TORTINI

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

COURTING CLIO: HISTORIANS UNDER OATH – Part 2

December 17th, 2011

Continued from Part 1:

Court-Appointed Historians

One lawyer, Jonathan Martin, trained in historical scholarship in Princeton University, has argued that historian expert witness opinion testimony is both unavoidable and refractory to the protections of judicial gatekeeping.  Martin, Historians at the Gate:  Accommodating Expert Historical Testimony in Federal Courts.” 78 N.Y.U.L. Rev. 1518 (2003).  Mr. Martin acknowledges that historians are beholding to an objective methodology, but when they are in the employ of lawyers, historians abridge or abrogate their commitment to objectivity:

Just as scientific testimony must adhere to the scientific method so too must historical testimony adhere to the historical method.  Unfortunately, historians often neglect the conventional method of their craft when offering expert testimony.  Outside the courtroom, historians generally expect one another to formulate complex, nuanced, and balanced arguments that take into account all available evidence, including any countervailing evidence.  At trial, however, the pressures of the adversary system routinely push historians toward interpretations of the past that are compressed and categorical . . .  .  As a result, historians now frequently offer unreliable evidence.

Id. at 1521.  Mr. Martin proposes to remedy the frequent, unreliable testimony from historians by the routine appointment of court-appointed expert witnesses.

In passing, Mr. Martin notes that others have urged judicial gatekeeping, under Daubert or Frye, to address unreliable historian testimony, but he rejects gatekeeping of adversarial expert witnesses as insufficient.  Id. at 1522 n.23.  Given the dearth of reported cases of such gatekeeping, this rejection seems premature.  Perhaps more important, Mr. Martin, in his rush to advocate court-appointed historians, fails to address how and why historians’ opinions are different from the opinions of experts in other fields, which are successfully subjected to cross-examination and to reliability analysis.  Historians are not alone, certainly, in succumbing to the temptation to stray from objective methodology.  Mr. Martin is correct, however, in his implicit acknowledgment that historian opinion testimony warrants increased judicial scrutiny.

One way historians differ from other fields of objective study is that historical scholarship is perfused with argument.  In biomedical and physical sciences, the presentation of research is carefully and routinely segregated into hypothesis, materials and methods, findings, and discussion.  Research findings are neatly presented without inferences to conclusions.  If conclusions can be reliably reached from the research or experiment, the investigators present their conclusions, with appropriate qualifications and caveats, in the discussion sections of their writings.  Readers understand that the discussion section is often the least important part of a published article.

Lawyering is similarly segregated into proofs and argument.  The trial lawyers’ evidence, whether real, documentary, or testimonial, is confined to a portion of the trial open for proof of facts in issue.  The trial court has the responsibility to prevent argument, argumentative questioning, and argumentative testimony in the proof-phase of the trial.  Only in closing argument, may the trial lawyers urge inferences and conclusions that assist the trier of fact to resolve the factual disputes in the case.  To be sure, trial lawyers try and sometimes succeed in advancing their argument in the proof phase of trial, either by clever juxtaposition in presenting facts, by adducing opinions in carefully defined exceptions (such as character evidence), or by successfully evading the trial court’s supervision.

Historians, in their scholarship, may acknowledge an objective method in their fact-finding, but they are under no professional constraint to separate their fact-finding and argument.  Both popular and academic historical scholarship blend fact and opinion in a manner antithetical to the sciences.  The strength and persuasiveness of historical scholarship often turns on how well the historian creates a complex narrative of fact, inference, argument, and opinion.  And the greatest art is that which conceals itself.

The pervasive role of argument is a relatively small problem compared to the dominance and legitimacy of subjective perspective in historical narrative.  Historians write from a point of view.  Openly and honestly, they narrate historical facts and events from a Marxist, labor, feminist, free-market, religious, or other point of view.  Sometimes, their point of view is covert, but it still colors the narrative.  Importantly, the point of view is often not scientific in that the scholars would likely refuse to count any empirical evidence as refuting the “truth” of their narrative.

The problems and excesses of historian opinion testimony are thus not likely to be remedied by having a court-appointed historian weigh in on the issues.  Such a court-appointed historian would present a challenge to the parties, who would need to cross examine vigorously, and to the court, which would be obligated to review and pass on the reliability of its own expert witness.  The prestige and imprimatur of court appointment would just as likely thwart as promote the truth-finding function of trial.  The argumentativeness of historical narrative would escape meaningful detection and confrontation.  Court appointments of historian witnesses might well have the effect of ending the dispute, but not in a way that advances the just resolution of the parties’ claims.

Appointment of “neutral” expert witnesses may appear to be an attractive judicial strategy to a trial court faced with party expert witnesses that are “too extreme.”  Trial judges, especially in federal Multidistrict Litigation (MDL), hear capable advocates present highly credentialed expert witnesses.  Often the opinions of the parties’ expert witnesses are diametrically opposed in ways that do not let the trial court gauge their competing claims to truth.  If trial courts find assessment of these expert witnesses’ opinions to be difficult, juries are not likely to fare better.  In perplexity, judges may try to align themselves in the middle, and comfort themselves with the belief that the trust must lie somewhere between the parties’ polar views of the world.

In the silicone gel breast implant litigation, MDL 926, Judge Sam Pointer found himself in the “middle.”  He had refused Daubert challenges to plaintiffs’ expert witnesses, and stated that the parties’ expert witnesses were too extreme.  After Judge Jack Weinstein sua sponte raised the issue of court-appointed experts in breast implant cases, plaintiffs’ counsel petitioned Judge Pointer to appoint expert witnesses in all the federal cases.  Over defendants’ objections, Judge Pointer appointed a toxicologist, a rheumatologist, an immunologist, and an epidemiologist to address the plaintiffs’ claims that silicone causes systemic autoimmune and connective tissue diseases.  After a lengthy, expensive, complex proceeding, the MDL court-appointed expert witnesses filed reports and gave testimony that rejected plaintiffs’ claims.  Much to Judge Pointer’s surprise, but not the scientific community’s, the Court’s expert witnesses opined that plaintiffs’ claims were not supported and shown by sound scientific evidence.  Subsequently, a committee of the Institute of Medicine, of the National Academy of Sciences, reached the same exculpatory conclusion.

In MDL 926, the resort to court-appointed witnesses was necessitated by that trial court’s refusal or failure to engage in meaningful gatekeeping.  Remarkably, before the MDL Court even embarked upon the expensive detour of four Rule 706 witnesses, another federal court, employing expert witness advisors, reached the same conclusion in Daubert proceedings.  Hall v. Baxter, 947 F.Supp. 1387 (D. Or. 1996).  Judge Weinstein, sitting on all federal cases in the Eastern and Southern District of New York, had already granted partial summary judgment to defendants on plaintiffs’ systemic injury claims.  In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996).  Rule 706 was used by plaintiffs’ counsel to prolong and protract the federal proceedings, in the hope that they would be saved by research that they were sponsoring through their expert witnesses.

In looking at disputes of historical scholarship, we can easily imagine that judges will see the parties’ expert witnesses as too extreme.  The time-consuming, expensive resort to court-appointed witnesses, however, will not likely advance the resolution of issues of historical scholarship.  Unlike the selection process in MDL 926, where Judge Pointer could relatively quickly find his way to well-qualified, credible, and disinterested witnesses, the selection of an historian would stumble over the disinterestedness criterion.  Historians, by the nature of their craft, are permitted, and are encouraged, to advance a point of view that is out of place in the judicial process.

Historian Witnesses on State-of-the-Art in Tort Cases

In products liability litigation over designs or warnings, a supplier or manufacturer is typically held to the knowledge and expertise of an expert in the field.  Unfortunately, the law offers little help in answering the obvious question of which expert, of all the experts in the world, sets the appropriate standard.  In litigation over the quality of medical care, the law in many states resolves this issue by providing a defense under the “Two Schools of Thought Doctrine.”  See, e.g., “Two Schools of Thought and Informed Consent Doctrine in Pennsylvania.”  98 Dickenson L. Rev. 713 (1994).  A physician does not deviate from the standard of care simply because many or most physicians reject the approach he or she took to the patient’s problem.  As long as a substantial minority of physicians would have concurred in the judgment of the defendant physician, the claim of malpractice fails.  The Two School Doctrine has obvious implications for the standard of design or warning in products cases.

What is clear in products liability cases is that the standard of expertise must be assessed at a given time, when the product or material enters the stream of commerce.  In silicosis cases, which may involve long latency periods between exposure and manifestation of claimed disease, the parties may face historical issues of what experts knew at the legally relevant time of the sale.  Intellectual historians may indeed provide helpful insights into what was actually believed by experts in the past, but such historical data about past “beliefs” can answer the state-of-the-art inquiry only in part.  Knowledge requires at least true, justified belief.  Robert Nozick, Philosophical Explanations 167-288 (Cambridge 1981).  Hunches, suspicions, and hypotheses, even when published in respected books or journals, do not rise to the level of scientific knowledge that can be charged to the manufacturer or the supplier defendants.  Historians, unless adequately trained and expert in scientific method and research, will be inadequate to the task of explaining whether a given belief was justified and true.  Historians, motivated by politics or ideology, may try to advance their causes by trumpeting some past scientific findings, but in the last analysis, scientific theories cannot be chosen the way one chooses to be a Democrat or a Republican.  Proof of “state of the art,” or who knew what when, will require substantial expertise in science and medicine.  Historians may have to emote on the sidelines of these debates.

