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Rockefeller and McCarthy — The Rush from Responsibility

December 4th, 2013

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Learned and sophisticated intermediary, Scientific Evidence | Comments Off on Rockefeller and McCarthy — The Rush from Responsibility

Pharmacovigilantism – Avandia Litigation

November 27th, 2013

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

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

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

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

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

Posted in Causation, Meta-analysis, Rule 702 | Comments Off on Pharmacovigilantism – Avandia Litigation

Avoiding Nonsense About Science — Ask For The Evidence

November 25th, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Slip op. at 2.

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

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

Slip op. at 8.

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

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

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

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

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

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

“Disclosure of facts or data underlying expert opinion.

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

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

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

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

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

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

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

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

Conflicted Public Interest Groups

November 3rd, 2013

The current “wisdom”:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Seventh Circuit Regresses on Rule 702

October 29th, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Id. at 22.

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

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

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

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

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

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

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

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

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Bendectin, Diclegis & The Philosophy of Science

October 26th, 2013

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

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

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

According to FDA regulations, Category A is defined:

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

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

A Litmus Test for Philosophy of Science?

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

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

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

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

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

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

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

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

 

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

 

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Litigation-Driven Access to Underlying Data and Materials

October 23rd, 2013

On Monday, October 21, 2013, the Center for Public Integrity published an editorial criticizing Georgia-Pacific Corporation for its “secretive research program.” See “Facing lawsuits over deadly asbestos, paper giant launched secretive research program.”  

Georgia-Pacific (GP) commissioned several studies to help advance its defenses in asbestos litigation. Given that plaintiffs, plaintiffs’ counsel, proxies for the plaintiffs, and self-appointed public health zealots have commissioned and conducted research designed to advance interests of the litigation industry (a/k/a the plaintiffs’ bar) and to undermine GP’s defenses, GP’s actions seem perfectly appropriate.  GP’s attempt to claim an attorney-client and work-product privilege in the communications with investigators, however, raises serious concerns by casting a shadow over industry sponsorship generally.

In response to publication of GP’s sponsored research, plaintiffs’ counsel Jerry Kristal sought discovery of some of the studies and GP’s role in instigating, planning, conducting, and interpreting the studies.  Again, these discovery requests seem perfectly reasonable, but GP reacted by asserting that its lawyers had been involved in the communication loop between GP and the scientists who conducted and published the research, and therefore, the requested evidence was protected by the attorney-client privilege.  As I have argued previously, GP’s position was a serious mistake, and it has opened itself up to a good deal of justified criticism for “secretive research.” See, e.g., Noah S. Seixas, “Protecting Our Science,” 57 Ann. Occup. Hyg. 963 (2013) (emphasizing that there was no evidence that GP’s research was in fact fraudulent, and that the papers published in the Annals of Occupational Hygiene had appropriate disclosures).  See also “A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013); “Using the Rule 45 Subpoena to Obtain Research Data” (July 24, 2013).

One measure of the lapse in judgment by GP in questionably asserting an attorney-client privilege is the ammunition that it gives to idealogues and zealots such as the Center for Public Integrity (CPI).  The CPI editorial quotes Harvard University Professor Sheila Jasanoff, as noting that:

“There’s something extremely smelly about claiming attorney-client privilege for something that is being claimed at the same time as good science. … Legal confidentiality protections should not be placed around good science.”

Professor Jasonoff is absolutely correct, but interestingly, her olfactory sense has been remarkably inconsistent.  Back in October 2007, Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss, and debate, litigation and compelled access to underlying research data.  Dr. Racette moaned and groaned about how disruptive subpoenas were into the operation of his research.  Some members of the Committee seemed sympathetic until I reminded them that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan. See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005).  See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009). Most members of the Committee expressed their reassurance that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data, but at the time, Professor Jasanoff maintained her opposition to the approach. 

Jasanoff’s selective sniffing reflects the hypocrisy and asymmetry that pervades current discussions of conflicts of interest (COI) and access to data.  COI accusations are directed at industry, but not at the litigation industry, staffed by the plaintiffs’ bar and advanced by eco-zealots.  Access to data is a rallying cry against pharmaceutical industry clinical trials, and industry-sponsored studies, but when stakeholders want access to non-industry study data, suddenly privacy interests and researchers’ privileges become paramount, and researchers “feel harrassed.”  It really is time to choose:  either we stop our insistence upon seeing the data themselves, or we formulate rules that apply across the board, independent of study sponsorship.

We are becoming, by fits and starts, a data-driven and evidence-based world.  The time has come and gone to rely upon authors’ own interpretation of the data, and to realize that there is a public trust, interest, and need for data sharing.  GP’s capital mistake was the same made by Dr. Racette, when he asserted various privileges to argue against disclosure of his underlying data.  (Had GP paid attention to prior disputes, it would have learned that the attorney-client privilege has been uniformly rejected, as it was in Racette’s case.)  Jasanoff’s capital mistake is to attribute stench to GP for asserting a privilege, but excusing it when done by scientists funded or supported by the “litigation industry.”

The CPI reported that a GP spokesman refused to answer questions, but referred a reporter to GP’s court filings, where GP maintained that it “properly commissioned studies to explore scientific issues that repeatedly arise in joint compound litigation, disclosed its role in the studies themselves, and submitted them to the technical rigors of scientific peer review by qualified scientists who were neither affiliated with nor selected by Georgia-Pacific.”

Sounds good, but then why try to assert an attorney-client privilege and an attorney-work product confidentiality?  Plaintiffs’ counsel, having relied upon some rather poorly conducted studies would likely known that peer review is not a very good filter for sound science, and they would press for access to the inner workings of the studies and the possible influence that the sponsor had on any aspect of the studies.  Furthermore, faced with the prospect of GP’s succeeding in its claim of privilege, the plaintiffs were surely warranted in trying to explore exceptions to the privilege, such as the crime-fraud exception, weak though the evidence may be to support such an exception.

Now Look Who Is Manufacturing Doubt!

