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The Not-So-Elite Defense Bar’s Approach to Gatekeeping

January 2nd, 2014

A couple of months ago, Professor David Bernstein posted to the Volokh Conspiracy, a short piece about some of the missteps and mistakes committed by “elite defense counsel” in litigating expert witness issues.  See David Bernstein, “The Elite Defense Bar and Expert Evidence” (Nov. 6, 2013).  Professor Bernstein makes some interesting points about questionable positions taken by “elite defense counsel” (read: “highly paid, large firm lawyers”).  For instance, according to Bernstein:

1. elite defense lawyers missed the boat early on by arguing that statistical evidence (observational epidemiology) was inadmissible or insufficient to prove general or specific causation;

2. defense counsel missed the significance of the Supreme Court’s opinion in Daubert;

3. defense counsel continued to press for Frye rule in state courts, although the Frye rule had been shown inadequate and unavailing as a rule to control medical causation opinions; and

4. defense bar has grown soft on Rule 702.

Although the charges seem at points overstated, Bernstein has presented an important indictment of the defense bar.  At the very least, the charges deserve a full exploration by a wider audience. Defense lawyers who are self-critical about their practice should certainly be concerned that someone as persistently pro-702 has taken aim at them.

On the first point, many of the early scientific causation battles were fought in tobacco litigation, in which defendants and their counsel were forced to deny and contest the obvious, the causal role for tobacco in carcinogenesis, at all costs.  The tobacco defense bar, however, should not be confused with the defense bar, generally.  Defense lawyers in Bendectin, silicone, and asbestos cases developed arguments against specious use of epidemiologic evidence, as well as sophisticated, affirmative use of epidemiologic evidence to show lack of association.  Even so, we should keep in mind that it often requires a large body of epidemiologic evidence to show “no association,” and it is not the defense’s burden to do so. 

The use of statistical or probabilistic evidence for inferring specific causation has been, and remains, problematic. See, e.g., Richard Doll, “Proof of Causality: Deduction from Epidemiological Observation,” 45 Perspectives in Biology & Medicine 499, 500 (2002) (“That asbestos is a cause of lung cancer in this practical sense is incontrovertible, but we can never say that asbestos was responsible for the production of the disease in a particular patient, as there are many other etiologically significant agents to which the individual may have been exposed, and we can speak only of the extent to which the risk of the disease was increased by the extent of his or her exposure.”) Notwithstanding the controversy, defense counsel and some astute judges have understood the indeterminate nature of statistical evidence for specific causation, and have advanced a pragmatic position of resolving specific causation controversies against plaintiffs when risk ratios failed to exceed two. See, e.g., In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 836 (E.D.N.Y. 1984) (“A government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship.  A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him. … This means that at least a two-fold increase in incidence of the disease attributable to Agent Orange exposure is required to permit recovery if epidemiological studies alone are relied upon.”), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988).

Early use of meta-analysis by plaintiffs’ expert witnesses elicited generalized attacks on meta-analysis by defense counsel.  See, e.g., In re Paoli Railroad Yard PCB Litigation, 706 F. Supp. 358, 373 (E.D. Pa. 1988) (Kelly, R., J.) (excluding plaintiffs’ expert witness Dr. William Nicholson and his testimony based upon his unpublished meta-analysis of health outcomes among PCB-exposed workers), rev’d 916 F.2d 829, 856-57 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991).  Again, it took some time for the defense to understand the potency of meta-analysis in synthesizing and presenting a summary point estimate that essentially rules out any meaningful play of chance. In the silicone gel breast implant litigation, one defense expert witness conducted and published his meta-analysis of autoimmune disease outcomes. Otto Wong, “A Critical Assessment of the Relationship between Silicone Breast Implants and Connective Tissue Diseases,” 23 Regulatory Toxicol. & Pharmacol. 74 (1996).  When the MDL 926 court got around to appointing court-appointed expert witnesses, they too picked up on the approach and made meta-analyses the hallmark of their reports. See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction:  A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998)”; Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000).

On the second charge, many defense lawyers missed, and continue to miss, the significance of a shift to evidence-based scientific testimony, as opposed to the authority-based worldview.  When I first started trying cases, senior trial lawyers instructed me not to engage plaintiffs’ expert witnesses on substantive issues, but to limit cross-examination to “collateral attack” on bias and related issues.  The problem that I saw was that when both sides limited the attack to the other side’s expert witness’s bias, the plaintiffs won because juries were often all too willing to think the worst of defense experts, and forgive plaintiffs’ experts.  Nothing short of dramatically confronting the jury with the rubbish, inconsistencies, and incoherence spouted by the plaintiffs’ expert witnesses worked.  I quickly learned to ignore the old timers’ advice, and most of them have now dropped off.

Bernstein gives the example of the Dow Corning lawyers’ declining the Ninth Circuit’s invitation to reframe their appeal in Hopkins v. Dow Corning, 33 F.3d 1116 (9th Cir. 1994), after the Supreme Court handed down Daubert.  He may well be right about that case, but the lawyers may have been inhibited by positions that they had taken earlier in the case, before the Supreme Court breathed life into Rule 702.  Still, the Hopkins decision remains a derelict on the jurisprudential sea of expert witness law. Truth be told, there are other cases that turned out badly because of overstated or poorly framed defense arguments. 

As for their persistent affection for Frye, the defense lawyers referenced by Bernstein certainly lacked imagination, and maybe even a full measure of zeal.  The Frye case had never proven itself to be an important defense against specious expert witness opinion testimony on medical causation issues.  Daubert held out the promise that trial judges would actually have to engage with the evidence, rather than counting noses for “general acceptance,” or kicking the can, after hearing qualifications. I still recall how my colleagues and friends viewed Daubert, in 1993.  Bristol Myers Squibb and other companies were inundated by silicone breast implant cases, and plaintiffs had managed to snucker a few juries into returning large verdicts against the defendants.  Daubert was a lifeline, a way to focus trial judges’ attention on the plaintiffs’ expert witnesses and the fatally flawed, even fraudulent scientific studies that had found their way into the peer-reviewed journals, and into the courtroom.

What has happened to Daubert?  Well, of course, it is no longer Daubert, but now a much more potent statutory rule, Federal Rule of Evidence 702, as amended in 2000, and recently “restylized.”  Professor Bernstein may be on to something in calling out the hubris of big firm lawyers, who think that their prowess in  litigating scientific issues comes from charging high fees.  The sad truth is that the level of scientific and statistical acumen of lawyers generally, whether at the bench or at the bar, is low.  There is much work for law schools to do to change this situation. 

There are other forces at work in creating the phenomena described by Professor Bernstein.  Many product liability cases involve multiple defendants.  Defending such cases from the defense perspective is often like herding house cats.  Every defense counsel thinks he or she knows the best course; no one wants to do anything that raises the profile of his client or increases the cost of defense. Furthermore, products liability defense work has become increasingly “commoditized” in the last two decades.  Clients and third-party payors increasingly impose budgets that do not allow defense lawyers sufficient time to develop the necessary expertise and learning to discover, understand, and challenge plaintiffs’ scientific expert witnesses fully and effectively. There is, sadly and unfortunately, a contingent of defense lawyers who would rather see speculative claims flourish and mature into full-scale litigation, with lots of trials and appeals (and large fees), than to see specious claiming pretermitted by pre-trial judicial gatekeeping.

Another factor that may have stunted the gatekeeping process is the growth of federal (and state) multi-district litigation (MDL).  By centralizing the pre-trial handling of large, multi-plaintiff tort litigation in the hands of a single judge, the MDL process has raised the stakes for the trial judge gatekeeping.  The MDL judge is no longer deciding a single case, but the fate of thousands of claimants.  The Rule 702 process suffers in several ways.  First, many MDL judges are clearly intimidated by the life-or-death control they have over hundreds, if not thousands, of claims.  These judges may well now be inclined to deny the Rule 702 challenges, in the fond hope that juries and appellate courts will take care of the problem. Second, there is no longer the incremental decision making of case-by-case exploration of the issues.  There are economies of scale, to be sure, but the single MDL judge cannot learn from previous trial judges’ decisions and records.  The evolutionary approach of the common-law is undermined by the efficiencies of MDL procedure. Third, the MDL process blunts one of the virtues of judicial gatekeeping in requiring the transparent statement of reasons for the grant or denial of a Rule 702 motion to exclude expert evidence.  By the time the scientific, legal academic, and legal practitioner communities can weigh in on the gatekeeping process, the Rule 702 decision is a fait accompli, in the form of a single judicial decision. Compare  In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.) (denying defendant’s Rule 702 motions with respect to plaintiffs’ expert witnesses’ opinions that Avandia causes heart attacks) with “FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2013) (re-evaluating evidence that Avandia does not increase risk of heart attacks).  See also “Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011).

