TORTINI

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

The Practicing Law Institute’s Second Edition of Products Liability Litigation

May 30th, 2021

In late March, the Practicing Law Institute released the second edition of its treatise on products liability. George D. Sax, Stephanie A. Scharf, Sarah R. Marmor, eds., Product Liability Litigation: Current Law, Strategies and Best Practices, (2nd ed. 2021).

The new edition is now in two volumes, which cover substantive products liability law, as well as legal theory, policy, and strategy considerations important to products liability law, both pursuers and defenders. The work of the editors, Stephanie A. Scharf and her colleagues, George D. Sax and Sarah R. Marmor, in managing this process is nothing short of Homeric.  The authors are mostly practitioners, with a wealth of practical experience. There are a good number of friends, colleagues, and adversaries, among the chapters’ authors, so any recommendation I make should be tempered by my disclosure.

Unlike the first edition, the PLI has doubled down on control of the copyright license, and so I am no longer able to upload my chapter on statistical evidence to ResearchGate, Academia.com, or my own website.  But here is the outline index to my contribution, Chapter 28, “Statistical Evidence in Products Liability Litigation”:

  • 28:1 History and Overview
  • 28:2 Litigation Context of Statistical Issues
  • 28:3 Qualifications of Expert Witnesses Who Give Testimony on Statistical Issues
  • 28:4 Admissibility of Statistical Evidence – Rules 702 and 703
  • 28:5 Significance Probability
  • 28:5.1 Definition of Significance Probability (The “p-value”)
  • 28:5.2 Misstatements about Statistical Significance
  • 28:5.3 Transposition Fallacy
  • 28:5.4 Confusion Between Significance Probability and Burden of Proof
  • 28:5.5 Hypothesis Testing
  • 28:5.6 Confidence Intervals
  • 28:5.7 Inappropriate Use of Statistics – Matrixx  Initiatives
    • [A]     Sequelae of Matrixx Initiatives
    • [B]     Is Statistical Significance Necessary?
  • 28: 5.8 American Statistical Association’s Statemen on P-Values
  • 28:6 Statistical Power
  • 28:6.1 Definition of Statistical Power
  • 28:6.2 Cases Involving Statistical Power
  • 28:7 Evidentiary Rule of Completeness
  • 28:8 Meta-Analysis
  • 28:8.1 Definition and History of Meta-Analysis
  • 28:8.2 Consensus  Statements
  • 28:8.3 Use of Meta-Analysis in Litigation
  • 28:8.4 Competing Models for Meta-Analysis
  • 28:8.5 Recent Cases Involving Meta-Analyses
  • 28:9 Statistical Inference in Securities Fraud Cases Against Pharmaceutical Manufacturers
  • 28:10 Multiple Testing
  • 28:11 Ethical Considerations Raised by Statistical Expert Witness Testimony
  • 28:12 Conclusion

A detailed table of contents for the entire treatise is available at the PLI’s website The authors and their chapters are set out below.

Chapter 1. What Product Liability Might Look Like in the Twenty-First Century (James M. Beck)

Chapter 2. Recent Trends in Product Claims and Product Defenses (Lori B. Leskin & Angela R. Vicari)

Chapter 3. Game-Changers: Defending Products Cases with Child Plaintiffs (Sandra Giannone Ezell & Diana M. Miller)

Chapter 4. Preemption Defenses (Joseph G. Petrosinelli, Ana C. Reyes & Amy Mason Saharia)

Chapter 5. Defending Class Action Lawsuits (Mark Herrmann, Pearson N. Bownas & Katherine Garceau Sobiech)

Chapter 6. Litigation in Foreign Countries Against U.S. Companies (Joseph G. Petrosinelli & Ana C. Reyes)

Chapter 7. Emerging Issues in Pharmaceutical Litigation (Allen P. Waxman, Loren H. Brown & Brooke Kim)

Chapter 8. Recent Developments in Asbestos, Talc, Silica, Tobacco, and E-Cigarette/Vaping Litigation in the U.S. and Canada (George Gigounas, Arthur Hoffmann, David Jaroslaw, Amy Pressman, Nancy Shane Rappaport, Wendy Michael, Christopher Gismondi, Stephen H. Barrett, Micah Chavin, Adam A. DeSipio, Ryan McNamara, Sean Newland, Becky Rock, Greg Sperla & Michael Lisanti)

Chapter 9. Emerging Issues in Medical Device Litigation (David R. Geiger, Richard G. Baldwin, Stephen G.W. Stich & E. Jacqueline Chávez)

Chapter 10. Emerging Issues in Automotive Product Liability Litigation (Eric P. Conn, Howard A. Fried, Thomas N. Lurie & Nina A. Rosenbach)

Chapter 11. Emerging Issues in Food Law and Litigation (Sarah L. Brew & Joelle Groshek)

Chapter 12. Regulating Cannabis Products (James H. Rotondo, Steven A. Cash & Kaitlin A. Canty)

Chapter 13. Blockchain Technology and Its Impact on Product Litigation (Justin Wales & Matt Kohen)

Chapter 14. Emerging Trends: Smart Technology and the Internet of Things (Christopher C. Hossellman & Damion M. Young)

Chapter 15. The Law of Damages in Product Liability Litigation (Evan D. Buxner & Dionne L. Koller)

Chapter 16. Using Early Case Assessments to Develop Strategy (Mark E. (Rick) Richardson)

Chapter 17. Impact of Insurance Policies (Kamil Ismail, Linda S. Woolf & Richard M. Barnes)

Chapter 18. Advantages and Disadvantages of Multidistrict Litigation (Wendy R. Fleishman)

Chapter 19. Strategies for Co-Defending Product Actions (Lem E. Montgomery III & Anna Little Morris)

Chapter 20. Crisis Management and Media Strategy (Joanne M. Gray & Nilda M. Isidro)

Chapter 21. Class Action Settlements (Richard B. Goetz, Carlos M. Lazatin & Esteban Rodriguez)

Chapter 22. Mass Tort Settlement Strategies (Richard B. Goetz & Carlos M. Lazatin)

Chapter 23. Arbitration (Beth L. Kaufman & Charles B. Updike)

Chapter 24. Privilege in a Global Product Economy (Marina G. McGuire)

Chapter 25. E-Discovery—Practical Considerations (Denise J. Talbert, John C. Vaglio, Jeremiah S. Wikler & Christy A. Pulis)

Chapter 26. Expert Evidence—Law, Strategies and Best Practices (Stephanie A. Scharf, George D. Sax, Sarah R. Marmor & Morgan G. Churma)

Chapter 27. Court-Appointed and Unconventional Expert Issues (Jonathan M. Hoffman)

Chapter 28. Statistical Evidence in Products Liability Litigation (Nathan A. Schachtman)

Chapter 29. Post-Sale Responsibilities in the United States and Foreign Countries (Kenneth Ross & George W. Soule)

Chapter 30. Role of Corporate Executives (Samuel Goldblatt & Benjamin R. Dwyer)

Chapter 31. Contacting Corporate Employees (Sharon L. Caffrey, Kenneth M. Argentieri & Rachel M. Good)

Chapter 32. Spoliation of Product Evidence (Paul E. Benson & Adam E. Witkov)

Chapter 33. Presenting Complex Scientific Evidence (Morton D. Dubin II & Nina Trovato)

Chapter 34. How to Win a Dismissal When the Plaintiff Declares Bankruptcy (Anita Hotchkiss & Earyn Edwards)

Chapter 35. Juries (Christopher C. Spencer)

Chapter 36. Preparing for the Appeal (Wendy F. Lumish & Alina Alonso Rodriguez)

Chapter 37. Global Reach: Foreign Defendants in the United States (Lisa J. Savitt)

NJ Appellate Division Calls for Do Over in Baby Powder Dust Up

May 22nd, 2021

There was quite a bit of popular media reporting of the $117 million (compensatory and punitive damages) awarded by a Middlesex County, New Jersey, jury to a man who claimed his mesothelioma had been caused by his use of baby powder. There was much less media coverage last month of the New Jersey Appellate Division’s reversal of the underlying verdicts, on grounds that the trial Judge Ana C. Viscomi had abused her discretion on several key issues.[1] The New Jersey appellate court reversed the trial court’s judgment, and remanded the Lanzo case for a new trial, in a carefully reasoned decision.[2]

Johnson & Johnson Consumer Inc. (JJCI) and Imerys Talc America, Inc. (Imerys) appealed from the judgment entered by Judge Viscomi, on April 23, 2018. The appellants lodged several points of error, but the most erroneous of the erroneous trial court decisions seemed to involve a laissez-faire attitude to weak and unreliable proffered expert witness opinions.

Judge Viscomi conducted a Rule 104 hearing on the admissibility of testing of plaintiffs’ expert witness, William Longo, on crowd-sourced samples of baby powder, without chain of custody or provenance evidence. Judge Viscomi denied the challenge to Longo’s test results.

The defense had also filed Rule 702 challenges to plaintiffs’ expert witnesses, James S. Webber, Ph.D., and Jacqueline Moline, M.D., and their opinion that non-asbestiform amphibole cleavage fragments can cause mesothelioma. Judge Viscomi refused these pre-trial motions, and refused to conduct a pre-trial Rule 104 hearing on the proffered opinions. Her Honor’s denial of the Rule 702 was accompanied with little to no reasoning, which proved to be the determinant of her abuse of discretion, and deviation from the standard of judicial care.

At trial, the defense re-asserted its objections to Moline’s opinion on cleavage fragments, but Judge Viscomi permitted Moline to testify about “non-asbestiform cleavage fragments from a medical point of view.” In other words, the trial judge gave Dr. Moline carte blanche to address causation.

Understandably, on appeal, JJCI and Imerys assigned various errors. With respect to the scientific evidence, the defendants alleged that plaintiffs’ expert witnesses (Webber and Moline) failed to:

“(1) explain what causes the human body to respond in the same way to the different mineral forms;

(2) acknowledge the contrary opinions of scientists and government agencies;

(3) provide evidentiary support for their opinion that non-asbestiform minerals can cause mesothelioma; and

(4) produce evidence that their theory that non-asbestiform minerals are harmful had been subject to peer-review and publication or was generally accepted in the scientific community.”

The Federal Fiber

The genesis of the scientific dispute lay in the evolution of the definition of asbestos itself. Historically, asbestos was an industrial term for one of six different minerals, the serpentine mineral chrysotile, and the amphibole minerals, amosite, crocidolite, tremolite, anthophyllite, and actinolite. Chrysotile is, by mineralogical definition, a serpentine mineral in fibrous form.  If not fibrous, the mineral is typically called antigorite.

For the five amphiboles, the definitional morass deepens. Amosite is, again, an industrial term, an acronym for “asbestos mines of South Africa,” although South Africa once mined chrysotile and crocidolite as well.  Amosite is an iron-rich amphibole in the cummingtonite-grunerite family, with a fibrous habit.  Cummingtonite-grunerite can be either fibrous or non-fibrous in mineral habit.

Crocidolite is an amphibole that by definition is fibrous. The same mineral, if not fibrous, is known as riebeckite. Crocidolite is, by far, the most potent cause of mesothelioma.

The remaining amphiboles, tremolite, anthophyllite, and actinolite, have the same mineralogical designation, regardless whether they occur as fibers or in non-fibrous forms.

The designation of a mineral as “asbestiform” is also rather vague, apparently conveying an industrial functionality from its fibrosity. Medically, the term asbestiform became associated with minerals that have sufficiently high aspect ratio, and small cross-sectional diameter, to be considered potentially capable of inducing pulmonary fibrosis or mesothelioma.

In 1992, the federal OSHA regulations removed non-asbestiform actinolite, tremolite, and anthophyllite from the safety standard, based upon substantial evidence that the non-asbestiform occurrences of these minerals did not present the health risks associated with asbestiform amphiboles. Because nothing is ever simple, the National Institute for Occupational Safety and Health (NIOSH) persisted in its recommendation that OSHA continue to regulate non-asbestiform amphiboles under asbestos regulatory standards. This NIOSH pronouncement, however, was extremely controversial among the ranks of NIOSH scientists. In any event, NIOSH recommendations are just that, suggestions and not binding regulations.

The mineralogical, medical, and regulatory definitions of asbestos and asbestiform minerals vary greatly, and require a great deal of discipline and precision in discussing what causes mesothelioma. The health effects of non-asbestiform minerals have been studied, however, and generally shown not to cause mesothelioma.[3]

Judge Viscomi Abused Her Discretion

The Appellate Division panel applied Accutane’s abuse of discretion standard, which permits judges to screw up to some extent, but requires reversal for their mistakes when “so wide off the mark that a manifest denial of justice resulted.” The appellate court had little difficulty in saying that the trial court was “so wide off the mark” in addressing expert witness opinion admissibility.

James Webber

In the Lanzo case, plaintiffs’ expert witnesses, James Webber and Jacqueline Moline, both opined that non-asbestiform minerals can cause mesothelioma. The gravamen of the defense’s appeal was that these expert witnesses had failed to support their opinions and that the trial judge had misapplied the established judicial gatekeeping procedures required by the New Jersey Supreme Court, in In re Accutane Litigation, 234 N.J. 340 (2018).

The Appellate Division then set out to do what Judge Viscomi had failed to do – look at the proffered opinions and assess whether they followed reasonably and reliably from the expert witnesses’ stated grounds. Although Webber opined that cleavage fragments could cause mesothelioma, he had never studied the issue himself; nor was he aware of any studies showing that showed that non-asbestiform cleavage fragments can cause mesothelioma. Webber had never expressed his opinion in scientific publications, and he failed to cite any support for his opinion in his report.

