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“Daubertizing”
Plaintiff’s Environmental Medicine Expert: A Case Study  |
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By: Mark A. Darling, Eileen P. Kavanagh
and Peter C. Kober Winter 2006 |
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| INTRODUCTION Litigation involving personal injury claims arising out of exposures to environmental contaminants or contamination from products poses special problems for defendants. It is not unusual for plaintiffs in these cases, whose symptoms or signs were not solely attributable to one or more alleged contaminants – to the extent that such symptoms of signs were attributable to such contaminants at all – to legitimatize their claims through the seemingly unimpeachable “differential diagnoses” of their treating physicians. Indeed, to the extent that these treating physicians have specialized their practices in the diagnosis and treatment of “environmental illness”, the task of limiting the effectiveness of the opinions of these experts can be particularly challenging. Conversely, if a defendant aggressively undertakes to preclude the opinions of such experts by means of a well-conceived “Daubert motion” , the results of that effort can prove outcome determinative, effectively leaving plaintiff without any means of establishing a causal link between the purported contaminant and his injuries. The case of John Zabilansky, et al. v. American Building Restoration Products, Inc., et al. serves as a remarkable example of the importance of successfully “Daubertizing” a plaintiff’s environmental medicine expert. In that case, plaintiffs John and Barbara Zabilansky alleged that they had suffered significant personal injuries, property damage and consequential damages as a result of their exposure to various contaminants contained in a wood preservative, known as “X-100 Natural Seal Interior Grade” ------------------------------------------------------------- 1 Mr. Darling is a graduate of Boston College (B.A., cum laude, 1984) and Suffolk University (J.D., cum laude, 1987), and is a partner in the Massachusetts office of Litchfield Cavo, LLP. Ms. Kavanagh attended St. Patrick’s College, Ireland and is a graduate of Bryn Mawr College (A.B., 1975), Seton Hall University (J.D., cum laude, 1983) and New York University (LL.M., Corporate Law, 1984), and is a partner in the Massachusetts office of Litchfield Cavo, LLP. Mr. Kober is a graduate of Denver University (B.A., cum laude, 1973) and Boston University (J.D., 1976), and is a partner in the Massachusetts office of Litchfield Cavo, LLP. 2 See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). See also General Electric Co. v. Joiner, 522 U.S. 136 (1997) and Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999). 3 Middlesex County (MA) Superior Court Civil Action No. MICV2001-01985, judgment entered, November 11, 2004. Mr. Darling, Ms. Kavanagh and Mr. Kober served as defense trial counsel in this case. (“Interior Grade”), that had been applied to the
wood beams and interior surfaces of their Nantucket, Massachusetts
home. Plaintiffs asserted claims against the manufacturer, supplier
and applicator of the product based on theories of negligence,
breach of warranty, misrepresentation and violations of Massachusetts
General Laws, Chapter 93A (the “Consumer Protection Act”).
I. PLAINTIFFS’ PROFFER OF THEIR ENVIRONMENTAL MEDICINE
A. The Environmental Medicine Expert The linchpin of plaintiffs’ theory of medical causation
was the proffered expert testimony of Howard Hu, M.D., a physician
with impressive credentials who had specialized in the field of
occupational and environmental medicine for 19 years, and treated
some 3,000 patients for “environmental exposures”.
Dr. Hu has a medical degree, a master’s degree in public
health and a doctorate in epidemiology. He is board certified
in occupational medicine, serves on the staff of two local, well
regarded hospitals, and is both an Associate Professor of Medicine
at Harvard Medical School and a Professor of Occupational and Environmental Medicine and Environmental
Health at the Harvard School of Public Health. Dr. Hu is also
the principal investigator of six current research grants and
projects funded by the National Institute of Health, and had served
as the Associate Director of the Harvard National Institute for
Environmental Health Sciences Center, the Director or the Harvard
Children’s Center for Environmental Health and Disease Prevention
Research and the Medical Editor of Environmental Health Perspectives,
which is the official journal of the National Institute for Environmental
Health Sciences. and “severe headache disorder and nausea with sensitivity
to volatile organic compounds [“VOCs”]”, and
that these and “other health problems” were as a result
of Mr.Zabilansky’s exposure to Interior Grade. Although
Dr. Hu was aware that the product contained VOCs and a single
fungicide, chlorothalonil, he did not identify any specific chemical
as the triggering agent for any of Mr. Zabilansky’s problems.
