TORTINI

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Beecher-Monas Proposes to Abandon Common Sense, Science, and Expert Witnesses for Specific Causation

September 11th, 2015

Law reviews are not peer reviewed, not that peer review is a strong guarantor of credibility, accuracy, and truth. Most law reviews have no regular provision for letters to the editor; nor is there a PubPeer that permits readers to point out errors for the benefit of the legal community. Nonetheless, law review articles are cited by lawyers and judges, often at face value, for claims and statements made by article authors. Law review articles are thus a potent source of misleading, erroneous, and mischievous ideas and claims.

Erica Beecher-Monas is a law professor at Wayne State University Law School, or Wayne Law, which considers itself “the premier public-interest law school in the Midwest.” Beware of anyone or any institution that describes itself as working for the public interest. That claim alone should put us on our guard against whose interests are being included and excluded as legitimate “public” interest.

Back in 2006, Professor Beecher-Monas published a book on evaluating scientific evidence in court, which had a few goods points in a sea of error and nonsense. See Erica Beecher-Monas, Evaluating Scientific Evidence: An Interdisciplinary Framework for Intellectual Due Process (2006)[1]. More recently, Beecher-Monas has published a law review article, which from its abstract suggests that she might have something to say about this difficult area of the law:

“Scientists and jurists may appear to speak the same language, but they often mean very different things. The use of statistics is basic to scientific endeavors. But judges frequently misunderstand the terminology and reasoning of the statistics used in scientific testimony. The way scientists understand causal inference in their writings and practice, for example, differs radically from the testimony jurists require to prove causation in court. The result is a disconnect between science as it is practiced and understood by scientists, and its legal use in the courtroom. Nowhere is this more evident than in the language of statistical reasoning.

Unacknowledged difficulties in reasoning from group data to the individual case (in civil cases) and the absence of group data in making assertions about the individual (in criminal cases) beset the courts. Although nominally speaking the same language, scientists and jurists often appear to be in dire need of translators. Since expert testimony has become a mainstay of both civil and criminal litigation, this failure to communicate creates a conundrum in which jurists insist on testimony that experts are not capable of giving, and scientists attempt to conform their testimony to what the courts demand, often well beyond the limits of their expertise.”

Beecher-Monas, “Lost in Translation: Statistical Inference in Court,” 46 Arizona St. L.J. 1057, 1057 (2014) [cited as BM].

A close read of the article shows, however, that Beecher-Monas continues to promulgate misunderstanding, error, and misdirection on statistical and scientific evidence.

Individual or Specific Causation

The key thesis of this law review is that expert witnesses have no scientific or epistemic warrant upon which to opine about individual or specific causation.

“But what statistics cannot do—nor can the fields employing statistics, like epidemiology and toxicology, and DNA identification, to name a few—is to ascribe individual causation.”

BM at 1057-58.

Beecher-Monas tells us that expert witnesses are quite willing to opine on specific causation, but that they have no scientific or statistical warrant for doing so:

“Statistics is the law of large numbers. It can tell us much about populations. It can tell us, for example, that so-and-so is a member of a group that has a particular chance of developing cancer. It can tell us that exposure to a chemical or drug increases the risk to that group by a certain percentage. What statistics cannot do is tell which exposed person with cancer developed it because of exposure. This creates a conundrum for the courts, because nearly always the legal question is about the individual rather than the group to which the individual belongs.”

BM at 1057. Clinical medicine and science come in for particular chastisement by Beecher-Monas, who acknowledges the medical profession’s legitimate role in diagnosing and treating disease. Physicians use a process of differential diagnosis to arrive at the most likely diagnosis of disease, but the etiology of the disease is not part of their normal practice. Beecher-Monas leaps beyond the generalization that physicians infrequently ascertain specific causation to the sweeping claim that ascertaining the cause of a patient’s disease is beyond the clinician’s competence and scientific justification. Beecher-Monas thus tells us, in apodictic terms, that science has nothing to say about individual or specific causation. BM at 1064, 1075.

In a variety of contexts, but especially in the toxic tort arena, expert witness testimony is not reliable with respect to the inference of specific causation, which, Beecher-Monas writes, usually without qualification, is “unsupported by science.” BM at 1061. The solution for Beecher-Monas is clear. Admitting baseless expert witness testimony is “pernicious” because the whole purpose of having expert witnesses is to help the fact finder, jury or judge, who lack the background understanding and knowledge to assess the data, interpret all the evidence, and evaluate the epistemic warrant for the claims in the case. BM at 1061-62. Beecher-Monas would thus allow the expert witnesses to testify about what they legitimately know, and let the jury draw the inference about which expert witnesses in the field cannot and should not opine. BM at 1101. In other words, Beecher-Monas is perfectly fine with juries and judges guessing their way to a verdict on an issue that science cannot answer. If her book danced around this recommendation, now her law review article has come out into the open, declaring an open season to permit juries and judges to be unfettered in their specific causation judgments. What is touching is that Beecher-Monas is sufficiently committed to gatekeeping of expert witness opinion testimony that she proposes a solution to take a complex area away from expert witnesses altogether rather than confront the reality that there is often simply no good way to connect general and specific causation in a given person.

Causal Pies

Beecher-Monas relies heavily upon Professor Rothman’s notion of causal pies or sets to describe the factors that may combine to bring about a particular outcome. In doing so, she commits a non-sequitur:

“Indeed, epidemiologists speak in terms of causal pies rather than a single cause. It is simply not possible to infer logically whether a specific factor caused a particular illness.”[2]

BM at 1063. But the question on her adopted model of causation is not whether any specific factor was the cause, but whether it was one of the multiple slices in the pie. Her citation to Rothman’s statement that “it is not possible to infer logically whether a specific factor was the cause of an observed event,” is not the problem that faces factfinders in court cases.

With respect to differential etiology, Beecher-Monas claims that “‘ruling in’ all potential causes cannot be done.” BM at 1075. But why not? While it is true that disease diagnosis is often made upon signs and symptoms, BM at 1076, sometimes physicians are involved in trying to identify causes in individuals. Psychiatrists of course are frequently involved in trying to identify sources of anxiety and depression in their patients. It is not all about putting a DSM-V diagnosis on the chart, and prescribing medication. And there are times, when physicians can say quite confidently that a disease has a particular genetic cause, as in a man with BrCa1, or BrCa2, and breast cancer, or certain forms of neurodegenerative diseases, or an infant with a clearly genetically determined birth defect.

Beecher-Monas confuses “the” cause with “a” cause, and wonders away from both law and science into her own twilight zone. Here is an example of how Beecher-Monas’ confusion plays out. She asserts that:

“For any individual case of lung cancer, however, smoking is no more important than any of the other component causes, some of which may be unknown.”

BM at 1078. This ignores the magnitude of the risk factor and its likely contribution to a given case. Putting aside synergistic co-exposures, for most lung cancers, smoking is the “but for” cause of individual smokers’ lung cancers. Beecher-Monas sets up a strawman argument by telling us that is logically impossible to infer “whether a specific factor in a causal pie was the cause of an observed event.” BM at 1079. But we are usually interested in whether a specific factor was “a substantial contributing factor,” without which the disease would not have occurred. This is hardly illogical or impracticable for a given case of mesothelioma in a patient who worked for years in a crocidolite asbestos factor, or for a case of lung cancer in a patient who smoked heavily for many years right up to the time of his lung cancer diagnosis. I doubt that many people would hesitate, on either logical or scientific grounds, to attribute a child’s phocomelia birth defects to his mother’s ingestion of thalidomide during an appropriate gestational window in her pregnancy.

Unhelpfully, Beecher-Monas insists upon playing this word game by telling us that:

“Looking backward from an individual case of lung cancer, in a person exposed to both asbestos and smoking, to try to determine the cause, we cannot separate which factor was primarily responsible.”

BM at 1080. And yet that issue, of “primary responsibility” is not in any jury instruction for causation in any state of the Union, to my knowledge.

From her extreme skepticism, Beecher-Monas swings to the other extreme that asserts that anything that could have been in the causal set or pie was in the causal set:

“Nothing in relative risk analysis, in statistical analysis, nor anything in medical training, permits an inference of specific causation in the individual case. No expert can tell whether a particular exposed individual’s cancer was caused by unknown factors (was idiopathic), linked to a particular gene, or caused by the individual’s chemical exposure. If all three are present, and general causation has been established for the chemical exposure, one can only infer that they all caused the disease.115 Courts demanding that experts make a contrary inference, that one of the factors was the primary cause, are asking to be misled. Experts who have tried to point that out, however, have had a difficult time getting their testimony admitted.”

BM at 1080. There is no support for Beecher-Monas’ extreme statement. She cites, in footnote 115, to Kenneth Rothman’s introductory book on epidemiology, but what he says at the cited page is quite different. Rothman explains that “every component cause that played a role was necessary to the occurrence of that case.” In other words, for every component cause that actually participated in bringing about this case, its presence was necessary to the occurrence of the case. What Rothman clearly does not say is that for a given individual’s case, the fact that a factor can cause a person’s disease means that it must have caused it. In Beecher-Monas’ hypothetical of three factors – idiopathic, particular gene, and chemical exposure, all three, or any two, or only one of the three may have made a given individual’s causal set. Beecher-Monas has carelessly or intentionally misrepresented Rothman’s actual discussion.

Physicians and epidemiologists do apply group risk figures to individuals, through the lens of predictive regression equations.   The Gail Model for 5 Year Risk of Breast Cancer, for instance, is a predictive equation that comes up with a prediction for an individual patient by refining the subgroup within which the patient fits. Similarly, there are prediction models for heart attack, such as the Risk Assessment Tool for Estimating Your 10-year Risk of Having a Heart Attack. Beecher-Monas might complain that these regression equations still turn on subgroup average risk, but the point is that they can be made increasingly precise as knowledge accumulates. And the regression equations can generate confidence intervals and prediction intervals for the individual’s constellation of risk factors.

