TORTINI

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

Milward’s Singular Embrace of Comment C

May 4th, 2013

Professor Michael D. Green is one of the Reporters for the American Law Institute’s Restatement (Third) of Torts: Liability for Physical and Emotional Harm.   Green has been an important interlocutor in the on-going debate and discussion over standards for expert witness opinions.  Although many of his opinions are questionable, his writing is clear, and his positions, transparent.  The seduction of Professor Green and the Wake Forest School of Law by one of the litigation-industry’s organizations, the Center for Progressive Reform, is unfortunate, but the resulting symposium gave Professor Green an opportunity to speak and write about the justly controversial comment c.   Restatement (Third) of Torts: Liability for Physical and Emotional Harm § 28, cmt. c (2010).

Mock Pessimism Over Milward

Professor Green professes to be pessimistic about the Milward decision, but his only real ground for pessimism is that Milward will not be followed.  Michael D. Green, “Pessimism about Milward,” 3 Wake Forest J. L & Policy 41 (2013).  Green describes the First Circuit’s decision in Milward as “fresh,” “virtually unique and sophisticated,” and “satisfying.” Id. at 41, 43, and 50.  Green describes his own reaction to the decision in terms approaching ecstasy:  “delighted,” “favorable,” and “elation.”  Id. at 42, 42, and 43.

Green interprets Milward to embrace four comment c propositions:

  1. “Recognizing that judgment and interpretation are required in assessments of causation.52
  2. Endorsing explicitly and taking seriously weight of the evidence methodology,53 against the great majority of federal courts that had, since Joiner, employed a Balkanized approach to assessing different pieces of evidence bearing on causation.54
  3. Appreciating that because no algorithm exists to constrain the inferential process, scientists may reasonably reach contrary conclusions.55
  4. Not only stating, but taking seriously, the proposition that epidemiology demonstrating the connection between plaintiff’s disease and defendant’s harm is not required for an expert to testify on causation.56 Many courts had stated that idea, but very few had found non-epidemiologic evidence that satisfied them.57

Id. at 50-51.

Green’s points suggest that comment c was designed to reinject a radical subjectivism into scientific judgments allowed to pass for expert witness opinions in American courts.  None of the points is persuasive.  Point (1) is vacuous.  Saying that judgment is necessary does not imply that anything goes or that we will permit the expert witness to be the judge of whether his opinion rises to the level of scientific knowledge.  The required judgment involves an exacting attention to the role of random error, bias, or confounding in producing an apparent association, as well as to the validity of the data, methods, and analyses used to interpret observational or experimental studies.  The required judgment involves an appreciation that not all studies are equally weighty, or equally worthy of consideration for use in reaching causal knowledge.  Some inferences are fatally weak or wrong; some analyses or re-analyses of data are incorrect.  Not all judgments can be blessed by anointing some of them “subjective.”

Point (2) illustrates how far the Restatement process has wondered into the radical terrain of abandoning gatekeeping altogether.  The approach that Green pejoratively calls “Balkanized” is a careful look at what expert witnesses have relied upon to assess whether their conclusions or claims follow from their relied upon sources.  This is the approach used by International Agency for Research on Cancer (IARC) working groups, whose method Green seems to endorse.  Id. at 59.  IARC working groups discuss and debate their inclusionary and exclusionary criteria for studies to be considered, and the validity of each study and its analyses, before they get to an assessment of the entire evidentiary display.  (And several of the IARC working groups have been by no means free of the conscious bias and advocacy that Green sees in party-selected expert witnesses.)  Elsewhere, Green refers to the approach of most federal courts as “corpuscular.”  Id. at 51. Clearly, expert witnesses want to say things in court that do not, so to speak, add up, but Green appears to want to give them all a pass.

Point (3) is, at best, a half truth.  Is Green claiming that reasonable scientists always disagree?  His statement of the point suggests epistemiologic nihilism. Although there are no clear algorithms, the field of science is littered with abandoned and unsuccessful theories from which we can learn when to be skeptical or dismissive of claims and conclusions.  Certainly there are times when reasonable experts will disagree, but there are also times when experts on one side or the other, or both, are overinterpreting or misinterpreting the available evidence.  The judicial system has the option and the obligation to withhold judgments when faced with sparse or inconsistent data.  In many instances, litigation arises because the scientific issues are controversial and unsettled, and the only reasonable position is to look for more evidence, or to look more carefully at the extant evidence.

Point (4) is similarly overblown and misguided.  Green states his point as though epidemiology will never be required.  Here Green’s sympathies betray any sense of fidelity to law or science.  Of course, there may be instances in which epidemiologic evidence will not be necessary, but it is also clear that sometimes only epidemiologic methods can establish the causal claim with any meaningful degree of epistemic warrant.

ANECDOTES TO LIVE BY

Anthony Robbins’ Howler

Professor Green delightfully shares two important anecdotes.  Both are revealing of the process that led up to comment c, and to Milward.

The first anecdote involves the 2002 meeting of the American Law Institute.  Apparently someone thought to invite Dr. Anthony Robbins as a guest. (Green does not tell us who performed this subversive act.)  Robbins is a member of SKAPP, the organization started with plaintiffs’ counsel’s slush fund money diverted from MDL 926, the silicone-gel breast implant litigation.

Robbins rose at the meeting to chastise the ALI for not knowing what it was talking about:

“clear, in my opinion, misstatements of . . . science” or reflected a misunderstanding of scientific principles that “leaves everyone in doubt as to whether you know what you are talking about . . . .”

Id. at 44 (quoting from 79th Annual Meeting, 2002 A.L.I. PROC. at 294).  Pretty harsh, except that Professor Green proceeds to show that it was Robbins who had no idea of what he was talking about.