In the GP case, the New York Appellate Division did not hold that GP had engaged in a fraudulent scheme, only that plaintiffs’ allegations were serious enough to support an order that the trial judge review, in camera, the supposedly privileged materials.  The CPI, however, has used the decision to support its overwrought generalization of charges against all industry-sponsored studies. 

The CPI has used the commonplace smear tactic of analogizing every company’s defensive strategies against litigation, even against unwarranted claims, as a manifestation of the same tactics used by Big Tobacco.  Unfortunately, GP advanced the attorney-client privilege theory, which had been asserted previously, and unsuccessfully, by tobacco companies.  This legal misstep, however, does not justify CPI’s smear campaign against the scientists who conducted the studies at issue.  There is nothing stated or suggested in CPI’s editorial that raises any meaningful question about the validity of the research sponsored by GP.

COI and Access to Data – Two-Way Street

GP’s misguided assertion of the attorney-client privilege opened itself and industry generally to the CPI charges of using “well-paid experts to minimize the hazards of toxic chemicals and fend off liability, regulation, or both.” Indeed, the CPI’s editorial is little more than a sustained ad hominem attack on industry’s efforts to protect itself from liability and regulation, without any acknowledgement that often the attempts to impose liability or regulation are based upon dubious science or imprudent policy. Some liability claims are corrupt, and must be defended, including many frivolous and fraudulent claims in the asbestos litigation.

While the CPI rails against industry experts, it is suspiciously silent about so-called public interest groups or claimants, using well-paid experts, or worse, over-zealous experts, to obtain litigation or regulation results. To be sure, there are many instances of plaintiffs’ expert witnesses failing to disclose their potential conflicts, as well as failing to disclose their funding or support from plaintiffs’ counsel, plaintiffs, or plaintiffs’ proxies. Mr. Kristal’s strategy of claiming fraud in failing to disclose potential conflicts of interest will lead to a regime that will be uncomfortable for many scientists and physicians who fail to make appropriate disclosures.  See, e.g., “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013); “The Mt. Sinai Catechism” (June 7, 2013).

The CPI’s complaint that GP hired experts who were aligned with their cause is curious given the history of the plaintiffs’ counsel to hire expert witnesses who were aligned with their clients’ labor unions and the like.  Irving Selikoff, who was engaged by the insulators’ union to conduct a study of their cancer mortality, had testified in worker compensation proceedings and in some of the early civil actions involving claims of asbestos-related injuries.  The CPI quotes plaintiffs’ lawyer Alan Golanski as alleging that GP had tried to “seed” the medical literature with “methodologically skewed, litigation-driven research.” Of course, this is exactly what plaintiffs’ expert witnesses have done over the last half century.

It really is time to stop.  COI disclosures cannot be a full, satisfactory answer because the most potent conflicts arise out of intellectual and political commitments, not money.  Increasing transparency and access to study protocols, data, analyses may perhaps help. 

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Expiation of Guilt by Expert Witnessing – The Strange Case of Gerrit Schepers

October 19th, 2013

Expert witnesses come in all sizes, colors, shapes, races, ethnicities, and personalities.  More interestingly, expert witnesses have various motives for becoming involved in the litigation process.  Most expert witnesses, I believe, become involved because they find the issues interesting, and intellectually challenging.  After looking at the claims and defenses put forward by the parties, these expert witnesses believe that one side or the other has the better warrant, or perhaps the only warrant, for its contentions.

Some witnesses sign up to “change the world.”  They are advocates, and they see the courtroom as an extension of the laboratory or the university.  They may want acceptance for their theories or beliefs, and they hope that favorable jury verdicts and judgments based upon those verdicts will elevate their theories in the world of science or policy.

Other expert witnesses are motivated by “white-hat bias.”  They see a verdict for the side for which they testify as promoting retributive, distributive, or social justice.  They may be deontological or utilitarian or Aristotelian in their assessments of the issues, but they are motivated by considerations that often transcend the facts of the particular case.

Of course, there are expert witnesses who see litigants and litigation as an ATM to aid their personal fisc.

I have known only one expert witness who was motivated by guilt.

                                                                               * * * * * *

Robert B. Anderson kindly alerted me to an interesting historical wiki on Saranac Lake, New York, with some interesting entries for some of the protagonists of the asbestos litigation:  Leroy Upson Gardner, Arthur Vorwald, Gerrit Schepers, and others. 

Dr. Edward Livingston Trudeau founded the Saranac Laboratory for the Study of Tuberculosis, in 1884, as a center for research and treatment of tuberculosis.  The Laboratory, later became known as the Trudeau Institute, was also one of the leading pneumoconiosis research facilities in the 20th century.  Many companies engaged the Laboratory to test their products, or the materials within their products; and Saranac Lake was the natural venue for various symposia and research meetings on industrial dust diseases.

As its director from 1927, until his death in 1946, Dr. Gardner helped put the Saranac Laboratory on the intellectual world map.  His directorship coincided with the period in which the pneumoconioses were becoming important topics in industrial medicine, and in labor-industry battles.  After Dr. Gardner’s death, Dr. Vorwald became the Director of Laboratories at Saranac. He held the position from 1947, until 1954, when he left to organize a new medical school department, of Industrial Medicine and Hygiene, in Wayne State University, in Michigan.

In 1954, the Laboratories fell into the hands of Dr. Schepers, who oversaw its passing into irrelevancy as research moved into the major universities.  Schepers left Saranac in 1958.

Dr. Schepers used his supposed personal knowledge of dealings with various companies to create a livelihood in later life, when he testified extensively for plaintiffs’ counsel in asbestos personal injury litigation.  As the litigation matured, so did Dr. Schepers, who became deaf and daft, and fantasized and testified to conversations with people, long dead, who could not contradict him.  Schepers thus used his longevity to good advantage.