Significance Probability and Statistical Significance

The discussion of significance probability and significance testing in Beecher-Monas’ book was frequently in error,[3] and this new law review article is not much improved. Beecher-Monas tells us that “judges frequently misunderstand the terminology and reasoning of the statistics used in scientific testimony,” BM at 1057, which is true enough, but this article does little to ameliorate the situation. Beecher-Monas offers the following definition of the p-value:

“The P- value is the probability, assuming the null hypothesis (of no effect) is true (and the study is free of bias) of observing as strong an association as was observed.”

BM at 1064-65. This definition misses that the p-value is a cumulative tail probability, and can be one-sided or two-sided. More seriously in error, however, is the suggestion that the null hypothesis is one of no effect, when it is merely a pre-specified expected value that is the subject of the test. Of course, the null hypothesis is often one of no disparity between the observed and the expected, but the definition should not mislead on this crucial point.

For some reason, Beecher-Monas persists in describing the conventional level of statistical significance as 95%, which substitutes the coefficient of confidence for the complement of the frequently pre-specified p-value for significance. Annoying but decipherable. See, e.g., BM at 1062, 1064, 1065. She misleadingly states that:

“The investigator will thus choose the significance level based on the size of the study, the size of the effect, and the trade-off between Type I (incorrect rejection of the null hypothesis) and Type II (incorrect failure to reject the null hypothesis) errors.”

BM at 1066. While this statement is sometimes, rarely true, it mostly is not. A quick review of the last several years of the New England Journal of Medicine will document the error. Invariably, researchers use the conventional level of alpha, at 5%, unless there is multiple testing, such as in a genetic association study.

Beecher-Monas admonishes us that “[u]sing statistical significance as a screening device is thus mistaken on many levels,” citing cases that do not provide support for this proposition.[4] BM at 1066. The Food and Drug Administration’s scientists, who review clinical trials for efficacy and safety will be no doubt be astonished to hear this admonition.

Beecher-Monas argues that courts should not factor statistical significance or confidence intervals into their gatekeeping of expert witnesses, but that they should “admit studies,” and leave it to the lawyers and expert witnesses to explain the strengths and weaknesses of the studies relied upon. BM at 1071. Of course, studies themselves are rarely admitted because they represent many levels of hearsay by unknown declarants. Given Beecher-Monas’ acknowledgment of how poorly judges and lawyers understand statistical significance, this argument is cynical indeed.

Remarkably, Beecher-Monas declares, without citation, that the

“the purpose of epidemiologists’ use of statistical concepts like relative risk, confidence intervals, and statistical significance are intended to describe studies, not to weed out the invalid from the valid.”

BM at 1095. She thus excludes by ipse dixit any inferential purposes these statistical tools have. She goes further and gives us a concrete example:

“If the methodology is otherwise sound, small studies that fail to meet a P-level of 5 [sic], say, or have a relative risk of 1.3 for example, or a confidence level that includes 1 at 95% confidence, but relative risk greater than 1 at 90% confidence ought to be admissible. And understanding that statistics in context means that data from many sources need to be considered in the causation assessment means courts should not dismiss non-epidemiological evidence out of hand.”

BM at 1095. Well, again, studies are not admissible; the issue is whether they may be reasonably relied upon, and whether reliance upon them may support an opinion claiming causality. And a “P-level” of 5 is, well, let us hope a serious typographical error. Beecher-Monas’ advice is especially misleading when there is there is only one study, or only one study in a constellation of exonerative studies. See, e.g., In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J. Super. Law Div. Atlantic Cty. Feb. 20, 2015) (excluding Professor David Madigan for cherry picking studies to rely upon).

Confidence Intervals

Beecher-Monas’ book provided a good deal of erroneous information on confidence intervals.[5] The current article improves on the definitions, but still manages to go astray:

“The rationale courts often give for the categorical exclusion of studies with confidence intervals including the relative risk of one is that such studies lack statistical significance.62 Well, yes and no. The problem here is the courts’ use of a dichotomous meaning for statistical significance (significant or not).63 This is not a correct understanding of statistical significance.”

BM at 1069. Well yes and no; this interpretation of a confidence interval, say with a coefficient of confidence of 95%, is a reasonable interpretation of whether the point estimate is statistically significant at an alpa of 5%. If Beecher-Monas does not like strict significant testing, that is fine, but she cannot mandate its abandonment by scientists or the courts. Certainly the cited interpretation is one proper interpretation among several.

Power

There were several misleading references to statistical power in Beecher-Monas’ book, but the new law review tops them by giving a new, bogus definition:

“Power, the probability that the study in which the hypothesis is being tested will reject the alterative [sic] hypothesis when it is false, increases with the size of the study.”

BM at 1065. For this definition, Beecher-Monas cites to the Reference Manual on Scientific Evidence, but butchers the correct definition give by the late David Freedman and David Kaye.[6] All of which is very disturbing.

Relative Risks and Other Risk Measures

Beecher-Monas begins badly by misdefining the concept of relative risk:

“as the percentage of risk in the exposed population attributable to the agent under investigation.”

BM at 1068. Perhaps this percentage can be derived from the relative risk, if we know it to be the true measure with some certainty, through a calculation of attributable risk, but confusing and conflating attributable and relative risk in a law review article that is taking the entire medical profession to task, and most of the judiciary to boot, should be written more carefully.

Then Beecher-Monas tells us that the “[r]elative risk is a statistical test that (like statistical significance) depends on the size of the population being tested.” BM at 1068. Well, actually not; the calculation of the RR is unaffected by the sample size. The variance of course will vary with the sample size, but Beecher-Monas seems intent on ignoring random variability.

Perhaps most egregious is Beecher-Monas’ assertion that:

“Any increase above a relative risk of one indicates that there is some effect.”

BM at 1067. So much for ruling out chance, bias, and confounding! Or looking at an entire body of epidemiologic research for strength, consistency, coherence, exposure-response, etc. Beecher-Monas has thus moved beyond a liberal, to a libertine, position. In case the reader has any doubts of the idiosyncrasy of her views, she repeats herself:

“As long as there is a relative risk greater than 1.0, there is some association, and experts should be permitted to base their causal explanations on such studies.”

BM at 1067-68. This is evidentiary nihilism in full glory. Beecher-Monas has endorsed relying upon studies irrespective of their study design or validity, their individual confidence intervals, their aggregate summary point estimates and confidence intervals, or the absence of important Bradford Hill considerations, such as consistency, strength, and dose-response. So an expert witness may opine about general causation from reliance upon a single study with a relative risk of 1.05, say with a 95% confidence interval of 0.8 – 1.4?[7] For this startling proposition, Beecher-Monas cites the work of Sander Greenland, a wild and wooly plaintiffs’ expert witness in various toxic tort litigations, including vaccine autism and silicone autoimmune cases.

RR > 2

Beecher-Monas’ discussion of inferring specific causation from relative risks greater than two devolves into a muddle by her failure to distinguish general from specific causation. BM at 1067. There are different relevancies for general and specific causation, depending upon context, such as clinical trials or epidemiologic studies for general causation, number of studies available, and the like. Ultimately, she adds little to the discussion and debate about this issue, or any other.


[1] See previous comments on the book at “Beecher-Monas and the Attempt to Eviscerate Daubert from Within”; “Friendly Fire Takes Aim at Daubert – Beecher-Monas And The Undue Attack on Expert Witness Gatekeeping; and “Confidence in Intervals and Diffidence in the Courts.”

[2] Kenneth J. Rothman, Epidemiology: An Introduction 250 (2d ed. 2012).

[3] Erica Beecher-Monas, Evaluating Scientific Evidence: An Interdisciplinary Framework for Intellectual Due Process 42 n. 30, 61 (2007) (“Another way of explaining this is that it describes the probability that the procedure produced the observed effect by chance.”) (“Statistical significance is a statement about the frequency with which a particular finding is likely to arise by chance.”).

[4] See BM at 1066 & n. 44, citing “See, e.g., In re Breast Implant Litig., 11 F. Supp. 2d 1217, 1226–27 (D. Colo. 1998); Haggerty v. Upjohn Co., 950 F. Supp. 1160, 1164 (S.D. Fla. 1996), aff’d, 158 F.3d 588 (11th Cir. 1998) (“[S]cientifically valid cause and effect determinations depend on controlled clinical trials and epidemiological studies.”).”

 

[5] See, e.g., Erica Beecher-Monas, Evaluating Scientific Evidence 58, 67 (N.Y. 2007) (“No matter how persuasive epidemiological or toxicological studies may be, they could not show individual causation, although they might enable a (probabilistic) judgment about the association of a particular chemical exposure to human disease in general.”) (“While significance testing characterizes the probability that the relative risk would be the same as found in the study as if the results were due to chance, a relative risk of 2 is the threshold for a greater than 50 percent chance that the effect was caused by the agent in question.”)(incorrectly describing significance probability as a point probability as opposed to tail probabilities).

[6] David H. Kaye & David A. Freedman, Reference Guide on Statistics, in Federal Jud. Ctr., Reference Manual on Scientific Evidence 211, 253–54 (3d ed. 2011) (discussing the statistical concept of power).

[7] BM at 1070 (pointing to a passage in the FJC’s Reference Manual on Scientific Evidence that provides an example of one 95% confidence interval that includes 1.0, but which shrinks when calculated as a 90% interval to 1.1 to 2.2, which values “demonstrate some effect with confidence interval set at 90%). This is nonsense in the context of observational studies.

Silicone Data Slippery and Hard to Find (Part 2)

July 5th, 2015

What Does a Scientist “Gain,” When His Signal Is Only Noise

When the silicone litigation erupted in the early 1990s, Leoncio Garrido was a research professor at Harvard. In 1995, he was promoted from Assistant to Associate Professor of Radiology, and the Associate Director of NMR Core, at the Harvard Medical School. Along with Bettina Pfleiderer, Garrido published a series of articles on the use of silicon 29 nuclear magnetic resonance (NMR) spectroscopy, in which he claimed to detect and quantify silicon that migrated from the silicone in gel implants to the blood, livers, and brains of implanted women[1].

