By Pamela C. Maloney, J.D.
Several causation experts testifying to the link between talcum powder and ovarian cancer met the Daubert reliability standards, although the court placed strict limits on some admittedly key opinions.
In a decision intended to apply to all pending challenges to the admissibility of expert testimony in a multi district litigation involving Johnson & Johnson’s allegedly cancer-causing talcum powder products, the U.S. District Court for the District of New Jersey concluded that testimony by the plaintiffs’ inflammation and oxidative expert was limited to the link between talc products and inflammation; the expert could not testify that use of talc caused ovarian cancer. In addition, testimony by the plaintiffs’ materials science expert was limited to the presence of trace talc and his findings based on his transmission electron microscope (TEM) testing. The opinions proffered by the plaintiffs’ general causation experts and those proffered by two of J&J’s generally were reliable, and challenges to their admissibility went to credibility and the weight to be given, both of which were preserved to the fact finder for determination (In re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Litigation, April 27, 2020, Wolfson, F.).
Alleging that prolonged perineal use of talcum powder products manufactured by Johnson & Johnson, including its baby powder and Shower to Shower products, caused ovarian cancer because it contained traces of asbestos and other heavy metals, consumers filed a products liability complaint against Johnson & Johnson (J&J), Johnson & Johnson Consumer Inc. f/k/a Johnson & Johnson Consumer Companies, Inc., Imerys Talc America, Inc. f/k/a Luzenac America, Inc. f/k/a Ro Tinto Minerals, Inc., and Personal Care Products Council. After years of discovery, both sides proffered experts on various scientific issues related to causation and the testing of talcum powder for asbestos, and each side moved to exclude the testimony of the other side’s experts. Although each party had named numerous experts, for a combined total of more than 35 experts, during the Daubert hearing only five experts testified on behalf of the plaintiffs, and three experts testified on behalf of the defendants. Before the court was whether these eight experts were qualified to testify and whether their proffered testimony was reliable and, therefore, admissible.
Inflammation and oxidative stress experts. J&J challenged the plaintiffs’ inflammation and oxidative expert, arguing that his in vitro study was not reliable because (1) he failed to follow his own methods; (2) he failed to use a relevant dose of talc; (3) the results of the study were not replicated; and (4) his lab notebooks were rife with errors that undermined the study. J&J also argued that the results of the expert’s study did not support his conclusion that use of talc caused ovarian cancer. The court agreed with J&J’s argument that the study did not support the expert’s causation extrapolation. Even the expert admitted that he was unable to determine through his study whether the cell proliferation was simply an acute response to talc or that use of talc ultimately could lead to ovarian cancer. The lack of support for the expert’s extrapolation from his study also was consistent with, and bolstered by, comments the expert had received from peer reviewers.
The court further found that the expert’s opinion with respect to causation was inadmissible because certain aspects of his study were unreliable. Specifically, the study was unreliable in establishing that talc caused cancer because (1) the cell lines used did not, and could not, actually transform into cancer; (2) a neoplastic transformation assay which was critical to a showing of transformation was not conducted; that would have demonstrated whether there was a "cause and effect" relationship between talc and ovarian cancer; (3) the study’s treatment of talc showed only an induction of cell mutation but no actual mutation or cell transformation; and (4) the cancer antigen marker set by the expert was not shown to be a clinically relevant bio marker for showing increased risk of ovarian cancer. As a result of these shortcomings in the testing method, the expert’s conclusion that there was a causal link between use of talc and ovarian cancer was not based on a reliable scientific method but on his own subjective beliefs.
Although the court excluded this admittedly critical portion of the expert’s testimony, it did find that the expert’s testimony with regard to the association between the use of talc and cellular oxidative stress was reliable and could be admitted because the expert had used a methodology that consisted of a testable hypothesis; his work was subject to peer-review; and the methodology was generally accepted in the scientific community. J&J’s objections to the expert’s opinions on the link between talc use and inflammation went to the weight of the testimony, which was preserved for the fact finder, and was not for the court to decide in its capacity as a gate keeper on a Daubert motion.
Materials science expert. As an initial matter, the court found that J&J’s challenges regarding the qualifications of the plaintiffs’ materials science expert, whom J&J repeatedly referred to as a "professional expert" because he had testified regularly on behalf of the plaintiffs, questioned the expert’s credibility, rather than his expertise, which was reserved for the fact finder. Turning to the expert’s testimony regarding the results of his testing of 72 historical talc samples of J&J’s and Imerys’ baby powder and Shower to Shower products from the 1960s, 1970s, 1980s, 1990s, and the early 2000s for asbestos, the court determined that the expert’s findings, which were based on the three-step TEM analysis and his reliance on the EPA Asbestos Hazard Emergency Response Act (AHERA) counting rules for determining the number of asbestos fibers contained in the talc samples, were reliable. The court again explained that J&J’s arguments in support of excluding this testimony went to the application of the methodologies, rather than their reliability, and, as such, were within the province of the fact finder.
