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Woodside & Davis on the Bradford Hill Considerations

August 23rd, 2013

Dr. Frank Woodside and Allison Davis have published an article on the so-called Bradford Hill criteria.  Frank C. Woodside, III & Allison G. Davis, “The Bradford Hill Criteria: The Forgotten Predicate,” 35 Thomas Jefferson L. Rev. 103 (2013).

Their short paper may be of interest to Rule 702 geeks, and students of how the law parses causal factors in litigation.

The authors argue that a “predicate” to applying the Hill criteria consists of:

  • ascertaining a clear-cut association,
  • determining the studies establishing the association are valid, and
  • satisfying the Daubert [1][sic] requirements.

Id. at 107.  Parties contending for a causal association often try to flyblow the need for statistical significance at any level, and argue that Bradford Hill did not insist upon statistical testing.  Woodside and Davis remind us that Bradford Hill was quite firm in insisting upon the need to rule out random variability as an explanation for an association:

“Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance.”

Id. at 105; see Hill, Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965).  The authors correctly note that the need for study validity is fairly implied by Bradford Hill’s casual expression about “perfectly clear-cut.”

Woodside and Davis appear to acquiesce in the plaintiffs’ tortured interpretation of Bradford Hill’s speech, on which statistical significance supposedly is unimportant.  Woodside & Davis at 105 & n.7 (suggesting that Bradford Hill “seemingly negates the second [the requirement of statistical significance] when he discounts the value of significance testing, citing Bradford Hill at 299).

Woodside and Davis, however, miss the heavy emphasis that Bradford Hill actually placed upon “tests of significance”:

“No formal tests of significance can answer those questions. Such tests can, and should, remind us of the effects that the play of chance can create, and they will instruct us in the likely magnitude of those effects. Beyond that they contribute nothing to the ‘proof’ of our hypothesis.”

Bradford Hill at 299.  Bradford Hill never says that statistical tests contribute nothing to proving an hypothesis; rather, his emphasis is on the insufficiency of statistical tests alone to establish causality.  Bradford Hill’s “beyond that” language clearly stakes out the preliminary, but necessary importance of ruling out the play of chance before proceeding to consider the causal factors.

Passing beyond their exegetical fumble, Woodside and Davis proceed to discuss the individual Bradford Hill considerations and how they have fared in the crucible of Rule 702.  Their discussion may be helpful to lawyers who want to track the individual considerations, and how they have treated, or dismissed, by trial courts charged with gatekeeping expert witness opinion testimony.

There is another serious problem in the Woodside and Davis paper.  The authors describe risk ratios and the notion of “confidence intervals”:

“A confidence interval provides both the relative risk found in the study and a range (interval) within which the risk would likely fall if the study were repeated numerous times.32 … As such, risk measures used in conjunction with confidence intervals are critical in establishing a perfectly clear-cut association when it comes to examining the results of a single study.35”

Woodside & Davis at 110.  The authors cite to the Reference Manual on Scientific Evidence (3d 2011), but they fail to catch important nuances of the definition of a confidence interval.  The obtained interval from a given study is not the interval within which the “risk would likely fall if the study were repeated… .”  Rather it is 95% of the many intervals, from the many repeated studies done on the same population, with the same sample size, which would capture the true risk.  As for the obtained interval, the true risk is either within it, or not, and no probability value attaches to the likelihood that the true value lies within the obtained interval.

It is a mystery why lawyers would bother to define something like the confidence interval, and then do it incorrectly.  Here is how Professors Finkelstein and Levin define the confidence interval in their textbook on statistics:

“A confidence interval for a population proportion P is a range of values around the proportion observed in a sample with the property that no value in the interval would be considered unacceptable as a possible value for P in light of the sample data.”

Michael Finkelstein & Bruce Levin, Statistics for Lawyers 166-67 (2d ed. 2001).   This text explains why and where Woodside and Davis went astray:

“It is the confidence limits PL and PU that are random variables based on the sample data. Thus, a confidence interval (PL, PU) is a random interval, which may or may not contain the population parameter P. The term “confidence” derives from the fundamental property that, whatever the true value of P, the 95% confidence interval will contain P within its limits 95% of the time, or with 95% probability. This statement is made only with reference to the general property of confidence intervals and not to a probabilistic evaluation of its truth in any particular instance with realized values of PL and PU.”

Id. at 167-71.

[1] Surely the time has come to stop referring to the Daubert factors and acknowledge that the Daubert case was just one small step in the maturation of evidence law.  The maturation consisted of three additional Supreme Court cases, many lower court cases, and a statutory revision to Federal Rule of Evidence 702, in 2000.  The Daubert factors hardly give due consideration to the depth and breadth of the law in this area.

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Second Circuit Hands down a Marvel Opinion on Historian Expert Testimony

August 17th, 2013

“What will history say?  History, sir, will tell lies as usual.”
George Bernard Shaw, The Devil’s Disciple (1901)

 * * * * *

Parties to products liability litigation have for some time resorted to the ruse of using historians as rhetoricians and advocates to argue partisan litigation positions to the jury, in the evidentiary phase of trials.  The obvious opening for this ruse has come in advancing party positions on “state of the art” to claim or defend against negligence.  When plaintiffs use this tactic, they seek not only to introduce evidence of pre-sale belief or knowledge of hazards, but also to disparage any challenges to, or doubts about, hazards as unreasonable, biased, or malicious.  When defendants use this tactic, they of course seek to return the favor, by employing their expert witnesses as advocates on crucial issues of historical knowledge.

Two historian gladiators, David Rosner and Gerald Markowitz, have served as capable arguers in silica, asbestos, lead, and vinyl chloride litigation.  Indeed, you might well expect to meet them at the Argument Clinic, although more recently, they starred in an appearance in a California lead paint case, currently on trial.  See CA Lead Paint Trial: Same old Rosner, Markowitz show (Aug. 07, 2013); Howard Mintz, “Hazardous lead paint: Legal battle comes to trial in California” (July 16, 2013) (quoting Rosner’s email exchange with reporter in which he previews his partisan opinions on lead paint in advance of his testimony).

We can find no clearer statement of judicial antipathy to expert witness advocacy than the famous copyright decision by Judge Learned Hand in Nichols v. Universal Pictures Corp., 45 F.2d 119 (2d Cir. 1930).  Both sides in Nichols presented expert testimony on “dramatic writing” in an effort to prove or disprove a claim that one screenplay infringed upon another. Deprecating the lengthy, argumentative testimony from both sides’ experts, Judge Hand declared that

“[i]t ought not be allowed at all. . . .”

Id. at 123. Judge Hand explained with his usual magisterial authority:

“Argument is argument whether in the box or at the bar, and its proper place is the last.”

Id.

Other areas of expertise, besides historical scholarship, fail to satisfy the basic requirements of expert witness testimony. For instance, Judge Hand’s complaints about the “literary critic” expert witnesses in Nichols, have been relodged against “ethics” witnesses. In GST v. Telecommunications, Inc., 192 F.R.D. 109 (S.D.N.Y. 2000), both parties offered expert witness on the ethics of the conduct of corporate officers. Invoking the helpfulness criterion of Federal Rule of Evidence 702, the Court found the proffered testimony would not aid the jury:

“It is evident that the contentious advocacy of the experts – illustrated by conclusions on the credibility of explanations regarding the business judgment of the board of directors . . . in clearly expressed, biased viewpoints – do little to aid the triers of fact on the underlying transactions.”

Id. at 110. The trial court discerned a serious danger that expert testimony on ethics would usurp the jury’s role in applying the law to the facts found in the case. Id. Permitting such testimony would allow expert witnesses to attempt to substitute their judgment for the jury’s. Id.; see, e.g., Pan American World Airways, Inc. v. Aetna Casualty & Surety, 505 F.2d 989, 998 (2d Cir. 1974) (noting disapprovingly that, evidence consisted “largely of hearsay, propaganda, speculation, and conjecture”). See also Imwinkelreid, “Expert Testimony by Ethicists: What Should Be the Norm?” 76 Temple L. Rev. 91, 114, 128 (2003) (noting that normative testimony will virtually always be inadmissible).

Of course, the substitution of an expert witness’s judgment for the jury’s is precisely what many trial lawyers hope to accomplish. Lawyers can select and present expert witnesses based upon their opinions and conclusions, whereas the conclusions of juries are all too unpredictable.  Trial courts must be vigilant to police expert witness opinion testimony in the area of history as much as, if not more than, in the area of scientific testimony. Rule 702’s requirement of knowledge that will assist the trier of fact is designed to prevent expert witnesses from testifying about matters within the common understanding of the jury, and about which the jurors can reason without help from an expert witness. In the Rezulin Multidistrict Litigation (MDL), testimony that was “a narrative of the case which a juror is equally capable of constructing” was precluded.  In re Rezulin Products Liability Litig., 309 F.Supp. 2d 531, 541 (S.D.N.Y. 2004).  Judge Kaplan explained that expert witnesses were not the appropriate conduit for a narrative of events, meetings, regulations, and documents, when they were not percipient witnesses. Such testimony was within the jury’s lay understanding, and the law prohibited the attempt to have expert witnesses “supplant the role of counsel in making argument at trial, and the role of the jury in interpreting the evidence.” Id. at 551.  See generally “Narratives & Historians for Hire”; and “How Testifying Historians Are Like Lawn-Mowing Dogs.”

In Marvel Characters, Inc. v. Kirby, 2013 WL 4016875 (2d Cir. Aug. 8, 2013), the Second Circuit reaffirmed Learned Hand’s jaundiced view of expert witness advocates in the form of historian testimony. Jack Kirby was among the artists responsible for creating comic strip characters of X-Men, the Hulk, Captain America, Thor, and the Fantastic Four. Kirby’s heirs claimed that the intellectual property rights in these characters passed to them.  Marvel Characters, Inc., sought a declaratory judgment that the characters were “works for hire,” now owned by Marvel Entertainment, a subsidiary of corporate oligarch, Walt Disney Co.

The district court rejected the claims of Kirby’s heirs, and the Second Circuit affirmed. Marvel Worldwide, Inc. v. Kirby, 777 F. Supp. 2d 720 (S.D.N.Y. 2011), aff’d, 2013 WL 4016875 (2d Cir. 2013).  In ruling on Marvel’s motion for judgment, the district evaluated and excluded the proffered expert witness testimony of John Morrow and Mark Evanier, who would have testified on the history of the relationship between Marvel and Jack Kirby. 777 F. Supp. 2d 720, 729-30 (S.D.N.Y. 2011). The Second Circuit held that the district court had clearly not abused its discretion in these exclusionary rulings.  Marvel Characters, Inc. v. Kirby, slip op. at 36.

In affirming the rejection of these historians’ proffered opinions, the Circuit waxed  historiosophical:

“We have no doubt that a historian’s ‘specialized knowledge’ could potentially aid a trier of fact in some cases. A historian could, for example, help to identify, gauge the reliability of, and interpret evidence that would otherwise elude, mislead, or remain opaque to a layperson. He or she might helpfully synthesize dense or voluminous historical texts. Or such a witness might offer background knowledge or context that illuminates or places in perspective past events.”

Slip op. at 34 (internal citations omitted).

Morrow and Evanier wandered far outside the permissible boundaries of historian expert testimony.  They sought to marshal opinions based largely upon hearsay statements of various artists, uttered in a variety of settings, about how Marvel treated artists back in the day. From these statements, the aspiring litigation historians speculated about intentions, understandings, and motivations of the historical actors at Marvel, and of Jack Kirby.  Id. at 35.

The appellate court recognized the serious danger of using historian expert witnesses as

“a conduit for introducing hearsay under the guise that the testifying expert used the hearsay as the basis of his testimony.”

Id. (internal citations omitted).  The Circuit recognized that implicit in Rule 703 is something akin to a “best evidence” rule, which relegated the historians to clearly less than best:

“The appropriate way to adduce factual details of specific past events is, where possible, through persons who witnessed those events. And the jobs of judging these witnesses’ credibility and drawing inferences from their testimony belong to the factfinder.”

Id. at 37.  The Circuit also noted that the expert opinion testimony from historians was beset a serious evidentiary challenges. In addition to relevance, legal and logical, and Rule 702, historian opinions raises basic issues about the source of the opinions.

Applying these principles, the appellate court recognized that the heirs’ witnesses were not using specialized knowledge or offering helpful historian insights, but they were marshalling hearsay:

“But Morrow and Evanier do not bring their expertise to bear in any such way. As the district court recognized, their reports are by and large undergirded by hearsay statements, made by freelance artists in both formal and informal settings, concerning Marvel’s general practices towards its artists during the relevant time period.  Drawing from these statements, they then speculate as to the motivations and intentions of certain parties… .”

