There has been an unusual amount of Frye action in the past six months.
The Supreme Court concluded that the 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. The Supreme Court stated that without supporting material, the plaintiff failed to satisfy the evidentiary requirements of Frye.
At issue in this case is the admissibility of the plaintiff's experts' opinions relating to the plaintiff's novel theory of medical causation. New York courts, applying the Frye test (see Frye v United States, 293 F 1013), 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 (see Parker v Mobil Oil Corp., 7 NY3d 434, 446; People v Wesley, 83 NY2d 417, 422; Cumberbatch v Blanchette, 35 AD3d 341, 342; Zito v Zabarsky, 28 AD3d 42). A Frye inquiry addresses the question of "whether the accepted techniques, when properly performed, generate results accepted as reliable within the scientific community generally" (People v Wesley, 83 NY2d at 422; Marso v Novak, 42 AD3d 377, 378 [internal quotation marks omitted]). The burden of proving general acceptance rests upon the party offering the disputed expert testimony (see Cumberbatch v Blanchette, 35 AD3d at 342; Zito v Zabarsky, 28 AD3d 42; Del Maestro v Grecco, 16 AD3d 364; Saulpaugh v Krafte, 5 AD3d 934, 935; Lara v New York City Health & Hosps. Corp., 305 AD2d 106). "[W]hile 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" (Frye v United States, 293 F at 1014).
"[G]eneral 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 at 44 [internal quotation marks omitted]; see Marsh v Smyth, 12 AD3d 307, 311 [stating, in concurrence by Saxe, J., that the "Frye test emphasizes counting scientists' votes, rather than . . . verifying the soundness of a scientific conclusion" (some internal quotation marks omitted)]).
The Frye test typically considers the admissibility of new scientific tests, techniques, or processes (see People v Wesley, 83 NY2d at 437 [noting that the trial court's Frye hearing was "virtually the first in the Nation to consider whether forensic application of DNA analysis had been generally accepted as reliable"]; see also Selig v Pfizer, Inc., 185 Misc 2d 600, 606 ["the majority of New York cases in which a Frye standard has been applied involve the admissibility of obviously novel forensic and social science techniques"], affd 290 AD2d 319; Blackwell v Wyeth, 408 Md 575, 971 A2d 235 [applying Frye test to preclude the plaintiffs' hypothesis that a substance in childhood vaccines can cause neurological defects, such as autism, since the plaintiffs' experts' fields of expertise were not relevant to the specific bodies of science related to autism and its causes]). For example, in Frye, the Court of Appeals of the District of Columbia considered the introduction of evidence based on a "systolic blood pressure deception test," a test which purportedly functioned by measuring fluctuations in blood pressure (Frye v United States, 293 F at 1013). In finding that the systolic blood pressure deception test was inadmissible, the court stated that the test "ha[d] not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made" (id. at 1014).
The Frye test has also been applied to determine the admissibility of expert testimony based on new social and behavioral theories. In People v Wernick (89 NY2d 111), the Court of Appeals affirmed the preclusion of a defendant's expert testimony regarding "neonaticide syndrome," a term used to describe a mother killing her newborn within 24 hours of birth, on the ground that the behavioral theory was not established as generally accepted in the profession as reliable (see People v LeGrand, 8 NY3d 449 [finding trial court erred in precluding defendant's expert from providing psychological testimony on the reliability of eyewitness identifications]; People v Taylor, 75 NY2d 277, 286 [affirming admission of expert testimony regarding "rape trauma syndrome" after concluding "that the relevant scientific community has generally accepted that rape is a highly traumatic event that will in many women trigger the onset of certain identifiable symptoms"]).
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" (Parker v Mobil Oil Corp., 7 NY3d at 447; see People v LeGrand, 8 NY3d at 457 [once the general reliability concerns of Frye are satisfied, the court will consider whether there is a proper foundation for the reception of the evidence at trial]; People v Wesley, 83 NY2d at 429).