Robbins asserted that the requirement of a relative risk of greater than two was scientifically incorrect. From Green’s telling of the story, it is difficult to understand whether Robbins was complaining about the use of relative risks (greater than two) for inferring general or specific causation.  If the former, there is some truth to his point, but Robbins would be wrong as to the latter.  Many scientists have opined that relative risks provide information about attributable fractions, which in turn permit inferences about individual cases.  See, e.g., Troyen A. Brennan, “Can Epidemiologists Give Us Some Specific Advice?” 1 Courts, Health Science & the Law 397, 398 (1991) (“This indeterminancy complicates any case in which epidemiological evidence forms the basis for causation, especially when attributable fractions are lower than 50%.  In such cases, it is more probable than not that the individual has her illness as a result of unknown causes, rather than as a result of exposure to hazardous substance.”).  Others have criticized the inference, but usually on the basis that the inference requires that the risk be stochastically distributed in the population under consideration, and we often do not know whether this assumption is true.  Of course, the alternative is that we must stand mute in the face of even very large relative risks and established general causation.  See, e.g., McTear v. Imperial Tobacco Ltd., [2005] CSOH 69, at ¶ 6.180 (Nimmo Smith, L.J.) (“epidemiological evidence cannot be used to make statements about individual causation… . Epidemiology cannot provide information on the likelihood that an exposure produced an individual’s condition.  The population attributable risk is a measure for populations only and does not imply a likelihood of disease occurrence within an individual, contingent upon that individual’s exposure.”).

Robbins second point was truly a howler, one that suggests his animus against gatekeeping may grow out of a concern that he would never pass a basic test of statistical competency.  According to Green, Robbins claimed that “increasing the number of subjects in an epidemiology study can identify small effects with ‘an almost indisputable causal role’.” Id. at 45 (quoting Robbins).  Ironically, lawyer and law professor Green was left to take Robbins to school, to educate him on the differences between sampling error, bias, and confounding.  Green does not get the story completely right because he draws an artificial line between observational epidemiology and experimental clinical trials, and incorrectly implies that bias and confounding are problems only in observational studies.  Id. at 45 n. 24.  Although randomization is undertaken in clinical trials to control for bias and confounding, it is not true that this strategy always works or always works completely.  Still, here we have a lawyer delivering the comeuppance to the scolding scientist.  Sometimes scientists really have no good basis to support their claims, and it is the responsibility of the courts to say so.  Green’s handling of Robbins’ errant views is actually a wonderful demonstration of gatekeeping in action.  What is lovely about it is that the claims and their rebuttal were documented and reported, rather than being swept away in the fog of a jury verdict.

Professor Green’s account of Robbins’ foolery should be troubling because, despite Robbins’ manifest errors, and his more covert biases, we learn that Robbins’ remarks had “a profound impact” on the ALI’s deliberations. Courts that are tempted by the facile answers of comment c should find this impact profoundly disturbing.

Alan Done’s Weight of the Evidence (WOE) or Mosaic Methodology

Professor Green relays an anecdote that bears repeating, many times.  In the Bendectin litigation, plaintiffs’ expert witness, Alan Done testified that Bendectin caused birth defects in children of mothers who ingested the anti-nausea medication during pregnancy.  Done had a relatively easy time spinning his speculative web in the first Bendectin trial because there was only one epidemiologic study, which qualitatively was not very good.  In his second outing, Done was confronted by the defense with an emerging body of exonerative epidemiologic research. In response, he deployed his “mosaic theory” of evidence, of different pieces or lines of evidence that singularly do not show much, but together paint a conclusive picture of the causal pattern. Id. at 61 (describing Done’s use of structure-activity, in vitro animal studies, in vivo animal studies, and his own [idiosyncratic] interpretation of the epidemiologic studies).  Done called his pattern a “mosaic,” which Green correctly sees is none other than “weight of the evidence.”  Id. at 62.

After this second trial was won with the jury, but lost on post-trial motions, plaintiffs’ counsel, Barry Nace, pressed the mosaic theory as a legitimate scientific strategy to demonstrate causation, and the appellate court accepted the strategem:

“Like the pieces of a mosaic, the individual studies showed little or nothing when viewed separately from one another, but they combined to produce a whole that was greater than the sum of its parts: a foundation for Dr. Done’s opinion that Bendectin caused appellant’s birth defects. The evidence also established that Dr. Done’s methodology was generally accepted in the field of teratology, and his qualifications as an expert have not been challenged.103

Id. at 61(citing Oxendine v. Merrell Dow Pharm., Inc., 506 A.2d 1100, 1110 (D.C. 1986).  Green then drops his bombshell:  the philosopher of science who developed the “mosaic theory” (WOE) was the plaintiffs’ lawyer, Barry Nace. According to Green, Nace declared the mosaic idea “Damn brilliant, and I was the one who thought of it and fed it to Alan [Done].”  Id. at 63.

Green attempts to reassure himself that Milward does not mean that Done could use his WOE approach to testify today that Bendectin causes human birth defects.  Id. at 63.  Alas, he provides no meaningful solution to protect against future bogus cases.  Green fails to come to grips with the obvious truth that Done was wrong ab initio.  He was wrong before he was exposed for his perjurious testimony.  See id. at 62 n. 107, and he was wrong before there was a “solid body” of exonerative epidemiology.  His method never had the epistemic warrant he claimed for it, and the only thing that changed over time was a greater recognition of his character for veracity, and the emergence of evidence that collectively supported the null hypothesis of no association.  The defense, however, never had the burden to show that Done’s methodology was unreliable or invalid, and we should look to the more discerning scientists who saw through the smokescreen from the beginning.

I Don’t See Any Method At All

May 2nd, 2013

Kurtz: Did they say why, Willard, why they want to terminate my command?
Willard: I was sent on a classified mission, sir.
Kurtz: It’s no longer classified, is it? Did they tell you?
Willard: They told me that you had gone totally insane, and that your methods were unsound.
Kurtz: Are my methods unsound?
Willard: I don’t see any method at all, sir.
Kurtz: I expected someone like you. What did you expect? Are you an assassin?
Willard: I’m a soldier.
Kurtz: You’re neither. You’re an errand boy, sent by grocery clerks, to collect a bill.

* * * * * * * * * * * * * * * *

The Royal Society, the National Academies of Science, the Nobel Laureates have nothing on the organized plaintiffs’ bar.  Consider the genius and the accomplishments of these men and women.  They have discovered and built a perpetual motion machine — the asbestos litigation.  They have learned how to violate the law of non-contradiction with impunity (e.g., industry is evil, and (litigation) industry is good).  In the realm of the sciences, especially as applied in the courtroom, they have demonstrated the falsity of one of core beliefs: ex nihilo nihil fit.  We have a lot to learn from the plaintiffs’ bar.