COURTING CLIO: HISTORIANS UNDER OATH – Part 1

December 17th, 2011

The role of historians as expert witnesses is precarious.  They purport to marshal factual evidence from reliable sources, but that is exactly what lawyers are supposed to do.  Historians argue reasonable inferences from facts to opinions about causation, motivation, and intent.  Again, that is what lawyers are supposed to do in the argument phase of a trial.  Generally speaking, historians are superfluous in trials.

Last year, John Ulizio and I submitted an abstract, “Courting Clio,” to the International Commission on Occupational Health (ICOH), for its Fourth International Conference on the History of Occupational and Environmental Health June 19 – 22, 2010.  My presentation received mixed reviews, with the negative reaction coming from a peanut gallery of a testifying historian expert witness.  SeeA Walk on the Wild Side” (July 16, 2010).  The abstract, “Courting Clio:  Historians and Their Testimony in Products Liability Action,” will appear next year in Brian Dolan and Paul Blanc, eds., At Work in the World: Proceedings of the Fourth International Conference on the History of Occupational and Environmental Health, Perspectives in Medical Humanities, University of California Medical Humanities Consortium, University of California Press (2012)(in press).

For an illustrative example of the gratuitousness of much of expert historian testimony, consider the following exchange in a deposition in a case involving claims of failure to warn, and of silicosis:

Q. Would you agree that in the 1930s, you would have to be quite a knucklehead – that’s a technical term – not to know that silica under some circumstances would cause silicosis?

A. I would agree with that characterization and the use of that technical term.

Gerald Markowitz Deposition, Mendez, at p. 115 (2005)

I believe you would have to be knucklehead to think that a jury needed Professor Markowitz to address historical knowledge about the hazards of excessive silica exposure, but plaintiffs’ lawyers persist in that practice in their silica cases.

What follows is the first part of an expanded version of the abstract presented at the ICOH.

COURTING CLIO:  HISTORIANS UNDER OATH

Introduction

Every trial involves a dispute about past facts and events.  The trier of fact must resolve the factual disputes based upon the evidence marshaled at trial.  In the common law system, the parties are primarily responsible for adducing evidence that will support their claims about historical facts.  A mature law of evidence governs admissibility of evidence, and what is reserved to counsel’s argument and the trier of fact’s reasonable inference.  The body of rules and principles that make up the law of evidence has evolved toward securing fairness, eliminating undue expense and delay, and ascertaining the truth.  Fed. R. Evid. 102.  Many would question the perfection of the current law of evidence, but few would agree to turn control over evidence and inference to historians appearing in court as expert witnesses.

Trial lawyers, using admissible evidence at trial, and fair comment in summation, attempt to persuade the triers of fact of the correctness of their version of historical facts relevant to the dispute.  In courthouses throughout the common-law world, trying cases ranging from car wrecks to complex anti-trust conspiracies, lawyers research, document, and adduce evidence of historical fact.  Judges regulate the proof of relevant historical facts by a system of rules that has been refined over centuries in the crucible of judicial experience.

At first blush, historians would appear to have little or no role in the litigation process.  Historians, in marshaling evidence and inference, are largely redundant to the lawyering process.  Indeed, reported decisions involving historians are relatively uncommon.  For the most part, historians are discussed as witnesses in only a few cases, involving such issues as land boundary disputes, navigability of rivers and riparian rights, Native American tribal status, or Nazi deportations.  See, e.g., Cayuga Indian Nation v. Pataki, 165 F.Supp. 2d 266, 300 (N.D.N.Y. 2001) (testimony on state’s purchase of tribal land); Denson v. Stack, 997 F.2d 1356, 1363-68 (11th Cir. 1993) (Clark, J., dissenting) (navigability of river in mid-19th century); Naujalis v. INS, 240 F.3d 642, 645 n.7 (7th Cir. 2001) (Nazi deportation); United States v. Dailide, 227 F.3d 385, 387 (6th Cir. 2000) (historian’s testimony in deportation proceeding).  The common themes to those cases are the arcane proofs, serious authenticity issues, and foreign language of the documentary evidence.

Historian As Advocate

There is a disturbing tendency for historians, as well as other academics, to view service as an expert witness as a way to effect social change.  Some historians have honestly acknowledged that they became lawyers manqué in their role as experts.  Professor Alfred Kelly, noted historian of the Reconstruction era, who served on the NAACP’s legal team in Brown v. Board of Education, 347 U.S. 483 (1954), strained to make out the historical case that the ratifiers of the Fourteenth Amendment had intended or anticipated to desegregate public schools.  In Richard Kluger’s history of Brown, Professor Kelly is quoted as saying that he “was caught between [his] ideals as an historian and what these people in New York [NAACP] wanted and needed.”  R. Kluger, Simple Justice:  The History of Brown v. Board of Education and Black America’s Struggle for Equality, 802 (N.Y. 1975).

Historian David Rothman recently acknowledged advocacy as the basic motivation for historians to serve as expert witnesses.  In his article, “Serving Clio and Client:  The Historian as Expert Witness,” 77 Bull. Hist. Med. 25 (2003), Rothman notes and embraces the tendentious nature of historical scholarship.  “Historians,” he tell us, “are no more or less ‘objective’ in the courtroom than they are in the lecture hall or in print.”  Id. at 44.  That assessment, alone, should give trial courts serious pause before allowing historians to testify.

In arguing why historians should serve as expert witnesses, Rothman advances the unexceptional point that litigants should have access to the expertise to have their day in court.  Id.  To the extent that historical expertise is the proper subject of opinion testimony, and the opinion is reliably based, Rothman’s point is well taken.  Emboldened, however, by the prospect of turning the witness chair into the bully pulpit, Rothman waxes expansively about the attraction of forays into the courtroom.  Historians, as expert witnesses, “may wish to bring their expertise to the support of a cause.”  Id (emphasis added).  Rothman sees historian expert witnesses as “advocates and agents of change.”  Id.

Rothman’s view of the historian as an advocate is by no means unique.  The American Historical Association (AHA), chartered by the United States Congress in 1889, has proclaimed that political views may “inform their historical practice.”  AHA, Statement on Standards of Professional Conduct, 2005 Edition, available at http://www.historians.org/pubs/Free/ProfessionalStandards.cfm (last revised January 2011).

The AHA urges hopefully that historians’ political views, when “applied with integrity,” can inform their historical researches and writing.  Id.  One of the public arenas contemplated for historical practice, by the AHA, is the courtroom, where historians will serve as expert witnesses.  Id.  In its Internet website guide to job opportunities for college graduates with degrees in history, the AHA describes “historians as advocates,” and encourages young historians that they may play an important part in the legal process by serving as expert witnesses.  AHA, http://www.historians.org/pubs/Free/careers/Index.htm (last visited on Dec.17, 2011).

Rothman’s and the AHA’s conception of the historian’s role in the trial process is inconsistent with long-established law of expert witness opinion.  Expert witnesses are simply not supposed to be advocates.  In their enthusiasm for an expansive role for historians, these historians have helped to identify much that is wrong with historian witness testimony.  Venality is a relatively weak motive, and one that is easily documented, compared with the corrupting influence of the zeal of advocacy, disguised as expert opinion.

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 wrote 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 witness in Nichols, have been re-lodged against witnesses with expertise in ethics.  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 requirement of helpfulness embodied in 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 Imwinkelried, “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 that of a jury is precisely what all trial lawyers hope to accomplish.  Lawyers can select and present expert witnesses based upon their opinions and conclusion, 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.


Barring Unreliable Opinion Testimony From Historians

Stripping the argument and advocacy from historian testimony would go a long way toward remedying what is unreliable and objectionable from such opinions.  Indeed, in many cases, lawyers may find themselves with little or no reason to call on historian witnesses.

If juries should be subjected to the opinion testimony of historians, serving as expert witnesses, are there any protections against unreliable historical opinions?  We are all familiar with the extravagant claims of revisionist historians, who endeavor to reinvent the past for some political purpose.  Consider, for example, the cottage industry that decimated our forests in an effort to exculpate the late Alger Hiss.  The prospect of similar opinion testimony in the forum of tort cases is no less daunting.