Plaintiffs touted Garrido’s work on NMR silicone as their “Harvard” study, to offset the prestige that the Harvard Nurses epidemiologic study[2] had in diminishing the plaintiffs’ claims that silicone caused autoimmune disease. Even though Garrido’s work was soundly criticized in the scientific literature[3], Garrido’s apparent independence of the litigation industry, his Harvard affiliation, and the difficulty in understanding the technical details of NMR spectroscopic work, combined to enhance the credibility of the plaintiffs’ claims.

Professor Peter Macdonald, who had consulted with defense counsel, was quite skeptical of Garrido’s work on silicone. In sum, Macdonald’s analysis showed that Garrido’s conclusions were not supported by the NMR spectra presented in Garrido’s papers. The spectra shown had signal-to-noise ratios too low to allow a determination of putative silicon biodegradation products (let alone to quantify such products), in either in vivo or ex vivo analyses. The existence of Garrido’s papers in peer-reviewed journals, however, allowed credulous scientists and members of the media to press unsupported theories about degradation of silicone into supposedly bioreactive silica.

A Milli-Mole Spills the Beans on the Silicone NMR Data

As the silicone litigation plodded on, a confidential informant dropped the dime on Garrido. The informant was a Harvard graduate student, who was quite concerned about the repercussions of pointing the finger at the senior scientist in charge of his laboratory work. Fortunately, and honorably, this young scientist more concerned yet that Garrido was manipulating the NMR spectra to create his experimental results. Over the course of 1997, the informant, who was dubbed “Mini-Mole,” reported serious questions about the validity of the silicon NMR spectra reported by Garrido and colleagues, who had created the appearance of a signal by turning up the gain to enhance the signal/noise ratio. Milli-mole also confirmed Macdonald’s suspicions that Garrido had created noise artifacts (either intentionally or carelessly) that could be misrepresented to be silicon-containing materials with silicon 29 NMR spectra.

In late winter 1997, “Mini-Mole” reported that Harvard had empanelled an internal review board to investigate Garrido’s work on silicon detection in blood of women with silicone gel breast implants. The board involved an associate dean of the medical school, along with an independent reviewer, knowledgeable about NMR. Mini-Mole was relieved that he would not be put into the position of becoming a whistle blower, and he believed that once the board understood the issues, Garrido’s deviation from the scientific standard of care would become clear. Apparently, concern at Harvard was reaching a crescendo, as Garrido was about to present yet another abstract, on brain silicon levels, at an upcoming meeting of the International Society of Magnetic Resonance in Medicine, in Vancouver, BC. Milli-Mole reported that one of the co-authors strongly disagreed with Garrido’s interpretation of the data, but was anxious about withdrawing from the publication.

Science Means Never Having to Say You’re Sorry

By 1997, Judge Pointer had appointed a panel of neutral expert witnesses, but the process had become mired in procedural diversions. Bristol-Myers Squibb sought and obtained a commission in state court (New Jersey) cases for a Massachusetts’ subpoena for Garrido’s underlying data late in1997. Before BMS or the other defendants could act on this subpoena, however, Garrido published a rather weak, non-apologetic corrigendum to one of his papers[4].

Although Garrido’s “Erratum” concealed more than it disclosed, the publication of the erratum triggered an avalanche of critical scrutiny. One of the members of the editorial board of Magnetic Resonance in Medicine undertook a critical review of Garrido’s papers, as a result of the erratum and its fallout. This scientist concluded that:

“From my viewpoint as an analytical spectroscopist, the result of this exercise was disturbing and disappointing. In my judgement as a referee, none of the Garrido group’s papers (1–6) should have been published in their current form.”

William E. Hull, “A Critical Review of MR Studies Concerning Silicone Breast Implants,” 42 Magnetic Resonance in Medicine 984, 984 (1999).

Another scientist, Professor Christopher T.G. Knight, of the University of Illinois at Urbana-Champaign, commented in a letter in response to the Garrido erratum:

“A series of papers has appeared in this Journal from research groups at Harvard Medical School and Massachusetts General Hospital. These papers describe magnetic resonance studies that purport to show significant concentrations of silicone and chemically related species in the blood and internal organs of silicone breast implant recipients. One paper in particular details 29Si NMR spectroscopic results of experiments conducted on the blood of volunteers with and without implants. In the spectrum of the implant recipients’ blood there appear to be several broad signals, whereas no signals are apparent in the spectrum of the blood of a volunteer with no implant. On these grounds, the authors claim that silicone and its degradation products occur in significant quantities in the blood of some implant recipients. Although this conclusion has been challenged, it has been widely quoted.

******

The erratum, in my opinion, deserves considerably more visibility, because it in effect greatly reduces the strength of the authors’ original claims. Indeed, it appears to be tantamount to a retraction of these.”

Christopher T.G. Knight, “Migration and Chemical Modification of Silicone in Women With Breast Prostheses,” 42 Magnetic Resonance in Med. 42:979 (1999) (internal citations omitted). Professor Knight went on to critique the original Garrido work, and the unsigned, unattributed erratum as failing to show a difference between the spectra developed from blood of women with and without silicone implants. Garrido’s erratum suggested that his “error” was simply showing a spectrum with the wrong scale, but Professor Knight showed rather conclusively that other manipulations had taken place to alter the spectrum. Id.

In a brief response[5], Garrido and co-authors acknowledged that their silicon quantification was invalid, but still maintained that they had qualitatively determined the presence of silicon entities. Despite Garrido’s response, the scientific community soon became incredulous about his silicone NMR work.

Garrido’s fall-back claim that he had detected unquantified levels of silicon using Si29 NMR was definitively refuted, in short order[6]. Ultimately, Peter Macdonald’s critique of Garrido was vindicated, and Garrido’s work became yet another weight that helped sink the plaintiffs’ case. Garrido last published on silicone in 1999, and left Harvard soon thereafter, to become the Director of the Instituto de Ciencia y Tecnología de Polímeros, in Madrid, Spain. He is now a scientific investigator at the Institute’s Physical Chemistry of Polymers Department. The Institute’s website lists Garrido as Dr. Leoncio Garrido Fernández. Garrido’s silicone publications were never retracted, and Harvard never publicly explained Garrido’s departure.


[1] See, e.g., Bettina Pfleiderer & Leoncio Garrido, “Migration and accumulation of silicone in the liver of women with silicone gel-filled breast implants,” 33 Magnetic Resonance in Med. 8 (1995); Leoncio Garrido, Bettina Pfleiderer, B.G. Jenkins, Carol A. Hulka, D.B. Kopans, “Migration and chemical modification of silicone in women with breast prostheses,” 31 Magnetic Resonance in Med. 328 (1994). Dr. Carol Hulka is the daughter of Dr. Barbara Hulka, who later served as a neutral expert witness, appointed by Judge Pointer in MDL 926.

[2] Jorge Sanchez-Guerrero, Graham A. Colditz, Elizabeth W. Karlson, David J. Hunter, Frank E. Speizer, Matthew H. Liang, “Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms,” 332 New Engl. J. Med . 1666 (1995).

[3] See R.B. Taylor, J.J. Kennan, “29Si NMR and blood silicon levels in silicone gel breast implant recipients,” 36 Magnetic Resonance in Med. 498 (1996); Peter Macdonald, N. Plavac, W. Peters, Stanley Lugowski, D. Smith, “Failure of 29Si NMR to detect increased blood silicon levels in silicone gel breast implant recipients,” 67 Analytical Chem. 3799 (1995).

[4] Leoncio Garrido, Bettina Pfleiderer, G. Jenkins, Carol A. Hulka, Daniel B. Kopans, “Erratum,” 40 Magnetic Resonance in Med. 689 (1998).

[5] Leoncio Garrido, Bettina Pfleiderer, G. Jenkins, Carol A. Hulka, Daniel B. Kopans, “Response,” 40 Magnetic Resonance in Med. 995 (1998).

[6] See Darlene J. Semchyschyn & Peter M. Macdonald, “Limits of Detection of Polydimethylsiloxane in 29Si NMR Spectroscopy,” 43 Magnetic Resonance in Med. 607 (2000) (Garrido’s erratum acknowledges that his group’s spectra contain no quantifiable silicon resonances, but their 29Si spectra fail to show evidence of silicone or breakdown products); Christopher T. G. Knight & Stephen D. Kinrade, “Silicon-29 Nuclear Magnetic Resonance Spectroscopy Detection Limits,” 71 Anal. Chem. 265 (1999).

Discovery of Retained, Testifying Statistician Expert Witnesses (Part 2)

July 1st, 2015

Discovery Beyond the Report and the Deposition

The lesson of the cases interpreting Rule 26 is that counsel cannot count exclusively upon the report and automatic disclosure requirements to obtain the materials necessary or helpful for cross-examination of statisticians who have created their own analyses. Sometimes just asking nicely suffices[1]. Other avenues of discovery are available, however, for reluctant disclosers. In particular, Rule 26(b) authorizes discovery substantially broader than what is required for inclusion in an expert witness’s report.

Occasionally, counsel cite caselaw that has been superseded by the steady expansion of Rule 26[2]. The 1993 amendments made clear, however, that Rule 26 sets out mandatory minimum requirements that do not define or exhaust the available discovery tools to obtain information from expert witnesses[3]. Some courts continue to insist that a party make a showing of necessity to go beyond the minimal requirements of Rule 26[4], although the better reasoned cases take a more expansive view of the proper scope of expert witness discovery[5].