Not surprisingly, plaintiffs’ counsel have gotten better at dressing up weak and fatally flawed evidence as “inference to the best explanation,” or “weight of the evidence” evaluations that have the appearance without the reality of scientific conclusions. And as evidenced by the Third Edition of the Reference Manual on Scientific Evidence, and many recent 702 decisions in the Circuits (and Matrixx Initiatives in the Supreme Court), the federal judiciary has lost its will and its way in applying Rule 702. An activist core of federal trial and appellate courts have shown increasing hostility and outright disregard for the gatekeeping process, and a willingness to disregard the language of the statute, Supreme Court precedent, and sound scientific and statistical methodology.  Rule 702 in its present form is a strong rule, but unfortunately it is neutralized in the hands of weak judges who cannot or will not explore the intricate methodological issues raised by Rule 702 and 703 motions.

The phenomenon identified by Professor Bernstein may be real, but like many natural (and unnatural) phenomena, the causes are not always easily discerned. The phenomenon and its causes are worth a deeper exploration.

Posted in Expert Witnesses, Rule 702 | Comments Off on The Not-So-Elite Defense Bar’s Approach to Gatekeeping

Gastwirth on the Wells Case

December 27th, 2013

One of the high points of 2013 for me was the Practicing Law Institute seminar on expert witness gatekeeping.  I am indebted to my co-chair David Cohen, and the talented participants, Dr. David Garabrant, Joe Cecil, Mary Wells, and Mike Williams.  I learned a great deal from all of them, even when we disagreed.

At the seminar, which addressed the slippage in the federal judiciary’s fidelity to Rule 702 text and principles, Joe Cecil kindly reminded me of Professor Gastwirth’s contribution on the Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262, 298 (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).  Joseph L. Gastwirth, “The need for careful evaluation of epidemiological evidence in product liablility cases: a reexamination of Wells v. Ortho and Key Pharmaceuticals,” 2 Law, Probability and Risk 151 (2003).

The Supreme Court recently reinvigorated the Wells case, and like Frankenstein’s monster, it walks again.  Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011).  See also “Matrixx Unloaded.”  As a result of the Matrixx decision, I revisited the untoward Wells decision several times this year. See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; and here, here, here, here, and here.  Joe’s reminder, however, provoked me to look one more time at Wells, through the lens of Gastwirth’s review.

Gastwirth is a well-known statistician, not a lawyer.  His article undertakes some interesting sensitivity analyses of the potential role of one known confounder in the epidemiologic studies of spermicides and birth defects, cited by witnesses in Wells. Not surprisingly, Gastwirth confuses important legal concepts, when he contends that science and law have different goals because science has the luxury of waiting for additional studies to resolve indeterminate datasets.  Gastwirth at 154. Gastwirth suggests that in law, causality determinations turn on fairness, but in science, they turn on the truth.  Gastwirth offers no support for his assertion, and there is much law to the contrary.  Federal Rule of Evidence 102, for instance, explains the “Purpose” of the Federal Rules and how they should be construed:

“These rules should be construed so as to administer every proceeding fairly, eliminate unjustifiable expense and delay, and promote the development of evidence law, to the end of ascertaining the truth and securing a just determination.”

Truth does count, at least in some courts, and it is hard to imagine a case in which the goals of truth and justice are bifurcated. Gastwirth sees law courts as unable to avoid judgment when the evidentiary display is weakly developed or not replicated, but he is wrong.  Courts can, do, and should avoid permitting judgments based upon indeterminate datasets.

Gastwirth also contends that the duty to warn in tort is based upon a possibility of causation, and he opines that this is perfectly satisfactory.  Gastwirth at 155.  Gastwirth cites the Restatement (Third) a/Torts for his view, but the Restatement does not couch the duty to warn as predicated upon merely possible risk:

“A defendant will not be liable under an implied warranty of merchantability for failure to warn about risks that were not reasonably foreseeable at the time of sale or could not have been discovered by way of reasonable testing prior to marketing the product. A manufacturer will be held to the standard of knowledge of an expert in the appropriate field, and will remain subject to a continuing duty to warn of risks discovered following the sale of the product at issue.”

Id. (emphasis added).  Gastwirth fails to explain why the epistemic standard of the Restatement should be diluted to include merely possible risks; nor does he explain why the law should impose a duty because a minority of so-called experts claim knowledge of the existence of a risk, whether potential or known.

Risks are based upon known causal relationships, viewed ex ante rather than post hoc.  Gastwirth attempts to defend the Wells decision on the basis that the trial judge, Judge Shoob, could have correctly found a possible risk, but this was not then or now the standard for imposing a duty to warn.  Even if possibilities were the basis for a duty to warn, the courts in Wells had to find sufficient evidence of cause in fact between the spermicidal jelly and the birth defect present in the infant plaintiff.  No merely possible risk could have satisfied this burden, and Gastwirth avoids this important issue in his review.  Ultimately, Gastwirth fails to come to grips with how the Wells courts artificially distinguished two causation standards – warning-harm and product-harm.  Gastwirth at 184.

When courts are required to work with an epistemic standard for evaluating opinions about causal claims, they will often confront sincere beliefs supported by “putative” justifications, but which turn out to be untrue.  The obvious implication is that the causal opinions were not “true” when offered, and the asserted, putative justification was no justification at all.  Twenty years post-Daubert should have made our courts more sensitive to the pathology of claiming, or pathoepistemology, as I call it.

Although Gastwirth is intent to show that the district and circuit court decisions in Wells were reasonable given the record evidence at the time of their decisions, Gastwirth’s defense is tepid at best. Gastwirth concedes that the plaintiffs’ evidence in the Wells case was not very convincing, and he is quick to point out that he does not conclude that spermicides cause limb reduction defects (although he does believe that the data were sufficient for his idiosyncratic diluted duty-to-warn legal standard:

 “The epidemiological evidence in the Wells case surely was not very convincing and it is understandable that scientists and legal scholars might desire stronger scientific evidence before holding a defendant liable. What seems unfortunate is the lack of discussion of the part of the record most supportive of the legal decisions from the published criticisms.201 While it is reasonable to ask how much evidence should be required before a warning is required, is it fair to rely on studies that were published after the time of exposure to assess the producer’s duty at the time?”

Gastwirth at 184-85.  The equivocation in this passage between assessing causation for a duty to warn and for product harm is typical of Gastwirth’s confusion throughout this article.  As noted, Gastwirth appears to believe it is sufficient to show the plausibility of the causal relationship such that the trial court’s findings of a duty to warn, and a breach of that duty, were reasonably supported:

“It should be stressed that our examination of the studies does not conclude that exposure to spermicides causes limb reduction defects. 202 Indeed, the studies published in the 1980s are sensitive to the potential effect of unmeasured known potential risk factors that were not controlled for in the analysis. Many studies observed that it is difficult to rule out small but meaningful risks given their sample size or that more studies including potential confounding variables be carried out before a scientific conclusion can be reached.203”

Gastwirth at 185 & n.202.  So small increased risks were difficult to rule in or rule out, but then how can a judgment for plaintiffs be sustained unless, as I have shown elsewhere, Judge Shoob improperly placed the burden of proof upon the defendant?  The studies published in the 1980s may have been sensitive to the potential effect of unmeasured and uncontrolled known potential risks, but Judge Shoob clearly was not sensitive to the problem at all.

