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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 (11^th 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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Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims

December 12th, 2013

In the spring of 2012, Judge Sandra Mazer Moss granted summary judgment to Proctor & Gamble, after excluding, on Frye grounds, plaintiff’s expert witnesses who opined that plaintiff suffered zinc neurotoxicity from his use of Fixodent. Jacoby v. Rite Aid Corp., 2012 Phila. Ct. Com. Pl. LEXIS 208 (2012). See “Philadelphia Plaintiff’s Claims Against Fixodent Prove Toothless” (May 2, 2012). Judge Moss’s exclusion of plaintiff’s expert witnesses involved a careful analysis of the evasive, hand-waving tactics of the witnesses. Among the plaintiff’s team of expert witnesses was Dr. Martyn Smith, the chief hand waver and obscurantist in Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012).

On Monday, December 9, 2013, after a careful review, the Pennsylvania Superior Court affirmed summary judgment for Proctor & Gamble in the Jacoby case. Jacoby v. Rite Aid Corp., Pa. Super. Ct. No. 1508 EDA 2012 (Dec. 9, 2013) [Slip op.] The Superior Court panel, consisting of Judges Stevens, Lazarus, and Colville, largely adopted Judge Moss’s analysis and affirmed in a signed, but unpublished, opinion by Judge Lazarus.

Like Judge Moss before them, the Panel saw through the attempt to pass off “Weight of the Evidence” (WOE) and “Totality of the Evidence” (TOE) as scientific methodologies. The witnesses, Martyn Smith and others, failed to specify what evidence they weighed, how they weighed the evidence, and what the weights supposedly were. Another expert witness vaguely pointed to the “Naranjo scale” in support of interpreting case reports to show causal association, but this scale was similarly incompetent other than as a crude “plausibility” scale for assessing case reports.

The Superior Court’s decision in Jacoby is noteworthy on several important issues. There was no material issue as to whether zinc at some dose and duration of exposure can cause neuropathies. The Court saw, however, that the important issue was whether zinc in the form, dose, and duration ingested by plaintiff can cause the outcome he experienced, and whether his exposure to zinc in Fix-o-dent actually caused his alleged injury. The Superior Court re-affirmed Pennsylvania’s case law that makes extrapolation from different doses, different durations, and different biological circumstances, a “novel” claim that is subject to the gatekeeping by the so-called Frye standard. Slip op. at 11.

The Superior Court’s opinion astutely observed that the issue was not whether WOE and TOE are accepted scientific methodologies, but whether expert witness Martyn Smith can “evade a reasoned Frye inquiry merely by making reference to accepted methods in the abstract.” Id. at 12 (citing Betz, at 58). When pressed, Martyn Smith’s invocation of WOE amounted to little more than a distortion and abridgment of the Bradford Hill factors. The Superior Court recognized, however, that the Bradford Hill guidelines provide an evaluative process to consider whether an association, after first being shown to be clear cut and not attributable to chance, is causal or spurious. Id. at 13. As Bradford Hill postulated the question that arises before his famous nine factors come into the analysis:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965) (emphasis added).

In this case, Smith never got off the dime with his evasive tactics. He did not identify a quantified association that could be assessed for the play of random variation, or bias and confounding. Smith tried to suggest that a mere possibility of an association was sufficient to invoke the Bradford Hill guidelines, but the Superior Court rejected this attempt to invent a new-age scientific method. Slip op. at 13.

The Superior Court acknowledged that the scientific literature describes WOE as varying from nothing more than “seat-of-the-pants qualitative assessment” to “aggregating diverse modalities.” Id. at 14. In Smith’s hands, WOE was little more than a personal, subjective opinion, an ipse dixit dressed as a scientific opinion. Smith never defined his WOE approach, and the other witnesses never defined their TOE approach. The plaintiffs’ witnesses in Jacoby failed to offer an accepted methodology when they failed to identify the forms of evidence they considered, and how they went about weighing the evidence upon which they had relied. Id. at 15.

In a brief discussion, the Panel also embraced another basic evidentiary principle to dismiss a common tactic in specious claiming. The plaintiffs’ challenged defendants’ pharmokinetic study and tried to suggest that their deconstruction counted as affirmative evidence to support their own theory of biological fate and distribution. Id. at 16. The Superior Court saw through the ruse; the plaintiffs had not created affirmative evidence for their theory by arguing that the defendants’ study was flawed.