After Dr. Schepers adopted the catechism of Mt. Sinai, his publications, from the early 1980s until his death, became particularly unreliable, and these typically are the only ones cited now by plaintiffs’ counsel and plaintiffs’ expert witnesses.  Fortunately, Dr. Schepers memorialized his contemporaneous observations, which frequently contradicted him when he was confronted by well-prepared defense counsel, in court or deposition examination.  Under the Federal Rules of Evidence, and most state evidentiary law, Schepers’ prior statements are admissible as they bear on his credibility and the truth of his later, scurrilous writings:

“When a hearsay statement … has been admitted in evidence, the declarant’s credibility may be attacked, and then supported, by any evidence that would be admissible for those purposes if the declarant had testified as a witness. The court may admit evidence of the declarant’s inconsistent statement or conduct, regardless of when it occurred or whether the declarant had an opportunity to explain or deny it. If the party against whom the statement was admitted calls the declarant as a witness, the party may examine the declarant on the statement as if on cross-examination.”

Federal Rule of Evidence 806.  See, e.g., “Gerrit W. H. Schepers, MD, RIP” (2011).

The Saranac Wiki also notes that Schepers was “an experienced anthropologist and neurologist.”  Most scientists, however, have been probably all too happy to forget Dr. Schepers’ work in this area.  See, e.g., G.W.H. Schepers, “The Corpus Callosum and Related Structures in the South African Negro Brain,” 24 Am. J. Physical Anthropology 161 (1938).

The Wiki points to a hagiographic obituary that quotes an anonymous friend who called Schepers “the Old War Horse, the record holder for longevity in the struggle against corporate crime.” Laurie Kazan-Allen and Barry Castleman,  “The Passing of a Great Man” (Sept. 13, 2011).   Schepers lived to 97, but his struggle was with his own past, not with alleged corporate crime.

Labor historian Jock McCulloch wrote about Schepers’ role in documenting silicosis disability among South African miners, but even Schepers’ good deeds came with a dubious shadow.  McCulloch describes a South African investigator who described “Dr Schepers as a man whose outstanding intellect was compromised by an ‘inexcusable scientific dishonesty’.”  Jock McCulloch, “Hiding a Pandemic: Dr G.W.H. Schepers and the Politics of Silicosis in South Africa,” 35 J. Southern African Studies 835, 838 (2009) (citing to South African National Archives, Pretoria, F 33\671, Supplementary Confidential Report of the Departmental Committee of Enquiry into the Relation between Silicosis and Pulmonary Disability. Departmental Committee to Inquire into the Definition of Silicosis & Chest Diseases (Oosthuizen) Departmental Committee at 23 (1954)).

Contrary to the fantasy “state of the art” that made Schepers so much in demand for plaintiffs’ lawyers, and endeared so to Kazan, Castleman, and McCulloch, Schepers’ publications tell a different story. Schepers’ very first publication on asbestos and cancer came in 1963, after the work by Dr. Christopher Wagner and others, from South Africa. At that time, he wrote about pulmonary cancers:

“Neoplasia occurs in two forms:  alveolar and bronchiole carcinoma, and pleural mesothelioma.  The latter is particularly common in crocidolite workers, and has been mainly reported from South Africa.”

G. Schepers, ““Lung Disease Caused by Inorganic and Organic Dust” 44 Chest 133, 136 (1963).  This statement came after his South Africa and Saranac experiences, but before senescence set in. Schepers also noted that “neoplasia has not yet resulted” from asbestos in experimental models.  Id. at 136.

American College of Chest Physicians (1964)     

In 1964, Schepers helped prepare a position paper on asbestosis for the American College of Chest Physicians.  This report noted that the enhanced prevalence of pulmonary neoplasia did not appear to apply for the chrysotile industry in North America:

“In the medical literature, there are more articles favoring a positive relationship between cancer of the lung and asbestosis than denying it. While it has been reported that there may be an enhanced prevalence of pulmonary neoplasia in some asbestos industries (e.g. crocidolite or amosite), or in some locations (e.g. South Africa, England), this does not appear to apply for the chrysotile industry in North America. This comment applies both with respect to intrapulmonary new growths and to pleural mesothelioma.”

Peter A. Theodos, John W. G. Hannon, Paul Cartier, Ross K. Childerhose, David T. Dubow, G. W. H. Schepers, Reginald H. Smart, and Roy E. Whitehead, “Asbestosis:  Report of the Section on Nature and Prevalence Committee on Occupational Diseases of the Chest,” 45 Chest 107, 109b (1964).  This report also put pleural plaques into proper historical and physiological perspective:

“In many individuals and perhaps even the majority of cases, these pleural plaques do not present any histologic lesions of asbestosis and contain no asbestos fibers. *** These plaques, though apparent on X‑ray, are not associated with any disability.”

Id. at 109a.

New York Academy of Science Conference on Asbestos (1964)

Also in 1964, Schepers was a significant presence at Dr. Selikoff’s 1964 conference of the New York Academy of Science, where he commented upon others’ presentations.  Here Schepers continued to express his doubts about the carcinogenicity of North American chrysotile:

“Finally, there is the question of whether inhalation of chrysotile is associated with neoplasia.  On critically reviewing the work histories of eleven cases of lung cancer in chrysotile workers, I find that all of these had at one time or another also been exposed to other forms of asbestos, mainly amosite or crocidolite.  Their predominant exposure was to chrysotile, but since there is strong evidence incriminating amosite as a carcinogen, the fact that these men also had been exposed to amosite is disruptive of a theory of carcinogenicity per se.”

Schepers, “Discussion,” in Biological Effects of Asbestos 132 Ann. N. Y. Acad. Sci. 589, 596 (1965). Schepers paved the way on manufacturing uncertainty when he suggested at the 1964 conference, an alternative hypothesis to crocidolite as a cause of mesothelioma; he suggested that some of the mesotheliomas in South Africa might have been caused by a native grass known as Klitsgras.

Talc Symposium (1973)

In May 1973, Schepers participated in a written presentation at a symposium on talc, sponsored by the United States Department of Interior.  At the time, Schepers was an employee of the United States government, the Chief of the Medical Service, Veterans Administration, in Lebanon, Pennsylvania:

“There are marked differences between the capacities of the individual classes of silicate minerals to provoke responses in human and animal tissues. There also are major misconceptions as to what these substances can do when inhaled by man or other mammals. Two of the most extreme of these are

(1) that all siliceous minerals are equally pathogenic and

(2) that there is even the least semblance between the effects of the asbestiform and the non-asbestiform silicates.”