Although the federal rules may not require the expert witness report to include, or to attach, all “working notes or recordings,” or calculations, alternative analyses, and data output files, these materials may be the subject of proper document requests to the adverse party or perhaps subpoenas to the expert witness.  The Advisory Committee Notes explain that the various techniques of discovery kick in by virtue of Rule 26(b), where automatic disclosure and report requirements of Rule 26(a) leave off:

“Rules 26(b)(4)(B) and (C) do not impede discovery about the opinions to be offered by the expert or the development, foundation, or basis of those opinions. For example, the expert’s testing of material involved in litigation, and notes of any such testing, would not be exempted from discovery by this rule. Similarly, inquiry about communications the expert had with anyone other than the party’s counsel about the opinions expressed is unaffected by the rule. Counsel are also free to question expert witnesses about alternative analyses, testing methods, or approaches to the issues on which they are testifying, whether or not the expert considered them in forming the opinions expressed. These discovery changes therefore do not affect the gatekeeping functions called for by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and related cases.[6]

The court in Ladd Furniture v. Ernst & Young explained the structure of Rule 26 with respect to underlying documents, calculations, and data[7].  In particular, the requirements of the Rule 26(a) report do not create a limitation on Rule 26(b) discovery:

“As a basis for withholding the above information, Ladd argues that Ernst & Young is not entitled to discover any expert witness information which is not specifically mentioned in Rule 26(a)(2)(B). However, as explained below, Ladd’s position on this point is not supported by the text of Rule 26 or by the Advisory Committee’s commentary to Rule 26(a). In the text, Rule 26(a)(2)(B) provides for the mandatory disclosure of certain expert witness information, even without a request from the opposing party. However, there is no indication on the face of the rule to suggest that a party is absolutely prohibited from seeking any additional information about an opponent’s expert witnesses. In fact, Rule 26(b)(1) describes the scope of allowable discovery as follows: ‛Parties may obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action… .’ Fed. R. Civ. P. 26(b)(1).[8]

Expert witness discovery for materials that go beyond what is required in an adequate Rule 26(a) report can have serious consequences for the expert witness who fails to produce the requested materials. Opinion exclusion is an appropriate remedy against an expert witness who failed to keep data samples and statistical packages because the adversary party “could not attempt to validate [the expert witness’s] methods even if [the witness] could specifically say what he considered.[9]

No doubt expert witnesses and parties will attempt to resist the call for working notes and underlying materials on the theory that the requested documents and materials are “draft reports,” which are now protected by the revisions to Rule 26.  For the most part, these evasions have been rejected[10].  In one case, for instance, in which an expert witness’s assistants compiled and summarized information from individual case files, the court rejected the characterization of the information as part of a “draft report,” and ordered their production.[11]

Choice of Discovery Method Beyond Rule 26 Automatic Disclosure

In addition to the mandatory expert report and disclosure of data and facts, and the optional deposition by oral examination, parties have other avenues to pursue discovery of information, facts, and data, from expert witnesses. Under Rule 33(a)(2), parties may propound contention interrogatories that address expert witnesses’ opinions and conclusions. As for methods of discovery beyond what is discussed specifically in Rule 26, courts are confronted with a threshold question whether Rule 34 requests to produce, Rule 30(b)(2) depositions by oral examination, or Rule 45 subpoenas are the appropriate discovery method for obtaining documents from a retained, testifying expert witness. In the view of some courts, the resolution to this threshold question turns on whether expert witnesses are within the control of parties such that parties must respond to discovery for information, documents, and things within the custody, possession, and control of their expert witnesses.

Subpoenas Are Improper

Some federal district courts view Rule 45 subpoenas as inappropriate discovery tools for parties[12] and persons under the control of parties. In Alper v. United States[13], the district court refused to enforce plaintiff’s Rule 45 subpoena that sought documents from defendant’s expert witness. Although acknowledging that Rule 45’s language was unclear, the Alper court insisted that since a party proffers an expert witness, that witness should be considered under the party’s control[14]. And because the expert witness was “within defendant’s control,” the court noted that Rule 34 rather than Rule 45 governed the requested discovery[15]. Alper seems to be a minority view, but its approach is attractive in streamlining discovery, eliminating subpoena service issues for expert witnesses who may live outside the district, and forcing the sponsoring party to respond and to obtain compliance with its retained expert witness.

Subpoenas Are Proper

The “control” rationale of the Alper case is questionable. Rule 45 contains no statement of limitation to non-parties[16]. Parties “proffer” fact witnesses, but their proffers do not restrict the availability of Rule 45 subpoenas. More important, expert witnesses are not truly under the control of the retaining parties. Expert witnesses have independent duties to the court, and under their own professional standards, to give their own independent opinions[17].

Many courts allow discovery of expert witness documents and information by Rule 45 subpoena on either the theory that Rule 45 subpoenas are available for both parties and non-parties or the theory that expert witnesses are sufficiently independent of the sponsoring party that they are non-parties who are clearly subject to Rule 45. If expert witnesses are not parties, and Rule 26’s confidentiality provisions do not constrain the available discovery tools for expert witnesses, then expert witness subpoenas would appear to a proper discovery tool to discover documents in the witnesses’ possession, control, and custody[18]. When used as a discovery tool in this way, subpoenas used are subject to discovery deadlines[19].

Particular Concerns for Discovery of Statistician Expert Witnesses

Statistician expert witnesses require additional care and discovery investigation in complex products liability cases[20].  The caselaw sometimes takes a crabbed approach that refuses to provide parties access to their adversaries’ statistical analyses, calculations, data input  and output files, and graphical files.

Statistician expert testimony will usually involve complex statistical evidence, models, assumptions, and calculations. These materials will in turn create a difficulty in discerning the statistician’s choices from available statistical tests, and whether the statistician exploited the opportunity for multiple tests to be conducted serially with varying assumptions until a propitious result was obtained. Given these typical circumstances, statistical expert witness testimony will almost always require full disclosure to allow the adversary a fair opportunity to cross-examine at trial, or to challenge the validity of the proffered analyses under Rules 702 and 703[21].

Statisticians create and use a variety of materials that are clearly relevant to the their opinion:

  • programs and programming code run to generate all specified analyses on specified data,
  • statistical packages,
  • all data available,
  • all data “cleaning” or data selection processes,
  • selection of variables from those available,
  • data frames that show what data were included (and excluded) in the analyses,
  • data input files,
  • all specified tests run on all data,
  • all data and analysis output files that show all analyses generated,
  • all statistical test diagnostics and tests of underlying assumptions, and
  • graphical output files.

The statistician may have made any number of decisions or judgments in selecting which statistical test results to incorporate into his or her final report.  The report will in all likelihood not include important materials that would allow another statistician to fully understand, test, replicate, and criticize the more conclusory analysis and statements in the report.  In addition, lurking in the witnesses files, or in the electronic “trash bin” may be alternative analyses that were run and discarded, and not included in the final report.  Why and how those alternative analyses were run but discarded, may raise important credibility or validity questions, as well as provide insight into the statistician’s analytical process, all important considerations in preparing for cross-examination and rebuttal.  The lesson of Rule 26, and the caselaw interpreting its provisions, is that lawyers must make specific request for the materials described above.  Only with these materials firmly in hand, can a deposition fully explore the results obtained, the methods used, the assumptions made, the assumptions violated, the alternative methods rejected, the data used, the data available, data not used, the data-dredging and manipulation potential, analytical problems, and the potential failure to reconcile inconsistent results. Waiting for trial, or even for the deposition, may well be too late[22].

The warrant for examining the integrity of data relied upon by expert witnesses appears to be securely embedded in the Federal Rules of Civil Procedure, and in the Federal Rules of Evidence. Evidence Rule 703 has particular relevance to statistical or epidemiologic testimony. Lawyers facing studies of dubious quality may need to press for discovery of underlying data and materials. In the Viagra vision loss multi-district litigation (MDL), the defendant sought and obtained discovery of underlying data from plaintiffs’ expert witness’s epidemiologic study of vision loss among patients using Viagra and similar medications[23]. Although the Viagra MDL court had struggled with inferential statistics in its first approach to defendant’s Rule 702 motion, the court understood the challenge based upon lack of data integrity, and reconsidered and granted defendant’s motion to exclude the challenged expert witness[24].

The lawyering implications for discovery of statistician expert witnesses are important. Statistical evidence requires counsel’s special scrutiny to ensure compliance with the disclosure requirements of Federal Rule of Civil Procedure 26. Given the restrictive reading of Rule 26 by some courts, counsel will need to anticipate the use of other discovery tools. Lawyers should request by Rule 34 or Rule 45, all computer runs, programming routines, and outputs, and they should zealously pursue witnesses’ failure to maintain and produce data. Given the uncertainty in some districts whether expert witnesses are subject to subpoenas, counsel may consider propounding both Rule 34 requests and serving Rule 45 subpoenas.

Lawyers in data-intensive cases should give early consideration to appropriate discovery plans that contemplate data production in advance of depositions, to allow full exploration of analyses at deposition[25]. Lawyers should also be alert to the potential need to show particularized need for the requested data and analyses. In instructing expert witnesses on their preparation of their reports, lawyers should consider directing their expert witnesses to express whether they need further access to the adversary’s expert witnesses’ underlying data and materials to fully evaluate the proffered opinions. Discovery of statisticians and their data and their analyses requires careful planning, as well as patient efforts to educate the court about the need for full exploration of all data and all analyses conducted, whether or not incorporated into the Rule 26 report.


[1] Randall v. Rolls-Royce Corp., 2010 U.S. Dist. LEXIS 23421, *4-5 (S.D. Ind. March 12, 2010) (“Dr. Harnett who began his evaluation of the analysis contained in the report … soon concluded that he needed the underlying studies and statistical programs created or used by Dr. Drogin. In response to the Defendants’ request for such materials, Plaintiffs produced four discs containing more than 1,000 separate electronic files”).

[2] Marsh v. Jackson, 141 F.R.D. 431, 432–33 (W.D. Va. 1992) (holding that Rule 45 could not be used to obtain an opposing expert’s files because Rule 26(b)(4) limits expert discovery to depositions and interrogatories as a policy matter)

[3] See Advisory Comm. Notes for 1993 Amendments, to Fed. R. Civ. P. 26(a) (“The enumeration in Rule 26(a) of items to be disclosed does not prevent a court from requiring by order or local rule that the parties disclose additional information without a discovery request. Nor are parties precluded from using traditional discovery methods to obtain further information regarding these matters, … .”); United States v. Bazaarvoice, Inc., C 13-00133 WHO (LB), 2013 WL 3784240 (N.D. Cal. July 18, 2013) (“Rule 26(a)(2)(B) . . . does not preclude parties from obtaining further information through ordinary discovery tools”) (internal citations omitted).

