Who Jumped the Shark in United States v. Harkonen

My friend Chris Guzelian thinks that I have jumped the shark in joining with Professors Makuch and Lash in filing an amicus brief in United States v. Harkonen.  Or maybe just a big-mouthed bass. No one has taken a longer, harder, more sustained look at false scientific speech than Professor Guzelian, and for the most part I agree with his assessment that scientific speech can be so false or misleading as to be the subject of prohibition. See, e.g., Christopher Guzelian & Philip Guzelian, “Editorial:  Prevention of false scientific speech: a new role for an evidence-based approach,” 27 Human & Experimental Toxicol. 733 (2008).

Professors Guzelian (Chris’s father is an esteemed medical toxicologist) note, with approval, several instances in which scientific speech is curtailed or even penalized.  Advertising claims for dietary supplements are subject to a salutary requirement of “Significant Scientific Agreement” (SSA), made out to the FDA’s satisfaction.  In order to make out SSA, sellers must show that the totality of sound, relevant evidence supports the health claim in a systematic review. FDA, Guidance for industry evidence-based review system for the scientific evaluation of health claims (2007).

Study quality and methodology must be pre-specified, with the hierarchical nature of various study designed honored. Making health claims on labels of homeopathic remedies is a bit like crying “fire!” in a crowded theater.  Most purchasers do not have the time or ability to evaluate the accuracy of the claim; and they react rather than deliberate, often to their detriment.

These and other examples provided by the Professors Guzelian are illustrative and revealing.  Context for the scientific speech to be proscribed is important.  Thus, when Ninth Circuit Judge Alex Kozinski expresses the libertarian position, he is no doubt thinking of what is published in scientific journals and texts:

“[T]here are many varieties of noncommercial speech that are just as objective as paradigmatic commercial speech and yet receive full first amendment protection. Scientific speech is the most obvious; much scientific expression can easily be labeled true or false, but we would be shocked at the suggestion that it is therefore entitled to a lesser degree of protection. If you want, you can proclaim that the sun revolves around the earth, that the earth is flat, that there is no such thing as nitrogen, that flounder smoke cigars, that you have fused atomic nuclei in your bathtub — you can spout any nonsense you want, and the government can’t stop you.”

Alex Kozinski & Stuart Banner, “Who’s Afraid of Commercial Speech?” 76 Va. L. Rev. 627, 635 (1990), cited and quoted in Christopher Guzelian, “Scientific Speech,” 93 Iowa L. Rev. 882, 910 (2008).

In other contexts, the government can and should intervene to avoid palpable harm from misleading scientific speech.  Surely, the judiciary can stop expert witnesses from opining that flounder smoke cigars, and many other unsubstantiated, speculative, unreliable opinions.  Federal Rule of Evidence 702.  The presentation of unreliable “expert” witness opinion testimony in court, to lay jurors, is also like shouting “fire!” in a crowded theater.  Someone will get hurt.  The courtroom is not a free speech zone although many zealous political scientists have sought to turn it into an “anything goes” forum.  As one district judge described the problem in a case with epidemiologic evidence:

“According to plaintiffs, the rate of PD [Parkinson’s disease] mortality is so poor a proxy for measuring the rate of overall PD incidence, that the Coggon study proves nothing. In the next breath, however, plaintiffs set forth an unpublished statistical analysis (by Dr. Wells) of PD mortality data collected by the National Center for Health Statistics, arguing it proves that welders, as a group, suffer earlier onset of PD than the general population.77 Of course, the devil is in the details, discussion of which is beyond the scope of this opinion (and perhaps beyond the scope of understanding of the average juror),78 but this example shows how hard it is to tease out whether the limitations of a given study make it unreliable under Daubert.