At trial, Judge Viscomi permitted Webber to go beyond his anemic report and to cite reliance upon four sources for his opinion. The Appellate Division carefully reviewed each of the four sources, and found that they either did not support Webber’s opinions or they were as equally without evidentiary support. “Webber did not identify any data underlying his opinion. Further, he did not demonstrate that any of the authorities he relied on would be reasonably relied on by other experts in his field to reach an opinion regarding causation.”

Webber cited an article by Victor Roggli, who opined that he had found asbestiform and non-asbestiform fibers in the lungs of mesothelioma patients, but who went on to conclude that fibers were the likely cause. Webber also cited an article by NIOSH scientist Martin Harper, who stated the opinion, without evidentiary support that NIOSH did not believe, in 2008, that there was “sufficient evidence for a different toxicity for non-asbestiform amphibole particles that meet the morphological criteria for a fiber.”[4]

Although Harper and company appeared to be speaking on behalf of NIOSH, in 2011, the agency clarified its position to state that its previous inclusion of non-asbestiform minerals in the definition of respirable asbestos fibers had been based upon “inclusive science”:

“Epidemiological evidence clearly indicates a causal relationship between exposure to fibers from the asbestos minerals and various adverse health outcomes, including asbestosis, lung cancer, and mesothelioma. However, NIOSH has viewed as inconclusive the results from epidemiological studies of workers exposed to EMPs[9] [elongate mineral particles] from the non[-]asbestiform analogs of the asbestos minerals.”[5]

The Appellate Division was equally unimpressed with Webber’s citation of a geologist who stated an opinion in 2009, that “using the term ‘asbestiform’ to differentiate a hazardous from a non-hazardous substance has no foundational basis in the medical sciences.” Not only was the geologist, Gregory P. Meeker, lacking in medical expertise, but his article was non-peer-reviewed (for what little good that would have done) and his opinion did not cite any foundational evidence or data in an appropriate scientific study.

Webber cited to an Environmental Protection Agency (EPA) document,[6] which stated that

“[f]or the purposes of public health assessment and protection, [the] EPA makes no distinction between fibers and cleavage fragments of comparable chemical composition, size, and shape.”

The Appellate Division observed that the EPA not provide any scientific support for its assessment. Furthermore, the language cited by Webber clearly suggests that the EPA was issuing a precautionary view, not a scientific one.

Considering the Daubert factors, and New Jersey precedent, the Appellate Division readily found that Webber’s opinion was inadmissible. His opinion about non-asbestiform minerals was unsupported by data and analysis in published, peer-reviewed studies; the opinion was clearly not generally accepted; and the opinion had never been published by Webber himself. Plaintiffs had failed to show that Webber’s “methodology involv[ed] data and information of the type reasonably relied on by experts in the scientific field.”[7] The trial court’s observation that the issue of cleavage fragments was “contested” could not substitute for the required assessment of methodology and of the underlying data relied upon by Webber. Judge Viscomi abused her discretion in admitting Webber’s testimony.

Jacqueline Moline

Moline’s expert testimony that non-asbestiform minerals can cause mesothelioma suffered from many of the same defects as Webber’s opinion on this topic. The trial court once again did not conduct a pre-trial or in-trial hearing to assess Moline’s opinion, and it did not perform the rigorous assessment required by Rule 702 and the Accutane case to determine whether Moline’s opinions met the applicable (so-called Daubert) standards. The Appellate Division emphatically held that the trial court erred in permitting Moline to testify, over objection.

Moline vacuously opined that non-asbestiform amphiboles cause mesothelioma, but failed to identify any specific studies that actually supported this proposition. Like Webber, she pointed to an EPA document, from 2006, which also failed to support her asseverations. Moline also claimed support from the CDC, the American Thoracic Society, and other EPA pronouncements, but never cited anything specifically. In her pre-trial report, Moline claimed that New York state talc minerals experienced mesotheliomas from exposure to the mining and milling of talc that contained about “50% non-asbestiform anthophyllite and tremolite.” Moline’s report, however, was devoid of any reference for this remarkable claim.

Moline’s trial testimony was embarrassed on cross-examination when the defense confronted her with prior testimony she gave in another case, in which she testified that she lacked “information … one way or the other” say whether non-asbestiform minerals were carcinogenic. Moline shrugged off the impeachment with a claim that she had since come to learn of mesothelioma occurrences among patients with non-asbestiform mineral exposures. Nonetheless, Moline still could not identify the studies she relied upon to answer the question whether “asbestos-related diseases can be caused by the non-asbestiform varieties of the six regulated forms of asbestos.”

Reversal and Remand

Having concluded that the trial court erred and abused its discretion in denying the defense motions contra Webber and Moline, and having found that the error was harmful to the defense’s right to a fair trial, the appellate court reversed and remanded for new (separate) trials against JJCI and Imerys. There will be, no doubt, attempts to persuade the New Jersey Supreme Court to consider the issues further. The state Supreme Court’s jurisdiction is discretionary, and assuming that the high Court rejects petitions for certification, the case will return to the Middlesex County trial court. The intended nature of further trial court proceedings is, at best, a muddle. The Appellate Division has already done what Judge Viscomi failed to do. The three-judge panel carefully reviewed the plaintiffs’ proffered opinion testimony on causation and found it inadmissible. It would thus seem that the order of business would be for the defense to file motions for summary judgment for lack of admissible causation opinions, and for the trial court to enter judgment for the defense.

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[1] To be fair, there was some coverage in local, and in financial and legal media. See, e.g., Jef Feeley, “J&J Gets Banker’s $117 Million Talc Verdict Tossed on Appeal,” (April 28, 2021); Mike Deak, “Appeals court overturns $117 million Johnson & Johnson baby powder verdict,” My Central Jersey (April 28, 2021); “J&J, Imerys Beat $117M Talc Verdicts Over Flawed Testimony,” Law360 (April 28, 2021); Irvin Jackson, “$117M J&J Talc Cancer Verdict Overturned By New Jersey Appeals Court,” About Lawsuits (April 30, 2021).

[2] See Lanzo v. Cyprus Amax Minerals Co., Docket Nos. A-5711-17, A-5717-17, New Jersey Superior Court, App. Div. (April 28, 2021).

[3] SeeIngham v. Johnson & Johnson – A Case of Meretricious Mensuration?” (July 3, 2020); “ Tremolitic Tergiversation or Ex-PIRG-Gation?” (Aug. 11, 2018).

[4] “Differentiating Non-Asbestiform Amphibole and Amphibole Asbestos by Size Characteristics,” 5 J. Occup. & Envt’l Hygiene 761 (2008).

[5] NIOSH, “Asbestos Fibers and Other Elongate Mineral Particles: State of the Science and Roadmap for Research,” Current Intelligence Bulletin 62 (April 2011).

[6] The document in question was issued in 2006, by EPA Region 9, in response to a report prepared by R.J. Lee Group, Inc. The regional office of the EPA criticized the R.J. Lee report for applying “a [g]eologic [d]efinition rather than a [p]ublic [h]ealth [d]efinition to [c]haracterize [m]icroscopic [s]tructures,” noting that the EPA made “no distinction between fibers and cleavage fragments of comparable chemical composition, size, and shape.” This document thus did not address, with credible evidence, the key issue in the Lanzo case.

[7] Lanzo (quoting Rubanick, 125 N.J. at 449).

Disqualifying Expert Witnesses for Conflicts of Interest

March 30th, 2021

Some notes on vexing issue, which fortunately has never serious issue for me. I do recall a former partner, who with great exuberance, called every potential expert witness and then felt hurt when some of them showed up as trial witnesses on the other side. Of course, these turncoats bragged of having been approached by, and having rejected work for, the defense.

Side Switching

Opportunism or carelessness can sometimes affect expert witness retention in a way that results in “side switching.” Some lawyers may think it wonderful to snag the other side’s expert witness, who comes with a credibility credit for having been first identified by the other side. Although no rule or statute prohibits side switching, state and federal courts have exercised what they have called an inherent power to supervise and control ethical breaches by lawyers and expert witnesses.[1]

The Wang Test

Although certainly not the first case on side-switching, the decision of a federal trial court, in Wang Laboratories, Inc. v Toshiba Corp., has become a key precedent on disqualification of expert witnesses.[2] The test spelled out in the Wang case has generally been followed in federal courts,[3] as well as in state courts.[4] Given that most of the side-switching cases are quite fact sensitive, it is instructive to detail the facts that lead to an expert witness’s disqualification in this frequently cited case.

The Wang case, as far disqualification is concerned, began with a telephone call from Wang’s lawyer to a computer consultant. From Wang’s lawyer’s perspective, the call resulted in “retention.” The consultant denied that he was retained; as far as he was concerned, he agreed only to examine the patents at issue in the litigation, and to serve as an expert witness only if he were convinced of the patents’ validity.

After their telephone conference, Wang’s lawyer sent the consultant copies of the disputed patents, some materials suggesting an infringement, and the lawyer’s memorandum discussing the history of the prosecution of the patents. A short while later, the lawyer sent another memorandum, labeled “Confidential Attorney-Work Product,” which discussed potential defenses in the suit.

After providing these written materials, Wang’s lawyer had further conversations with the consultant about technical aspects of the case, and disclosed additional confidential information. The lawyer recounted that he had told the consultant that the conversations were confidential. The consultant denied receipt of any confidential information, and stated that he had not referred to the confidential memorandum because he had first to determine the validity of the patent. Working at a preliminary, investigatory stage, the consultant did not see himself as retained unless and until he concluded that the patents were valid.

Upon completed his preliminary investigation, the consultant concluded that the patents were not valid. The consultant informed Wang’s lawyer of his conclusion, and his decision to decline serving as an expert witness for Wang. Wang’s lawyer requested a short report from the consultant, who sent the requested report, which documented that he had read the patents and the “Work-Product” information.

After this interaction between Wang and the consultant, one of Wang’s adversaries, NEC approached the consultant and retained him as an expert witness. When NEC designated the consultant as an expert witness to be called at trial, Wang moved promptly to disqualify the consultant.

The Wang court recognized that if a retained expert witness receives confidential information and then switches sides, he or she is out. In Wang, both retention and receipt of confidential information were contested. The court held that both conditions were required for disqualification. Hence we have the two-prong Wang Test:

  1. A Confidential Relationship. This prong requires an inquiry into whether the party that claimed to have made the retention was objectively reasonable in concluding that a confidential relationship had been created between the party and the consultant. This fact-sensitive inquiry will typically turn on all the facts and circumstances surrounding the lawyer-consultant interaction, such as:
  • an agreement that contemplates sharing of confidential materials,
  • the lawyer’s having provided the consultant with confidential documents,
  • the existence of an agreement about retention,
  • the extent of the lawyer-consultant communications and meetings,
  • the payment of consideration for the consultant’s work, and
  • the extent of the consultant’s work and whether he or she formed any opinions about the issues in the case
  1. Secrets Shared. The second Wang prong inquires into whether confidential or privileged material had been shared with the consultant. The sharing of such information is evidence of a confidential relationship, but it is also required as an independent basis to satisfy the Wang court’s test. One party’s secret is another party’s commonplace, and the moving party must show that:
  • the information in question was specifically related to the case,
  • the information was privileged or confidential,
  • the information was not evidence that would have been discovered inevitably by the adversary, independent of the consultant’s side-switching
  • the information was not purely technical or otherwise in the public domain

In Wang, as in many similar cases, the lawyer and the consultant gave rather wildly inconsistent accounts of their interactions. The disputatious nature of disqualification motions is sadly all too common. The burden of proving both prongs of the Wang test is on the moving party, and in the Wang case, the court found that Wang’s lawyer had prevailed on both prongs. The consultant was disqualified.

The Wang two-prong test is the majority rule; both prongs must be satisfied. A minority of courts have disqualified expert witnesses “even if no disclosures occur,” in the name of the judicial process integrity.[5]

Public Policy Limits on Wang

Although the Wang test is sometimes characterized as a “bright-line” test, the Wang court itself was sensitive to potential abuse by lawyers who wished to silence certain expert witnesses by creating what appears to be a confidential relationship without actually sharing confidential information. After Wang, some courts moved beyond the two-part test to consider the policy implications of the requested disqualification.[6] Some of the policy considerations that have been advanced and been factored into judicial decisions whether to disqualify an expert witness include:

  • protecting freedom of contract, and the consultant’s right to pursue a livelihood,
  • preventing “sham” retentions to set up later disqualification, especially when there is a limited availability of qualified expert witnesses on the issues, and
  • preventing prejudice to the innocent second party that approached the consultant.

Procedural Issues

Burden of Proof. The case law clearly places the burden of proving the elements of disqualification on the moving party.

Timeliness of Objections. The case law also makes clear that a party must move promptly to object to an expert witness’s conflict of interest.[7]

Not the same product, but similar product, in a later case

When the expert witness in question testified for an adversary in a different case, the analysis of confidential aspect of the shared information becomes more difficult.

Mass Tort Cases

In mass tort cases, many individual plaintiffs have typically sued a single or limited group of defendants. Such litigation can take decades to resolve, or may even become a perpetual motion litigation machine, such as asbestos personal injury cases. Such litigation creates a great need for expert witnesses on various topics, and the duration of the litigation may lead to innocent or deliberate recruitment of the other side’s former expert witnesses.