Gerrit W. H. Schepers, “The Biological Action of Talc and Other Silicate Minerals,” at 54, in Aurel Goodwin, Proceedings of the symposium on talc: U.S. Bureau of Mines; Information Circular 8639 (1974).  This view was directly opposed to the Mt. Sinai gospel about to be delivered in another government proceeding. See U.S. Environmental Protection Agency v. Reserve Mining Co., 514 F.2d 492 (8th Cir. 1975) (en banc).  Schepers, however, had not yet gotten the memo, or perhaps his loyalty was still to his employer, the United States government.  Schepers was not, however, under the influence of any company or corporate interest, when he wrote:

“Is chrysotile a carcinogen? This is a very perplexing question. A crescendo of popular opinion has sought to incriminate chrysotile. This author remains unconvinced.  The main premise for carcinogenicity stems from epidemiological observation of employees of the insulation and shipbuilding industries. In both these industries there has been in the past considerable exposure of pipe laggers to asbestos dust. Only in recent decades, however, have these insulation bats been composed predominantly of chrysotile. In former years crocidolite and amosite were important components.

                                                                               ***

Finally, it should be pointed out that the role of cigarette smoking has not been satisfactorily discounted in the referenced epidemiological studies of lung cancer among insulation workers. In some groups reported an excess prevalence of lung cancer was not demonstrable when cigarette smoking was taken into consideration. Epidemiological surveys of chrysotile workers in Quebec showed no excess of lung cancer. A review of pleural mesothiliomatosis in Canada also failed to focus attention on Quebec or any other center where chrysotile industries are concentrated.”

Gerrit W. H. Schepers, “The Biological Action of Talc and Other Silicate Minerals,” at 70.  Unlike Dr. Selikoff, Schepers was not a crocidolite denier.

OSHA Proceedings 1976

In 1970, the Williams-Steiger Act created a new federal agency, the Occupational Safety and Health Administration, and one of its first missions was to address an asbestos problem that emerged in the 1960s.  The new agency held extensive hearings and engaged in factfinding, which was dominated by Dr. Selikoff and other proxies for the labor unions.

In 1976, Schepers was not yet under the influence of the Mt. Sinai crowd; indeed, he was an employee of the United States.  Here are the contemporaneous views of Dr. Schepers, as he attempted to influence the OSHA investigation of the asbestos fiber controversy.  In a letter dated July 19, 1976, Schepers wrote Grover Wrenn, Chief, Division of Health Standards Development, OSHA:

“This is a follow-up on our recent meeting with the Assistant Secretary of Labor at which we discussed the question of asbestosis and berylliosis and the relationship of exposure of various industrial substances to lung cancer.

I promised to help you place items in the record which you appeared not have available.”

                                                        ***

“As you can see my researches cast considerable doubt on the proposition that American fibrous minerals are carcinogenic.  I am not one of those that deny the carcinogenicity of everything.  To the contrary, I believe that I have helped prove that some environmental pollutants are carcinogenic.  For this reason you may perhaps accept the credibility of my findings when I state that I could detect no evidence of carcinogenicity for either chrysotile, talc or fiberglass.”

Asbestos Litigation – The Gathering Storm (1978)

By the late 1970s, asbestos litigation was swamping American courtrooms.  The United States Navy in particular was threatened by the potential expense of compensating its large civilian shipyard workforce.  Schepers sought out the role of testifying witness, in a letter dated March 10, 1978, Dr Schepers wrote to Captain Hoeffler, of the Navy’s Bureau of Medicine and Surgery, in Washington D.C.  Schepers shamelessly took credit for discovering the connection between mesothelioma and amphibole asbestos, in 1949. Of course, if this self-aggrandizing claim were true, Schepers would have been involved in a much more devastating cover-up than any American company.  Here is the substance of Schepers’ 1978 solicitation letter:

“Here is a CV and some reprints which will possibly be helpful.  Since I have been involved with so many things, my expertise with respect to asbestosis is somewhat hidden among the rest.  For emphasis therefore let me summarize that my clinical and research involvement with asbestosis and thus also lung cancer spans some thirty years.  I commenced this work in South Africa, where as a …. Medical director for the pneumoconiosis Bureau we researched the working conditions and health of all employees of that countries [sic] extensive crocidolite and amosite mines and industries.  The fact that mesothelioma can be associated with asbestos dust was first discovered by me during 1949 at the Penge Egnep mines in the Eastern Transvaal.  It is also important to know that only one out of three persons who develop mesothelioma ever was exposed to asbestos dust.  The Institute for Pneumoconiosis Research which I started there has abundant evidence about this.

In the USA I next studied the asbestos problem for the Quebec Government and the Johns Mansville Company and also for various asbestos producing companies.  This embraced research on human subjects, lung tissue and experimental animals.  The net result of my fifteen years of work in this field has been to convince me that chrysotile, which is the North American type of asbestos, is relatively innocuous as compared to the African and Russian varieties.  I have never seen a case of lung cancer develop on any person exposed to chrysotile only.  However I have seen plenty of lung cancers in asbestos workers.

This is because most asbestos workers are exposed to carcinogenic materials other than asbestos and all the cases with lung cancer also were chronic lung self-mutilators through cigarette smoking.  In a rather major set of experiments of mine, I exposed animals to the most potent known carcinogenic (beryllium sulphate) and then exposed them to asbestos (chrysotile) dust.  These animals had fewer cancers than those exposed to the beryllium sulphate.  So chrysotile is not even a significant co-carcinogen.  I reversed the order of the exposure – namely asbestos (chrysotile) first and the the BeSO4.  The result was the same.  The animals exposed only to chrysotile never developed any lung cancers.

I probably have the largest collection of asbestosis case materials, having been a consultant to hundreds of physicians.  I have a very detailed knowledge of what various types of asbestos can and cannot do to the lungs.  If my command of this subject can be of use to the Navy in the current law suit, please feel to use my services as consultant as you deem fit.”

