TORTINI

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

Climategate on Appeal

August 17th, 2014

Michael Mann, a Professor of Meteorology at Penn State University, studies and writes about climate change. When the email servers of the University of East Anglia were hacked in 2009, Mann’s emails were among those used to suggest that there was a conspiracy to suppress evidence inconsistent with climate change.

Various committees investigated allegations of scientific malfeasance, which has come to be known as “climategate”; none found evidence of scientific misconduct. Some of the committees, however, did urge that the investigators engage in greater sharing of their supporting data, methods, and materials.

In February 2010, Penn State issued a report of its investigation, which found there was “no credible evidence that Dr. Mann had or has ever engaged in, or participated in, directly or indirectly, any actions with an intent to suppress or to falsify data.” A Final Investigation Report, from Penn State in June 2010, further cleared Mann.

In the United Kingdom, a Parliamentary Committee on Science and Technology published a report, in March 2010, finding that the criticisms of the Climate Research Unit (CRU) at the University of East Anglia (UEA) were not well founded. A month later, the UEA issued a Report of an International Panel, which found no evidence of deliberate scientific malpractice. Another UEA report, the Independent Climate Change Email Review report, found no reason to doubt the honesty of the scientists involved. An official UK governmental report, in September 2010, similarly cleared the climate researchers of wrongdoing.

The view from this side of the Atlantic largely exonerated the climate researchers of any scientific misconduct. An EPA report, in July 2010, dismissed the email content as merely a “candid discussion” among scientists collaborating on complex data. An independent review by the Department of Commerce’s Inspector General found no “inappropriate” manipulation of data in the emails. The National Science Foundation reported, in August 2011, that it could discern no research misconduct in the climategate emails.

Rand Simberg, an adjunct scholar with the Competitive Enterprise Institute (CEI) wrote a blog post, “The Other Scandal in Unhappy Valley” (July 13, 2012), in which he referred to Mann and his research as “wrongdoing” and “hockey-stick deceptions.” Simberg describes the hacked UEA emails as having “revealed” that Mann “had been engaging in data manipulation to keep the blade on his famous hockey-stick graph.” Similarly, Simberg states that “many of the luminaries of the ‛climate science’ community were shown to have been behaving in a most unscientific manner.”

The current on-line version of the Simberg’s blog post ends with a note[1]:

*Two inappropriate sentences that originally appeared in this post have been removed by the editor.

A post by Mark Steyn on the National Review online website called Mann’s hockey stick “fraudulent.” A subsequent National Review piece offered that in “common polemical usage, ‛fraudulent’ doesn’t mean honest-to-goodness criminal fraud. It means intellectually bogus and wrong.”

Legal counsel for Penn State wrote the Competitive Enterprise Institute, in August 2012, to request an apology from Simberg and the CEI, and a retraction of Simberg’s blog post. I am not sure what was in the two, subsequently removed, “inappropriate sentences” in Simberg’s piece were, or when the sentences were removed, but Dr. Mann, represented by Cozen O’Connor, went on to  sue Mark Steyn, Rand Simberg, the CEI, and National Review, for libel, in October 2012, in the Superior Court of the District of Columbia. Further publications led to an Amended Complaint in 2013.

Mann obviously does not like being called the author of fraudulent and intellectually bogus work, and he claims that the publications by Simberg and Steyn are libelous as “allegations of academic fraud.”

The D.C. Superior Court denied defendants’ motion to dismiss, setting up interlocutory appeals to the D.C. Court of Appeals, which is the highest court for the District. The appellate court allowed an interlocutory appeal, with a schedule that calls for appellants’ briefs by August 4, 2014. Dr. Mann’s brief is due by September 3, 2014, and appellants’ reply briefs by September 24, 2014.  The Court set consideration of the appeal for its November calendar.

Defendants CEI and National Review filed their opening briefs last week. This week, on August 11, 2014, the Cato Institute, Reason Foundation, Individual Rights Foundation and Goldwater Institute filed a brief in support of CEI and National Review. Other amici who filed in support of the defendants are Mark Steyn, the District of Columbia, and the Alliance Defending Freedom, and the Electronic Frontier Foundation.

I am not sure that all the epithets point to academic fraud.  Some of the adjectives, such as “bogus” do not really connote scienter or intent to deceive.  The use of the adjective “fraudulent,” however, does connote intentional falsity, designed to mislead. Deceit and intent to mislead seem to be at the heart of an accusation of fraud.

The defendants’ arguments, and their amici, on appeal predictably rely heavily upon the First Amendment to protect their speech, but surprisingly, they characterize labeling someone’s research as “fraudulent” as merely “hyperbolic” or “robust” debate and polemics.

Some of the defendants’ other arguments are even more surprising.  For instances, Cato correctly points out that “Courts are ill-suited to officiate scientific debate to determine ‛truth’ or ‛falsity’.” True, but officiate they must in criminal fraud, intellectual property, product liability, and in securities fraud cases, as well as many other kinds of litigations. Cato admonishes that the “[e]volution of scientific thought over time highlights the danger of courts[’] determining ‛truth’ in public debate.” Dangerous indeed, but a commonplace in state and federal courts throughout the land.