Other problems abound. The studies involved in the Wells case not only failed to account for the few known confounders at the time, but they could not and did not sort out the residual confounding.  Gastwirth concedes the point in a footnote, in which he cites a paper by Professor Gary Shaw on the role of multivitamin use in preventing birth defects. See Gastwirth at 185 & n. 202 (citing Shaw et al., “Maternal Periconceptional Use of Multivitamins and Reduced Risk for Conotruncal Heart Defects and Limb Deficiencies Among Offspring,” 59 Am. J. Med. Genetics 536 (1995) (showing that children of mothers who had taken vitamins and folic acid had a 30-35% lower risk of limb defects).  Gastwirth sees the discovery of causes not previously controlled for in the spermicide/birth defect studies of the 1980s as example of the differences between scientific and legal judgments.  Another way to look at such discoveries is to impose some standard of intellectual modesty upon courts in basing their findings upon speculative causal claims.

Gastwirth’s casual dismissiveness of the need for replication in a legal standard of causation is difficult to square with his acknowledgment that early studies often prove misleading about the existence of a true risk.  Gastwirth, for instance, acknowledges that later publications quite commonly do not support initial hypotheses.  Gastwirth at 179, 184 (citing Michael B. Bracken, “Spermicidal Contraceptives and Poor Reproductive Outcomes: The Epidemiologic Evidence Against an Association,” 151 Am. J. Obstet. & Gyncecol. 552, 555 (1985)).  Gastwirth channels the anti-manufacturer Zeitgeist for his claim that “firms” may not report studies that show risk, but he ignores the pervasive, prevalent practice of academic and advocacy scientists’ not publishing negative studies in the first place, and even later in the natural history of scientific controversies.

Ultimately, however, Gastwirth’s own judgment is a self-fulfilling prophecy of how the law and science should part company over false-positive assertions of causality.  Fortunately, the law has evolved in a different direction, towards convergence of scientific and legal modes of assessing causal claims.  Now judges must evolve as well.

Posted in Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Gastwirth on the Wells Case

How Law Professors Think — About Expert Evidence

December 19th, 2013

In a recent law review article, two University of Virginia law professors question whether expert evidence should be subject to its own exclusionary rules.  Frederick Schauer and Barbara A. Spellman, “Is Expert Evidence Really Different?” 89 Notre Dame L. Rev. 1 (2013)[Schauer & Spellman]. Professors Schauer and Spellman argue that expert evidence is not really different from other kinds of evidence, and they suggest that the exclusionary procedures introduced by Daubert and its progeny are ill conceived.

Gedankenexperiment

In order to understand the exact nature of the harms of “junk science,” the authors conduct an interesting Gedanken experiment:

“Suppose ten witnesses testify that they had never been sick a day in their lives, that they then moved in middle age to a community in close proximity to a defendant’s chemical plant, and that they were all diagnosed with the same form of cancer within a year. And suppose that this is the only evidence of causation.”

The authors conclude that this evidence is relevant under Federal Rule of Evidence 401, and sufficient to raise a triable issue of fact.  From their conclusion, the authors argue further all the dangers of mass tort causation evidence are independent of junk science because a jury would be free to reach a verdict for plaintiffs based upon pure sympathy, anti-corporate animus, white-hat bias, or Robin Hood motives.  The authors see, in their hypothetical, a jury reaching a judgment against the defendant

“regardless of any strong evidence of causation, and without any junk science whatsoever.”

Schauer and Spellman’s conclusions, however, are wrong.  Their hypothetical evidentiary display is not even minimally logically relevant.  They are correct that there is no strong evidence of causation, but whence comes the conclusion that no “junk science” would be involved in the jury’s determination?  That determination would not have even the second-hand support of an expert witness opinion, but it would be jury’s first-hand, jejune interpretation of a completely indeterminate fact pattern.

These authors, after all, do not specify what kind of cancer is involved. Virtually no cancer has an induction period of less than a year.  Their hypothetical does not specify what chemicals are “released,” in what route of exposure, in what level, and for what duration. Furthermore, the suggestion of logical relevance implies that the described occurrence is beyond what we would care to ascribe to chance alone, but we do not know the number of people involved, or the baseline risk of the cancer at issue.  One in a million happens eight times a day, in New York City. Flipping a coin ten times, and observing 6 heads and 4 tails, would not support an inference that the best evidence we have is that the coin will always favor heads to tails in a ratio of 1.5.

Schauer and Spellman might improve their hypothetical, but they are unlikely to free themselves of the need for expertise beyond the ken of a lay jury to evaluate the clinical, epidemiologic, scientific, and statistical issues raised by their supposed disease “outbreak.”  And although they have taken the expert witness as the usual purveyor of junk science out of the hypothetical by design, they have simply left the jury to draw a bogus inference.  The junk is still at work, only the jury is no longer a passive recipient of the inference; they are themselves the authors of the junk-science inference.

Schauer and Spellman’s Claim That Expert Evidence Is Not Really Different

The authors make the case that there are some instances in which expert witness opinion testimony is not so different from lay opinions about intoxication or speed of a car or eyewitness identification.  But Schauer and Spellman are wrong to allow themselves to be fooled about expert witness testimony in many complex mass tort cases.

Such cases commonly involve several scientific disciplines, such as toxicology, epidemiology, exposure assessment, neuropsychology, and others. The expert witness for each discipline might have a few dozen studies that are germane to the issues in the case, and each one of those studies might cite or rely upon several papers for their background, methods  and inferences.  Reference lists for each expert witness might run into the hundreds of articles, and in some cases, the experts might need to access underlying data and materials to understand fully the papers upon which they have relied.  A careful reading of each paper might require an hour or more for the expert to understand the claims and limitations of the study.  The expertise to understand the articles fully may have taken years or decades of education.

Juries do not have the time, the interest, the aptitude, the training, the experience, to read, understand, and synthesize the data and information in the studies themselves.  Our trials involving complex technical issues are much like Plato’s allegory of the cave; the jury never sees the actual evidence, only shadows cast by evidence they are usually not permitted to see, and don’t care to see when they have the chance. Juries decide technical issues based upon mostly the appearance of expertise, not upon evidence.

Some years ago, I tried an asbestos case against Charles “Joey” Grant, in front of Judge Armand Della Porter and a jury in Philadelphia Court of Common Pleas.  Joey represented a man who claimed that he had asbestosis from working at the Philadelphia Naval Shipyard. His chest X-ray interpretation was disputed, but he has small-airways obstruction, which his expert witness attributed to asbestosis.  The defense expert thought smoking was a much more likely cause of the obstruction, but the plaintiff had denied smoking in his deposition.  In order to test his assertion, the defense asked a private investigator to conduct surveillance of the plaintiff to determine whether or not he was a smoker.

The investigator, retired Alcohol Tobacco and Firearms agent Frank Buenas, tailed the plaintiff and observed and photographed him smoking.  Plaintiff’s counsel, Joey Grant, seized on my not having provided Buenas an authenticated photograph of the plaintiff, and challenged the identification and every aspect of the surveillance.  The direct examination lasted no more than 25 minutes; the cross-examination lasted about four hours.

Joey was a very good trial lawyer.  He had just come out of the Philadelphia District Attorney’s office, after having successfully prosecuted Nicodemo “Little Nicky” Scarfo.  Joey was also a good looking African American man who played well to our all female, all African American jury.  The issues of the surveillance, and of whether or not he plaintiff was a smoker, were understandable and accessible to the jurors, who were riveted by Joey’s cross-examination. Ultimately, the issues were resolved for the jury in a dramatic fashion.  The plaintiff, who continued to work at the Navy Yard, returned to court at the end of his shift, towards the end of the day in court.  Over objection, I called him back to the stand. He had not heard the investigator’s testimony, but when I showed him Buenas’ photographs, he exclaimed “that’s my bald head!”  The jurors practically lunged out of their seats when I published the photographs to the jury over Joey’s objection.

The point of the war story is to recount how the jury followed a protracted examination, and ignored their bias in favor of Joey, and their prejudice against me, the white guy representing the “asbestos companies” in this reverse-bifurcated trial.  The testimony involved a predicate issue whether Buenas had followed and photographed the right man in the act of smoking.  Would a jury, any jury, follow the testimony of a scientist who was being challenged on methodological details of a single study, for four hours?  Would any jury remain attentive and engaged in the testimony of expert witnesses who testified on direct and cross-examination in similar detail about hundreds of studies?

Having tried cases that involve both the simple, straightforward issue such as Buenas’ investigation and surveillance, and also complex scientific issues, I believe the answer is obvious.  None of the studies cited by Schauer and Spellman address the issue of complexity and how it is represented in the courtroom. 

