Experts

Simpson v Edghill, 169 AD3d 737 [2d Dept. 2019]

In opposition, the affidavit of the plaintiff’s expert failed to raise a triable issue of fact as to the causation element. “ ’While it is true that a medical expert need not be a specialist in a particular field in order to testify regarding accepted practices in that field . . . the witness nonetheless should be possessed of the requisite skill, training, education, knowledge or experience from which it can be assumed that the opinion rendered is reliable’ ” (Behar v Coren, 21 AD3d 1045, 1046-1047 [2005], quoting Postlethwaite v United Health Servs. Hosps., 5 AD3d 892, 895 [2004]). “Thus, where a physician opines outside his or her area of specialization, a foundation must be laid tending to support the reliability of the opinion rendered” (Behar v Coren, 21 AD3d at 1047; see Galluccio v Grossman, 161 AD3d 1049, 1052 [2018]). Here, the plaintiff’s expert, who was board certified in ophthalmology, was qualified to, and did, raise a triable issue of fact as to whether Edghill deviated from the accepted standard of care in failing to refer the plaintiff to a neurologist to further evaluate his symptoms. However, the affidavit was insufficient to establish that the plaintiff’s meningioma could have been treated by radiation instead of surgery if it had been detected in November 2014. The plaintiff’s expert failed to articulate that he had any training in the treatment of meningiomas or what, if anything, he did to familiarize himself with the applicable standard of care. The affidavit, therefore, lacked probative value and failed to raise a triable issue of fact as to whether any departure from the accepted standard of care proximately caused the plaintiff’s injuries (see Feuer v Ng, 136 AD3d 704, 707 [2016]; Tsimbler v Fell, 123 AD3d 1009, 1010 [2014]).

Noble v Kingsbrook Jewish Med. Ctr., 168 AD3d 1077 [2d Dept. 2019] (same as Simpson v Edghill, 169 AD3d 737 [2d Dept. 2019]

Sanchez v L.R.S. Cab Corp., 169 AD3d 733 [2d Dept. 2019]

In opposition, the appellant failed to raise a triable issue of fact. The affirmed report of the appellant’s neurologist was insufficient to raise a triable issue of fact, as it failed to expressly compare the appellant’s range of motion to a normal range of motion, and it failed to provide any qualitative assessment of the appellant’s condition (see Toure v Avis Rent A Car Sys., 98 NY2d at 350; Fiorillo v Arriaza, 52 AD3d 465, 466-467 [2008]; Kaminski v Kawamoto, 49 AD3d 501, 502 [2008]).

Cho v Demelo, 2019 NY Slip Op 06467 [2d Dept. 2019]

The Supreme Court should not have granted that branch of the defendants’ motion which was for summary judgment dismissing the complaint on the ground that the plaintiff did not sustain a serious injury. The defendants failed to meet their prima facie burden on the motion (see generally Toure v Avis Rent A Car Sys., 98 NY2d 345; Gaddy v Eyler, 79 NY2d 955). The affirmed report of their orthopedic surgeon failed to identify the objective tests that were utilized to measure the plaintiff’s ranges of motion, and thus, did not support the conclusion that the plaintiff suffered no limitations as a result of the accident (see Zavala v Zizzo, 172 AD3d 793, 794; Bayk v Martini, 142 AD3d 484Durand v Urick, 131 AD3d 920Exilus v Nicholas, 26 AD3d 457). It is therefore unnecessary to determine whether the papers submitted by the plaintiff in opposition to the motion were sufficient to raise a triable issue of fact (see Winegrad v New York Univ. Med. Ctr., 64 NY2d 851, 853).

Experts

Wei Lin v Sang Kim, 2019 NY Slip Op 00161 [2d Dept. 2019]

In a medical malpractice action, a defendant moving for summary judgment has the burden of establishing, prima facie, either the absence of any departure from good and accepted medical practice, or that any departure was not a proximate cause of the plaintiff’s injuries (see Kelly v Rosca, 164 AD3d 888, 891; Barley v Bethpage Physical Therapy Assoc., P.C., 122 AD3d 784Wall v Flushing Hosp. Med. Ctr., 78 AD3d 1043, 1044). The burden is not met if the defendant’s expert renders an opinion that is conclusory in nature or unsupported by competent evidence (see Alvarez v Prospect Hosp., 68 NY2d 320, 324; Bongiovanni v Cavagnuolo, 138 AD3d 12, 17; Barley v Bethpage Physical Therapy Assoc., P.C., 122 AD3d at 784; Duvidovich v George, 122 AD3d 666).