Schepers Reinvented

As we can see from his 1978 correspondence, Dr. Schepers was not shy about touting his expertise, or his opinions about the innocuousness of chrysotile asbestos.  Castleman’s revisionist history has some support only from Scheper’s own later attempts to reinvent his past.  See, e.g., Gerrit W.H. Schepers, “Chronology of Asbestos Cancer Discoveries: Experimental Studies of the Saranac Laboratory,” 27 Am. J. Indus. Med. 593-606 (1995). The contemporaneous history of Schepers’ views is, however, completely at odds with words written only after decades of consulting with, and testifying for, plaintiffs’ counsel in asbestos litigation.

Like many other defense lawyers, I confronted Dr. Schepers in cases in which he testified both on state-of-the-art issues and on the causation of mesothelioma.  Towards the end of his testifying career, he likened his courtroom performances to that of “performing seal for lawyers in the courtroom.”  Testimony of Gerrit W. Schepers, in Hill v. Carey Canada, New Jersey Superior Court, Law Division for Camden County, Docket No. L-051429-84, 48-50 (July 24, 1990) (before Judge Supnick and a jury). 

The interviews he gave for the media were even more of a performance. In one interview that Schepers gave about a year or so before his death, he cut even more grandiose poses of a whistleblower and crusader.  See Lorraine Mallinder, “Deadly Secret: A 1940s whistle-blower uncovers hidden evidence linking asbestos to cancer,” 91 Canada’s History 33 (April 2011). 

Why did Schepers commit himself in retirement to the plaintiffs’ bar and their relentless prosecution of asbestos cases?  Marxist historians and writers such as McCulloch and Castleman, who see every societal ill as the result of corporate influence will not likely discern Schepers’ true motivations.  By the time I encountered Schepers he was no longer a needy former civil servant.  He was trying to rewrite history because he was personally responsible for the continued use of South African crocidolite in the United States, for decades after he claimed to have discovered its causal relation to mesothelioma.  He was a man tormented by guilt, and his ritualistic participation in trials of mesothelioma claims was expiation for his role in the tragedy.

It is sad that the asbestos litigation is still with us. Dean Wellington’s pipedream of turning the asbestos litigation feeding frenzy into an administrative routine is long gone.  The bankruptcies of dozens of companies, with the losses of jobs and income for many thousands of American workers is a great tragedy; but so is the loss of historical perspective.

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British Labor Historians Belaboring American Labor History – Gauley Bridge

October 14th, 2013

Jock McCulloch and Geoffrey Tweedale are labor historians, which means mostly they write about the issues of interest to industrial workers, from an unremittingly pro-labor and anti-management perspective.  Recently, these British writers have weighed in on American labor history, and the role of Dr. Anthony Lanza in the litigation that followed the Gauley Bridge tunnel construction.  See Jock McCulloch and Geoffrey Tweedale, “Anthony J. Lanza, Silicosis and the Gauley Bridge ‘Nine’,” 26 Social History of Medicine (2013), in press [cited as M&T]

Here is the authors’ abstract:

“Gauley Bridge was the scene of America’s biggest industrial disaster, in which hundreds of workers died from silicosis in the aftermath of the drilling in 1930–31 of a hydro-electric tunnel at Hawk’s Nest. This article scrutinises for the first time the role of Dr A. J. Lanza (a medical director of Metropolitan Life Insurance Company) in hiding the extent of acute silicosis amongst the tunnellers. Lanza and his allies in the medical profession were able to impose their own interpretation on events at Gauley Bridge. Their analysis of nine autopsies ignored the evidence of acute silicosis, in favour of one which emphasised tuberculosis, racial susceptibility, syphilis, the supposed negligence of the workforce and alleged racketeering by lawyers. The result was that acute silicosis largely disappeared from medical discourse and Gauley Bridge was denied a place in America’s national consciousness.”

McCulloch & Tweedale’s investigation into Lanza’s role in the litigation is interesting, but hardly surprising.  He was, after all, a medical director of a large insurance company, and no doubt that the Gauley Bridge litigation, which started in 1932, threatened Met Life’s interests and his own.  These British authors, however, do a much less convincing job of investigating the bias of the physicians who testified for some of the Gauley Bridge victims, and of the plaintiffs’ lawyers, who had a substantial interest in passing off tuberculosis, pneumonia, and other respiratory illnesses as silicosis.

Was Gauley Bridge Denied A Place in America’s National Consciousness?

McCulloch and Tweedale claim that the Gauley Bridge disaster hardly registered in the nation’s memory.  Their claim is demonstrably false. M&T at 2. These authors appear to make their claim to advance a conspiratorial labor view of history that fails to account for evidence from many other walks of life. They write:

“The neglect of Hawk’s Nest—which is indicative of the way that risks in the workplace and silicosis in particular have been underplayed or ignored by historians and social scientists—is unfortunate.”

M&T at 3.  While their suggestion that Hawk’s Nest, another name for the Gauley Bridge locale, has been ignored by social historians until recently has some plausibility, their implication of more widespread neglect cannot be sustained. Furthermore, their suggestion that Gauley Bridge fits into their Marxist paradigm of corporate corruption of science (citing similar works by Michaels, Castleman, Rosner, et al.) ignores the robust debate from all sectors of society, including the scientific community, organized labor, political actors, industry, government, and academia.

The Gauley Bridge disaster, and disaster it was, was memorialized in song, in literature, and most important, in a refined understanding of how extreme silica exposures can lead to rapid onset of silicosis.  These “non-labor” sources are generally ignored in the authors’ “tunnel vision.” McCulloch and Tweedale’s indictment against Lanza asserts that Lanza:

“did not seek to find a truthful explanation for the premature deaths of these men(and countless others), but instead hijacked the medical agenda to serve powerful business interests. In doing so, they certainly proved to be accomplices, but hardly unknowing ones.”

M&T at 3-4.

The historical evidence may support Lanza’s work behind the scenes in the Gauley Bridge trials, but the authors broad, overwrought implications are non-sequiturs:

“As a result, for almost half a century Hawk’s Nest was denied a place in the national consciousness and silicosis was elided as a major public health issue in the USA.”

M&T at 4.

In Song

In 1936, Josh White wrote and sang a labor protest song, “Silicosis is Killing Me”:

I said silicosis, you made a mighty bad break of me.
Awww, silicosis made a mighty bad break of me.
You robbed me of my youth and health;
All you brought poor me was misery.