The American Historical Association (A.H.A.) has recently promulgated updated standards necessary for the productions of reliable history.  Statement on Standards, supra at http://www.historians.org/pubs/Free/ProfessionalStandards.cfm (last revised January 2011).  These standards raise the important question whether courts, to the extent they permit historical testimony at all, will insist upon a showing of “reliability” before allowing widely disparate historical opinions to be presented to juries.  Surely, historical opinion that is unreliable, like unreliable scientific opinion, would not be helpful to the trier of fact.  Courts, employing various evidentiary standards, routinely exclude unhelpful testimony.  Furthermore, few lawyers would contend that they have a right, constitutional or otherwise, to present unreliable or unhelpful testimony.

The AHA’s Standards may provide a starting point for judicial consideration of the reliability of proffered historical testimony.  The Association views itself as having a special obligation to address “dilemmas and concerns about the practice of history that historians have regularly brought to the A.H.A. seeking guidance and counsel.”  Id.  The AHA Standards address “forms of professional misconduct that are especially troubling to historians,” and “identify a core set of shared values that professional historians strive to honor in the course of their work.”  Id.  The AHA thus acts as have many medical and scientific societies that have put forward guidelines and consensus statements on methodologic issues.

The AHA Standards explicitly acknowledge that historical scholarship is pursued and presented in many venues and formats, including as expert witness testimony in public arenas:

Practicing history in the public realm presents important challenges, for when historians communicate with a wide public, they must represent not just a particular interpretation or body of facts, but the best practices of the discipline of history itself.  This means they must inevitably walk a tightrope in balancing their desire to present a particular point of view with their responsibility to uphold the standards and values that underpin their professional authority as historians.  This challenge can be especially complex for . . . historians working in advocacy roles.

Id.  The Standards in many respects adopt a standard of care for historians.  Practicing history with integrity is defined in terms of both duties of aspiration and prohibition.  Among those standards relevant to a reliability assessment of historian testimony is the exhortation to acknowledge “the limits and uncertainties” of one’s arguments, as well as not to omit evidence that tends to counter or undermine one’s interpretations.  Id.  Although the Standards acknowledge the legitimacy of “point of view,” they define professional integrity in terms of, among other things, “a readiness to follow sound method and analysis wherever they may lead.”  Id.

The limits suggested by the AHA can certainly help courts evaluate historians’ testimony when carrying out their gatekeeping role for these expert witnesses.  The Standards, however, should not usurp the judicial function to define and apply criteria for the reliability and helpfulness of opinion testimony.

(to be continued)

Philadelphia Mass Tort Litigation Acknowledges Its Errant Procedures

December 16th, 2011

Judge John Herron, Administrative Judge of the Trial Division of the Philadelphia Court of Common Pleas recently announced that the Philadelphia courts will suspend their use of consolidation and reverse bifurcation in mass tort actions .  The Court had previously announced that it was studying whether consolidation and reverse bifurcation procedures have adequate procedural safeguards in place “to assure fair and just disposition of actions filed.”  See Notice to the Bar – Mass Tort Program (Dec. 8, 2011).  The Court also indicated that after a period of studying these procedures, the Court may reinstate reverse bifurcation and consolidation if the Court believes that the procedures are implemented fairly.  Reverse bifurcation in pharmaceutical cases will end permanently as of January 1, 2012.

The procedural unfairness of Philadelphia’s handling of so-called mass torts has been described by Joshua D. Wright, a professor of law and economics at George Mason University School of Law, in his study, “Are Plaintiffs Drawn to Philadelphia’s Civil Courts? An Empirical Examination.”  See also Michelle J. White, “Asbestos Litigation: Procedural Innovations and Forum Shopping,” 35 J. Leg. Stud. 365  (June 2006); Michelle J. White, “Understanding the Asbestos Crisis” (2003).

These articles only scratch the surface of what goes on in Philadelphia.  SeePhiladelphia Courts – Structural Bias and Reverse Bifurcation” (Oct. 27, 2011).

The United States Constitution places limits on courts’ abilities to grant separate trials. The Seventh Amendment’s Reexamination Clause provides that:

“no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.”

U.S. CONST, amend. VII.  The Supreme Court interpreted the Reexamination Clause to prohibit a grant of a partial new trial in some circumstances:

“Where the practice permits a partial new trial, it may not properly be resorted to unless it clearly appears that the issue to be retried is so distinct and separable from the others that a trial of it alone may be had without injustice.  . . . Here the question of damages on the counterclaim is so interwoven with that of liability that the former cannot be submitted to the jury independently of the latter without confusion and uncertainty, which would amount to a denial of a fair trial.”

Gasoline Prods. Co. v. Champlin Refining Co., 283 U.S. 494, 500 (U.S. 1931). Lower courts have divided over whether the Reexamination Clause is an obstacle to trial bifurcation, with some courts holding that the procedure is prohibited when overlapping issues in the phases of the trial will be reexamined successively in multiple trials.  See W. Russell Taber III, The Reexamination Clause: Exploring Bifurcation in Mass Tort Litigation, 73 Def. Counsel J. 63 (2006).

Philadelphia-style, across-the-board reverse bifurcation certainly has the potential to offend the Reexamination Clause, as well as other constitutional guarantees.  If the bifurcated trials contain issues that are not independent, then the Reexamination Clause would seem offended.  On the other hand, if the trial issues are independent, then the so-called “conjunction paradox” suggests that bifurcation undermines the jury’s evaluation of the burden of proof.  The product rule of probability teaches us that the probability of multiple independent events occurring is the product of the probabilities of each event’s occurring.  If, for instance, the probability of a particular plaintiff’s medical causation claim is 75%, and the plaintiff’s proximate cause claim is 75%, and the plaintiff’s negligence (breach of duty) claim is 75%, the probability of all necessary elements having occurred jointly would be 42.2%.  In a bifurcated trial, plaintiff would win each separate trial easily, but in a “straight-through” trial, plaintiff should fail to carry his burden of proof.  See generally Ward Farnsworth, The Legal Analyst: A Toolkit for Thinking about the Law 273-76 (Chicago 2007).

Apparently, last month, Philadelphia Common Pleas Court Judge Sandra Mazer Moss, who now coordinates the so-called Complex Litigation Center, announced certain asbestos cases – mesothelioma cases in which defendants did not contest diagnosis or asbestos etiology – would be tried in unbifurcated (“straight through”) trials. Michael P. Tremoglie & Jon Campisi, “Reverse Bifurcation Suspended in Philly Mass Torts,” Legal Newsline (Dec. 9, 2011); and The Pennsylvania Record (Dec. 9, 2011).

This policy, like its former incarnations, draws an invidious distinction between those cases in which diagnosis or medical causation is contested and those cases in which diagnosis or medical causation is uncontested.  Previously, Judge Moss would “sever crossclaims,” and force a defendant to proceed to try only its own liability.  The result was that a loss on both medical causation and liability required the judgment defendant to bond an entire judgment, without offset for settling defendants’ shares.  The common thread appears to be pressure defendants to settle, regardless of due process or substantial fairness.

Legalline‘s coverage noted that Judge Moss limited her abandonment of reverse bifurcation in ways that perpetuate the unfairness of Philadelphia procedures:

“This is something the litigants asked for and Judge Moss agreed to. A lot of times the cases would resolve after the damages were seen.

* * * * *

“But since it will be uncontested as to the cause, it will be a ‘straight through’ trial. This way cases will move faster through the court.”

This reasoning makes no sense.  If defendants acquiesce in medical causation, say of a lung cancer claim, they obtain a fair chance to litigate their liability defenses.  If both medical causation and liability are contested, however, defendants are subject to the backwards method of having to risk an adverse medical and damages verdict before the jury hears the defendants’ liability defenses.  Given that very few lung cancer cases, and no extrapulmonary cancers, are caused by asbestos, Philadelphia’s procedures still leave a lot to be desired.

Silica Science – Junk Science is Not Limited to The Courts

December 12th, 2011

“Clowns to the left of me; Jokers to the right; here I am, stuck in the middle with you.”


David Michaels, head of OSHA, back in October, was testifying at a House congressional oversight hearing, “Workplace Safety: Ensuring a Responsible Regulatory Environment.” The Congressmen were inquiring into OSHA’s enforcement and regulatory initiatives on several fronts, including silica exposures.

This is the same David Michaels who used to be a hired expert witness for plaintiffs in toxic tort cases. SeeDavid Michaels’ Public Relations Problem,” (Dec. 2, 2011).

Not surprisingly, when the questioning turned to silica, Michaels played the cancer card:  crystalline silica is a “known” human carcinogen.

Republican congressman Larry Bucshon (R-IN), a surgeon when he is not holding forth in Congress, found the talk of cancer to be provocative.  Buchson scolded Michaels:

“I don’t like it when people use buzz words that try to get people’s attention, and cancer is one of those.”

* * * * *

“…I’m a thoracic surgeon, so I want to focus a little bit on what you said earlier as it relates to silica dust. I’m curious about your comment about silica-dust related lung cancer, because I’ve been a thoracic surgeon for 15 years and I’ve done a lot of lung cancer surgery, and I haven’t seen one patient that’s got it from silica dust.”