The Superior Court squarely confronted the limitations and inadequacy of relying upon descriptive, anecdotal case reports. Case reports provide a narrative and temporal history of events with respect to exposure and outcome, but they cannot fully account for confounding by known and unknown factors. Case reports represent post hoc assessments that were not planned, and therefore lack data that would permit distinguishing coincidence from causality. Id. at 17 (citing Dr. Lorene Nelson’s report). See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345 (S.D. Fla.2011).

Proctor & Gamble had the good fortunate to have obtained a good ruling in the MDL litigation in the Southern District of Florida, which no doubt helped focus the gatekeeping process in Pennsylvania state court. Unfortunately, the Superior Court Panel chose not to publish its decision. This decision is regrettable for its inconsistency with the transparency and due process expected of all courts. See Erica Weisgerber, “Unpublished Opinions: A Convenient Means to an Unconstitutional End,” 97 Georgetown L.J. 621 (2009).

Posted in Causation, Expert Witnesses, Frye, Scientific Evidence | Comments Off on Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims

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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Rockefeller and McCarthy — The Rush from Responsibility

December 4th, 2013

William Rockefeller was the engineer who operated the Metro-North Railroad train at 83 mph around the Spuyten Dyvel curve, in the Bronx. The general speed limit is 70 mph, and the speed limit going into the curve is 30 mph. The train derailed, killing four passengers and injuring many more, some very seriously. Rockefeller told investigators that he had become “dazed,” whatever that means in the absence of some “dazing” event. Matt Flegenheimer & William K. Rashbaum, “Train Engineer Was Dazed Before Crash, Lawyer Says” (Dec. 3, 2013 ). George Orwell would have appreciated the slippery and soul-less use of the passive voice. Who did the dazing?

Jeffrey P. Chartier, Rockefeller’s lawyer, described his client as suffering from “highway hypnosis.” Chartier, testifying for his client, claimed that Rockefeller had lost concentration only momentarily, and that he was “extremely remorseful.” Metro-North trains are pretty substantial trains, not the sort that can accelerate momentarily from 30 to 82 mph.

Rockefeller is a member of the Association of Commuter Rail Employees, and so, of course, his union representative, Anthony Bottalico, had to weigh in on the issue. Bottalico casually mentioned that Rockefeller had described himself as having nodded off before the derailment. When pressed, Bottaclico realized his error in acknowledging responsibility, and he quickly changed up:

“People use the word ‘zoned out,’ ‘nod,’ ‘fell asleep,’ … I’m not a sleep expert.”

Bottalico’s indiscretion, in speaking to the media about a pending investigation (and trying to spin the facts to exculpate the union engineer) led the safety board to remove the union as a party to the investigation.

The search for responsibility is part of our human condition. Legal categories often drive the search. In occupational exposure cases, employers have tort immunity by virtue of workman’s compensation immunity. The Depression-era bargain between labor and management on workplace injuries pushes our legal system, and the litigation industry, to place responsibility on remote vendors of products and raw materials to the workplace, despite their lack of control over the dissemination of information on the job. In most so-called sophisticated intermediary cases, the accident or injury would not have occurred at all had the employer and the employees done their respective jobs with respect to providing a safe workplace.

In the Spuyten Duyvil crash, Rockefeller’s lawyer and rail safety pundits suggest that automatic systems might have prevented the derailment. The hard fact remains, however, that Rockefeller was the most important link in the causal chain. He was the “least expensive” means to avoid the disaster because it was his job and his responsibility to do so. Had Rockefeller simply done his job, four people killed in the crash would be alive today. And many more would not be crippled and in pain.

In today’s New York Times, Joe Nocera muses about how Long Island Congresswoman Carolyn McCarthy, was diagnosed with lung cancer. McCarthy, who is 69 years old, was a life-long cigarette smoker, yet in her court filings she refers to her lung cancer as her asbestos disease. Joe Nocera, “The Asbestos Scam” N.Y. Times (Dec. 3, 2013). We live in a free country (well, sort of free) and people should be free to deceive themselves and indulge their superstitions. But surely we can draw the line at deceiving others with such nonsense. McCarthy was never an asbestos insulator or an asbestos-exposed tradesperson. McCarthy’s lawyer, supposedly told The New York Post that “it has been conclusively proven that cigarette smoking and asbestos exposure act synergistically to cause lung cancer.”