WOE to Corporate America

Steve Baughman Jensen is a plaintiffs’ lawyer and he justifiably gloats over his success as lead counsel in Milward v. Acuity Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).  In a recent article for the litigation industry’s scholarly journal, Jensen touts Milward as Ariadne’s thread, which will take plaintiffs out of the mazes and traps set for them by the benighted law of expert witnesses.  Steve Baughman Jensen, “Reframing the Daubert Issue in Toxic Tort Cases,” 49 Trial 46 (Feb. 2013).  Jensen alleged that his client worked with solvents that contained varying amounts of  benzene, which caused him to develop Acute Promyelocytic Leukemia (APL), a subtype of Acute Myeloid Leukemia (AML).  The district court excluded plaintiffs’ expert witnesses’ causation opinions; the First Circuit reversed.  Jensen crows about his accomplished feat.

Weight of the Evidence (WOE) — Let Them Drink Ripple

Jensen, with help from philosopher of popular science Carl Cranor and toxicologist Martyn Smith persuaded the appellate court that a “weight of the evidence” (WOE) analysis necessarily involves scientific judgment. (Millward, 639 F.3d at 18), and that this “use of judgment in the weight of the evidence methodology is similar to that in differential diagnosis, which we have repeatedly found to be a reliable method of medical diagnosis.” Id. (internal citations omitted).

Is this what judicial gatekeeping of scientific expert opinion has come to?  Phrenology, homeopathy, aroma therapy, and reflexology involve medical judgment, of sorts, and so they too are now reliable methodologies.  Ripple makes red wine, and so does Chateau Margaux.  Chateau Margaux is based upon judgment in oenology, and so is Ripple.  That only one of these products will stand the test of time is irrelevant; both are the product of oenological judgment.  It’s all a question of the weight you would assign the differing qualities of Ripple and a premier cru bordeaux.

Jensen never defines WOE; the closest he comes to describing WOE is to tell us that it essentially involves a delegation to expert witnesses to validate their own subjective weighing of the evidence. As in the King of Hearts, Jensen rejoices that the inmates are now running the asylum.

Too Much of Nothing

Jensen complains about a “divide and conquer” strategy by which defendants take individual studies, one at a time, pronounce them inadequate to support a judgment of causality, and then claim that the aggregate evidence fails to support causality as well.  Surely sometimes that approach is misguided; yet sometimes the evidentiary display collectively represents “too much of nothing.”  In some litigations, there are hundreds of studies, which despite their numbers, still fail to support causation.  In General Electric v. Joiner, the Supreme Court discerned that the studies relied upon were largely irrelevant or inconclusive, and that taken alone or together, the cited studies failed to support plaintiffs’ claim of causality.  In the silicone-gel breast implant litigation, the plaintiffs’ steering committee submitted banker boxes of studies and argument to the court’s appointed expert witnesses, in an attempt to manufacture causation.  The committee, however, took its time and saw that the evidence taken individually or collectively did not amount to a scientific peppercorn.

Let Ignorance Rule

One of Jensen’s clever attempts to beguile the judiciary involves the transmutation of scientific inference into personal credibility.  “Second-guessing an expert’s application of scientific judgment necessarily requires assessing that expert’s credibility, which is the jury’s role.” Jensen, 49 Trial at 49.  Jensen attempts to reduce the “battle of experts” to a credibility contest and thus outside the purview of judicial gatekeeping.  His argument conflates credibility with methodology and its application. Because the expert witness will predictably opine that he applied the methodology faithfully, Jensen asserts that the court is barred from examining the correctness of the expert witness’s self-validation.

But scientific inference is scientific because it does not depend upon the person drawing it.  The inference may be weak, strong, erroneous, valid, or invalid.  How we characterize the inference will turn on the data and their analysis, not on the witness’s say so.

Jensen cites comment c, to Section 28 of Restatement (Third) of Torts, as supporting his reactionary arguments for abandoning judicial gatekeeping of expert witness opinion testimony.  “Juries, not judges, should determine the validity of two competing expert opinions, both of which typically fall within the realm of reasonable science.” Jensen, 49 Trial at 51 (emphasis added).  The law, however, requires trial courts to assess the validity vel non of would-be testifying expert witnesses:

“[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.”

General Elec. Co. v. Joiner, 522 U.S. 136, 147–49 (1997) (Breyer, J., concurring) (citations omitted).  Not only is Jensen’s argument contrary to the law, the argument is based upon a cynical understanding that juries will usually have little time, experience, or aptitude for assessing  validity issues, and that delegating validity issues to juries ensures that the legal system will not be able to root out pathologically weak evidence and inferences. The resolution of validity issues will be hidden behind the secretive walls of the jury room, rather than in the open sight of reasoned, published opinions, subject to public and scholarly commentary.   See, e.g., In re Welding Fume Prods. Liab. Litig., No. 1:03-CV-17000, MDL 1535, 2006 WL 4507859, *33 n.78 (N.D. Ohio 2006).  (“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.”)

Martyn Smith

Jensen extols the achievements of Dr. Martyn Smith, his expert witness who was excluded by the trial court in Milward.  A disinterested reader might mistakenly think that Smith was among the leading benzene researchers in the world, but a little Googling would turn up that Milward was not his first litigation citation.  Smith has been pulled over for outrunning his expert-witness headlights in several other litigations, including:

  • Jacoby v. Rite Aid, Phila. Cty. Ct. Common Pleas (Order of April 27, 2012; Opinion of April 12, 2012) (excluding Smith as an expert witness on the toxicity of Fix-o-Dent)
  • In re Baycol Prods. Litig., 495 F. Supp.2d 977 (D. Minn. 2007)
  • In re Rezulin Prods. Liab. Litig., MDL 1348, 441 F.Supp.2d 567 (S.D.N.Y. 2006)(“silent injury”)

None of these other cases involved benzene, but they all involved speculative opinions.

The Milward Symposium

Jensen took another victory lap at the Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses.  The presentations from this symposium have now appeared in print:  Wake Forest Publishes the Litigation Industry’s Views on MilwardSee Steve Baughman Jensen, “Sometimes Doubt Doesn’t Sell:  A Plaintiffs’ Lawyer’s Perspective on Milward v. Acuity Products,” 3 Wake Forest J. L. & Policy 177 (2013).  Jensen’s contribution was mostly a shrill ad hominem against corporations, as well as their lawyers and scientists who complicitly support an alleged campaign to manufacture doubt.

