Schachtman Law » Silica

TORTINI

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

The Webb of Unsophistication in Products Liability Law

May 29th, 2016

The Heart of the Matter

The classic early cases in products liability law were about consumers hurt by consumer products, sold by manufacturers or dealers directly to consumers. The key component of these cases was inequality of bargaining power, of knowledge about latent defects or hazards, and of control over the discovery of latent hazards or defects. American products liability law was created around consumer products. Just think of Henningsen, Escola, and MacPherson.[1] These were all consumer products for which the rhetoric about inequality of bargaining, knowledge, and control over design, manufacturing, and latent hazards sometimes makes sense. The paradigmatic model for products liability, however, frequently does not work for the three-way relationship of sales of products to large industrial employers. The model especially does not work when the product is a raw material used throughout a factory, or incorporated into another product.

Many courts have failed to come to grips with the inadequacy of the consumer model for products liability cases in instances of occupational harm to industrial employees. Courts have been trying to ram this square peg into a round hole since the early asbestos litigation (which perhaps made some sense because there was inequality between Johns Manville and most vendees), but makes no sense when John Manville is itself the purchaser.

The Tangled Webb in California Law

The Webb case received some attention after the California Court of Appeals reversed a trial court’s entry of JNOV for defendant Special Electric on the so-called sophisticated intermediary defense. See “California Supreme Court Set To Untangle Webb” (July 7, 2013); “Big Blue & The Sophisticated User and Intermediary Defenses” (Sept. 27, 2014); G. Jeff Coons, “What a Tangled Webb We Weave: Court Imposes Failure to Warn Liability On Supplier to Johns-Manville” (April 2013). Special Electric petition for review, and eventually the California Supreme Court called for full briefing and oral argument in the Webb case.

The wheels of justice grind slowly in California. Special Electric filed its opening brief on the merits, on September 10, 2013. Webb’s widow answered in December 2013, and Special Electric replied in February 2014. Several amici curiae joined the fray in April 2014. Mark A. Behrens filed a brief on behalf of the Coalition for Litigation Justice, Inc., Chamber of Commerce, NFIB Small Business Legal Center, and American Chemistry Council. The Pacific Legal Foundation also filed, as did Elementis Chemicals Inc.

After mulling over the briefs for two years, the California Supreme Court heard argument on March 1, 2016, and then in surprisingly short order, affirmed the intermediate appellate, earlier this week. The Supreme Court’s ruling upheld a Court of Appeal’s decision that reversed a judgment for defendant Special Electric, based upon a jury verdict in favor of William Webb, who was exposed to crocidolite sold by Special Electric, and which caused him to develop mesothelioma in 2011. The Supreme Court’s opinion [2] held that sophisticated intermediary doctrine was a complete legal defense, even potentially for an asbestos supplier, but declined to apply it to the benefit of Special Electric, which had misrepresented facts about crocidolite and offered no evidence that its purchaser was sophisticated about crocidolite asbestos and its unique relationship with mesothelioma. [Slip opinion cited here as Webb.] Webb v. Special Elec. Co., Inc., 2016 BL 163642, Cal., No. S209927, 5/23/16).

The majority opinion[3] fortunately was able to separate the poorly framed and supported defense by Special Electric from the basic tenets of tort law and the sophisticated intermediary defense. To the extent that anyone doubted the validity of the sophisticated intermediary defense, the Webb Court formally adopted the doctrine as the law of California, as set out in the Second and Third Restatements of Tort Law. Webb at 15-16. According to the Court, a defendant may set up sophisticated intermediary doctrine as a complete defense, to failure to warn claims for known or knowable product risks, sounding in negligence or in strict liability, when the defendant supplier:

“(1) provides adequate warnings to the product’s immediate purchaser, or sells to a sophisticated purchaser that it knows is aware or should be aware of the specific danger, and

(2) reasonably relies on the purchaser to convey appropriate warnings to downstream users who will encounter the product.”

Webb at 16 (emphasis in original).[4]

As an affirmative defense, the defendant supplier must carry its burden of showing that it adequately warned the intermediary, or that it knew the intermediary knew or should have known of the specific hazard, and that it reasonably relied upon the purchaser to transmit warnings. Id.