Id. at 36 (internal citations omitted).

The Second Circuit’s decision is timely.  Perhaps the California trial court pondering the claims against the paint industry will heed the Marvel opinion.  The Marvel Characters opinion should close the door on the use of Rosner and Markowitz’ historical argument, as well as that of other would-be testifying historians in other cases.  In products liability cases, many of the proffered witnesses seek to testify about hearsay statements, and argue inferences about intentions, understandings, and motivations of the historical actors.  Like Morrow and Evanier, they should be excluded from the litigation process.

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The Rhetoric and Challenge of Conflicts of Interest

July 30th, 2013

The Challenge

Critics and anti-industry zealots have argued that industry-sponsored science is vitiated by conflicts of interest.  The critics of industry research have supported their attack with studies that claim to show that industry studies disproportionately report outcomes favorable to their sponsors.

The potential conflicts posed by industry-sponsored research studies are fairly obvious.  Industries that make or sell products, raw materials, or chemicals have an interest in having toxicological and epidemiologic studies support claims of safety.  Research that suggests an industry’s product causes harm may hurt the industry’s financial interests directly by inhibiting sales, or indirectly by undermining the industry’s position in litigation, or by leading to greater regulatory scrutiny and control.  If the harm evidenced by the research is sufficiently severe, the research may lead to product recall or bans, again with serious economic consequences for the industry.  Evidence of harm may require heightened warnings or instructions, which may limit sales or encourage sales of competing, less hazardous products.

The Response.

The answer to the anti-industry challenge lies in a reality more complicated and nuanced that the simplistic views of the critics.  Industry often must conduct or sponsor research to live up to its common law or regulatory duties to test its products.  At other times, industry sponsors research in response to emerging scientific papers that claim that the industry product is harmful in ways not previously known.  While on occasion, industry might be accused of “manufacturing doubt[1],” there are scientists equally intent upon “manufacturing certainty,” whether from dodgy data or iffy inferences.

The motives and interests of scientists intent on manufacturing a faux certainty are harder to discern than the potential conflicts of industry and scientists who are funded by industry.  Many scientists purport to have only the lofty goals of science or the public interest at heart in pursuing their research, but a close look shows that there are several potential conflicts of interest prevalent in the research community, and that these interests help shape science into anti-industry positions.

1.  White Hat Bias

Over 20 years ago, a science journalist published an account of how dire predictions of asbestos deaths had not come to pass.  Tom Reynolds, “Asbestos-Linked Cancer Rates Up Less Than Predicted,” 84 J. Nat’l Cancer Instit. 560 (1992).  In trying to understand why the earlier predictions had been disconfirmed by later data, Reynolds quoted one scientist as saying that:

“the government’s exaggeration of the asbestos danger reflects a 1970s’ Zeitgeist that developed partly in response to revelations of industry misdeeds.  ‘It was sort of the “in” thing to exaggerate … [because] that would be good for the environmental movement’….  ‘At the time it looked like you were wearing a white hat if you made these wild estimates. But I wasn’t sure whoever did that was doing all that much good.”

Id. at 562.  Reynolds captured the essence of “white-hat” bias, a form of political correctness applied to issues that really depend upon scientific method and data for their resolution.

More recently, David Allison and Mark Cope, two public health researchers described[2] white-hat bias as a prevalent cognitive bias in how research is reported and interpreted.  They described white-hat bias as a “bias leading to the distortion of information in the service of what may be perceived to be righteous ends.” Perhaps the temptation to overstate the evidence against a toxic substance is unavoidable, but it diminishes the authority and credibility of regulators entrusted with promulgating and enforcing protective measures.  And error is still error, regardless of its origin.  Allison and Cope give examples of white-hat bias in how papers are cited, with “exonerative” studies cited less often than those than claim harmful outcomes.  And when positive papers were cited, they were often interpreted misleadingly to overstate the harms previously reported.

2. Other “Interested” Actors Who Sponsor and Conduct Scientific Research

The discussion and debate surrounding industry sponsorship of scientific research often ignores the activities of other, intensely interested sponsors and researchers.  Labor unions, for instance, have sponsored research on occupational hazards.  Evidence of harm often becomes potent ammunition in labor-management negotiations over work conditions and wages.  Environmental groups have sponsored studies with sympathetic researchers who are openly eager to embarrass industrial interests and support increasing regulatory restrictions or bans on chemicals or products.  Plaintiffs’ counsel may well be the largest rent-seeking group in the United States, and they have sponsored studies with the implicit or explicit goal of supporting their claims for compensation.  Disease support groups, often aligned with plaintiffs’ counsel, have sponsored research, to support their claims for compensation and fees, the more, the better.  Scientists and physicians who serve as expert witnesses for plaintiffs’ counsel have undertaken research to advance and support their testimonial enterprise in the litigation brought by the counsel who engaged them to testify.

3.  Regulatory Biases

Many scientists are funded by regulatory agencies intent upon showing harm from particularly exposures or industrial processes.  The agencies may be motivated by their desire to expand their regulatory control under their statutory mandate by having scientific evidence that fits their political and regulatory goals.  Some scientists may be politically aligned, or simply believe that the public interest requires the sought after enhanced regulation.

4.  Publication Bias

“Null” studies, studies that do not find a statistical significant increased risk of harm from exposure, do not sell.  More to the point, null studies do not routinely get published.  Spending substantial amounts of time on a study without obtaining an outcome that will make the study publishable is a sure-fire way to sideline one’s academic career.  Publications are the measurable units of success in academic circles.  Publications beget future grants and funding, which further enhance academic reputation and careers.

The pressure on researchers to find some untoward outcome from research on a potential toxic material or product is great.  As John Ioannides and others have shown, prevalent research methods encourage technique that will lead to some findings.  For instance, an epidemiologic cohort study will compare a group with and without exposure, but will look at multiple health outcomes.  Perhaps there was an a priori hunch that lung cancer rates would be increased among the exposed group, but the researchers also looked at a 100 other cancers, and perhaps another 100 other non-malignant diseases, in the study.  Chance alone would have led to several statistically significant findings of increased disease outcomes among the exposed group, and researchers can publish these findings that encourages readers to believe that they were the subject of the research all along.

Similarly, case-control studies can collect cases of a disease of interest and compare them with non-diseased controls in terms of dozens if not hundreds of prior exposures and life-style variables.  Again, the researchers can report the exposures and variables statistically significantly associated with the disease, and neglect to report all those not associated.[3]

5. Biased Studies with Biased Outcomes, Making Biased Claims

The critics of industry-sponsored studies have themselves conducted “studies of studies,” to assess whether sponsorship correlated with outcomes favorable to the sponsor.  These studies of studies claim to find that industry studies invariably or disproportionately favor their sponsors’ interests, but these studies of studies are themselves critically flawed by selection bias.[4]

To understand the selection bias involved, we need only pay attention to the conditions that lead industry to conduct the study.  In connection with potential toxicities of chemicals or products, industry  often is responding to an emerging scientific literature that claims the industrial materials cause harm.  If the studies that claim harm are clearly valid, there is likely to be no counter-study undertaken.  In this scenario, the anti-industry critics will find no industry study for inclusion in their analysis of whether industry studies are correlated with a favorable outcome.

Studies with doubtful data or overstretched conclusions are more likely to provoke an industrial concern into sponsoring research, and given the inciting condition, we should not be surprised that outcome is more favorable to industry than the previously published studies.    Studies ultimately favorable to the defense are thus counted in the “studies of studies,” but given the circumstances that led to the sponsorship, the imbalance in the results is exactly what we should expect to see. Of course, if the study somehow supports the prior findings, the critics of industry will claim that the industry-sponsored study is an “admission” of harm.  Inconclusive or exonerative studies will be dismissed by these critics as uninformative or vitiated by conflicts of interest.

There are many examples of how this selection bias plays out. In the early days of the silicone gel breast implant litigation, ostensibly neutral researchers published papers that claimed an association between silicone implants and scleroderma.  See Harry Spiera, “Scleroderma After Silicone Augmentation Mammoplasty,” 260 J. Am. Med. Ass’n 236 (1988).  These papers led to an FDA-imposed moratorium, which in turn instigated a litigation tsunami.  The then current and former manufacturers of silicone implants sponsored several epidemiologic studies.  Although the companies engaged reputable researchers from the leading medical research centers in the United States, public-interest advocates such as Sidney Wolfe decried the “biased” industry-financed research that came out.  Not surprisingly, the sponsored studies mostly exonerated any causal role of silicone in producing autoimmune diseases.

The biases of the physicians who supported the alleged causal association were much more difficult to ferret out.  Many of the physicians adopted pro-causation views to attract patients from the many support “victim” support groups, and many of the scientists who advocated pro-causation opinions sought to market test kits that would identify biomarkers of a unique silicone-induced disease.  The house of cards created by the support groups and plaintiffs’ counsel ultimately collapsed when court-appointed expert witnesses and the Institute of Medicine examined the evidence closely.  Today, the entire episode can be chalked up mostly to litigation fraud.  See Hon. Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation.” Cardozo Law Review DeNovo 1, 14 (2009) (“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”).

Another example is provided by the welding fume litigation.  In 2001, Dr. Brad Racette published a case series that he erroneously called a case-control study, which purported to find an earlier age of onset for Parkinson’s disease among welders.  In 2005, working in cooperation with plaintiffs’ counsel, Racette transmuted litigation screenings into a cross-sectional study, which purported to find an increased prevalence ratio of “parkinsonism” among welders.  Both studies were seriously flawed, but the plaintiffs’ counsels’ use of Racette’s studies created an incentive for industry to sponsor several studies.  The plaintiffs’ counsel blasted the industry defendants for “manufacturing doubt,” but in fact, the industry-sponsored studies were valid scientific efforts, conducted by respected epidemiologists.  The industry sponsored studies were corroborated several times over by governmentally sponsored studies, conducted in the United States and abroad.  A meta-analysis published last year by well-regarded neuroepidemiologists ultimately vindicated the industry position, as well as the industry-sponsored studies.  See James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012) (reporting a statistically significant decreased risk of Parkinson’s disease among welding tradesmen).

In the pharmaceutical industry, publications will invariably show outcomes favorable to drug sponsors.  New drugs that fail to show efficacy in clinical trials will not likely be written about because the sponsor will not file an application for regulatory approval.  Writing up the clinical trials for publication typically is part of the process of seeking regulatory approval, and the publication effort is not undertaken unless there is a reasonable chance of approval.  Unremarkably, the published papers describing these clinical trials disproportionately show efficacy and manageable side effects.

 

6. Hypocrisy Over Conflicts of Interest

The persistence in ignoring non-financial conflict of interests is not innocent.  By elevating financial conflicts of interest, public advocates attempt to silence industry and discount industry-sponsored studies.  The single-minded focus on financial conflicts of interest misdirects attention away from the existence of other sorts of biases, and the distortions they create.[5]

Conflicts of interest have thus largely and incorrectly been reduced to financial conflicts.  For instance, in 2011, the National Institutes of Health (NIH) addressed only financial issues when it promulgated rules for managing conflicts of interest in the field of medical research.[6]  Several commentators advocated regulation of non-financial COI, but the agency refused to include such conflicts within its rules.[7] The Institute of Medicine (IOM), in a monograph on conflicts of interest in medicine, similarly gave almost exclusive priority to financial ties.[8]

The focus on economic conflicts of interest is dangerous because it instills complacency about non-financial interests, and provides a false sense of assurance that the most serious biases are disclosed or eliminated.  One need only consider the many examples of retractions, frauds, and ethical lapses in biomedical research to understand that non-financial interests, such as friendships and alliances, institutional hierarchies, intellectual biases and commitments, beneficence, “white-hat” advocacy, as well as the drive for professional achievement, recognition, and rewards, all have the potential to complicate, distort, and sometimes undermine scientific research in myriad ways. The failure to recognize and regulate non-economic conflicts and biases endangers the validity of science.  Not only are these non-financial threats ignored, but financial interests receive undue attention, resulting in the erosion of public trust in scientific research that is sound.