Most judges, when acting as the trier of fact, lack the interest, time, training, and competence to try complex cases. Consider the trial judge who conducted bench trial of a claim of autoimmune disease caused by silicone.  The trial judge was completely unable to assess the complex immunological, toxicological, and epidemiologic evidence in the case.  See Barrow v. Bristol Myers Squibb Co., No. 96 689 CIV ORL 19B, 1998 WL 812318 (M.D. Fla. Oct. 29, 1998).  In another courtroom, not far away, Judge Sam Pointer had appointed four distinguished expert witnesses under Rule 706. In re Silicone Gel Breast Implant Prods. Liab. Litig. (MDL 926), 793 F. Supp. 1098 (J.P.M.L. 1992) (No. CV92-P-10000-S), Order No. 31, 31B, 31E.  In November 1998, a month after the Middle District of Florida trial court decided the Barrow case, the four court-appointed expert witnesses filed their joint and individual reports that concluded that silicone in breast implants “do[es] not alter incidence or severity of autoimmune disease” and that women who have had such implants  “do[] not display a silicone-induced systemic abnormality in the . . . cells of the immune system.” National Science Panel, Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction, Executive Summary at 5-6  (Nov. 17, 1998).  The Panel also found that “[n]o association was evident between breast implants and any of the . . . connective tissue diseases . . . or the other autoimmune/rheumatic conditions” claimed by the thousands of women who had filed lawsuits. Id. at 6-7. 

Another case, in the causal chain that produced the Daubert decision, might also have cautioned Professors Schauer and Spellman against oversimplifying the distinctions between expert and other evidence.  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).  The Wells case was a bench trial, in which the trial judge honestly professed not to have understood the epidemiologic evidence, and to have decided the case on his assessment of expert witness demeanor and atmospherics.  And like the Barrow case, the Wells case was clearly wrongly decided. See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1” (Nov. 12th, 2012) (footnote 1 collects a sample of citations criticizing Judge Shoob’s failure to engage with the scientific evidence).

Jury determinations, unlike the clearly erroneous determinations in Barrow and Wells, are “black boxes.”  The public and the scientific community cannot really criticize jury decisions because the jury does not explain their inferences from evidence .  The lack of explanation, however, does not save them from engaging in junk science.  Outside the Gedanken experiment above, jurors can blame expert witnesses for their errors.  In the experiment’s hypothetical, junk science is still taking place.

The Discomfort With Daubert

The authors recount many of the charges against and criticisms of the Daubert decision.  Schauer & Spellman at 2. They note that some commentators assert that the Justices in Daubert embraced a “clumsy philosophy of science.” But at least Justice Blackmun engaged with the philosophy of science, and the epistemic requirements of Rule 702, and made some attempt to reconcile the truth-finding process in court with what happens in science.  The attempted reconciliation was long overdue.

The authors also point out that some commentators have expressed concern that Daubert burdens mass tort and employment discriminations who “non-traditional experts and expertise.” Id. To paraphrase Tim Minchin, there is non-traditional opinion known not to be true, and non-traditional opinion not known to be true, but if non-traditional opinion is known to be true, then we call it … knowledge.  Perhaps Schauer and Spellman think that our courts should be more open and inclusive, warmer and fuzzier, for clinical ecologists, naturopaths, aromatherapists, homeopaths, and other epistemiopaths.  My sense is that these non-traditional experts should be relegated to live in their own world of magical thinking.

The authors give voice to “the broad worry that law should not outsource its own irreducibly legal determinations to science and scientists with different goals and consequently different standards.” But science and the law are both engaged in truth determinations.  Maybe the law should worry more about having jurors and judges making their determinations with different goals and standards.  Maybe the law should be more concerned with truth and scientific accuracy, and should not outsource its “irreducibly fact determinations” to the epistemiopaths.

Expert witness testimony is clearly different in many important respects from lay witness testimony and other evidence.  The expert witness testimony is largely opinion.  It relies upon many layers of hearsay, with many of the layers not subject to ready scrutiny and testing for veracity in a courtroom.  Many layers of the “onion” represent evidence that would not be admissible under any likely evidentiary scenario in a courtroom.

And jurors are reduced to using proxies for assessing the truth of claims and defenses.  Decisions in a courtroom are often made based upon witness demeanor, style, presentation, qualifications, and appearance of confidence and expertise. The authors lament the lack of empirical support for the last point, but this misses the larger point that the issue is not primarily an empirical one, and the point is not limited to jury competence.  Hon. Jed S. Rakoff, “Lecture: Are federal judges competent? Dilettantes in an age of economic expertise,” 17 Fordham J. Corp. & Fin. L. 4 (2012).

The Monte Hall Problem and Cognitive Biases

The “Monty Hall problem” was originally framed by statistician Steve Selvin in publications in the American Statistician in 1975 (Selvin 1975a), (Selvin 1975b).  The problem was then popularized by an exposition in Parade magazine in 1990, by Marilyn vos Savant.  The problem, based upon Monty Hall’s television game show Let’s Make a Deal, and Monty’s practice of asking contestants whether they wanted to switch.  A full description of the problem can be found elsewhere.

For our purposes here, the interesting point is that the correct answer was not intuitively obvious.  After vos Savant published the answer, many readers wrote indignant letters, claiming she was wrong.  Some of these letters were written by college and university professors of mathematics.  Vos Savant’s popularization of Selvin’s puzzle illustrates that there are cognitive biases, flaws in reasoning, and paradoxes, the avoidance of which requires some measure of intelligence and specialty training in probability and statistics.  See also Amos Tversky and Daniel Kahneman, “Judgment under Uncertainty: Heuristics and Biases,” 185 Science 1124 (1974).

Our system of justice suffers enough from the current regime of trial by sound-bite.  It should not be further undermined by the abandonment of judicial gatekeeping and judicial review of the quality and quantity of scientific evidence in our civil and criminal trials. Opponents of gatekeeping imply that the Federal Rules of Evidence should be “liberally” construed, by which they usually mean, construed consistent to their biases and prejudices.  The adjective “liberal,” both traditionally and today, however, connotes enlightened, free from superstition, bias, prejudice, and promoting accuracy in judgments that are important to institutional respect and prestige.  Let’s hope that 2014 is a better year for science in the courtroom.

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Supreme Court Denies Certiorari in Harkonen v. United States

December 16th, 2013

The Supreme Court took up Dr. Harkonen’s petition for certiorari on Friday, December 13, 2013.  The SCOTUS Blog made the petition its “Petition of the Day.”

Unfortunately, the blog’s attention did not carry over to the Court’s conference. The Court release its orders this morning, which included a denial of certiorari in Harkonen v. United States.

Although there was a good deal of noise about Dr. Harkonen’s intent, that issue is uniquely case specific.  The real issue going forward would seem to be the reach of the government’s position, and now the Ninth Circuit’s position, that failure to disclose multiple testing or deviation from a protocol is demonstrably false or misleading.  In Dr. Harkonen’s case, the causal inference was reasonably supported despite the non-protocol analysis.  The use of the verb “demonstrate,” however, is often used carelessly, and the Harkonen decision may well breathe life into Rule 702 gatekeeping.

 

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The Misbegotten Judicial Resistance to the Daubert Revolution

December 8th, 2013

David Bernstein is a Professor at the George Mason University School of Law.  Professor Bernstein has been writing about expert witness evidentiary issues for almost as long as I have been litigating them.  I have learned much from his academic writings on expert witness issues, which include his contributions to two important multi-authored texts, The New Wigmore: Expert Evidence (2d ed. 2010), Phantom Risk: Scientific Inference and the Law (MIT Press 1993).

Bernstein’s draft article on the Daubert Counter-revolution, which some might call a surge by judicial reactionaries, has been available on the Social Science Research Network, and on his law school’s website. See “David Bernstein on the Daubert Counterrevolution” (April 19, 2013).  Professor Bernstein’s article has now been published in the current issue of the Notre Dame Law Review, and is available at its website. David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013).  This article might well replace the out-dated chapter by the late Professor Berger in the latest edition of the Reference Manual on Scientific Evidence.

