TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Gatekeeping of Expert Witnesses Needs a Bair Hug

December 20th, 2017

For every Rule 702 (“Daubert”) success story, there are multiple gatekeeping failures. See David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013).1 Exemplars of inadequate expert witness gatekeeping in state or federal court abound, and overwhelm the bar. The only solace one might find is that the abuse-of-discretion appellate standard of review keeps the bad decisions from precedentially outlawing the good ones.

Judge Joan Ericksen recently provided another Berenstain Bears’ example of how not to keep the expert witness gate, in litigation claims that the Bair Hugger forced air warming devices (“Bair Huggers”) cause infections. In re Bair Hugger Forced Air Warming, MDL No. 15-2666, 2017 WL 6397721 (D. Minn. Dec. 13, 2017). Although Her Honor properly cited and quoted Rule 702 (2000), a new standard is announced in a bold heading:

Under Federal Rule of Evidence 702, the Court need only exclude expert testimony that is so fundamentally unsupported that it can offer no assistance to the jury.”

Id. at *1. This new standard thus permits largely unsupported opinion that can offer bad assistance to the jury. As Judge Ericksen demonstrates, this new standard, which has no warrant in the statutory text of Rule 702 or its advisory committee notes, allows expert witnesses to rely upon studies that have serious internal and external validity flaws.

Jonathan Samet, a specialist in pulmonary medicine, not infectious disease or statistics, is one of the plaintiffs’ principal expert witnesses. Samet relies in large measure upon an observational study2, which purports to find an increased odds ratio for use of the Bair Hugger among infection cases in one particular hospital. The defense epidemiologist, Jonathan B. Borak, criticized the McGovern observational study on several grounds, including that the study was highly confounded by the presence of other known infection risks. Id. at *6. Judge Ericksen characterized Borak’s opinion as an assertion that the McGovern study was an “insufficient basis” for the plaintiffs’ claims. A fair reading of even Judge Ericksen’s précis of Borak’s proffered testimony requires the conclusion that Borak’s opinion was that the McGovern study was invalid because of data collection errors and confounding. Id.

Judge Ericksen’s judicial assessment, taken from the disagreement between Samet and Borak, is that there are issues with the McGovern study, which go to “weight of the evidence.” This finding obscures, however, that there were strong challenges to the internal and external validity of the study. Drawing causal inferences from an invalid observational study is a methodological issue, not a weight-of-the-evidence problem for the jury to resolve. This MDL opinion never addresses the Rule 703 issue, whether an epidemiologic expert would reasonably rely upon such a confounded study.

The defense proffered the opinion of Theodore R. Holford, who criticized Dr. Samet for drawing causal inferences from the McGovern observational study. Holford, a professor of biostatistics at Yale University’s School of Public Health, analyzed the raw data behind the McGovern study. Id. at *8. The plaintiffs challenged Holford’s opinions on the ground that he relied on data in “non-final” form, from a temporally expanded dataset. Even more intriguingly, given that the plaintiffs did not present a statistician expert witness, plaintiffs argued that Holford’s opinions should be excluded because

(1) he insufficiently justified his use of a statistical test, and

(2) he “emphasizes statistical significance more than he would in his professional work.”

Id.

The MDL court dismissed the plaintiffs’ challenge on the mistaken conclusion that the alleged contradictions between Holford’s practice and his testimony impugn his credibility at most.” If there were truly such a deviation from the statistical standard of care, the issue is methodological, not a credibility issue of whether Holford was telling the truth. And as for the alleged over-emphasis on statistical significance, the MDL court again falls back to the glib conclusions that the allegation goes to the weight, not the admissibility of expert witness opinion testimony, and that plaintiffs can elicit testimony from Dr Samet as to how and why Professor Holford over-emphasized statistical significance. Id. Inquiring minds, at the bar, and in the academy, are left with no information about what the real issues are in the case.

Generally, both sides’ challenges to expert witnesses were denied.3 The real losers, however, were the scientific and medical communities, bench, bar, and general public. The MDL court glibly and incorrectly treated methodological issues as “credibility” issues, confused sufficiency with validity, and banished methodological failures to consideration by the trier of fact for “weight.” Confounding was mistreated as simply a debating point between the parties’ expert witnesses. The reader of Judge Ericksen’s opinion never learns what statistical test was used by Professor Holford, what justification was needed but allegedly absent for the test, why the justification was contested, and what other test was alleged by plaintiffs to have been a “better” statistical test. As for the emphasis given statistical significance, the reader is left in the dark about exactly what that emphasis was, and how it led to Holford’s conclusions and opinions, and what the proper emphasis should have been.

Eventually appellate review of the Bair Hugger MDL decision must turn on whether the district court abused its discretion. Although appellate courts give trial judges discretion to resolve Rule 702 issues, the appellate courts cannot reach reasoned decisions when the inferior courts fail to give even a cursory description of what the issues were, and how and why they were resolved as they were.