In one Fen-Phen case, one plaintiff sought to retain an expert witness previously retained by Wyeth to testify about the same diet drug (fenfluramine) in a case brought by a different plaintiff. The trial court readily concluded that there was clear overlap, with sufficient evidence that Wyeth had shared its confidential case strategies and confidential information related to the same drug.[8]

In some instances of side switching, the allegedly defective product may have been similar but not the same. Determining how much overlap makes the sharing harmful of confidential information has proceeded on a case-by-case basis. One thing, however, is clear: there is no overarching duty of loyalty. In one case, a federal court allowed expert witnesses to testify for and against the same defendant in concurrent patent litigation.[9] The court reasoned that the expert witnesses’ testimony in each case addressed only the specific, different patents in the case, and there was no overall sharing of general litigation strategy common to both cases. The testimony in each case did not overlap with the testimony in the other case. The challenge failed to show that confidences were shared that affected both cases.

One New Jersey appellate court upheld the disqualification of an expert witness who had worked for the State of New Jersey on a case that involved confidential disclosures by the State’s lawyers and its agencies, which disclosures were necessarily involved in the expert witness’s subsequent retention by the State’s adversary in a different case.[10] This decision, like most in this area, turned on a close analysis of the facts and circumstances of the retentions and consultations of the expert witness.

Practice Considerations

Obviously, lawyers must research consultants before approaching them. After making contact with a consultant, it is incumbent upon counsel to ask the consultant specifically about past and current engagements and any confidentiality limitations.[11]

Lawyers should clearly communicate their intention to create a confidential relationship that will permit candid exchange of views and information; consultants should similarly express their reservations and doubts about entering into such the proposed working relationship.[12]

In entertaining motions for disqualification, courts generally want to see confirmation of retention in writing.[13] Such writings should recite agreements on fees, billing, payment, as well as an explanation of the nature of the consulting relationship and the anticipation of shared confidences. Some commentators have suggested, imprudently in my view, that the agreement specifically prohibit side switching.

After the consultancy has begun, lawyers should clearly label their work-product communications. The 2010 amendments to the Federal Rules of Civil Procedure protect such communications from discovery in the litigation process.[14] The 2010 amendments did not, however, protect communications relating to compensation, or the lawyer’s identification of facts or data, which the expert witness then considered in forming opinions, or the lawyer’s identification of assumptions to be made by the expert witness in reaching opinions.[15]  Lawyers must exercise great care in navigating the relevant state and federal rules to protect their work-product that has been shared with expert witnesses who will be disclosed as trial witnesses.

Role and Relationship Conflict

Managerial Employees

A company’s former executives or former high-level employees who had access to internal, deliberative and confidential communications, such as communications with legal counsel, are off limits to an adversary that wishes to engage the former employees as expert witnesses in litigation involving the confidences.

Treating Physicians

Treating physicians act in a role of sharing confidences and trust with their patients. Generally, courts have disallowed parties from engaging physicians as expert witnesses in litigation against the physicians’ patients. In mass tort litigation, however, courts have been willing to permit physicians to serve as expert witnesses, even when some of their patients are plaintiffs, as long as they serve as expert witnesses only in cases brought by non-patients.

Physicians frequently have important factual testimony that bears on litigation, and courts have rejected disqualification of physicians as fact witnesses. In Ngo v. Standard Tools & Equip. Co., Inc., 197 F.R.D. 263 (D. Md. 2000), the court rejected plaintiff’s attempt to disqualify his own treating physician as a defense witness. The plaintiff claimed that he and his counsel had engaged the physician as an expert witness, but the court found that no confidential relationship had been formed. The physician was allowed to testify as a fact witness for the defense. It would be extremely unlikely that an engagement of the physician as a consulting expert witness would have prevented the adverse party from calling the physician as a fact witness, in any event.

Treating Psychotherapists

The psychotherapy-patient relationship is one in which the very nature of the relationship may disqualify the psychotherapist from acting as an expert witness in support of a patient’s claim. The psychiatric profession generally recognizes that providing therapy to a patient and forensic services in support of the patient’s legal claims can adversely affect the therapeutic relationship and impair the therapist’s objectivity as an expert witness.[16] Interestingly, there is not much case law on this potential source of disqualification. In one uncelebrated case, a motion to disqualify a treating psychiatrist from serving as an expert witness was filed, but the case was dismissed on other grounds.[17]

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[1] Grant Thornton, LLP v. Fed. Deposit lnsur. Corp., 297 F. Supp. 2d 880, 881-82 (S.D. W.Va. 2004); Wang Lab., lnc. v. Toshiba Corp., 762 F. Supp. 1246, 1248 (E.D. Va. 1991) (“protect the integrity of the adversary process and promote public confidence in the fairness and integrity of the legal process”).

[2] 762 F. Supp. 1246 (E.D. Va. 1991); see also Vershuta, “New Rules of War in the Battle of the Experts: Amending the Expert Witness Disqualification Test for Conflicts of Interest,” 81 Brooklyn L. Rev. 733 (2016); Brian Hooven, “The Science Behind Expert Disqualification: A Guide,” 12 Expert Witnesses 13 (Fall 2016); Lynne Bernabei, Matthew Radler & Lauren R. S. Mendonsa “Ethical Duties and Standards in Disqualifying, Retaining, and Communicating with Expert Witnesses,” 43 Brief 1 (2013); Maya M. Eckstein & Paul Nyffeler, “The Expert of My Enemy Is My Expert: Conflicts of Interests Amongst Expert Witnesses,” 17 Litig. News 1 (Summer 2012); Douglas R. Widin & Francis J. Maloney III, “Conflicts of Interest and Litigation Experts,” chap. 4, in Cynthia H. Cwik, ed., Scientific Evidence Review: Current Issues at the Crossroads of Science, Technology and the Law, Monograph No. 7 (2006); Cathy Altman & Dena Denooyer Stroh, “Keeping It Confidential: Disqualifying Experts,” Commerical & Bus. Litig. J. 10 (Spring 2005); Kendall Coffey, “Inherent judicial Authority and the Expert Disqualification Doctrine,” 56 Fla. L. Rev. 195 (2004); Douglas R. Richmond, “Regulating Expert Testimony,” 62 Mo. L. Rev. 485 (1997).

[3] See, e.g., Greene, Tweed of Delaware, Inc. v. DuPont Dow Elastomers, LLC, 202 F.R.D. 426, 429 (E.D. Pa. 2001); In re Orthopedic Bone Screw Prod. Liab. Litig., 1995 U.S. Dist. LEXIS 21526 at *8 (E.D. Pa. 1995); Hewlett-Packard Co. v. EMC Corp., 330 F. Supp. 2d 1087, 1092-093 (N.D. Cal. 2004); Crenshawv. Mony Life Ins. Co., 318 F. Supp. 2d 1015, 1026 (S.D. Cal. 2004); Syngenta Seeds, Inc. v. Monsanto Co., 2004 WL 2223252 at *2, No. 02-1331-SLR (D. Del Sept. 27, 2004); Mays v. Reassure America Life Ins. Co., 293 F. Supp. 2d 954, 957 (E.D. Ark. 2003); Cordy v. Sherwin-Williams Co., 156 F.RD. 575, 580 (D.N.J. 1994); English Feedlot, Inc. v. Norden Lab., Inc., 833 F. Supp. 1498, 1452 (D. Colo. 1993).

[4] See, e.g., Mitchell v. Wilmore, 981 P.2d 172, 175 (Colo. 1999); Formosa Plastics Corp., U.S.A. v. Kajima Internat’l, Inc., 2004 WL 2534207 at *2 (Tex. Ct. App. Nov. 10, 2004), rev. denied, 15 S.W.3d 289 (Tex. 2004); Turner v. Thiel, 553 S.E.2d 765, 768 (Va. 2001).

[5] City of Springfield v. RHI Holdings, Inc., 111 F. Supp. 2d 71, 74 (D. Mass. 2000).

[6] See, e.g., Cordy v. Sherwin-Williams Co., 156 F.R.D. 575 (D.N.J. 1994).

[7] See Popular, Inc. v. Popular Staffing Services. Corp., 239 F. Supp. 2d 150, 153 (D. Puerto Rico 2003).

[8] Righetti v. Wyeth, Inc., No. 07-20144, 2009 WL 1886131 (E.D. Pa. 2009). See also Rhodes v. E.I. Du Pont De Nemours & Co., 558 F. Supp. 2d 660 (2008).

[9] Bone Care Internat’l, LLC v. Pentech Pharms, Inc., 2009 WL 249386, at *2–3 (N.D. Ill. Feb. 2, 2009).

[10] Conforti & Eisele, Inc. v. Div. of Bldg. & Constr., 405 A.2d 487 (N.J. Super. Ct., L. Div. 1979) (noting that the court’s “decision should in no way be read to indicate that an expert who has traditionally been hired by one attorney in a particular type of litigation would be precluded from offering his services to that particular attorney’s adversary in an unrelated matter”).

[11] English Feedlot, Inc. v. Norden Lab., Inc., 833 F. Supp. 1498, 1505 (D. Colo. 1993) (“[C)ounsel seeking to retain a consultant should inquire specifically whether the consultant’s past employment presents any confidentiality roblems.”).

[12] Wang Lab., lnc. v. Toshiba Corp., 762 F. Supp. 1246, 1246, 1248-49 (E.D. Va. 1991) (noting that fairness require that lawyers bear a burden to communicate to consultants that they desire and intend to create a confidential relationship, and that consultants express their doubts unequivocally and decline any disclosures until their doubts are resolved).

[13] See, e.g., id. at 1249-50; Syngenta Seeds, Inc. v. Monsanto Co., 2004 WL 2223252 at *2 (D. Del. Sept. 27, 2004); See also Hewlett-Packard Co. v. EMC Corp., 330 F. Supp. 2d 1087, 1091 (N.D. Cal. 2004) (discussing the practical importance of written retention agreements).

[14] Fed. R. Civ. P. 26(b)(4)(B), (C).

[15] Fed. R. Civ. P. 26(b)(4)(C)(i)-(iii).

[16] Psychiatrists’ Program, “Can a Treating Psychiatrist Double As Expert Witness for Same Patient?” 39 Psychiatric News at 16 (Aug. 20, 2004); “Assuming Conflicting Roles Can Be Risky,” 36 Psychiatric News at 25 (Oct. 19, 2001); see also Larry H. Strasburger, Thomas G. Gutheil & Archie Brodsky, “On Wearing Two Hats: Role Conflict in Serving as Both Psychotherapist and Expert Witness,” 154 Am. J. Psychiatry 448 (1997).

[17] Conant v. Tru-Test Manufacturing Co., N.J. Law Div., Burlington Cty. No. L-03214-97 (Oct. 25, 2002).

The Misplaced Focus of Enterprise Liability on the Wrong Enterprise

March 27th, 2021

Well, soon the pandemic of Trump Flu will come to a close.  In the future, children too young or born after the pandemic will ask, “where were you during the pandemic, and what did you do?”

For lawyers, trials adjourned and courtrooms went dark, although discovery and motion practice continued. With some free time, I thought it a good time to write about the mess that American tort law has made of employer responsibility in product liability law. And the time seemed right because the Supreme Court had only recently provided a fascinating case study in how out of touch some courts can be with the realities of workplace injuries. The recent decision in DeVries v. Air & Liquid Systems Corp., 139 S.Ct. 986 (2019), was a perfect canvas on which to sketch out tort law’s failure to come to grips with the three-way relationship among industrial product seller, sophisticated industrial or military purchasers and employers, and injured plaintiffs.[1]

Many commentators might have viewed the justices who squared off in DeVries, Kavanaugh for the majority, Gorsuch for the dissent, as cut from the same judicial cloth, but their two opinions diverged in interesting ways. The entire court, however, shared a frail and faulty understanding of the role of third-party employers and product purchasers in providing a safe workplace. Not surprisingly, both the majority and dissenting opinions failed to do justice to the depth of Navy knowledge of the hazards of asbestos, Navy control over the workplace, and the futility of warning of asbestos exposure to the Navy, which had superior knowledge of both general asbestos hazards, the specific conditions it created, and the methods needed to protect its workers and sailors.