 

 

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Pharmacovigilantism – Avandia Litigation

November 27th, 2013

Six and one-half years ago, I gave a presentation on the then newly emerging controversy over Avandia (rosiglitazone).  Plaintiffs’ counsel Vance Andrus chaired the program, Mealey’s™ Avandia Litigation Conference, in Chicago on July 13, 2007.  Vance was a gracious host despite my skepticism about the potential for plaintiffs to cash in on their use of Avandia.

Despite Vance’s best efforts, the program was one of those lopsided affairs, and I was the only presenter who came prepared to address the scientific evidence from a skeptical perspective.  The remaining presenters were mostly cheerleaders for their declaration of war against GlaxoSmithKline over claims of heart attack and stroke from the use of Avandia.

This week, a Food and Drug Administration announcement sent me back to my presentation slides, which were provocatively titled “Pharmacovigilantism and Avandia.” Dr. Steven Nissen had published a meta-analysis in the New England Journal of Medicine in May 2007, and it had all the appearances of a contrived effort to embarrass GSK. See Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007).  A few weeks later, Dr. George Diamond published a thorough debunking of the Nissen meta-analysis, by showing that the statistically significant result in Nissen’s meta-analysis could be achieved only by choosing an inappropriate meta-analytic method.  Any other choice resulted in a result that lacked statistical significance for the rate of heart attack among patients taking Avandia.

Litigation, of course, followed and the Rule 702 hearings and decision resulted in a serious abridgement of the scientific process.  The federal MDL trial judge denied GSK’s motions to exclude plaintiffs’ causation witnesses in an opinion that has become a model for Rule 702 avoidance.  In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.).  See “Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011)

This week, without much fanfare, the FDA announced that maybe the evidence supporting the claims that Avandia causes heart attacks is not so strong, after all.  See “FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2011).  The Avandia MDL stands out as an expensive, negligent rush to judgment; a case more of phamacovigilantism than of pharmacovigilance.

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The Seventh Circuit Regresses on Rule 702

October 29th, 2013

Earlier this month, a panel of the Seventh Circuit of the United States Court of Appeal decided a relatively straight forward case by reversing the trial court’s exclusion of a forensic accountant’s damages calculation.  Manpower, Inc. v. Insurance Company of the State of Pennsylvania, No. 12‐2688 (7th Cir. Oct. 16, 2013).  In reversing, the appellate court disregarded a congressional statute, Supreme Court precedent, and Circuit decisional law.

The case involved a dispute over insurance coverage dispute and an economic assessment of Manpower, Inc.’s economic losses that followed a building collapse.  The trial court excluded Manpower’s accounting expert witness, Sullivan, who projected a growth rate (7.76%) for the plaintiff by comparing total revenues for a five month period in 2006 to the same five months in the previous year.  Id. at 8.  The historical performance, however, included a negative annual growth rate of 4.79% , over the years 2003 to 2009.  Over the five months immediately preceding Sullivan’s chosen period in 2006, the growth rate was merely 3.8%, less than half his projected growth rate.  Id.  Sullivan tried to justify his rather his extreme selectivity in data reliance by adverting to information that he obtained from the company about its having initiated new policies and installed new managers by the end of 2005.  Id.

The trial court held that Sullivan, who was not an expert on business management, had uncritically accepted the claimant’s proffered explanation for a very short-term swing in profitability and revenue.  Id. at 9.  While suggesting that Sullivan’s opinion was not “bulletproof,” the panel of the Seventh Circuit reversed.  The panel, which should have been reviewing the district court for potential “abuse of discretion,” appears to have made its own independent determination that Sullivan opinion was “sufficiently reliable to present to a jury.” Id. at 17.  In reversing, the panel explained that “the district court exercised its gatekeeping role under Daubert with too much vigor.” Id.

The panel attempted to justify its reversal by suggesting that a district court “usurps the role of the jury, and therefore abuses its discretion, if it unduly scrutinizes the quality of the expert’s data and conclusions rather than the reliability of the methodology the expert employed.” Id. at 18.  The panel’s reversal illustrates several methodological and legal confusions that make this case noteworthy beyond its mundane subject matter.

Of course, the most striking error in the panel’s approach is citing to a Supreme Court case, Daubert, which has been effectively superseded by a Congressional statute, Federal Rule of Evidence 702, in 2000:

“A witness who is qualified as an expert … may testify in the form of an opinion or otherwise if:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.”

Pub. L. 93–595, § 1, Jan. 2, 1975, 88 Stat. 1937; Apr. 17, 2000 (eff. Dec. 1, 2000); Apr. 26, 2011, eff. Dec. 1, 2011.)  Ironically, the Supreme Court’s Daubert case itself, had the Manpower panel paid attention to it, reversed the Ninth Circuit for applying a standard, the so-called Frye test, which predated the adoption of the Federal Rules of Evidence in 1975.  Rather than following the holding of the Daubert case, the panel got mired down in its dicta about a distinction between methodology and conclusion.  The Supreme Court itself abandoned his distinction a few years later in General Electric Co. v. Joiner, when it noted that

“conclusions and methodology are not entirely distinct from one another.”

522 U.S. 136, 146 (1997).

The panel of the Seventh Circuit concluded, without much real analysis, that the district court had excluded Sullivan’s opinions on a basis that implicated his conclusion and data selection, not his methodology.  Id. at 19-20.  The problem, of course, is that how one selects data of past performance to project future performance is part and parcel of the methodology of making the economic projection.  The supposed distinction advanced by the panel is illusory, and contrary to post-Daubert decisions, and the Congressional revision of the statute, which requires attention to whether “the testimony is based on sufficient facts or data; the testimony is the product of reliable principles and methods; and, the expert has reliably applied the principles and methods to the facts of the case.” Rule 702.

To make matters worse, the appellate court in Manpower proceeded to attempt to justify its reversal on grounds of “[t]he latitude we afford to statisticians employing regression analysis, a proven statistical methodology used in a wide variety of contexts.” Id. at 21. Here the appellate court suggests that if expert witnesses use a statistical test or analysis, such as regression analysis, it does not matter how badly they apply the test, or how worthless their included data are.  Id. at 22.  According to the Manpower panel:

“the Supreme Court and this Circuit have confirmed on a number of occasions that the selection of the variables to include in a regression analysis is normally a question that goes to the probative weight of the analysis rather than to its admissibility. See, e.g.,Bazemore v. Friday, 478 U.S. 385, 400 (1986) (reversing lower court’s exclusion of regression analysis based on its view that the analysis did not include proper selection of variables); Cullen v. Indiana Univ. Bd. of Trustees, 338 F.3d 693, 701‐02 & n.4 (7th Cir. 2003) (citing Bazemore in rejecting challenge to expert based on omission of variables in regression analysis); In re High Fructose Corn Syrup Antitrust Litigation, 295 F.3d 651, 660‐61 (7th Cir. 2002) (detailing arguments of counsel about omission of variables and other flaws in application of the parties’ respective regression analyses and declining to exclude analyses on that basis); Adams v. Ameritech Servs., Inc., 231 F.3d 414, 423 (7th Cir. 2000) (citing Bazemore in affirming use of statistical analysis based solely on correlations—in other words, on a statistical comparison that employed no regression analysis of any independent variables at all). These precedents teach that arguments about how the selection of data inputs affect the merits of the conclusions produced by an accepted methodology should normally be left to the jury.”

Id. at 22.

Again, the Seventh Circuit’s approach in Manpower is misguided. Bazemore involved a multivariate regression analysis in the context of a discrimination case.  Neither the Supreme Court nor the Fourth Circuit considered the regression at issue in Bazemore as evidence; rather the analysis was focused upon whether, within the framework of discrimination law, the plaintiffs’ regression satisfied their burden of establishing a prima facie case that shifted the burden to the defendant. No admissibility challenge was made to the regression in Bazemore under Rule 702.  Of course, the Bazemore litigation predates the Supreme Court’s decision in Daubert by several years.  Furthermore, even the Bazemore decision acknowledged that there may be

“some regressions so incomplete as to be inadmissible as irrelevant… .”

