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.

————————————————————————————————————

[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).