The plaintiff's experts asserted that acetaminophen was a known hepatotoxin, a substance that is harmful to the liver, and that repeated exposure to acetaminophen can cause chronic inflammation which can lead to fibrosis, or scarring of the liver, which may then cause liver cirrhosis. In support of their contentions, the plaintiff's experts relied upon, inter alia, various medical studies, and the plaintiff's liver pathology slides, clinical history, and biopsy reports.

Dieterich, a gastroenterologist and a hepatologist, was prepared to testify that the toxic effects of acetaminophen could be seen at doses that were “only slightly greater than recommended therapeutic doses,” and that people who are fasting, malnourished, or “predispos[ed]” are at a greater risk of acetaminophen toxicity, even at therapeutic doses. Dieterich opined that, after “ruling out other possibilities” and analyzing “the evidence using techniques consistent with those that he use[d] in his practice,” to a reasonable degree of medical and scientific certainty, the plaintiff's cirrhosis was caused or substantially contributed to by acetaminophen

[933 N.Y.S.2d 326]

. In support of his contentions, Dieterich relied upon, among other things, four case studies performed on mice and rats.

[91 A.D.3d 66] Theise, a pathologist and professor of hepatopathology, planned to testify about how exposure to hepatotoxins can result in toxic hepatitis, which can then lead to the development of hepatic fibrosis and liver cirrhosis. Theise would rely upon scientific publications and literature which he asserted indicated that acetaminophen could cause hepatitis, fibrosis, and cirrhosis. After reviewing the plaintiff's liver slides, he noted a pattern of scarring and nodularity consistent with a diagnosis of ISC. Theise found that the plaintiff's ISC indicated a regression of scarring and attributed this regression to the plaintiff's discontinuation of acetaminophen approximately three years prior to her 2004 liver transplant.

Rosen, a pharmacologist, would testify that the defendant failed to provide an adequate warning to consumers about the hepatotoxicity of acetaminophen, and that had methionine or other compounds been added as an ingredient to Tylenol, the hepatotoxicity of acetaminophen would have been effectively eliminated. Lastly, Parisian, a former chief medical officer with the Food and Drug Administration, would testify that the defendant had downplayed the potential risks posed by the hepatotoxicity of Tylenol, and failed to design, test, label, and market Extra Strength Tylenol to consumers in a reasonably prudent and safe manner.

The Defendant's Motion to Preclude and for Summary Judgment

Following discovery, the defendant moved to preclude the plaintiff's expert testimony relating to the plaintiff's theory of medical causation and for summary judgment dismissing the amended complaint. The defendant argued that the plaintiff's experts' opinion that acetaminophen can cause cirrhosis of the liver or contributed to the plaintiff's cirrhosis did not satisfy the standard for admissibility of scientific evidence, and should be excluded under Frye v. United States, 293 F. 1013. In support of the motion, the defendant relied upon the opinion of Howard J. Worman, a physician specializing in the fields of hepatology and cell biology. In an affidavit, Worman conceded that acetaminophen is toxic to the liver in overdose and that “in cases of massive overdose, acetaminophen can cause acute liver failure.” However, Worman averred that the theory that long-term acetaminophen use at therapeutic doses can cause cirrhosis was not generally accepted in the medical and scientific communities. He defined cirrhosis as fibrosis or scarring of the liver[91 A.D.3d 67] , with widespread nodules of regenerating cells, which can lead to liver failure.

Worman asserted that the plaintiff's experts' opinions were based upon a faulty conclusion on the nature of her diagnosis. According to Worman, the plaintiff was actually diagnosed with HPS, rather than cirrhosis. In support, Worman relied upon a medical study published in 2007, in which he identified the plaintiff as “patient 7,” and where that patient was found to have, among other things, ISC and HPS. That study made no mention of acetaminophen. Worman contended that the cause of HPS was unknown, and that HPS with ISC had never been attributed to acetaminophen use in scientific or medical literature.

Worman contended that the medical literature that the plaintiff's experts relied upon consisted almost exclusively of case reports and animal studies about acetaminophen overdose, and that such data about overdoses could not be extrapolated to explain the cause of the plaintiff's condition. Worman supplemented his affidavit with,

[933 N.Y.S.2d 327]

inter alia, two medical articles which concluded that acetaminophen was safe in therapeutic doses, even for individuals suffering from liver disease.

The Plaintiff's Opposition

In opposition, the plaintiff argued that the defendant's motion should be denied because there was nothing novel in the methodologies employed by her experts, and that a Frye hearing was unnecessary. In an affidavit, the plaintiff averred that she stopped using Tylenol in 2001 or 2002 when she was informed that her liver condition was the result of Tylenol use; it was then that she was placed on a liver transplant list. The plaintiff asserted that she would never have used Tylenol if she had been warned about its dangers. She stated that she did not have the means to pay for a costly Frye hearing and submitted additional statements from her proposed experts.

Theise opined that chronic, daily use of the maximum therapeutic dose of acetaminophen contributed significantly to the need for the plaintiff's liver transplant. Theise conceded that extrapolations from injuries in rodents to humans could not be made in terms of the likelihood and range of injuries, but that such injuries in rodents were indicative of the range of possibilities that one might expect in humans. He argued that even a clinical study with hundreds of patients would be insufficient to make a determination as to idiosyncratic toxicities of acetaminophen[91 A.D.3d 68] . He asserted that only after the accumulation of numerous individual case studies linking acetaminophen to cirrhosis, could epidemiologic studies be conducted to address that data, leading “clinicians [to] become more aware of the possibility of idiosyncratic drug reactions and a consensus builds around the link.” Overall, Theise opined, within a reasonable degree of scientific certainty, that there was a significant, potential cumulative impact of consistent, repetitive use of even therapeutic doses of acetaminophen over a long term, indicating a cause of the...

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