 

The Cure

1. Push Back Against the Rhetoric of Conflicts of Interest

Industry should not be cowed by the anti-industry attack on industry-sponsored studies.  Twenty years ago, one of the leading epidemiologists, Professor Kenneth Rothman, referred to the anti-industry bias as “new McCarthyism in science.[9]”  This intolerance toward corporate sponsorship has been going on for some time, fueled by one-sided accounts of industry-sponsored studies.  As noted by one of the leading 20th century epidemiologists, “an opinion should be evaluated on the basis of its contents, not on the interests or credentials of the individuals who hold it.[10]”  Courageously, some scientists have fought for science to be judged on its merits.[11]

Professor Stossel and others created an organization, ACRE – The Association of Clinical Researchers and Educators, to defend legitimate interactions between Physicians and Industry. ACRE has spoken out against the lopsided demonization of the pharmaceutical industry, and the lionizing of the industry’s critics.  A few years ago, a scientist working for the pharmaceutical industry, joined Professor Rothman, to cry out against the unfairness and partiality of journals’ conflict-of-interest rules and policies.[12]  Dr. Hirsch published a strongly worded commentary that journals’ concerns are often poorly disguised prejudices against industry.  Many of the journals in question rarely or never fuss over the obvious conflicts of interest created by the “profit motive” of researchers who want to climb the academic ladder, increase their salaries, enlarge their budgets, extend their influence, travel to organizational conferences, bolster their prestige, win more grants, enhance their reputations, or advance their political goals or ideologies.

The medical profession, the courts, and the public are seriously misled by the obsession with conflicts of interest, on either side.  The obsession allows a disclosed or undisclosed conflict of interest to substitute for the much harder work of considering the merits of a study.


[1] David Michaels, Doubt is Their Product (2008).

[2] Mark B. Cope and David B. Allison, “White hat bias: examples of its presence in obesity research and a call for renewed commitment to faithfulness in research reporting,” 34 Internat’l J. Obesity 84 (2010).

[3] The works of John Ioannides explore the problem of false discovery rate and publication practices that encourage error.  See N. S. Young, J. P. Ioannidis and O. Al-Ubaydli, 2008. Why current publication practices may distort science. PLoS Medicine, 5, e20.

[4] Miquel Porta, Sander Greenland, and John M. Last, eds., A Dictionary of Epidemiology 225-26 (5th ed. 2008).

[5] Richard S. Saver, “Is It Really All About The Money? Reconsidering Non-Financial Interests In Medical Research,” 40 J. L. Med. & Ethics 467 (2012).

[6] Department of Health and Human Services, “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors,” 76 Fed. Reg. 53256 (Aug. 25, 2011).

[7] Id. at 53258.

[8] Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice (Washington, D.C.: The National Academies Press, 2009).

[9] Kenneth J. Rothman, “Conflict of interest: the new McCarthyism in science,” 269 J. Am. Med. Ass’n 2782 (1993).

[10] Brian MacMahon, “Epidemiology:  another perspective,” 37 Internat’l J. Epidem. 1192, 1192 (2008).

[11] See Thomas P. Stossel, “Has the hunt for conflicts of interest gone too far?” 336 Brit. Med. J. 476 (2008); Nature Publishing Group, “Nothing to see here: based on one company’s past poor publishing practices, a top-tier medical journal misguidedly stigmatizes any paper from industry,” 26 Nature Biotechnol. 476 (2008); Kenneth J. Rothman & S. Evans, “Extra scrutiny for industry funded trials: JAMA’s demand for an additional hurdle is unfair–and absurd, 331 Brit. Med. J. 1350 (2005), and 332 Brit. Med. J. 151 (2006) (erratum).

[12] Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811 (2009).

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Securities Fraud vs Wire Fraud

July 29th, 2013

Pharmaceutical manufacturers are particularly vulnerable to securities fraud claims arising from the manufacturers’ pronouncements about safety or efficacy, the evidence for which is often statistical in nature.  Safety claims may involve complex data sets, both from observational studies and clinical trials.  Efficacy claims are typically based upon clinical trial data.

Publicly traded manufacturers may find themselves caught between competing securities regulations.  In evaluating safety or efficacy data, manufacturers will often consult with an outside science advisory board, or report to regulatory agencies.  Securities regulations specify that any disclosure of confidential inside information to an outsider triggers an obligation of prompt public disclosure of that information.[1]  Companies also routinely seek to keep investors informed of research and marketing developments.  Generally, manufacturers will make their public disclosures through widely circulated press releases.[2]  Not surprisingly, disgruntled investors may challenge the accuracy of the press releases, when the product or drug turns out to be less efficacious or more harmful than represented in the press release.  These challenges, brought under the securities laws, often are maintained in parallel to product liability actions, sometimes in the same multi-district litigation.

Securities laws require accurate disclosure of all material information.[3]  Rule 10b-5 of the Securities Exchange Commission (SEC) prohibits any person from making “any untrue statement of material fact” or from omitting “a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading.”[4]

A prima facie case of securities fraud requires that plaintiff allege and establish, among other things, a material misrepresentation or omission.[5]  The obligations to speak and to speak accurately have opened manufacturers to second guessing in their analyses of safety and efficacy data.  In most securities fraud cases, courts have given manufacturers a wide berth by rejecting differences in opinions about the proper interpretation of studies as demonstrating fraud under the securities regulations.[6]  This latitude has been given both in judgment of what test procedures to use, as well as in how best to interpret data.[7]   In Padnes v. Scios Nova Inc., the manufacturer was testing a drug for treatment of acute kidney failure.  Scios Nova issued a press release after its phase II trial, to announce a statistically significant reduction in patients’ need for dialysis.  When the early phase III results failed to confirm this result, plaintiffs sued Scios Nova for not disclosing the lack of statistically significant outcomes on other measures of kidney function, as well as for its interpretation of dialysis results as statistically significant.[8]  The trial court dismissed the complaint.[9]

Several securities fraud cases have turned on investor dissatisfaction on how companies interpreted clinical trial subgroup data.  In Noble Asset Management v. Allos Therapeutics, Inc.,[10] the company issued a press release, noting no statistically significant increase overall in survival advantage from a drug for breast cancer, but also noting a statistically significant increased survival in a non-prespecified subgroup of patients with metastatic breast cancer.[11] The plaintiff investors claimed that the company should have disclosed that the FDA was unlikely to approve an indication based upon an ad hoc subgroup analysis, but the trial court rejected this claim because FDA policy on drug approvals is public and well known.[12] The plaintiffs also complained that the press release referred to statistically significant results from a Cox multiple regression analysis rather than the log-rank (non-parametric survival) analysis required by FDA. The trial court rejected this claim as well, opining that the analysis was not misleading when the company correctly reported the raw data and the results of the Cox multiple regression analysis.[13]

Two recent appellate decisions emphasize the courts’ unwillingness to scrutinize the contested statistical methodology that underlies plaintiffs’ claims of misrepresentation.  In In re Rigel Pharmaceuticals, Inc. Securities Litigation, the plaintiff investors were dissatisfied, not with reporting of subgroups, but rather with the failure of the company to report geographic subgroup results, as well as its use of allegedly improper statistical tests and its failure to account for multiple comparisons.[14]

The Ninth Circuit affirmed the dismissal of a complaint.  The appellate court held that allegations of “statistically false p-values” were not sufficient; plaintiffs must allege facts that explain why the difference between two statements “is not merely the difference between two permissible judgments, but rather the results of a falsehood.”[15] Alleging that a company should have used a different statistical method to analyze the data from its clinical trial is not sufficient to raise an issue of factual falsity under the securities fraud statute and regulations.[16]  The Court explained that the burden was on plaintiffs to plead and prove that the difference between two statistical statements “is not merely the difference between two permissible judgments, but rather the result of a falsehood.”[17] The Court characterized the plaintiffs’ allegations to be about judgments of which statistical tests or methods are appropriate, and not about false statements.  Furthermore, the Court emphasized that the company’s statistical method was called for in the trial protocol, and was selected before the data were unblinded and provided to the company.[18]

In Kleinman v. Elan Corporation[19], the Second Circuit affirmed the dismissal of a securities fraud class action against two pharmaceutical joint venturers, which issued a challenged press release on interim phase II clinical trial results for bapineuzumab, a drug for mild- to moderate-Alzheimer’s disease.  The press release at issue announced “top line” findings and promised a full review at an upcoming international conference.[20]  According to the release, the clinical trial data did not show a statistically significant benefit on the primary efficacy end point, but “[p]ost-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups.”[21]

The plaintiffs in Kleinman complained that the clinical trial had started with crucial imbalances between drug and placebo arms, thus indicating a failure in randomization, and that the positive results had come from impermissible post-hoc subgroup analyses.[22]  The appellate court appeared not to take the randomization issue seriously, and rejected the notion that statements can be false when they represent a defendant company’s reasonable interpretation of the data, even when the interpretation later turns out to be shown to be false[23]:

“At bottom, Kleinman simply has a problem with using post-hoc analyses as a methodology in pharmaceutical studies.  Kleinman cites commentators who liken post-hoc analyses to moving the goal posts or shooting an arrow into the wall and then drawing a target around it. Nonetheless, when it is clear that a post-hoc analysis is being used, it is understood that those results are less significant and should have less impact on investors.  Our job is not to evaluate the use of post-hoc analysis in the scientific community; the FDA has already done so.”

In United States v. Harkonen[24], the government turned the law of statistical analyses in securities fraud on its head, when it prosecuted a pharmaceutical company executive for his role in issuing a press release on clinical trial data. The jury acquitted Dr. Harkonen on a charge of misbranding[25], but convicted on a single count of wire fraud.[26] Dr. Harkonen’s crime?  Bad statistical practice.

The government conceded that the data represented in the press release were accurate, as were the calculated p-values.  The chargeable offense lay in Dr. Harkonen’s describing the clinical trial results as “demonstrating a survival benefit” of the biological product (interferon γ-1b) in a clinical trial subgroup of patients with mild- to moderate-idiopathic pulmonary fibrosis.  The p-value for the subgroup was 0.004, with an effect size of 70% reduction in mortality.  The subgroup, however, was not prespecified, and was not clearly labeled as a post-hoc analysis.  The trial had not achieved statistical significant on its primary end point.

In prosecuting Dr. Harkonen, the government offered no expert witness opinion.  Instead, it relied upon a member of the clinical trial’s data safety monitoring board, who advanced a strict, orthodox view that if the primary end point of a trial “failed,” then the data could not be relied upon to infer any meaningful causal connection within secondary end points, let alone non-prespecified end points.  The prespecified survival secondary end point showed a 40 percent reduction in mortality, p = 0.08 (which shrank to 0.055 on an intent-to-treat analysis). The press release also relied upon a previous small clinical trial that showed a benefit in survival at five years, with the therapy group at 77.8%, compared with 16.7% in the control groups, p = 0.009.

The trial court accepted the government’s claim that p-values less than 0.05 were something of “magic numbers,”[27] and rejected post-trial motions for accquittal. Dr. Harkonen’s use of “demonstrate” to describe a therapeutic benefit was, in the trial court’s view, fraudulent, because of the lack of “statistical significance” on the primary end point, and the multiple testing with respect to the secondary survival end point.  The Ninth Circuit affirmed the judgment of conviction in an unpublished per curiam opinion[28].

In contrast to the criminal wire fraud prosecution, the civil fraud actions against Dr. Harkonen and the company were dismissed.[29] The prosecution and the judgment in United States v. Harkonen is at odds with the latitude afforded companies in securities fraud cases.  Furthermore, the case cannot be fairly squared with the position that the government took as an amicus curiae in Matrixx Initiatives, Inc. v. Siracusano[30], where the Solicitor General’s office, along with counsel for the Food and Drug Division of the Department of Health & Human Services, in their zeal to assist plaintiffs on claims against an over-the-counter pharmaceutical manufacturer, disclaimed the necessity, or even the importance, of statistical significance[31]:

“[w]hile statistical significance provides some indication about the validity of a correlation between a product and a harm, a determination that certain data are not statistically significant … does not refute an inference of causation.”

Suddenly, when prosecuting an unpopular pharmaceutical company executive, the government’s flexibility evaporated. Government duplicity was a much greater problem than statistical multiplicity in Harkonen.[32]

[1] Security Exchange Comm’n Regulation FD, 17 C.F.R. § 243.100 (requiring prompt  public disclosure of any confidential, material inside information after disclosed to non-insiders).

[2] Selective Disclosure and Insider Trading, Securities Act Release No. 7881, Fed. Sec. L. Rep. (CCH) ¶ 86,319 (Aug. 15, 2000) (“As a general matter, acceptable methods of public disclosure for purposes of Regulation FD will include press releases distributed through a widely circulated news or wire service . . . .”).

[3] Section 10(b) of the Exchange Act of 1934 prohibits any person “[t]o use or employ, in connection with the purchase or sale of any security . . . any manipulative or deceptive device or contrivance in contravention of such rules and regulations as the [Securities and Exchange Commission] may prescribe.”  15 U.S.C. § 78j(b).

[4] 17 C.F.R. § 240.10b-5.

[5] Stoneridge Inv. Partners LLC v. Scientific-Atlanta, 552 U.S. 148, 157 (2008) (“(1) a material misrepresentation or omission []; (2) scienter; (3) a connection between the misrepresentation or omission and the purchase or sale of a security; (4) reliance upon the misrepresentation or omission; (5) economic loss; and (6) loss causation.”)