A fascinating exchange for several reasons.

First, we could expect Michaels to play the cancer card, just as he has in his role as plaintiffs’ expert witness.  As we will see, his cancer evidence is not far fetched, although it is also not particularly convincing.

Second, the junk science from Congressman Buchson is distressing.  As a physician, he should know better that his experience in surgery has no relevance at all to the question whether crystalline silica can cause lung cancer.

Back in 1996, a working group of the World Health Organization’s International Agency for Research on Cancer (IARC) voted to reclassify crystalline silica, the most ubiquitous mineral on the face of Planet Earth, a known human carcinogen.  Michaels recited this “evidence,” but he failed to mention that the evidence was conflicting, as were the votes of the working group. The response of the scientific community to the IARC pronouncement was highly critical.  See Patrick A. Hessel, John F. Gamble, J. Bernard L. Gee, Graham Gibbs, Francis H.Y. Green, W. Keith C. Morgan, and Brooke T. Mossman, “Silica, Silicosis, and Lung Cancer: A Response to a Recent Working Group Report,” 42 J. Occup. Envt’l Med. 704 (2000).

The vote of the working group was very close; indeed, the swing of a single vote would have changed the outcome. One of the working group members later wrote:

“Some equally expert panel of scientists presented with the same information on another occasion could of course have reached a different verdict. The evidence was conflicting and difficult to assess and such judgments are essentially subjective.”

Corbett McDonald & Nicola Cherry, “Crystalline Silica and Lung Cancer:  The Problem of Conflicting Evidence,” 8 Indoor Built Environment 121, 121 (1999).  Remarkably, this panel member explained his decision to vote for reclassification as follows:

“The basic problem was that the evidence for carcinogenicity was conflicting – generally absent in situations of high and widespread exposure and strong only in a few rather special occupations.  The advice by the IARC to consider hazard rather than risk did much to resolve the difficulty.”

Id. at 125.  I suspect that the evidence for a difference in meaning between “hazard” and “risk” is even more tenuous and conflicting than the evidence in favor of carcinogenicity.

IARC classifications, however, take on a life of their own.  They are an invitation to stop thinking, and to stop analyzing the evidence.  Federal bureaucrats and staff scientists love them for exactly this reason:  they can hide behind the authority of the WHO without having to work on reviewing the evidence, or updating their judgment when new studies come out.

It should not be surprising, therefore, that the National Institutes of Health’s National Toxicology Program (NTP), working off the WHO decision, recognized crystalline silica as a human carcinogen. Other groups followed in lock step.  Other agencies and medical groups followed.

What you will not hear from Michaels or his followers is that when the National Institute for Occupational Safety and Health conducted the largest mortality study on the issue, it found a decreased lung cancer risk among men who actually had sufficient silica exposure to develop silicosis. See Geoffrey Calvert, et al., “Occupational silica exposure and risk of various diseases:  an analysis using death certificates from 27 states of the United States,” 60 Occup. Envt’l Med. 122 (2003).  Cf. “Congressman tells OSHA chief not to use “buzz” words like cancer.” (Oct. 10, 2011).

To give the devil his due, at least Michaels had “some” evidence to support his pronouncement, even if the evidence was incomplete and contradicted by other important evidence.  Congressman Bucshon’s recitation of his experience as a surgeon was completely off the mark.  His staffers obviously failed him in their research, and Bucshon’s reliance upon his own anecdotal experience was quite inappropriate to rebut the dubious judgment of the OSHA Administrator.

Some people might describe the exchange between Bucshon and Michaels as resembling two monkeys playing chess.  I think of it as exemplifying the scientific illiteracy in all three branches of our government.

David Michaels’ Public Relations Problem

Scientific American(s) and the other 99%

December 7th, 2011

If you have an interest in the history of science, especially as it plays out in the so-called state-of-the-art defense in products liability litigation, you may find the following offer helpful.  For the remainder of the month, Scientific American, which is now published by Nature, is making its archived issues, 1845-1909, available free of charge.

There is more fascinating than to read what people were thinking, saying, and writing, at times past.  Most of what we think we know about the past is filtered by historians rather than being obtained by accessing primary sources.  The Scientific American archive is a useful corrective measure, especially in the contentious area of health-effects litigation.

Here are some of the interesting historical insights.  In 1871, 140 years ago, Scientific American ran an article on the ill-health effects of smoking.  “To smoke or not to smoke,” Scientific American 375 (Dec. 9, 1871).  Here are some highlights:

“M. Beau notices eight cases of angina pectoris caused by the use of tobacco.

Professor Lizars records several cases of cancer of the tongue and lips caused by the use of the pipe. The writer has known one such ill stance, and never wishes to see another example of such terrible suffering resulting from a worse than useless habit.”

These pronouncements might not pass muster under today’s evidence-based medicine, but they were astute observations in need of testing, in 1871.

Not all the medical observations and claims were equally prescient.  Our forebears were not immune from the idiocies and enthusiasms of medical quackery.  Cancer remedies seemed to be a particular focus of much unenlightened attention:

“Col. Ussery, of the parish of De Soto, informs the Editor of the Caddo Gazette that he fully tested a remedy for this troublesome disease, recommended to him by a Spanish woman, a native of the country. The remedy is this:  Take an egg and break it, then pour out the white, retaining the yolk in the shell, put in salt and mix with the yolk as long as it will receive it, stir them together until the salve is formed, put a portion of this on a piece of sticking plaster and apply it to the cancer about twice a day. He has made the experiment twice in his own family with complete success.”

Remedy for Cancer,” Scientific American 298 (June 12, 1847).

Or this forerunner of the clinical trial:

“The Tuscaloosa Observer says it has seen it stated, more than once, that the common cranberry was efficacious in the cure of cancer, but have never, until very recently, been an eye-witness to the fact. Mr. Middleton Belk, residing within four or five miles of this city, who was afflicted with a cancer on the nose for the last eight years, was induced to try cranberries applied as a poultice; and to his great joy and satisfaction, has experienced a perfect and radical cure. We mention this fact at the instanee of Mr. Belk, who is desirous that others suffering under the same affliction, may avail themselves of this simple, but valuable remedy.”

Cranberries a Cure for Cancer,” 3 Scientific American 408 (Sept. 9, 1848).  Another article, three years later, touted mineral naptha as a cancer cure.  “Mineral Naptha,” 6 Scientific American 243 (April 19, 1851).

The pages of Scientific American document the rise of asbestos use and the growing awareness of asbestos’ great utility to help control and prevent fire and burns.  For instance, in 1876, the magazine described the utility of asbestos in roofing materials and in pipecovering.  “The Industrial Uses of Asbestos,” Scientific American 258 (April 22, 1876).

A few years later, an article described the widespread use of asbestos in industrial applications, both in Europe and in the United States:

“For some time past Toope’s covering for steam surfaces has been in use in England, giving great satisfaction and receiving the indorsement of many prominent English engineers.  The business of manufacturing and selling it is conducted there by a limited company located in London.
In this country Mr. Charles Toope, manufacturing agent, having an office and works at 353 East 78th street, New York City, is making and introducing the covering.  The covering is readily applied, requires no previous preparation, and when in place is permanent, being incapable of injury by jarring or pounding.”

Felt and Asbestos Covering for Steam Surfaces,” Scientific American 357 (December 4, 1880). [353 East 78th is right around the corner from me.  I doubt that many of the residents of this mid-rise apartment building know that an asbestos factory once graced their property.]  See also The Prevention of Fires in Theaters,” 35 Scientific American 401 (Dec. 23,1876); Insulated Coverings for Pipes, Boilers, Etc.,” 59 Scientific American 355, 355 (Dec. 8, 1888).

Federal Rules Get a Makeover

December 2nd, 2011

Bellbottoms are out; cuffs are in.  Robert Frost is out; Philip Levine is in.

So too with the Federal Rules.

The Federal Rules of Evidence have been “restyled.” Yesterday, the new, restyled Federal Rules of Evidence went into effect.

A PDF of the new rules is available at several places on the web, including the Federal Evidence Review website, which also has also links to the legislative history and guiding principles for this restyling.   The Legal Information Institute (LII) at Cornell Law School helpfully has posted ebooks, as ePub or mobi files, of the restyled Federal Rules of Civil Procedure, Criminal Procedure, and Evidence.

The legislative history of the restyled Evidence Rules 101-1103 make clear that the changes were designed to make the rules simpler, more readable and understandable, without changing their substantive meaning.  Was this effort worth the time and money?

The rules on expert witness opinion testimony are my particular interest.

Rule 703. Bases of an Expert’s Opinion Testimony

An expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed. If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted. But if the facts or data would otherwise be inadmissible, the proponent of the opinion may disclose them to the jury only if their probative value in helping the jury evaluate the opinion substantially outweighs their prejudicial effect.

(Legislative History: Pub. L. 93-595, Jan. 2, 1975; Mar. 2, 1987, eff. Oct. 1, 1987; Apr. 17, 2000, eff. Dec. 1, 2000; Apr. 26, 2011, eff. Dec. 1, 2011.)