Now silicosis, you’re a dirty robber and a thief.
Awww silicosis, dirty robber and a thief.
Robbed me of my right to live and all you brought poor me was grief.

I was there digging that tunnel for six bits a day;
I was there digging that tunnel for six bits a day;
Didn’t know I was digging my own grave, silicosis eating my lungs away.

I says mama, mama, mama, cool my fevered head.
I says mama, mama, come and cool my fevered head.
I’m going to meet my Jesus, God knows I’ll soon be dead.

Six bits I got for digging, digging that tunnel hole.
Six bits I got for digging, digging that tunnel hole.
Takes me away from my baby, it sure done wrecked my soul.

Now tell all my buddies, tell all my friends you see;
Now tell all my buddies, tell all my friends you see.
I’m going way up yonder, please don’t grieve for me.

In Cinema

Silicosis was addressed in the emerging art form of cinema, but perhaps most notably in The Citadel (1938), which featured Robert Donat as a physician trying to treat and prevent silicosis.  The movie was nominated for an Academy Award, for best picture in 1939; King Vidor was nominated for his directing of the movie.

Perhaps less artistic, but no less compelling than King Vidor, in 1937, Secretary of Labor Frances Perkins declared war on silicosis, toured mines, convened national conferences on the problem, and issued a film entitled, “Stop Silicosis.”

 

Secretary Perkins as she appeared in “Stop Silicosis.”

 

In Media

The Gauley Bridge disaster and aftermath were covered widely in newspapers and  magazines through the mid- to late-1930s.  McCulloch and Tweedale concede the existence “extensive national media coverage.” M&T at 14.  They complain, however, that “press interest subsided.” Id.  Before we advert to conspiracy theories and suggestions of mass attention deficit disorder, we need only remind ourselves that soon after the Congressional hearings, and the National Silicosis Conference, of the 1930s, Hirohito and Hitler occupied center stage.  Press interest is, almost by definition, ephemeral.

In Legislative Action

In 1936, Congress reacted angrily to the media coverage of the Gauley Bridge tunnel workers’ developing and dying of acute silicosis.

A contemporaneous account described the congressional hearings and quoted from the Committee’s official report:

“In a two hundred printed page report the Committee on Labor of the House of Representatives at Washington furnishes the ‘Hearings’ on House Joint Resolution 449 – the legislative vehicle which rudely trundled into the light of publicity the secrets of the silicosis tragedy at Gauley Bridge, West Virginia.  This Committee of the Congress presents the testimony of many specialists, including several from the United States Bureau of Mines and the Public Health Service, as well as of special investigators and several surviving victims of the occupational disease from this now notorious tunnel operation. The official report of the investigation

concludes:

‘That the whole driving of the tunnel was begun, continued, and completed with grave and inhuman disregard of any consideration for the health, lives, and future of the employees.

That as a result many workmen became infected with silicosis; that many died of the disease and many not yet dead are doomed to die from the ravages of the disease as a result of their employment and the negligence of the employing contractor. That such negligence was either willful or the result of inexcusable and indefensible ignorance there can be no doubt on the face of the evidence presented to the committee.’

The record presents a story of a condition that is hardly conceivable in a democratic government in the present century. It would be more representative of the middle ages. It is the story of a tragedy worthy of the pen of a Victor Hugo–the

story of men in the darkest days of the depression, with work hard to secure, driven by despair and the stark fear of hunger to work for a mere existence wage under almost intolerable conditions.”

26 Am. Labor Legis. Rev. 66 (1936)

Francis Perkins, Roosevelt’s Secretary of Labor, in 1938 convened a National Silicosis Conference, which brought together organized labor, industry, government, and academics to address the outstanding safety and health issues in industries that gave rise to unsafe silica exposures among their workers.  The National Silicosis Conference published its proceedings in a series of reports, which in turn were memorialized in textbooks of the time.  See, e.g., Jewett V. Reed & A.K. Harcourt, The Essentials of Occupational Disease 162 & n. 15 (1941) (citing National Silicosis Conference, Report on Medical Control. United States Dep’t of Labor Bull. No. 21, Part 1 (1938)).

LITIGATION:  plus ça change, plus c’est la même chose

Jock McCulloch and Geoffrey Tweedale deplore Dr. Lanza’s participation in the silicosis litigation that followed the Gauley Bridge disaster.  They go to great lengths to suggest that Lanza suppressed the diagnostic entity of “acute silicosis,” and that he was motivated by race prejudice against the African American tunnel workers and bias in favor of the insurance company for which he worked.

Their narrative of the Gauley Bridge litigation, however, is selective and fatally incomplete.  They report that the first case to go to trial in 1933, Raymond Johnson v. Rinehart & Dennis Company, resulted in a hung jury, and they offer multiple hearsay to suggest that the defense bribed several members of the jury.  Perhaps there is something to the innuendo, but these historians ignore the contemporaneous accounts that described the circus atmosphere created by the histrionics of the plaintiffs’ counsel.  Newsweek described the “legal pyrotechnics”:  the plaintiffs’ lawyers

“threw handfuls of white silica dust into the air to show jurors how it hung like an ectoplasmic pall.  The plaintiffs’ legal team arranged a court room procession of doomed silicosis sufferers — the parade of the living dead.”

“Silicosis Tunneling Through an Atmosphere of Deadly Dust” Newsweek 33, 34 (Jan. 25, 1936).  Rinehart & Dennis settled 200 cases in the aftermath of the hung jury.  The plaintiffs’ lawyers filed additional cases, but McCulloch and Tweedale fail to report that the next jury, sitting in Charleston, rejected the worker’s claim. Id.

In 1949, the U. S. Supreme Court, following the lead of the New York Court of Appeals, declared it to be a matter of common knowledge that breathing silica dust “is injurious to the lungs and dangerous to health,” a fact the plaintiff’s employer “was bound to know.” Urie v. Thomas, 337 U.S. 163, 180 (1949), citing Sadowski v. Long Island R.R., 292 N.Y. 448, 456 (1944).