2 P. D. McGovern, M. Albrecht, K. G. Belani, C. Nachtsheim, P. F. Partington, I. Carluke, and M. R. Reed, “Forced-Air Warming and Ultra-Clean Ventilation Do Not Mix: An Investigation of Theatre Ventilation, Patient Warming and Joint Replacement Infection in Orthopaedics,” 93 J. Bone Joint 1537 (2011). The article as published contains no disclosures of potential or actual conflicts of interest. A persistent rumor has it that the investigators were funded by a commercial rival to the manufacturer of the Bair Hugger at issue in Judge Ericksen’s MDL. See generally, Melissa D. Kellam, Loraine S. Dieckmann, and Paul N. Austin, “Forced-Air Warming Devices and the Risk of Surgical Site Infections,” 98 Ass’n periOperative Registered Nurses (AORN) J. 354 (2013).

3 A challenge to plaintiffs’ expert witness Yadin David was sustained to the extent he sought to offer opinions about the defendant’s state of mind. Id. at *5.

White Hat Bias in the Lab and in the Courtroom

February 20th, 2017

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FOIA Exemptions Gobble Up The Statute

November 27th, 2015

Last week, the Supreme Court refused to hear a case in which petitioners sought review of a First Circuit decision that upheld the “commercial information” exemption (exemption 4) to the Freedom of Information Act, 5 U.S.C. § 552 (FOIA). New Hampshire Right to Life v. Dep’t Health & Human Services, 778 F.3d 43 (1st Cir. 2015). See Lyle Denniston, “Court bypasses FOIA challenge,” SCOTUSblog (Nov. 16, 2015).

An anti-abortion group filed a FOIA request to obtain documents that Planned Parenthood had sent to the federal government’s Department of Health and Human Services, in support of federal funding, for family planning activities in New Hampshire. The requested documents described Planned Parenthood’s internal medical standards and guidelines, as well as its set fees for various services. The federal trial court upheld the agency’s refusal to disclose the Planned Parenthood documents on the basis of § 552(b)(4) (Exemption 4, for “trade secrets and commercial or financial information obtained from a per­son and privileged or confidential”), as well as internal agency documents, on the basis of § 552(b)(5) (Exemption 5). The First Circuit affirmed the non-freedom of information. 778 F.3d 43.

Justice Thomas, joined by Justice Scalia, dissented from the Court’s denial of review. New Hampshire Right to Life, No. 14–1273, SCOTUS (Nov. 16, 2015) [Thomas Dissent] Justice Thomas intimated that the First Circuit’s decision may well have offended the Supreme Court’s interpretation of FOIA as reflecting “a general philosophy of full agency disclosure unless information is exempted under clearly delineated statutory language.” Department of Defense v. FLRA, 510 U. S. 487, 494 (1994).

Justice Thomas noted that the First Circuit based its conclusion not on the ordinary meaning of the term “confidential,” but on speculation whether FOIA disclosure might harm Planned Parenthood’s position in a conjectured market. The First Circuit ordained the Planned Parenthood manual confidential because “[a]potential future competitor could take advantage of the institutional knowledge contained in the Manual” to com­pete against the organization in the future. Justice Thomas intimated that he, and concurring Justice Scalia, disapproved of this speculation upon speculation approach. Thomas Dissent at 2. The dissenters also noted that the Supreme Court has yet to interpret Exemption 4, to FOIA, and that the lower courts have embraced this exemption as a broad exclusion, in derogation of the language and spirit of FOIA.

In discovery efforts to obtain information about litigation science, funded by the National Institute of Environmental Health and Science (NIEHS), FOIA officers appear to invoke Exemption 4 routinely to deny disclosure. One case in point was the effort to obtain information about NIEHS-funded research of Dr. Brad A. Racette, on the prevalence of parkinsonism among welding tradesmen in Wisconsin Great Lakes shipyards. Racette is an academic researcher, on the faculty of Washington University St. Louis; he is not engaged in any commercial enterprise, in any imaginable use of the word “commercial.” His Wisconsin research was sponsored by the Boilermakers’ union, which had worked with the litigation industry (trial bar) to develop a litigation case against the manufacturers of welding rods. FOIA requests for scientific data, protocols, and analyses were met, by NIEHS, with over-zealous redactions with the invocation of FOIA exemptions, including assertions that data and analyses were “confidential commercial information.”

The redaction of one of Racette’s ESNAP reports, on Grant Number SR01ES13743-4, is illustrative. The multi-year grant, entitled “Epidemilogy [sic] of Parkinsonism in Welders,” was awarded to principal investigator Brad Racette in 2007. On October 29, 2009, Racette submitted a report that included data and data analysis. The NIEHS, on its own, or acting at the request of the principal investigator, redacted data, analyses, and conclusions, on grounds of “confidential commercial information.” Invoking an exemption for “commercial information” for federally funding of an epidemiologic study, conducted by university-based scientists seems an extreme distortion of the FOIA statute.