Is this Think Tank Thuggery or robust free speech? The use of “fraudulent” seems to be an accusation, and it would have much more “robust” to have had a careful documentation of what exactly was Professor Mann’s supposed deviation from a scientific standard of care.


[1] The words “fraud” and “fraudulent” do not appear in the current on-line version of Simberg’s post.

Homeopathy on Trial

August 7th, 2014

As Tim Minchin put it in his poem, “Storm,” an alternative medicine is either not shown to be effective or has been shown to be ineffective; because if an alternative medicine has been shown to be effective, then we call it “medicine.”

Standard Homeopathic Company makes and sells various so-called alternative medicine remedies. Plaintiffs filed suit against Standard for misleadingly claiming efficacy, and sought class action certification.  Class actions have become increasingly difficult to maintain in federal court, but this one seems like a worthy candidate. The plaintiffs, in their Third Amended Complaint, alleged that “there is ‘little evidence’ that homeopathy is effective.” Usually, plaintiffs are perfectly happy with just a ‘little evidence’ to support claims for many dollars, but here they complained about being duped by homeopathy and its claims of dubious validity.

On August 1, 2014, District Judge Dolly Gee certified a class on behalf of purchasers of defendants’ homeopathic remedies (Calms Forte, Teething Tablets, Migraine Headache Relief, Colic Tablets, etc.) from February 2008 to the present. Allen v. Hyland’s Inc., 2:12-cv-01150, 2014 WL 3819713 (C.D. Calif. Aug. 1, 2014). The win was no doubt as sweet as the sugar pills that they had bought.

Standard Homeopathic is represented by Norton Rose Fulbright, which also represents ethical drug manufacturers.  Curiously, the defense lawyers must not have seen the substantial potential conflict of interest in representing a homeopathic manufacturer. Watching defendants’ attempts to defend the truth of their advertised claims for homeopathic remedies should make for an interesting litigation to watch.

 

The Illinois Medical Studies Act and Access to Underlying Research Data

August 2nd, 2014

In the course of the welding fume litigation, defense counsel sought underlying data and documentation from a study published by Dr. Brad Racette and others, on their observations of Alabama welders[1]. The Alabama study, with its duplicate publication, aroused counsel’s suspicion for several reasons, not the least of which was that plaintiffs’ counsel had participated in creating the study by providing their clients as participants at screenings to be conducted by Dr. Racette and his colleagues.  According to the disclosure in the Neurology article, the study was

“[s]upported by NIH grants K23NS43351 and NS41509, the Greater St. Louis Chapter of the American Parkinson’s Disease Association, and the Welder Health Fund. The Welder Health Fund was created by Gulf States Trial Attorneys to support medical–legal screening of welders for Parkinson disease. No author has taken any money personally related to this research.”

A little research showed that the referenced NIH grants were not for this specific study, which was a creation of the litigation industry d/b/a the Welder Health Fund.

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette author of study on welding and parkinsonism).

Dr. Racette continued the controversy with a one-sided editorial in Neurology, which he wrote along with his legal counsel from the subpoena contest. Brad A. Racette, Ann Bradley, Carrie A. Wrisberg, and Joel S. Perlmutter, “The Impact of Litigation on Neurologic Research,” 67 Neurology 2124 (2006) [“Litigation Impact”]. Defense counsel wrote a response, which was limited due to the nature of the 400-word cap on letters to the editor. Nathan A. Schachtman, “The Impact of Litigation on Neurologic Research,” 69 Neurology 495 (2007).  A slightly more expansive response was published on the TortsProf blog. Schachtman, “Letter: Litigation and Research” (April 15, 2007).

The debate continued in October 2007, when Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss litigation and compelled access to underlying research data.  Dr. Racette complained about how disruptive subpoenas were into the operation of his research.  The Committee members appeared unimpressed by the alleged burdens when they realized that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan[2]. Most members of the Committee expressed the view that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data.

The fight over Dr. Racette’s data had consequences in the courtroom.  Defense expert witnesses were able to see how Dr. Racette was able to generate the appearance of large increased prevalence of “parkinsonism” (idiosyncratically defined and ascertained), which appearance was at odds with the vast data from analytical epidemiologic studies from around the world. James Mortimer, Amy Borenstein, and Laurene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012) (reporting a statistically significant decreased risk of Parkinson’s disease among welding tradesmen).  Remarkably, the plaintiffs’ counsel, who had sponsored the Alabama study, did not show the underlying Racette data and materials to their expert witnesses.  Within a short time after the subpoena was enforced, plaintiffs’ counsel mostly withdrew the epidemiologic component of their cases. Racette’s study ceased to play a major role in the plaintiffs’ claims. The debate over access to underlying data continues, both for clinical trials and for observational studies[3].