On appeal, the California Supreme Court held that defendant Special Electric failed to preserve its entitlement to the sophisticated intermediary defense because “it never attempted to show that it actually or reasonably relied on Johns-Manville to warn end users. Nor did Special Electric request a jury instruction or verdict form question on the sophisticated intermediary doctrine.” Webb at 23.

Alternatively, on the assumption that Special Electric preserved the defense, the Court held that this defendant failed to establish the defense as a matter of law because:

“[a]lthough the record clearly shows Johns-Manville was aware of the risks of asbestos in general, no evidence established it knew about the particularly acute risks posed by the crocidolite asbestos Special Electric supplied. In addition, plaintiffs presented evidence that at least one Special Electric salesperson told customers crocidolite was safer than other types of asbestos fiber, when the opposite was true.”

Webb at 23.

The Webb Court reviewed the Tort Restatements’ embrace of the sophisticated intermediary defense in both the Second and Third editions. The Webb Court noted that the Third Restatement demonstrated the continued validity and vitality of the defense, as had been expressed in the Section 388 of the Restatement Second of Torts.[5] The Court noted and followed the Third Restatement’s recitation of guiding considerations for invoking and sustaining the defense:

“There is no general rule as to whether one supplying a product for the use of others through an intermediary has a duty to warn the ultimate product user directly or may rely on the intermediary to relay warnings. The standard is one of reasonableness in the circumstances. Among the factors to be considered are the gravity of the risks posed by the product, the likelihood that the intermediary will convey the information to the ultimate user, and the feasibility and effectiveness of giving a warning directly to the user.”

Webb at 15 (citing Restatement 3d Torts, Products Liability, § 2, com. i, at p. 30.) Citing California precedent, the Webb Court noted that

“[t]he focus of the [sophisticated intermediary] defense . . . is whether the danger in question was so generally known within the trade or profession that a manufacturer should not have been expected to provide a warning specific to the group to which plaintiff belonged.”

Webb at 9-10 (quoting from Johnson v. American Standard, Inc. 43 Cal.4th 56, 72 (2008). The pertinent legal test is whether a reasonable supplier would have known of the intermediary’s sophistication with respect to the relevant risk. Webb at 20.[6] Of course, the existence of a pervasive regulatory control of risk creation, detection, and mitigation in the workplace would count heavily in this objective test. “Every person has a right to presume that every other perform his duty and obey the law.” Webb at 21 (internal citation omitted) (emphasis added).

The Restatement factors, however, did not support Special Electric’s invocation of the defense in a case involving:

(1) crocidolite asbestos, one of the most hazardous substances known,

(2) defendant’s affirmative and blatantly false misrepresentations of the relative safety of crocidolite relative to chrysotile asbestos,[7] and

(3) a complete failure of proof that the purchaser, Johns Manville, knew that crocidolite was especially hazardous with respect to the causation of mesothelioma.

Webb at 23-24. Factors one and two were givens for defense counsel, but factor three speaks to unnecessary coyness on the part of the defense. Showing that Johns Manville was well aware of the extraordinarily great hazard of crocidolite would have been relatively easy to do from past transcripts, articles, speeches, and litigation conduct of the Johns Manville companies. Despite the extreme hazards from uncontrolled asbestos exposures, the Webb case explained that the sophisticated intermediary defense was not per se inapplicable to asbestos cases, and went so far as to disapprove an earlier California Court of Appeals decision that refused to apply the defense in the asbestos personal injury context when no warnings had been given.[8] “Sophistication obviates the need for warnings because a sophisticated purchaser already knows or should know of the relevant risks.” Webb at 17-18.

The Webb case acknowledged that defective design claims against raw material suppliers are incoherent and invalid, whether for the raw material itself, or for downstream design defect claims against for the product with the incorporated raw material. “[A] basic raw material such as sand, gravel, or kerosene cannot be defectively designed.” Webb at 11-12 (quoting from Restatement 3d Torts, Products Liability, § 5, com. c, at p. 134).[9]

The Webb Court also evinced a healthy disrespect for the notion that tort law is only about spreading risk and compensating injured persons. The Court acknowledged that in some instances, there were competing policies of compensating persons injured by products and “encouraging conduct that can feasibly be performed.” Webb at 2. The Court also acknowledged that there were hazards to warning when none was needed or when the absence of a warning would not be a legal cause of harm:

“Because sophisticated users already know, or should know, about the product’s dangers, the manufacturer’s failure to warn is not the legal cause of any harm. A sophisticated user’s knowledge is thus the equivalent of prior notice. The defense serves public policy, because requiring warnings of obvious or generally known product dangers could invite consumer disregard and contempt for warnings in general.”