The failings of scholarship and analysis in DeVries have a bigger context.[2] The role of third parties – sophisticated intermediaries – received careful consideration in the First and Second Restatements of Torts, in Section 388 and its comments.[3] The Third Restatement continued to endorse this important defense, based upon the practical and sensible limits of liability, but placed the relevant discussion in a hard-to-find comment to a very broad, general section:

“5. The Restatement, Second, of Torts § 388, Comment n, utilizes the same factors set forth in Comment i in deciding whether a warning should be given directly to third persons. It has been relied on by numerous courts. See, e.g., Goodbar v. Whitehead Bros., 591 F. Supp. 552 (W.D.Va.1984), aff’d sub nom. Beale v. Hardy, 769 F.2d 213 (4th Cir.1985) (applying Virginia law)… .”[4]

At least these celebrated sophisticated intermediary defense cases were cited by the Third Restatement, in a comment. Many current tort textbooks fail to mention the defense at all.[5] Tort theorists stress the importance of the boundaries between consumers and industrial enterprises, but ignore the frequent setting in which the purchaser is itself an industrial enterprise, and has independent legal and regulatory duties to provide safe workplaces with the products at issue.[6] Highly sensitive to the need to protect ordinary consumers from the predations of large manufacturing companies, many tort theorists are insensate to the need to protect manufacturers-sellers from the predations of large employing purchasing corporations upon the purchasers’ employees.[7]

Many scholars have written about the United States government’s historical knowledge of asbestos dangers,[8] but without any sense of outrage or concern, such as you might find in the purple prose of Paul Brodeur.[9] Although Brodeur did ever so slightly touch upon lawsuits against the United States government for conditions in Naval shipyards and elsewhere, he quoted with seeming approval the comments by Captain George M. Lawton, given in a 1979 interview. When asked whether the Navy was responsible for workplace conditions at the Navy’s Electric Boat shipyard, Lawton flippantly shrugged off the suggestion with the observation:

“If I order an automobile and the way they make automobiles is to throw people into a furnace, I am not responsible for that.”[10]

Brodeur, who was quick to judge the asbestos product manufacturers, fails to note that it was Captain Lawton’s Navy that was throwing people in furnace at its Navy yards around the country. Similarly, asbestos plaintiffs’ expert witness, Barry Castleman, who had written a trial manual for plaintiffs’ lawyers based upon distorted assessment of individual companies’ historical involvement with asbestos, spends no time investigating the huge record of United States governmental knowledge of asbestos use.[11] Castleman, schooled by the lawsuit industry lawyers, understood that documenting the knowledge of the intermediary, product purchaser, and workplace owner, detracts from the David-and-Goliath narrative his retaining counsel needed to prevail in litigation. Writers such as Brodeur and Castleman are fond of citing historical writings of governmental health agencies for claims of health hazards. Captain Lawton’s Navy was, of course, possessed and was bound by the knowledge of those very same public health agencies.[12]

In the mid-1970’s, amidst economic turmoil, and declining military budgets, the United States Navy found itself with a big problem. Payments to civilians under the FECA (Federal Employees’ Compensation Act), a statute that gives civilian employees of shipyards the equivalent of workers’ compensation benefits, came right out of the Navy’s budget for shipbuilding. The Navy had no insurance for FECA payments, and suddenly it found itself facing a large uptick in the number of claims made by civilians for asbestos-related injuries. About the same time, many states adopted some version of strict product liability, some stricter than others. None was likely stricter than Pennsylvania’s version, which made referring to employer responsibility virtually impossible. Ultimately, the plaintiffs’ bar found that strict liability recoveries and settlements were too certain to encumber themselves and their clients with government liens, and they stopped filing their FECA cases altogether.

When I first started practicing “asbestos law,” I routinely found copies of letters from JAG lawyers to shipyard workers, in their personnel files. The letters notified the workers that they had been diagnosed with asbestosis, usually by a local pulmonary physician who performed contract services for surveillance for the shipyard. (These diagnosing physicians went on to make fortunes by serving as expert witnesses in subsequent civil litigation.) The letters notified the workers that they might have rights under FECA, but emphasized that the workers had remedies against the Navy’s vendors of asbestos-containing products, and that if they sued in tort, the Navy would have a lien against any recovery. In practice, the lien was so unwieldy, that most of the Philadelphia plaintiffs’ firms would forego filing the FECA claim altogether. Thus the Navy effectively limited its liability, and kept its munitions budgets intact, while dozens of its vendors went bankrupt. The cruel irony of the FECA (or workers’ compensation) statutes is that the employer pays regardless of fault, that the employer can’t be sued in civil actions, and that the employer can recover ~80% of its payments from settlements or judgment proceeds from a civil defendant.

The government’s role in fueling the explosion of asbestos civil actions has not received very much, if any, real scrutiny. What a story is hidden away in those old files! Not only did the Navy know of the asbestos hazards, hide them from its civilian workers, but when those workers got sick, the Navy turned on its outside suppliers by encouraging its workers to sue the suppliers, while hiding behind the exclusive remedy provision of the FECA.

The story of the Navy’s misdeeds, misrepresentations, and misinformation has been told, in bits and pieces, here and there. What was needed back in the 1980s was someone who could write a thorough documentary history of the Navy’s predations upon its employees and its sailors. There is a trove of materials from before World War II, but increasing dramatically with the wartime efforts of Dr. Philip Drinker to obtain safe asbestos workplaces for both workers both at contract and naval shipyards.

In the postwar period, Navy culpability became even clearer. In 1957, for instance, more than a decade after Drinker’s investigations and reports of asbestos safety hazards, the Navy held a Conference of Pipe and Copper Shop Master Mechanics, at the Boston Naval Shipyard, on May 8 -10. Representatives from every naval shipyard, as well as the Bureau of Ships, and Commander Simpson, were present. A master pipefitter, O.W. Meeker, visiting from Shop 56, Long Beach Naval Shipyard, presented on “Pipe Insulation Processes and Procedures.” Notwithstanding confusion between asbestosis and silicosis, and between asbestos and silica, Mr. Meeker’s remarks speak volumes about the government’s role in the “asbestos mess”:

“The asbestos which we use is a mineral as much as is the rock in which it is found. Furthermore, its principal ingredient is silicon, which is responsible for the disease which we know as silicosis [sic].

Asbestos, silicosis, is caused by prolonged breathing of silica dust [sic]. Asbestos, when handled dry, produces vast amounts of silica dust. In new applications the material can be dampened to reduce the amount of dust liberated. However, the specified type of amosite for use on cold water piping is water repellent. Also material which must be removed from an existing installation is dry and powdery, being an excellent dustproducer.

The most apparent symptom of asbestosis is lethargy or a lack of vitality. What we suspect to be lead in the posterior might well be asbestos in the lungs. During 1956, 11 deaths from asbestosis were reported on the Pacific Coast alone. One insulator died of asbestosis at the age of 29.

Asbestosis is extremely difficult to detect – particularly at the early stages. I know that two of my insulators are afflicted with this condition. How many more will become afflicted is something which I hesitate to predict. Again, the solution is obvious. Remove the cause by substituting other products such as Armaflex or StaFoam for asbestos whenever possible. However, this will take some doing.

In the meantime, the answer is wearing of respirators by all who handle asbestos products. To many the very idea of wearing respirator is repugnant. However, a respirator on the face is preferable to asbestos in the lungs.

Therefore, gentlemen, ours definitely is the important and difficult task of providing and installing effective insulating materials aboard Naval Vessels. Moreover, this task must be accomplished without sacrificing our workmen in the process.”

Tort law and history itself have been distorted by the law’s focus on manufacturing defendants as deep pockets simply because the purchasing enterprises have had immunity from civil liability.

———————————————————————————-

[1]  Schachtman, “Products Liability Law – Lessons from the Military and Industrial Contexts,” 13 J. Tort Law 303 (2020).

[2]  “Asbestos and Asbestos Litigation Are Forever” (Sept. 16, 2014).

[3]  Restatement (First) of Torts § 388, comment 1 (1934); Restatement (Second) of Torts § 388, comment n (1965).

[4]  Restatement (Third) of Torts: Products Liability § 2 Categories of Product Defect (1998), Comment i. Inadequate instructions or warnings.

[5] See, e.g., John C. P. Goldberg & Benjamin C. Zipursky, The Oxford Introductions to U.S. Law: Torts (2010); Anita Bernstein, Questions & Answers: Torts (3d ed. 2014); Saul Levmore & Catherine M. Sharkey, Foundations of Tort Law (2d ed. 2011); Mark A. Geistfeld, Principles of Products Liability (2006). But see John L. Diamond, Lawrence C. Levine, and Anita Bernstein, Understanding Torts 392 (6th ed. 2018) (citing Taylor v. American Chem. Council, 576 F.3d 16, 25 (1st Cir. 2009) (applying Massachusetts law, and affirming summary judgment for defendant PVC trade association on failure-to-warn claim, on ground that the plaintiff’s employer was a sophisticated use and well aware of the danger).

[6]  See, e.g., Gregory C. Keating, “Products Liability As Enterprise Liability,” 10 J. Tort Law 41, 60 (2017).

[7] Thomas H. Koenig & Michael L. Rustad, In Defense of Tort Law 2 (2001); Stephen R. Perry, “The Moral Foundations of Tort Law,” 77 Iowa L. Rev. 449 (1992).

[8] George M. Lawton & Paul J. Snyder, “Occupational Health Programs in United States Naval Shipyards,” 11 Envt’l Res. 162 (1976); Peter A. Nowinski, “Chronology of Asbestos Regulation in United States Workplaces,” in Karen Antman & Joseph Aisner, eds., Asbestos-Related Malignancy 99 (1986) (Nowinski represented the government in direct lawsuits against the United States for its role in creating the asbestos hazards of federal and contract shipyards); Jacqueline Karnell Corn & Jennifer Stan, “Historical Perspective on Asbestos: Policies and Protective Measures in World War II Shipbuilding,” 11 Am. J. Indus. Med. 359 (1987); Statement of Linda G. Morra, Associate Director Human Resources Division, on behalf of the United States General Accounting Office, “The Status of Asbestos Claims Against The Federal Government”; before the House Committee on the Judiciary, Subcommittee on Administrative Law and Governmental Relations (June 30, 1988); Samuel A. Forman, “U.S. Navy Shipyard Occupational Medicine Through World War II,” 30 J. Occup. Med. 28 (1988); Susan L. Barna, “Abandoning Ship: Government Liability for Shipyard Asbestos Exposures,” 67 New York Univ. L. Rev. 1034 (1992);  Kenneth W. Fisher, “Asbestos: Examining the Shipyard’s Responsibility: An examination of relevant U.S. archives from the 1930s through the 1980s” (2001); Denis H. Rushworth, “The Navy and Asbestos Thermal Insulation,” Naval Engineers J. 35 (Spring 2005); Danielle M. Dell, Bruce K. Bohnker, John G. Muller, Alan F. Philippi, Francesca K. Litow, W. Garry Rudolph, Jose E. Hernandez, David A. Hiland, “Navy Asbestos Medical Surveillance Program 1990–1999: Demographic Features and Trends in Abnormal Radiographic Findings,” 8 Military Med. 717 (2006); John L. Henshaw, Shannon H. Gaffney, Amy K. Madl & Dennis J. Paustenbach, “The Employer’s Responsibility to Maintain a Safe and Healthful Work Environment: An Historical Review of Societal Expectations and Industrial Practices,” 19 Employee Responsibilities & Rights J. 173 (2007); Kara Franke & Dennis Paustenbach, “Government and Navy knowledge regarding health hazards of Asbestos: A state of the science evaluation (1900 to 1970),” 23(S3) Inhalation Toxicology 1 (2011).

[9]  Paul Brodeur, Outrageous Misconduct: The Asbestos Industry on Trial (1985).

[10]  Id. at 251 (quoting Lawton’s interview published in Connecticut Magazine, in 1979).

[11]  Barry I. Castleman, Asbestos: Medical and Legal Aspects (1984).

[12]  See Miller v. Diamond Shamrock Co., 275 F.3d 414, 422-23 (5th Cir. 2001) (“There can be no reasonable dispute that knowledge possessed by the United States Public Health Service, … [and] the Navy’s Bureau of Medicine and Surgery is the knowledge of the military.”).

Cancel Causation

March 9th, 2021

The Subversion of Causation into Normative Feelings

The late Professor Margaret Berger argued for the abandonment of general causation, or cause-in-fact, as an element of tort claims under the law.[1] Her antipathy to the requirement of showing causation ultimately involved her deprecating efforts to inject due scientific care in gatekeeping of causation opinions. After a long, distinguished career as a law professor, Berger died in November 2010.  Her animus against causation and Rule 702, however, was so strong that her chapter in the third edition of the Reference Manual on Scientific Evidence, which came out almost one year after her death, she embraced the First Circuit’s notorious anti-Daubert decision in Milward, which also post-dated her passing.[2]

Despite this posthumous writing and publication by Professor Berger, there have been no further instances of Zombie scholarship or ghost authorship.  Nonetheless, the assault on causation has been picked up by Professor Alexandra D. Lahav, of the University of Connecticut School of Law, in a recent essay posted online.[3] Lahav’s essay is an extension of her work, “The Knowledge Remedy,” published last year.[4]

This second essay, entitled “Chancy Causation in Tort Law,” is the plaintiffs’ brief against counterfactual causation, which Lahav acknowledges is the dominant test for factual causation.[5] Lahav begins with a reasonable, reasonably understandable distinction between deterministic (necessary and sufficient) and probabilistic (or chancy in her parlance) causation.

The putative victim of a toxic exposure (such as glyphosate and Non-Hodgkin’s lymphoma) cannot show that his exposure was a necessary and sufficient determinant of his developing NHL. Not everyone similarly exposed develops NHL; and not everyone with NHL has been exposed to glyphosate. In Lahav’s terminology, specific causation in such a case is “chancy.” Lahav asserts, but never proves, that the putative victim “could never prove that he would not have developed cancer if he had not been exposed to that herbicide.”[6]

Lahav’s example presents an example of a causal claim, which involves both general and specific causation, which is easily distinguishable from someone who claims his death was caused by being run over by a high-speed train. Despite this difference, Lahav never marshals any evidence to show why the putative glyphosate victim cannot show a probability that his case is causally related by adverting to the magnitude of the relative risk created by the prior exposure.