The rule specifies what happens “[i]f experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject,” but what happens “if not“?  The common reading interpolates “only” before “if,” but Rule 703 before and after restyling misses this drafting point.

So too does Rule 702:

Rule 702. Testimony by Expert Witnesses

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

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

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

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

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

(Legislative History: Pub. L. 93-595, Jan. 2, 1975; Apr. 17, 2000, eff. Dec. 1, 2000; Apr. 26, 2011, eff. Dec. 1, 2011.)

And if not?

The enumeration of (a) through (d) in Rule 702, however, is an improvement for reading and comprehension, especially with the conjunction connecting the last member of the series.

I suppose at age 36, everyone is entitled to a makeover.

David Michaels’ Public Relations Problem

December 2nd, 2011

OSHA requires strong, credible leadership from someone who will not outrun his scientific headlights, while at the same time enforcing standards that protect workers. President Obama made a serious error in appointing David Michaels, whose scientific and enforcement bona fides are weak.

Michaels has made a career out of targeting industry for perceived ethical lapses, yet he has routinely failed to make adequate disclosures himself, and some of his disclosures are downright deceptive.  This hypocrisy might be shrugged off as part of the politicization of occupational and environmental medicine, except that Michaels is now an Undersecretary of Labor.  When his agency starts handing out legal opinion letters to his former employers in the United States litigation industry, Michaels’ hypocrisy becomes something of a public nuisance and a scandal.  SeeManufacturing Certainty” (Oct. 25, 2011).  The Department of Labor’s “Dear Mr. Wodka” letter can now be found online at OSHA’s website.

Well before David Michaels became head of OSHA, his hypocrisy over conflicts of interest was noteworthy.  SeeHypocrisy In Conflict Disclosure Rules.” In his book, Doubt is Their Product: How Industry’s War on Science Threatens Your Health (2008), Michaels provides no disclosure of his prior activities and testimonial adventures on behalf of the litigation industry.  There is, among his acknowledgments, a tip of the hat to friends and colleagues, such as Steven Wodka.  Wodka is a plaintiffs’ lawyer who retained and paid Michaels in various litigations, but you will not learn that from reading Doubt is Their Product.  Not surprisingly, this book is waved around by plaintiffs’ counsel in cross-examinations in courtrooms all across the United States.

Michaels does reveal that his organization, The Project on Scientific Knowledge and Public Policy (SKAPP), accepted funding from “the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation.”  This revelation is, however, quite misleading.  The “Trust” is a fund for plaintiffs’ counsel in the silicone gel breast implant litigation, which was diverted to help support Michaels, and others who would advocate against evidence-based limitations to expert witness opinions.

Michaels insists that SKAPP accepts only unrestricted funding, but this insistence is also misleading.  Plaintiffs’ counsel could feel safe putting “their” money into the coffers of SKAPP, which was openly committed to undermining the implementation of evidence-based standards for causation opinion testimony in federal and state courts.  If the manufacturing industry, as opposed to the litigation industry, funded a not-for-profit, headed up by one of its testifying expert witnesses, most folks would call this maneuver “money laundering.”  Dirty money is dirty money, regardless whose ox is gored.  See also David Michaels & Celeste Monforton, “Scientific Evidence and the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory System,” 18 J. Law & Policy 17 (2005) (“Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation.”).

Other anemic or absent conflict of interest disclosures abound in Michaels’ publications.

Michaels has been involved in at least four different mass tort litigations, involving alleged injuries from exposures to asbestos, ortho-toluidene, beryllium, and vinyl chloride.  He has collaborated with Wodka in three of these litigations, by serving as Wodka’s expert witness.  This litigation collaboration should raise serious questions about the “Dear Mr. Wodka letter.”

Asbestos Litigation

Michaels has written several publications about health outcomes in sheet metal workers.  The premise of these papers is that the workers were exposed to asbestos, and they might have greater than expected cancer mortality as a result.  Most of Michaels’ papers fail to reveal that he consulted and testified for asbestos claimants.  See, e.g., David Michaels & Stephen Zoloth, “Asbestos Disease in Sheet Metal Workers: Proportional Mortality Update,” 13 Am. J. Indus. Med. 731-734 (1988).

One of Michaels’ publications on asbestos exposure and health outcomes does contains a disclosure, which even reveals on which side of asbestos litigation he worked:

“This work was supported by the Sheet Metal Occupational Health Institute Trust. Drs. Welch, Michaels, and Dement have worked as consultants for law firms representing individuals with asbestos-related disease. None of the authors have a financial interest in any organization that could profit from the research presented here.”

Laura Welch, Elizabeth Haile, John Dement, and David Michaels, “Change in Prevalence of Asbestos-Related Disease Among Sheet Metal Workers 1986 to 2004,” 131 Chest 863, 863 (2007).  Note the advocacy even in the disclosure.  Law firms that represent only individuals with asbestos-related disease!  Do we infer from this that Michaels did not consult for any law firms that represented individuals who claimed asbestos-related disease, but where the truth in God’s eye would have it that their claims were erroneous?  Perhaps the Principle of Charity requires us to infer that Michaels meant to disclose that he consulted for firms that represented persons claiming asbestos-related disease.  Having read Michaels’ litigation testimony, however, I think he really meant to say that what appears in the article.

There have been many thousands of asbestos cases, most of which have been settled or dismissed.  It is thus difficult to know exactly how many asbestos cases have seen the consulting work of David Michaels.  Clearly, however, some of Michaels’ asbestos testimony was given at the request of Steve Wodka, for Wodka’s clients.  See David Michaels deposition testimony at p. 41,  in Nicastro v. Aceto Corp., New Jersey Superior Court, Law Division for Monmouth County, Docket No. L-3062-08 (Sept. 2, 2009).

Ortho-Toluidine Litigation

According to federal Magistrate Judge H. Kenneth Schroeder, Jr., Steve Wodka represents numerous plaintiffs who claim to have been harmed by exposure to ortho-toluidine.  David Michaels is a common fixture in these cases brought by Wodka.  See Pardee v. E.I. DuPont Nemours & Co., Case 1:07-cv-00268-WMS-HKS Document 29 (W.D.N.Y. March 31, 2008).  Faced with losing his expert witness to OSHA, Wodka noticed a trial deposition de bene esse of David Michaels in several cases.

Michaels was permitted to give his testimony, before moving into his OSHA position, in the following cases:

Pardee v. E.I. DuPont Nemours & Co., W.D.N.Y., Plaintiff, No. 07-CV-0268S(Sr)

Band v. E.I. DuPont Nemours & Co., W.D.N.Y., No. 07-CV-0267S(Sr)

Weist v. E.I. DuPont Nemours & Co., W.D.N.Y., No. 05-CV-0534A(Sr)

Nicastro v. Aceto Corp., New Jersey Superior Court, Law Division for Monmouth County, Docket No. L-3062-08

Polyvinyl Chloride Litigation

David Michaels served as a plaintiffs’ expert witness in at least one PVC case, Lattin v. Borden Chemical Co., New Jersey Superior Court, Law Div. Mercer Cty. Docket No. L-3850-01.  Mr. Wodka was the attorney for plaintiff.

Beryllium Litigation

One of David Michaels’ publications criticized the beryllium industry, on grounds that it advanced weak scientific data and arguments against changes in permissible exposure limits. David Michaels & Celeste Monforton, “Beryllium’s Public Relations Problem: Protecting Workers When There Is No Safe Exposure Level,” 123 Public Health Reports 79 (2008).  In this article, Michaels acknowledges that he “served as an expert witness in a civil suit involving chronic beryllium disease.”  Apparently, Michaels forgot to point out that he was paid for his services, and that the payor was the claimant, whose interests he was advancing in his paper.

Marc Kolanz for one of the companies sued over beryllium health claims noted, in rebuttal, that:

“Dr. Michaels is a paid expert witness in beryllium litigation.  Dr. Michaels’ has not published beryllium industrial hygiene or medical research; however, he has provided litigation support serving as a paid expert witness for plaintiffs in beryllium litigation. Consistent with this role, as a hired advocate for plaintiff’s counsel, he has sought to ‘manufacture certainty’ by applying a hindsight approach to criticize the good works of dedicated beryllium researchers.”

Marc Kolanz, “Beryllium History and Public Policy,” 123 Public Health Reports 423, 427 (2008).

Michaels was an expert witness for Philadelphia plaintiffs’ attorney, Ed Reeves, in the Lonnie Pierce case, in Pennsylvania.

*   *   *   *

There is nothing ignoble or disreputable in serving as an expert witness.  Indeed, real experts may well have an obligation to make their expertise available to the civil and criminal justice system.  What is unseemly is the incessant hypocrisy in accusing manufacturing industry of conflicts of interest, while hiding and misrepresenting litigation industry conflicts.  David Michaels has been in the forefront of this hypocrisy.  The “Dear Mr. Wodka” letter deserves more scrutiny under the principles that Michaels has advocated for manufacturing industry.