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 (see Parker v Mobil Oil Corp., 7 NY3d at 447 [explaining that because "(t)here is no particular novel methodology at issue for which the Court needs to determine whether there is general acceptance . . . the inquiry here is more akin to whether there is an appropriate foundation for the experts' opinions"]; People v Garrow, 75 AD3d 849, 852 [Frye hearing was not required because expert testimony offered by the prosecution did not involve any novel procedures or innovative scientific theory]; Nonnon v City of New York, 32 AD3d 91, affd 9 NY3d 825 [in action where plaintiffs alleged that elevated levels of toxic substances at Pelham Bay Landfill caused their injuries, the court held that plaintiff's experts' testimony, based upon deductions of epidemiologist and toxicologists, was not novel and therefore admissible without a Frye hearing]; see also Marsh v Smyth, 12 AD3d at 312-313 [in concurrence by Saxe, J., stating "(u)nlike a newly developed test or process, a (novel) theory about the mechanism of an injury will not prompt the profession generally to weigh in with its own studies or publications on the subject"; thus, "to require proof . . . that a propounded theory of causation is accepted by a substantial percentage of the profession, would be to impose a virtually insurmountable hurdle"]).
The plaintiff argues that the Supreme Court erred in precluding her experts' theory of causation, and thereupon awarding summary judgment to the defendant dismissing the amended complaint. She asserts that the studies and case reports addressed the long term use of acetaminophen and found the potential for serious life-threatening liver injury. The defendant does not dispute that acetaminophen is a hepatotoxin and has been associated with liver failure in certain cases of massive overdose, nor does the defendant dispute the credentials of the plaintiff's experts. Instead, the defendant asserts that there is no scientific support for the general theory that acetaminophen taken within recommended doses can cause cirrhosis of the liver and, therefore, that there is no support for the specific theory that the plaintiff's cirrhosis is attributable to acetaminophen (see generally Parker v Mobil Oil Corp., 7 NY3d at 448 ["It is well-established that an opinion on causation should set forth a plaintiff's exposure to a toxin, that the toxin is capable of causing the particular illness (general causation) and that plaintiff was exposed to sufficient levels of the toxin to cause the illness (specific causation)"]).
As the plaintiff correctly contends, her proffered experts have not utilized any novel scientific techniques or evidence. Rather, the plaintiff's experts 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 (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. In Zito, the plaintiff alleged that the defendant physician departed from accepted medical practices by prescribing an excessive dose of the drug Zocor, causing the plaintiff to develop polymyositis, an autoimmune condition. At a Frye hearing, the plaintiff's experts pointed to the temporal relationship between the plaintiff's drug ingestion and injury, the "accepted scientific theory of the dose/response relationship" (id. at 46), and cited one article where a patient had developed an autoimmune disease that was likely induced by simvastatin, the generic name for Zocor. The trial court precluded the plaintiff's experts on the basis that no medical literature expressly reported a causal nexus between an excessive dose of Zocor and the onset of polymyositis.
On appeal, this Court reversed, holding that "[t]he fact that there was no textual authority directly on point to support the experts' opinion [was] relevant only to the weight to be given the testimony, but does not preclude its admissibility" (id.). This Court explained that "[w]ith 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 [Frye] test were restrictively applied" (id.; see Lugo v New York City Health & Hosps. Corp., AD3d, 2011 NY Slip Op 06475 [2d Dept 2011] [where the Supreme Court determined that the testimony of the plaintiffs' experts that the infant plaintiff's brain injuries were caused by an episode of severe neonatal hypoglycemia lasting 81 minutes was inadmissible, this Court disagreed, finding that the Supreme Court had applied the Frye test too restrictively given that hypoglycemia can cause brain injury, that certain infants are more susceptible than others to neurologic injury, and that hypoglycemia is a toxic and dangerous state with no safe level]; DieJoia v Gacioch, 42 AD3d 977, 978 [holding that the trial court applied the Frye test too restrictively in precluding plaintiff's expert based "almost exclusively on the fact that he could not produce any medical literature" to support the precise theory of causation, specifically "that cardiac catheterization has ever caused thrombosis and, subsequently, paralysis"]).
