(Text of Opinion in Section A. Mealey's Document #15-980615-101.)
Kathleen Lavender sued Bayer Corp. for the death of her husband, John, an employee of
an independent electrical contractor. Lavender alleged John died from acute monocytic leukemia (AML) resulting from benzene exposure at Bayer's job site in New Martinsville, W.Va.
In addition to asserting that John Lavender was not exposed to benzene in an amount sufficient to have caused his leukemia, Bayer sought to offer the testimony of Harvey M. Golomb, M.D., and
Richard Irons, Ph.D. The proffered testimony sought to demonstrate that Lavender's chromosomal changes did not match the abnormalities of the fifth or seventh chromosomes necessary
to establish a causal connection with benzene exposure. Lavender's estate sought in limine to exclude this testimony under the West Virginia Rules of Evidence.
In his findings of fact and conclusions of law, Marshall County Circuit Court Judge Mark Karl said that although cytogenetic information has a variety of clinical purposes, including predicting
the course of leukemia, diagnosing the particular cell types of leukemia and making decisions regarding treatment, no article has been cited for the proposition that cytogenetic information can
disprove etiology or causation.
Dr. Golomb
The judge turned first to the testimony of Dr. Golomb, who opined that Lavender's AML is unrelated to his benzene exposure based on cytogenetics
and the decedent's specific cytogenetic findings. This theory and underlying methodology are based upon Dr. Golomb's work in attempting to determine whether there are specific chromosomal
abnormalities associated with a particular type of leukemia and with some source that causes leukemia, such as chemotherapy agents.
"Reducing Golomb's hypothesis to its simplest terms: because some
portion of the 95% unknown-cause group have a history of occupational exposure to various substances and chromosome changes similar to those found in the 5% chemotherapy-caused
group, all benzene-related leukemias must have chromosome changes consistent with chemotherapy-related leukemias," the judge said.
"Dr. Golomb cannot cite any scientific link or 'good grounds' for his
assertion that Mr. Lavender simply could not have a benzene-induced leukemia because he does not exhibit chromosomal aberrations which are similar to chemotherapy-induced chromosomal aberrations," Judge Karl
wrote. "Moreover, Dr. Golomb admits that there is no specific set of genetic signatures established for benzene-exposed individuals."
Dr. Golomb has not reviewed the benzene literature in a long time,
has never seen a benzene-induced leukemia and has never treated a patient in which he could document a major benzene exposure, the judge said. Also, Dr. Golomb has not published an article on his
theory that specific cytogenetic abnormalities are required before a leukemia can be attributed to benzene exposure, the judge said.
"Dr. Golomb's extrapolation is beyond the current available
scientific knowledge in this field; the best that can be said of the data on chromosome aberrations and benzene is that it is inconclusive," the judge said. "Dr. Golomb's attempt to analogize or
extrapolate data from the chemotherapy- therapy-induced leukemia arena to opine, definitively, on the merits of Mr. Lavender's benzene-induced leukemia is not based upon any
validated scientific methodology and is, therefore, not scientific knowledge."
The judge added that Dr. Golomb's theory is contrary to the
published literature and contains a significant "analytical gap" in assuming a relationship between chemotherapy-induced chromosomal abnormalities and those caused by benzene exposure.
Dr. Irons
Dr. Irons also opined that the decedent's AML is unrelated to his benzene exposure because there were no aberrations of the fifth and seventh chromosomes.
"Dr. Irons' anticipated testimony will likely posit the assertion that a 5 and/or 7 chromosomal aberration is a diagnostic requirement for
a benzene- induced leukemia," the judge said. "Like Dr. Golomb, Dr. Irons' assertion is nothing more than an untested, unsupported hypothesis cloaked in the aura of scientific knowledge."
The judge said the peer review process has found that Irons' assertion cannot be based upon valid scientific knowledge.
"Defendants' assertion that Drs. Golomb's and Irons' hypotheses
have been favorably peer reviewed is without merit," the judge said. "The medical and scientific literature has identified certain chemotherapy-induced chromosomal abnormalities. This body of
literature has been peer reviewed. However, the assertion that this process includes identification and peer review of benzene- induced chromosomal abnormalities is . . yet another 'leap of faith."'
The judge said the lack "of even one study indicating that such a 5 and/or 7 cytogenetic finding was statistically significant in terms of identifying or diagnosing a benzene-induced leukemia" bars the
testimony from being admitted.
The judge had earlier granted plaintiff's motion to exclude the testimony of a defense
industrial hygienist under Daubert, finding his methodology is flawed
and his estimates of a decedent's cumulative benzene exposure are "guesstimates" because they are based on air monitoring data that does not simulate the types of exposure experienced by Lavender.
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