In “Litigation Impact,” Racette and colleagues offered specific remedial suggestions concerning the access of data.  One suggestion is to prohibit all data access categorically. Ironically, Racette’s suggestion run contrary to the widespread view that clinical trial data must be shared. Here is how Racette presents his suggestion:

“Stronger, more comprehensive federal legislation recognizing a research scholar privilege and ensuring that research data are uniformly protected against disclosure in all states is essential to advancing medical science.

Protections for study participants and researchers against disclosure of study data could be modeled after provisions such as those set forth in the Illinois Medical Studies Act. This Act specifically designates medical research study data and protocols as protected and prohibits the disclosure of research data obtained as part of a medical study.40,41 Enforcement includes a potential misdemeanor conviction for any person disclosing medical study data. Such legislation must strike a critical balance between the rights of industry to defend itself and the rights of researchers.”

Litigation Impact at 2128.

Is Racette correct that Illinois Medical Studies Act prevents disclosure of underlying research study data?

The claim seems dubious, but the Act is hardly a model of clarity:

Sec. 8-2101. Information obtained. All information, interviews, reports, statements, memoranda, recommendations, letters of reference or other third party confidential assessments of a health care practitioner’s professional competence, or other data of the Illinois Department of Public Health, local health departments, the Department of Human Services (as successor to the Department of Mental Health and Developmental Disabilities), the Mental Health and Developmental Disabilities Medical Review Board, Illinois State Medical Society, allied medical societies, health maintenance organizations, medical organizations under contract with health maintenance organizations or with insurance or other health care delivery entities or facilities, tissue banks, organ procurement agencies, physician-owned insurance companies and their agents, committees of ambulatory surgical treatment centers or post-surgical recovery centers or their medical staffs, or committees of licensed or accredited hospitals or their medical staffs, including Patient Care Audit Committees, Medical Care Evaluation Committees, Utilization Review Committees, Credential Committees and Executive Committees, or their designees (but not the medical records pertaining to the patient), used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services, except that in any health maintenance organization proceeding to decide upon a physician’s services or any hospital or ambulatory surgical treatment center proceeding to decide upon a physician’s staff privileges, or in any judicial review of either, the claim of confidentiality shall not be invoked to deny such physician access to or use of data upon which such a decision was based.
(Source: P.A. 92-644, eff. 1-1-03.)

Ill.Ann.Stat. ch. 735 § 5 (Code of Civil Procedure)/8–2101, et seq. (Medical Studies).

Racette’s suggestion that the Act protects the underlying data from research studies is not supported by reliable precedent.  Plaintiffs’ lawyers, including lawyers who worked with Dr. Racette in the welding litigation, have objected to discovery on the basis of the Act, but the objections were apparently not further litigated. See Videotape Deposition of Paul A. Nausieda, M.D. in Boren v. A.O. Smith Corp., Circuit Court of Illinois, Third Judicial Circuit (Dec. 22, 2004).

The Act itself has no ostensible connection to protecting the underlying data in an epidemiologic study.  Niven v. Siquiera, 109 Ill. 2d 357, 487 N.E.2d 937 (1985) (“the purpose of the Act is to encourage candid and voluntary studies and programs used to improve hospital conditions and patient care or to reduce the rates of death and disease”); Matviuw v. Johnson, 70 Ill. App.3d 481, 486, 388 N.E.2d 795, 799 (1st Dist. 1979). The Act protects peer-review or quality-control committees that supervise overall medical care with a view to improving the quality and standard of care, and reducing morbidity and mortality of patients. The privilege is designed to permit persons to speak freely to committees, and to protect their self-evaluative deliberations. Id.; Walker v. Alton Memorial Hospital Ass’n, 91 Ill. App.3d 310, 314, 414 N.E.2d 850, 853 (5th Dist. 1980). For a document to fall within the scope of the Act, it must be “generated specifically for the use of a peer-review committee.” Webb v. Mt. Sinai Hospital and Medical Center of Chicago, Inc., 807 N.E.2d 1026, 1033 (Ill. App. Ct. 2004)(internal citation omitted).

Given the language of the Act, and its interpretation in the Illinois courts, it is not surprising that attempts to assert the statutory privilege to defeat research subpoenas have failed.

In Andrews v. Eli Lilly & Co., Inc., 97 F.R.D. 494 (N.D. Ill. 1983), the district judge quashed a subpoena that sought production of records from research that was exploring the association between maternal use of diethylstilbestrol and daughters’ development of adenocarcinoma of the vagina. In granting the motion to quash, the district judge acknowledged that the Medical Studies Act protected the records from disclosure. Id. at 500. The party seeking discovery, argued that the Illinois statute was limited to hospital peer review.  The district court acknowledged that the purpose of the Act was to ensure confidentiality of the peer-review process, but that the “plain language” of the statute did not limit protected material to that used for peer review. Id. at 500 n.19. In any event, Andrews was stripped of any precedential force when it was vacated by the United States Court of Appeals.   Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1984).