Epidemiology, Risk, and Causation – Report of Workshops

November 15th, 2011

This month’s issue of Preventive Medicine includes a series of papers arising from last year’s workshops on “Epidemiology, Risk, and Causation,” at Cambridge University. The workshops were organized by philosopher Alex Broadbent,  a member of the Department of History and Philosophy of Science, in Cambridge University.  The workshops were financially sponsored by the Foundation for Genomics and Population Health (PHG), a not-for-profit British organization.

Broadbent’s workshops were intended for philosophers of science, statisticians, and epidemiologists, lawyers involved in health effects litigation will find the papers of interest as well.  The themes of workshops included:

  • the nature of epidemiologic causation,
  • the competing claims of observational and experimental research for establishing causation,
  • the role of explanation and prediction in assessing causality,
  • the role of moral values in causal judgments, and
  • the role of statistical and epistemic uncertainty in causal judgments

See Alex Broadbent, ed., “Special Section: Epidemiology, Risk, and Causation,” 53 Preventive Medicine 213-356 (October-November 2011).  Preventive Medicine is published by Elsevier Inc., so you know that the articles are not free.  Still you may want to read these at your local library to determine what may be useful in challenging and defending causal judgments in the courtroom.  One of the interlocutors, Sander Greenland, is of particular interest because he shows up as an expert witness with some regularity.

Here are the individual papers published in this special issue:

Alfredo Morabia, Michael C. Costanza, Philosophy and epidemiology

Alex Broadbent, Conceptual and methodological issues in epidemiology: An overview

Alfredo Morabia, Until the lab takes it away from epidemiology

Nancy Cartwright, Predicting what will happen when we act. What counts for warrant?

Sander Greenland, Null misinterpretation in statistical testing and its impact on health risk assessment

Daniel M. Hausman, How can irregular causal generalizations guide practice

Mark Parascandola, Causes, risks, and probabilities: Probabilistic concepts of causation in chronic disease epidemiology

John Worrall, Causality in medicine: Getting back to the Hill top

Olaf M. Dekkers, On causation in therapeutic research: Observational studies, randomised experiments and instrumental variable analysis

Alexander Bird, The epistemological function of Hill’s criteria

Michael Joffe, The gap between evidence discovery and actual causal relationships

Stephen John, Why the prevention paradox is a paradox, and why we should solve it: A philosophical view

Jonathan Wolff, How should governments respond to the social determinants of health?

Alex Broadbent, What could possibly go wrong? — A heuristic for predicting population health outcomes of interventions, Pages 256-259

The Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence

November 14th, 2011

Meta-analysis is a statistical procedure for aggregating data and statistics from individual studies into a single summary statistical estimate of the population measurement of interest.  The first meta-analysis is typically attributed to Karl Pearson, circa 1904, who sought a method to overcome the limitations of small sample size and low statistical power.  Statistical methods for meta-analysis, however, did not mature until the 1970s.  Even then, the biomedical scientific community remained skeptical of, if not out rightly hostile to, meta-analysis until relatively recently.

The hostility to meta-analysis, especially in the context of observational epidemiologic studies, was colorfully expressed by Samuel Shapiro and Alvan Feinstein, as late as the 1990s:

“Meta-analysis begins with scientific studies….  [D]ata from these studies are then run through computer models of bewildering complexity which produce results of implausible precision.”

* * * *

“I propose that the meta-analysis of published non-experimental data should be abandoned.”

Samuel Shapiro, “Meta-analysis/Smeta-analysis,” 140 Am. J. Epidem. 771, 777 (1994).  See also Alvan Feinstein, “Meta-Analysis: Statistical Alchemy for the 21st Century,” 48 J. Clin. Epidem. 71 (1995).

The professional skepticism about meta-analysis was reflected in some of the early judicial assessments of meta-analysis in court cases.  In the 1980s and early 1990s, some trial judges erroneously dismissed meta-analysis as a flawed statistical procedure that claimed to make something out of nothing. Allen v. Int’l Bus. Mach. Corp., No. 94-264-LON, 1997 U.S. Dist. LEXIS 8016, at *71–*74 (suggesting that meta-analysis of observational studies was controversial among epidemiologists).

In In re Paoli Railroad Yard PCB Litigation, Judge Robert Kelly excluded plaintiffs’ expert witness Dr. William Nicholson and his testimony based upon his unpublished meta-analysis of health outcomes among PCB-exposed workers.  Judge Kelly found that the meta-analysis was a novel technique, and that Nicholson’s meta-analysis was not peer reviewed.  Furthermore, the meta-analysis assessed health outcomes not experienced by any of the plaintiffs before the trial court.  706 F. Supp. 358, 373 (E.D. Pa. 1988).

The Court of Appeals for the Third Circuit reversed the exclusion of Dr. Nicholson’s testimony, and remanded for reconsideration with instructions.  In re Paoli R.R. Yard PCB Litig., 916 F.2d 829, 856-57 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991); Hines v. Consol. Rail Corp., 926 F.2d 262, 273 (3d Cir. 1991).  The Circuit noted that meta-analysis was not novel, and that the lack of peer-review was not an automatic disqualification.  Acknowledging that a meta-analysis could be performed poorly using invalid methods, the appellate court directed the trial court to evaluate the validity of Dr. Nicholson’s work on his meta-analysis.

In one of many squirmishes over colorectal cancer claims in asbestos litigation, Judge Sweet in the Southern District of New York was unimpressed by efforts to aggregate data across studies.  Judge Sweet declared that “no matter how many studies yield a positive but statistically insignificant SMR for colorectal cancer, the results remain statistically insignificant. Just as adding a series of zeros together yields yet another zero as the product, adding a series of positive but statistically insignificant SMRs together does not produce a statistically significant pattern.”  In In re Joint E. & S. Dist. Asbestos Litig., 827 F. Supp. 1014, 1042 (S.D.N.Y. 1993).  The plaintiffs’ expert witness who had offered the unreliable testimony, Dr. Steven Markowitz, like Nicholson, another foot soldier in Dr. Irving Selikoff’s litigation machine, did not offer a formal meta-analysis to justify his assessment that multiple non-significant studies, taken together, rule out chance as a likely explanation for an aggregate finding of an increased risk.

Judge Sweet was quite justified in rejecting this back of the envelope, non-quantitative meta-analysis.  His suggestion, however, that multiple non-significant studies could never collectively serve to rule out chance as an explanation for an overall increased rate of disease in the exposed groups is wrong.  Judge Sweet would have better focused on the validity issues in key studies, the presence of bias and confounding, and the completeness of the proffered meta-analysis.  The Second Circuit reversed the entry of summary judgment, and remanded the colorectal cancer claim for trial.  52 F.3d 1124 (2d Cir. 1995).  Over a decade later, with even more accumulated studies and data, the Institute of Medicine found the evidence for asbestos plaintiffs’ colorectal cancer claims to be scientifically insufficient.  Institute of Medicine, Asbestos: Selected Cancers (Wash. D.C. 2006).

Courts continue to go astray with an erroneous belief that multiple studies, all without statistically significant results, cannot yield a statistically significant summary estimate of increased risk.  See, e.g., Baker v. Chevron USA, Inc., 2010 WL 99272, *14-15 (S.D.Ohio 2010) (addressing a meta-analysis by Dr. Infante on multiple myeloma outcomes in studies of benzene-exposed workers).  There were many sound objections to Infante’s meta-analysis, but the suggestion that multiple studies without statistical significance could not yield a summary estimate of risk with statistical significance was not one of them.

In the last two decades, meta-analysis has emerged as an important technique for addressing random variation in studies, as well as some of the limitations of frequentist statistical methods.  In 1980s, articles reporting meta-analyses were rare to non-existent.  In 2009, there were over 2,300 articles with “meta-analysis” in their title, or in their keywords, indexed in the PubMed database of the National Library of Medicine.  See Michael O. Finkelstein and Bruce Levin, “Meta-Analysis of ‘Sparse’ Data: Perspectives from the Avandia Cases” (2011) (forthcoming in Jurimetrics).

The techniques for aggregating data have been studied, refined, and employed extensively in thousands of methods and application papers in the last decade. Consensus guideline papers have been published for meta-analyses of clinical trials as well as observational studies.  See Donna Stroup, et al., “Meta-analysis of Observational Studies in Epidemiology: A Proposal for Reporting,” 283 J. Am. Med. Ass’n 2008 (2000) (MOOSE statement); David Moher, Deborah Cook, Susan Eastwood, Ingram Olkin, Drummond Rennie, and Donna Stroup, “Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement,” 354 Lancet 1896 (1999).  See also Jesse Berlin & Carin Kim, “The Use of Meta-Analysis in Pharmacoepidemiology,” in Brian Strom, ed., Pharmacoepidemiology 681, 683–84 (4th ed. 2005); Zachary Gerbarg & Ralph Horwitz, “Resolving Conflicting Clinical Trials: Guidelines for Meta-Analysis,” 41 J. Clin. Epidemiol. 503 (1988).