Perhaps someday the law journal’s faculty advisors and editors will feel some embarrassment over the lack of balance and scholarship in Jensen’s contribution to the symposium.  Corporations are bad; get it?  They manufacture doubt about the litigation industry’s enterprise.  Don’t pay attention to massive litigation fraud, such as faux silicosis, faux asbestosis, faux fen-phen heart disease, faux product identification, etc.  See Larry Husten, “79-Year-Old Cardiologist Sentenced To 6 Years In Prison For Fen-Phen Fraud,” Forbes (Mar. 27, 2013).   Forget that ATLA/AAJ is one of the most powerful rent-seeking lobbies in the United States.  Litigants have a constitutional right to extrapolate as they please.  If a substance causes one disease at a very high dose, then it causes every ailment known to mankind at moderate or low doses.  Specific disease entails general disease, etc.  What you balk?  You must be a doubt mongerer.

Jensen assures us that many scientists support and agree with Martyn Smith, both in his methodology and in his conclusions.  Jensen’s articles are sketchy on details, and of course, the devil is in the details.  See Amended Amicus Curiae Brief of the Council for Education and Research on Toxins et al., In Support of Appellants, in Milward.  This Council seems to fly under the internet radar, but I suspect that its membership and that of the Center for Progressive Reform overlaps somewhat.

Jensen’s article is just one of several published in the Wake Forest Journal of Law & Policy.  Let’s hope the remaining articles have more substance to them.

Who Jumped the Shark in United States v. Harkonen

April 28th, 2013

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.

Wake Forest Publishes the Litigation Industry’s Views on Milward

April 20th, 2013

This week, The Wake Forest Journal of Law & Policy published six articles from its 2012 Spring Symposium, on “Toxic Tort Litigation After Milward v. Acuity Products.”  The Symposium was a joint production of The Center for Progressive Reform and the Wake Forest University School of Law.  The articles are now available online:

Steve C. Gold, “A Fitting Vision of Science for the Courtroom” PDF

Michael D. Green, “Pessimism About Milward” PDF

Thomas O. McGarity & Sidney A. Shapiro, “Regulator Science in Rulemaking and Tort: Unifying the Weight of the Evidence Approach,PDF

Carl F. Cranor, “Milward v. Acuity Specialty Products: Advances in General Causation Testimony in Toxic Tort Litigation,” PDF

Joseph Sanders , “Milward v. Acuity Specialty Products Group: Constructing and Deconstructing Sciences and Law in Judicial Opinion,” PDF

Steve Baughman Jensen, “Sometimes Doubt Doesn’t Sell: A Plaintiffs’ Lawyer’s Perspective on Milward v. Acuity Products” PDF

As I noted previously, this symposium was a decidedly lopsided affair, as one might expect from its sponsorship by The Center for Progressive Reform (CPR), which speaks for the litigation industry in the United States. SeeMilward Symposium Organized By Plaintiffs’ Counsel and Witnesses” (Feb. 16th, 2013).

Consistent with its sponsorship, the articles are largely cheerleading for the Milward decision.  The Milward plaintiffs’ partisan expert, Carl Cranor, has a paper here, as does a plaintiffs’ lawyer prominent in ATLA/AAJ.  The defense expert witnesses from Milward were not represented at the symposium in the symposium proceedings; nor were there any papers from defense counsel presented or published.  Of the six published papers, only Professor Sanders adopts a somewhat neutral stance towards Milward and the First Circuit’s embrace of Weight of the Evidence in analyzing Rule 702 issues. Cf. Elizabeth Laposata, Richard Barnes, & Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa L. Rev. 1 (2012) (arguing that tobacco lawyers influenced the American Law Institute’s Restatement process).

David Bernstein on the Daubert Counterrevolution

April 19th, 2013

David Bernstein has posted a draft of an important new article on the law of expert witnesses, in which he documents the widespread resistance to judicial gatekeeping of expert witness opinion testimony among federal judges.  Bernstein, “The Daubert Counterrevolution” (Mar. 11, 2013).  Professor Bernstein has posted his draft article, set to be published in the Notre Dame Law Review, both on the Social Science Research Network, and on his law school’s website.

Professor Bernstein correctly notes that the Daubert case, and the subsequent revision to Federal Rule of Evidence 702, marked important changes in the law of expert witnesses.  These changes constituted important reforms, which in my view were as much evolutionary, as revolutionary.  Even before the Daubert case, the law was working to find ways to improve expert witness testimony, and to downplay “authoritative” opining in favor of well-documented ways of knowing.  After all, Rule 702, with its emphasis on “knowledge,” was part of the Federal Rules of Evidence, as adopted in 1975.  Pub. L. 93–595, § 1, Jan. 2, 1975, 88 Stat. 1926 (effective July 1, 1975).  Since their first adoption, Rule 702 required that expert witnesses’ knowledge be helpful to the trier of fact.  By implication, the rule has always suggested that hunches, speculation, and flights of fancy did not belong in the court room.

Professor Bernstein certainly acknowledges that Daubert did not spring out of a vacuum.  Critics of judicial decisions on expert witnesses had agitated for decades to limit expert witness conduct by standards and guidances that operate in the scientific community itself.  The Supreme Court’s serial opinions on Rule 702 (Daubert, Joiner, Kumho Tire, and Weisgram) reflect the need for top-down enforcement of a rule, on the books since 1975, while many lower courts were allowing “anything goes.”

What is perhaps surprising, but well documented by Professor Bernstein, is that after four opinions from the Supreme Court, and a revision in the operative statute itself (Rule 702), some lower federal courts have engaged in a rearguard action against expert witness gatekeeping.  Professor Bernstein rightfully settles on the First Circuit’s decision in Milward as exemplifying a trend to disregard the statutory language and mandate for gatekeeping.  For Bernstein, Milward represents the most recent high-water mark of counterrevolution, with its embrace of errors and fallacies in the name of liberal, if not libertine, admissibility.