In the Orthopedic Bone Screw MDL, plaintiffs sought research study documents from the Scoliosis Research Society. Invoking the Illinois Medical Studies Act, the Society moved for a protective order to prevent disclosure of the names of physicians and patients who participated in “The Pedicle Screw Cohort Study,” and the disclosure of documents from that study. In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1996 WL 34394351 (E.D. Pa. Feb. 14, 1996), app. dism’d, 94 F.3d 110 (3d Cir. 1996). The Society claimed that the Act provided an unconditional confidentiality for all data and related information underlying a “a medical study.” Id. at *2.

The MDL court denied the plaintiffs’ motion to enforce, but rejected the claim that the Act created a privilege that applied in the case. Id. at *3 (citing the predominant federal interest in determining whether a state court privilege applied, and the lack of Illinois interests in a choice of law analysis).

In another multi-district litigation, Pfizer sought peer reviewer and editorial comments from the Journal of the American Medical Association, on articles and manuscripts of studies involving its COX-2 inhibitor medications, Bextra and Celebrex.  In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., Case No. 08 C 402, 2008 U.S. Dist. LEXIS 21098; 2008 WL 4345158 (N.D. Ill. Mar. 14, 2008). The Journals asserted privileges, including a statutory privilege under the Illinois Medical Studies Act. Id. at *10-12. The federal district court ruled that the privilege appeared not to apply to manuscripts, articles, peer reviewer and editorial comments:

“The Medical Studies Act, 735 ILCS 5/8-2101, provides that [a]ll information, interviews, reports, statements, memoranda, recommendations, letters of reference or third party confidential assessments of a health care practitioner’s professional competence, or other data …  of allied medical societies . . . used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services . . . . 735 ILCS 5/8-2101. The purpose of the Act is to ‛ensure that members of the medical profession can maintain effective professional self-evaluation and to improve the quality of healthcare’.

To that end, the Act clearly protects from disclosure information gathered in the course of a peer review, but only if it is used in connection with a program or study designed to improve internal quality control or patient care, or to reduce morbidity and mortality. Putting aside the question of whether the Journals would qualify as ‛allied medical societies’, the Court is not persuaded that the specific information identified in the subpoenas fits within this definition. In her declaration, Dr. DeAngelis represented that JAMA ‛publishes scientific articles, commentaries, and news involving all fields of medicine, including medical research, significant clinical observations, diagnostic and therapeutic developments, legal and social matters of interest to  physicians, and issues of medical ethics’; JAMA’s motto, she said, is ‛to promote the science and art of medicine and the betterment of the public health’. DeAngelis Declaration, PP12-13. A lofty goal – but one that far transcends the provisions of the Medical Studies Act. The Act protects from disclosure documents only when ‛used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation’; surely not everything published in JAMA and AIM – or everything considered for publication – can fairly be described this way. And, on the limited record before it, the Court cannot say that all of the documents requested in the subpoenas can be either.”

Id. at *11-14.

Racette’s suggestion that the Illinois Medical Studies Act can provide guidance with respect to research subpoenas is wrong on the law, facts, and policy of the need for data sharing. The public, and its members, remain entitled to every man’s evidence. See Lord Hardwicke’s Speech on Lord Orford’s Bill (May 25, 1742), quoted in George Harris, The Life of Lord Chancellor Hardwicke; with Selections from His Correspondence, Diaries, Speeches, and Judgments, Vol. 2, at 8 (1847).


[1] See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006).

[2] See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005).  See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009).

[3] See, e.g., Jesse A Berlin, Sandra Morris, Frank Rockhold, Lisa Askie, Davina Ghersi, and Joanne Waldstreicher, “Bumps and bridges on the road to responsible sharing of clinical trial data,” 11 Clinical Trials 7 (2014); Rebecca Kush & Michel Goldman, “Fostering Responsible Data Sharing through Standards,” 370 New Engl. J. Med. 2163 (June 5, 2014); Jerome P. Reiter & Satkartar K. Kinney, “Sharing Confidential Data for Research Purposes: A Primer,” 22 Epidemiology 632 (2011).

The Role of the “Science Lawyer” in Modern Litigation

July 27th, 2014

“For the rational study of the law the blackletter man may be the man of the present, but the man of the future is the man of statistics and the master of economics.”[1]

“Judges commonly are elderly men, and are more likely to hate at sight any analysis to which they are not accustomed, and which disturbs repose of mind … .”[2]

The emergence of complex scientific issues in post-World War II American litigation has challenged state and federal legal systems, both civil and criminal. Various issues, such as the validity of forensic science and biological causation, have tested the competency of lawyers, both judges and counsel. This scientific complexity also questions whether lay juries can or should be continued in their traditional role as fact finders[3].  Some commentators have suggested that complexity should be a basis for reallocating fact finding to judges.[4] Other commentators remain ideologically or constitutionally committed to the jury as fact finder.