Repeatedly, Lahav asserts that when causation is chancy – probabilistic – it can never be shown by counterfactual causal reasoning, which she claims “assumes deterministic causation.” And she further asserts that because probabilistic causation cannot fit the counterfactual model, it can never “meet the law’s demand for a binary determination of cause.”[7]

Contrary to these ipse dixits, probabilistic causation can, at both the general and specific, or individual, levels be described in terms of counterfactuals. The modification requires us, of course, to address the baseline situation as a rate or frequency of events, and the post-exposure world as one with a modified rate or frequency. The exposure is the cause of the change in event rates. Modern physics addresses whether we must be content with probability statements, rather than precise deterministic “billiard ball” physics, which is so useful in a game of snooker, but less so in describing quarks. In the first half of the 20th century, the biological sciences learned with some difficulty that it must embrace probabilistic models, in genetic science, as well as in epidemiology. Many biological causation models are completely stated in terms of probabilities that are modified by specified conditions.

When Lahav gets to providing an example of where chancy causation fails in reasoning about individual causation, she gives a meaningless hypothetical of a woman, Mary, who is a smoker who develops lung cancer. To remove any semblance to real world cases, Lahav postulates that Mary had a 20% increased risk of lung cancer from smoking (a relative risk of 1.2). Thus, Lahav suggests that:

“[i]f Mary is a smoker and develops lung cancer, even after she has developed lung cancer it would still be the case that the cause of her cancer could only be described as a likelihood of 20 percent greater than what it would have been otherwise. Her doctor would not be able to say to her ‘Mary, if you had not smoked, you would not have developed this cancer’ because she might have developed it in any event.”

A more pertinent, less counterfactual hypothetical, is that Mary had a 2,000% increase in risk from her tobacco smoking. This corresponds to the relative risks in the range of 20, seen in many, if not most, epidemiologic studies of smoking and lung cancer. And there is an individual probability of causation that would be well over 0.9, for such a risk.

To be sure, there are critics of using the probability of causation because it assumes that the risk is distributed stochastically, which may not be correct. Of course, claimants are free to try to show that more of the risk fell on them for some reason, but of course, this requires evidence!

Lahav attempts to answer this point, but her argument runs off its rails.  She notes that:

“[i]f there is an 80% chance that a given smoker’s cancer is caused by smoking, and Mary smoked, some might like to say that she has met her burden of proof.

This approach confuses the strength of the evidence with its content. Assume that it is more likely than not, based on recognized scientific methodology, that for 80% of smokers who contract lung cancer their cancer is attributable to smoking. That fact does not answer the question of whether we ought to infer that Mary’s cancer was caused by smoking. I use the word ought advisedly here. Suppose Mary and the cigarette company stipulate that 80% of people like Mary will contract lung cancer, the burden of proof has been met. The strength of the evidence is established. The next question regards the legal permissibility of an inference that bridges the gap between the run of cases and Mary. The burden of proof cannot dictate the answer. It is a normative question of whether to impose liability on the cigarette company for Mary’s harm.”[8]

Lahav is correct that an 80% probability of causation might be based upon very flimsy evidence, and so that probability alone cannot establish that the plaintiff has a “submissible” case. If the 80% probability of causation is stipulated, and not subject to challenge, then Lahav’s claim is remarkable and contrary to most of the scholarship that has followed the infamous Blue Bus hypothetical. Indeed, she is making the very argument that tobacco companies made in opposition to the use of epidemiologic evidence in tobacco cases, in the 1950s and 1960s.

Lahav advances a perverse skepticism that any inferences about individuals can be drawn from information about rates or frequencies in groups of similar individuals.  Yes, there may always be some debate about what is “similar,” but successive studies may well draw the net tighter around what is the appropriate class. Lahav’s skepticism and her outright denialism, is common among some in the legal academy, but it ignores that group to individual inferences are drawn in epidemiology in multiple contexts. Regressions for disease prediction are based upon individual data within groups, and the regression equations are then applied to future individuals to help predict those individuals’ probability of future disease (such as heart attack or breast cancer), or their probability of cancer-free survival after a specific therapy. Group to individual inferences are, of course, also the basis for prescribing decisions in clinical medicine.  These are not normative inferences; they are based upon evidence-based causal thinking.

Lahav suggests that the metaphor of a “link” between exposure and outcome implies “something is determined and knowable, which is not possible in chancy causation cases.”[9] Not only is the link metaphor used all the time by sloppy journalists and some scientists, but when they use it, they mostly use it in the context of what Lahav would characterize as “chancy causation.” Even when speaking more carefully, and eschewing the link metaphor, scientists speak of probabilistic causation as something that is real, based upon evidence and valid inferences, not normative judgments or emotive reactions.

The probabilistic nature of the probability of causation does not affect its epistemic status.

The law does not assume that binary deterministic causality, as Lahav describes, is required to apply “but for” or counterfactual analysis. Juries are instructed to determine whether the party with the burden of proof has prevailed on each element of the claim, by a preponderance of the evidence. This civil jury instruction is almost always explained in terms of a posterior probability greater than 0.5, whether the claimed tort is a car crash or a case of Non-Hodgkin’s lymphoma.

Elsewhere, Lahav struggles with the concept of probability. Her essay suggests that

“[p]robability follows certain rules, or tendencies, but these regular laws do not abolish chance. There is a chance that the exposure caused his cancer, and a chance that it did not.”[10]

The use of chance here, in contradistinction to probability, is so idiosyncratic, and unexplained, that it is impossible to know what is meant.

Manufactured Doubt

Lahav’s essay twice touches upon a strawperson argument that stretches to claim that “manufacturing doubt” does not undermine her arguments about the nature of chancy causation. To Lahav, the likes of David Michaels have “demonstrated” that manufactured uncertainty is a genuine problem, but not one that affects her main claims. Nevertheless, Lahav remarkably sees no problem with manufactured certainty in the advocacy science of many authors.[11]

Lahav swallows the Michaels’ line, lure and all, and goes so far as to describe Rule 702 challenges to causal claims as having the “negative effect” of producing “incentives to sow doubt about epidemiologic studies using methodological battles, a strategy pioneered by the tobacco companies … .”[12] There is no corresponding concern about the negative effect of producing incentives to overstate the findings, or the validity of inferences, in order to get to a verdict for claimants.

Post-Modern Causation

What we have then is the ultimate post-modern program, which asserts that cause is “irreducibly chancy,” and thus indeterminate, and rightfully in the realm of “normative decisions.”[13] Lahav maintains there is an extreme plasticity to the very concept of causation:

“Causation in tort law can be whatever judges want it to be… .”[14]

I for one sincerely doubt it. And if judges make up some Lahav-inspired concept or normative causation, the scientific community would rightfully scoff.

Taking Lahav’s earlier paper, “The Knowledge Remedy,” along with this paper, the reader will see that Lahav is arguing for a rather extreme, radical precautionary principle approach to causation. There is a germ of truth that gatekeeping is affected by the moral quality of the defendant or its product. In the early days of the silicone gel breast implant litigation, some judges were influenced by suggestions that breast implants were frivolous products, made and sold to cater to male fantasies. Later, upon more mature reflection, judges recognized that roughly one third of breast implant surgeries were post-mastectomy, and that silicone was an essential biomaterial.  The recognition brought a sea change in critical thinking about the evidence proffered by claimants, and ultimately brought a recognition that the claimants were relying upon bogus and fraudulent evidence.[15]

—————————————————————————————–

[1]  Margaret A. Berger, “Eliminating General Causation: Notes towards a New Theory of Justice and Toxic Torts,” 97 Colum. L. Rev. 2117 (1997).

[2] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012)

[3]  Alexandra D. Lahav, “Chancy Causation in Tort,” (May 15, 2020) [cited as Chancy], available at https://ssrn.com/abstract=3633923 or http://dx.doi.org/10.2139/ssrn.3633923.

[4]  Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020). SeeThe Knowledge Remedy Proposal” (Nov. 14, 2020).

[5]  Chancy at 2 (citing American Law Institute, Restatement (Third) of Torts: Physical & Emotional Harm § 26 & com. a (2010) (describing legal history of causal tests)).

[6]  Id. at 2-3.

[7]  Id.

[8]  Id. at 10.

[9]  Id. at 12.

[10]  Id. at 2.

[11]  Id. at 8 (citing David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020), among others).

[12]  Id. at 18.

[13]  Id. at 6.

[14]  Id. at 3.

[15]  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).

Reference Manual on Scientific Evidence v4.0

February 28th, 2021

The need for revisions to the third edition of the Reference Manual on Scientific Evidence (RMSE) has been apparent since its publication in 2011. A decade has passed, and the federal agencies involved in the third edition, the Federal Judicial Center (FJC) and the National Academies of Science Engineering and Medicine (NASEM), are assembling staff to prepare the long-needed revisions.

The first sign of life for this new edition came back on November 24, 2020, when the NASEM held a short, closed door virtual meeting to discuss planning for a fourth edition.[1] The meeting was billed by the NASEM as “the first meeting of the Committee on Emerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence.” The Committee members heard from John S. Cooke (FJC Director), and Alan Tomkins and Reggie Sheehan, both of the National Science Foundation (NSF). The stated purpose of the meeting was to review the third edition of the RMSE to identify “identify areas of science, technology, and medicine that may be candidates for new or updated chapters in a proposed new (fourth) edition of the manual.” The only public pronouncement from the first meeting was that the committee would sponsor a workshop on the topic of new chapters for the RMSE, in early 2021.

The Committee’s second meeting took place a week later, again in closed session.[2] The stated purpose of the Committee’s second meeting was to review the third edition of the RMSE, and to discuss candidate areas for inclusion as new and updated chapters for a fourth edition.

Last week saw the Committee’s third, public meeting. The meeting spanned two days (Feb. 24 and 25, 2021), and was open to the public. The meeting was sponsored by NASEM, FJC, along with the NSF, and was co-chaired by Thomas D. Albright, Professor and Conrad T. Prebys Chair at the Salk Institute for Biological Studies, and the Hon. Kathleen McDonald O’Malley, who sits on the United States Court of Appeals for the Federal Circuit. Identified members of the committee include:

Steven M. Bellovin, professor in the Computer Science department at Columbia University;

Karen Kafadar, Departmental Chair and Commonwealth Professor of Statistics at the University of Virginia, and former president of the American Statistical Association;

Andrew Maynard, professor, and director of the Risk Innovation Lab at the School for the Future of Innovation in Society, at Arizona State University;

Venkatachalam Ramaswamy, Director of the Geophysical Fluid Dynamics Laboratory of the National Oceanic and Atmospheric Administration (NOAA) Office of Oceanic and Atmospheric Research (OAR), studying climate modeling and climate change;

Thomas Schroeder, Chief Judge for the U.S. District Court for the Middle District of North Carolina;

David S. Tatel, United States Court of Appeals for the District of Columbia Circuit; and

Steven R. Kendall, Staff Officer

The meeting comprised five panel presentations, made up of remarkably accomplished and talented speakers. Each panel’s presentations were followed by discussion among the panelists, and the committee members. Some panels answered questions submitted from the public audience. Judge O’Malley opened the meeting with introductory remarks about the purpose and scope of the RMSE, and of the inquiry into additional possible chapters.

  1. Challenges in Evaluating Scientific Evidence in Court

The first panel consisted entirely of judges, who held forth on their approaches to judicial gatekeeping of expert witnesses, and their approach to scientific and technical issues. Chief Judge Schroeder moderated the presentations of panelists:

Barbara Parker Hervey, Texas Court of Criminal Appeals;

Patti B. Saris, Chief Judge of the United States District Court for the District of Massachusetts,  member of President’s Council of Advisors on Science and Technology (PCAST);

Leonard P. Stark, U.S. District Court for the District of Delaware; and

Sarah S. Vance, Judge (former Chief Judge) of the U.S. District Court for the Eastern District of Louisiana, chair of the Judicial Panel on Multidistrict Litigation.

  1. Emerging Issues in the Climate and Environmental Sciences

Paul Hanle, of the Environmental Law Institute moderated presenters:

Joellen L. Russell, the Thomas R. Brown Distinguished Chair of Integrative Science and Professor at the University of Arizona in the Department of Geosciences;

Veerabhadran Ramanathan, Edward A. Frieman Endowed Presidential Chair in Climate Sustainability at the Scripps Institution of Oceanography at the University of California, San Diego;

Benjamin D. Santer, atmospheric scientist at Lawrence Livermore National Laboratory; and

Donald J. Wuebbles, the Harry E. Preble Professor of Atmospheric Science at the University of Illinois.

  1. Emerging Issues in Computer Science and Information Technology

Josh Goldfoot, Principal Deputy Chief, Computer Crime & Intellectual Property Section, at U.S. Department of Justice, moderated panelists:

Jeremy J. Epstein, Deputy Division Director of Computer and Information Science and Engineering (CISE) and Computer and Network Systems (CNS) at the National Science Foundation;

Russ Housley, founder of Vigil Security, LLC;

Subbarao Kambhampati, professor of computer science at Arizona State University; and

Alice Xiang, Senior Research Scientist at Sony AI.

  1. Emerging Issues in the Biological Sciences

Panel four was moderated by Professor Ellen Wright Clayton, the Craig-Weaver Professor of Pediatrics, and Professor of Law and of Health Policy at Vanderbilt Law School, at Vanderbilt University. Her panelists were:

Dana Carroll, distinguished professor in the Department of Biochemistry at the University of Utah School of Medicine;

Yaniv Erlich, Chief Executive Officer of Eleven Therapeutics, Chief Science Officer of MyHeritage;

Steven E. Hyman, director of the Stanley Center for Psychiatric Research at Broad Institute of MIT and Harvard; and

Philip Sabes, Professor Emeritus in Physiology at the University of California, San Francisco (UCSF).