I suppose that I would go a step further than Professor Bernstein and label the trend he identifies as “reactionary.”  What is clear is that many courts have been willing to flout the statutory language of Rule 702, in favor of old case law, and evasive reasoning on expert witness admissibility.  Indeed, the Supreme Court itself joined the trend in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), when it unanimously affirmed the reversal of a trial court’s Rule 12(b)(6) dismissal of a securities fraud class action.  The corporate defendant objected that the plaintiffs failed to plead statistical significance in alleging causation between Zicam and the loss of the sense of smell.  The Supreme Court, however, made clear that causation was not required to make out a claim of securities fraud.  It was, and would be, sufficient for the company’s product to have raised sufficient regulatory concerns, which in turn would bring regulatory scrutiny and action that would affect the product’s marketability.

Not content to resolve a relatively simple issue of materiality, for which causation and statistical significance were irrelevant, the Supreme Court waxed on, in obiter dicta, about causation and statistical significance, perhaps unwittingly planting seeds for those who would eviscerate Rule 702.  See Matrixx Unloaded (Mar. 29, 2011).  Although the Supreme Court disclaimed any intention to address expert witness admissibility in a case that was solely about the sufficiency of pleading allegations, it cited three cases for the proposition that statistical significance was not necessary for assessing biological causation:

“We note that courts frequently permit expert testimony on causation based on evidence other than statistical significance. See, e.g., Best v. Lowe’s Home Centers, Inc., 563 F. 3d 171, 178 (6th Cir 2009); Westberry v. Gislaved Gummi AB, 178 F. 3d 257, 263–264 (4th Cir. 1999) (citing cases); Wells v. Ortho Pharmaceutical Corp., 788 F. 2d 741, 744–745 (11th Cir. 1986). We need not consider whether the expert testimony was properly admitted in those cases, and we do not attempt to define here what constitutes reliable evidence of causation.”

Id. at 1319.

Remarkably, two of the three cases were about specific causation, arrived at using so-called “differential etiology,” which presupposed the establishment of general causation.  These cases never involved general causation or statistical reasoning, but rather simply the process of elimination (iterative disjunctive syllogism).  The citation to the third case, Wells, was a notorious pre-Daubert, pre-Rule 702 revision case, revealed disappointing scholarship.  Wells involved at least one study that purported to find a statistically significant association.  What was problematic about Wells was its failure to consider the complete evidentiary picture, and to evaluate study validity, bias, and confounding, as well as significance probability.  See Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1 (Nov. 12, 2012).

Wells was an important precursor to Daubert in that it brought notoriety and disrepute to how federal courts (and state courts as well) were handling expert witness evidence.  Significantly, Wells was a bench trial, where the trial judge opined that plaintiffs’ expert witnesses seemed more credible based upon atmospherics rather than on their engagement with the actual evidence. See Marc S. Klein, “After Daubert:  Going Forward with Lessons from the Past,” 15 Cardozo L. Rev. 2219, 2225-26 (1994) (quoting trial testimony of trial testimony of Dr. Bruce Buehler: “I am sorry sir, I am not a statistician . . . I don’t understand confidence levels. I never use them. I have to use the author’s conclusions.” Transcript of Jan. 9, 1985, at 358, Wells v. Ortho Pharm. Corp., 615 F. Supp. 262 (N.D. Ga. 1985).

Given the Supreme Court’s opinion in Matrixx, the reactionary movement among lower courts is unsurprising.  Lower courts have now cited and follow the Matrixx dicta on statistical significance in expert witness gatekeeping, despite the Supreme Court’s clear pronouncement that it did not intend to address Rule 702.  See In re Chantix (Varenicline) Prods. Liab. Litig., 2012 U.S. Dist. LEXIS 130144, at *22 (N.D. Ala. 2012); Cheek v. Wyeth Pharm. Inc., 2012 U.S. Dist. LEXIS 123485 (E.D. Pa. Aug. 30, 2012).

Professor Bernstein’s article goes a long way towards documenting the disregard for law and science in this movement.  The examples of reactionary decisions could easily be multiplied. Take for instance, the recent Rule 702 gatekeeping decision in litigation over Celexa and Lexapro, two antidepressant medications.  Judge Rodney W. Sippel denied the defense motions to exclude plaintiffs’ principal expert witness, Dr. David Healy.  In re Celexa & Lexapro Prods. Liab. Litig.,  ___ F.3d ___, 2013 WL 791780 (E.D. Mo. 2013).  In attempting to support its decision, the court announced that:

1. Cherry picking of studies, and data within studies, is acceptable for expert witnessesId. at *5, *7, *8.

2. Outdated law applies, regardless of being superseded by later Supreme Court decisions, and the statutory revision in Rule 702Id. at *2 (citing pre-Joiner case:   “The exclusion of an expert’s opinion is proper only if it is so fundamentally unsupported that it can offer no assistance to the jury.” Wood v. Minn. Mining & Mfg. Co., 112 F.3d 306, 309 (8th Cir.1997) (internal quotation marks and citation omitted).”

3.  The Bradford Hill factors can be disregardedId. at *6 (citing In re Neurontin Mktg., Sales Practices, and Prod. Liab. Litig., 612 F. Supp. 2d 116, 133 (D. Mass. 2009) (MDL 1629), and In re Viagra, 572 F.2d 1071 (D. Minn. 2008)).

These features of the Celexa decision are hardly novel.  As Professor Bernstein shows in his draft article, disregard of Rule 702’s actual language, and of the post-Daubert Supreme Court decisions, is prevalent.  See, e.g., In re Avandia Marketing, Sales Practices & Prod. Liab. Litig., 2011 WL 13576 (E.D. Pa. 2011)(announcing that MDL district judge was bound to apply a “Third Circuit” approach to expert witness gatekeeping, which focused on the challenged expert witnesses’ methodology, not their conclusions, in contravention of Joiner, and of Rule 702 itself).

The Celexa decision pushes the envelope on Bradford Hill.  The two decisions cited downplayed Bradford Hill’s considerations, but did not dismiss them.  In re Neurontin Mktg., Sales Practices, and Prod. Liab. Litig., 612 F. Supp. 2d 116, 133 (D. Mass. 2009) (MDL 1629)(“Although courts have not embraced the Bradford Hill criteria as a litmus test of general causation, both parties repeatedly refer to the criteria, seemingly agreeing that it is a useful launching point and guide. Accordingly, this Court will begin its inquiry by evaluating Plaintiffs’ evidence of an association between Neurontin and suicide-related events, the starting point for an investigation under the criteria.”);  In re Viagra Prods. Liab. Litig., 572 F.Supp.2d at 1081 (“The Court agrees that the Bradford Hill criteria are helpful for determining reliability but rejects Pfizer’s suggestion that any failure to satisfy those criteria provides independent grounds for granting its Daubert Motion.”).