In Occupational Medicine

Before the Gauley Bridge disaster, acute silicosis was not a well-defined diagnostic condition.  A paper published in the Journal of the American Medical Association, in 1932, states that “acute silicosis” did not gain recognition until 1929.  Earle M. Chapman, “Acute Silicosis,” 98 J. Am. Med. Ass’n 1439 (1932).  The author described cases arising out of the abrasive soap manufacturing industry, where silica exposures were confounded by exposure to alkali soap powder.

Two papers in 1933, in the American Journal of Public Health, gave tentative recognition to acute silicosis, and cautiously labeled the condition, “so-called acute silicosis.”  Homer L. Sampson, “The Roentgenogram in So-Called ‘Acute’ Silicosis, 23 Am. J. Pub. Health 1237 (1933); and Leroy U. Gardner, “Pathology of So-Called Acute Silicosis,” 23 Am. J. Pub. Health 1237 (1933).

Unfortunately for McCulloch and Tweedale’s thesis, the recognition of acute silicosis, and the assessment of the prevalence of all varieties of silicosis, were confounded by the wide-spread prevalence of tuberculosis (TB).  The radiographic appearance of TB often consists of  nodular opacities, which physicians, using early, unsophisticated chest radiography, could easily confuse with silicosis.  Often workers had both TB and silicosis, and the severity of the patients’ conditions could not easily be attributed to one or the other condition.

Reading the medical literature of the day is a healthful antidote to the glib generalizations that unfairly import present-day knowledge into the discussion of silicosis in the 1930s.  In 1934, Dr. John Hawes, in the New England Journal of Medicine, noted that:

“Our ideas concerning silicosis have undergone radical changes during the past ten to fifteen years.”

John B. Hawes, II & Moses Stone, “The Effect of Acute Respiratory Tract Infections Upon Latent Silicosis,” 211 New Engl. J. Med. 1147, 1147 (1934).  Tuberculosis and tuberculosilicosis were major confounders in the clinical, diagnostic picture confronted by physicians in the 1930s and 1940s. See, e.g., Louis Benson, “Tuberculosilicosis,” 223 New Engl. J. Med. 398 (1940);  H. K. Taylor & H. Alexander, “Silicosis and Silico-Tuberculosis,” 111 J. Am. Med. Ass’n 400 (1938); G. Ornstein & D. Olmar, “Tuberculosis and Silicosis,” 2 Quarterly Bulletin Seaview Hospital 28 (1936).

An editorial in the New England Journal of Medicine, in 1936, presented a balanced view of the issues, and noted that both labor and management had important work to do to bring the safety issues under control.  Editorial, “The Problem of Silicosis,” 214 New Engl. J. Med. 794 (1936).

Effective therapies for TB became available in the 1950s.  During the 1930s, silicotuberculosis was often called “complicated” silicosis; i.e., silicosis was complicated by mycobacterial infection.  In the 1950s, with the advent of antiobiotic therapies for TB, “complicated silicosis” changed meaning to refer to advanced chronic silicosis in which small silicotic nodules had coalesced into large nodules.

Even after antibiotics became available for TB, silicosis was hardly forgotten.  Of course, the medical profession and the citizenry had other pressing issues in the 1950s: polio, an emerging epidemic of tobacco-related lung cancer, the threat of war and nuclear holocaust.  Still, silicosis remained part of the larger discussion of occupational and environmental hazards.  See, e.g., Harriet L. Hardy, “Medical Progress: Occupational Medicine,” 247 New Engl. J. Med. 473 (1951).  See also Schachtman, “Conspiracy Theories: Historians, In and Out of Court” (2013) (discussing the quantitation of publication rates about silicosis in both PubMed and in Google labs, both of which show continuing interest in, and publication about, silicosis throughout the 1950s and 1960s, into the OSHA era).

The Gauley Bridge litigation was a short-lived side show in the history of silicosis. Contrary to the McCulloch and Tweedale’s narrative, however, acute or rapid-onset silicosis became a well-accepted diagnostic entity.  See, e.g., Lewis Gregory Cole & William Gregory Cole, Pneumoconiosis (Silicosis) – The Story of Dusty Lungs – A Preliminary Report (N.Y. 1940); Jewett V. Reed & A.K. Harcourt, The Essentials of Occupational Disease 164 (1941); Rutherford T. Johnstone, Occupational Medicine and Industrial Hygiene 337 (1948); Donald Hunter, Diseases of the Occupations 837, 849 (1955).

Prevalent Racketeering

McCulloch and Tweedale concede that accurate diagnoses of silicosis require a chest X-ray (which labor radicals and plaintiffs’ lawyers in the 1930s disputed), as well as well as careful clinical examination and full occupational and personal medical histories. M&T at 5.  Although they note the diagnostic difficulties, the authors miss the lack of specialization and experience among many general practice physicians to make an accurate diagnosis of silicosis.  They acknowledge that the use of X-rays in diagnosis was still contested in the early 1930s.  M&T at 11.  The situation in the 1930s was thus ripe for specious claiming.

What McCulloch and Tweedale also seem to miss in their focus on a few compelling Gauley Bridge cases is that the diagnostic difficulties and confounders were a prescription for fraud and scamming on the wider stage.  In deploring management’s lobbying for workmen compensation laws, they ignore that many labor unions concurred.  In the context of silicosis hazards, plaintiffs faced serious legal hurdles against their employers, in the form of limitations, assumption of risk, fellow worker, and contributory negligence defenses.

In 1936, in the pages of the New England Journal of Medicine, Dr. Hawes commented upon the widespread scamming and racketeering that accompanied the serious silicosis cases in West Virginia.