  1. Emerging areas in Psychology, Data, and Statistical Sciences

Gary Marchant, Lincoln Professor of Emerging Technologies, Law and Ethics, at Arizona State University’s Sandra Day O’Connor College of Law, moderated panelists:

Xiao-Li Meng, the Whipple V. N. Jones Professor of Statistics, Harvard University, and the Founding Editor-in-Chief of Harvard Data Science Review;

Rebecca Doerge, Glen de Vries Dean of the Mellon College of Science at Carnegie Mellon University, member of the Dietrich College of Humanities and Social Sciences’ Department of Statistics and Data Science, and of the Mellon College of Science’s Department of Biological Sciences;

Daniel Kahneman, Professor of Psychology and Public Affairs Emeritus at the Princeton School of Public and International Affairs, the Eugene Higgins Professor of Psychology Emeritus at Princeton University, and a fellow of the Center for Rationality at the Hebrew University in Jerusalem; and

Goodwin Liu, Associate Justice of the California Supreme Court.

The Proceedings of this two day meeting were recorded and will be published. The website materials are unclear whether the verbatim remarks will be included, but regardless, the proceedings should warrant careful reading.

Judge O’Malley, in her introductory remarks, emphasized that the RMSE must be a neutral, disinterested source of information for federal judges, an aspirational judgment from which there can be no dissent. More controversial will be Her Honor’s assessment that epidemiologic studies can “take forever,” and other judges’ suggestion that plaintiffs lack financial resources to put forward credible, reliable expert witnesses. Judge Vance corrected the course of the discussion by pointing out that MDL plaintiffs were not disadvantaged, but no one pointed out that plaintiffs’ counsel were among the wealthiest individuals in the United States, and that they have been known to sponsor epidemiologic and other studies that wind up as evidence in court.

Panel One was perhaps the most discomforting experience, as it involved revelations about how sausage is made in the gatekeeping process. The panel was remarkable for including a state court judge from Texas, Judge Barbara Parker Hervey, of the Texas Court of Criminal Appeals. Judge Hervey remarked that [in her experience] if we judges “can’t understand it, we won’t read it.” Her dictum raises interesting issues. No doubt, in some instances, the judicial failure of comprehension is the fault of the lawyers. What happens when the judges “can’t understand it”? Do they ask for further briefing? Or do they ask for a hearing with viva voce testimony from expert witnesses? The point was not followed up.

Leonard P. Stark’s insights were interesting in that his docket in the District of Delaware is flooded with patent and Hatch-Waxman Act litigation. Judge Stark’s extensive educational training is in politics and political science. The docket volume Judge Stark described, however, raised issues about how much attention he could give to any one case.

When the panel was asked how they dealt with scientific issues, Judge Saris discussed her presiding over In re Neurontin, which was a “big challenge for me to understand,” with no randomized trials or objective assessments by the litigants.[3] Judge Vance discussed her experience of presiding in a low-level benzene exposure case, in which plaintiff claimed that his acute myelogenous leukemia was caused by gasoline.[4]

Perhaps the key difference in approach to Rule 702 emerged when the judges were asked whether they read the underlying studies. Judge Saris did not answer directly, but stated she reads the reports. Judge Vance, on the other hand, noted that she reads the relied upon studies. In her gasoline-leukemia case, she read the relied-upon epidemiologic studies, which she described as a “hodge podge,” and which were misrepresented by the expert witnesses and counsel. She emphasized the distortions of the adversarial system and the need to moderate its excesses by validating what exactly the expert witnesses had relied upon.

This division in judicial approach was seen again when Professor Karen Kafadar asked how the judges dealt with peer review. Judge Saris seemed to suggest that the peer-reviewed published article was prima facie reliable. Others disagreed and noted that peer reviewed articles can have findings that are overstated, and wrong. One speaker noted that Jerome Kassirer had downplayed the significance of, and the validation provided by, peer review, in the RMSE (3rd ed 2011).

Curiously, there was no discussion of Rule 703, either in Judge O’Malley’s opening remarks on the RMSE, or in the first panel discussion. When someone from the audience submitted a question about the role of Rule 703 in the gatekeeping process, the moderator did not read it.

Panel Two. The climate change panel was a tour de force of the case for anthropogenic climate change. To some, the presentations may have seemed like a reprise of The Day After Tomorrow. Indeed, the science was presented so confidently, if not stridently, that one of the committee members asked whether there could be any reasonable disagreement. The panelists responded essentially by pointing out that there could be no good faith opposition. The panelists were much less convincing on the issue of attributability. None of the speakers addressed the appropriateness vel non of climate change litigation, when the federal and state governments encouraged, licensed, and regulated the exploitation and use of fossil fuel reserves.

Panel Four. Dr. Clayton’s panel was fascinating and likely to lead to new chapters. Professor Hyman presented on heritability, a subject that did not receive much attention in the RMSE third edition. With the advent of genetic claims of susceptibility and defenses of mutation-induced disease, courts will likely need some good advice on navigating the science. Dana Carroll presented on human genome editing (CRISPR). Philip Sabes presented on brain-computer interfaces, which have progressed well beyond the level of sci-fi thrillers, such as The Brain That Wouldn’t Die (“Jan in the Pan”).

In addition to the therapeutic applications, Sabes discussed some of potential forensic uses, such as lie detectors, pain quantification, and the like. Yaniv Erlich, of MyHeritage, discussed advances in forensic genetic genealogy, which have made a dramatic entrance to the common imagination through the apprehension of Joseph James DeAngelo, the Golden State killer. The technique of triangulating DNA matches from consumer DNA databases has other applications, of course, such as identifying lost heirs, and resolving paternity issues.

Panel Five. Professor Marchant’s panel may well have identified some of the most salient needs for the next edition of the RMSE. Nobel Laureate Daniel Kahneman presented some of the highlights from his forthcoming book about “noise” in human judgment.[5] Kahneman’s expansion upon his previous thinking about the sources of error in human – and scientific – judgment are a much needed addition to the RMSE. Along the same lines, Professor Xiao Li Meng, presented on selection bias, and how it pervades scientific work, and detracts from the strength of evidence in the form of:

  1. cherry picking
  2. subgroup analyses
  3. unprincipled handling of outliers
  4. selection in methodologies (different tests)
  5. selection in due diligence (check only when you don’t like results)
  6. publication bias that results from publishing only impressive or statistically significant results
  7. selection in reporting, not reporting limitations all analyses
  8. selection in understanding

Professor Meng’s insights are sorely lacking in the third edition of the RMSE, and among judicial gatekeepers generally.  All too often, undue selectivity in methodologies and in relied-upon data is treated by judges as an issue that “goes to the weight, not the admissibility” of expert witness opinion testimony. In actuality, the selection biases, and other systematic and cognitive biases, are as important as, if not more important than, random error assessments. Indeed a close look at the RMSE third edition reveals a close embrace of the amorphous, anything-goes “weight of the evidence” approach in the epidemiology chapter.  That chapter marginalizes meta-analyses and fails to mention systematic review techiniques altogether. The chapter on clinical medicine, however, takes a divergent approach, emphasizing the hierarchy of evidence inherent in different study types, and the need for principled and systematic reviews of the available evidence.[6]

The Committee co-chairs and panel moderators did a wonderful job to identify important new trends in genetics, data science, error assessment, and computer science, and they should be congratulated for their efforts. Judge O’Malley is certainly correct in saying that the RMSE must be a neutral source of information on statistical and scientific methodologies, and it needs to be revised and updated to address errors and omissions in the previous editions. The legal community should look for, and study, the published proceedings when they become available.

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[1]  SeeEmerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence – Committee Meeting” (Nov. 24, 2020).

[2]  SeeEmerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence – Committee Meeting 2 (Virtual)” (Dec. 1, 2020).

[3]  In re Neurontin Marketing, Sales Practices & Prods. Liab. Litig., 612 F. Supp. 2d 116 (D. Mass. 2009) (Saris, J.).

[4]  Burst v. Shell Oil Co., 104 F.Supp.3d 773 (E.D.La. 2015) (Vance, J.), aff’d, ___ Fed. App’x ___, 2016 WL 2989261 (5th Cir. May 23, 2016), cert. denied, 137 S.Ct. 312 (2016). SeeThe One Percent Non-solution – Infante Fuels His Own Exclusion in Gasoline Leukemia Case” (June 25, 2015).

[5]  Daniel Kahneman, Olivier Sibony, and Cass R. Sunstein, Noise: A Flaw in Human Judgment (anticipated May 2021).

[6]  See John B. Wong, Lawrence O. Gostin, and Oscar A. Cabrera, “Reference Guide on Medical Testimony,” Reference Manual on Scientific Evidence 723-24 (3ed ed. 2011) (discussing hierarchy of medical evidence, with systematic reviews at the apex).

Falsehood Flies – The ASA 2016 Statement on Statistical Significance

February 26th, 2021

Under the heading of “falsehood flies,” we have the attempt by the American Statistical Association (ASA) to correct misinterpretations and misrepresentations of “statistical significance,” in a 2016 consensus statement.[1] Almost before the ink was dried, lawsuit industry lawyers seized upon the ASA statement to proclaim a new freedom from having to exclude random error.[2] Those misrepresentations were easily enough defeated by the actual text of the ASA statement, as long as lawyers bothered to read it carefully.

In 2019, Ronald Wasserstein, the ASA executive director, along with two other authors wrote an editorial, which explicitly called for the abandonment of using “statistical significance.” Although the piece, published in the American Statistician, was labeled “editorial,”[3] I predicted that Wasserstein’s official title, which appears in the editorial, and the absence of a disclaimer that the piece was not an ex cathedra pronouncement, would lead to widespread confusion, abuse, and further misrepresentations of the ASA’s views.[4]

Some people pooh-poohed the danger of confusion, but I was doubtful, given the experience with what happened with the anodyne 2016 ASA statement. What I did not realize until recently was that the Wasserstein editorial was misunderstood to be an official policy statement by the ASA’s own publication, Significance!

Significance is a bimonthly magazine on statistics for educated laypeople, published jointly the ASA and the Royal Statistical Society. In August 2019, the editor of Significance, Brian Turran, published an editorial that clearly reflected that Turran interpreted the Wasserstein editorial as an official ASA pronouncement.[5] Indeed, Turran cited the Wasserstein 2019 editorial as the ASA “recommendation.”

Donald Macnaughton, President of MatStat Research Consulting Inc., in Toronto, wrote a letter to point out Turran’s error.[6] Macnaughton noted that Wasserstein had disclaimed an official imprimatur for his ideas in various oral presentations, and that the editors of the New England Journal of Medicine had explicitly rejected the editorial’s call for abandoning statistical significance.[7]

In reply, Tarran graciously acknowledge the mistake, and pointed to an ASA press release that had led him astray:

“Thank you for this clarification. Our mistake was to give too much weight to the headline of a press release, ‘ASA Calls Time on “Statistically Significant” in Science Research’ (bit.ly/2UBWKNq).”

Inquiring minds might wonder why the ASA allowed such a press release to go out.

In 2019, then President of the ASA, Karen Kafadar, wrote on multiple occasions, in AmStat News, to correct any confusion or misimpression created by Wasserstein’s editorial:

“One final challenge, which I hope to address in my final month as ASA president, concerns issues of significance, multiplicity, and reproducibility. In 2016, the ASA published a statement that simply reiterated what p-values are and are not. It did not recommend specific approaches, other than ‘good statistical practice … principles of good study design and conduct, a variety of numerical and graphical summaries of data, understanding of the phenomenon under study, interpretation of results in context, complete reporting and proper logical and quantitative understanding of what data summaries mean’.

The guest editors of the March 2019 supplement to The American Statistician went further, writing: ‘The ASA Statement on P-Values and Statistical Significance stopped just short of recommending that declarations of “statistical significance” be abandoned. We take that step here. … [I]t is time to stop using the term “statistically significant” entirely’.

Many of you have written of instances in which authors and journal editors – and even some ASA members – have mistakenly assumed this editorial represented ASA policy. The mistake is understandable: The editorial was coauthored by an official of the ASA. In fact, the ASA does not endorse any article, by any author, in any journal – even an article written by a member of its own staff in a journal the ASA publishes.”[8]

Kafadar did not address the hyperactivity of the ASA public relations’ office, but her careful statement of the issues should put the matter to bed. There are now citable sources to correct the incorrect claim that the ASA has recommended the complete abandonment of significance testing.

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[1]  Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The Am. Statistician 129 (2016); seeThe American Statistical Association’s Statement on and of Significance” (March 17, 2016).

[2]  “The American Statistical Association Statement on Significance Testing Goes to Court – Part I” (Nov. 13, 2018); “The American Statistical Association Statement on Significance Testing Goes to Court – Part 2” (Mar. 7, 2019).

[3]  Ronald L. Wasserstein, Allen L. Schirm, and Nicole A. Lazar, “Editorial: Moving to a World Beyond ‘p < 0.05’,” 73 Am. Statistician S1, S2 (2019).

[4]  “Has the American Statistical Association Gone Post-Modern?” (Mar. 24, 2019); “American Statistical Association – Consensus versus Personal Opinion” (Dec. 13, 2019). See also Deborah G. Mayo, “The 2019 ASA Guide to P-values and Statistical Significance: Don’t Say What You Don’t Mean,” Error Statistics Philosophy (June 17, 2019); B. Haig, “The ASA’s 2019 update on P-values and significance,” Error Statistics Philosophy  (July 12, 2019).

