By Michael Hoenig - New York Law Journal -
December 12, 2011
have elaborated on the ripening of New York law regarding
judicial screening, or "gatekeeping," of the reliability of
expert testimony.1 Particularly after the New York
Court of Appeals' pivotal October 2006 decision in
Parker v. Mobil Oil Corp.,2 courts and
lawyers were alerted to a remarkably clear, yet substantially
nuanced, road map on approaching questions of experts'
reliability. Clear road maps, however, do not mean the roadways
to be traveled are always straight or smoothly paved or sans
obstacles or detours. Complexities can intrude to distract or
divert attention from or obfuscate the quest for true
reliability in the particular expert's methodology, foundational
predicates and opinions. Our Sept. 16 column dealing with
reliability concerns when experts use or misuse scientific
articles sets forth examples.3
On paper, the
reliability-policing rules seem simple enough. If novel
scientific evidence is involved, New York's application of the
Frye "general acceptance" test has the judge determine
"whether the accepted techniques, when properly performed,
generate results accepted as reliable within the scientific
community generally." If the answer is "no," the testimony
flunks and is precluded or excluded. If the answer is "yes," the
proponent of the novel expert opinion has survived the threshold
test but must also meet a second reliability standard—one I have
called the "foundational reliability" question.
the Court said the Frye inquiry is "separate and distinct
from the admissibility question applied to all evidence—whether
there is a proper foundation—to determine whether the accepted
methods were appropriately employed in a particular case."
Parker clarified that the focus moves "from the general
reliability concerns of Frye to the specific reliability
of the procedures followed to generate the evidence proffered
and whether they establish a foundation for the reception of
evidence at trial." Indeed, in the Parker case itself,
which claimed that a gas station attendant's leukemia was caused
by exposure to benzene in gasoline, the Court said that no
particular novel methodology was at issue for which "general
acceptance" needed to be determined. Rather, the issue was
foundational reliability, "an inquiry…more akin to whether there
is an appropriate foundation for the experts' opinions." The
question in Parker was not a Frye issue but
whether the methodologies "lead to a reliable result."
novel scientific evidence is involved, the opponent of the
proffered expert opinion may throw, and the proponent may have
to dodge, a "one-two punch," first Frye's "general
acceptance" hurdle and, then, if necessary, the "foundational
reliability" obstacle. When the scientific evidence is not
novel, however, reliability-policing goes forward nonetheless
since the foundational reliability requirement must be met. In
Parker, the plaintiff's experts, although highly
qualified in their respective fields, "failed to demonstrate
that exposure to benzene as a component of gasoline caused [Mr.]
New York courts have not adopted the federal Daubert
gatekeeping standard,4 the Court of Appeals in
Parker referred in its footnote 4 to federal case law on how
much precise exposure information a toxic tort plaintiff needs
to prove and stated: "We recognize that these cases employ a
Daubert analysis. However, they are instructive to the
extent they address the reliability of an expert's methodology."
Thus, although the Frye test governs the reliability
issue in novel science cases, federal case law employing
Daubert analysis may be "instructive" on the foundational
reliability issue courts have to grapple with in all expert
testimony cases where reliability concerns are properly raised.
gatekeeping decision offering salient points and valuable
insights was issued on Nov. 22 by the Appellate Division, Second
Ratner v. McNeil-PPC Inc.,5 a case in which
it was claimed that plaintiff's ingestion of the common
medication, Tylenol, caused liver cirrhosis. In an opinion
authored by Justice John M. Leventhal, the court concluded that
the trial judge properly granted defendant's motion to preclude
plaintiff's expert testimony relating to plaintiff's theory of
medical causation and for summary judgment dismissing the
complaint. Since the appellate opinion is informative, we
briefly review highlights here.
1985, plaintiff ingested Tylenol and Extra Strength Tylenol as
needed to relieve migraine headaches, never exceeding the
maximum recommended dosage. Acetaminophen is the sole active
ingredient of the over-the-counter analgesic. In 1997 she
underwent a liver biopsy based on symptoms of "portal
hypertension," but established cirrhosis was not shown. In 2001
an MRI indicated she had "microndular cirrhosis." In July 2004
she underwent liver transplant surgery. Later, she was diagnosed
with liver conditions called "incomplete septal cirrhosis" (ISC)
and "hepataportal sclerosis" (HPS), an uncommon condition.
manufactures and sells Tylenol. Plaintiff sued for negligence,
failure to warn, defective design, breach of warranties and a
violation of the General Business Law. During discovery four
experts were identified to testify on behalf of plaintiff. Two
were prepared to set forth the theory that acetaminophen caused
her liver cirrhosis. The experts asserted that acetaminophen was
a known hepatoxin, a substance harmful to the liver. Repeated
exposure can cause chronic inflammation that can lead to
scarring of the liver which, in turn, may cause cirrhosis. The
experts relied on medical studies, plaintiff's liver pathology
slides, clinical history and biopsy reports.
Expert D, a
gastroenterologist and a hepatologist, would testify that toxic
effects of acetaminophen could be seen at doses "only slightly
greater than recommended therapeutic doses." Further, some
persons, those who are fasting, malnourished or "predisposed"
are at a greater risk of toxicity, even at therapeutic doses.
After "ruling out other possibilities" and "using techniques
consistent with those used in his practice," D concluded that
acetaminophen caused the cirrhosis. D also relied on four case
studies performed on mice and rats.