Meta-analyses, of observational studies and of randomized clinical trials, routinely are relied upon by expert witnesses in pharmaceutical and so-called toxic tort litigation. Id. See also In re Bextra and Celebrex Marketing Sales Practices and Prod. Liab. Litig., 524 F. Supp. 2d 1166, 1174, 1184 (N.D. Cal. 2007) (holding that reliance upon “[a] meta-analysis of all available published and unpublished randomized clinical trials” was reasonable and appropriate, and criticizing the expert witnesses who urged the complete rejection of meta-analysis of observational studies)

The second edition of the Reference Manual on Scientific Evidence gave very little attention to meta-analysis.  With this historical backdrop, it is interesting to see what the new third edition provides for guidance to the federal judiciary on this important topic.

STATISTICS CHAPTER

The statistics chapter of the third edition gives continues to give scant attention to meta-analysis.  The chapter notes, in a footnote, that there are formal procedures for aggregating data across studies, and that the power of the aggregated data will exceed the power of the individual, included studies.  The footnote then cautions that meta-analytic procedures “have their own weakness,” without detailing what that one weakness is.  RMSE 3d at 254 n. 107.

The glossary at the end of the statistics chapter offers a definition of meta-analysis:

“meta-analysis. Attempts to combine information from all studies on a certain topic. For example, in the epidemiological context, a meta-analysis may attempt to provide a summary odds ratio and confidence interval for the effect of a certain exposure on a certain disease.”

Id. at 289.

This definition is inaccurate in ways that could yield serious mischief.  Virtually all meta-analyses are built upon a systematic review that sets out to collect all available studies on a research issue of interest.  It is a rare meta-analysis, however, that includes “all” studies in its quantitative analysis.  The meta-analytic process involves a pre-specification of inclusionary and exclusionary criteria for the quantitative analysis of the summary estimate of risk.  Those criteria may limit the quantitative analysis to randomized trials, or to analytical epidemiologic studies.  Furthermore, meta-analyses frequently and appropriately have pre-specified exclusionary criteria that relate to study design or quality.

On a more technical note, the offered definition suggests that the summary estimate of risk will be an odds ratio, which may or may not be true.  Meta-analyses of risk ratios may yield summary estimates of risk in terms of relative risk or hazard ratios, or even of risk differences.  The meta-analysis may combine data of means rather than proportions as well.

EPIDEMIOLOGY CHAPTER

The chapter on epidemiology delves into meta-analysis in greater detail than the statistics chapter, and offers apparently inconsistent advice.  The overall gist of the chapter, however, can perhaps best be summarized by the definition offered in this chapter’s glossary:

“meta-analysis. A technique used to combine the results of several studies to enhance the precision of the estimate of the effect size and reduce the plausibility that the association found is due to random sampling error.  Meta-analysis is best suited to pooling results from randomly controlled experimental studies, but if carefully performed, it also may be useful for observational studies.”

Reference Guide on Epidemiology, RSME3d at 624.  See also id. at 581 n. 89 (“Meta-analysis is better suited to combining results from randomly controlled experimental studies, but if carefully performed it may also be helpful for observational studies, such as those in the epidemiologic field.”).  The epidemiology chapter appropriately notes that meta-analysis can help address concerns over random error in small studies.  Id. at 579; see also id. at 607 n. 171.

Having told us that properly conducted meta-analyses of observational studies can be helpful, the chapter hedges considerably:

“Meta-analysis is most appropriate when used in pooling randomized experimental trials, because the studies included in the meta-analysis share the most significant methodological characteristics, in particular, use of randomized assignment of subjects to different exposure groups. However, often one is confronted with nonrandomized observational studies of the effects of possible toxic substances or agents. A method for summarizing such studies is greatly needed, but when meta-analysis is applied to observational studies – either case-control or cohort – it becomes more controversial.174 The reason for this is that often methodological differences among studies are much more pronounced than they are in randomized trials. Hence, the justification for pooling the results and deriving a single estimate of risk, for example, is problematic.175

Id. at 607.  The stated objection to pooling results for observational studies is certainly correct, but many research topics have sufficient studies available to allow for appropriate selectivity in framing inclusionary and exclusionary criteria to address the objection.  The chapter goes on to credit the critics of meta-analyses of observational studies.  As they did in the second edition of the RSME, the authors repeat their cites to, and quotes from, early papers by John Bailar, who was then critical of such meta-analyses:

“Much has been written about meta-analysis recently and some experts consider the problems of meta-analysis to outweigh the benefits at the present time. For example, John Bailar has observed:

‘[P]roblems have been so frequent and so deep, and overstatements of the strength of conclusions so extreme, that one might well conclude there is something seriously and fundamentally wrong with the method. For the present . . . I still prefer the thoughtful, old-fashioned review of the literature by a knowledgeable expert who explains and defends the judgments that are presented. We have not yet reached a stage where these judgments can be passed on, even in part, to a formalized process such as meta-analysis.’

John Bailar, “Assessing Assessments,” 277 Science 528, 529 (1997).”

Id. at 607 n.177.  Bailar’s subjective preference for “old-fashioned” reviews, which often cherry picked the included studies is, well, “old fashioned.”  More to the point, it is questionable science, and a distinctly minority viewpoint in the light of substantial improvements in the conduct and reporting of meta-analyses of observational studies.  Bailar may be correct that some meta-analyses should have never left the protocol stage, but the RMSE 3d fails to provide the judiciary with the tools to appreciate the distinction between good and bad meta-analyses.

This categorical rejection, cited with apparent approval, is amplified by a recitation of some real or apparent problems with meta-analyses of observational studies.  What is missing is a discussion of how many of these problems can be and are dealt with in contemporary practice:

“A number of problems and issues arise in meta-analysis. Should only published papers be included in the meta-analysis, or should any available studies be used, even if they have not been peer reviewed? Can the results of the meta-analysis itself be reproduced by other analysts? When there are several meta-analyses of a given relationship, why do the results of different meta-analyses often disagree? The appeal of a meta-analysis is that it generates a single estimate of risk (along with an associated confidence interval), but this strength can also be a weakness, and may lead to a false sense of security regarding the certainty of the estimate. A key issue is the matter of heterogeneity of results among the studies being summarized.  If there is more variance among study results than one would expect by chance, this creates further uncertainty about the summary measure from the meta-analysis. Such differences can arise from variations in study quality, or in study populations or in study designs. Such differences in results make it harder to trust a single estimate of effect; the reasons for such differences need at least to be acknowledged and, if possible, explained.176 People often tend to have an inordinate belief in the validity of the findings when a single number is attached to them, and many of the difficulties that may arise in conducting a meta-analysis, especially of observational studies such as epidemiologic ones, may consequently be overlooked.177

Id. at 608.  The authors are entitled to their opinion, but their discussion leaves the judiciary uninformed about current practice, and best practices, in epidemiology.  A categorical rejection of meta-analyses of observational studies is at odds with the chapter’s own claim that such meta-analyses can be helpful if properly performed.  What was needed, and is missing, is a meaningful discussion to help the judiciary determine whether a meta-analysis of observational studies was properly performed.

MEDICAL TESTIMONY CHAPTER

The chapter on medical testimony is the third pass at meta-analysis in RMSE 3d.   The second edition’s chapter on medical testimony ignored meta-analysis completely; the new edition addresses meta-analysis in the context of the hierarchy of study designs:

“Other circumstances that set the stage for an intense focus on medical evidence included

(1) the development of medical research, including randomized controlled trials and other observational study designs;

(2) the growth of diagnostic and therapeutic interventions;141

(3) interest in understanding medical decision making and how physicians reason;142 and

(4) the acceptance of meta-analysis as a method to combine data from multiple randomized trials.143

RMSE 3d at 722-23.

The chapter curiously omits observational studies, but the footnote reference (note 143) then inconsistently discusses two meta-analyses of observational, rather than experimental, studies:

“143. Video Software Dealers Ass’n v. Schwarzenegger, 556 F.3d 950, 963 (9th Cir. 2009) (analyzing a meta-analysis of studies on video games and adolescent behavior); Kennecott Greens Creek Min. Co. v. Mine Safety & Health Admin., 476 F.3d 946, 953 (D.C. Cir. 2007) (reviewing the Mine Safety and Health Administration’s reliance on epidemiological studies and two meta-analyses).”

Id. at 723 n.143.