[5]  Brian Tarran, “THE S WORD … and what to do about it,” Significance (Aug. 2019).

[6]  Donald Macnaughton, “Who Said What,” Significance 47 (Oct. 2019).

[7]  See “Statistical Significance at the New England Journal of Medicine” (July 19, 2019); See also Deborah G. Mayo, “The NEJM Issues New Guidelines on Statistical Reporting: Is the ASA P-Value Project Backfiring?” Error Statistics Philosophy  (July 19, 2019).

[8]  Karen Kafadar, “The Year in Review … And More to Come,” AmStat News 3 (Dec. 2019) (emphasis added); see Kafadar, “Statistics & Unintended Consequences,” AmStat News 3,4 (June 2019).

Larding Up the Literature

February 20th, 2021

Another bio-medical journal?

In October 2019, The Journal of Scientific Practice and Integrity published its inaugural volume one, number one issue, online. This journal purports to cover scientific integrity issues, which may well not be adequately covered in the major biomedical journals. There are reasons to believe, however, that this journal may be more of a threat to scientific integrity than a defender.

Thenew journal describes itself as:

“an interdisciplinary, peer-reviewed journal that publishes scholarly debate and original research on scientific practices that impact human and environmental health.”

The editorial board reads like a Who’s Who’s list of “political scientists” who testify a LOT for claimants, and who, when not working for the lawsuit industry, practice occupational and environmental medicine for the redistribution of wealth.

David Egilman, contemnor and frequent plaintiffs’ expert witness in personal injury litigation is editor in chief. Tess Bird, an Egilman protégé, is managing editor. Another Egilman protégé, Susana Rankin Bohme, an associate Director of Research at Corporate Accountability International, also sits on the editorial board. You may be forgiven for believing that this journal will be an Egilman vanity press. The editorial board also includes some high-volume testifying plaintiffs expert witnesses:

Peter Infante, of Peter F. Infante Consulting, LLC, Virginia

Adriane Fugh-Berman, of PharmedOut

Barry Castleman,

William E. Longo, President, MAS, LLC

David Madigan,

Michael R. Harbut,

David Rosner, and

Gerald Markowitz

The journal identifies the Collegium Ramazzini as one of its “partners.” Cue the “Интернационал”!

The first issue of this new journal features a letter[1] from the chief and managing editors, Egilman and Bird, which states wonderfully aspirational goals. The trick will be whether the journal can apply its ethical microscope to all actors in the world of scientific publishing, or whether this new journal is just not another lawsuit industry propaganda outlet.

Egilman’s previous editorial perch was at the International Journal of Occupational and Environmental Health, which was published by Maney Publishing. In 2015, the British company, the Taylor & Francis Group, acquired the IJOEH, with Maney’s other journals, and installed a new editor-in-chief, Andrew Maier. Egilman was cast out; hence the new journal.

Egilman’s new journal will feature among other types of articles, “reviews of legal testimony,” as a scholarly subject. It will be interesting to see whether such reviews assess the testimony of lawsuit industry witnesses, as well as manufacturing industry witnesses.

The new journal requires the use of the International Committee of Medical Journal Editors (ICMJE) conflict-of-interest and funding disclosure rules, and the use of the ICMJE form. Accordingly, authors “should” report all conflicts, including:

“[a]ny financial contributions, payments, or funding for the present work;

relevant financial activities outside of the submitted work;

any patents or copyrights broadly relevant to the work; and

any relationships that readers could perceive to influence the submitted work.”

There have been only two issues of Egilman’s new journal so far, but I decided to spot check compliance. The first article[2] I saw was by Colin Soskolne, who has testified for the lawsuit industry in a diacetyl case.[3] Oops; no disclosure.

Does Soskolne’s bias show? In the spot-checked article, authors Sokolne and Baur reprise a publication previously part of a 2018 Collegium Ramazzini convocation entitled “Corporate Influence Threatens the Public Health.” The aim of the convocation speakers was to press their claims that [manufacturing] corporate influence undermines scientific integrity through discernible methods, all by “those in the pay of industry”:

  • infiltrating journal editorial boards by scientists, with the resulting publication of poorly designed, biased research that foments doubt;
  • interfering with “the independent activities of IARC” and similar agencies;
  • blocking “much needed” regulation of “hazardous agents,” such as pesticides and polyfluoroalkyl substances (PFAS); and
  • promulgating causal criteria, which are baseless and which “block workers’ access to legal remedies for occupational illness and premature death.”[4]

There can be little doubt that Soskolne is not interested in messing with “those in the pay of the lawsuit industry.” Soskolne’s biases are fairly clear, clear enough for us to complain that he has not disclosed that he has been compensated by the lawsuit industry, and that he has deep positional conflicts as well. Ironically, he is writing in a journal that itself appears to lack “balance.” The editorial board of the journal for which Soskolne was writing is composed of many of “those in the pay of the lawsuit industry.”

Soskolne is keen to preserve the independence of IARC, but that perceived independence has become a sad, sick joke, with the exclusion of most anyone who has had any working relationship with manufacturing industry, while engaging many with deep ties to the lawsuit industry. Soskolne’s assessment of “much needed” regulation ultimately must be evaluated on the facts and data of each putative toxic substance. If the claim of harmful effects is correct, then regulation may well be “much needed.” If the claim is not correct, then regulation will be much “unneeded.” As for promulgating causal criteria, there is no doubt that the Soskolne, along with the editorial board of this new journal, would like to see the abrogation of causal criteria, so that workers have legal remedies ad libitum.

Soskolne and Baur provide their hit list of the methods of obfuscation or of techniques used to undermine science and policy.[5] There is precious little in their list, however, that is not common place among all journals that publish occupational and environmental epidemiology, including the journals that have been captured by the lawsuit industry’s scientists. Soskolne and Baur also provide a catalogue of how lawsuit industry scientists would subvert science and lock in their biased and selective interpretation of data:

  • elevate biological plausibility into sufficient basis for causal inference
  • conflate species and ignore species differences in order to allow animal studies to suffice for causal inference for humans
  • ignore substantial, relevant biological differences in even slight structural differences among various molecules to enable assertions of harm based upon similar molecular structure of a putative toxic substance

Soskolne ends with a quote from the “pink panthers,” two radical, labor historians, both editorial board members of this new journal, and who both have testified many times for the lawsuit industry:

“[A]s a society, we cannot entrust those with self-interest to be the judge and jury of what is and what is not a danger[;] … that can only lead to compromised science, a questionable decisionmaking process, and a potentially polluted world.”[6]

The pink panthers are, of course, correct, but we must understand that self-interest and conflict of interest can be, and are, both ideological, positional, as well as economic.


[1]  Tess Bird & David Egilman, “Letter from the Editors: An Introduction to the Journal of Scientific Practice and Integrity,” 1 J. Sci. Practice & Integrity 1 (2019).

[2]  Colin Soskolne & Xaver Baur, “How Corporate Influence Continues to Undermine the Public’s Health,” 1 J. Sci. Practice & Integrity 1 (2019), available at DOI: 10.35122/jospi.2019.878137 [cited as Soskolne & Baur]

[3]  See Watson v. Dillon Companies, 797 F. Supp. 2d 1138 (D. Colo. 2011) (addressing Soskolne’s testimony).
[4]  Soskolne & Baur at 1-2.

[5]  Soskolne & Baur at 3.

[6]  Soskolne & Baur at 4, quoting from Gerald Markowitz & David Rosner, “Monsanto, PCBs, and the creation of a ‘world-wide ecological problem’,” 39 J. Pub. Health Policy 463 (2018).

Dr. Harry Shubin – Asbestos Litigation Hall of Shame

February 19th, 2021

Many physicians took and failed the so-called B-reader examination for proficiency in using the International Labor Office’s grading schema of chest radiographs for pneumoconiosis. Famously, Irving Selikoff was someone who took but failed this examination, and he stopped serving as a clinical expert witness in asbestos cases. No one can say for sure whether there was cause and effect. In Philadelphia, South Jersey pulmonary physician, Dr. Joseph Sokolowski, was a frequent testifier for plaintiffs, despite his having failed the B-Reader examination three times. Sokolowski was conditionally fined and disqualified from testifying in Philadelphia because of his refusal to comply with compulsory process for his B-Reader test results.[1]

The only physician I encountered who lied outright about his B-reader examination results was the late Harry Shubin. Some people may know of Dr. Shubin only because of the “Harry Shubin, M.D. Statesman in Healthcare Administration Award,” presented by the American Academy of Medical Administrators. Indeed, Shubin had a long career in hospital administration. He was graduated from Temple School of Medicine in 1937, and went into family practice, at the age of 22. Later, he specialized in the treatment of tuberculosis and pulmonary disease.[2] Over his long career, he was a patron of the arts and of other charities in Philadelphia.

In 1955, Dr Shubin became the president of the American Academy of Tuberculosis Physicians.[3] In 1958, Shubin was elected head of staff at Pennsylvania General Hospital.[4] He later became the medical director of the Northern Division of Philadelphia General Hospital.

In 1962, along with 18 other physicians, Shubin purchased a 104-bed hospital, known as the Broad Street Hospital, at 739 South Broad Street, for which he would become medical director.[5] When the Jefferson Medical College sold its Barton Memorial Hospital for “diseases of the chest,” including silicosis and coal workers’ pneumoconiosis, at Broad and Fitzwater Streets, the South Broad Street Medical Center, Inc., bought it.  Shubin was the medical director.[6]

Shubin’s career as a medical director suffered in the ensuing decades.[7] In 1970, after a hearing, Dr. Shubin was disqualified by the U.S. Food & Drug Administration from receiving investigational products.[8] And then in 1981, his Center City Hospital, at 1829 Pine Street, closed, under pressure from both Blue Cross and the federal Health Systems Agency.[9]

Perhaps those setbacks explain Dr. Shubin’s foray into the lucrative world of expert witnessing in the asbestos litigation. Shubin started turning up as an expert witness for plaintiffs in hundreds of cases, in 1985. Dr. Peter Theodos, a prominent Philadelphia pulmonary physician had been designated to testify in these cases, but he died while the cases languished due to the huge backlog of asbestos cases in Philadelphia.

Shubin’s qualifications to replace Theodos were thin, Aside from an insignificant paper in a Pennsylvania Medicine,[10] Shubin had not written anything on asbestos or asbestos-related disease. Shubin was, however, a media hound, and in 1985, he was turning up at union halls and town hall meetings across Pennsylvania.[11]

Despite his lack of significant experience and expertise in asbestos-related disease, Shubin could put on a great show for uncritical Philadelphia juries. He was charming and persuasive. His years of public speaking on behalf of his beleaguered hospitals gave him confidence and skills of evasion in the witness box. When confronted with statements from Selikoff’s book or articles, Shubin would chuckle, smile knowingly, and say that he taught Selikoff everything about asbestos. His demeanor was avuncular and cherubic, which made cross-examination even more difficult.

Initially, Shubin testified that he was a B-reader, but after the defense verified his absence from the NIOSH list of certified B-readers, he “modified” his next trial’s testimony to state that he had started, but had not finished, the examination because of an eye problem.

After inquiring at NIOSH and learning that Shubin had finished the examination, defense counsel confronted Shubin yet again, only to have his tale embellished by a claim that he had withdrawn from the examination after finishing because of the eye problem, and wrote to NIOSH to ask that his examination not be evaluated.

In 1986, the leading asbestos plaintiffs’ firm was pushing one of its many cases to trial, with a Shubin report to support its claims.[12] Although the defense expert witnesses had given this plaintiff a clean bill of health, we had sufficient concerned about Shubin’s testimonial skills, that I decided to document Shubin’s perjury on the subject of his B-Reader status.

In 1986, the records’ custodian of B-Reader test results for NIOSH was Mitizie Martin, in Morgantown, West Virginia. After a good deal of procedural wrangling, I was able to obtain a court order that required plaintiffs’ counsel’s appearance for a deposition of Ms. Martin, in Morgantown. I noticed her deposition in all Philadelphia asbestos cases and gave all plaintiffs’ firms notice of the event. And so, in the first week of September, 1986, plaintiffs’ counsel, John DiDonato, and I were on board a small airplane for a bumpy ride to Morgantown, for Ms. Martin’s deposition.[13]

Martin was a wonderful witness. In 1986, she was Chief of the X-ray Receiving Center Section, Division of X-Ray Disease Studies, for NIOSH. She had been with NIOSH or its predecessor for 20 years.[14] Martin explained NIOSH’s role in teaching the A-Reader course, and in administering the B-Reader examination, along with the American College of Radiology, and its record retention policies.