478 U.S. 385, 400 n.10 (1986).

The need for quantitative analysis of race and other suspect class discrimination under the equal protection clause no doubt led the Supreme Court, and subsequent lower courts to avoid looking too closely at regression analyses.  Some courts, such as the Manpower panel view Bazemore as excluding regression analysis from gatekeeping of statistical evidence, which magically survives Daubert. The better reasoned cases, however, even within the Seventh Circuit fully apply the principles of Rule 702 to statistical inference and analyses. See, e.g., ATA Airlines, Inc. v. Fed. Express Corp., 665 F.3d 882, 888–89 (2011) (Posner, J.) (reversing on grounds that plaintiff’s regression analysis should never have been admitted), cert. denied, 2012 WL 189940 (Oct. 7, 2012); Zenith Elecs. Corp. v. WH-TV Broad. Corp., 395 F.3d 416 (7th Cir.) (affirming exclusion of expert witness opinion whose extrapolations were mere “ipse dixit”), cert. denied, 125 S. Ct. 2978 (2005); Sheehan v. Daily Racing Form, Inc. 104 F.3d 940 (7th Cir. 1997) (Posner, J.) (discussing specification error).  See also Munoz v. Orr, 200 F.3d 291 (5th Cir. 2000).  For a more enlightened and educated view of regression and the scope and application of Rule 702, from another Seventh Circuit panel, Judge Posner’s decision in ATA Airlines, supra, is an essential starting place. See “Judge Posner’s Digression on Regression” (April 6, 2012).

There is yet one more flaw in the Manpower decision and its rejection of the relevancy of data quality for judicial gatekeeping.  Federal Rule of Evidence 703 specifically addresses the bases of an expert witness’s opinion testimony.  The Rule, in relevant part, provides that:

“If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted.”

Here the district court had acted prudently in excluding an expert witness who accepted the assertions of new management that it had, within a very short time span, turned a company from a money loser into a money earner.  As any observer of the market knows, there are too many short-term “fixes,” such as cutting personnel, selling depreciated property, and the like, to accredit any such short-term data as “reasonably relied upon.”  See In re Agent Orange Product Liability Lit., 611 F. Supp. 1223, 1246 (E.D.N.Y. 1985) (excluding opinions under Rule 703 of proffered expert witnesses who relied upon checklists of symptoms prepared by the litigants; “no reputable physician relies on hearsay checklists by litigants to reach a conclusion with respect to the cause of their affliction”), aff’d on other grounds, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).

Manpower represents yet another example of Court of Appeals abrogating gatekeeping by reversing a district judge who attempted to apply the Rules and the relevant Supreme Court precedent.  The panel in Manpower ignored Congressional statutory enactments and precedents of its own Circuit, and it relied upon cases superseded and overruled by later Supreme Court cases.  That’s regression for you.

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Bendectin, Diclegis & The Philosophy of Science

October 26th, 2013

In April of this year, the United States Food and Drug Administration (FDA) approved Diclegis, a combination of doxylamine succinate and pyridoxine hydrochloride for sale in the United States, for pregnant women experiencing nausea and vomiting. See FDA News Release, “FDA approves Diclegis for pregnant women experiencing nausea and vomiting,” (April 8, 2013). The return of this drug to the United States market was held up as a triumph of science over the will of the lawsuit industry. See Gideon Koren, “The Return to the USA of the Doxylamine-Pyridoxine Delayed Release Combination (Diclegis®) for Morning Sickness — A New Morning for American Women,” 20 J. Popul. Ther. Clin. Pharmacol. e161 (2013).

The sponsor of the drug, Duchesnay USA, wisely did not use the medication’s former name, Bendectin, which was the victim of a litigation industry jihad in the late 1970s through the mid-1990s. The plaintiffs’ lawyers’ war against Bendectin and its United States manufacturer is chronicled in two book-length accounts, and hundreds of articles. See Joseph Sanders, Bendectin on Trial: A Study of Mass Tort Litigation (Ann Arbor 1998); Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (Philadelphia 1996).

As recently approved by the FDA, Declegis is categorized as “Pregnancy Category A,” which means that it is medication indicated for use in pregnant women. Most drugs are not tested in pregnant women in randomized clinical trials for obvious ethical and practical reasons. Perhaps one of the good things that came out of the Bendectin litigation wars was that Bendectin became one of the most intensely studied medications available for pregnant women. Another good thing was the achievement of evidence-based standards for expert witness opinion testimony in federal court. See David Bernstein, “Bendectin is Back” (April 9, 2013).

According to FDA regulations, Category A is defined:

“(1) Pregnancy category A. If adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters), the labeling must state: ‘Pregnancy Category A. Studies in pregnant women have not shown that (name of drug) increases the risk of fetal abnormalities if administered during the first (second, third, or all) trimester(s) of pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, (name of drug) should be used during pregnancy only if clearly needed.’ The labeling must also contain a description of the human studies. If animal reproduction studies are also available and they fail to demonstrate a risk to the fetus, the labeling must also state: ‘Reproduction studies have been performed in (kinds of animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to (name of drug).’ The labeling must also contain a description of available data on the effect of the drug on the later growth, development, and functional maturation of the child.

21 CFR § 201.57 (c)(9)(i)(A)(1) (April 2012).

A Litmus Test for Philosophy of Science?

The inability to discriminate between valid and invalid science should be a disqualifying characteristic in a putative philosopher of science, or a putative expert, for that matter. Professor Susan Haack, whose writings provide both insight and confusion on the role of science in the law, revealed her robust biases and prejudices in commenting upon the Bendectin litigation. These revelations should raise red flags about her objectivity in commenting on the legal process. See Susan Haack, “Irreconcilable Differences? The Troubled Marriage of Science and Law,” 72 Law & Contemporary Problems 1 (2009).

Haack’s paper on the marital discord was based upon her presentation at the Fourth Coronado Conference, organized by SKAPP (The Project on Scientific Knowledge and Public Policy), an ideological group dedicated to opening the courthouse doors to every quackacademic theory, and shadily funded by the litigation industry of plaintiffs’ lawyers from their left-over spoils from the silicone breast implant litigation. See SKAPP A LOT (April 30, 2010); “Haacking at the Truth – Part Two” (Oct. 31, 2010).

Haack provided examples of “marginal” science and witnesses who disturb her for biases and prejudices she perceives in these witnesses. Haack focuses upon Dr. Robert Brent, a toxicologist, who appears to her as Merrell Dow’s expert witness “always ready to testify that Bendectin does not cause birth defects.” Id. At 17. Haack presented no evidence or basis to suggest that Brent was wrong, and indeed, Brent published widely on his views of the subject. Multiple publications do not necessarily mean that Brent was right, but at least he was willing to subject himself to professional peer review, and post-publication, professional challenges. Still, Haack is distressed that Dr Robert Brent opines with “unwarranted certainty” that Bendectin does not cause birth defects, but she offers no suggestion or support that his certainty was or is misplaced.

In stark contrast, Haack expressed no discomfort with Bendectin plaintiffs’ expert witness, Dr Done, or with the facile ease with which he opined with scientific certainty that Bendectin causes birth defects. Here there really is a great deal of empirical evidence, and along with the FDA’s recent approval of Diclegis for use in pregnant women, the evidence has vindicated Dr. Brent’s views on the safety and efficacy of Bendectin/Diclegis. Dr. Done’s subjective appreciation of “flaws” in some clinical studies does not turn criticism into affirmative evidence in favor of the opinion that he so zealously, and overzealously, advocated in many Bendectin cases, for his own substantial pecuniary benefit. What is remarkable about Haack’s article is that she singles out Dr. Brent in the context of a discussion of “marginal” and “willing” testifying scientists, but she omits any mention of the plaintiffs’ cadre of ready, willing, and somewhat disreputable testifiers. Perhaps even more remarkable is that Haack overlooks that Dr. Done was essentially fired from his university for his entrepreneurial testimonial activities of dubious scientific worth, and that he probably lied about his credentials. See Michael Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation 280 – 82 (Philadelphia 1996) (citing decisional law in which Done’s lack of veracity was judicially noted).

Of course, what is most remarkable about Haack’s infatuation with Dr. Alan Done and his mosaic theory is that the theory was the concoction of plaintiffs’ lawyer, Barry Nace, and that the theory leads to such a palpably incorrect result. Barry Nace was one of the lead plaintiffs’ counsel in the Bendectin litigation. Nace was also formerly President of the litigation industry’s principal lobbying organization, the American Trial Lawyers Association (now the AAJ). After the second Ninth Circuit Daubert decision, Nace declined to pursue one of his Bendectin cases, and his client sued him. Nace’s attorney moved for summary judgment in August 1998, on grounds that included the assertion that “courts soundly and uniformly reject the notion that Bendectin causes birth defects.” See David Bernstein, “A Day Late and a Dollar Short on Bendectin” (June 28, 2005).