Webb at 9 (internal citations omitted) (emphasis added). Furthermore, the sophisticated intermediary defense balances the need for the worker-consumer’s safety with “the practical realities of supplying products.” Webb at 17.

The Webb decision puts California in line with the majority rule that recognizes the validity of the sophisticated intermediary defense, and embraces real-world truth that:

“[in] some cases, the buyer’s sophistication can be a substitute for actual warnings, but this limited exception only applies if the buyer was so knowledgeable about the material supplied that it knew or should have known about the particular danger.”

Webb at 17.[10] The Court noted and agreed with the Restatement Third’s observation that imposing liability upon raw material suppliers for failure to warn can be unduly and unfairly burdensome when such liability would require remote suppliers

“to develop expertise regarding a multitude of different end-products and to investigate the actual use of raw materials by manufacturers over whom the supplier has no control.”

Webb at 12 (quoting from Restatement 3d Torts, Products Liability, § 5, com. c, at p. 134).

Concurrence

Chief Justice Tani Gorre Cantil-Sakauye, along with Justice Ming W. Chin, concurred in the result, but dissented from the majority’s rationale as overly broad. The concurring justices insisted that a supplier reasonably relies upon its purchaser only when the purchaser has actual awareness of the product’s risks. Webb concurrence at 4. Even this stingier approach noted that one of the purpose of warnings is

“to enable the consumer or others who might come in contact with the product to choose not to expose themselves to the risks presented.”

Webb Concurrence at 3 (citing Restatement3d Torts, Products Liability, § 2, com. i, at p. 30). In many sophisticated intermediary contexts involving occupational exposures to fumes, vapors, and dusts, workers (consumers) cannot appreciate whether they might come in contact with the product such that they have actual risks unless the sophisticated intermediary measures its specific workplace exposures, given its actual engineering, administrative, and person protection controls.

Commentary

The Webb Court failed to address in any meaningful form how Special Electric could discharge a duty to warn Mr. Webb directly, when it sold blue asbestos to Johns-Manville, which then incorporated that fiber, along with other recycled asbestos into transite pipes. To this extent, the Webb decision carries forward the glib belief in efficacy of warnings, without any evidence or critical thought.

It is hard to imagine an industrial purchaser that was unaware of the special hazards of crocidolite by 1970, and yet Special Electric apparently failed to offer evidence on the issue whether Johns-Manville had such awareness. A court might take judicial notice of Johns-Manville sophistication, but there is not even the suggestion that Special Electric attempted to supplement the vacuous record with a request for judicial notice.

If the California Supreme Court’s recitation of the facts of the case is correct, then we are left with an unflattering inference about Special Electric’s trial strategy and execution. Perhaps Special Electric was coyly trying to avoid a downside outcome in which it was responsible for 99.99% of the verdict because its blue asbestos was by far the most important cause of Mr. Webb’s tragic disease, a disease that would have almost certainly been avoided had never had exposure to blue asbestos. The propensity of crocidolite to cause mesothelioma is orders of magnitude greater than chrysotile, which by itself may not even be a competent cause of the harm suffered by Mr. Webb.

In the final analysis, the Webb Court correctly adopted the sophisticated intermediary principle as an essential limit to tort liability, but denied its benefit to Special Electric. The sophisticated intermediary doctrine should not, however, be conceived of as an affirmative defense. The scope of the rule is defined by the rationale for its existence, and the sophisticated intermediary situation lies outside the realm and rationale of protecting, by warning, consumers against latent hazards. It is time that courts recognize that much litigation brought to its doors is really the result of labor-management issues within the workplace, and not the doings or responsibility of remote suppliers of raw materials.

[1] See, e.g, MacPherson v. Buick Motor Co., 217 N.Y. 382, 111 N.E. 1050 (1916) (holding that privity of contract did not bar suit and that product manufacturers could be liable to consumers for injuries); Henningsen v. Bloomfield Motors, Inc., 32 N.J. 358, 161 A.2d 69 (1960); Escola v. Coca Cola Bottling Co., 24 Cal. 2d 453, 150 P. 2d 436 (1944).

