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Hollingsworth LLP Files Industry Coalition Amicus Brief in U.S. Supreme Court

news | October 13, 2011

On October 13, 2011, Hollingsworth LLP filed an industry coalition amicus brief in support of U.S. Steel’s petition for writ of certiorari in U.S. Steel Corporation v. Milward seeking review of a First Circuit opinion that reversed a federal district court Daubert ruling excluding the testimony of an expert causation witness that was based upon a “weight of the evidence methodology.”  As set forth in the amicus brief, the First Circuit opinion is directly contrary to the Supreme Court’s holdings in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) and General Elec. Co. v. Joiner, 522 U.S. 136 (1997), which require expert testimony to be based upon the scientific method as opposed to expert ipse dixit and, if not reversed, would mark a major victory for the plaintiffs’ bar in its ongoing efforts to undermine the Daubert standard.  The First Circuit’s opinion in Milward is cited repeatedly in the just released Reference Manual on Scientific Evidence –Third and likely will be cited in plaintiff briefs across the country absent Supreme Court review.

According to Firm Partner Eric Lasker, the respondents’ arguments in opposition to certiorari in this case highlight the significance and danger of the Milward opinion.  Rather than attempting to narrow the potential significance of the First Circuit’s ruling, the respondents in their opposition brief argue for a fairly dramatic rewriting of the Daubert standard.  Under the respondents’ proposed Daubert standard, “because the record established that Dr. Smith’s opinions at least fell within the range of where reasonable experts can differ, his opinion was based on reliable methodology and substantial evidence that he explained.”  Respondents get  to this purported “reasonableness” standard by misapplying the Supreme Court’s analysis of non-scientific expert testimony (in Kumho) to a scientific causation opinion.  But much of Kumho focuses on the fact that the factors that a district court should consider in analyzing scientific reliability and relevance do not work with non-scientific experts, which requires the court to screen the non-scientific expert testimony using different approaches.  Nothing in Kumho suggests that scientific evidence can be admitted without the Daubert and Joiner screening.  Daubert and Joiner do not set forth a “reasonable scientist” standard; they set forth a scientific reliability and relevance standard.

Respondents also never explain in their opposition brief how a district court could ever exercise its gatekeeping authority to exclude scientific expert evidence under their newly-minted standard.  Under the respondents’ approach, so long as there is a debate in the scientific community over an issue, then the evidence is admissible.  That is a pretty dramatic restatement of the rejected argument that law leads science.  In virtually every case in which science does not have an answer to a question, there will be competing camps of scientists advocating one theory or another.  That is how science works.  But Daubert is very clear in stating that this is not and cannot be the standard for admissibility in legal matters.
This same reality also answers the respondents’ argument that scientists use the weight of the evidence approach in regulatory contexts.  This can be a valid approach in science because it allows scientists to develop and hone hypotheses that can then be tested in a more effective way.  But the scientific methodology set forth in Daubert requires that testing and validation occur before evidence is admissible in court.  Thus, a number of courts have rejected the argument that a regulatory decision-making constitutes admissible scientific evidence of causation in a tort case.  See, e.g., Rider, 295 F.3d at 1201 (“A regulatory agency such as the FDA may choose to err on the side of caution.  Courts, however, are required by the Daubert trilogy to engage in objective review of the evidence to determine whether it has sufficient scientific basis to be considered reliable.”); Glastetter, 252 F.3d at 991 (“The methodology employed by a government agency results from the preventive perspective that the agencies adopt in order to reduce exposure to harmful substances.  … The FDA’s 1994 decision that Parlodel can cause strokes is unreliable proof of medical causation in the present case because FDA applies a reduced standard (vis-a-vis tort liability) for gauging causation when it decides to rescind drug approval.”).  Regulatory decision makers agree.  See Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use, 67 Fed. Reg. 72,555, at 72,556 (Dec. 6, 2002) (“FDA’s decision to act in an instance such as this one need not meet the standard of proof required to prevail in a private tort action.  … To mandate a warning or take similar regulatory action, FDA need not show, nor do we allege, actual causation.”) (citing Glastetter).
Respondents’ reliance on the Reference Manual and the Restatement (3rd) also demonstrates the importance of Supreme Court review and reversal of the First Circuit’s opinion.  Again, instead of positioning Milward as a one-off case, the respondents have elevated its importance (particularly given the circular nature of respondents’ argument, where the new Reference Manual specifically cites Milward as support for the weight of the evidence approach that the respondents now argue is accepted as shown by the Reference Manual).
Finally, respondents repeat an increasingly asserted canard that their causation expert’s weight of the evidence is consistent with the Bradford Hill criteria.  The Hill criteria starts with statistically significant epidemiology; without that, none of the other criteria even comes into play.  See Hill AB, The Environment and Disease: Association or Causation, Proceedings of the Royal Society of Medicine (1965), at 295 (introducing discussion of the Hill criteria as follows: “Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance.  What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”).

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