Reference Manual on Scientific Evidence v4.0

The need for revisions to the third edition of the Reference Manual on Scientific Evidence (RMSE) has been apparent since its publication in 2011. A decade has passed, and the federal agencies involved in the third edition, the Federal Judicial Center (FJC) and the National Academies of Science Engineering and Medicine (NASEM), are assembling staff to prepare the long-needed revisions.

The first sign of life for this new edition came back on November 24, 2020, when the NASEM held a short, closed door virtual meeting to discuss planning for a fourth edition.[1] The meeting was billed by the NASEM as “the first meeting of the Committee on Emerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence.” The Committee members heard from John S. Cooke (FJC Director), and Alan Tomkins and Reggie Sheehan, both of the National Science Foundation (NSF). The stated purpose of the meeting was to review the third edition of the RMSE to identify “identify areas of science, technology, and medicine that may be candidates for new or updated chapters in a proposed new (fourth) edition of the manual.” The only public pronouncement from the first meeting was that the committee would sponsor a workshop on the topic of new chapters for the RMSE, in early 2021.

The Committee’s second meeting took place a week later, again in closed session.[2] The stated purpose of the Committee’s second meeting was to review the third edition of the RMSE, and to discuss candidate areas for inclusion as new and updated chapters for a fourth edition.

Last week saw the Committee’s third, public meeting. The meeting spanned two days (Feb. 24 and 25, 2021), and was open to the public. The meeting was sponsored by NASEM, FJC, along with the NSF, and was co-chaired by Thomas D. Albright, Professor and Conrad T. Prebys Chair at the Salk Institute for Biological Studies, and the Hon. Kathleen McDonald O’Malley, who sits on the United States Court of Appeals for the Federal Circuit. Identified members of the committee include:

Steven M. Bellovin, professor in the Computer Science department at Columbia University;

Karen Kafadar, Departmental Chair and Commonwealth Professor of Statistics at the University of Virginia, and former president of the American Statistical Association;

Andrew Maynard, professor, and director of the Risk Innovation Lab at the School for the Future of Innovation in Society, at Arizona State University;

Venkatachalam Ramaswamy, Director of the Geophysical Fluid Dynamics Laboratory of the National Oceanic and Atmospheric Administration (NOAA) Office of Oceanic and Atmospheric Research (OAR), studying climate modeling and climate change;

Thomas Schroeder, Chief Judge for the U.S. District Court for the Middle District of North Carolina;

David S. Tatel, United States Court of Appeals for the District of Columbia Circuit; and

Steven R. Kendall, Staff Officer

The meeting comprised five panel presentations, made up of remarkably accomplished and talented speakers. Each panel’s presentations were followed by discussion among the panelists, and the committee members. Some panels answered questions submitted from the public audience. Judge O’Malley opened the meeting with introductory remarks about the purpose and scope of the RMSE, and of the inquiry into additional possible chapters.

  1. Challenges in Evaluating Scientific Evidence in Court

The first panel consisted entirely of judges, who held forth on their approaches to judicial gatekeeping of expert witnesses, and their approach to scientific and technical issues. Chief Judge Schroeder moderated the presentations of panelists:

Barbara Parker Hervey, Texas Court of Criminal Appeals;

Patti B. Saris, Chief Judge of the United States District Court for the District of Massachusetts,  member of President’s Council of Advisors on Science and Technology (PCAST);

Leonard P. Stark, U.S. District Court for the District of Delaware; and

Sarah S. Vance, Judge (former Chief Judge) of the U.S. District Court for the Eastern District of Louisiana, chair of the Judicial Panel on Multidistrict Litigation.

  1. Emerging Issues in the Climate and Environmental Sciences

Paul Hanle, of the Environmental Law Institute moderated presenters:

Joellen L. Russell, the Thomas R. Brown Distinguished Chair of Integrative Science and Professor at the University of Arizona in the Department of Geosciences;

Veerabhadran Ramanathan, Edward A. Frieman Endowed Presidential Chair in Climate Sustainability at the Scripps Institution of Oceanography at the University of California, San Diego;

Benjamin D. Santer, atmospheric scientist at Lawrence Livermore National Laboratory; and

Donald J. Wuebbles, the Harry E. Preble Professor of Atmospheric Science at the University of Illinois.

  1. Emerging Issues in Computer Science and Information Technology

Josh Goldfoot, Principal Deputy Chief, Computer Crime & Intellectual Property Section, at U.S. Department of Justice, moderated panelists:

Jeremy J. Epstein, Deputy Division Director of Computer and Information Science and Engineering (CISE) and Computer and Network Systems (CNS) at the National Science Foundation;

Russ Housley, founder of Vigil Security, LLC;

Subbarao Kambhampati, professor of computer science at Arizona State University; and

Alice Xiang, Senior Research Scientist at Sony AI.