“Very few physicians are aware of the extent to which claims for alleged injury and disease due to dust are being brought before courts and industrial accident boards in this country. The situation in this regard amounts to a ‘racket’ compared with which others, notorious in New York, Chicago and elsewhere, fade into insignificance.   Unscrupulous lawyers have their ‘runners’ on the lookout for any employee who is exposed to dust in the course of his work, no matter what the nature of the dust nor however harmless it may be, who happens to come down with a cough or a cold or indeed with almost any other illness and then and there try to persuade him to bring suit. Unfortunately, in too many instances, physicians partly through ignorance and partly through an honest desire to help their patients and perhaps on the general theory of ‘soaking the insurance company’ are willing to testify that the dust to which this individual had been exposed was entirely responsible for his condition. In nearly 100 per cent of such cases the doctor takesat its face value the word of the worker and his friends as to the dust hazard without any real knowledge of the situation obtained from a personal inspection of the plant or at least by interviewing those in a position to know.”

John B. Hayes, II, MD, “Silicosis,” 215 New Engl. J. Med. 143 (1936).

Although the medical understanding of silicosis has advanced tremendously, the racketeering, alas, is still with us to this day.  See In re Silica Products Liab. Lit., 398 F. Supp. 2d 563 (S.D. Tex. 2005) (Jack, J.) (describing the attorneys’ manufacturing fraudulent silicosis claims in MDL 1553).  Of course, there are real silicosis cases, but overwhelmingly they are “simple” silicosis cases, typically unaccompanied by impairment or disability.  Tuberculosis is now rarely a confounder, but histoplasmosis and coccidioidomycosis are important confounders of simple silicosis in some areas of the United States.

The Charge of Racism

McCulloch and Tweedale point out that Lanza formed an opinion that black workers were more prone to TB and silica-related disease because of their race and prevalent syphilis.  To be sure, there was (and still is) much race, ethnic, and religious prejudice in the United States.  Lanza’s views on race, however, are irrelevant to the ultimate acceptance of acute or rapid-onset silicosis as an occupational hazard of extremely high-levels of occupational silica exposure.  The race theory appeared to play no role in the civil litigation in West Virginia, and it receives no mention in the many textbooks that describe and accept acute silicosis as a diagnostic entity. As for the continuing existence of race prejudice, McCulloch and Tweedale might have noted that Dr. Gerrit Schepers, who testified for plaintiffs in asbestos and silica cases in the United States for decades, described young black African children as “pickaninnies.”  See Gerrit Schepers, “Discussion,” 132 Annals N. Y. Acad. Sci. 246, 247 (1965). It is a relatively easy, ad hominem game to play, to dismiss a scientist’s views because of his irrational race prejudices. Lanza may have been influenced by his racial theories in acting behind the scenes of the Gauley Bridge litigation, but McCulloch and Tweedale would be hard pressed to find them articulated in Lanza’s textbooks or articles.

The Rosner-Markowitz Hypothesis

The authors note that Lanza, with Metropolitan Life, helped to form the Air Hygiene Foundation (later the IHF), and they insinuate that these organizations were involved in various nefarious actions:

“The AHF (later named the Industrial Hygiene Foundation) was an enduring and powerful industry group, which helped defuse the silicosis crisis by helping companies defend compensation claims, by conducting industry-sponsored industrial hygiene studies and by assuaging public fears. This organisation, in effect, took the dust problem away from the trade unions and the public and sequestered it inside laboratories and private gatherings, where health issues could be mediated by experts and government, safe from untoward publicity. Industry lobbying was able to influence the shaping of state compensation laws for silicosis, which protected big business.”

M&T at 15-16.  These insinuations are borrowed, with attribution, from fellow labor historians, David Rosner and Gerald Markowitz.  The claims are a mixed lot.  For instance, why would not an industry work to help companies defend compensation claims?  Organized labor worked to help its members prosecute claims.  Surely McCulloch and Tweedale do not believe that every claim made was valid or that every defense frivolous.

Assuming that the AHF/IHF had some role in pressing for state workman compensation laws, then it was aligned with many labor unions that pushed for similar reforms.  As noted above, plaintiffs were often at a serious disadvantage in litigation against employers, and they frequently were turned out of court on grounds of limitations, contributory negligence, fellow-worker rule, or assumption of risk.  Plaintiffs needed certainty in coverage for occupational disease, not a jury lottery system, and employers needed some reasonable limits on the extent of liability.  Workman’s compensation was a compromise, bound not to satisfy everyone.

As for helping companies institute industrial hygiene measures and conduct hygiene studies, the AHF/IHF was helping industry live up to its obligations to provide a safe workplace.  The United States government, under the Presidency of Franklin Roosevelt, was involved in similar measures in the 1930s.  See, e.g., United States Dep’t of Labor, Silicosis Prevention:  Dust Control in Foundries (1939).

McCulloch and Tweedale’s accusation that the AHF/IHF “in effect, took the dust problem away from the trade unions and the public and sequestered it inside laboratories and private gatherings, where health issues could be mediated by experts and government, safe from untoward publicity,” is, of course, borrowed directly from the writings of Rosner and Markowitz.  The accusation does not gain any credibility from being repeated.  Involving scientists and competent laboratories that would study the issues and publish their results was a responsible step for industry to take.  Much of the early political rhetoric about silicosis was driven by personal, subjective anecdotes and uncontrolled observations.  The involvement of scientists was a step followed by labor unions, as in the example of the asbestos insulation workers union hiring Dr. Irving Selikoff in the 1950s to investigate their concerns about occupational cancer risk.

There was much to be gained by de-escalating the emotion and vitriol of the labor-management conflicts of the 1930s, although the de-escalation was unsatisfactory to radicals on both sides.  The fact is that the labor unions remained interested in, and concerned about, silicosis, both before and after World War II.  Labor unions had their own private gatherings, and engaged in rent-seeking from state and federal agencies, as did industry.  After the passage of the Occupational Health and Safety Act of 1970, labor’s interests generally prevailed at the agency level.

“The result was that acute silicosis largely disappeared from medical discourse and Gauley Bridge was denied a place in America’s national consciousness.” M&T at Abstract.  This causal conclusion is demonstrably wrong.  If you like conspiracy theories, McCulloch and Tweedale’s history might well be self-referentially labeled, Deceit and Denial, after the work of their American counterparts, Rosner and Markowitz.

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Christopher Bryson and the Problem of Political Science

October 12th, 2013

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

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

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

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

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

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

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

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

* * *

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

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

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

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

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

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Christopher Bryson and the Problem of Political Science

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