Expert T, a
pathologist and professor of hepatopathology, planned to testify
how exposure to hepatoxins can result in toxic hepatitis, then
to hepatic fibrosis and liver cirrhosis. He would rely on
scientific literature. He also reviewed plaintiff's liver slides
and noticed a regression of scarring coinciding with plaintiff's
discontinuation of the product. Expert R, a pharmacologist, was
to testify about inadequate warnings as well as the ability of
defendant to eliminate the hepatoxicity by adding an ingredient
called methionine. Expert P, a former chief medical officer with
the Food and Drug Administration would testify that defendant
downplayed the potential risks and failed to safely design, test
and label Extra Strength Tylenol.
to preclude the expert testimony on medical causation and for
summary judgment. Defense expert W, a physician specializing in
hepatology and cell biology, in an affidavit, conceded that
acetaminophen is toxic to the liver in overdose and can cause
failure in massive overdose. But, the theory that long-term
acetaminophen use at therapeutic doses can cause cirrhosis was
not generally accepted in the medical and scientific
communities. W asserted that plaintiff's experts' opinions were
based on a faulty conclusion regarding the nature of her
diagnosis. W criticized the reliance on medical literature
consisting almost exclusively of case reports and animal studies
involving overdose. Such data about overdoses "could not be
extrapolated" to explain the cause of the plaintiff's condition.
W supplemented his affidavit with two medical articles
concluding that acetaminophen was safe in therapeutic doses,
even for individuals suffering from liver disease.
opposed the motion arguing that there was nothing novel in the
methodologies employed by her experts. A Frye hearing was
therefore unnecessary. Experts T, D, R and P urged that the drug
caused the disease. The trial judge, noting that almost all of
the case reports involved ingestion of doses greater than the
recommended dose, or involved a patient with a disease other
than cirrhosis, concluded that plaintiff's novel premise that
normal ingestion caused cirrhosis failed to satisfy the
evidentiary requirements of Frye.
Division restated the Frye rule quoting from prior
precedents. The test typically considers the admissibility of
new scientific tests, techniques or processes.6 It
has also been used to determine admissibility of expert
testimony based on new social and behavioral theories. However,
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."7
Parker, among other precedents, the court said that, when
the 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,
the plaintiff's experts did not utilize any novel scientific
techniques or evidence, but they did seek to set forth "the
novel theory that therapeutic acetaminophen use caused the
plaintiff's liver cirrhosis primarily based on the fact that
acetaminophen is a hepatoxin and that certain case studies
suggest a relationship between acetaminophen and cirrhosis."8
observed that deductive reasoning or "extrapolation," even in
the absence of medical texts or literature supporting 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." Indeed, deduction,
extrapolation, drawing inferences from existing data, and
analysis are not novel methodologies and are accepted stages of
the scientific process.9 Nevertheless, where there is
"simply too great an analytical gap between the data and the
opinion proffered," the opinion should be rejected.10
Here the court
found that the data upon which the plaintiff's experts relied
was insufficient to support their novel theory of medical
causation, "rendering that theory speculative." Each of the case
reports or observational studies plaintiff's experts used did
not overcome the "analytical gap" between the scientific data
and the experts' theory of causation, a gap "widened by the
contrary scientific articles concluding that acetaminophen is
safe in therapeutic doses, even for individuals suffering from
plaintiff did not offer any clinical or epidemiological data or
peer reviewed studies showing a causal link between therapeutic
use and liver cirrhosis. In the absence of such evidence,
plaintiff had to set forth other scientific evidence "based on
accepted principles." The methodology employed by the experts,
primarily based on case studies, was "fundamentally
speculative." The court emphasized 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 that burden
was not met.11
struggle to assure that only reliable and relevant expert
testimony gets to the jury is robustly addressed by New York
courts using Frye analysis in novel science and
technology cases augmented by penetrating inquiry into
foundational reliability in all cases. Although the objective is
clear and the legal road map is lucid, in practice, nuanced
tensions are presented. For example, is there a distinction in
determining causation when a new drug is involved as opposed to
one popularly used for 50 years? The dynamics in given cases
call for diligent gatekeeping efforts. The Appellate Division's
Ratner decision helps readers understand not only the
rules but some of the nuances.
Michael Hoenig is a
member of Herzfeld & Rubin.
1. Hoenig, "Judicial
Gatekeeping: 'Frye,' 'Foundational Reliability,'" New York
Law Journal, Feb. 11, 2008, p. 3; "'Parker,'
'Frye' and Gatekeeping of Experts: an Update," NYLJ, June
17, 2009, p.3.
2. 7 N.Y. 3d 434 (2006).
3. Hoenig, "Testifying
Experts and Scientific Articles: Reliability Concerns," NYLJ,
Sept. 16, 2011, p. 3 (citing prior articles on experts' use of
unreliable hearsay, scientific papers questioning the
reliability of biomedical articles, and reporting serious
shortcomings even in those that were peer reviewed).
4. See Fed. R. Evid. 702;
Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S.
General Elec. Co. v. Joiner, 522 U.S. 136 (1997);
Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).
5. 2011 NY Slip Op 08575 (2d
Dept., Nov. 22, 2011).
6. Ratner, Id., Slip
Op, at p. 10.
7. Id., Slip Op, at p. 11.
8. Id., Slip Op, at p. 12.
9. Id., Slip Op, at p. 12-13
(citing and discussing
Zito v. Zabarsky, 28 A.D.3d 42) (extrapolation or
deduction warranted where theory pertains to new drug) and
citing other cases.
10. Id., Slip Op, at p. 13
(quoting from General Elec. Co. v. Joiner, 522 U.S. 136,
11. Id., Slip Op, at pp. 15-16.
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