This is the same Barry Nace lauded by Michael Green for having devised the notorious matrix theory of scientific evidence (a.k.a. the tsumish theory). Michael D. Green, “Pessimism About Milward,” 3 Wake Forest J. Law & Policy41, 62-63 (2013). Professor Haack sees Nace’s matix theory as the practical application of some of her theories. Susan Haack, “Irreconcilable Differences? The Troubled Marriage of Science and Law,” 72 Law & Contemporary Problems 1, 17 (2009); Susan Haack, “Proving Causation: The Holism of Warrant and the Atomism of Daubertm” 4 J. Health & Biomedical Law 273, 274-78 (2008). Haack’s embrace of the dubious Bendectin causal claims as supported by her matrix theory of causal inference raises the issue why we should credit a theory in the face of such a compelling counter example? As Professor Ronald Allen put the matter, before Bendectin was reintroduced into the United States market this year:

“Given the weight of evidence in favor of Bendectin’s safety, it seems peculiar to argue for mosaic evidence from a case in which it would have plainly been misleading.”

Ronald J. Allen and Esfand Nafisi, “Daubert and its Discontents,” 76 Brooklyn L. Rev. 132, 148 (2010). Peculiar indeed. Professor Allen’s point is important for its wide-ranging implications. Methodologies that yield false-positive results are unreliable. Perhaps a methodology can be saved if we could quantify that a given methodology rarely yields such false results, but the matrix theory of Barry Nace and his expert witnesses seems so vague and insubstantial that no one, in all likelihood, could frame a test for the generalized approach. Expert witnesses perhaps should be judged by their track record over time, as well. See David Kaye, “The Experts in Daubert.”[1]

 

[1] Dr. Alan Done (pediatrician, pharmacology, toxicology); Dr. Jay Glasser (biostatistician, epidemiologist); Dr. Adrian Gross (veterinarian); Dr. Stuart Newman (developmental biologist); Dr. Wayne Snodgrass (Assoc. Professor of Pediatrics, Pharmacology, and Toxicology); Dr. Shanna Swan (epidemiologist); Dr. Johannes Thiersch (pathologist and pharmacologist); Dr. John Palmer (Professor of pharmacology).

 

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Christopher Bryson and the Problem of Political Science

October 12th, 2013

Fluoridation of water has long been a “political science” issue, with radical libertarians and anarchists viewing fluoridation as the high-water mark of state paternalism.  The motive to misstate and misrepresent the science may at times be obvious, but individual statements, standing alone, may be difficult to judge.

Fluorine chemistry and toxicology are sufficiently advanced that misrepresentations should be easy to detect.  Fluorine is a halogen; the lightest in the series.  As a gas, fluorine is extremely reactive and toxic, as are other halogen gases, such as chlorine.  Fluorine gas was used for uranium enrichment in the Manhattan project, and project scientists conducted research on fluorine toxicity to help them set exposure limits in a new manufacturing process.

As devotees of Breaking Bad no doubt have learned, hydrogen fluoride is extremely toxic and corrosive.  Other halogen-based acids are, of course, toxic and corrosive, such as hydrogen chloride.

Compounds of fluorine are generically fluorides, and the properties of the salts and compounds varies considerably with the cation and the chemical structures involved.  Many modern medications, such as atorvastatin and fluoxetine contain fluorine in their chemical structures.  The toxicology of the fluorine compounds must, therefore, take into account the variability of structure and function of fluorine.  Toxicity of fluorine gas or of hydrogen fluoride cannot be “extrapolated” to a simple sodium salt, and more than the toxicity of chlorine gas can be imply the toxicity or ordinary table salt, sodium chloride.  The allergenicity of a compound such as potassium aluminumtetrafluoride cannot be the basis for asserting the immunogenicity of a simple alkali salt.

Recently, I came across a YouTube video of a journalist, Christopher Bryson, holding forth on his perception of a vast conspiracy to poison people by the fluoridation of drinking water.  Bryson’s passion and selectivity in making his case resembles the deep flaws of our tort system, which allows lawyers and expert witnesses to overwhelm judges and juries with emotion, selectivity, and overstatement.  Bryson refers to all fluorine chemicals, whether the elemental gas, the acid, or the many complex and variable salts as “fluoride.”  Occupational and environmental exposures to hydrogen fluoride are equated with micromolar levels of sodium fluoride in drinking water. Never once does he actually quantitate the exposures he labels as “toxic.” Largely, Bryson proceeds by ad hominems, ad nauseam.  If scientists have industry connections, they are bad, and their science is corrupt.  If a scientist has ever done something productive (e.g., George L. Waldbott), and he opines that water fluoridation is bad, then that scientist must be correct.  Apparently, Bryson has never heard of Linus Pauling and his Vitamin C fiasco.  See K. Frank Austen, M. Dworetzky, Richard S. Farr, G.B. Logan, S. Malkiel, E. Middleton Jr., M.M. Miller, Roy Patterson, C.E. Reed, S.C. Siegel, and P.P. Van Arsdel Jr., “A statement on the question of allergy to fluoride as used in the fluoridation of community water supplies,” 47 J. Allergy & Clinical Immunology 347 (1971) (“no”).

Bryson makes for an interesting case study in hysteria.  He is also very much a public example of the tone and substance of many of the plaintiffs’ theories that clog the civil dockets of our court system.  Bryson’s passion and intensity — heat without illumination  — are reminiscent of the courtroom antics in many a so-called “toxic tort” case.  Bryson’s video is thus a good place to start to try to understand science in the courtroom, and the need for strong gatekeeping.  The potential for inflammatory advocacy, distortion, and misrepresentation have always been part of legal proceedings, but when it comes to advocacy about claims that turn on “scientific” evidence, there is a difference.  Juries in common law cases, in 1789, were not confronted with the abuses of the sort that Bryson so well exemplifies.

The Bryson video led me to look at Bryson’s book, The Fluoride Deception.  The book starts with “Notes on Terminology,” which warns that

“THE TERMS fluorine and fluoride should not be confused in a book about chemical toxicity.”

* * *

“In these pages I’ve tried to be clear when I’m referring to the element fluorine or to a compound, a fluoride. And because different fluoride compounds often have unique toxicities, where relevant or possible, I have also given the compound’s specific name.”

So far so good, but then Bryson, having baited, switches:

“Mostly, however, for simplicity’s sake, I have followed convention and used the shorthand fluoride when referring to the element and its multiple manifestations, a procedure approved and used by the U.S. National Academy of Sciences.”

Christopher Bryson, The Fluoride Deception at xi (2004).

Fluoride deception indeed Mr. Bryson.  The cited source for the indiscriminate use of fluoride makes clear that it uses “fluoride” as a general term when differentiation is not necessary for its discussion.  It is not, however, a basis for conflating or confusing the toxicities of fluorine species or doses.  National Research Council, Biological Effects of Atmospheric Pollutants: Fluorides 3 (1971).  Bryson provides an apt example of how science communication works in politicized contexts, such as the courtroom or the legislature.

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LNT in Milward v. Acuity Specialty Products Group

September 28th, 2013

Professor Edward J. Calabrese previously has written about the shadowy origins of the linear no threshold (LNT) model of cancer causation.  See The Dubious Origins of the Linear No Threshold Model of Carcinogenesis (Jan. 10, 2013).  Recently, Calabrese has deepened his historical scholarship with two additional, interesting articles. See “Toxicologist Says NAS Panel ‘Misled the World’ When Adopting Radiation Exposure Guidelines” (Aug. 13, 2013).

These articles, now available online, are important tools in the work chest of lawyers who litigate health effect claims.  Edward J. Calabrese, “How the US National Academy of Sciences misled the world community on cancer risk assessment: new findings challenge historical foundations of the linear dose response,” 87 Arch. Toxicol. (2013) (in press); Edward J. Calabrese, “Origin of the linearity no threshold (LNT) dose–response concept,” 87 Arch. Toxicol. 1621 (2013). Professor Calabrese illuminates the exaggerations and ipse dixit in the origins of the linear-no threshold model, first applied to radiogenic cancers, and later to human carcinogenesis more generally.