[4] Morriss v. BNSF Ry. Co., No. 8:13CV24, 2014 WL 128393, at *4–6, 2014 U.S. Dist. LEXIS 3757, at *17 (D.Neb. Jan. 13, 2014) (holding that “absent some threshold showing of “compelling reason,” the broad discovery provisions of Rules 34 and 45 cannot be used to undermine the specific expert witness discovery rules in Rule 26(a)(2)”).

[5] Modjeska v. United Parcel Service Inc., No. 12–C–1020, 2014 WL 2807531 (E.D. Wis. June 19, 2014) (holding that Rule 26(a)(2)(B) governs only disclosure in expert witness reports and does not limit or preclude further discovery using ordinary discovery such as requests to produce); Expeditors Int’l of Wash., Inc. v. Vastera, Inc., No. 04 C 0321, 2004 WL 406999, at *3 (N.D. Ill. Feb.26, 2004). See also Wright & Miller, 9A Federal Practice & Procedure Civ. § 2452 (3d ed. 2013).

[6] Adv. Comm. Note for Rule 26(b)(4)(B)(2010).  See, e.g., Ladd Furniture v. Ernst & Young, 1998 U.S. Dist. LEXIS 17345, at *34-37 (M.D.N.C. Aug. 27, 1998).

[7] Id.

[8] Id. at *36-37.

[9] Innis Arden Golf Club v. Pitney Bowes, Inc., 629 F. Supp. 2d 175, 190 (D. Conn. 2009) (excluding expert opinion because his samples and data packages no longer existed and thus “[d]efendants could not attempt to validate [his] methods even if he could specifically say what he considered”). See also Jung v. Neschis, No. 01–Civ. 6993(RMB)(THK), 2007 WL 5256966, at *8–15 (S.D.N.Y. Oct. 23, 2007) (finding that a party’s failure to produce tape recordings that its medical expert witness relied upon for his opinion was ‘‘disturbing’’; precluding expert witness’s testimony).

[10] See, e.g., Dongguk Univ. v. Yale Univ., No. 3:08-CV-00441, 2011 WL 1935865, at *1 (D. Conn. May 19, 2011) (holding that “an expert’s handwritten notes are not protected from disclosure because they are neither drafts of an expert report nor communications between the party’s attorney and the expert witness”).

[11] D.G. ex rel. G. v. Henry, No. 08-CV-74-GKF-FHM, 2011 WL 1344200, at *1 (N.D. Okla. Apr. 8, 2011) (ordering production of the assistants’ notes because the expert witness had relied upon them in forming his opinion, which brought them within the scope of “facts or data” under the rule).

[12] Mortgage Info. Servs, Inc. v. Kitchens, 210 F.R.D. 562, 564-68 (W.D.N.C. 2002) (holding that nothing in Rule 45 precludes its use on a party); See also Mezu v. Morgan State Univ., 269 F.R.D. 565, 581 (D. Md. 2010) (“courts are divided as to whether Rule 45 subpoenas should be served on parties”); Peyton v. Burdick, 2008 U.S. Dist. LEXIS 106910 (E.D. Cal. 2008) (discussing the split among courts on the issue).

[13] 190 F.R.D. 281 (D. Mass. 2000).

[14] Id. at 283.

[15] Id. See Ambrose v. Southworth Products Corp., No. CIV.A. 95–0048–H, 1997 WL 470359, 1 (W.D. Va. June 24, 1997) (holding a “naked” subpoena duces tecum directed to a non-party expert retained by a party is not within the ambit of a Rule 45 document production subpoena, and not permitted by Fed. R. Civ. Pro. 26(b)(4)); see also Hartford Fire Ins. v. Pure Air on the Lake Ltd., 154 F.R.D. 202, 208 (N.D. Ind. 1993) (holding a party cannot use Rule 45 to circumvent Rule 26(b)(4) as a method to obtain an expert witness’s files); Marsh v. Jackson, 141 F.R.D. 431, 432 (W.D. Va. 1992) (noting that subpoena for production of documents directed to non-party expert retained by a party is not within ambit of Fed. Rule 45(c)(3)(8)(ii)).

[16] See James Wm. Moore, 9 Moore’s Federal Practice § 45.03[1] (noting that “[s]ubpoenas under Rule 45 may be issued to parties or non-parties”).

[17] See Glendale Fed. Bank, FSB v.United States, 39 Fed. Cl. 422, 424 (Fed. Cl. 1997) (“The expert witness, testifying under oath, is expected to give his own honest, independent opinion… He is not the sponsoring party’s agent at any time merely because he is retained as its expert witness”). See also National Justice Compania Naviera S.A. v. Prudential Assurance Co. Ltd., (“The Ikarian Reefer”), [1993] 2 Lloyd’s Rep. 68 at 81-82 (Q.B.D.), rev’d on other grounds [1995] 1 Lloyd’s Rep. 455 at 496 (C.A.) (embracing the enumeration of duties, including a duty to “provide independent assistance to the Court by way of objective unbiased opinion in relation to matters within his expertise,” and a duty to eschew “the role of an advocate”).

[18] Western Res., Inc. v. Union Pac. RR, No. 00-2043-CM, 2002 WL 1822428, at *3 (D. Kan. July 23, 2002) (ordering expert witness to produce prior testimony under Rule 45); All W. Supply Co. v. Hill’s Pet Prods. Div., Colgate-Palmolive Co., 152 F.R.D. 634, 639 (D. Kan. 1993) (“With regard to nonparties such as plaintiff’s expert witness, a request for documents may be made by subpoena duces tecum pursuant to Rule 45”); Smith v. Transducer Technology, Inc., No. Civ. 1995/28, 2000 WL 1717332, 2 (D.V.I. Nov. 16, 2000) (holding that Rule 30(b)(5) deposition notice, served upon opposing party, is not an appropriate discovery tool to compel expert witness to produce documents from at his deposition) (noting that a “Rule 45 subpoena duces tecum in conjunction with a properly noticed deposition may do so (subject however to any Rule 26 limitations)”); Thomas v. Marina Assocs., 202 F.R.D. 433, 434 (E.D. Pa. 2001) (denying motion to quash subpoenas issued to party’s expert witness); Quaile v. Carol Cable Co., Civ. A. No. 90-7415, 1992 WL 277981, at *2 (E.D. Pa. Oct. 5, 1992) (granting motion to compel discovery concerning expert witness’s opinions pursuant to a Rule 45 subpoena); Lawrence E. Jaffe Pension Plan v. Household Int’l, Inc., No. 02 C 5893, 2008 WL 687220, at *2 (N.D. Ill Mar. 10, 2008) (“It is clear . . . that a subpoena duces tecum . . . is an appropriate discovery mechanism against . . . a party’s expert witness”) (internal citation omitted); Expeditors Internat’l of Wash., Inc. v. Vastera, Inc., No. 04 C 0321, 2004 WL 406999, at *2-3 (N.D. Ill. Feb. 26, 2004) (holding Rule 45, not Rule 34, governs discovery from retained experts) (“Subpoena duces tecum is . . . an appropriate discovery mechanism against nonparties such as a party’s expert witness”); Reit v. Post Prop., Inc., No. 09 Civ. 5455(RMB)(KNF), 2010 WL 4537044, at *9 (S.D.N.Y. Nov. 4, 2010) (“Subpoena duces tecum … is an appropriate discovery mechanism against a nonparty expert”).

[19] See, e.g., Williamson v. Horizon Lines LLC , 248 F.R.D. 79, 83 (D. Me. 2008) (“[C]ontrary to Horizon Lines’ contention, there is a relationship between Rule 26 and Rule 45 and parties should not be allowed to employ a subpoena after a discovery deadline to obtain materials from third parties that could have been produced before discovery.”).

[20] Bartley v. Isuzu Motors Ltd., 151 F.R.D. 659, 660-61 (D. Colo. 1993) (ordering party to create and preserve “the input and output data for each variable in the program, for each iteration, or each simulation,” as well as a record of all simulations performed, even those that do not conform to the plaintiff’s claims and theories in the case).

[21] See City of Cleveland v. Cleveland Elec. Illuminating Co., 538 F. Supp. 1257 (N.D. Ohio 1980) (“Certainly, where, as here, the expert reports are predicated upon complex data, calculations and computer simulations which are neither discernible nor deducible from the written reports themselves, disclosure thereof is essential to the facilitation of effective and efficient examination of these experts at trial.”); Shu-Tao Lin v. McDonnell-Douglas, Corp., 574 F. Supp. 1407, 1412-13 (S.D.N.Y. 1983) (granting new trial, and holding that expert witness’s failure to disclosure the “nature of [the plaintiff’s testifying expert’s] computer program or the underlying data, the inputs and outputs employed in the program” deprived adversary of an “adequate basis on which to cross-examine plaintiff’s experts”), rev’d on other grounds, 742 F.2d 45 (2d Cir. 1984).

[22] Manual for Complex Litigation at 99, § 11.482 (4th ed. 2004) (“Early and full disclosure of expert evidence can help define and narrow issues. Although experts often seem hopelessly at odds, revealing the assumptions and underlying data on which they have relied in reaching their opinions often makes the bases for their differences clearer and enables substantial simplification of the issues. In addition, disclosure can facilitate rulings well in advance of trial on objections to the qualifications of an expert, the relevance and reliability of opinions to be offered, and the reasonableness of reliance on particular data.207”). See also ABA Section of Antitrust Law, Econometrics: Legal, Practical, and Technical Issues at 75-76 (2005) (advising of the necessity to obtain all data, all analyses, and all supporting materials, in advance of deposition to ensure efficient and effective discovery procedures).

[23] In re Viagra Prods. Liab. Litig., 572 F. Supp. 2d 1071, 1090 (D. Minn. 2008).

[24] In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 936, 945 (D. Minn. 2009).

[25] See Fed. R. Civ. Pro. 16(b); 26(f).