Of course, Sir Austin’s considerations were merely those that he identified in a speech to a medical society.  They were not put forward in a scholarly article; nor are his considerations the last word on the subject.  Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965).

Even as a précis, given almost 50 years ago, Hill’s factors warrant some consideration rather than waving them off as not a litmus test (whatever that means), followed by complete disregard for any of the important considerations in evaluating the causality of an association.

There was brief bright spot in this fairly dim judicial decision.  The district judge refused to exclude Dr. Healy on grounds that his opinion about particular studies differed from the authors’ own interpretations.  In re Celexa & Lexapro Prods. Liab. Litig.,  ___ F.3d ___, 2013 WL 791780, at *5 (E.D. Mo. 2013) (Sippel, J.).

That is the correct approach, even though there is language in Joiner that suggests that the authors’ views are dominant.  See Follow the Data Not the Discussion.  But the refusal to discount Healy’s opinions on this ground was done without any real inquiry whether Healy had offered a valid, competing interpretation of the data in the published studies.

At the core of the reactionary movement identified by Professor Bernstein is an unwillingness, or an inability, to engage with the scientific evidence that is at issue in various Rule 702 challenges.  Let’s hope that Bernstein’s article induces closer attention to the law and the science in future judicial gatekeeping.

Conspiracy Theories: Historians, In and Out of Court

April 17th, 2013

“The United States has long been a breeding ground for conspiracy theorists… .”  It did not take long for conspiracy theories surrounding the tragedy in Newtown, Connecticut, to circulate.  Lee-Anne Goodman, “Latest American conspiracy theory claims Newtown mass shooting a hoax” (Jan. 15, 2013) (Associated Press) (“Sandy Hook Truthers, as they’ve been dubbed, believe last month’s mass shooting in Newtown, Conn., was a hoax”).  And the tragedy of the Boston marathon bombing gave rise to conspiracy theories within hours of the horror.  Meghan Keneally, “Conspiracy theorists claim Boston was ‘false flag’ attack arranged by the government” (April 17, 2013) (“false flag” staged attack); Amanda Marcotte, “The Boston Marathon Bombing Could Become a Conspiracy Theory Hotbed” (April 16, 2013).

Conspiracy theories are not confined in the United States to the lunatic fringe; nor are they the creatures of internet fantasies.  Conspiracy theories inundate our courts, and occasionally make for a rattling good yarn from academic writers. A couple of years ago, I wrote about historians of occupational health and safety as particularly susceptible to the lure of conspiracy theories.

Professors Rosner and Markowitz, historians of silicosis, certainly come to mind:

“In the postwar era, professionals, industry, government, and a conservative labor movement tried to bury silicosis as an issue.”

David Rosner & Gerald Markowitz, Deadly Dust:  Silicosis and the Politics of Occupational Disease in the Twentieth Century America 213 (Princeton 1991).  This is a remarkable group libel of scientists, physicians, industrialists, and labor union leaders. Perhaps readers may infer that the unions branded “conservative” are the ones not committed to Marxist-Leninist principles, such as the Western Federation of Miners, later known as International Union of Mine, Mill, and Smelter Workers.  In their book, Rosner and Markowitz singled this union out for its for heroic resistance to the putative conspiracy of government, academics, scientists, industry, and the non-Communist-influenced labor movement.

Reality is often much less glorious than speculative conspiracy theories.  Professor Beth J. Rosenberg, an Assistant Professor, in the Department of Public Health & Community Medicine, in Tufts University School of Medicine, Boston, Massachusetts, is an unabashed activist.   She has championed workers’ safety and rights.  She has tried, but failed, to organize workers and unions in Massachusetts over the real hazards of abrasive sandblasting, only to find that their concerns lay elsewhere.  Beth Rosenberg, “Second Thoughts About Silicosis,” 13 New Solutions 223 (2003).

“The main point here is that the men I’ve interviewed are not terribly concerned about silica dust. They care about being treated decently and respectfully by their bosses. They’re concerned about being encouraged to work too fast to work safely. They care about lead dust, particularly bringing it home to their families, so they get really angry when the foreman wants to lock up the yard at five o’clock and doesn’t leave them enough time to shower and change their clothes. They feel that they are expendable. And although most are fully aware of silica’s dangers, silica is not a top priority for them. The silica agenda was set by some physicians and health professionals who are outraged that anybody is still dying of this 100 percent preventable disease. This is understandable, and I am one of those people, but I’m not sure this is the best way to be of service. I see that there are other, more pressing issues than silica.

Id. at 229 (emphasis added).  See also  CDC, “Ten Great Public Health Achievements – United States, 1900 – 1999,” 48(12) CDC Morbidity and Mortality Weekly Report 241 (April 02, 1999)(“Work-related health problems, such as coal workers’ pneumoconiosis (black lung), and silicosis — common at the beginning of the century — have come under better control.”).

Is there any substance to the claim that everyone, after the Great Depression, other than a few radical labor leaders, tried to bury the issue of silicosis?  As I have noted, we can find some objective indication of continued interest in silicosis from the number of publications in the National Library of Medicine’s database (PubMed) on silicosis.  A simply search on “silicosis,” with limits to each decade after the 1930s reveals a pattern that silicosis had not been buried at all:

Date Range                    Number of Articles from Keyword Search

1940 – 1949                      113

1950 – 1959                    1,421

1960 – 1969                    1,867

1970 – 1979                    1,178

1980 – 1989                       940

1990 – 1999                       882

2000 – 2009                      843

To be sure, the low count in the 1940s likely results from the lack of coverage of publications in the database, as well as the growth in the number of biomedical journals after the 1940s.  The Post-War era certainly presented distractions in the form of other issues, including the development of antibiotics, chemotherapies for tuberculosis, the spread of poliomyelitis and the development of vaccines for this and other viral diseases, radiation exposure and illnesses, tobacco-related cancers, and other chronic diseases.  Given the exponential expansion in scope of public health, the continued interest in silicosis after World War II, documented in the PubMed statistics, is remarkable.