[6] In re Medimmune, Inc. Sec. Litig., 873 F.Supp. 953, 965 (D. Md. 1995).  The biological product at issue in this case was Respivir, a polyclonal antibody product, which “significantly” reduced frequency of hospitalization for respiratory syncytial virus (RSV).  Plaintiffs alleged “flaws” in study design, but the trial court appeared to interpret the statistical significance to mean that Respivir was “unquestionably efficacious.” Id. at 967.

[7] See, e.g., Padnes v. Scios Nova Inc., No. C 95-1693 MHP, 1996 WL 539711, at *5 (N.D. Cal. Sept. 18, 1996) (Patel, J.)[cited herein as Padnes].  See also DeMarco v. DePoTech Corp., 149 F.Supp. 2d 1212, 1225 (S.D. Cal. 2001)(“Although plaintiffs have established a legitimate difference in opinion as to the proper statistical analysis, they have hardly stated a securities fraud claim.”); n re Aldor Corp. Sec. Litig., 616 F.Supp. 2d 551, 568 n.15 (E.D. Pa. 2009) (allegations as to how data should have been analyzed do not support claims for false or misleading statements).

[8] Padnes at *2.

[9] Id. at *10.

[10] 2005 WL 4161977 (D. Colo. Oct. 20, 2005).

[11] Id. at *1.

[12] Id. at *6-7.

[13] Id. at *11.

[14] 2010 WL 8816155 (N.D. Cal. Aug. 24, 2010).

[15] 697 F.3d 869, 877 (9th Cir. 2012) (internal citations omitted), aff’g 2010 WL 8816155 (N.D. Cal. Aug. 24, 2010).

[16] Id. at 877-78.

[17] Id. at 878.

[18] Id. (“Because there are many ways to statistically analyze data, it is necessary to choose the statistical methodology before seeing the data that is collected during the trial; otherwise someone can manipulate the unblinded data to obtain a favorable result.”), citing and attempting to distinguish United States v. Harkonen, 2010 WL 2985257, at *4 (N.D. Cal. July 27, 2010).

[19] 706 F.3d 145 (2d Cir. 2013).

[20] Id. at 149.

[21] Id. at 149-50 (also noting that the press release provided a “preliminary analysis,” which might be less favorable upon further analysis).

[22] Id. at 150.

[23] Id. at 154-55 & 155n.11 (citing and quoting FDA Center for Drug Evaluation and Research:  E9 Statistical Principles for Clinical Trials, 63 Fed. Reg. 49583, 49595 (Sept. 16, 1998), that post-hoc analyses are exploratory and “unlikely” to be accepted as support of efficacy.)

[24] United States v. Harkonen, 2010 WL 2985257 (N.D. Calif. 2010) ((Patel, J.) (denying defendant’s post–trial motions to dismiss the indictment, for acquittal, or for a new trial).  Sometimes judges are looking for bright lines in the wrong places).

[25] 21 U.S.C. §§ 331(k), 333(a)(2), 352(a).

[26] 18 U.S.C. § 1343.

[27] United States v. Harkonen, 2010 WL 2985257, at *5 (N.D. Calif. 2010).

[28] United States v. Harkonen, 2013 WL 782354 (9th Cir. 2013).

[29] In re Actimmune Marketing Litig., 2010 WL 3463491 (N.D. Cal. Sept. 1, 2010), aff’d,  464 Fed.Appx. 651 (9th Cir. 2011).

[30] 131 S. Ct. 1309 (2011).

[31] Brief for the United States as Amicus Curiae Supporting Respondents, in Matrixx Initiatives, Inc. v. Siracusano, 2010 WL 4624148, at *14 (Nov. 12, 2010).

[32] Dr. Harkonen is expected to petition the Supreme Court for certiorari on statutory and constitutional grounds.  See Alex Kozinski & Stuart Banner, “Who’s Afraid of Commercial Speech?” 76 VA. L. REV. 627, 635 (1990) (“[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.”).

 

Posted in statistical evidence | Comments Off on Securities Fraud vs Wire Fraud

Using the Rule 45 Subpoena to Obtain Research Data

July 24th, 2013

Back in June, Mr. William Ruskin posted a blog post, “When Should Data Underlying Scientific Studies Be Discoverable?” on his firm’s Toxic Tort Litigation Blog.  Earlier this week, the Defense Research Institute’s blog, dri-today republished the post, and I posted a response, “Research Data from Published Papers Generally Should Be Available,” on the DRI blog.

Mr. Ruskin’s blog post calls attention to the important problem of access to research data in litigation and other contexts.  The effort to obtain Dr. Racette’s underlying data is an interesting case study in these legal discovery battles.  Ruskin notes that there is the potential for “injustice” from such discovery, but he fails to acknowledge that the National Research Council has been urging scientists for decades to have a plan for data sharing as part of their protocol, and that the National Institutes of Health now requires such planning.  Some journals require a commitment to data sharing as a condition to publication.  The Annals of Internal Medicine, which is probably the most rigorously edited internal medicine journal, requires authors to state to what extent they will share data when their articles appear in print. Ultimately, litigants are entitled to “everyman’s” and “every woman’s” evidence, regardless whether they are scientists. If scientists complied with the best practices, guidances, and regulations on planning for data sharing, the receipt of a subpoena for underlying data would not be a particularly disruptive event in their laboratories.

In the case of Dr. Racette, it was clear that the time he needed to spend to respond to defense counsel’s subpoena was largely caused by his failure to comply with NIH guidelines on data sharing.  Racette was represented by university counsel, who refused to negotiate over the subpoena, and raised frivolous objections. Ultimately, the costs of production were visited upon the defendants who paid what seemed like rather exorbitant amounts for Racette and his colleagues to redact individual identifier information.  The MDL court suggested that Racette was operating independently of plaintiffs’ counsel, but the fact was that plaintiffs’ counsel recruited the study participants and brought them to the screenings, where Racette and colleagues videotaped them to make their assessments of Parkinsonism.  Much more could be said but for a protective order that was put in place by the MDL court.  What I can say is that after the defense obtained a good part of the underlying data, the Racette study was no longer actively used by plaintiffs’ counsel in the welding fume cases.

It is not only litigation that gives rise to needs for transparency and openness. Regulation and public policy disputes similarly create need for data access.  As Mr. Ruskin acknowledges, the case of Weitz & Luxenberg v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013), is very different, but at bottom is the same secrecy and false sense of entitlement to privilege underlying data. The Appellate Division’s invocation of the crime-fraud exception seems to be hyperbolic precisely because no attorney-client privilege attached in the first place. Basic tenets of openness and transparency in science should have guided the Appellate Division.

The Georgia-Pacific effort was misguided on many levels, but we should at least rejoice that science won, and that G-P will be required to share underlying data with plaintiffs’ counsel or whoever wants access. Without reviewing the underlying data and documents, it is hard to say what the studies were designed to do, but saying that they were designed “to cast doubt,” as Mr. Ruskin does, is uncharitable to G-P. After all, G-P may well have found itself responding in court to some rather dodgy data, and thought it could sponsor stronger studies that were likely to refute the published papers.  And the published papers may have been undertaken to “cast certainty,” or even a faux certainty, over issues that were not what they were portrayed to be in the papers.

Earlier this month, Judge Reggie Walton granted a motion to compel a litigant’s motion for underlying research in the denture cream litigation.  Plaintiffs’ counsel contracted with Dr. Salim Shah and his companies Sarfez Pharmaceuticals, Inc. and Sarfez USA, Inc. (“Sarfez”) to conduct human research in India, to support their claims that zinc in denture cream causes neurological damage.  In re Denture Cream Prods. Liab. Litig., Misc. Action 13-384 (RBW), 2013 U.S. Dist. LEXIS 93456, *2 (D.D.C. July 3, 2013).  When defense counsel learned of the Sarfez study, known as the Zinc/077/12 Study, and the plaintiffs’ counsel’s payments of over $300,000, to support the study, they sought discovery of raw data, study protocol, statistical analyses, and other materials from plaintiffs’ counsel.  Plaintiffs’ counsel protested that they did not have all the materials, and directed defense counsel to Sarfez.  Although other courts have made counsel produce similar materials from the scientist independent contractors they engaged, in this case, defense counsel followed the trail of documents to contractor, Sarfez.  Id. at *3-4.

After serving a Rule 45 subpoena on Sarfez, things got interesting.  Raising no objections, and asserting no privileges, Sarfez served about 1,500 pages of responsive documents.  Some of the documents were emails, but crucial attachments were missing, including protocols, analytical reports, and raw data.  Id. at *12-13.  When the defendant, Proctor & Gamble Company (P&G) pressed, Sarfez resisted further production.  P&G filed a motion to compel, and Sarfez objected on various  grounds, including lack of relevancy.

The objections did not go very far.  Plaintiffs’ counsel, who probably should have been tasked with producing the subpoenaed materials in the first instance, had already declared their intent to rely upon the study that they contracted for with Sarfez.  Id. at *9. Judge Walton noted that relevancy did not require that the subpoenaed materials be admissible at trial, but only that they may be relevant to the claim or defense of a party.  Id. at *6.  Judge Walton also upheld the subpoena, which sought underlying data and non-privileged correspondence, to be within the scope of Rules 26(b) and 45, and not unduly burdensome. Id. at *9-10, *20.

Sarfez attempted to suggest that the email attachments might not exist, but Judge Walton branded the suggestion “disingenuous.”  Attachments to emails should be produced along with the emails.  Id. at *12 (citing and collecting cases). Although Judge Walton did not grant a request for forensic recovery of hard-drive data or for sanctions, His Honor warned Sarfez that it might be required to bear the cost of forensic data recovery if it did not comply the district court’s order.  Id. at *15, *22.

The Denture Cream case is a helpful reminder that not only industrial defendants sponsor scientific studies in litigation contexts.  Plaintiffs’ counsel, and sometimes their interest proxies — labor unions, support groups, advocacy groups, zealous scientists, and regulatory agencies — sponsor and conduct studies as well.  Proctor & Gamble should not have been put to the expense and trouble of a Rule 45 subpoena, but it is encouraging to see that Judge Walton cut through the evasions and disingenuous claims, and enforced the research subpoena in this case.

 

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THE COUNCIL FOR EDUCATION AND RESEARCH ON TOXICS

July 9th, 2013

When the Milward case hit the U.S. Court of Appeals for the First Circuit, it attracted the attentions of an amicus, the Council for Education and Research on Toxics (CERT).  I had never heard of CERT before, and the amicus brief filed by CERT was rather sketchy on the nature of the organization.

A bit of research on CERT revealed the following.  It is a non-profit California corporation, EIN: 42-1571530, founded in 2003.  CERT has a business address at:

401 E Ocean Blvd., Ste. 800, Long Beach, California 90802-4967

And a telephone number:  1-877-TOX-TORT

CERT’s mission statement? Furthering scientific understanding of toxins.

Plaintiffs’ lawyer Ralph Metzger is noted as the contact person for CERT.

Given its phone number and its contact person, one might think that its mission statement was “furthering legal positions on toxins.”

But wait; it gets better.  Ralphael Metzger, at the same Long Beach, California, address is the attorney for CERT on its amicus brief in Milward!

The potential conflicts grow deeper and wider.  Metzger has represented CERT, which shares at least his offices, if not his alter ego, in lawsuits including CERT v. Brad Berry Co., Ltd., No. BC461182 (Cal. Super. Ct., Los Angeles County, Cent. Dist., filed May 9, 2011), and CERT v. Starbucks Corp., BC435759 (L.A. Super. Ct., filed April 13, 2010).

CERT has sued McDonald’s and Burger King over its claim that their french fries contained high levels of acrylamide, a chemical “known” to the State of California to cause cancer. CERT has sued Chemtura on claims that the company’s chemical fire-preventive products, known as PBDEs, cause injuries to wildlife and humans.

Although not definitive, it seems that CERT’s mission is not exactly scientific, and the description of its interests in its Milward brief just a tad misleading.

In addition to the CERT, the other amici joining the brief include:

Nicholas A. Ashford,
Nachman Brautbar,
David C. Christiani,
Richard W. Clapp,
James Dahlgren,
Devra Lee Davis,
Malin Roy Dollinger,
Brian G. Durie,
David A. Eastmond,
Arthur L. Frank,
Frank H. Gardner,
Peter L. Greenberg,
Robert J. Harrison,
Peter F. Infante,
Philip J. Landrigan,
Barry S. Levy,
Melissa A. McDiarmid,
Myron Mehlman,
Ronald L. Melnick,
Mark Nicas,
David Ozonoff,
Stephen M. Rappaport,
David Rosner,
Allan H. Smith,
Daniel Thau Teitelbaum,
Janet Weiss, and
Luoping Zhang

An interesting bunch; eh?  Page two of the amicus brief tells us that:

“None of the amici has any financial or other similar interest in the outcome of this lawsuit. Amici appear on their own behalf to inform this Court of the substantial medical knowledge and understanding of leukemia arising from exposure to benzene.”