Plaintiffs responded to defendants’ motion with an affidavit from Dr. Hu, which stated that TDI, chlorothalonil and “other chemical irritants” – which Dr. Hu did not identify – “are capable of causing asthma”, including the variant of asthma known as Reactive Airways Dysfunction Syndrome (“RADS”) “if exposure occurs at a high enough level to cause irritation, tissue injury and inflammation”. Dr. Hu’s affidavit went on to state that TDI, chlorothalonil and “other chemical irritants” can also cause “central nervous system depression[,]” e.g., headaches, nausea, dizziness and excessive fatigue, and that “[i]t is documented in the medical literature and verified through my own clinical experience that exposures to these types of chemical irritants are capable of causing chronic headaches in some exposed individuals.” Dr. Hu also opined in his affidavit that, “[a]s is documented in the medical literature and also in my clinical experience, following an acute toxic exposure, changes occurring in the liver can include development of hepatocellular necrosis and chemical hepatitis.” Finally, Dr. Hu concluded, to a reasonable degree of medical certainty, that Mr. Zabilansky’s “acute” exposure to Interior Grade was responsible for each of these conditions. Dr. Hu’s affidavit was followed by two pages of “references”, i.e., scientific journal articles, that purported to support his conclusions. At the subsequent Daubert/Lanigan hearing, Dr. Hu testified that RADS generally requires a “higher exposure” to an “irritant”, but did not state what “high” concentrations of any “irritant”, e.g., TDI, would be sufficient to trigger RADS. However, he focused on what he described as Mr. Zabilansky’s “tissue injury” – i.e., a red face – and concluded from that “tissue injury”, as well as from what he described as “chronic symptoms consistent with asthma after the incident”, that Mr. Zabilansky had been “exposed to enough of the irritant to cause tissue injury and RADS[.]” Dr. Hu then went on testify with respect to two of the journal articles referenced in his affidavit, which he stated related to TDI exposure and RADS, and upon which he had relied in concluding that the product had caused Mr. Zabilansky’s RADS. However, Dr. Hu was silent with respect to any purported causal relationship between exposure to chlorothalonil and symptoms of RADS. In fact, the scientific and medical literature did not support any of Dr. Hu’s conclusions. As defendants revealed to the court, both through the direct testimony of their own expert, Dr. Linden, and through cross-examination of Dr. Hu, the articles relating TDI exposure to RADS, which Dr. Hu had identified in his testimony or cited as “references” to his affidavit, were inapposite because they clearly involved either massive TDI exposures or indicated that TDI exposures in concentrations permitted by OSHA probably did not result in RADS. Moreover, after initially representing to the court that “[t]here’s literature demonstrating that people exposed to toluene diisocyanates will develop neurologic symptoms, including headache, that become chronic over time[,]” Dr. Hu eventually admitted that none of the articles referenced in his affidavit contained data supporting his conclusion that an acute TDI exposure could cause chronic headaches. Although Dr. Hu then sought to salvage his testimony by stating that he believed that Mr. Zabilansky’s headaches were not exclusively caused by TDI, but were “induced by the combination of exposures” of chemicals in Interior Grade, he also had to admit that no article in his affidavit supported the theory that exposure to chlorothalonil, TDI and VOCs caused what he called “chronic headache syndrome”. With respect to chemical hepatitis, Dr. Hu initially testified that “[t]he literature supports that solvents can cause chemical hepatitis and the diagnosis can be made by ruling out other potential causes and appreciating a significant history of exposure to solvents.” When questioned directly by the court, however, Dr. Hu admitted that he was not “aware” of any scientific literature that linked short-term exposure to TDI or chlorothalonil to chemical hepatitis. Perhaps sensing that their efforts to utilize scientific and