We agree with the Supreme Court’s determination denying the defendant’s motion for summary judgment dismissing the complaint, although on a different ground than that relied on by the court. In support of his motion, the defendant failed to establish, prima facie, that he did not depart from good and accepted medical practice, or that any departure was not a proximate cause of the injured plaintiff’s injuries. The defendant’s expert merely summarized the medical records and certain deposition testimony, and opined in a conclusory manner that the defendant’s treatment of the injured plaintiff did not represent a departure from good and accepted medical practice (see Kelly v Rosca, 164 AD3d at 891; Barley v Bethpage Physical Therapy Assoc., P.C., 122 AD3d at 784). Since the defendant failed to establish his prima facie entitlement to judgment as a matter of law, we need not consider the sufficiency of the plaintiffs’ opposition papers (see Winegrad v New York Univ. Med. Ctr., 64 NY2d 851, 853).

The bold is mine.

Sikorjak v City of New York, 2019 NY Slip Op 00157 [2d Dept. 2019]

 It was a provident exercise of discretion for the court to limit the testimony of the plaintiff’s expert to issues calling for professional or technical knowledge (see De Long v County of Erie, 60 NY2d 296, 307; Century Sur. Co. v All in One Roofing, LLC, 154 AD3d 803, 808; Kohler v Barker, 147 AD3d 1037, 1038; Galasso v 400 Exec. Blvd.LLC, 101 AD3d 677, 678). The court also providently exercised its discretion in sustaining an objection to improper opinion testimony by a fact witness (see Guzek v B & L Wholesale Supply, Inc., 151 AD3d 1662, 1664; LaPenta v Loca-Bik Ltee Transp., 238 AD2d 913, 914). 

Daniele v Pain Mgt. Ctr. of Long Is., 2019 NY Slip Op 00093 [2d Dept. 2019]

The Supreme Court also should not have allowed the plaintiff’s experts, Jason Brajer and Paul Edelson, to testify as expert witnesses in emergency medicine. “[W]here a physician opines outside his or her area of specialization, a foundation must be laid tending to support the reliability of the opinion rendered” (Mustello v Berg, 44 AD3d 1018, 1019; see Behar v Coren, 21 AD3d 1045, 1046-1047). Whether a particular witness is qualified to testify as an expert is ordinarily a discretionary determination (see de Hernandez v Lutheran Med. Ctr., 46 AD3d 517, 517), which will not be disturbed in the absence of a serious mistake, an error of law, or an improvident exercise of discretion (see id. at 517-518). Brajer was board-certified in anesthesiology and pain management. He did not testify that he had training in emergency medicine, and did not adequately explain how he was familiar with the standard of care in emergency medicine based upon his prior experience of being called to the emergency room to prepare patients for surgery, or evaluating urgent back pain (see Galluccio v Grossman, 161 AD3d 1049, 1052; cf. Ocasio-Gary v Lawrence Hosp., 69 AD3d 403, 405). Edelson, a pediatrician, had minimal experience in emergency medicine. More importantly, that experience, which consisted of moonlighting at a hospital for five hours per week in the late 1970s and early 1980s, was simply too remote in time to qualify him to testify as an expert in emergency medicine as of September 2010, the time of the treatment at issue in this case. Edelson otherwise failed to demonstrate that he possessed the specialized knowledge, training, or education that would have qualified him as an expert in this area (see Lavi v NYU Hosps. Ctr., 133 AD3d 830, 831; de Hernandez v Lutheran Med. Ctr., 46 AD3d at 517-518; Mustello v Berg, 44 AD3d at 1018-1019). Accordingly, the court should not have permitted their expert testimony.

The bold is mine.