Nevertheless, "[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered" (General Elec. Co. v Joiner, 522 US 136, 146; see Blackwell v Wyeth, 408 Md 575 [finding that the analysis of data or extrapolation requires more than mere conjecture to pass reliability scrutiny]). As discussed below, we find that the data upon which the plaintiff's experts relied is insufficient to support their novel theory of medical causation, rendering that theory speculative.
Before the Supreme Court, the plaintiff adduced only two case reports of individuals that linked therapeutic usage of acetaminophen and the development of liver cirrhosis in otherwise healthy subjects. The Itoh study reported the case of a 53-year-old man in whom viral, alcoholic, and other metabolic injuries were excluded. Over the course of 12 years, the man ingested 12-20 tablets per day of a drug which contained 58 mg of acetaminophen and 5 mg of codeine; a biopsy revealed micronodular cirrhosis. The Johnson study, entitled "Chronic Liver Disease and Acetaminophen," reported the case of a 59-year-old woman who took 2,925 mg of acetaminophen daily for one year. Approximately one month before entering a hospital, the woman developed anorexia and "easy fatigability." The woman had a histological pattern typical of chronic aggressive hepatitis with cirrhosis.
"Courts have recognized that . . . observational studies or case reports are not generally accepted in the scientific community on questions of causation" (Heckstall v Pincus, 19 AD3d 203, 205 [precluding expert's opinion where plaintiff presented "no clinical or epidemiological data or peer reviews" linking the drug to the disease, and supported claim of causation solely with case reports]; see Pauling v Orentreich Med. Group, 14 AD3d 357 [save for the plaintiff's expert's own unpersuasive observational studies, the plaintiff failed to submit any medical literature to support existence of a novel disease]). We note that the two aforementioned case studies relied upon by the plaintiff 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. In this regard, the Johnson study specifically stated that "[t]he role of acetaminophen ingestion in this patient's liver disease is uncertain." 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. Moreover, the analytical gap between the plaintiff's scientific data and her experts' theory of causation is widened by the contrary scientific articles submitted by the defendant which, among other things, concluded that acetaminophen is safe in therapeutic doses, even for individuals suffering from liver disease.
This case is distinguishable from Zito because, among other things, 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 has been studied extensively. Indeed, Dieterich, the plaintiff's expert, acknowledges that acetaminophen "has been the subject of thousands of journal articles and a vehicle for extensive research into hepatotoxicity."
The singular clinical study that the plaintiff relies upon to connect therapeutic acetaminophen ingestion to the development of cirrhosis is a 2006 study by, among others, Paul B. Watkins. This study involved the development of a product which combined hydrocodone and acetaminophen. The study was prematurely ceased once it was found that 31% to 44% of the healthy adults who ingested the maximum recommended dose of acetaminophen had serum alanine aminotransferase levels (hereinafter ALT) (a liver enzyme) that were greater than 3 times the upper limit of normal (hereinafter the ULN) and marked elevations (14 times and 16 times the ULN) in several subjects. However, this clinical study 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 4 g daily has been confirmed to be safe."
The speculative nature of the 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 the plaintiff's presumed liver disease was cryptogenic cirrhosis, the authors of the study wrote, "[t]he 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." Further, we note that this study does not even mention acetaminophen, much less draw a correlation between the plaintiff's condition and her use of acetaminophen.
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. Here, the plaintiff failed to meet that burden.
Thus, the Supreme Court did not err in granting that branch of the defendant's motion which was to preclude the plaintiff's expert testimony relating to the plaintiff's theory of medical causation, and thereupon granting that branch of the defendant's motion which was for summary judgment dismissing the amended complaint.