Nocera points out that in fact it has not. Even Selikoff himself, who did so much to perpetuate a theory of multiplicative, synergistic reactivity, wrote that his insulator cohort synergistic risk estimates could not be extrapolated to other exposures (such as the evanescent household exposures alleged by Congresswoman McCarthy):

“These particular figures apply to the particular groups of asbestos workers in this study. The net synergistic effect would not have been the same if their smoking habits had been different; and it probably would have been different if their lapsed time from first exposure to asbestos dust had been different or if the amount of asbestos dust they had inhaled had been different.”

Selikoff, et al., “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. at 487 (1979). Despite Selikoff’s atypical care, his colleagues who carried the Mt. Sinai banner into courtrooms all around this country, glibly ignored his qualification. See also “Irving Selikoff and the Right to Peaceful Dissembling.” Of course, when Selikoff’s heirs updated his insulator study, they did not find evidence of interaction even for insulators who lacked sufficiently heavy exposure to cause asbestosis. Steve Markowitz, Stephen Levin, Albert Miller, and Alfredo Morabia, “Asbestos, Asbestosis, Smoking and Lung Cancer: New Findings from the North American Insulator Cohort,” Am. J. Respir. & Critical Care Med. (2013). See “The Mt. Sinai Catechism” (June 7, 2013). I doubt that these qualifications will find their way into the reporting of The New York Post.

Ultimately, Irving Selikoff and his heirs helped create a litigation industry that has placed responsibility for asbestos disease on vendors, not employers, and completely out of proportion to any realistic appraisal of traditional tort law. Rockefeller and McCarthy, and Selikoff (and the litigation industry he helped to start) all illustrate the misallocation of responsibility for avoidable human suffering. Denialism is where you find it.

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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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Avoiding Nonsense About Science — Ask For The Evidence

November 25th, 2013

Sense about Science is a British charitable organization that is devoted to helping people understand scientific and medical claims. Sense about Science acknowledges that:

“Sharing scientific reasoning involves giving people the tools to question pseudoscience and misleading claims, to help cut through the noise around scientific or medical issues.”

To further its laudable goals, Sense about Science has launched an “Ask for Evidence Campaign”:

“We hear daily claims about what is good for our health, bad for the environment, how to improve education, cut crime, treat disease or improve agriculture. Some are based on reliable evidence and scientific rigour. Many are not. How can we make companies, politicians, commentators and official bodies accountable for the claims they make? If they want us to vote for them, believe them or buy their products, then we should Ask for Evidence.”

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

Mr. Nicholas Kristof grew up on a cherry farm, and went on to a successful academic and writing career. For over a decade, Kristof has written “columns” for The New York Times, a public platform that has helped him win two Pulitzer Prizes. Sometimes, Kristof’s early experience in cherry picking has helped him with discussions of scientific issues, which seem more like “Nonsense about Science.” Consider yesterday’s New York Times, in which, Kristof combines cherry picking with scare mongering. See “Danger Lurks in That Mickey Mouse Couch”:

“RESEARCHERS this summer purchased 42 children’s chairs, sofas and other furniture from major retailers and tested them for toxic flame retardants that have been linked to cancer, birth defects, diminished I.Q.’s and other problems.”

Besides the vague and conclusory language of “links,” Kristof does not cite a scintilla of evidence; instead he cites opinion from an environmentalist organization, Center for Environmental Health (CEH). What is the CEH? From its website, the CEH appears to be a group led by actors, community activists, politicians, self-styled “philanthropists,” advocates for “environmental justice.” No serious scientists appear on the CEH’s board of directors, or on its staff, which is populated mostly by lawyers and activists.

Does the CEH, without the benefit of real scientific talent, marshal serious scientific evidence? You should judge for yourself by reading the webpage that Kristof cites. See CEH, “Playing on Poisons: Children’s Furniture Found with Harmful Flame Retardant Chemicals” (November 20, 2013). If diligent readers of Kristof’s column were to read his “source,” they would find only hand waving and opinionated pronouncements without any reference to supporting scientific studies. Perhaps there is something to the accusations made by Kristof and his band of “environmental justice” advocates, but nothing in the column or its sources would shed any light on the matter.