No foundation for the expert opinion [biomechanical engineering]

Imran v R. Barany Monuments, Inc., 2018 NY Slip Op 08921 [2d Dept. 2018]

Under the circumstances of this case, we agree with the Supreme Court’s determination to grant the plaintiff’s motion pursuant to CPLR 4404(a) to set aside the jury verdict on the issue of damages (see Dovberg v Lauback, 154 AD3d 810). “An expert’s opinion must be based on facts in the record or personally known to the witness'” (Pascocello v Jibone, 161 AD3d 516, 516, quoting Hambsch v New York City Tr. Auth., 63 NY2d 723, 725). Here, a proper foundation was lacking for the admission of McGowan’s opinion (see Parker v Mobil Oil Corp., 7 NY3d 434, 447). Among other things, McGowan failed to calculate the force exerted by all four vehicles, the crash test he utilized to determine the delta-v differed in several significant respects from the instant accident, and he reviewed simulations in which the weight of the dummies was not similar to that of the plaintiff.

Experts

Salinas v World Houseware Producing Co., Ltd., 2018 NY Slip Op 07938 [1st Dept. 2018]

Where the conclusion of an expert relies upon facts contrary to the plaintiff’s testimony, the affirmation will fail to raise an issue of fact sufficient to defeat summary judgment (see Feaster-Lewis v Rotenberg, 93 AD3d 421, 422 [1st Dept 2012], lv denied 19 NY3d 803 [2012]; Wengenroth v Formula Equip. Leasing, Inc., 11 AD3d 677, 679 [2d Dept 2004]). Here, the validity of plaintiff’s experts’ opinions rely upon the assumption that the subject potholder caught fire after contacting the heating element of plaintiff’s oven, a fact plaintiff specifically denied several times during her deposition. Plaintiff was not equivocal at her deposition, nor did she seek to correct her testimony at any time thereafter.

 

Experts have to know what they are talking about and CPLR 2106

Galluccio v Grossman, 2018 NY Slip Op 03664 [2d Dept. 2018]

In opposition, the affirmation of the plaintiffs' expert failed to raise a triable issue of fact. "While it is true that a medical expert need not be a specialist in a particular field in order to testify regarding accepted practices in that field, the witness nonetheless should be possessed of the requisite skill, training, education, knowledge or experience from which it can be assumed that the opinion rendered is reliable" (Postlethwaite v United Health Servs. Hosps., 5 AD3d 892, 895 [internal quotation marks and citations omitted]). "Thus, where a physician opines outside his or her area of specialization, a foundation must be laid tending to support the reliability of the opinion rendered" (Mustello v Berg, 44 AD3d 1018, 1019; see Behar v Coren, 21 AD3d 1045, 1046-1047). Here, the plaintiffs' expert, who was board-certified in internal medicine and infectious disease, did not indicate in his affirmation that he had training in emergency medicine, or what, if anything, he did to familiarize himself with the standard of care for this specialty. The affirmation, therefore, [*3]lacked probative value, and failed to raise a triable issue of fact (see Lavi v NYU Hosps. Ctr., 133 AD3d 830, 831). Accordingly, the Supreme Court should have granted the motion of Friedman and Island Medical for summary judgment dismissing the complaint and all cross claims insofar as asserted against them.

***

Although the plaintiffs initially opposed the motion with physician affirmations that did not comply with CPLR 2016, the court providently disregarded the defect after the plaintiffs replaced the affirmations with affidavits (see CPLR 2001). However, the court should have granted that branch of the motion which was for summary judgment dismissing the cause of action alleging lack of informed consent insofar as asserted against those defendants, since, as elucidated in the bill of particulars, the claim does not involve an affirmative violation of the plaintiff's physical integrity as is required to state a cause of action for lack of informed consent (see Martin v Hudson Val. Assoc., 13 AD3d 419, 420).