The superiority of judges as fact finders in complex scientific cases remains to be shown. Clearly juries often perform better than individual lay judges as scientific fact finders, but their time commitment is inadequate.  Furthermore, the jury decision process is typically a binary decision without any articulation of reasoning.  The jury’s hidden reasoning process on important scientific issues violates basic tenets of transparency and due process.  Many modern cases present such difficult scientific issues that some authors have argued that we should establish scientific courts or institute procedures for blue-ribbon juries[5].  The constitutionality of having scientists, or specially qualified judges, serve as fact finders has never been clearly addressed.[6]  Other commentators have argued in favor of the existing set of judicial tools, such as appointment of testifying “neutral” expert witnesses and scientific advisors for trial judges.[7] These approaches have been generally available in federal and some state trial courts, but they have rarely been used.  Some examples of their deployment include the silicone gel breast implant litigation[8], and cases involving Parlodel[9] and Bendectin[10].

Over 20 years ago, in 1993, the United States Supreme Court handed down its Daubert decision.  In large measure, the Court’s insistence upon trial court gatekeeping of expert witnesses has obscured the discussion and debate about science courts and alternative procedures for addressing complex scientific issues in litigation.  With fear and trembling, and sometimes sickness not quite unto death, federal and state judges, and lawyers on both sides of the “v,” must now do more than attack, defend, and evaluate expert witnesses on simplistic surrogates for the truth, such as personal bias or qualifications.  Lord have mercy, judges and lawyers must now actually read and analyze the bases of expert witnesses’ opinions, assess validity of studies and conclusions, and present their challenges and evaluations in clear, non-technical language.

The notion that “law is an empty vessel” is an imperfect metaphor, but it serves to emphasize that lawyers may have to get their hands wet with vessel’s contents, now and then.  In litigating scientific issues, lawyers and judges will necessarily have to engage with substantive matters.  Lawyers without scientific training or aptitude are not likely to serve clients, whether plaintiffs or defendants, well in the post-Daubert litigation world.  Untrained lawyers will choose the wrong theory, emphasize the wrong evidence, and advance the wrong conclusions.  The stakes are higher now for all the players.  An improvident claim or defense will become a blot on a lawyer’s escutcheon.  A poor gatekeeping effort or judicial decision[11] can embarrass the entire judicial system[12].

Over a decade ago, Professor David Faigman asked whether science was different for lawyers.  Professor Faigman emphatically answered his own question in the negative, and urged lawyers and courts to evolve from their pre-scientific world view.[13] Both lawyers and judges must learn about the culture, process, and content of science.  Science is often idealized as a cooperative endeavor, when in fact, much scientific work can be quite adversarial.[14]Some judges and commentators have argued that the scientific enterprise should be immune from the rough and tumble of legal discovery because the essential collaborative nature of science is threatened by the adversarial interests at play in litigation.  In becoming better judges of science, judges (and lawyers) need to develop a sense of the history of science, with its findings, fanaticisms, feuds, and fraud. The good, bad, and the ugly are all the proper subject for study. Professor George Olah, in accepting his Nobel Prize in Chemistry, rebutted the lofty sentiments about scientific collegiality and collaboration[15]:

“Intensive, critical studies of a controversial topic always help to eliminate the possibility of any errors. One of my favorite quotation is that by George von Bekessy (Nobel Prize in Medicine, 1961).

‘[One] way of dealing with errors is to have friends who are willing to spend the time necessary to carry out a critical examination of the experimental design beforehand and the results after the experiments have been completed. An even better way is to have an enemy. An enemy is willing to devote a vast amount of time and brain power to ferreting out errors both large and small, and this without any compensation. The trouble is that really capable enemies are scarce; most of them are only ordinary. Another trouble with enemies is that they sometimes develop into friends and lose a good deal of their zeal. It was in this way the writer lost his three best enemies. Everyone, not just scientists, needs a few good enemies!’”

In other words, peer review is a shabby substitute for cross-examination and an adversarial process.[16]  That adversarial process cannot always unfold fully and fairly in front of a jury.

Chief Justice Rehnquist no doubt spoke for most judges and lawyers in expressing his discomfort with the notion that courts would have to actually look at science (rather than qualifications, demeanor, and credibility)[17]:

“I defer to no one in my confidence in federal judges; but I am at a loss to know what is meant when it is said that the scientific status of a theory depends on its ‘falsifiability’, and I suspect some of them will be, too.”

Before the Daubert decision, some commentators opined that judges and lawyers were simply too innumerate and too dull to be involved in litigating scientific issues[18]. Today, most federal judges at least would not wear their ignorance so proudly, largely because of the efforts of the Federal Judicial Center, and its many educational efforts.  Judges (and lawyers) cannot and should not be scientific or statistically illiterate[19].  If generalist judges think this is beyond their ken, then they should have the intellectual integrity to say so, and get out of the way.  If the scientific tasks are beyond the ken of judges, then they are likely beyond the abilities of ordinary jurors as well, and we should start to think seriously once again about science courts and blue-ribbon juries.