Mr. Kristof prefers to deal in vague, if not meaningless terms, such as “links” between chemical exposures and myriad dire outcomes. He patronizes readers by giving them no understanding of the quantity or quality of the evidence that supports his innuendo. Kristof repeats his bad, unscientific brand of journalism on his blog. See Nicholas Kristof, “Are You Sitting Down? On a Couch?” (Nov. 23, 2013).

Citing regulatory approval of the fire retardants at issue, the American Chemistry Council has taken Mr. Kristof to task. See “New York Times columnist and new docudrama mislead public on importance of flame retardants, strong fire safety standards” (Nov. 23, 2013). The Council’s webpage points to other sites that provide some additional evidence of regulatory approvals and efficacy testing of fireproofing chemicals, but it does not list the chemicals involved, and it does not address the biological causal claims made by Kristof and the CEH. Nor does the American Chemistry Council mention that the litigation industry (a/k/a plaintiffs’ bar) has waged war against the use of companies for using natural, flammable fabrics and materials.

The Sense about Science organization focuses upon scientific nonsense mostly in the United Kingdom. Kristof’s brand of hit-and-run journalism illustrates that we very much need a similar organization in the United States. The discussion and debate over health issues should not take place by the trading of assertions and adjectives, without reference to the actual evidence at hand. Interestingly, in the same issue of the New York Times, which carried Kristof’s column, two reporters, Walt Bodganich and Glenn Silber, covered a flawed forensics investigation in Florida. Bodganich & Silber, “Two Gunshots on a Summer Night,” New York Times, A1 (Nov. 24, 2013). In almost four full pages of coverage, these Times reporters analyze the circumstantial and forensic evidence in great detail to expose a flawed police investigation. Although the death involved, and the police incompetence suggested by these journalists, is a tragedy, the inability of a newspaper to cover a story that alleges many thousands of deaths, with any attention to the actual evidence, is a much greater tragedy.

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

The aversion to reading and understanding the actual scientific evidence finds ample expression in the legal arena. In the recent case of Jackson v. Pollion, the Seventh Circuit chided the lawyers, and trial judges, for their failure to examine and understand the scientific evidence at issue in the merits of the case. Jackson v. Pollion, No. No. 12-2682 (7th Cir. Oct. 28, 2013) (Posner, J.). Judge Posner argued the noteworthiness of the lapse by the advocates and the judges:

“This lapse is worth noting because it is indicative of a widespread, and increasingly troublesome, discomfort among lawyers and judges confronted by a scientific or other technological issue.”

Slip op. at 2.

And in more Kierkegaardian terms, Judge Posner admonishes the legal profession:

“The legal profession must get over its fear and loathing of science.”

Slip op. at 8.

Indeed! Judge Posner’s admonition is undermined by the current Federal Rule of Evidence, which diminish the value of underlying data and evidence in expert witness opinion. Rule 702 makes opinion admissible, and Rule 703 acknowledges that much of the bases for expert witness opinion will itself be inadmissible. The structure of the Federal Rules of Evidence, however, undermines the importance of underlying evidence by not requiring that expert witnesses disclose the facts and data upon which they rely.

The evidence law of some states is to the contrary. Consider Hansen v. Wyeth Inc., 77 Pa. D. & C.4th 501, 2005 WL 3068256 (Phila. Cty. Ct. Com.Pl. 2005) (Bernstein, J.). The Hansen case focused on the testimony that was given by Dr. Harris Busch in a fenfluramine products liability case in Philadelphia. Some may recall Busch as a veteran plaintiffs’ expert witness from the silicone gel breast implant litigation. See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans” and the litigation as largely based upon fraud).

In Hansen, Busch testified that Wyeth had been negligent, but on post-trial motions, Judge Bernstein found that:

“The doctor’s opinion, however, was presented in conclusory form and was ‘generically’ predicated on voluminous materials.”

Hansen, 77 Pa. D. & C.4th at 501.

Applying Pennsylvania’s version of Rule 705, which incorporated the state’s traditional common-law approach, Judge Bernstein held that Dr. Busch’s failure to give a detailed accounting of the evidentiary basis for his opinion rendered his opinion inadmissible. Pennsylvania Rule 705 provides:

“Disclosure of facts or data underlying expert opinion.