medical literature as a basis for Dr. Hu’s opinions had seriously backfired, plaintiffs also sought to elicit from Dr. Hu that his clinical experience in differentially diagnosing other patients – none of whom had ever been identified, and whose medical and personal histories had never been provided to defendants – supported the differential diagnosis of RADS. However, noting that there had been no prior disclosure of any data regarding these other patients’ exposure to chemicals or the nature of their illnesses, the court precluded this “basis” for Dr. Hu’s opinion. Despite these seemingly insurmountable problems now facing the admissibility of their expert’s proffered trial testimony, plaintiffs did not retreat from their efforts to proffer Dr. Hu’s opinions. Instead, they provided the court with a second affidavit from Dr. Hu, the day after he testified at the Daubert/Lanigan hearing, in which he now opined that he had treated approximately 30-50 other patients for environmental asthma, 3-5 other patients for chemical hepatitis, and 10-15 other patients for chronic headaches, whose illnesses had been caused by “an environmental exposure of the magnitude experienced by John Zabilansky.” Dr. Hu’s new affidavit did not identify either the patients or what chemical, e.g., TDI, was the source of these unidentified patients’ “environmental exposure[s]”. The court then requested that the parties submit proposed findings of fact concerning Dr. Hu’s opinions. Plaintiffs’ proposed findings referenced not only Dr. Hu’s medical records, his first affidavit and his Daubert/Lanigan testimony, but also included references to his treatment of his “other patients” with RADS, chronic headaches and chemical hepatitis – i.e., the portion of his testimony that the court had precluded, but which plaintiffs had attempted to resurrect by submission of his second affidavit. Plaintiffs also submitted a lengthy appendix of abstracts of articles, which they described as the “extensive medical literature establishing that short term exposures to solvents can cause headaches[,]” some of which purported to “document that causal connection for different solvents in the [product] to which John Zabilansky was exposed.” Defendants objected to plaintiffs’ proposed findings, insofar as they contained the precluded portion of Dr. Hu’s hearing testimony or plaintiffs’ latest appendix of “medical literature”. III. THE RULINGS LIMITING DR. HU’S TESTIMONY Altogether, the court issued five written rulings with respect to Dr. Hu’s testimony. The collective effect of these rulings was to limit Dr. Hu’s trial testimony to opining that Mr. Zabilansky’s RADS had been caused by exposure to TDI, i.e., they precluded him from testifying that Mr. Zabilansky’s chronic headaches or “chemical hepatitis” had been caused by exposure to any chemical in the product, and from testifying that any chemical other than TDI was responsible for his RADS. Moreover, Dr. Hu could not testify that Mr. Zabilansky’s RADS had “evolved” into “non-specific asthma” in which he reacted to “low levels of environmental irritants.” Finally, Dr. Hu was barred from testifying that, because of “residual exposures”, Mr. Zabilansky should avoid living in plaintiffs’ residence. Significantly, with the exception of what she characterized as Dr. Hu’s “arguably ‘shaky’” opinion that TDI caused Mr. Zabilansky’s RADS, the court agreed with defendants’ contentions that Dr. Hu’s opinions were unsupported by the scientific and medical literature. In this context, the court noted that Dr. Hu identified no particular chemical in the product that caused either headaches or hepatitis; identified no studies that chlorothalonil or VOCs caused headaches; identified no studies that TDI or chlorothalonil caused hepatitis; identified only one study – which the court viewed as inapposite – that TDI caused headaches; and identified no studies that chemicals other than TDI caused RADS. Just as importantly, the court declined to permit Dr. Hu to testify to his opinions on the basis of his own clinical experience, i.e., his treatment of other patients who had purportedly been exposed to “environmental exposures” and whom he had purportedly treated for RADS, chronic headaches