However, to the extent the materials science expert based his opinions on his polarized light microscope (PLM) analysis or opined on the exposure of talc users to asbestos, his opinions were not admissible. The court explained that even though the expert was not required by any of the relevant scientific methods to use the PLM methodology, he nevertheless conducted the PLM analyses to further support his results under the TEM analysis. There was no explanation as to the expert’s choice of which ISO standard he used when running his PLM analysis, which differed from the standard he had used in previous talc-related trials. In addition, the chosen methodology was replete with subjectivity and reproducibility problems.
The court also agreed with J&J’s argument that the expert failed to offer any scientific support for his opinion that the use of J&J’ stalc products caused exposure, let alone significant exposure, to asbestos. According to the court, the expert’s opinion on the likelihood that talc users were exposed to "significant" amounts of asbestos, and indeed, any exposure, was too attenuated from his findings of trace levels of asbestos in the talc samples.
Having found the expert’s causation evidence inadmissible, the court nevertheless held that the materials science expert’s remaining opinion on the presence of "ultra-trace" asbestos in J&J’s talc products was still admissible as useful to the trier of fact. The issue of whether there was asbestos, and the amount of asbestos, in J&J’s talc products remained key issues in this litigation.
General causation experts. The plaintiffs’ three remaining general causation experts—an epidemiologist, a gynecologic-oncologist, and a toxicologist—were found to be qualified to testify and each one was found to have formed general causation opinions using the Brad ford Hill criteria, which consisted of nine factors widely used in the scientific community to assess general causation. After reviewing each expert’s methodologies and conclusions, the court concluded that each expert reliably had applied each Brad ford Hill factor, even if their conclusions in the context of some of these factors demonstrated a relatively minimal causal relationship between talc use and ovarian cancer. Accordingly, because the opinions of each of these experts were based on facts; a reasonable investigation (including documented findings); and traditional technical/mechanical expertise, and because each expert had provided a reasonable link between the information and procedures used and the conclusions reached, the Daubert requirements were met and their testimony was admissible. The court rejected J&J’s argument that these general causation experts should be excluded as unreliable because their opinions were generally inconsistent with the scientific consensus that a causal relationship between talc use and ovarian cancer had not been established. The court explained that the general causation evidence relied on by the experts on both sides in this matter revealed that the body of relevant scientific evidence was inconclusive and could be open to different interpretations. Furthermore, it could not be determined by the court whether one side’s interpretation was more reliable than the other. Ultimately, the question of whose experts were correct was a question for the jury and it would be erroneous for the court to make those factual findings on a Daubert motion.
J&J’s experts. The plaintiffs challenged J&J’s qualified epidemiology expert, arguing that his opinions were unreliable, and specifically challenging his assessment of the consistency of association, dose-response, and biological plausibility criteria. After performing a Brad ford Hill analysis, the epidemiologist opined that the body of relevant epidemiological evidence did not support a causal connection between perineal use of talcum powder products and ovarian cancer. Both the expert’s testimony at the Daubert hearing and his expert report demonstrated to the court that his opinions reasonably flowed from the epidemiological studies and that he followed a reliable methodology in reaching his conclusions.
J&J’s gynecologic-oncologyexpert, who also was qualified to testify, did not complete a full Brad ford Hill analysis as part of her methodology but, instead, considered certain of the Brad ford Hill criteria in rendering her opinion and criticized the Brad ford Hill analyses conducted by the plaintiffs’ experts. The plaintiffs raised two key arguments as to why this testimony should be excluded: first, the expert did not properly consider the "totality of the evidence" because she gave greater weight to the cohort studies than the case-control studies; and second, she did not rely on any epidemiologic authority for her dismissal of the case-control studies. With respect to the first objection, the court found that the expert had provided "good grounds" for her opinions with respect to the weight she placed on the varying case-control and cohort studies. As for the second argument, the expert’s deliberate choice to not review scientific studies and articles identified by the plaintiffs did not render her opinion inadmissible. The expert explained that because the studies referred to, but did not reveal, any malignancy from talc, she did not view them as relevant on the question of biological plausibility. The fact that J&J’s expert reached a different conclusion from that reached by the plaintiffs’ causation experts again went to the experts’ credibility and did not deter from the court’s finding that the opinions were admissible under Daubert.
The case is MDL No. 2738; Civil Action No. 16-2738 (FLW).
Attorneys: Carmen Sessions Scott (Motley Rice LLC) for James Chakalos. Gene M. Williams (Shook Hardy & Bacon L.L.P) for Johnson & Johnson. Cullen W. Guilmartin (Gordon Rees Scully Mansukhani, LLP) for Imerys Talc America Inc.
Companies: Johnson & Johnson; Imerys Talc America Inc.
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