That’s probably true for the Milward case itself, but more interesting for what the disclosure does not say.  Many of the amici have testified frequently in toxic tort cases, and several have been excluded by the straightforward application of Rule 702 or its state counterparts.  Some have lost income as a result of judicial gatekeeping, and most have seen their advocacy science curtailed by such gatekeeping.

Appendix I to the brief provides further information on the amici, but there is no mention of their testimonial adventures, their financial stake in expert witnessing, or their political or positional commitments.

I suppose from CERT you get CERT-i-tude, a certain kind of attitude.

Posted in Conflicts of Interest, Rule 702 | Comments Off on THE COUNCIL FOR EDUCATION AND RESEARCH ON TOXICS

California Supreme Court Set To Untangle Webb

July 7th, 2013

Asbestos personal injury cases have been around for decades, and they show no sign of abating.  They could well be evidence for the supreme ingenuity of the plaintiffs’ bar in devising the first perpetual motion machine.  Workman’s compensation cases offer the prospect of “no-fault” recoveries, but the compensation is often based upon a scheduled award, which in some states may not adequate.  Civil actions, on the other hand, offer the prospect of jackpot recoveries, but the tort law duty is not always applicable, and plaintiffs must show duty, breach, proximate cause, in addition to injury and damages.

A recent California decision illustrates how the tort system has been twisted and tortured to make up for the perceived inadequacies of the workman’s compensation system.  At age 67, William Webb developed pleural mesothelioma.  He and his wife sued several companies, including Special Electric Company, Inc., and some automobile brake suppliers.

Starting in 1969, Webb worked for a plumbing supply company, Pyramid Pipe and Supply (Pyramid), where he regularly handled a Johns-Manville (JM) asbestos pipe, known as Transite.

Special Electric brokered South African crocidolite (blue asbestos) in the United States, including some sales (about 7,000 tons) to JM’s Long Beach, California, facility, which manufactured Transite.  JM sold the Transite to Familian (a pipe supply company), which in turn sold the Transite to plaintiff’s employer, Pyramid .

By the time of trial, only Special Electric and two automobile brake suppliers remained in the case.  A jury heard the case in January and February 2011, in Los Angeles County Superior Court, Case No. BC436063, before the Hon. John Shepard Wiley, Jr.  The brake defendants pointed the finger to the blue asbestos in J-M’s Transite, but then, their courage lagging behind their convictions, they settled during closing arguments.  The jury returned a verdict, for the Webbs, for over $5 million, with allocations of 18% to Special; 49% to JM, 33% to other third parties. Webb v. Special Electric Company, Inc., 214 Cal.App. 4th 595, 153 Cal.Rptr. 3d 882, 888 (2013).

 

PROCEDURAL PRETZELS

Before the case was submitted to the jury, Special Electric moved for a directed verdict on the failure to warn claims because JM had been warned or because the dangers were “obvious and known” to JM, and because Special Electric had no duty to warn downstream, unsophisticated customers when it reasonably relied upon JM to provide warnings.  Id. at 888-889.  The Webbs countered that there was some evidence that not all asbestos shipped to JM had warnings, and that the warnings given to JM were inadequate.  Id. at 889. These counters were  non-responsive to Special Electric’s motions.  The Webbs also argued that there was no finding that Special Electric had reasonably relied upon JM to warn downstream buyers.  Id. This argument also was irrelevant to Special’s legal argument about objective reasonable reliance.

The trial court granted Special’s motions, noting that “[t]elling Johns-Mansville about asbestos is like telling the Pope about Catholicism,” id. at 889, or like “carrying coals to Newcastle,” id. at 895.

Exactly when the trial court ruled on Special’s motions in relation to entry of judgment  is unclear, but the trial court did enter judgment n.o.v. for Special on the failure to warn claims.  The Webbs objected to the lack of written notice and other procedural aspects to the timing of the trial court’s decision.

The Webbs appealed on procedural and substantive grounds.  Special did not file a protective cross-appeal.  The California Court of Appeals, over a trenchant dissent by Judge Rothschild, reversed on both procedural and substantive issues.  Last month, June 12, 2013, the California Supreme Court vacated the intermediate appellate court’s decision and granted review on both the substantive and procedural issues.  Webb v. Special Electric Co., Inc., S209927 Cal. S. Ct. (granting review June 12, 2013).

 

MENDACIOUS HISTORY

Many asbestos cases have been tried in which the issue of who knew what, when, was relevant to the existence of a duty to warn.  The essential nature of a failure to warn case is that the seller has “knowledge” not available to the buyer.  The law addresses this inequality of knowledge by imposing a tort obligation to warn about these hidden or undisclosed hazards. Imposing tort liability for failure to warn often makes sense in the context of a product sold to consumers by sophisticated sellers.  In that context, the imbalance of knowledge will be significant and “actionable.”  In the context of sales of raw materials to large manufacturing concerns, the imbalance will often be in the opposite direction; the buyer will know more about the hazards, and especially about the circumstances of the use of the raw material, than the seller.

Certainly, there are some asbestos cases fall into the category in which the sellers of asbestos-containing products had “secret” knowledge of hazards, which was unknown to the buyers.  There are also some cases in which the parties might dispute whether the seller knew, or should have known, of the undisclosed hazards.

The Webb case may well represent a new generation of asbestos case in which the relevant exposure took place so “late in the day” that the historical evolution of knowledge about asbestos hazards, and the historical inequality of knowledge between sellers and buyers, are irrelevant to the tort law goal of addressing failing to warn.

Special Electric brokered the crocidolite fiber in question to JM, from 1974, until about 1982.  Id. at 898.  JM incorporated this crocidolite into its Transite pipe product, which it supplied to Familian, which in turn supplied Transite to Pyramid.  Special was not the only supplier of crocidolite to JM, and thus it was not clear that any Transite that went to Pyramid actually contained crocidolite brokered by Special.

Mr. Webb thus could possibly not have used Transite, which may have had Special’s crocidolite, before 1974, and probably not before 1975.  The relevant “state of the art” thus was the mid-1970s forward.

The plaintiffs presented an expert witness, Barry R. Horn, MD, who testified that beginning before the 1920s (thus sometime in 1910s), “there was ‘an enormous literature, just huge’, that occupational exposure to asbestos posed a great risk of cancer.” Id. at 900.  Horn is a “regular” plaintiffs’ witness.  He testifies about once a week for asbestos cases, always for plaintiffs.  Testimony of Barry Horn in McGrail v. Thorpe Insulation Co., Superior Ct Calif., Los Angeles Cty. No. BC 363913 (Nov. 11, 2008).  Presumably, Horn has plenty of opportunity to get the historical state-of-the-art knowledge correct; yet, his testimony that there was any literature, let alone “an enormous literature” before the 1920s about the carcinogenicity of any kind of asbestos is blatantly false.  His testimony was also, in the context of the Webb case, blatantly irrelevant.

By 1974, the public, labor, industry, government, and academics had spent over a decade of absorbing, developing, and disseminating information about the hazards of asbestos, and specifically, the cancer-causing nature of asbestos.  By the time JM Transite, which might have contained Special’s crocidolite, could have arrived at Pyramid, Webb’s employer, the cancer hazards of asbestos were discussed on television and radio, written about in newspapers, and testified to in Congress.  Asbestos cancer hazards were the primary issue that galvanized the resolve of organized labor, and drove passage of the Williams-Steiger Act of 1970, 84 Stat. 1590 et seq., 29 U.S.C. 651 et seq., which led to the formation of the federal Occupational Safety & Health Administration (OSHA).  Of course, at the top of OSHA’s priorities in 1971 and 1972, were the formulation and promulgation of regulations on asbestos permissible exposure limits.  The OSHA efforts thus kept public awareness of asbestos hazards at a high level throughout the early 1970s.  By 1975, EPA and OSHA had promulgated regulations that curtailed the use of asbestos, of all types, in the United States.

Asbestos cancer hazards were, by 1974, public knowledge, open and obvious to everyone.  There was no imbalance of knowledge; no hidden or secret knowledge, at issue. Horn’s false testimony about knowledge of cancer risks before the1920s was thus irrelevant to the issues in the Webb case.

 

A MISREPRESENTED MISREPRESENTATION

According to the majority’s opinion, the trial record included evidence that Special had instructed its sales force to market its crocidolite asbestos as “much safer” than other chrysotile asbestos, and even safer than fiberglass.  Webb v. Special Electric Co., Inc., 214 Cal.App. 4th at ___, 153 Cal.Rptr. 3d at 898, 900, 901, 904 (2013).  If Special’s salesmen made this misrepresentation to JM, their lie would have been truly reprehensible.  The evidence, however, does not make sense.  Accepting that such lies were told, the appellate court never mentions whether the lies were told to JM.  If they had been, JM, an owner and operator of chrysotile mines in Canada, would have found the suggestion that crocidolite was safer than chrysotile laughable.  By the mid-1970s, JM was reasonably advocating the relative harmlessness of chrysotile compared to crocidolite.

The majority, however, is dodgy about whether and when the supposed misrepresentation was made to JM.  According to the dissent, there was but one salesman who made these misrepresentations about crocidolite, and he left Special Electric in 1973.  There was no evidence that this salesman had any dealings with JM, and there was no evidence that Special supplied any crocidolite to JM, at its Long Beach facility, before 1974.  Id. at 913 n.8.

Interestingly, the dissent also noted that there was no evidence that Special Electric knew or should have known that crocidolite was more dangerous than other asbestos minerals.  Id.  The omission of such evidence in the record is curious because it would have been easy to have shown, at the relevant time, not only that crocidolite was known to be more dangerous than chrysotile, but that JM was interpreting the available data as showing that crocidolite and amosite were the predominant causes of mesothelioma and that chrysotile did not cause mesothelioma at all.

 

DUTY IS THE COURT’S DUTY TO DEFINE

The Court of Appeals spends a good deal of effort in trying to identify the factual issues for the jury, and the jury’s failure to find in favor of Special Electric on particular factual issues such as:

  • whether all the asbestos shipped to JM had warnings,
  • whether the warnings on the crocidolite brokered by Special were adequate
  • whether Special Electric knew or should have known that JM was unreliable as a conduit for warnings
  • whether Special had undertaken reasonable efforts to warn downstream users

The appellate court took the jury’s verdict to mean that these issues were disputed, and that the Webbs had carried their burden of persuasion on them.  Id. at 895.  The appellate court focused unduly upon whether jury instructions were given to determine whether issues had been raised and resolved by the jury.  The problem is that Special Electric’s motions for directed verdict and for j.n.o.v., would have had to assume the correctness of all plaintiffs’ evidence and inferences.  Its motions were made to obtain a ruling on a question of law, on undisputed facts.  The appellate court’s meanderings thus take it away from the central issues in Special’s motions.

The Court of Appeals declares that Special had a duty, as a matter of law, because it knew that crocidolite was dangerous, and it knew that users, such as Webb, would not know it was dangerous.  Id. at  897.  This formulation, of course, ignores and omits, the essential role of the intermediaries in the case.  The formulation also ignores the realities of the post-1964, post-Selikoff world. Webb may have testified he was unaware of the hazards, but by 1974, such testimony, from someone who worked in a plumbing supply store, is suspect.  In any event, the Court of Appeals simply assumes without evidence that Special would have known that Webb did not know.

Pushed to the wall to find a source of the duty to warn, the Court of Appeals invokes Restatement Second of Torts § 402A, but this section addresses only the selling of goods that are expected to reach the ultimate user without substantial change in their condition.  Id. at 894, citing earlier California intermediate appellate court decisions, Stewart v. Union Carbide Corp., 190 Cal. App. 4th 23, 29, 117 Cal. Rptr. 3d 791 (2010); Jenkins v. T&N PLC, 45 Cal.App. 4th 1224, 1228-1231, 53 Cal.Rptr. 2d 642 (1996).  In the Webb case, there clearly was an expectation that the asbestos fiber would be incorporated into a finished product, and that there was no practicable way for the fiber supplier to warn the ultimate user.

The dissent calls attention to the majority’s misdirections and confusions between law and fact, and points out that California and other courts have generally held that the reliance issue is really not a factual issue to be litigated:

“commerce would be impossible without the operation of such a presumption. When a manufacturer or distributor  has no effective way to convey a product warning to the ultimate consumer, the manufacturer should be permitted to rely on downstream suppliers to provide the warning. ‘Modern life would be intolerable unless one were permitted to rely to a certain extent on others doing what they normally do, particularly if it is their duty to do so’.”