  1. Emerging Issues in the Biological Sciences

Panel four was moderated by Professor Ellen Wright Clayton, the Craig-Weaver Professor of Pediatrics, and Professor of Law and of Health Policy at Vanderbilt Law School, at Vanderbilt University. Her panelists were:

Dana Carroll, distinguished professor in the Department of Biochemistry at the University of Utah School of Medicine;

Yaniv Erlich, Chief Executive Officer of Eleven Therapeutics, Chief Science Officer of MyHeritage;

Steven E. Hyman, director of the Stanley Center for Psychiatric Research at Broad Institute of MIT and Harvard; and

Philip Sabes, Professor Emeritus in Physiology at the University of California, San Francisco (UCSF).

  1. Emerging areas in Psychology, Data, and Statistical Sciences

Gary Marchant, Lincoln Professor of Emerging Technologies, Law and Ethics, at Arizona State University’s Sandra Day O’Connor College of Law, moderated panelists:

Xiao-Li Meng, the Whipple V. N. Jones Professor of Statistics, Harvard University, and the Founding Editor-in-Chief of Harvard Data Science Review;

Rebecca Doerge, Glen de Vries Dean of the Mellon College of Science at Carnegie Mellon University, member of the Dietrich College of Humanities and Social Sciences’ Department of Statistics and Data Science, and of the Mellon College of Science’s Department of Biological Sciences;

Daniel Kahneman, Professor of Psychology and Public Affairs Emeritus at the Princeton School of Public and International Affairs, the Eugene Higgins Professor of Psychology Emeritus at Princeton University, and a fellow of the Center for Rationality at the Hebrew University in Jerusalem; and

Goodwin Liu, Associate Justice of the California Supreme Court.

The Proceedings of this two day meeting were recorded and will be published. The website materials are unclear whether the verbatim remarks will be included, but regardless, the proceedings should warrant careful reading.

Judge O’Malley, in her introductory remarks, emphasized that the RMSE must be a neutral, disinterested source of information for federal judges, an aspirational judgment from which there can be no dissent. More controversial will be Her Honor’s assessment that epidemiologic studies can “take forever,” and other judges’ suggestion that plaintiffs lack financial resources to put forward credible, reliable expert witnesses. Judge Vance corrected the course of the discussion by pointing out that MDL plaintiffs were not disadvantaged, but no one pointed out that plaintiffs’ counsel were among the wealthiest individuals in the United States, and that they have been known to sponsor epidemiologic and other studies that wind up as evidence in court.

Panel One was perhaps the most discomforting experience, as it involved revelations about how sausage is made in the gatekeeping process. The panel was remarkable for including a state court judge from Texas, Judge Barbara Parker Hervey, of the Texas Court of Criminal Appeals. Judge Hervey remarked that [in her experience] if we judges “can’t understand it, we won’t read it.” Her dictum raises interesting issues. No doubt, in some instances, the judicial failure of comprehension is the fault of the lawyers. What happens when the judges “can’t understand it”? Do they ask for further briefing? Or do they ask for a hearing with viva voce testimony from expert witnesses? The point was not followed up.

Leonard P. Stark’s insights were interesting in that his docket in the District of Delaware is flooded with patent and Hatch-Waxman Act litigation. Judge Stark’s extensive educational training is in politics and political science. The docket volume Judge Stark described, however, raised issues about how much attention he could give to any one case.

When the panel was asked how they dealt with scientific issues, Judge Saris discussed her presiding over In re Neurontin, which was a “big challenge for me to understand,” with no randomized trials or objective assessments by the litigants.[3] Judge Vance discussed her experience of presiding in a low-level benzene exposure case, in which plaintiff claimed that his acute myelogenous leukemia was caused by gasoline.[4]

Perhaps the key difference in approach to Rule 702 emerged when the judges were asked whether they read the underlying studies. Judge Saris did not answer directly, but stated she reads the reports. Judge Vance, on the other hand, noted that she reads the relied upon studies. In her gasoline-leukemia case, she read the relied-upon epidemiologic studies, which she described as a “hodge podge,” and which were misrepresented by the expert witnesses and counsel. She emphasized the distortions of the adversarial system and the need to moderate its excesses by validating what exactly the expert witnesses had relied upon.

This division in judicial approach was seen again when Professor Karen Kafadar asked how the judges dealt with peer review. Judge Saris seemed to suggest that the peer-reviewed published article was prima facie reliable. Others disagreed and noted that peer reviewed articles can have findings that are overstated, and wrong. One speaker noted that Jerome Kassirer had downplayed the significance of, and the validation provided by, peer review, in the RMSE (3rd ed 2011).

Curiously, there was no discussion of Rule 703, either in Judge O’Malley’s opening remarks on the RMSE, or in the first panel discussion. When someone from the audience submitted a question about the role of Rule 703 in the gatekeeping process, the moderator did not read it.