On remand from the First Circuit, the trial judge in Milward, now the Hon. Douglas Woodlock, faced a renewed Rule 702 motion directed to Milward’s specific causation expert witnesses.  Milward v. Acuity Specialty Products Group, Inc., Civil Action No. 07–11944–DPW, 2013 WL 4812425 (D. Mass. Sept. 6, 2013). Plaintiffs attempted to invoke the dubious LNT concept to argue that benzene should be in the “differential” for ascertaining the specific cause of Mr. Milward’s APL. In performing a careful Rule 702 analysis, Judge Woodlock rule that, “[t]o the extent Butler [Milward’s expert witness] seeks to establish specific causation based on the argument that any level of benzene is sufficient to cause leukemia—a so-called “no safe level,” “no threshold,” or “linear” model—her opinion is inadmissibly unreliable.”  Id. at *8.

In recognizing Dr. Butler’s reliance upon LNT concepts in civil litigation as unreliable, Judge Woodlock followed the lead of other courts, within the First Circuit, which have previously rejected expert witness opinion testimony founded upon the LNT model.  See, e.g., Whiting v. Boston Edison Co., 891 F.Supp. 12, 25 (D.Mass.1995) (“[t]he linear non-threshold model cannot be falsified, nor can it be validated. To the extent that it has been subjected to peer review and publication, it has been rejected by the overwhelming majority of the  scientific community. It has no known or potential rate of error. It is merely an hypothesis.” ); Sutera v. Perrier Group of America Inc., 986 F.Supp. 655, 666 (D.Mass.1997) (“Accordingly, although there is evidence that one camp of scientists … believes that a non-linear model is appropriate basis for predicting the risks of low-level exposures to benzene, there is no scientific evidence that the linear no-safe threshold analysis is an acceptable scientific technique used by experts in determining causation in an individual instance.”).  Strong precedent outside the First Circuit also supports Judge Woodlock’s holding.  See Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198 (5th Cir.1996); Henricksen v. ConocoPhillips Co., 605 F.Supp. 2d 1142, 1166 (E.D.Wash.2009) (“[Plaintiffs’ expert witness’s] theory that any amount of exposure more than negligible should be considered substantial risk factor for AML flies in the face of the scientific literature reviewed and other expert testimony in this case that there is a threshold or dose below which you do not see a statistically significant risk of developing AML.”); In re W.R. Grace & Co. 355 B.R. 462, 476 (Bankr. D. Del. 2006) (the “no threshold model . . . flies in the face of the toxicological law of dose-response . . . doesn’t satisfy Daubert, and doesn’t stand up to scientific scrutiny”); Cano v. Everest Minerals Corp., 362 F. Supp. 2d 814, 853–54 (W.D. Tex. 2005) (even accepting the linear, no-threshold model for uranium mining and cancer, it is not enough to show exposure, you must show causation as well). See also McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1244 (11th Cir. 2005) (“in evaluating the reliability of the experts’ opinions on general causation, it would help to know how much additional risk for heart attack or ischemic stroke Metabolife consumers have over the risks the general population faces”). National Bank of Commerce v. Assoc. Milk Producers, 22 F. Supp. 2d 942, 960 (E.D. Ark. 1998), aff’d, 191 F.3d 858 (8th Cir.1999). See generally Federal Judicial Center, Reference Manual on Scientific Evidence, at 643 n. 28 (3d ed.2011).

The district court in Milward held that because Dr. Butler “did not and could not quantify a threshold exposure level for benzene, Milward cannot posit that his cumulative exposure level crossed a relevant threshold.” Milward, 2013 WL 4812425, at 8.  In addressing Milward’s reliance upon LNT, Judge Woodlock rejected three specious arguments, which frequently recur in Rule 702 litigation.

First, the district saw through the argument that the claimed benzene-APL LNT model was good science because the United States Environmental Protection Agency (EPA) relies upon it.  The EPA applies the LNT model for benzene

“due to uncertainty about the shape of the dose-response curve below 40 ppm-years.”

Id. at 8[1]. The district court recognized that the EPA’s reasoning was a “classic example of a cautious prophylactic administrative rule” that “does not support the reliability of the linear, no-threshold model in establishing specific causation.”  Id.  In so ruling, the Milward district court joins a long line of courts that have distinguished administrative rulemaking from civil litigation standards for causation.  See, e.g., Allen v. Pa. Eng’g Corp., 102 F.3d 194, 198 (5th Cir. 1996)(“This methodology results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances. The agencies’ threshold of proof is reasonably lower than that appropriate in tort law, which traditionally makes more particularized inquiries into cause and effect.”)

Second, the Milward district court also saw through plaintiffs’ argument that the First Circuit’s embrace of its “weight of the evidence” general causation approach, which appears to enjoy support among federal bureaucrats, required approval of plaintiffs’ attempt to use a LNT prophylactic or precautionary approach. Milward, 649 F.3d at 18 & n. 9.  Plaintiffs have the burden of showing reliability of the LNT model, and the EPA’s acknowledged uncertainty about the model for benzene was an insuperable barrier to their success.  Milward, 2013 WL 4812425, at 8 & n.4.

Third, the district court rejected Dr. Butler’s attempt to “bait and switch,” by pointing to a study on hematotoxicity as opposed to carcinogenicity.  Butler argued that there was “no clear evidence of a threshold below which benzene does not cause hematotoxicity in humans.”[2] The court recognized that the study referred to the lack of a hematotoxicity threshold for low average doses of benzene. Hematotoxicity is not necessarily induction of APL; nor was the lack of clear evidence for a threshold evidence against a threshold.

Even in the regulatory realm, the LNT model is losing traction.  See Chlorine Chemistry Council v. EPA, 206 F.3d 1286, 1287 (D.C. Cir. 2000) (invalidating EPA regulation under the Safe Drinking Water Act, when the EPA persisted in using an LNT model, after it had concluded that chloroform, a contaminant in drinking water from chlorination exerted a “a nonlinear mode of carcinogenic action”).  In the scientific realm, researchers can merely watch in amazement at the “political science” that proceeds under a mistaken, outdated model of carcinogenesis.  See, e.g., Brant A. Ulsh, “Checking the Foundation: Recent Radiobiology and the Linear No-Threshold Theory,” 99 Health Physics 747 (2010) (“However, a large and rapidly growing body of radiobiological evidence indicates that cell and tissue level responses to this damage, particularly at low doses and/or dose-rates, are nonlinear and may exhibit thresholds. To the extent that responses observed at lower levels of biological organization in vitro are predictive of carcinogenesis observed in vivo, this evidence directly contradicts the assumptions upon which the microdosimetric argument is based.”); Bernard L. Cohen, “The Linear No-Threshold Theory of Radiation Carcinogenesis Should Be Rejected,” 13 J. Am. Physicians & Surgeons 70, 75 (2008) (“The conclusion from the evidence reviewed in this paper and more extensively elsewhere is that the linear-no threshold theory (LNT) fails very badly in the low-dose region, grossly overestimating the risk from low-level radiation. This means that the cancer risk from the vast majority of normally encountered radiation exposures is much lower than given by usual estimates, and may well be zero or even negative.”); Maurice Tubiana, Ludwig E. Feinendegen, Chichuan Yang, and Joseph M. Kaminski, “The Linear No-Threshold Relationship Is Inconsistent with Radiation Biologic and Experimental Data,” 251 Radiology 13, 13, 15-16, 18 (2009) (noting that LNT model is obsolete in view of known upregulation of cellular protective mechanisms against cancer; “LNT was a useful model half a century ago. But current radiation protection concepts should be based on facts and on concepts consistent with current scientific results and not on opinions. Preconceived concepts impede progress; in the case of the LNT model, they have resulted in substantial medical, economic, and other societal harm.”).


[1] The court EPA Office of Research and Development, Carcinogenic Effects of Benzene: An Update, at 38–39 (April 1998).

[2] Dr. Butler cited Richard B. Hayes, et al., “Benzene and Lymphohemaptopoietic Malignancies in Humans,” 40 Am. J. Indus. Med. 117, 120 (2001).

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