In re Welding Fume Prods. Liab. Litig., No. 1:03-CV-17000, MDL 1535, 2006 WL 4507859, *33 (N.D. Ohio 2006).  In footnote 78, the district judge elaborated about what she meant by stating that the issues were beyond the scope of the average juror’s understanding:

“The Court does not at all mean to impugn the intelligence of the average juror; however, even the smartest and most attentive juror will be challenged by the parties’ assertions of observation bias, selection bias, information bias, sampling error, confounding, low statistical power, insufficient odds ratio, excessive confidence intervals, miscalculation, design flaws, and other alleged shortcomings of all of the epidemiological studies.”

Id. at *33 n.78.  The danger of harm in subversion of the fact-finding process requires that district judges intervene and make threshold decisions under Rules 702 and 703.  As one Supreme Court Justice expressed the matter:

“[A] trial judge, acting as ‘gatekeeper’, must ‘ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable’.  This requirement will sometimes ask judges to make subtle and sophisticated determinations about scientific methodology and its relation to the conclusions an expert witness seeks to offer— particularly when a case arises in an area where the science itself is tentative or uncertain, or where testimony about general risk levels in human beings or animals is offered to prove individual causation. ***

Of course, neither the difficulty of the task nor any comparative lack of expertise can excuse the judge from exercising the ‘gatekeeper’ duties that the Federal Rules impose — determining, for example, whether particular expert testimony is reliable and ‘will assist the trier of fact’, Fed. Rule Evid. 702, or whether the ‘probative value’ of testimony is substantially outweighed by risks of prejudice, confusion or waste of time. Fed. Rule Evid. 403. To the contrary, when law and science intersect, those duties often must be exercised with special care.”

General Elec. Co. v. Joiner, 522 U.S. 136, 147–49 (1997) (Breyer, J., concurring) (citations omitted).

Jurors are especially vulnerable to the misleading speech of expert witnesses.  They are selected for their ignorance of the underlying scientific principles, and in many jurisdictions, no one on the jury will have any significant training or experience in scientific or statistical principles. By the nature of their engagement, jurors are further prohibited from seeking outside assistance or making their own independent inquiries.  Explicit time limitations on witness examinations, or implicit limitations that result from jurors’ lack of aptitude or attention to scientific methodology result in extreme abridgments of scientific evidence in American civil and criminal trials.  This situation calls out for tight control over scientific evidence and speech in the courtroom.

Press releases are a very different context in which scientific evidence is presented and described. For many years, press releases have been used by commercial and academic scientists to announce study results.  None of the imminent, irremediable harms from arguably misleading courtroom scientific speech are at issue in the context of press releases.  Scientists and physicians do not need to make a decision on the basis of claims in a press release, and they are trained to demand more careful presentation of data and analysis.  Even law students recognize that press releases are different:

“When submitting studies for peer review, scientists choose significance levels so as to minimize the chance of Type I error and maximize the potential for advancing scientific knowledge.134 When submitting press releases, however, scientists tend to report positive aspects of study results with less caution than they would in a scientific journal.135

“Developments in the Law: Confronting the New Challenges of Scientific Evidence,” 108 Harv. Law. Rev. 1481, 1553 & n.135 (1995) (citing Lawrence K. Altman, MD, “The Doctor’s World; Promises of Miracles:  News Releases Go Where Journals Fear to Tread,” New York Times (Jan. 10, 1995) (“When speaking to the public, some scientists, in conjunction with their institution’s press office, are willing to make much bolder claims for their work. *** Many come from a news release or news conference, when public relations officials get carried away with enthusiasm. Sometimes scientists become willing partners with institution officials and say things in releases that they would never dream of saying in a scientific paper, where evidence is demanded to support a claim.”)

A press release that accurately reports data, but draws a conclusion that is more enthusiastic than the government thinks to be appropriate is hardly criminal fraud.  Here context is important, especially when the press release announces that more detailed presentation of data and analyses will be forthcoming within a week or so.  Surely, given the fulsome reports of retractions and investigations of false and fabricated data in published articles, the government must have better things to do than to police press releases.

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