Government Secrecy That Denies Defendant A Fair Trial – Because of Reasons

June 20th, 2015

In Davis v. Ayala, defendant Hector Ayala challenged the prosecutor’s use of preemptory challenges in an apparently racially motivated fashion. The trial judge allowed the prosecutor to disclose his reasons in an ex parte session, without the defense present. Under the Supreme Court’s decision in Batson, the defendant should have had the opportunity to inquiry into the bona fides of the prosecutor’s claimed motivations. Based upon the prosecutor’s one-sided presentation, the trial judge ruled that the prosecutor had valid, race-neutral grounds for the contested strikes. After a trial, the empanelled jury convicted Ayala of murder, and sentenced him to death. In a 5-4 decision, the Supreme Court held that the trial court’s error was harmless. Davis v. Ayala, Supreme Court, No. 13–1428 (June 18, 2015). Justice Kennedy issued a concurrence. His conscience was curiously not troubled by the Star Chamber proceedings, but the facts of Ayala’s post-conviction incarceration, which has taken place largely in solitary confinement.

Remarkably, the New York Times weighed in on the Ayala case, but not to castigate the Court for rubber-stamping Kafkaesque Rules of Procedure that permits the defense to be excluded and prevented from exercising its Constitutionally protected role. The Times chose to spill ink instead on Justice Kennedy’s concurrence on the length of solitary confinement. Editorial, “Justice Kennedy on Solitary Confinement,” N.Y. Times (June 19, 2015).

What is curious about Justice Kennedy’s focus, and the Times’ cheerleading, is that they run roughshod over a procedural error that excused prosecutorial secrecy and that affected the adjudication of guilt or innocence, only to obsess about whether a man, taken to be guilty, has been treated inhumanely by the California prison system. Even more curious is the willingness to the Times to castigate, on bogus legal grounds, Justice Thomas for responding to Justice Kennedy:

“In a brief, sour retort that read more like a comment to a blog post, Justice Clarence Thomas quipped that however small Mr. Ayala’s current accommodations may be, they are ‘a far sight more spacious than those in which his victims, Ernesto Dominguez Mendez, Marcos Antonio Zamora, and Jose Luis Rositas, now rest’. It was a bizarre and unseemly objection. The Eighth Amendment does not operate on a sliding scale depending on the gravity of a prisoner’s crime.”

Id. (emphasis added). Except, of course, the Eight Amendment’s requirement of proportionality does operate on a sliding scale[1]. In Kennedy v. Louisiana, 554 U.S. 407 (2008), for instance, the Court held that the Eighth Amendment’s Cruel and Unusual Punishments Clause prohibited a state from imposing the death penalty to punish a child rapist because of the sanction’s disproportionality[2].

Perhaps the New York Times could hire a struggling young lawyer to fact check its legal pronouncements? Both Justice Kennedy and Justice Thomas were in the same majority that would tolerate denying the defendant of his constitutional right to examine prosecutor’s motivation for striking black and Hispanic jurors. What a “sour note” for the Times to sound over Justice Thomas’s empathy for the victims of the defendant’s crimes.


[1] William W. Berry III, “Eighth Amendment Differentness,” 78 Missouri L. Rev. 1053 (2013); Charles Walter Schwartz, “Eighth Amendment Proportionality Analysis and the Compelling Case of William Rummel,” 71 J. Crim. L. & Criminology 378 (1980); John F. Stinneford, “Rethinking Proportionality Under the Cruel and Unusual Punishments Clause,” 97 Va. L. Rev. 899 (2011).

[2] Also curious was that then Senator Barack Obama criticized the Supreme Court for its decision in the Kennedy case. See Sara Kugler “Obama Disagrees With High Court on Child Rape Case,” ABC News (June 25, 2008) (archived from the original).

Asymmetries in the Law Between the Pursuer and the Defender

April 5th, 2014

There are some important asymmetries in the law.  A single defendant is at risk of collateral estoppel, but each individual plaintiff will claim independence lack of privity with the rest of the herd.  Similarly, a defendant in a mass tort may be bound by its cross-examination of a now unavailable witness, but plaintiffs may be able to disavow a previous plaintiff’s examination even though there was a common representation.

Plaintiffs have sought discovery of confidential consulting expert witnesses of a defendant in multi-district litigation, while successfully evading discovery of their own consulting expert witnesses.  Again plaintiffs’ success turns on the lack of privity between and among the many plaintiffs, or because plaintiffs’ counsel indulge the fiction that they were not acting in their role as attorney for claimants.

Expert witnesses for plaintiffs accuse scientists who testify for a defendant of “conflicts of interest,” but conveniently ignore and fail to disclose their own. SeeMore Hypocrisy Over Conflicts of Interest” (Dec. 4, 2010) (Arthur Frank and Barry Castleman); James Coyne, “Lessons in Conflict of Interest: The Construction of the Martyrdom of David Healy and The Dilemma of Bioethics,” 5 Am. J. Bioethics W3 (2005).

Plaintiffs often seek to use evidence of lobbying or “rent-seeking” by defendants.  See Bruce R. Parker and Jennifer Lilore, “Application of the Noerr-Pennington Doctrine to Drug and Medical Device Litigation,”  Rx for the Defense 2 (Fall 1995) (“Typically, plaintiffs will argue that the petitioning activity was designed to minimize or eliminate regulations pertaining to safety and efficacy in order to maximize profits. Plaintiffs’ counsel often assert that such conduct is reckless and supports an award of punitive damages.”). See, e.g., Ruth v. A.O. Smith Corp., 2006 WL 530388 at *13 (N.D. Ohio Feb. 27, 2006); In re Welding Fume Prods. Liab. Litig., No. 1:03–CV–17000, MDL no. 1535, 2010 WL 7699456, *93 (June 4, 2010) (“Trial Template for Welding Fume MDL Cases”; summarizing previous Noerr-Pennington ruling in this MDL, and rejecting defendants’ motion, in part, to bar use of defendants’ petitioning governmental and quasi-governmental entities to consider scientific studies and arguments concerning “threshold limit values,” despite constitutional protection of speech).

Of course, the plaintiffs’ bar lobbies as an organized entity, and perhaps its activities should be imputed to all members of the relevant organizations.  Mutuality might chill plaintiffs’ enthusiasm for attacking defendants for their efforts to influence policy. The plaintiffs’ bar is, after all, the litigation industry.  A few weeks ago, the Association of Trial Lawyers of America (ATLA), now operating under the pseudonym American Association of Justice (AAJ), issued a press release (Mar. 13, 2014), praising a proposed FDA regulation that would undermine preemption defenses for manufacturers of generic pharmaceuticals. The press release conveniently omitted that the proposed regulation praised was one that plaintiffs helped craft. Paul Berard, “Trial lawyers helped FDA with rule opening generic drug firms to lawsuits” Wash. Examiner (Mar. 27, 2014).

Last week, the FDA in response to a Congressional inquiry, acknowledged that high-level officials of the agency met with plaintiffs’ lawyer, Ed Blizzard, and regulatory counsel for ATLA-AAJ, Sarah Rooney, and ATLA’s lobbyist, Michael Forscey. See Jeff Overley, “FDA Chief Questioned Over Staff Meeting With Trial Lawyers,” Law360, New York (Mar. 28, 2014).  The meeting was calendared, in February 2013, at the FDA as a follow up to the Supreme Court’s decision in Pliva v. Mensing, which held that FDA regulations preempted state liability claims against makers of generic drugs. The FDA participated through high-level officials, including its chief counsel, and policy advisors.  Congressman Kevin Yoder interrogated FDA Commissioner Margaret Hamburg as to why a private session with plaintiffs’ lawyers and lobbyists, who are in the litigation business.  The news accounts did not provide an explanation why the plaintiffs’ litigation lobbyists could not have submitted their comments publicly.  Mr. Blizzard’s and the ATLA’s lobbying snow storm was, however, registered on the FDA’s public calendar for February 11-15, 2013.

Jim Beck documents that this is not first time that the plaintiffs’ bar has lobbied for their fee-generating activities with the FDA, for rules that fostered their litigation product.  SeeThe More Things Change, The More They Remain The Same” (April 3, 2014). Perhaps when the plaintiffs next make their argument that the FDA is captured by industry, courts should take judicial notice that the plaintiffs’ bar has a great deal of influence as well.

VECTORS, STRESSORS, AND CRANORS

May 10th, 2013

Offense to that man by whom the WOE cometh!

A few weeks ago, the Wake Forest Journal of Law & Policy published six articles from its 2012 Spring Symposium, on “Toxic Tort Litigation After Milward v. Acuity Products.”  Not a single paper is critical of Milward, which is no surprise given that the Symposium was a joint production of The Center for Progressive Reform and the Wake Forest University School of Law.

In previous posts, I addressed concerns about papers from Professors Green and Sanders.  One of the partisan expert witnesses from the Milward case, Carl Cranor, presented at the symposium, and published in the Journal.  See Carl F. Cranor, “Milward v. Acuity Specialty Products: Advances in General Causation Testimony in Toxic Tort Litigation,” PDF 3 Wake Forest J. L. & Policy 105 (2013) [cited herein as Cranor].

The partisan nature of the Wake Forest/CPR symposium is obvious, and perhaps disclosures of conflicts of interest, so real and palpable, are unnecessary.  Cranor acknowledges that he testified for plaintiffs in Milward, but his disclosure does not address how deep his conflict of interest was.  Cranor at 105. In addition to his consulting, report writing, and testifying, Cranor has written briefs for plaintiffs in this and in other litigations.  Unlike the potential for conflict of interest supposedly raised by payments, Cranor’s conflict of interest is actual.  He has been a long-time advocate for radical precautionary principle regulation, legislation, and adjudication.  Cranor’s conflicts are revealed by his writings, his associations, and his activities.

There is nothing wrong with advocacy per se, and Cranor’s ideas, such as they are, deserve to be judged on their merits.  Cranor will no doubt complain that I am addressing one idea at a time, in a corpuscularian fashion, and that his ideas can only be appreciated as a complete gestalt.  If the individual ideas and claims, however, are incorrect, incomplete, inconsistent, and incoherent, we may rightfully reject the entirety of his claims.