Astute and diligent gatekeeping judges and qualified juries can get the job done[20]. Certainly, some judges have seen through expert witnesses’ evasions and errors in reasoning, and lawyers’ shystering on both sides of litigation.  Evaluating scientific evidence and drawing inferences from scientific studies do require understanding of basic statistical concepts, study design, and scientific apparatus, but at the bottom, there is no esoteric “scientific method” that is not careful and skeptical reasoning about evidence in the context of all the facts.[21]  Surely, judges with university educations, “20 years of schooling,” and at least 10 years of exemplary professional practice should, in theory, be able to get the job done, even if a few judges are unqualified or ill suited by aptitude or training. To take an example from the breast implant litigation, understanding a claim about immunology may well require some depth in what the immune system is, how it works, and how it may be altered.  This understanding will require time, diligence, intellectual energy, and acumen.  Surely, ordinary lay juries often do not have the time to devote to such a case to do justice to the issues. If judges do not have the interest or the time to render the required service, they should say so.

And what about lawyers?  Twenty years into the Daubert era is time enough for law schools to implement curriculum to train lawyers to understand and to litigate scientific issues, in civil, criminal, and regulatory contexts.  Many law schools still fail to turn out graduates with basic competence to understand and advocate about scientific issues.[22]  Lawyers who want to litigate scientific issues owe their clients and themselves the commitment to understand the issues.  It has been a long time since C.P. Snow complained of the “two cultures,” science and the humanities, and the hostility he faced when he challenged colleagues about their ignorance of science.[23]  Law schools have a role in building a bridge between the two cultures of science and the humanities. Just as tax programs in law schools require basic accounting, law schools should ensure that their graduates, destined to work on scientific litigation, legislation, and regulation, have had some education in statistics, probability, and scientific method.

Becoming or remaining scientific literate is a daunting but essential task for busy lawyers who hope to serve clients well in technical litigation.  There are many resources available for the “scientific legal counselor.”  Dr. David Schwartz at Innovative Science Solutions LLC has published a resource guide, The Litigator’s Guide to Combating Junk Science, available at his firm’s website.[24] Sense About Science, a charitable trust, has worked hard to advance an evidence-based world view, and to help people, including lawyers, make sense of scientific and medical claims.  Its website offers some helpful publications,[25] one of the more interesting being its recent pamphlet, Making Sense of Uncertainty.[26]

The Sense About Science group’s annual lectures are important events, which have featured lectures by:

  • Dr Fiona Godlee, the editor of the British Medical Journal, on “It’s time to stand up for science once more,” in 2010.[27]
  • Dr Olivia Judson, scientist and science journalist, on “Why Experiment?” in 2009.[28]
  • Professor Alan Sokal, quantum physicist and famous perpetrator of the Sokal hoax[29] that helped deconstruct the post-modernist deconstructionists, on “What is Science and Why Should We Care?” in 2008.[30]
  • Sir John Krebs FRS, discoverer of the Krebs cycle, on “Science Advice, Impartiality and Policy,” in 2006.[31]

In addition to keeping abreast of scientific developments, science lawyers need to understand both how science is “made,” and how it goes bad.  The National Institutes of Health website has many resources about the grant process.  Science lawyers should understand the grant process and how to use the Freedom of Information Act to obtain information about research at all stages of development.  Contrary to the fairy-tale accounts of idealized science, the scientific research process goes astray with some frequency, so much so that there is a federal agency, the Office of Research Integrity (ORI) tasked with investigating research misconduct. News of the ORI’s investigations, and findings, is readily available through its website and its informative blog.[32] Research misconduct has resulted in an ever-increasing rate of retractions in peer-reviewed journals.  The Retraction Watch[33] blog offers a fascinating window into the inadequacies of peer review, and the attempts, some successful, some not, of the scientific community to police itself.

Before Daubert was decided, the legal system emphasized credentials and qualifications of witnesses, “authoritative texts,” and general acceptance.  Science, however, is built upon an evidence-based foundation.  Since 1663, the Royal Society has sported the motto:  “Nullius in verba”: on no person’s authority.  When confronted with a pamphlet entitled “100 Authors against Einstein,” Albert Einstein quipped “if I were wrong, one would have been enough.”[34]  Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the prestige of the speaker.  The shift from authority-based decision making to evidence-based inferences and conclusions has strained the legal system in the United States, where people are free to propagate cults and superstitions.  The notion that lawyers who spend most of their time litigating leveraged boxcar leases can appreciate the nuances, strengths, weaknesses, and flaws of scientific studies and causal inference is misguided.  Litigants, whether those who make claims or those who defend claims, deserve legal counsel who are conversant with the language of their issues.  Law schools, courts, and bar associations must rise to the occasion to meet the social need.


[1] Oliver Wendell Holmes, Jr., “The Path of the Law,” 10 Harv. L. Rev. 457, 469 (1897)

[2] Oliver Wendell Holmes, Jr., Collected Legal Papers 230 (1921).

[3] An earlier version of this post appeared as a paper in David M. Cohen & Nathan A. Schachtman, eds., Daubert Practice 2013: How to Avoid Getting Sliced by Cutting-Edge Developments in Expert Witness Challenges (PLI 2013).