An expert with no facts

Pascocello v Jibone, 2018 NY Slip Op 03466 [1st Dept. 2018]

An expert's opinion "must be based on facts in the record or personally known to the witness" (Hambsch v New York City Tr. Auth., 63 NY2d 723, 725 [1984] [internal quotation marks omitted]; see Roques v Noble, 73 AD3d 204, 206 [1st Dept 2010]), and in the absence of such record support, an expert's opinion is without probative force (see Diaz v New York Downtown Hosp., 99 NY2d 542, 544 [2002]). Here, Supreme Court properly precluded Dr. Toosi from offering an opinion based on photographs for which no proper foundation had been established.

unqualified expert and not disqualified expert

Von Ohlen v East Meadow Union Free Sch. Dist., 2014 NY Slip Op 00652 [2nd Dept. 2014]

While the plaintiffs submitted the affidavit and report of their purported expert, there was no showing that the purported expert had any specialized knowledge, experience, training, or education regarding playground equipment so as to qualify him to render an opinion in this area (see Y.H. v Town of Ossining, 99 AD3d 760, 762). Furthermore, the expert's opinions were speculative and conclusory (see Rivas-Chirino v Wildlife Conservation Socy., 64 AD3d 556, 558). Additionally, the plaintiffs' reliance on the handbook of the United States Consumer Product Safety Commission was inadequate to raise a triable issue of fact as to the School District's negligence, since the standards promulgated by that agency are not mandatory but, rather, are merely suggested guidelines (see Miller v Kings Park Cent. School Dist., 54 AD3d 314, 315; Soldano v Bayport-Blue Point Union Free School Dist., 29 AD3d 891; Pinzon v City of New York, 197 AD2d 680, 681).

Winzelberg v 1319 50th St. Realty Corp., 2014 NY Slip Op 00656 [2nd Dept. 2014]

The appellants failed to establish a sufficient basis for disqualifying the plaintiff's expert witness. The record demonstrated that the expert was originally and continuously retained on the plaintiff's behalf, such that no confidential relationship existed between the plaintiff's expert and any defendants in this action (see Roundpoint v V.N.A., Inc., 207 AD2d 123; see generally Berkowitz v Berkowitz, 176 AD2d 775; cf. Mancheski v Gabelli Group Capital Partners, Inc., 22 AD3d 532, 534; Matter of Walden Fed. Sav. & Loan Assn. v Village of Walden, 212 AD2d 718, 719). No other basis for finding a conflict of interest was presented. Accordingly, the appellants' motion to disqualify the plaintiff's expert witness was properly denied.

Experts: reports relied on unattached = report has no probative value

Meteorologist

Cotter v Brookhaven Mem. Hosp. Med. Ctr., Inc., 2012 NY Slip Op 05382 (2nd Dept. 2012)

Here, the defendant property owner failed to establish, prima facie, that it was entitled to judgment as a matter of law dismissing the complaint based on the storm in progress rule. In support of its motion, the defendant submitted an affirmed report of a meteorologist who opined that a storm was in progress at the time the plaintiff allegedly slipped and fell on ice. However, copies of the records upon which the meteorologist relied in forming his opinion were not attached to the report, and thus, the report has no probative value (see Diaz v New York Downtown Hosp., 99 NY2d 542; Romano v Stanley, 90 NY2d 444, 451; Daniels v Meyers, 50 AD3d 1613; Schuster v Dukarm, 38 AD3d 1358). To meet its prima facie burden, the defendant could not rely on its submission of such records for the first time in its reply papers (see David v Byron, 56 AD3d 413, 414-415; Rengifo v City of New York, 7 AD3d 773; Voytek Tech. v Rapid Access Consulting, 279 AD2d 470, 471).

Industry custom and practice

Cassidy v Highrise Hoisting & Scaffolding, Inc., 2011 NY Slip Op 07936 (1st Dept., 2011)

The affidavit of plaintiffs' site safety expert failed to create questions of fact warranting denial of summary judgment. An expert's opinion should be disregarded where no authority, treatise, standard, building code, article or other corroborating evidence is cited to support the assertion concerning an alleged deviation from good and accepted industry custom and practice (Buchholz v Trump 767 Fifth Ave., LLC, 5 NY3d 1, 2 [2005]). "Before a claimed industry standard is accepted by a court as applicable to the facts of a case, the expert must do more than merely assert a personal belief that the claimed industry-wide standard existed at the time the design was put in place" (Hotaling v City of New York, 55 AD3d 396, 398 [2008], affd 12 NY3d 862 [2009]).

Frye

There has been an unusual amount of Frye action in the past six months.

Ratner v McNeil-PPC, Inc., 2011 NY Slip Op 08575 (2nd Dept., 2011)

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.

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"]).
Discussion

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.