Recently, in my own blog reading, I came across a post by David Oliver on the use of Google’s database of digitized books to create charts of word hits in this digital library.  See David Oliver, Fun With Google Books’ Ngram Viewer (Dec. 17, 2010).  Oliver hypothesizes that the number of times that a word appears in the database of over 5 million books is a reasonable proxy for identifying the active interests and concerns of society.  Google labs offers the opportunity to run this search as a function of year, and to produce a chart that reflects the prevalence of the keyword over time.

With David Oliver’s permission, here charts he prepared, using Google labs, for two very different diseases, mesothelioma and silicosis, with their very different levels of interest and concern among various writers:

* * * * * * * * * * *

 

 * * * * * * * * * * *

 

* * * * * * * * * * *

This Google tool may be incomplete and imperfect, but it shows, along with the PubMed database, that it may well be time to look for more objective bases for historical opinions, both in court and in academia.

 

Washington Supreme Court Illustrates the Difference Between Frye and Rule 702

April 15th, 2013

Last month, the Washington Supreme Court decided a public and private nuisance case against a local utility for fear of future illnesses from exposure to electro-magnetic frequency radiation (EMF).  Lakey v. Puget Sound Energy, Inc., ___ Wn. 2d ___ , 2013 WL 865468 (Mar. 6, 2013).

The defendant utility and local municipality had moved for the exclusion of plaintiffs’ expert witnesses, under Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923), and the Washington state version of Rule 702.  The plaintiff homeowners submitted declarations from two expert witnesses, Dr. De Kun Li and and Dr. David Carpenter.

Dr. Carpenter was the Director of the Institute for Health and the Environment at the University at Albany and a Professor of Environmental Health Sciences within the School of Public Health. He also has held the position of Dean of the School of Public Health at the University of Albany and the Director of the Wadsworth Center for Laboratories and Research of the New York State Department of Health.  Dr. Carpenter apparently has been active in testifying about EMF health issues.  See, e.g., Amended Declaration of David Carpenter (2011).

The trial court conducted a three-day Frye hearing, at which both sides offered expert witness testimony.  Plaintiffs called Carpenter, and the defendants called Dr. Nancy Lee, an epidemiologist, and Dr. Mark Israel, a professor at Dartmouth’s Geisel School of Medicine, and a specialist in the molecular and cellular biology of brain tumors.

At the hearing, Dr. Lee testified that Carpenter had failed to follow generally accepted epidemiologic methodology of considering all pertinent data.  Carpenter had “cherry picked”; his opinion selectively ignored studies that contradicted his conclusions.  Even among the studies that Carpenter had relied upon, he ignored data that undermined or contradicted his conclusion.  Slip op. at 6.  Furthermore, Carpenter ignored the toxicologic data and studies available. Id.  Among the studies ignored by Carpenter were the most recent, and most carefully conducted, studies. Id.  The trial court excluded Li and Carpenter, and the plaintiffs appealed.

Affirming the exclusion, the Supreme Court of Washington engaged in a curious two step.  The Court reversed the trial court’s exclusion on Frye grounds.  In Supreme Court’s view, the plaintiffs’ witnesses sufficiently deployed a generally accepted method when they waded into the field of epidemiology because epidemiology is generally accepted.  The Frye doctrine does not require that expert witnesses apply the established methodology well, reliably, or soundly.  The expert witnesses are immunized from exclusion by relying upon studies from a generally accepted discipline, no matter how poorly or selectively they have analyzed and interpreted these studies.  An expert witness’s errors in engaging with a particular scientific discipline that is in general considered generally accepted “go to the weight, not the admissibility, of the evidence unless the error renders the evidence unreliable.” Slip op. at 11.

Carpenter’s cherry-picking approach to data and studies, however, was properly excluded under Rule 702.  Carpenter’s approach vitiated the reliability of his opinion with the consequence of :

“seriously tainting his conclusions because epidemiology is an iterative science relying on later studies to refine earlier studies in order to reach better and more accurate conclusions. Carpenter refused to account for the data from the toxicological studies, which epidemiological methodology requires unless the evidence for the link between exposure and disease is unequivocal and strong, which is not the case here. Carpenter also selectively sampled data within one of the studies he used, taking data indicating an EMF-illness link and ignoring the larger pool of data within the study that showed no such link, Carpenter’s treatment of this data created an improper false impression about what the study actually showed.”

Slip op. at 12.

So that’s the difference between Frye and Rule 702!

Further Musings on U.S. v. Harkonen

April 15th, 2013

Epistemic Crimes

In U.S. v. Harkonen, the government prosecuted a physician, company CEO, for issuing a press release that stated a clinical trial “demonstrated” benefit when the government believed that the clinical trial was inconclusive.  No doubt the government was intent upon punishing what it thought was off-label promotion in the same press release, but the jury acquitted on the charge of misbranding, and convicted on the wire fraud count.  The trial court denied post-trial motions, and recently, the United States Court of Appeals, for the Ninth Circuit, affirmed, in an unpublished per curiam opinion.  United States v. Harkonen, No. 11-10209, No. 11-10242, 2013 WL 782354, 2013 U.S. App. LEXIS 4472 (9th Cir. March 4, 2013).

A Gedanken Experiment

An expert witness writes a report that X, a drug therapy, causes Y, a benefit in survival, for a disease, Z.

The expert witness sent his report by email, and regular mail, to counsel, who then served it upon his adversary.  The report set out some of the support for the opinion, as follows.

The expert witness relied upon a randomized clinical trial, conducted with one primary and nine secondary endpoints.  The multiple endpoints were chosen because of uncertainty of how the anticipated benefit would manifest.  Mortality (survival), although obviously a very important endpoint, was not made primary endpoint because the scientists who conducted the trial did not anticipate sufficient deaths over the course of the trials to see a statistically significant benefit.

This clinical trial had surprising results. Although the trial did not show a difference on the primary endpoint, a composite defined in terms of various pulmonary functional changes or death, the trial did “demonstrate,” according to the witness, a survival benefit.  Indeed, the survival benefit was clinically significant.  Patients randomized to therapy experienced a 40% decrease in mortality, compared to those randomized to placebo. (p = 0.084).  The expert witness pointed out, in his report, that the survival benefit was even stronger in a subgroup of the clinical trial, which consisted of the patients who had mild- to moderate-disease at the time of randomization.  For this subgroup, the decrease in mortality was even more dramatic, 70%, p = 0.004.  The witness’s report did not clearly label this subgroup as “post-hoc,” although a discerning reader might well have assessed it as such.