Panel Two. The climate change panel was a tour de force of the case for anthropogenic climate change. To some, the presentations may have seemed like a reprise of The Day After Tomorrow. Indeed, the science was presented so confidently, if not stridently, that one of the committee members asked whether there could be any reasonable disagreement. The panelists responded essentially by pointing out that there could be no good faith opposition. The panelists were much less convincing on the issue of attributability. None of the speakers addressed the appropriateness vel non of climate change litigation, when the federal and state governments encouraged, licensed, and regulated the exploitation and use of fossil fuel reserves.

Panel Four. Dr. Clayton’s panel was fascinating and likely to lead to new chapters. Professor Hyman presented on heritability, a subject that did not receive much attention in the RMSE third edition. With the advent of genetic claims of susceptibility and defenses of mutation-induced disease, courts will likely need some good advice on navigating the science. Dana Carroll presented on human genome editing (CRISPR). Philip Sabes presented on brain-computer interfaces, which have progressed well beyond the level of sci-fi thrillers, such as The Brain That Wouldn’t Die (“Jan in the Pan”).

In addition to the therapeutic applications, Sabes discussed some of potential forensic uses, such as lie detectors, pain quantification, and the like. Yaniv Erlich, of MyHeritage, discussed advances in forensic genetic genealogy, which have made a dramatic entrance to the common imagination through the apprehension of Joseph James DeAngelo, the Golden State killer. The technique of triangulating DNA matches from consumer DNA databases has other applications, of course, such as identifying lost heirs, and resolving paternity issues.

Panel Five. Professor Marchant’s panel may well have identified some of the most salient needs for the next edition of the RMSE. Nobel Laureate Daniel Kahneman presented some of the highlights from his forthcoming book about “noise” in human judgment.[5] Kahneman’s expansion upon his previous thinking about the sources of error in human – and scientific – judgment are a much needed addition to the RMSE. Along the same lines, Professor Xiao Li Meng, presented on selection bias, and how it pervades scientific work, and detracts from the strength of evidence in the form of:

  1. cherry picking
  2. subgroup analyses
  3. unprincipled handling of outliers
  4. selection in methodologies (different tests)
  5. selection in due diligence (check only when you don’t like results)
  6. publication bias that results from publishing only impressive or statistically significant results
  7. selection in reporting, not reporting limitations all analyses
  8. selection in understanding

Professor Meng’s insights are sorely lacking in the third edition of the RMSE, and among judicial gatekeepers generally.  All too often, undue selectivity in methodologies and in relied-upon data is treated by judges as an issue that “goes to the weight, not the admissibility” of expert witness opinion testimony. In actuality, the selection biases, and other systematic and cognitive biases, are as important as, if not more important than, random error assessments. Indeed a close look at the RMSE third edition reveals a close embrace of the amorphous, anything-goes “weight of the evidence” approach in the epidemiology chapter.  That chapter marginalizes meta-analyses and fails to mention systematic review techiniques altogether. The chapter on clinical medicine, however, takes a divergent approach, emphasizing the hierarchy of evidence inherent in different study types, and the need for principled and systematic reviews of the available evidence.[6]

The Committee co-chairs and panel moderators did a wonderful job to identify important new trends in genetics, data science, error assessment, and computer science, and they should be congratulated for their efforts. Judge O’Malley is certainly correct in saying that the RMSE must be a neutral source of information on statistical and scientific methodologies, and it needs to be revised and updated to address errors and omissions in the previous editions. The legal community should look for, and study, the published proceedings when they become available.

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[1]  SeeEmerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence – Committee Meeting” (Nov. 24, 2020).

[2]  SeeEmerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence – Committee Meeting 2 (Virtual)” (Dec. 1, 2020).

[3]  In re Neurontin Marketing, Sales Practices & Prods. Liab. Litig., 612 F. Supp. 2d 116 (D. Mass. 2009) (Saris, J.).

[4]  Burst v. Shell Oil Co., 104 F.Supp.3d 773 (E.D.La. 2015) (Vance, J.), aff’d, ___ Fed. App’x ___, 2016 WL 2989261 (5th Cir. May 23, 2016), cert. denied, 137 S.Ct. 312 (2016). SeeThe One Percent Non-solution – Infante Fuels His Own Exclusion in Gasoline Leukemia Case” (June 25, 2015).

[5]  Daniel Kahneman, Olivier Sibony, and Cass R. Sunstein, Noise: A Flaw in Human Judgment (anticipated May 2021).

[6]  See John B. Wong, Lawrence O. Gostin, and Oscar A. Cabrera, “Reference Guide on Medical Testimony,” Reference Manual on Scientific Evidence 723-24 (3ed ed. 2011) (discussing hierarchy of medical evidence, with systematic reviews at the apex).