The expert may testify in terms of opinion or inference and give reasons therefore; however the expert must testify as to the facts or data on which the opinion or inference is based.”

Hansen, 77 Pa. D. & C.4th at 504 (citing and quoting Rule 705). The Pennsylvania version of Rule 705 differs significantly from the Federal Rule of Evidence 705 by requiring actual disclosure of the evidence upon which an expert witness opines. In Pennsylvania state court, it is not sufficient for juries or judges to evaluate expert witness testimony upon looks, demeanor, apparent bias, and the like:

“While most rules of evidence concern the admission of facts, Rule 705 concerns itself not with admission but disclosure. Absent a clear disclosure of the factual basis of opinion testimony, an expert’s opinion does not so much assist the jury with their determination of the facts as replace the jury’s essential factfinding role. Without a clear disclosure, the jury has no basis for determining whether the facts as understood or assumed by the expert are compatible with the facts as the jury finds them to be. Thus, Rule 705 was adopted to preserve the exclusive factfinding function of the jury.”

Id. at 507 (internal citations omitted). Pennsylvania Rule of Evidence 705 requires specificity by the testifying expert witness in identifying the actual basis for his or her opinion:

“The Rule 705 requirement of presenting the ‘facts and data’ which form the basis of the opinion may not be satisfied by a mere formalistic recitation of the material reviewed or considered. That pro forma routine absolutely obscures what Rule 705 intends to clarify and is tantamount to the clearly impermissible tactic of offering an opinion based on ‘all the evidence’.”

Id. at 511 -12 (internal citations omitted).

The omission of the Pennsylvania rule from federal practice and many other states’ practices illustrates our legal system’s failure to insist upon showing the factfinder the actual evidence. We have a long way to go, in journalism, politics, and law, to become an evidence-based society.

Posted in Expert Witnesses, Underlying Data | Comments Off on Avoiding Nonsense About Science — Ask For The Evidence

Conflicted Public Interest Groups

November 3rd, 2013

The current “wisdom”:

“Conflict of interest in science is a very important issue, and it is a very big problem, because if uncontrolled, it can lead to biased, misleading and even false opinions about scientific evidence.” Dariusz Leszczynski, “Conflicting statements by the two experts of the Royal Society of Canada,” (Nov. 1, 2013)

This statement and the remainder of the blog post is an example of the current obsession and delusion over conflicts of interest (COIs). COIs do not lead to false opinions (assuming an opinion can be false); fraud, misrepresentation, errors in data collection and analyses, fallacies, and inferential mistakes are what lead to misleading and false statements in science. COIs may perhaps trigger greater scrutiny for error, but there is nothing in a COI disclosure, or lack of disclosure, that helps us ascertain the validity vel non of a study.

In a recent post, Celeste Monforton, of George Washington University School of Public Health & Health Services, wrote about conflicts of interest and the recent Georgia-Pacific decision out of the First Department of the New York Appellate Division, Weitz & Luxenberg P.C. v. Georgia–Pacific LLC, 2013 WL 2435565 (N.Y. App. Div., 1st Dep’t June 6, 2013). Monforton, “Thou dost protest too much. Let the disclosure chips fall where they may” (Oct. 28, 2013).

The bashing of Georgia-Pacific is based upon rather dodgy factual and hypocritical ethical analyses. Historically, authors did not disclose their COIs. In the polarized, political world of occupational safety, studies funded or sponsored by industry, labor unions, plaintiffs’ counsel, or their proxies were rarely or never accompanied by disclosures of COIs. To be sure, current ethical guidelines emphasize the importance of disclosure, but not limited to financial conflicts. Committee on Publication Ethics. If positional and political conflicts of interest were disclosed, we might actual shine light where it is needed, but I suspect Monforton would not be happy with that sort of illumination.

Georgia-Pacific has found itself in a controversy that is driven by one-sided emphasis on industry funding, without a balanced attention to sponsorship by advocacy groups, the litigation industry (a/k/a the “the trial bar”). If Monforton is willing to let the chips fall where they may, she will welcome the attention to her own COIs and the COIs of her advocacy organization, “The Project on Scientific Knowledge and Public Policy” (SKAPP).