Cynics may say that Justices Thomas and Scalia dissented in the Planned Parenthood case because they were eager, to advance their theological ideology to exploit the opportunity to order disclosure that could hurt the good work that Planned Parenthood does. The dissenting justices deserve, however, to be taken at their word, and applauded for chastising their colleagues who were willing to abide the frustation of the word and spirit of the FOIA statute. Sadly, federal agencies seem to be determined to make information unfree. In the most recent evaluations, the Department of Health and Human Services received a failing grade, among the lowest grades for FOIA performance and responsiveness; only the State Department failed with a lower score. National Freedom of Information Coalition, “FOIA report card shows federal agencies missing the mark,” (Mar. 16, 2015); Center for Effective Government, “Making the Grade – Access to Information Scorecard 2015.”

Woodside on Access to Underlying Research Data

October 10th, 2015

Access to underlying data and materials, source codes, and other research materials is a two-edged sword. Many scientists who hold forth on the issue, including some prominent plaintiffs’ expert witnesses, have been extremely critical of the pharmaceutical and other industries for not sharing underlying data of their research. On the other hand, some of the same people have resisted sharing data and information when the litigants have sought access to these materials to understand or to challenge the published conclusions and analyses.[1]

Dr. Frank Woodside, of Dinsmore & Shohl, kindly sent me a copy of his recent law review article, written with a colleague, which advocates for full disclosure of underlying research data when research becomes material to the outcome of litigation.[2] Frank C. Woodside & Michael J. Gray, “Researchers’ Privilege: Full Disclosure,” 32 West. Mich. Univ. Cooley L. Rev. 1 (2015). The authors make the case that the so-called researcher’s privilege has little or no support in federal or state law. My previous posts have largely supported this view, at least for research that has been published, and especially for research that is being relied upon by testifying expert witnesses in pending litigation. As Lord Chancellor Hardwicke put the matter, “the public has a right to every man’s evidence,”[3] and scientists should not be immune to the requirement of giving and sharing their evidence.

Woodside and Gray have updated the scholarship in this area, and their article should be consulted in any ongoing discovery, subpoena, or Freedom of Information Act (FOIA) battle. Their discussion of the evolving case law under FOIA is especially timely. Despite the strong presumption in favor of disclosure under FOIA,[4] and President Obama’s pronouncements[5] about a new era in FOIA openness and transparency, the government’s compliance is at an all-time low. See Ted Bridis, “Obama administration sets new record for withholding FOIA requests,” PBS News Hour (Mar. 18, 2015). Court decisions have made clear that researchers cannot refuse to produce underlying data simply “because disclosure would diminish the researchers’ ability to publish their results in prestigious journals.”[6] And yet the National Institute of Environmental Health and Safety continues in its aggressive resistance to disclosure of underlying data, often by invoking FOIA exemption number four. In my cases, I have seen the NIEHS resort to this exemption that protects documents that reveal “[t]rade secrets and commercial or financial information obtained from a person and privileged or confidential,”[7] even when the research in question was conducted by academic researchers funded by the NIEHS.


[1] See, e.g., Enoch v. Forest Research Institute, Inc., N.J. Law Div. Hudson Cty., Civ. Div. L-3896-14, Order Granting Defendants’ Motion to Compel Production of Documents Necessary to Verify the Validity and Accuracy of a Study by Plaintiffs’ Expert, Anick Berard, Ph.D. (Oct. 9, 2015) (Jablonski, J.) (ordering plaintiffs to “produce the documents sought by the Forest defendants to verify the validity and accuracy of the study known as “Berard et al., Sertraline Use During Pregnancy and the Risk of Major Malformations, Am. J. Obstet. Gynecol. (2015), doi 10.1016/j.ajog.2015.01.034, namely the study’s SAS source codes and the specific generalized estimating equation models that were used to generate Table 2 of the study”).

[2] And I should thank Dr. Woodside and Mr. Gray for their generous citations to your humble blogger’s posts on this subject.

[3] Debate in the House of Lords on the Bill to Indemnify Evidence, 12 Hansard’s Parliamentary History of England, 675, 693, May 25, 1742, quoted in 8 Wigmore on Evidence at 64, § 2192 (3d ed. 1940).

[4] See S. REP. No. 89-813, at 3 (1965) (the purpose of FOIA is to “establish a general philosophy of full agency disclosure . . . and to provide a court procedure by which citizens and the press may obtain information wrongfully withheld”).

[5] See Executive Order, Memorandum, 74 Fed. Reg. 4685 (Jan. 21, 2009).

[6] See Burka v. U.S. Dep’t of Health and Human Serv., 87 F.3d 508, 515 (D.C. Cir. 1996).

[7] See 5 U.S.C. § 552(b)(4).