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Plaintiff Sues Drug Manufacturer, New York Court of Appeals Weighs in on Use of Expert Testimony


In 1997, plaintiff underwent a liver biopsy based upon symptoms of portal hypertension which did not show established cirrhosis. In 2001, a magnetic resonance imaging exam indicated that the plaintiff had micronodular cirrhosis. In July 2004, plaintiff underwent liver transplant surgery. Thereafter, 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, 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.

Subsequently, plaintiff commenced the instant action against defendant, which manufactures and sells Tylenol; that her intake of Tylenol caused her injuries. 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; to recover damages for the personal injuries suffered under product liability. Expert disclosures were presented before the court.

Following discovery, defendant moved to preclude plaintiff’s expert testimony relating to the plaintiff’s theory of medical causation and for summary judgment dismissing the amended complaint.

On 19 January 2010, the Supreme Court, inter alia, granted the defendant’s motion in its entirety. The Supreme Court determined that defendant met its burden by demonstrating that there was no evidence linking acetaminophen to cirrhosis. The Supreme Court stated that there were no studies or medical literature concluding that the ingestion of normal doses of acetaminophen caused cirrhosis and that plaintiff was attempting to draw a medical parallel between the ingestion of proper doses and excessive doses to conclude that acetaminophen caused cirrhosis; that almost all of the case reports involved the ingestion of doses greater than the recommended dose, or involved a patient who had a disease other than cirrhosis; and the conclusion that plaintiff’s condition was uncommon was not accepted within the medical community. The Supreme Court concluded that plaintiff had failed to introduce any studies, peer reviewed articles, professional literature, judicial opinions, or recognized textbooks that set forth the plaintiff’s experts’ novel premise that the normal ingestion of acetaminophen can cause cirrhosis; that without supporting material, plaintiff failed to satisfy the evidentiary requirements of Frye.

Hence, plaintiff appeals the aforesaid decision.

The Issue:

The issue here is the admissibility of the plaintiff’s experts’ opinions relating to the plaintiff’s novel theory of medical causation.

The Ruling:

New York courts in applying the Frye test permit expert testimony based on scientific principles, procedures, or theories only after the principles, procedures, or theories have gained general acceptance in the relevant scientific field. A Frye inquiry addresses the question of whether the accepted techniques, when properly performed, generate results accepted as reliable within the scientific community generally. The burden of proving general acceptance rests upon the party offering the disputed expert testimony. While courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.

As a rule, 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.

The Frye test typically considers the admissibility of new scientific tests, techniques, or processes. The Frye test has also been applied to determine the admissibility of expert testimony based on new social and behavioral theories. Nevertheless, where there is no novel or innovative science involved, or where the tendered scientific deduction has been deemed generally accepted as reliable, there remains a separate inquiry applied to all evidence. This inquiry is whether there is a proper foundation to determine whether the accepted methods were appropriately employed in a particular case. Hence, where a plaintiff’s qualified experts offer no novel test or technique, but intend to testify about a novel theory of causation, where such opinion is supported by generally accepted scientific methods, it is proper to proceed directly to the foundational inquiry of admissibility, which is whether the theory is properly founded on generally accepted scientific methods or principles.

Here, plaintiff correctly contends that her proffered experts have not utilized any novel scientific techniques or evidence but seek to set forth the novel theory that therapeutic acetaminophen use caused the plaintiff’s liver cirrhosis primarily based upon the fact that acetaminophen is a hepatotoxin and that certain case studies suggest a relationship between acetaminophen and cirrhosis.

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. Deduction, extrapolation, drawing inferences from existing data, and analysis are not novel methodologies and are accepted stages of the scientific process. Nevertheless, a court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.

Thus, the court finds that the data upon which plaintiff’s experts relied upon is insufficient to support their novel theory of medical causation, rendering that theory speculative.

In the instant case, plaintiff only adduced two case reports of individuals before the Supreme Court that linked therapeutic usage of acetaminophen and the development of liver cirrhosis in otherwise healthy subjects. Courts have recognized that observational studies or case reports are not generally accepted in the scientific community on questions of causation and the case studies relied upon constitute merely observational data which are of a lesser caliber than controlled clinical studies from which results can be reviewed and verified. Moreover, even taking the two case studies at face value, they do not unequivocally state that acetaminophen caused the liver cirrhosis observed therein. The two studies merely hypothesized that the liver injuries sustained by the patients therein were related to ingestion of therapeutic doses of acetaminophen and that further study was warranted.

Furthermore, the analytical gap between the plaintiff’s scientific data and her experts’ theory of causation is widened by the contrary scientific articles submitted by defendant that concluded, among other things, that acetaminophen is safe in therapeutic doses, even for individuals suffering from liver disease. Acetaminophen is not a new drug. For over 50 years,

acetaminophen has been widely available without a prescription. The record is replete with evidence showing that the effects of acetaminophen on the human liver have been studied extensively. Indeed, plaintiff’s expert acknowledges that acetaminophen has been the subject of thousands of journal articles and a vehicle for extensive research into hepatotoxicity.

What’s more, the singular clinical study that plaintiff relied upon to connect therapeutic acetaminophen ingestion to the development of cirrhosis is a 2006 study which does not support the plaintiff’s theory of causation since it states that the clinical importance of the ALT elevations was unclear, and the authors of the study did not interpret the finding of raised ALT levels to be indicative of serious liver injury. Indeed, the authors found that acetaminophen clearly has a remarkable safety record when taken as directed, and chronic treatment with 4g daily has been confirmed to be safe.

In addition, the speculative nature of plaintiff’s experts’ theory of causation is exemplified by a review of the 2007 HPS study, in which the defendant identified the plaintiff as “patient 7”. While that study indicated that plaintiff’s presumed liver disease was cryptogenic cirrhosis, the authors of the study wrote that the scarcity of reported cases of HPS requiring a liver transplant may be because of the fact that this unusual entity may often go unrecognized and be classified as cryptogenic cirrhosis. This study does not even mention acetaminophen much less draw a correlation between the plaintiff’s condition and her use of acetaminophen.

In conclusion, 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.

Henceforth, the court finds 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 and that there was too great an analytical gap between the data and the opinion proffered. 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. Plaintiff failed to meet that burden.

Accordingly, the court affirms the decision of the Supreme Court in granting that branch of the defendant’s motion which was to preclude plaintiff’s expert testimony relating to plaintiff’s theory of medical causation; that branch of defendant’s motion which was for summary judgment dismissing the amended complaint is granted.

For free legal consultations, call Stephen Bilkis & Associates and talk to our Kings County Personal Injury Lawyers. Speak to a Kings County Product Liability Lawyer, and the like, from our firm. Our legal teams have the skill, experience and expertise to provide you with the best legal advice on the remedies or actions you can file before courts of law to protect your interests.

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