[4] See Ross v. Bernhard, 396 U.S. 531, 538 n.l0 (1970) (suggesting that the right to a jury trial may be limited by considerations of complexity, and that practical abilities and limitations of juries are a factor in determining whether an issue is to be decided by the judge or the jury).  See also Note, “The Right to a Jury Trial in Complex Civil litigation,” 92 Harv. L. Rev. 898 (1979) (considering the implications of footnote 10 in Ross for complex litigation; noting that the Ross test has been applied infrequently, and in the limited contexts of antitrust or securities cases); Peter Huber, “Comment, A Comment on Toward Incentive-Based Procedure: Three Approaches for Regulating Scientific Evidence by E. Donald Elliott,” 69 Boston Univ. L. Rev. 513, 514 (1989) (arguing that judges cannot make difficult scientific judgments).  See also George K. Chamberlin, “Annotation: Complexity of Civil Action as Affecting Seventh Amendment Right to Trial by Jury,” 54 A.L.R. FED. 733, 737-44 (1981).

[5] James A. Martin, “The Proposed Science Court,” 75 Mich. L. Rev. 1058, 1058-91 (1977) (evaluating the need and feasibility of various proposals for establishing science courts); Troyen A. Brennan, “Helping Courts with Toxic Torts,” 51 U. Pitt. L. Rev. 1, 5 (1989) (arguing for administrative panels or boards to assist courts with scientific issues); Donald Elliott, “Toward Incentive-Based Procedure: Three Approaches for Regulating Scientific Evidence,” 69 Boston Univ. L. Rev. 487, 501-07 (1989) (discussing various models of ancilliary peer review for courts); Paul K. Sidorenko, “Comment, Evidentiary Dilemmas in Establishing Causation: Are Courts Capable of Adjudicating Toxic Torts?” 7 Cooley L. Rev. 441, 442 (1990) (recommending administrative panels of scientific experts in toxic tort litigation); John W. Osborne, “Judicial Technical Assessment of Novel Scientific Evidence,” 1990 U. Ill. L. Rev. 497, 540-46 (arguing for procedures with specially qualified judges); Edward V. DiLello, “Note, Fighting Fire with Firefighters: A Proposal for Expert Judges at the Trial Level,” 93 Colum. L. Rev. 473, 473 (1993) (advocating establishment of specialist judicial assistants for judges).  For a bibliography of publications on the science court concept, see Jon R. Cavicchi, “The Science Court: A Bibliography” (1994) <http://ipmall.info/risk/vol4/spring/bibliography.htm>, last visited on July 27, 2014.

[6] See Ross v. Bernhard, 396 U.S. at 538 n.l0.

[7] John W. Wesley, “Scientific Evidence and the Question of Judicial Capacity,” 25 William & Mary L. Rev. 675, 702-03 (1984).

[8] See Karen Butler Reisinger, “Expert Panels: A Comparison of Two Models,” 32 Indiana L.J. 225 (1998); Laural L. Hooper, Joe S. Cecil & Thomas E. Willging, Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation, (Federal Judicial Center 2001), available at http://www.fjc.gov/public/pdf.nsf/lookup/neuscipa.pdf/$file/neuscipa.pdf

[9] Soldo v. Sandoz Pharms. Corp., 244 F. Supp. 2d 434 (W.D. Pa. 2003); see also Joe S. Cecil, “Construing Science in the Quest for Ipse Dixit,” 33 Seton Hall L. Rev. 967 (2003).

[10] DePyper v. Navarro, No. 191949, 1998 WL 1988927 (Mich. Ct. App. Nov. 6, 1998)

[11] See, e.g., Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986).

[12] See, e.g., James L. Mills and Duane Alexander, “Teratogens and ‘Litogens’,” 15 New Engl. J. Med. 1234 (1986); Samuel R. Gross, “Expert Evidence,” 1991 Wis. L. Rev. 1113, 1121-24 (1991) (“Unfortunately, Judge Shoob’s decision is absolutely wrong. There is no scientifically credible evidence that Ortho-Gynol Contraceptive Jelly ever causes birth defects.”). See also Editorial, “Federal Judges v. Science,” N.Y. Times, December 27, 1986, at A22 (unsigned editorial);  David E. Bernstein, “Junk Science in the Courtroom,” Wall St. J. at A 15 (Mar. 24,1993) (pointing to Wells as a prominent example of how the federal judiciary had embarrassed American judicial system with its careless, non-evidence based approach to scientific evidence); Bert Black, Francisco J. Ayala & Carol Saffran-Brinks, “Science and the Law in the Wake of Daubert: A New Search for Scientific Knowledge,” 72 Texas L. Rev. 715, 733-34 (1994) (lawyers and leading scientist noting that the district judge “found that the scientific studies relied upon by the plaintiffs’ expert were inconclusive, but nonetheless held his testimony sufficient to support a plaintiffs’ verdict. *** [T]he court explicitly based its decision on the demeanor, tone, motives, biases, and interests that might have influenced each expert’s opinion. Scientific validity apparently did not matter at all.”) (internal citations omitted); Troyen A. Brennan, “Untangling Causation Issues in Law and Medicine: Hazardous Substance Litigation,” 107 Ann. Intern. Med. 741, 744-45 (1987) (describing the result in Wells as arising from the difficulties created by the Ferebee case; “[t]he Wells case can be characterized as the court embracing the hypothesis when the epidemiologic study fails to show any effect”).  Kenneth R. Foster, David E. Bernstein, and Peter W. Huber, eds., Phantom Risk: Scientific Inference and the Law 28-29, 138-39 (MIT Press 1993) (criticizing Wells decision); Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation § 6.5, at 93 (1997) (noting the multiple comparisons in studies of birth defects among women who used spermicides, based upon the many reported categories of birth malformations, and the large potential for even more unreported categories); id. at § 6.5 n.3, at 271 (characterizing Wells as “notorious,” and noting that the case became a “lightning rod for the legal system’s ability to handle expert evidence.”).