The expert witness was not relying upon only one clinical trial.  His report identified an earlier trial, published in a leading clinical medical journal, which reported benefit from the drug, p < 0.001.  This trial was extended, with continuing strong evidence of differential survival.  In terms of survival at five years, the earlier trial showed survival in the therapy group at 77.8%, compared to 16.7% in the control groups, p = 0.009.

The expert witness’s report did not explicitly reference clinical experience, or the in vitro and in vivo mechanistic evidence that the therapy, X, plays a role in inhibiting processes that are clearly involved in producing the disease, Z.  The expert witness could have written a stronger expert witness report with these references, but did not expect that this level of completeness was required.  The expert witness did note that he would marshal the data in more detail at a later time. The expert witness further relied upon the assessment of the principal investigator of the later clinical, who had written that the benefit against mortality of X was “compelling,” and that the finding was “a major breakthrough.”  The principal investigator of the trial noted that X was “the first treatment ever to show any meaningful clinical impact in this disease in rigorous clinical trials, and these results would indicate that [X] should be used early in the course of this disease in order to realize the most favorable long-term survival benefit.”  The report went on to note, accurately, that there are no FDA-approved therapies for Z.

Adversary counsel, receiving this report, moved pursuant to Federal Rules of Evidence 702 and 703, to exclude the expert witness’s report and his opinions.  The motion to exclude was made in advance of the deposition, and without a preliminary motion for more detail about the supporting data.  In particular, the motion to exclude claimed that the expert witness was unjustified in concluding that a benefit had been “demonstrated,” as opposed to being merely suggested.

What would be the challenger’s chances of success on the Rule 702 motion?  The outcome, Y, was not “statistically significant” at the conventional two-tail 5% (but would have been on a one-tail test).  The subgroup that sported a p-value of 0.004 was not clearly marked as a post-hoc subgroup, although the challenger could discern that it was likely exploratory, and challenged it as uncorrected for multiple testing.  The challenger, however, did not attempt to offer a modified p-value that took into account of multiple testing.  The essence of this challenge was that the expert witness’s statement that a benefit had been “demonstrated” was not supported by sufficient evidence, and that the low p-value of 0.004 was not truly “significant” because the result emerged from an analysis that was not pre-planned.

My hunch, based upon published judicial opinions on both state and federal Rule 702 motions, is that many judges would allow the challenged expert witness to testify.  There would be the usual judicial hand waving about the challenge’s going to the weight not the admissibility of the expert witness’s opinion.  Perhaps an occasional judge might order additional discovery.  I believe that most judges would not find that this expert witness had engaged in pathologically bad science such that the party proponent should be denied its expert witness.

Transmuting Disputed Causal Inferences Into Criminal Fraud

Instead of moving to exclude the expert witness’s opinion, why not turn the report over to the U.S. Attorney’s office to prosecute for wire or mail fraud?  Even if a trial court were to brand the opinion “inadmissible,” that outcome would hardly suggest that the opinion was the kind of speech that could qualify as fraudulent under federal wire or mail fraud statutes. Branding a scientist as a fraudfeasor, however, was exactly the result reached in U.S. v. Harkonen, where the Ninth Circuit upheld a wire fraud conviction of a physician whose written statements would likely have been admissible in most federal courtrooms, under Federal Rule 702.  As much as I would like to see more stringent gatekeeping of expert witness opinions, there is something unseemly about the government’s efforts here to criminalize scientific opinions with which it disagrees.

Dr. Harkonen has petitioned the Ninth Circuit for reconsideration, in a brief filed by attorneys, Mark Haddad and colleagues, of Sidley Austin.  Petition for Rehearing En Banc (filed 29, 2013).  The case raises important First Amendment and due process issues, which were addressed by the party and amici briefs before the Panel.

The case also raises the specter of prosecutions of scientists for speech in various contexts, including grant applications and reports, under the False Claims Act, for witness perjury for testimony in judicial, administrative, or legislative proceedings, or for wire or mail fraud for manuscript submissions to journals. On April 8th, Professor Robert Makuch, of Yale University, Professor Timothy Lash, of Emory University, and I filed an amicus brief, which addresses the government’s controversial branding statements “false as a matter of statistics.” The government has gone from one extreme of painting, broad brush, that statistical significance is not important or necessary (in Matrixx Initiatives Inc. v. Siracusano), to the other extreme that statistical significance is so important that a scientist who his opinion on causality on evidence the government believes is not statistically significant has committed fraud (in Harkonen).  Both extreme positions are untenable.

Gatekeeping in Allen v. Martin Surfacing — Postscript

April 11th, 2013

Back in November 2012, I wrote a review and analysis of a district court’s handling of Rule 702 challenges to expert witness opinions, in a case involving a tragic ALS death, Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009).  See Bad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing (Nov. 30, 2012).

I received correspondence from one of the plaintiffs’ expert witnesses, Dr. Marcia Ratner, who was not entirely happy with my discussion of the Allen case.  Suffice it to say, on the medico-legal issues, we do not have much common ground for agreement.  Dr. Ratner, however, asked me to update my post by noting two facts:

1.  First, plaintiffs’ counsel had asked her to testify that solvent fumes, including toluene, had caused Mr. Allen’s ALS, and she refused.  She was unwilling to acquiesce in their request, and she testified only about acceleration of onset.

2.  Second, Dr. Ratner objected to my including the colorful comments about her brush with the law.  My report was factual and documented, but I am sympathetic.  Dr. Ratner would have me note that she is a registered Republican and a staunch defender of Second Amendment rights; her arrest result when she “inadvertently stepped into a liberal trap when [she] came down [to Massachusetts] from Vermont.”

As a lawyer, I am indeed sympathetic to anyone who has truly stepped into a trap.  As for the Allen case, the matter settled, and so there never was a chance to see how a jury would react to the various theories in the case.  More important, there never was appellate judicial review of the gatekeeping efforts.

UC Davis Daubert Symposium

March 28th, 2013

Earlier this month, I wrote about a Symposium on Daubert at the University of California Davis School of Law.  The UC Davis Law Review has now published the proceedings of the Symposium, including a transcript of the direct and cross-examinations of the mock expert witnesses:

Symposium — The Daubert Hearing: From All the Critical Perspectives

 

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