Cranor asserts that he is representing how scientists go about their business in reaching judgments of causality.  He has, however, inaccurately described serious attempts to judge causality in order to distort causal assessments into precautionary practice. Cranor presents a reductionist, abridged notion of scientific assessment of causality in order to legitimate the CPR’s radical agenda in both regulation and adjudication.

VAPID AND VACUOUS

Cranor’s principal claim is that “weight of the evidence” (WOE) is a complete, sufficient description of how scientists do, and should, engage in judging causality.  This claim, however, fails because WOE is not a methodology for attributing causation.

In his symposium article, Cranor introduces WOE by telling us that:

“‘Weight of the evidence argument’ is just another name for nondeductive reasoning.”

Cranor at 113 (citing Larry Wright, Practical 46-49 (Fogelin, ed. 1989)

So WOE is equivalent to induction, abduction, analogy, and every other form and manner of non-deductive reasoning.  So, let’s see.  A rat dropped from the top of my building falls to the ground, accelerating at 32 ft/sec/sec.  A mouse dropped accelerates at the same rate.  Rats and mice are both murine mammal species.  This could be a great analogy.  Rats fed large quantities of saccharin develop bladder tumors.  So by analogy, mice develop bladder tumors from saccharin.  It’s an analogy, but it goes very badly wrong.  But Cranor’s explication of WOE fails to explain why this analogy fails to explain or predict the outcome in mice.  See Kenneth Rothman, Sander Greenland, and Timothy Lash, Modern Epidemiology 30 (3d ed. 2008) (“Whatever insight might be derived from analogy is handicapped by the inventive imagination of scientists who can find analogies everywhere”).

Cranor proceeds to introduce a qualitative criterion, “best support,” in non-deductive settings:

“[N]o one conclusion is ‘guaranteed’ by the premises. Consequently, the evaluative task in assessing such inferences is to judge which conclusion the evidence best supports (or, to put it another way, which explanation best accounts for the evidence in the premises) and how well it does so.”

Cranor at 114-15.  Although the requirement of a superlative qualitative assessment seems promising, as we will see, Cranor ensures that the assessment is empty.  Cranor applauds the First Circuit for adopting his identification of WOE with non-deductive reasoning to the best explanation:

“[Nondeductive reasoning or reasoning] to the best explanation can be thought of as involving six general steps, some of which may be implicit. The scientist must

(1) identify an association between an exposure and a disease,

(2) consider a range of plausible explanations for the association,

(3) rank the rival explanations according to their plausibility,

(4) seek additional evidence to separate the more plausible from the less plausible explanations,

(5) consider all of the relevant available evidence, and

(6) integrate the evidence using professional judgment to come to a conclusion about the best explanation.”

Cranor at 115 (citing Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11, 17−18 (1st Cir. 2011)).  Cranor’s and the Circuit’s embrace of this description is seriously flawed.  They move from WOE to “reasoning to the best explanation,” but they do provide any guidance on the key elements:

(1) what constitutes an association?

(2) what renders an explanation plausible, and when is “unknown on the current evidence” an appropriate explanation to offer?

(3) what are the criteria for ranking plausible explanations?

(4) what evidence will discriminate between and among rival explanations?

(5) how do we consider all relevant evidence without using qualitative and quantitative weights?  If we use weights, how?

(6) how do we integrate disparate lines of evidence, and which profession will provide the critical assessment of validity for the integration, and the determinant of what is the “best explanation”?

Cranor harrumphs with the First Circuit:

“[n]o serious argument can be made that the weight of the evidence approach is inherently unreliable.”

Cranor at 115 (quoting Milward, at 18−19).  The double negative is revealing, and so is the utter lack of content to the so-called methodology.  Even if WOE were a method, the Circuit’s statement is meaningless, much like saying that no one could say that physics is inherently unreliable.  Such a statement certainly would not help us judge the bona fides of cold fusion advocates.

WOE IN COURT

Perhaps in an attempt to induce judges and lawyers to lower their intellectual guard, Cranor tells us that WOE is nothing other than what happens in jury trials:

“Jurors, or judges conducting bench trials, use such inferences to find the most plausible account of whether a person is guilty of a crime or has committed a tort. To convict a person of a crime, jurors must find that the total body of relevant evidence supports the conclusion of a nondeductive argument beyond a reasonable doubt; to hold a person accountable for a tort, jurors must find that the total body of relevant evidence supports the conclusion of a nondeductive argument by a preponderance of the evidence, a lower standard of proof.”

Cranor 116.  To be sure, “weight of the evidence” does have a legal usage.  Any superficial appeal of this analogy between scientific assessment of causation and litigation of facts quickly dissipates when we realize the relevant evidence has been filtered for the jury by recognized rules of evidence.  Evidence deemed too weak, too speculative, too prejudicial will have been excluded in a jury trial.  In addition, there are social norms and contexts that operate in a jury trial that may be inimical to the truth-finding process.  My favorite Philadelphia trial anecdote from a former Assistant District Attorney is about a jury that convicted a man for murder.  Although there were racial issues that made the case difficult and the outcome uncertain, after the trial, the forewoman explained that reaching a verdict was easy because the defendant’s mother, who was identified as living near the courthouse, never showed up for the trial.  More “scientific” studies document the role of race, ethnic, and socio-economic prejudice and bias.  Furthermore, in civil and criminal trials, the evidence is generally unweighted except by lawyers’ argument and rhetoric.  A lawyer unhappy with a study’s result may argue that one author had a conflict of interest, even though the study was well designed and conducted, and provided the “weightiest” evidence on the issue to be decided.  Perhaps Cranor advances the trial example because almost “anything goes” in lawyers’ argument and juries’ assessments of scientific issues.

WOE is vacuous as described by Cranor. Statements that all types of relevant research should be considered do not tell us anything.  Stating that “scientific judgment” is necessary says everything, and thus nothing, because it leaves out any description of the methodology to inform and apply the judgment.  Expert witnesses should not be allowed to invoke WOE as a way to avoid methodological scrutiny.

The WOE Cranor would inflict upon the judicial process has been described as a “black box,” which fails to provide any operative method of specifying relevancy or weight for differing kinds of evidence, or method for synthesizing the disparate studies.  We should not be surprised by the lack of endorsement from the scientific community itself for WOE-ful methods.  The phrase is vague and ambiguous; its use, inconsistent.

See, e.g., V. H. Dale, G.R. Biddinger, M.C. Newman, J.T. Oris, G.W. Suter II, T. Thompson, et al., “Enhancing the ecological risk assessment process,” 4 Integrated Envt’l Assess. Management 306 (2008)(“An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence.”);

Igor Linkov, Drew Loney, Susan M. Cormier, F. Kyle Satterstrom, and Todd Bridges, “Weight-of-evidence evaluation in environmental assessment: review of qualitative and quantitative approaches,” 407 Science of Total Env’t 5199–205 (2009) (reviewing the use of WOE methods and concluding that the approach is not particularly rigorous, and that the approach “does not lend itself to transparency or repeatability except in simple cases”);

Douglas Weed, “Weight of Evidence: A Review of Concept and Methods,” 25 Risk Analysis 1545 (2005) (noting the vague, ambiguous, indefinite nature of the concept of “weight of evidence” review);

R.G. Stahl, Jr., “Issues addressed and unaddressed in EPA’s ecological risk guidelines,” 17 Risk Policy Report 35 (1998); (noting that U.S. Environmental Protection Agency’s guidelines for ecological weight-of-evidence approaches to risk assessment fail to provide guidance);

Glenn Suter II & Susan Cormier, “Why and how to combine evidence in environmental assessments:  Weighing evidence and building cases,” 409 Science of the Total Environment 1406, 1406 (2011)(noting arbitrariness and subjectivity of WOE “methodology”);

Charles Menzie, Miranda Hope Henning, Jerome Curac, et al. “A weight-of-evidence approach for evaluating ecological risks; report of the Massachusetts Weight-of-Evidence Work Group,” 2 Human Ecological Risk Assessment 277 (1996) (“although the term ‘weight of evidence’ is used frequently in ecological risk assessment, there is no consensus on its definition or how it should be applied”);

Sheldon Krimsky, “The Weight of Scientific Evidence in Policy and Law,” 95 Supp.(1) Am. J. Pub. Health S129, S131 (2005) (“However, the term [WOE] is applied quite liberally in the regulatory literature, the methodology behind it is rarely explicated.”)

Describing WOE, Krimsky notes that “WOE seems to be coming out of a ‘black box’ of scientific judgment.”  Krimsky at S131.  Revealingly, Krimsky references a report from the Agency for Toxic Substances and Disease Registry (ATSDR) of the Department of Health and Human Services, which describes WOE as an alternative to causal determinations when trying to set policy, when “causality is out of reach.”  Id. (citing citing ATSDR, “The Assessment Process: An Interactive Learning Program,” available at http://www.atsdr.cdc.gov/training/public-health-assessment-overview/html/module2/sv18.html (last visited May 8, 2013).

Krimsky thus acknowledges what Cranor tries so hard to obscure:  WOE is a precautionary approach to be applied when the scientific answer is “I don’t know.”

Who Jumped the Shark in United States v. Harkonen

April 28th, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Conspiracy Theories: Historians, In and Out of Court

April 17th, 2013

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

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

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

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

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

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

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

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

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

Date Range                    Number of Articles from Keyword Search

1940 – 1949                      113

1950 – 1959                    1,421

1960 – 1969                    1,867

1970 – 1979                    1,178

1980 – 1989                       940

1990 – 1999                       882

2000 – 2009                      843

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

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

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

* * * * * * * * * * *

 

 * * * * * * * * * * *

 

* * * * * * * * * * *

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

 

Harriet Hardy’s Views on Asbestos Issues

March 13th, 2013

The Marxist-Leninist would-be historians of occupational health are particularly adept in demonizing those scientists and fellow-historians whose views evidence any lack of support for labor’s positions.  What passes for history of asbestos disease in American courtrooms, marshaled to show notice of hazards to manufacturers, is particularly corrupted by political and ideological animus.