[13] David L. Faigman, “Is Science Different for Lawyers?” 297 Science 339, 340 (2002) (“some courts are still in a prescientific age”).

[14] McMillan v. Togus Reg’l Office, 294 F. Supp. 2d 305, 317 (E.D.N.Y. 2003) (“As in political controversy, ‘science is, above all, an adversary process’.”) (internal citation omitted).

[15] George A. Olah, “My Search for Carbocations and Their Role in Chemistry,” Nobel Lecture (Dec. 8, 1994), quoting George von Békésy, Experiments in Hearing 8 (N.Y. 1960).

[16] Nietzsche expressed Olah’s sentiment more succinctly.  Friedrich Nietzsche, The Twilight of the Idols Maxim 8 (1899) (“Out of life’s school of war: What does not destroy me, makes me stronger.”).

[17] Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 598 (1993) (Justice Rehnquist, C.J., concurring and dissenting).

[18] Joseph Nicol, “Symposium on Science and the Rules of Evidence,” 99 F.R.D. 188, 221 (1983) (claiming that lawyers and judges are “simply are incapable by education, and all too often by inclination, to become sufficiently familiar with scientific evidence to discharge their responsibilities toward the administration of justice.”)

[19] Robert P. Merges, “The Nature and Necessity of Law and Science,” 381 Leg. Educ. 315, 324-26 (1988) (arguing that lawyers can and should understand scientific concepts and issues)

[20] David L. Faigman, “To Have and Have Not: Assessing the Value of Social Science to the Law as Science and Policy,” 38 Emory L.J. 1005, 1014, 1030 (1989) (contending that judges can understand science and that lawyers must probe beyond conclusions into methods by which the conclusions were reached).

[21] David H. Kaye, “Proof in Law and Science,” 32 Jurimetrics J. 313, 318 (1992) (arguing that science and law share identical methods of establishing factual conclusions); Lee Loevinger, “Standards of Proof in Science and Law,” 32 Jurimetrics J. 323, 328 (1992) (“[T]he basic principles of reasoning or logic are no different in the field of law than science.”).

[22] Howell E. Jackson, “Analytical Methods for Lawyers,” 53 J. Legal Educ. 321 (2003); Steven B. Dow, “There’s Madness in the Method:  A Commentary on Law, Statistics, and the Nature of Legal Education,” 57 Okla. L. Rev. 579 (2004).

[23] C.P. Snow, The Rede Lecture 1959.

[24] Available with registration at http://www.innovativescience.net/complimentary-copy-of-our-junk-science-ebook/

[25]http://www.senseaboutscience.org/

[26] http://www.senseaboutscience.org/resources.php/127/making-sense-of-uncertainty

[27] http://www.senseaboutscience.org/pages/annual-lecture-2010.html

[28] http://www.senseaboutscience.org/pages/annual-lecture-2009.html

[29] Sokal’s famous parody of postmodern writers, the so-called “‘Sokal Hoax,” was his publication in one of the postmodernists’ own journals on how gravity was nothing more than a social construct.  Alan D. Sokal, “Transgressing the Boundaries: Towards a Transformative Hermeneutics of Quantum Gravity,” Social Text 217 (Nos. 46/47 1996) (“It has thus become increasingly apparent that physical ‘reality’, no less than social ‘reality’, is at bottom a social and linguistic construct; that scientific ‘knowledge’, far from being objective, reflects and encodes the dominant ideologies and power relations of the culture that produced it; that the truth claims of science are inherently theory-laden and self-referential; and consequently, that the discourse of the scientific community, for all its undeniable value, cannot assert a privileged epistemological status with respect to counter-hegemonic narratives emanating from dissident or marginalized communities.”)

[30] http://www.senseaboutscience.org/pages/annual-lecture-2008.html

[31] http://www.senseaboutscience.org/pages/annual-lecture-2006.htm

[32] http://ori.hhs.gov/blog/

[33] http://retractionwatch.wordpress.com/

[34] See Remigio Russo, 18 Mathematical Problems in Elasticity 125 (1996) (quoting Einstein).

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