Martin described the B-reader examination, which at the time required a showing of proficiency in interpreting 125 chest films for the presence and absence of various pneumoconiosis, according to the ILO scale.[15]

Finally, and most important, Martin authenticated the Shubin file, and laid a foundation for its admissibility at all future asbestos trials. Shubin had sought to become a B-Reader by taking the required test, in March 1982, in Orlando, Florida.[16] He completed but failed that examination in 1982, after which he wrote to Ms. Martin, to express his desire to take the test again. He made no mention of an eye problem; nor did he request that the 1982 results be disregarded. Martin wrote back to explain that he would have to wait a year before taking the examination again.[17]

Shubin waited three years, but he eventually signed up for, and took, the B-Reader examination a second time, in March 1985, on Kiawah Island, South Carolina. This second attempt resulted in a second failure, and a notification to Shubin that he had received a “failing grade, deficient in most categories.”[18] Shubin had thus taken the B-Reader examination twice, and failed both times. He had never abandoned the test; nor had he written to NIOSH to request a withdrawal from the examination, or to notify the agency of an eye-sight problem.[19]

My then colleague, Terri Keeley, was set to try the next-schedule case in which Dr. Shubin was supposed to have testified, in September 1986. Unsurprisingly, the case resolved. As soon as I received the transcript, I provided a copy gratis to every asbestos plaintiffs’ firm in Philadelphia. The result was that we never saw Dr. Shubin in an asbestos case again. Occasionally, we would receive a Dr. Shubin report, but a quick reminder of the procedural history behind Ms. Mitzie Martin’s deposition testimony sealed his effectual exclusion.

Remarkably, despite the notoriety he had gained in the Philadelphia asbestos litigation, Shubin showed up in the high-profile Paoli Railroad PCB case, as an expert witness on causation.[20] In the Paoli case, Shubin gave rather unscientific testimony that conflated general and specific causation, and assumed that PCBs caused individual plaintiffs’ disease because PCBs can cause disease.[21] As far I can determine, he was never confronted with his perjuries from the Philadelphia asbestos cases.

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[1]  Downing v. Johns-Manville Corp., Philadelphia Cty. Ct. C.P. 1981- 11- 3762, Order sur Motion to Compel Dr. Sokolowski to answer interrogatories and produce documents related to his failure of the B-Reader examination (Mar. 31, 1988).

[2]  “Harry Shubin Obituary,” Phila. Inq. at 25 (Mar. 7, 1997) (Dr. Shbuin died March 2, 1997).

[3]  “News from the Field,” 45 Am. J. Pub. Health 1399 (1955).

[4]  “Pennsylvania General Hospital,” Phila. Inq. at 29 (Mar. 25, 1958).

[5]  “Doctor-Owned Hospital Opens in South Philadelphia,” Phila. Daily News at p.19 (Feb. 5, 1962).

[6]  “Medical Center Sells Building,” Phila. Daily News at 57 (May 5, 1961).

[7]  Frank Dougherty, “11 Hospitals Cut from Blue Cross,” Phila. Daily News at p.3 (Nov. 14, 1972) (Broad Street Hospital cut).

[8]  Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (Mar. 16, 1970).

[9]  Phila. Inq. at 5 (Mar. 18, 1981) (Shubin, medical director).

[10]  Harry Shubin, “Asbestosis: inhalation disease of the lungs,” 88 Pa. Med. 54, 56, 58 (1985).

[11]  See, e.g., “Pat Purcell, Angry Man,” Pottsville Republican (Pottsville, PA) at p.1 (Mar. 14, 1987); Frank Scholz, “Help Coming for Asbestos Victims Living Here,” The Times-Tribune (Scranton, PA Sept. 15, 1985).

[12]  Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981). Years later, I met Mr. Nyman at my sister-in-law’s wedding, where he and his wife were dancing vigorously.

[13]  Deposition of Mitzie Martin, in Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981), taken on Sept. 5, 1986.

[14]  Id. at 3.

[15]  Id. at 7.

[16]  Id. at 12-13.

[17]  Id. at 14.

[18]  Id. at 14-15.

[19]  Id. at 16-19.

[20] In re Paoli R.R. Yard PCB Litig., 706 F. Supp. 358, 364-65 (E.D. Pa. 1988), rev’d, 916 F.2d 829, 840 (3d Cir. 1990), cert. denied, 111 S. Ct. 1584 (1991).

[21]  Susan R. Poulter, “Science and Toxic Torts: Is There a Rational Solution to the Problem of Causation?” 7 High Technology L.J. 189, 238 (1993).

Carl Cranor’s Inference to the Best Explanation

February 12th, 2021

Carl Cranor pays me the dubious honor of quoting my assessment of weight of the evidence (WOE) pseudo-methodology as used by lawsuit industry expert witnesses, in one of his recent publications:

“Take all the evidence, throw it into the hopper, close your eyes, open your heart, and guess the weight. You could be a lucky winner! The weight of the evidence suggests that the weight-of-the-evidence (WOE) method is little more than subjective opinion, but why care if it helps you to get to a verdict!”[1]

Cranor’s intent was to deride my comments, but they hold up fairly well. I have always maintained that if were wrong, I would eat my words, but that they will be quite digestible. Nothing to eat here, though.

In his essay in the Public Affairs Quarterly, Cranor attempts to explain and support his advocacy of WOE in the notorious case, Milward, in which Cranor, along with his friend and business partner, Martyn Smith, served as partisan, paid expert witnesss.[2] Not disclosed in this article is that after the trial court excluded the opinions of Cranor and Smith under Federal Rule of Evidence 702, and plaintiff appealed, the lawsuit industry, acting through The Council for Education and Research on Toxics (CERT) filed an amicus brief to persuade the Court of Appeals to reverse the exclusion. The plaintiffs’ counsel, Cranor and Smith, and CERT failed to disclose that CERT was founded by the two witnesses, Cranor and Smith, whose exclusion was at issue.[3] Many of the lawsuit industry’s regular testifiers were signatories, and none raised any ethical qualms about the obvious conflict of interest, or the conspiracy to pervert the course of justice.[4]

Cranor equates WOE to “inference to the best explanation,” which reductively strips science of its predictive and reproducible nature. Readers may get the sense he is operating in the realm of narrative, not science, and they would be correct. Cranor goes on to conflate WOE methodology with “diagnostic induction,” and “differential diagnosis.”[5] The latter term is well understood in both medicine and in law to involve the assessment of an individual patient’s condition, based upon what is already known upon good and sufficient bases. The term has no accepted or justifiable meaning for assessing general causation. Cranor’s approach would pretermit the determination of general causation by making the disputed cause a differential.

Cranor offers several considerations in support of his WOE-ful methodology. First, he notes that the arguments for causal claims are not deductive. True, but indifferent as to his advocacy for WOE and inference to the best explanation.

Second, Cranor describes a search for relevant evidence once the scientific issue (hypothesis?) is formulated. Again, there is nothing unique about this described step, but Cranor intentionally leaves out considerations of validity, as in extrapolations between high and low dose, or between species. Similarly, he leaves out considerations of validity of study designs (such as whether any weight would be given to case studies, cross-sectional, or ecological studies) or of validity of individual studies.

Cranor’s third step is the formulation of a “sufficiently complete range of reasonable and plausible explanations to account for the evidence.” Again, nothing unique here about WOE, except that Cranor’s WOE abridges the process by ignoring the very real possibility that we do not have the correct plausible explanation available.

Fourth, according to Cranor, scientists rank, explicitly or implicitly, the putative “explanations” by plausibility and persuasiveness, based upon the evidence at hand, in view of general toxicological and background knowledge.[6] Note the absence of consideration of the predictive abilities of the competing explanations, or any felt need to assess the quality of evidence or the validity of study design.

For Cranor, the fifth consideration is to use the initial plausibility assessments, made on incomplete understanding of the phenomena, and on incomplete evidence, to direct “additionally relevant /available evidence to separate founded explanations from less well-founded ones.” Obviously missing from Cranor’s scheme is the idea of trying to challenge or test hypotheses severely to see whether withstand such challenges.

Sixth, Cranor suggests that “all scientifically relevant information” should be considered in moving to the “best supported” explanation. Because “best” is determined based upon what is available, regardless of the quality of the data, or the validity of the inference, Cranor rigs his WOE-ful methodology in favor of eliminating “indeterminate” as a possible conclusion.

In a seventh step, Cranor points to the need to “integrate, synthesize, and assess or evaluate,” all lines of “available relevant evidence.” There is nothing truly remarkable about this step, which clearly requires judgment. Cranor notes that there can be convergence of disparate lines of evidence, or divergence, and that some selection of “lines” of evidence may be endorsed as supporting the “more persuasive conclusion” of causality.[7] In other words, a grand gemish.

Cranor’s WOE-ful approach leaves out any consideration of random error, or systematic bias, or data quality, or study design. The words “bias” and “confounding” do not appear in Cranor’s essay, and he erroneously discusses “error” and “error rates,” only to disparage them as the machinations of defense lawyers in litigation. Similarly, Cranor omits any serious mention of reproducibility, or of the need to formulate predictions that have the ability to falsify tentative conclusions.

Quite stridently, Cranor insists that there is no room for any actual weighting of study types or designs. In apparent earnest, Cranor writes that:

“this conclusion is in accordance with a National Cancer Institute (NCI) recommendation that ‘there should be no hierarchy [among different types of scientific methods to determine cancer causation]. Epidemiology, animal, tissue culture and molecular pathology should be seen as integrating evidences in the determination of human carcinogenicity.”[8]

There is much whining and special pleading about the difficulty, expense, and lack of statistical power of epidemiologic studies, even though the last point is a curious backdoor endorsement of statistical significance. The first two points ignore the availability of large administrative databases from which large cohorts can be identified and studied, with tremendous statistical power. Case-control studies can in some instances be assembled quickly as studies nested in existing cohorts.

As I have noted elsewhere,[9] Cranor’s attempt to level all types of evidence starkly misrepresents the cited “NCI” source, which is not at all an NCI recommendation, but rather a “meeting report” of a workshop of non-epidemiologists.[10] The cited source is not an official pronouncement of the NCI, the authors were not NCI scientists, and the NCI did not sponsored the meeting. The meeting report appeared in the journal Cancer Research as a paid advertisement, not in the NCI’s Journal of the National Cancer Institute as a scholarly article:

“The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.”[11]

Tellingly, Cranor’s deception was relied upon and cited by the First Circuit, in its Milward, decision.[12] The scholarly fraud hit its mark. As a result of Cranor’s own dubious actions, the Milward decision has both both ethical and scholarship black clouds hovering over it.  The First Circuit should withdraw the decision as improvidently decided.

The article ends with Cranor’s triumphant view of Milward,[13] which he published previously, along with the plaintiffs’ lawyer who hired him.[14] What Cranor leaves out is that the First Circuit’s holding is now suspect because of the court’s uncritical acceptance of Cranor’s own misrepresentations and CERT’s omissions of conflict-of-interest disclosures, as well as the subsequent procedural history of the case. After the Circuit reversed the Rule 702 exclusions, and the Supreme Court denied the petition for a writ of certiorari, the case returned to the federal district court, where the defense lodged a Rule 702 challenge to expert witness opinion that attributed plaintiff’s acute promyelocytic leukemia to benzene exposure. This specific causation issue was not previously addressed in the earlier proceedings. The trial court sustained the challenge, which left the plaintiff unable to show specific causation. The result was summary judgment for the defense, which the First Circuit affirmed on appeal.[15] The upshot of the subsequent proceedings, with their dispositive ruling in favor of the defense on specific causation, is that the earlier ruling on general causation is no longer necessary to the final judgment, and not the holding of the case when all the proceedings are considered.

In the end, Cranor’s WOE leaves us with a misdirected search for an “explanation of causation,” rather than a testable, tested, reproducible, and valid “inference of causation.” Cranor’s attempt to invoke the liberalization of the Federal Rules of Evidence ignores the true meaning of “liberal” in being free from dogma and authority. Evidence does not equal eminence, and expert witnesses in court must show their data and defend their inferences, whatever their explanations may be.

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[1]  Carl F. Cranor, “How Courts’ Reviews of Science in Toxic Tort Cases Have Changed and Why That’s a Good Thing,” 31 Public Affairs Q. 280 (2017), quoting from Schachtman, “WOE-fully Inadequate Methodology – An Ipse Dixit by Another Name” (May 1, 2012).

[2]  Milward v. Acuity Specialty Products Group, Inc., 639 F. 3d 11 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).

[3]  SeeThe Council for Education and Research on Toxics” (July 9, 2013).

[4] Among the signatures were Nachman Brautbar, David C. Christiani, Richard W. Clapp, James Dahlgren, Arthur L. Frank, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, David Ozonoff, David Rosner, Allan H. Smith, and Daniel Thau Teitelbaum.

[5]  Cranor at 286-87.

[6]  Cranor at 287.

[7]  Cranor at 287-88.

[8]  Cranor at 290.

[9]  “Cranor’s Defense of Milward at the CPR’s Celebration” (May 12, 2013).

[10]  Michelle Carbone, Jack Gruber, and May Wong, “Modern criteria to establish human cancer etiology,” 14 Semin. Cancer Biol. 397 (2004).

[11]  Michele Carbone, George Klein, Jack Gruber and May Wong, “Modern Criteria to Establish Human Cancer Etiology,” 64 Cancer Research 5518 (2004).

[12]  Milward v. Acuity Specialty Products Group, Inc., 639 F. 3d 11, 17 (1st Cir. 2011) (“when a group from the National Cancer Institute was asked to rank the different types of evidence, it concluded that ‘[t]here should be no such hierarchy’.”), cert. denied, 132 S.Ct. 1002 (2012).

[13]  Cranor at 292.

[14]  SeeWake Forest Publishes the Litigation Industry’s Views on Milward” (April 20, 2013).

[15]  Milward v. Acuity Specialty Products Group, Inc., 969 F. Supp. 2d 101 (D. Mass. 2013), aff’d sub nom. Milward v. Rust-Oleum Corp., 820 F.3d 469 (1st Cir. 2016).

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