One of the heroes of the left is the late Dr. Harriet Louise Hardy (1906 – 1993), who helped put occupational medicine on the map of American medical research and scholarship.  There is much to admire in the life of Dr. Hardy (who remarkably does not have a Wikipedia entry.) Dr. Hardy’s collaboration with Alice Hamilton, M.D, on the revision of the textbook, Industrial Toxicology, is well known.  Hardy’s colleagues at Harvard wrote a glowing tribute to her, after her death.  John D. Stoeckle, Homayoun Kazemi, Rose Goldman, and Chris Oliver, “Faculty of Medicine: Memorial Minute for Harriet L. Hardy (1905-1993)” (May 1, 1997):

“As she often admitted, her professional life was not a planned academic or specialty career but an accidental product of several influences — her interest in clinical medicine, her school and college health jobs of working with the young and healthy, her identification with and study of the industrial disablements of blue-collar workers, and the support of senior colleagues who encouraged her interests in the illnesses of the workplace, in what she called “clinical preventive medicine”. In such work, unlike the ‘company doc’, whose attachments were to the corporation, hers were to the worker, for whom she advocated in her writings, clinical care, and testimonies before the Workmens’ Compensation Board.”

Her colleagues noted that she suffered from a meningioma, requiring surgery in 1972, and during the last years of her life, from lymphoma.  In 1991, when Hardy was suffering from cancer and the sequelae of serious central nervous system disease, Dr. David Egilman sought her out to write a letter to the editor of the “red journal,” to complain about the use of the medical literature in interpreting the historical evolution of knowledge of asbestos hazards.  See Harriet Hardy & David Egilman, “Corruption of Occupational Medical Literature:  The Asbestos Example,” 20 Am. J. Indus. Med. 127 (1991).

Given Hardy’s credentials and her collaboration with an asbestos plaintiffs’ expert witness, it seems worthwhile to examine her views about asbestos given in her autobiography.  Harriet Hardy, M.D., Challenging Man-Made Disease:  The Memoirs of Harriet L. Hardy, M.D. (1983).  Hardy was plain spoken and practical.  Although she had no bias in favor of industry, she was not beset with the ideological animus of so many contemporary testifying witnesses.  Hardy addresses asbestos in several pages of her autobiography, which should be required reading for judges and lawyers coping with asbestos litigation:

“The media in industrialized Western countries have publicized the ill effects of asbestos quite out of proportion to the risk, especially that in city streets, schools, hospitals, and drinking water.”

Id. at 94.

Hardy describes two of her own cases of lung cancer in asbestos workers, in the 1950s.  She notes that she published the first case with Hanna Klaus in the 1950s. Kurt J. Isselbacher, Hanna Klaus, and Harriet L. Hardy, “Asbestosis and bronchogenic carcinoma: Report of one autopsied case and review of the available literature,” 15 Am. J. Med. 721 (1953).  Hardy reports that her contemporaneous reaction:  “A note on the second case included the query, Since men were heavy smokers, might not the cancer be due to a combination of cigarette smoking and inhalation of asbestos fibers?”  Id. at 95. A question, not an answer, to be sure.

Hardy addresses the more obvious case of asbestos and mesothelioma, with an answer that would dismay the Lobby:

“A fatal malignancy [mesothelioma] associated with inhalation of a single form (crocidolite) of asbestos invaded the chest wall (pleura) and/or the abdominal wall.”

Id. at 95 (emphasis added).

“I feel that the facts to date do not support the many claims of asbestos effect on those with slight exposure.”

Id.

“This story of asbestos damage is now internationally known, and unanswered questions of differences in fibers from various areas and their harmful effect and the problem of safe working and neighborhood levels are engaging the skills of research groups.”

Id.  Hardy ends her discussion with a plea for skepticism and epistemological modesty in interpreting lay media reports, which have been dominated by scaremongers:

“I would plead that every reader look at all reports in the lay press and on television with great skepticism.  My reasons are shown by the following examples. A state health commissioner is using funds that he has to underwrite an antismoking campaign.  Deception is a mistake no matter how noble the cause.  Because a plant situated on a U.S. Great Lake dumped waste asbestos into the lake, which serves as a public water supply to a nearby city, fishing was forbidden and the livelihood of an important number of people denied.  The evidence that water containing asbestos fibers is harmful and may cause cancer has yet to be assembled.”

Id. at 98.

Those familiar with the Reserve Mining fiasco know that the evidence was never forthcoming.  Throughout her autobiography, Hardy’s compassion and disinterestedness are manifest.  It is unfortunate that Hardy did not serve directly as a more influential voice on asbestos issues.

U.C. Davis Symposium on the “Daubert” Hearing

March 11th, 2013

Professor David Faigman’s recent article, “The Daubert Revolution and the Birth of Modernity:  Managing Scientific Evidence in the Age of Science,” 102 U.C. Davis Law Rev. 101 (2013), notes that the paper grew out of informal remarks given at a recent symposium.  A little Googling quickly turned up the Symposium Site on the University of California, Davis, website.  Like Professor Faigman’s paper, this symposium is a valuable contribution to the art and learning of what Rule 702 hearings should, and should not, be.

The symposium, The Daubert Hearing — From All the Critical Perspectives (March 2, 2012) described itself:

Pretrial practice has long been the center of gravity in modern litigation. The vast majority of cases never go to trial. Instead, after pretrial discovery and in limine motions, the cases settle. The Supreme Court’s celebrated 1993 decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, has solidified that trend. In Daubert, the Court abandoned the traditional general acceptance standard for the admissibility of scientific testimony and announced a new empirical validation test. Throughout the country counsel began basing pretrial in limine motions on Daubert to target opposition expert testimony. In criminal cases, defense counsel started challenging the prosecution’s forensic evidence identifying the accused as the perpetrator. In civil tort cases, defense counsel filed motions attacking the plaintiff’s evidence on general causation. When counsel won these motions, the opposition lacked sufficient evidence to go to trial. The hearing on the pretrial Daubert motion became the centerpiece of the litigation.

This symposium will begin with a demonstration Daubert hearing. After the demonstration, all the participants will deliver remarks, giving their perspective on the law and tactics of Daubert hearings. In addition, there will be expert academic commentary by Professor David Faigman of U.C. Hastings School of Law, the lead author of the popular treatise, MODERN SCIENTIFIC EVIDENCE.

The symposium featured a list of distinguished speakers:

Hon. James M. Rosenbaum

Robert G. Smith

Bert Black

Professor David L. Faigman

Professor Edward Imwinkelried

Dr. William A. Toscano, Jr.

Dr. Sander Greenland

The symposium’s hypothetical is available on line, and the symposium itself, which was video recorded, is available for viewing at the UC Davis website.

The scientists who role-played as expert witnesses, Drs. Toscano and Greenland,  were obviously pushed to articulate certain positions that they did not personally subscribe to.  Still, their true colors managed to show, and to influence the mock hearing.  For instance, Dr. Toscano stated several times that causation is very difficult to prove, and in so stating, he managed to convey the impression that he had a personal, subjective higher bar for causal claims than the rest of the scientific community.  This approach is a common rookie mistake for defense counsel and their expert witnesses, and it should be avoided.  There are plenty of good examples of causal relationship that have been established with epidemiology, and the defense expert should be prepared to identify them, and to explain why in some cases, the causal relationships required more exacting evidence.  The other glaring error in the defense presentation was that the exact methodological error was not made clear through Dr. Toscano’s testimony although the defense lawyer, Mr. Smith, explored the gaps and leaps of faith in his cross-examination of Dr. Greenland.  In this setting, the defense expert witness’s focus is on the methodological inadequacies of the plaintiffs’ witness, not on why he rejected the causal claim.

Dr. Greenland was his inimitable self, even going so far as to talk into his magic marker under the impression that it was a microphone.  Who knows; perhaps it was, but it also wrote on the white board.  More telling was that Dr. Greenland embraced a probabilistic conception of causation, which he explained was essentially a bet on the correct result.  This metaphor seems fatally defective.  A bet is a bet, but you cannot call the bet until you have actual evidence of who won.  It may be lovely that Dr. Greenland, or some other expert witness, is willing to place the bet, perhaps with odds, but this metaphor fails to take causal inference out of the subjective realm.  Along with his betting metaphor, Greenland emphasized that the causation decision is driven by a cost-benefit analysis of Type I and II errors.  The slippery slide into substituting the precautionary principle for causal analysis was obvious.

On the plaintiffs’ side, Bert Black, an apostate defense lawyer, did a very good job of portraying the shenanigans used by plaintiffs’ lawyers to avoid and evade gatekeeping.  Statistical significance is not necessary; epidemiology is not necessary; Bradford Hill factors are not necessary; therefore, I can show causation without much of anything.  Black illustrated nicely how the focus is redirected to other cases, such as when someone from a drug company wrote an improvident article that concludes causation from case reports alone.  Or cases involving signature diseases, or acute outbreaks, for which causal relations were discerned and embraced by scientists on the basis of very informal epidemiologic studies or even case series (which someone characterized as anecdata).

Former federal judge James Rosenbaum presided magisterially, and cowardly denied the cross-motion Rule 702 challenges.  In his comments after the mock, Judge Rosenbaum revealed his conception of the gatekeeping process as essentially a determination that the witness is competent.  Of course this is not the law, and much more is required than to determine that the witness is minimally qualified.  Professor Faigman respectfully chastised the judge for ignoring the statute and the caselaw.

One of the more interesting dialogues in the discussions after the mock centered on the harm to an expert witness’s reputational interests from the gatekeeping process.  To be sure there can be such harm, but as Professional Faigman pointed out, the potential for such harm cannot intimidate judges from ruling on the facts and law before them.  I believe though that expert witnesses should be aware of the potential for this sort of harm from their testimonial adventures, and should require certain contractual assurances from the lawyers who engage them.  For instance, expert witnesses should insist upon whether such challenges are possible in the jurisdiction, what the standards are, and whether they will have an opportunity to speak to the challenges.  The expert witnesses should insist upon prompt notification of all such challenges, and upon prompt receipt of all briefs and affidavits that challenge the validity or reliability of their opinions, as well as an opportunity to be heard on their responses.