Celeste Monforton is on the staff of SKAPP, which purports to support the examination of science and “how it is used and misused in government decision-making and legal proceedings.” SKAPP funds scholarship and research designed to promote “transparent decision-making, based on the best available science, to protect public health.” In other words, SKAPP supports “progressive,” pro-labor, anti-industry, science results, often without regard to the niceties of proper methodology.

The SKAPP website tells us that this organization is guided and supported by an advisory committee, consisting of:

Eula Bingham, PhD
Les Boden, PhD
Richard Clapp, DSc, MPH
Polly Hoppin, ScD
Sheldon Krimsky, PhD
David Michaels, PhD, MPH
David Ozonoff, MD, MPH
Anthony Robbins, MD, MPA

Clapp is a regular testifying witness for the litigation industry. Michaels testified for the litigation industry before President Obama appointed him to be the OSHA Administrator. Ozonoff and Bingham have also shown up in litigation, always on the plaintiffs’ side. Krimsky has been unremitting scold of industry-sponsored science. Robbins was the physician invited to the American Law Institute meeting, where he criticized a draft of the Restatement (Third) of Torts: Liability for Physical and Emotional Harm and accused the ALI of not understanding scientific principles or knowing what it was talking about. 79th Annual Meeting, 2002 A.L.I. PROC. at 294. See Michael D. Green, “Pessimism about Milward,” 3 Wake Forest J. L & Policy 41 (2013). Professor Green, however, has given a thorough rebuttal to Robbins’ partisan and ad hominem criticisms, which suggest that it was Robbins who did not know what he was talking about. See “Milward’s Singular Embrace of Comment C (May 4, 2013).

And whence comes the funding for SKAPP’s one-sided advocacy? At its inception, for some time afterwards, SKAPP was funded by the litigation industry, from a walking-around fund of the plaintiffs’ lawyers in the silicone gel breast implant litigation. SKAPP misleadingly continues to represent this funding as “a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation,” but the fund is nothing more than the fund that exists in virtually every multi-district litigation to allow plaintiffs’ counsel to find and pay expert witnesses, conduct studies, and engage in other activities for the common benefit of the plaintiff-litigants. SKAPP a Lot (April 30, 2010).

The funding ruse by SKAPP raises the question what other “public interest” groups are proxies for the litigation industry? Consider for instance, Public Citizen, which describes itself, on its website, as follows:

“Public Citizen serves as the people’s voice in the nation’s capital. ***

For four decades, we have proudly championed citizen interests before Congress, the executive branch agencies and the courts. We have successfully challenged the abusive practices of the pharmaceutical, nuclear and automobile industries, and many others. We are leading the charge against undemocratic trade agreements that advance the interests of mega-corporations at the expense of citizens worldwide.
* * *
Public Citizen is a nonprofit organization that does not participate in partisan political activities or endorse any candidates for elected office. We accept no government or corporate money – we rely solely on foundation grants, publication sales and support from our 300,000 members.”

As it turns out, this group does take corporate money, but selectively from the litigation industry itself. A recent newsletter from Public Citizen (May 2013) highlighted the prevalence of several magnates and trade organizations (AAJ) of the litigation industry among the names of large donors:

the Attorneys Information Exchange Group (one of the AAJ’s operating groups); Patrick Malone (plaintiffs’ personal injury lawyer);

Barry Nace (former President of ATLA);
Robert Habush (former President of ATLA 1986-87);
Frederic Levin; (plaintiffs’ personal injury lawyer);
Ken Suggs (President of ATLA/AAJ 2005-06);
Robert L. Habush Endowment (funding arm of the AAJ)

I suspect that you will not find many publications or positions from Public Citizen that challenge “the abusive practices of the” litigation industry.

The point is, of course, that there are plenty of conflicts to go around, and so little valid data and analysis. The Monfortons of the world have used COI rhetoric to chill freedom of speech and to bias the discussion towards their preferred outcomes.

Posted in Conflicts of Interest | Comments Off on Conflicted Public Interest Groups

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.

Posted in Rule 702, Rule 703, statistical evidence | Comments Off on The Seventh Circuit Regresses on Rule 702

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).

Posted in Causation, Expert Witnesses, Rule 702 | Comments Off on Bendectin, Diclegis & The Philosophy of Science

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