Id. at 908-09 (quoting Restatement Second Torts § 388, com. n) (internal citations omitted).

Astonishingly, the Court of Appeals states that it is

“not called upon to confront whether it would have been difficult or even impossible for Special Electric to effectively warn consumers of its asbestos, as the trial court apparently concluded. That question was not made an issue at trial. Special Electric offered no evidence that it would have been difficult or impossible to warn Webb, nor evidence that it had even considered that question. Special Electric did not request that the jury be instructed that a finding of reasonable efforts on its part would satisfy its duty to warn. Finally, Special Electric failed to request a finding by the jury, either that it could not reasonably have acted to warn Webb, or that it had acted reasonably in failing to do so.”

Id. at 902.  Of course, the question identified by the majority was exactly the question that Special Electric was asking the trial court to decide, and which was decided. The appellate court’s immersion in the jury instructions obscures

the legal issue that was before the trial court. The appellate court majority went as far as declaring that its holding was limited to the trial factual issues:

“We do not hold that an asbestos-supplier’s duty to warn users of its asbestos cannot be obviated by proof that the users needed no warning, or that its duty may not be discharged by a showing of reasonable efforts to provide warnings, or by reasonable reliance upon others to do so. The effect of the trial court’s ruling was to hold that—as a matter of law—Special Electric had no duty to warn foreseeable users of the dangers of its asbestos, even though Special Electric knew or should have known that those foreseeable users would be unaware of the dangers.

The conclusion that Special Electric had no such duty, or that its duty was discharged as a matter of law, is unjustified by the law and is contrary to the record in this case.”

Id. at 903.

The dissent seized upon the majority’s failure to engage with the actual evidence at hand, and the arguments that were made.  The majority had acknowledged that:

“No one in this appeal doubts that Johns–Manville was a sophisticated user of asbestos, who needed no warning about its dangers.”

Id. at 895.  This, of course, was the issue, and none of the collateral factual issues that were submitted to the jury, or not submitted to the jury, detracted from the legal significance of this judicially noticeable fact.  By ignoring this material fact, the majority was able to persuade itself:

“that it can be a tort to fail to tell someone something they already know, and that it can also be a tort to fail to impose on someone a contractual duty to do something they already have a tort duty to do.”

Id. at 906 (Rothschild, J., dissenting).

The dissent appropriately emphasized that plaintiffs conceded at trial, and in oral argument on appeal, that Special Electric did not owe a warning directly to Mr. Webb.  Id. at 907.  The plaintiffs’ theory was that Special Electric should have contractually obligated JM to provide warnings on products that incorporated Special’s crocidolite.  Id. at 908.  This theory, however, is counter to central principles that permit persons to presume that others will know and comply with the law.  Such a contractual requirement would have been unsupported  by consideration.  A contract that required anything else other than the buyer’s compliance with the law would have been void.  Moreover, the suggestion that brokers and sellers of raw materials should dictate such terms of their contracts with corporate behemoths such as JM is unrealistic in the extreme.

 

QUESTIONABLE TESTIMONY FROM JM EMPLOYEE

A former JM employee testified that Special Electric’s brokered crocidolite did not have warnings until 1980 or 1981, and that no one from Special visited JM to inspect JM’s use of warnings on finished products going out to market.  Id. at 900.  This unnamed employee further testified that JM was “evil,” and “started to panic” in the mid-1970s, when it became a target for personal injury lawsuits.  Id.   The questionable provenance of this testimony was not discussed, but the veracity of the testimony is doubtful.

The Court of Appeals notes that correspondence from 1975, shortly after Special began brokering fiber to JM, from Special’s president, showed that Special was concerned with potential liability, and that it had been discussing the need to identify the bags as containing hazardous materials.  The contemporaneous evidence thus casts doubt on the 30+ year recall that Special’s asbestos had no warnings in the 1970s.  The Court of Appeals takes the 1975 correspondence as “indicating” that warnings were not given before 1975, and then embellishes that some JM employees were unaware of asbestos dangers until the mid-1970s.  The correspondence, however, has a much less sinister interpretation.  The fiber was being brokered.  Special was not mining, milling, and bagging the fiber, which came from South Africa.  The bags of crocidolite fiber may well have lacked warnings, but U.S. law required warnings on asbestos by 1975.  Special understandably taking steps to ensure that JM did what the law required it, as both an employer, and a seller, to do.  The Court of Appeals’ inference that there were no warnings given before 1975 is, at best, irrelevant given that Mr. Webb did not begin to handle JM Transite pipe that might have had Special’s brokered crocidolite until the mid-1970s.

 

SUPREME COURT REVIEW

Both majority and dissent do not discuss the regulatory structure that was in place in California, and in the United States.  Employers had (and still have) a duty to notify employees of the dangerous materials that they handle, and to instruct them on the use of safety equipment.  The entire discussion of knowledge of hazards proceeds without taking notice that the country was a decade past the most sensationalistic exposes of asbestos cancer hazards.   Perhaps these deficiencies reflect the abridgments of the record that occur in judicial opinion writing.  Even if the record is spotty on many of these facts, the California Supreme Court, and parties, can supply many of these facts by judicial notice.

The opening brief in this appeal was due July 12, 2013, but Special’s counsel filed a request for an extension until September 10.  Let’s hope that the Supreme Court does not delay restoring rationality to the law of product warnings.  The time has come to state that the duty to warn must be based upon the seller’s knowledge, actual or constructive, of hazards unknown to the buyer.

Posted in Learned and sophisticated intermediary | Comments Off on California Supreme Court Set To Untangle Webb

Trevor Ogden’s Challenge to the Lobby’s Hypocrisy

July 6th, 2013

Trevor Ogden, the editor of the Annals of Occupational Hygiene, addressed sharing of underlying research data in an editorial, a few years ago.  See Trevor Ogen, “Data Sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth,” 53 Ann. Occup. Hyg. 651 (2009). Ogden was responding to attacks on industry-sponsored research and demands that the exposure data from such studies be made available as a condition of publication in the Annals.

Ogden reported that he was sympathetic, to an extent, with the attack on industry bona-fides, but that editorial board discussions raised several issues with data sharing:

“(1) The researcher puts a lot of effort into getting good exposure data and may have plans for their further use; also access to the unpublished data can be an asset in getting further grants.

(2) It takes time and effort to prepare data for publication, and in the short term the people who do this to make their data available are not the ones who benefit by their availability.

(3) There may be problems with confidentiality and liability for the workplaces where the measurements were obtained.

(4) The data may be misused; in particular, they may be reinterpreted by those with a commercial interest in undermining the conclusions drawn by the original researchers.”

Id. at 652.

Had Ogden stopped there, he might have been spared the unceremonious attacks by members of “The Lobby,” but he went further to point out that some of the accusers (David Michaels; McCullogh & Tweedale) were guilty of their own rhetorical excesses.

While acknowledging that industry has taken errant positions or distorted research data on occasions, Ogden thought it was important to note that:

“industry is not always wrong, and campaigners can overlook this because it is easier to identify the paymaster than judge the science.”

* * * *

“It is a mistake if we think that because the industry helped pay for the study and has exploited the findings in its propaganda, the results must necessarily be wrong—life, including science, is not this simple.”

Id. at 653 -54.

Ogden offered, as a scientist would, further alternative explanations for why industry-sponsored scientific research appears to yield results favorable to the sponsor:

“It seems that an industry-sponsored study is much more likely to find results favourable to industry, but this may partly or wholly be because non-industry researchers find it harder to publish negative or inconclusive results. Scientific studies must be judged primarily on the quality of the evidence, not on who pays for them.”

Id. at 654. Ogden might well have opened his mind to the possibility that some government agency and academic scientists may well be biased in favor of finding outcomes that support greater agency regulation and control of occupational and environmental exposures. In any event, Ogden interpreted the situation to require skepticism of all positions, both pro- and anti-industry:

“This is not a very encouraging picture. It looks as if we cannot trust industry, and its critics are not very reliable either.”

Ogden would thus not let any side off the hook when it came to disclosures of potential conflicts of interest:

“Declarations of interest in publications are essential, especially if the authors are likely to be involved in legal testimony. Failure to offer this must be treated very seriously.”

Id. at 655.

Even Ogden’s more modest alternative explanation and his balanced comments provoked shouts of outrage from “the Lobby.” See “The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013).  Ogden, however, gave them ample space in which to voice their disagreements. See Celester Monforton, Colin Soskolne, John Last, Joseph Ladou, Daniel Teitelbaum , Kathleen Ruff, “Comment on: Ogden T (2009) ‘data sharing, federal rule of evidence 702, and the lions in the undergrowth’,” 54 Ann. Occup. Hyg. 365 (2010); Barry I. Castleman, Fernand Turcotte, Morris Greenberg, “Comment on: Ogden T (2009) ‘Data sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth’,” 54 Ann. Occup. Hyg. 360 (2010).

The remarkable thing about the Lobby’s letters to the editor is that they scolded industry for conflicts of interests, but failed to reveal their own.  Celeste Monforton, for instance, declared her academic affiliations, but overlooked her connection with an anti-Daubert advocacy organization that is funded by left-over common-benefit trust fund money from the silicone gel breast implant litigation. See SKAPP A LOT (April 30, 2010). Monforton and all her co-authors did, however, report their membership in the Rideau Institute on International Affairs, a Canadian “non-profit” organization, established in 2007. They failed, however, to disclose that the Rideau Institute engages in lobbying and advocacy efforts for trade unions and “non-profits.”  See Rideau Institute website  (“The Rideau Institute is an independent research, advocacy, and consulting group based in Ottawa. It provides research, analysis and commentary on public policy issues to decision makers, opinion leaders and the public.”).  Several of Monforton’s co-authors have testified, some frequently, for the litigation industry (plaintiffs) in occupational and environmental exposure cases.  Daniel Thau Teitelbaum, for instance, was an early testifier in the silicone breast implant litigation, and was the subject of analysis in General Electric Co. v. Joiner, 522 U.S. 136 (1997).

Barry Castleman’s letter is even more offensive to its own stated principles of extirpating conflicted science.  Castleman has been part of the litigation industry’s expert witness army in asbestos cases for over three decades.

Ogden’s statement of the problem was insightful, even if not definitive.  His suggestion that “hostile” analysts should be kept from access to underlying data ignores the intense need for this access in areas of science that inform litigation and regulation.  As George A. Olah pointed out in his Nobel Prize address, scientists need adversaries to keep them creative, focused, and accurate. Ogden’s call for disclosure of interests, “especially if the authors are likely to be involved in legal testimony,” ignores that litigants on both sides need access to scientific expertise on the issues that drive litigation and regulatory battles.  More distressingly, however, Ogden’s journal let his interlocutors slide on their obligation to disclose their deep financial and positional conflicts of interests.

Posted in Conflicts of Interest, Scientific Evidence, Scientific Misconduct | Comments Off on Trevor Ogden’s Challenge to the Lobby’s Hypocrisy

EPA Research on Ultrafine Particulate Matter

June 26th, 2013

White Hat Bias

Hyping environmental and so-called toxic risk has gone on so long that many Americans have no sense of the truth when it comes to the causal consequences of personal, occupational, and environmental exposures.  Recently, I listened to a lecture given by Judge Calibresi of the Second Circuit.  In the course of talking about regulatory prohibitions and tort-law incentives, he told of his visit to the late Professor Bickel, who had then just been diagnosed with brain cancer.  In his lecture, Judge Calibresi stated that he knew that Bickel’s brain cancer was caused by his smoking, and went on to muse whether banning smoking would have saved his friend’s life.  Judge Calibresi’s ruminations upon the nature of regulation and tort law were profound; his cursory hipshot about what caused his friend’s terminal illness, juvenile.

Some years ago, a science journalist published an account of how dire predictions of asbestos deaths had not come to pass.  Tom Reynolds, “Asbestos-Linked Cancer Rates Up Less Than Predicted,” 84 J. Nat’l Cancer Instit. 560 (1992)

Reynolds quoted one scientist as saying that:

“the government’s exaggeration of the asbestos danger reflects a 1970s’ Zeitgeist that developed partly in response to revelations of industry misdeeds.  ‘It was sort of the “in” thing to exaggerate … [because] that would be good for the environmental movement’….  ‘At the time it looked like you were wearing a white hat if you made these wild estimates. But I wasn’t sure whoever did that was doing all that much good.”