and chemical hepatitis. The court focused on the absence of information relative to the identity or concentrations of chemicals, or relative to the patients’ symptoms and clinical courses, such that she was unable to conclude that Dr. Hu’s clinical experience rendered his opinion reliable. With respect to Dr. Hu’s diagnosis regarding Mr. Zabilansky’s “evolving” asthma, the court rejected plaintiffs’ contention that this diagnosis substantively differed from Dr. Hu’s original – and since abandoned – diagnosis of MCS. The court noted that plaintiffs themselves distinguished the two conditions on the basis that MCS was a multi-organ condition, whereas asthma involved only a single organ, and because Mr. Zabilansky had reportedly experienced and had been diagnosed with multiple organ system symptoms, i.e., severe headaches and nausea with sensitivity to certain VOCs. Accordingly, the Court found that Dr. Hu’s “evolving” asthma diagnosis was no different from MCS. Furthermore, to the extent that plaintiffs contended that MCS and Mr. Zabilansky’s “evolving” asthma were actually different, they had never disclosed such a distinction to defendants in a timely manner, such that “it would be improper and unfair” to allow Dr. Hu to offer such a “shifting” diagnosis. Dr. Hu was also precluded from offering his “opinion” – which, because it was phrased in terms of possibility, not probability, was not really an opinion at all – that Mr. Zabilansky should leave his home. The court noted that Dr. Hu’s opinion was not supported by “objective facts” that the product still emitted chemicals at levels harmful generally or to Mr. Zabilansky in particular. In this context, the court observed that there was testimony from two scientists (one retained by plaintiffs and one retained by defendants) who had testified that their respective air quality samples had not revealed the presence of any -------------------------------------------------------------------------- 10 Zabilansky (Hinkle, J., April 30, 2004), pp. 14-19, 19-20, 21-22. 11 Id., 20-21, 22. \hazardous substance in any concentrations considered harmful
to humans. Finally, the court found that Dr. Hu had conducted
no testing of the residence himself, and had not identified any
scientific literature indicating that individuals with RADS should
avoid the location of their initial “exposure” because
of possible adverse reactions to “residual chemicals”.
Although the rulings in Zabilansky may have been a remarkable
example of “judicial gatekeeping”, they were hardly
unique. The courts are more vigilant than ever with respect to
the issue of “junk science”, and with respect to their
responsibility for precluding it. Once a party raises a challenge
to the “reliability” of an expert’s opinions,
the court is bound to determine if there is proof that the basis
for 13 Zabilansky (Gershengorn, J., June 4, 2004), p. 6. 14 The role of the court in conducting a “preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issues[]” has been described as a “gatekeeper role”. Com. v. the opinion has “general acceptance”, or absent
such proof, whether the basis for the opinion has been subjected
to peer review and publication; whether it can be or has been
tested, and the outcome of such testing; and whether there exists
an error rate or controls, or standardization. 15 See, e.g., Com. v. Montanez, 55 Mass.App.Ct. 132, 145 (2004), citing Kumho Tire Co. v. Carmichael, 526 U.S. 137, 159 (1999) (Scalia, J., concurring). 16 Theresa Canavan’s Case, 432 Mass. 304, 313 (2000), citing Lanigan, supra at 26. its underlying basis lacks scientific reliability. Here, it
is vital to provide the court with references to medical and scientific
literature describing not only that the treating physician’s
opinion is the subject of ongoing controversy, but also that the
relevant scientific or medical community has not (yet) accepted
what is a threshold basis for that expert’s opinion. It
is also important, to the extent that the treating physician seeks
to justify his own views by references to medical and scientific
literature, to examine critically whether the cited literature
indeed says what the expert says it does.
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