The medical testimony chapter then provides further confusion by giving a more detailed listing of the hierarchy of medical evidence in the form of different study designs:

3. Hierarchy of medical evidence

With the explosion of available medical evidence, increased emphasis has been placed on assembling, evaluating, and interpreting medical research evidence.  A fundamental principle of evidence-based medicine (see also Section IV.C.5, infra) is that the strength of medical evidence supporting a therapy or strategy is hierarchical.  When ordered from strongest to weakest, systematic review of randomized trials (meta-analysis) is at the top, followed by single randomized trials, systematic reviews of observational studies, single observational studies, physiological studies, and unsystematic clinical observations.150 An analysis of the frequency with which various study designs are cited by others provides empirical evidence supporting the influence of meta-analysis followed by randomized controlled trials in the medical evidence hierarchy.151 Although they are at the bottom of the evidence hierarchy, unsystematic clinical observations or case reports may be the first signals of adverse events or associations that are later confirmed with larger or controlled epidemiological studies (e.g., aplastic anemia caused by chloramphenicol,152 or lung cancer caused by asbestos153). Nonetheless, subsequent studies may not confirm initial reports (e.g., the putative association between coffee consumption and pancreatic cancer).154

Id. at 723-24.  This discussion further muddies the water by using a parenthetical to suggest that meta-analyses of randomized clinical trials are equivalent to systematic reviews of such studies — “systematic review of randomized trials (meta-analysis).” Of course, systematic reviews are not meta-analyses, although they are a necessary precondition for conducting a meta-analysis.  The relationship between the procedures for a systematic review and a meta-analysis are in need of clarification, but the judiciary will not find it in the new Reference Manual.

OSHA’s HazCom Standard — Statistical and Scientific Nonsense

November 13th, 2011

Almost 28 years ago, the United States Department of Labor (Occupational Safety and Health Administration or OSHA) promulgated The Hazard Communication Standard. 29 C.F.R. § 1910.1200 (November 1983; effective date November 25, 1985) (HazCom standard).  Initially the HazCom standard applied to importers and manufacturers of chemicals.  Starting one year later, November 25, 1986, the standard covered manufacturing employers, under OSHA jurisdiction, by defining their duties to protect and inform employees.

The HazCom standard applies to all chemical manufacturers and distributors and to

“any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency.”

29 C.F.R. § 1910.1200(b)(1), and (b)(2).  The standard requires manufacturers and distributors of hazardous chemicals inform not only their own employees of the dangers posed by the chemicals, but downstream employers and employees as well.  The standard implements this duty to warn downstream employers’ employees by requiring that containers of hazardous chemicals leaving the workplace are labeled with “appropriate hazard warnings.”  See Martin v. American Cyanamid Co., 5 F.3d 140, 141-42 (6th Cir. 1993) (reviewing agency’s interpretation of the standard).

The HazCom standard attempts to provide some definition of the health hazards for which warnings are required:

“For health hazards, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in this section.”

29 C.F.R. § 1910.1200(d)(2).

This regulatory language is troubling. What does statistically significant mean?  The concept remains important in health effects research, but several writers have subjected the use of significance testing specifically, and frequentist statistics generally, to criticisms.  See, e.g., Stephen T. Ziliak and Deirdre N. McCloskey, The Cult of Statistical Significance: How the Standard Error Costs Us Jobs, Justice, and Lives (Ann Arbor 2008) (example of one of the more fringe, and not particularly cogent, criticisms of frequentist statistics).  And what are the “established scientific principles,” which would allow a single “positive study” to “establish” a hazardous “effect”?

The HazCom standard is important not only for purposes of regulatory compliance, but for its potential implications for products liability law, as well.  With its importance in mind, what can be said about the definition of health hazard, provided in 29 C.F.R. § 1910.1200(d)(2)?

Perhaps a good place to start is with the guidance provided by OSHA on compliance with the HazCom standard.  To be sure, like most agency guidance statements, this one is prefaced with caveats and cautions:

“This guidance is not a standard or regulation, and it creates no new legal obligations. It is advisory in nature, informational in content, and is intended to assist employers in providing a safe and healthful workplace. Pursuant to the Occupational Safety and Health Act, employers must comply with safety and health standards promulgated by OSHA or by a state with an OSHA-approved state plan. In addition, pursuant to Section 5(a)(1), the General Duty Clause of the Act, employers must provide their employees with a workplace free from recognized hazards likely to cause death or serious physical harm. Employers can be cited for violating the General Duty Clause if there is a recognized hazard and they do not take reasonable steps to prevent or abate the hazard. However, failure to implement any specific recommendations in this guidance is not, in itself, a violation of the General Duty Clause. Citations can only be based on standards, regulations, and the General Duty Clause.”

U.S. Dep’t of Labor, Guidance for Hazard Determination for Compliance with the OSHA Hazard Communication Standard (29 CFR § 1910.1200) (July 6, 2007).

Section II of the Guidance describes how manufacturers may assess whether their chemicals are “hazardous.”  A health hazard is defined as a chemical

“for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees.”

A fair-minded person might object that this is no guidance at all.  Statistically significant is not defined in the regulations. Study is not defined.  The guidance specifies that the study or studies must be conducted in accordance with “established scientific principles,” but must the interpretation or judgment of causality be made similarly in accordance with such principles? One would hope so, but the Guidance does not really specify.  The use of “may” seems to inject a level of conjecture or speculation into the hazard assessment.

Section V of the Guidance addresses data analysis, and here the agency attempts to provide some meaning to statistical significance and other terms in the regulation, but in doing so, the Guidance offers incoherent, incredible advice.

The Guidance notes that the regulation specifies one “positive study,” which presumably is a study that is some evidence in favor of an “effect.”  Because we are dealing with chemical exposures in occupational settings, the studies at issue will be, at best, observational studies.  Randomized clinical trials are out.  The one study (at least) at issue must be sufficient to establish a hazardous effect if that effect is considered a “health hazard” within the meaning of the regulations.  This is problematic on many levels.  What sort of study are we discussing?  An experimental study in planaria worms, a case study of a single human, an ecological study, or an analytical epidemiologic (case-control or cohort) study?  Whatever the study is, it would be a most remarkable study if it alone were “sufficient” to “establish” an “effect.”

A reasonable manufacturer or disinterested administrator surely would interpret the sufficiency requirement to mean that the entire evidentiary display must be considered rather than whether one study, taken in isolation, ripped from its scientific context, should be used to suggest a duty to warn.  The Guidance, and the regulations, however, never address the real-world complexity of hazard assessment.

Section V of the Guidance offers a failed attempt to illuminate the meaning of statistical significance:

“Statistical significance is a mathematical determination of the confidence in the outcome of a test. The usual criterion for establishing statistical significance is the p-value (probability value). A statistically significant difference in results is generally indicated by p < 0.05, meaning there is less than a 5% probability that the toxic effects observed were due to chance and were not caused by the chemical. Another way of looking at it is that there is a 95% probability that the effect is real, i.e., the effect seen was the result of the chemical exposure.”

Few statisticians or scientists would accept the proffered definition as acceptable.  The Guidance’s statement that a p-value is equivalent to the probability of the “toxic effect” occurring by chance is unacceptable for several reasons.

First, it is a notoriously incorrect, fallacious statement of the meaning of a p-value:

“Since p is calculated by assuming the null hypothesis is correct (that there is no difference [between observed and expected] in the full population), the p-value cannot give the chance that this hypothesis is true.  The p-value merely gives the chance of getting evidence against the null hypothesis as strong or stronger than the evidence at hand — assuming that the null hypothesis … is correct.”

David H. Kaye, David E. Bernstein, and Jennifer L. Mnookin, The New Wigmore: Expert Evidence § 12.8.2, at 559 (2d ed. 2010) (discussing the transpositional fallacy).

Second, even if we could ignore the statistical solecism, the Guidance’s use of a mechanical test for statistical significance is troubling.  The p-value is not necessarily an appropriate protection against Type I error, or a “false alarm” that there is an association between the exposure and outcome of interest.  Multiple testing and other aspects of a study may inflate the number of false alarms to the point that a study with a low p-value, even one much lower than 5%, will not rule out the likely role of chance as an explanation for the study’s result.

Third, the Guidance’s suggestion that “statistical significance” boils down to a conclusion that the “effect is real” may be its greatest offense against scientific and statistical methodology.  Section V of the Guidance emphasizes that the HazCom standard states that

“evidence that is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the [HCS] definitions of health hazards.”

This is nothing more than semantic fiat and legerdemain.

Statistical significance may, in some circumstances, permit an inference that the divergence from the expected was not likely due to chance, but it cannot, in the context of observational studies, allow for a conclusion that the divergence resulted because of a cause-effect relationship between the exposure and the outcome.  Statistical significance cannot rule out systemic bias or confounding in the study; nor can it help us reconcile inconsistencies across studies.  The study may have identified an association, which must be assessed for its causal or non-causal nature, in the context of all relevant evidence.  See Arthur Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965).”

The OSHA Guidance is really no guidance at all.  Ensuring worker health and safety by requiring employers to provide industrial hygiene protections for workers is an exceedingly important task, but this aspect of the HazCom standard is incoherent and incompetent. Workers and employers are in the dark, and product suppliers are vulnerable to arbitrary and capricious enforcement.

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.