Id. at 562.  Reynolds’ quote captures the nature of “white-hat” bias, a form of political correctness applied to issues that really depend upon scientific method and data for their resolution.  Perhaps the temptation to overstate the evidence against a toxic substance is unavoidable, but it diminishes the authority and credibility of regulators entrusted with promulgating and enforcing protective measures.

White-Hat Bias & Black-Hat Ethics

I recently came across a disturbing article in the Environmental Health Perspectives, a peer-reviewed journal, supported by the National Institute of Environmental Health Sciences, National Institutes of Health, United States Department of Health and Human Services.  The article detailed a case report of an individual woman experimentally exposed to ultrafine particulate matter (PM 2.5) in a test chamber.  Andrew J. Ghio, Maryann Bassett, Tracey Montilla, Eugene H. Chung, Candice B. Smith, Wayne E. Cascio, and Martha Sue Carraway, “Case Report: Supraventricular Arrhythmia after Exposure to Concentrated Ambient Air Pollution Particles,” 120 Envt’l Health Perspect. 2275 (2012) [Ghio article].  There were no controls.

The point of the case report was that a person exposed to PM 2.5, experimentally, experienced a “cardiac event,” (atrial fibrillation or AFib) which resolved after cessation of exposure.  The experiment was conducted in a federal agency facility, Environmental Public Health Division, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Chapel Hill, North Carolina.

The authors stated that the experiment had the approval of the University of North Carolina School of Medicine Committee on the Protection of the Rights of Human Subjects. Given that the EPA has made extraordinary claims about the harmfulness of PM 2.5, including heart disease, lung disease, and cancers, and that there was no imaginable benefit to the subject from participating in the experiment, this experiment seemed dubious indeed.  The narrative of the case report, however, reveals even more disturbing information about the potential improprieties of the human experiment.

The PM Chamber

The human guinea pig was 58 years old.  Her age is significant. Although the authors claim that AFib is uncommon among those under 60, it does increase with age.  The human subject in the published experiment was close to the age at which AFib is no longer uncommon, and she was unwell to begin with.

The case report notes that the human subject had previously participated in the same exposure “protocol” without “complications.”  The report does not explain why this human subject was returning to the EPA center for being placed in a “chamber,” and being exposed sequentially to “filtered air and concentrated ambient particles (CAPs).” The implied suggestion is that she was a likely candidate to experience a “cardiac event” eventually from repeated exposures in the PM 2.5 chamber.

The “Subject”

The human subject was not well.  Although she was asymptomatic on the day of the experimental exposure to CAPs, she had a history of osteoarthritis and hypertension.  The latter condition was being treated with an angiotensin-converting enzyme inhibitor and a diuretic (10 mg. lisinopril and 12.5 mg. hydrochlorothiazide).  The subject had had surgeries for hernia repair, cholecystectomy, and knee arthroplasty. She was a little over 5 feet 6 inches tall, and obese, weighing over 230 pounds, with a 45 inch waist.

In addition to her chronic hypertension, morbid obesity, and musculoskeletal disease, the subject also had a family and personal history of heart disease.  Her father had died from a myocardial infarction, at the age of 57.  Immediately before the experimental exposure, a Holter monitor showed evidence of increased supraventricular ectopy, with 157 ± 34 premature atrial contractions/hour.

The investigators do not tell us how the experimental exposure relates to typical urban exposures, or to EPA regulatory standards, guidelines, or recommendations.  About 23 minutes after exposure to CAPs started (filter weight, 112 μg/m3; particle number, 563,912/cc), the human subject developed a “nonsustained atrial fibrillation that quickly organized into atrial flutter.”  The woman remained asymptomatic, and her EKG showed that she spontaneously reverted to a normal sinus rhythm.

The investigators acknowledge that there are many risk factors for AFib, and that the subject had several of them: hypertension, obesity, and possibly family history.  The woman had a history of premature atrial contractions, which may have increased her risk for AFib.

Despite this rich clinical background, the authors claim, without apparently trying very hard, that there was no “obvious” explanation for the subject’s arrhythmia while in the chamber.  They argue, however, that the exposure to PM 2.5 was causal because the arrhythmia began in the chamber, and resolved when the subject was removed from exposure.  The argument is rather weak considering that the subject may have been stressed by the mere fact of placement in a chamber, or being wired up to monitors.  See, e.g., Luana Colloca, MD, PhD, and Damien Finniss, MSc Med., “Nocebo Effects, Patient-Clinician Communication, and Therapeutic Outcomes,” 307 J. Am. Med. Ass’n 567, 567 (2012). The authors of the PM 2.5 case report acknowledge that “coincident atrial fibrillation cannot be excluded,” but they fail to deal with the potentially transient nature of AFib.

Human experimentation requires a strong rationale in terms of helping the experimental participant.  What was the rationale for this human experiment?  Here is what the EPA investigators posit:

“Although epidemiologic data strongly support a relationship between exposure to air pollutants and cardiovascular disease, this methodology does not permit a description of the clinical presentation in an individual case. To our knowledge, this is the first case report of cardiovascular disease after exposure to elevated concentrations of any air pollutant.”

Ghio at 275. The authors seemed to be saying that we know that PM 2.5 causes cardiovascular disease, but we wanted to be able to describe a person in the throes of a cardiovascular event brought on by exposure. See also Andrew J. Ghio, Jon R. Sobus, Joachim D. Pleil, Michael C. Madden, “Controlled human exposures to diesel exhaust,” 142 Swiss Med. Weekly w13597 (2012).

The Whole Truth

The Ghio article mentions only the one woman who experienced the mild, transient AFib.  A reader might wonder whether she was the only test subject.  Why was she retested after a previously incident-free experience in the chamber? How many other people were subjected to this protocol?

What is remarkable is that the authors claim not only an “association,” but causality, in a totally uncontrolled experiment, and without ruling out chance, bias, or confounding.  The article is both deficient in scientific methodological rigor, and dubious on ethical principles.

EPA – Hoisted With Its Own Petard

What I did not realize when I read this experimental case report is that the article had been a cause célèbre of the anti-regulatory right.  The EPA had walked right onto an ethical landmine by first sponsoring this research, and then by relying upon it to support a regulatory report. Steven Milloy editorialized about the EPA research, followed by a FOIA investigation. In September 2012, a regulatory watchdog group filed a lawsuit to strike an EPA report, which was based in part upon the questionable research.

Milloy’s strategy was designed to impale the EPA on the horns of a dilemma:

“I accused EPA of either: (1) conducting unethical human experimentation or exaggerating the dangers of fine airborne particulate matter (PM2.5). It must be one or the other; it can’t be neither, according to EPA’s own documents.”

Steven Milloy, “Did Obama’s EPA relaunch Tuskegee experiments?” (April 24, 2012).  The EPA had branded diesel particulate, which was used in the experiments, as “carcinogenic” and “lethal,” even from short exposures.  Accordingly, if the EPA were sincere, it should have never conducted the experiment documented in Environmental Health Perspectives.  If the agency believed that PM 2.5 was innocuous, then it unethically exaggerated and overstated its dangers.

In course of his FOIA initiative, Milloy did obtain answers to some of the questions I had from reading the Ghio article.  There were apparently about 40 human subjects, who were subjected to PM 2.5 exposure in chambers fed by diesel exhaust or other sources.  The exposure levels were upwards of 20 times what the EPA labeled a “permissible” level.  Of course, the EPA is positionally committed to a “linear, no-threshold” model of carcinogenesis, which makes any exposure to a substance it “knows” to cause cancer ethically improper.

The information from the FOIA requests puts the Ghio article in an extremely bad light.  The human subject on whom the authors reported had run about 40 other people through their chamber without ill effect, but failed to mention these cases.  The consent forms and IRB documents show that the investigators were specifically interested in “vulnerable” patients, who had diabetes, asthma, etc.  The fair inference is that the investigators wanted to provoke an anecdote that would support their causal narrative, which they believed had already been established with epidemiologic evidence.  This seems like a scientific hat trick: bad science, bad ethics, and bad publication practice.

The lawsuit did not fare well.  Predictably, it foundered on the lack of final agency action, and the lack of standing.  On January 31, 2013, Judge Anthony J. Trenga dismissed the complaint, after having previously denied a temporary restraining order.  The American Tradition Institute Environmental Law Center v. U.S. EPA, Case 1:12-cv-01066-AJT-TCB (E.D. Va. 2013).  While legally correct, the opinion is blandly devoid of any sense of ethical concern.

From a brief search, there does not appear to be an appeal to the Fourth Circuit in the works.  Of course, there were no personal injuries alleged in the ATI lawsuit, and the human subject in the Ghio article has appeared not to have sued.  Despite the lack of legal recourse, the science “right” is up in arms over EPA duplicity.  In a recent publication, Milloy and a co-author, quote former EPA Administrator Lisa Jackson, at a congressional hearing:

“Particulate matter causes premature death. It’s directly causal to dying sooner than you should.”

When Representative, now Senator, Edward J. Markey asked, “How would you compare [the benefits of reducing airborne PM2.5] to the fight against cancer?” Jackson answered hyperbolically:

“If we could reduce particulate matter to healthy levels, it would have the same impact as finding a cure for cancer in our country.”

Steve Milloy & John Dale Dunn, “Environmental Protection Agency’s Air Pollution Research: Unethical and Illegal?” 17 J. Am. Phys. & Surg. 109 (2012) (quoting Jackson).  The FOIA and other background materials from this EPA posturing can be found on one of Milloy’s websites.

Sadly, I found the answers raised by the Ghio article only because of the anti-regulatory activism of Milloy and the American Tradition Institute.  The white-hat bias remains a potent force in regulatory agencies, and in scientific laboratories.

Posted in Causation, Scientific Misconduct, Underlying Data | Comments Off on EPA Research on Ultrafine Particulate Matter

A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation

June 21st, 2013

Weitz & Luxenberg P.C. v. Georgia-Pacific

Earlier this month, the First Department of the New York Appellate Division upheld a trial court’s ruling that a former manufacturer of an asbestos-containing product, Georgia-Pacific LLC (G-P), must produce underlying data from eight published research studies, funded by the company.  These studies apparently addressed health outcomes from the use of the company’s product, a joint compound, or from its chrysotile asbestos component.  The trial court had also ordered an in camera review of various other documents on G-P’s privilege log.  Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013)

The appellate court accepted that G-P had funded the eight studies as part of its legal defense to asbestos personal injury litigation.  The studies at issue involved recreating G-P’s asbestos-containing joint compound to assess biopersistence and pathogenicity of its (past) chrysotile content.  According to the Appellate Division’s opinion, G-P was closely involved in the development of the published articles.  G-P’s Director of Toxicology and Chemical Management, Stewart Holm, became a contractor to provide “consulting services” to G-P’s in-house counsel.  Both Holm and in-house counsel were involved in pre-publication review of the articles.

G-P claimed attorney-client and work-product privilege to resist production of documents that reflected communications with consulting experts or legal staff.  The Special Master directed an in camera review of documents on G-P’s privilege log, and the production of the underlying data and materials from the studies.  The motion court refused G-P’s motions to vacate the Special Master’s recommendations, and to reconsider.

The trial and appellate court rulings seem fairly straightforward except that the appellate court omitted serious consideration of the existence and scope of the privilege, and focused upon the applicability of the crime-fraud exception.  This exception requires that the legal advice, sought to be protected, involves some fraudulent scheme or wrongful conduct, but the court seemed all too willing to engage in an analysis of the applicability of the exception before it considered whether the privilege applied in the first place.   

The Appellate Division held that the plaintiffs had made a sufficient “showing of a factual basis adequate to support a good faith belief by a reasonable person that in camera review of the materials may reveal evidence to establish the claim that the crime-fraud exception applies.” Slip op. at 4.  Here is how the appellate court described the plaintiffs’ claim that the attorney-client privilege had been lost:

“Holm co-authorized nearly all of the studies, which were intended to cast doubt on the capability of chrysotile asbestos to cause cancer. On the two articles that he did not co-author, he [*4]and GP’s counsel participated in lengthy ‘WebEx conferences’ in which they discussed the manuscripts and suggested revisions. Despite this extensive participation, none of the articles disclosed that GP’s in-house counsel had reviewed the manuscripts before they were submitted for publication. Two articles falsely stated that ‘[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript’. For articles lead-authored by David M. Bernstein, Ph.D., and co-authored by Holm, the only disclosure was that the research was ‘sponsored’ or ‘supported’ by a grant from GP. The articles did not disclose that Holm was specially employed by GP for the asbestos litigation or that he reported to GP’s in-house counsel. Furthermore, there were no grant proposals, and Dr. Bernstein was hired by GP on an hourly basis. Nor did the articles reveal that Dr. Bernstein has been disclosed as a GP expert witness in NYCAL since 2009, that he had testified as a defense expert for Union Carbide Corporation in asbestos litigation, or that he had been paid by, and spoken on behalf of, the Chrysotile Institute, the lobbying arm of the Quebec chrysotile mining industry. Although GP belatedly endeavored to address the inadequacies of certain of its disclosures, its corrections failed to acknowledge its in-house counsel’s participation and did not make clear that Dr. Bernstein’s testimony as an expert witness preceded the publication of the first GP reformulated joint compound article in 2008.”

The court was obviously concerned that G-P in-house counsel was involved in the publication process, and that this involvement was not disclosed. Slip at 4, citing United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D. D.C. 2006) (applying fraud-crime exception to tobacco industry), aff’d in relevant part, 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S.Ct. 3501 (2010).

What Appellate Division appeared to overlook is whether the attorney-client privilege applied in the first place.  In her initial recommendation, Special Master Laraine Pacheco gave careful consideration to the logically prior question whether the disputed materials were “legal” such that any privilege even attached to the disputed materials in the first place. See Recommendation of Special Master at 3, citing United States Postal Serv. v. Phelps Dodge Ref. Corp., 852 F. Supp. 156, 160 (E.D.N.Y. 1994) (“Defining the scope of the privilege for in-house counsel is complicated by the fact that these attorneys frequently have multi-faceted duties that go beyond traditional tasks performed by lawyers. . . . Needless to say, the attorney-client privilege attaches only to legal, as opposed to business, services. The communication must be made to the attorney acting in her capacity as counsel. If the communication is made to the attorney in her capacity as a business adviser, for example, it ought not be privileged”); In re Grand Jury Subpoena, 599 F.2d 504, 511 (2d Cir. 1979) (“Participation of the general counsel does not automatically cloak the investigation with legal garb”). The Special Master seemed to think that there was no privilege, which stood in need of an exception.

The Special Master also noted that no privilege attaches to materials that were intended for ultimate publication: 

 “New York of course accepts the unremarkable proposition that if a client communicates to the lawyer with the intent that the communication is to be released to the public, that communication is not privileged.”

Recommendation at 3, citing In re New York Renu with Moistureloc Prod. Liability Litig. , 2008 U.S. Dist. LEXIS 88515, at *5, 14 (D.S.C. May 8, 2008) (applying New York law) (relying on Michael M. Martin, et al., New York Evidence Handbook  318 (2d ed. 2002)).  Furthermore, there was a question whether G-P had waived its privilege claim by selectively producing some documents that it wanted to put into the record of the case.  Id.  The Special Master’s points appear important and persuasive, but the Appellate Division skipped over them in order to address the exception, which assumes that the privilege applies in the first place.

American Law Institute (ALI), The Law Governing Lawyers § 68 (1998). The mere participation of in-house counsel is not dispositive of the question.  The privilege applies to communications made for the purpose of obtaining legal advice. In-house lawyers are often consulted for advice on non-legal issues.  Courts have thus been drawn in to controversies over sorting out whether the communication was engaged in for purpose of obtaining “legal assistance.” ALI § 72. The law acknowledges that communications may have multiple purposes and motives, but the predominant function of the communication must relate to legal advice if it is to retain its privileged status. ALI § 72, comment c.

In Burton v. R.J. Reynolds Tobacco Co., both the magistrate and district judges accepted, as a general principle:

 “An analysis of scientific data may be the subject of a privileged communication. To establish that such communications are protected by the attorney-client privilege there must be a connection between the scientific information which is the subject of the communication and the rendering of legal advice.”

200 F.R.D. 661, 668 (D. Kan. 2001). The court, however, proceeded to analyze the disputed claims of privilege and rejected most of them on grounds that the attorney communications were not in response to requests for legal advice. For instance, the court rejected the claim of privilege for a memorandum, written by an RJR scientist who assisted RJR patent lawyers as a scientific paralegal. The RJR scientist commented on “patentability,” but the court found that the document primarily concerned scientific research with no connection to the rendering of legal advice. Id. at 670. Even stingier was the court’s interpretation of a memorandum from RJR’s CEO to its general counsel, which discussed outside counsel’s recommendation that the company “should fund additional medical research in order to gain additional facts that [it]] can use to defend [itself] against [its] critics.” The court characterized the referenced advice as relating to public relations advice, not legal counsel. Id. at 672.

In the Vioxx MDL, Judge Fallon struggled with the issue whether many of activities of in-house counsel were truly “legal,” especially when the attorney communications were comments and edits of “scientific reports, articles accepted for publication in noted journals, and research proposals,” or word choice comments in scientific articles and study proposals. In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 800, 802 (E.D.La. 2007)(“We could not see the legal significance of these comments… .”).

Merck advanced a theory that the pharmaceutical industry was so pervasively regulated that the court should assume that its in-house lawyers were providing legal advice in making such comments and edits. Special Master Rice, a noted privilege scholar appointed to review the privilege claims, and Judge Fallon, never accepted Merck’s blanket rationale, although they did acknowledge that some service, initially appearing to be non-legal (such as “commenting upon and editing television ads and other promotional materials”) could in fact be legal advice when understood in the context of the pharmaceutical industry’s regulatory framework. Id. (citing Vodra et al., “The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges,” 61 Food & Drug L.J. 623 (2006)).

Concerned that such a blanket justification would seriously curtail discovery, the Special Master and the MDL Court insisted that Merck, in claiming a privilege, carry its burden to show that each document was, in fact, a confidential communication of legal advice. Id. The Special Master professed to be receptive to Merck’s evidence that, in the context of the highly regulated pharmaceutical industry, in-house counsel’s extensive changes and commentary to technical and scientific matters were legal services. Id. at 811-12.  Judge Fallon, quoting from the Special Master Rice’s report, noted that:

 “The responsive communication from the attorney is protected only to the extent that the response reveals the content of the client’s prior confidential communication.”

In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 795 (E.D.La. 2007).  As a result, an attorney’s transmission to the client of information obtained from third-parties is not privileged. Id. at 796. Similarly, the derivative nature of the privilege may lead to a refusal to apply it to in-house lawyers’ line edits of a non-privileged document, which was circulated to other corporate employees outside the legal department. Id.

The Vioxx analysis shows that the presumption that in-house or outside (or out-house) counsel are writing to provide legal advice, in response to client communications can be lost.  When the communications at issue are not for the purpose of providing legal advice, there may well be no protection under the attorney-client privilege.  In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 797 n. 12 (E.D. La. 2007)(quoting Special Master Rice, who was quoting from his treatise at § 7.28). See also . In re Seroquel Prods. Liab. Litig., 2008 WL 1995058, at* 6- 7 (M.D. Fla. 2008) (rejecting “pervasive regulation” theory, and relying heavily upon Judge Fallon’s analysis in Vioxx).

The Appellate Division’s enthusiasm for accepting the existence of the privilege in Georgia-Pacific, and to except its application by the crime-fraud exception, is deeply troubling because the court left unclear exactly what G-P’s crime or fraud was.  Perhaps G-P had failed to disclose some of the above-quoted facts in its discovery, but the anemic disclosures are all-too-common in most publications.  They are hardly a crime.  No provision of the penal code was cited.  Although some of the suggested conduct is unseemly, it is not clearly a fraud.

The only supposed falsehood was that “[t]wo articles falsely stated that ‘[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript’.”  Slip op. at 4.  The recited “good faith” belief does not suggest that G-P designed or analyzed the studies.  It is unclear whether G-P’s in-house counsel’s participation in a Webex conference realistically could be considered “preparing” a manuscript.  The court’s vague accusations leave unclear exactly what G-P did to design the study, analyze the data, or prepare the manuscript.  Such vague accusations would hardly pass the strictures of Federal Rule of Civil Procedure 9(b) (“Fraud or Mistake; Conditions of Mind. In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”)

Work Product Protection

The Appellate Division’s decision was on firmer ground with respect to rejecting G-P’s asserted work-product protection for attorney mental impressions, writings, trial preparation materials, and the like.  As the court noted, there is a strong public interest in having disputes resolved on the basis of complete, accurate information.  Slip op. at 6, citing In re American Tobacco Co., 880 F.2d 1520, 1529 (2d Cir 1989).  Of course, in the American Tobacco case, the Second Circuit upheld a subpoena (previously quashed by New York state courts) against Dr. Selikoff’s Environmental Sciences Department, at the Mt. Sinai School of Medicine.

In the case on appeal, the court noted that G-P had admitted to commissioning the studies in anticipation of litigation, and to having its trial counsel or its expert witnesses use the studies at trial.  Slip op. at 6.  The appellate court also held that the plaintiffs’ substantial need for the underlying data and related materials, and the prejudice from being denied access, were obvious.  The appellate court cast a broad, but not an unlimited net, for materials that would have to be produced.  “[T]he data, protocols, process, conduct, discussion, and analyses underlying these studies” must be produced, but not “any internal communications that portray its attorneys’ or consultants’ notes, comments or opinions.” Slip op. at 7.  The court identified the rationale for requiring production:

 “A significant expenditure of time and money would be required to duplicate the studies, if they could be exactly duplicated at all, whereas scrutiny of the underlying data may provide a permissible manner in which to attack the findings that would be consistent with the intent of the CMO to minimize the cost of and streamline discovery.”

Id.  Indeed, the lesson of the American Tobacco case, cited by the court, is that a party’s need and entitlement to underlying data and materials trumps even an independent researcher’s claim of “scholar’s privilege” or proprietary interest in data.  Litigants are entitled to everyman’s and everywoman’s evidence, even if they are scientists.  Courts may have to fashion protection to protect some of the scientists’ interests, but the wholesale denial of access to underlying data from published studies is, and should be, a relic of the past.

It is reflective of the Zeitgeist that the appellate court couched some of its rationale in corporation bashing:

 “Large corporations often invest strategically in research agendas whose objective is to develop a body of scientific knowledge favorable to a particular economic interest or useful for defending against particular claims of legal liability.”

Slip op. at 6, quoting from In re Welding Fume Prods. Liability Litig., 534 F.Supp. 2d 761, 769 n.10 (N.D. Ohio 2008). Well the litigation industry, a.k.a. the plaintiffs’ bar, similarly invests in its research agenda, as evidenced in any number of litigations, including asbestos, silicone, welding cases, etc.  More important, the plaintiffs’ bar has powerful interest proxies, such as support groups, labor unions, so-called public-interest groups, and captured governmental agencies, which are frequently involved in advocacy science.  The need for access to underlying data, protocols, questionnaires, research materials is not limited to plaintiffs or defendants in litigation.

Eight Articles

A Pubmed search turned up exactly eight articles for <S.E. Holm and asbestos>.  Two of the articles at issue did not have Holm as an author, so the following list is not identical to the eight articles at issue.

1. Exposures from chrysotile-containing joint compound: evaluation of new model relating respirable dust to fiber concentrations.

Brorby GP, Sheehan PJ, Berman DW, Bogen KT, Holm SE.

Risk Anal. 2013 Jan;33(1):161-76.

2. More on the dynamics of dust generation: the effects of mixing and sanding chrysotile, calcium carbonate, and other components on the characteristics of joint-compound dusts.

Berman DW, Brorby GP, Sheehan PJ, Bogen KT, Holm SE.

Ann Occup Hyg. 2012 Aug;56(7):852-67.

3. Chamber for testing asbestos-containing products: validation and testing of a re-created chrysotile-containing joint compound.

Sheehan PJ, Brorby GP, Berman DW, Bogen KT, Holm SE.

Ann Occup Hyg. 2011 Aug;55(7):797-809.

4. Quantification of the pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite-asbestos following short-term inhalation exposure.

Bernstein DM, Rogers RA, Sepulveda R, Donaldson K, Schuler D, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2011 Jun;23(7):372-91.

5. Potential artifacts associated with historical preparation of joint compound samples and reported airborne asbestos concentrations.

Brorby GP, Sheehan PJ, Berman DW, Bogen KT, Holm SE.

J Occup Environ Hyg. 2011 May;8(5):271-8.

6. The pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite asbestos following short-term inhalation exposure: interim results.

Bernstein DM, Rogers RA, Sepulveda R, Donaldson K, Schuler D, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2010 Sep;22(11):937-62.

7. Re-creation of historical chrysotile-containing joint compounds.

Brorby GP, Sheehan PJ, Berman DW, Greene JF, Holm SE.

Inhal Toxicol. 2008 Sep;20(11):1043-53.

8. A biopersistence study following exposure to chrysotile asbestos alone or in combination with fine particles.

Bernstein DM, Donaldson K, Decker U, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2008 Sep;20(11):1009-28.

I thank William Ruskin for calling my attention to this interesting case in his blog post about the Weitz & Luxenberg v. Georgia-Pacific case.

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