[2] See Steven Sellers, “California Ruling Defines Asbestos Supplier’s Duty to Warn,” BNA Product Safety & Liability Reporter (May 24, 2016).

[3] The majority opinion was written by Associate Justice Carol A. Corrigan, and joined by Associate Justices Kathryn Mickle Werdegar, Goodwin Liu, Mariano-Florentino Cuéllar and Leondra R. Kruger.

[4] See also Webb at 2 (“Under the sophisticated intermediary doctrine, the supplier can discharge this duty if it conveys adequate warnings to the material’s purchaser, or sells to a sufficiently sophisticated purchaser, and reasonably relies on the purchaser to convey adequate warnings to others, including those who encounter the material in a finished product. Reasonable reliance depends on many circumstances, including the degree of risk posed by the material, the likelihood the purchaser will convey warnings, and the feasibility of directly warning end users.”); Webb at 6 (“[T]he sophisticated intermediary doctrine provides that a supplier can discharge its duty to warn if it provides adequate warnings, or sells to a sufficiently sophisticated buyer, and reasonably relies on the buyer to warn end users about the harm.”). Webb at 17 (“If a purchaser is so knowledgeable about a product that it should already be aware of the product’s particular dangers, the seller is not required to give actual warnings telling the buyer what it already knows.”).

[5] See Webb at 15 (“The drafters intended this comment to be substantively the same as section 388, comment n, of the Restatement Second of Torts.”) (citing Restatement 3d Torts, Products Liability, § 2, com. i, reporter’s note 5, at p. 96; Humble Sand & Gravel Inc. v. Gomez, 146 S.W.3d 170, 190 (Tex. 2004). See also Webb at 9 (citing Restatement 2d Torts, § 388 (b), com. k, at pp. 306-307) (“Courts have interpreted section 388, subdivision (b), to mean that if the manufacturer reasonably believes the user will know or should know about a given product’s risk”).

[6] Relevant considerations may include the general dissemination of knowledge of relevant risks, the intermediary’s knowledge of those risks, and the intermediary’s reputation for care. Webb at 20.

[7] Webb at 3, 23.

[8] See Webb at 17-18 (disapproving of the holding in Stewart v. Union Carbide Corp., 190 Cal. App. 4th 23, 29-30 (2010)).

[9] See also Webb at 12 (quoting from Restatement 3d Torts, Products Liability, § 5, com. c, at p. 134) (“Inappropriate decisions regarding the use of such materials are not attributable to the supplier of the raw materials but rather to the fabricator that puts them to improper use.”).

[10] citing approvingly Cimino v. Raymark Industries, Inc., 151 F.3d 297, 334 (5th Cir. 1998) (holding that raw asbestos supplier did not need to warn asbestos product manufacturer Fibreboard, which was “a sophisticated, expert, and knowledgeable manufacturer” of insulation products, about asbestos risks); Higgins v. E.I. DuPont de Nemours & Co., 671 F. Supp. 1055, 1061-1062 (D. Md. 1987) (exculpating supplier when purchaser was a highly sophisticated manufacturer with knowledge from independent sources, as well as its suppliers), aff’d, 863 F.2d 1162 (4th Cir. 1988).

Posted in Asbestos, Silica, Sophisticated User | Comments Off on The Webb of Unsophistication in Products Liability Law

Ramazzini Serves Courtroom Silica Science Al Dente

July 25th, 2015

Collegium Ramazzini styles itself as an “independent, international academy.” The Collegium Ramazzini was founded in 1982, by the late Irving Selikoff and others to serve as an advocacy forum for their pro-compensation and aggressive regulation views on social and political issues involving occupational and environmental health.

The Collegium is a friendly place where plaintiffs’ expert witnesses, consultants, and advocates never have to declare their conflicts of interest.[1] Last year, in October 2014, the Collegium conducted a conference on silica health issues, entitled “Silica Three Hundred Years Later: Occupational Exposure, Medical Monitoring, and Regulation.”

The silica session was chaired by Christine Oliver, one of plaintiff’s key expert witnesses in Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009). See “Bad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing” (Nov. 30, 2012). The purported goal of the session was

“to shine a light on silica as a persistent and dangerous threat to the health of exposed workers worldwide,” focusing on the following issues:

“1) Occupational silica exposures, new and old;

2) silica as a recognized human lung carcinogen and its interaction with other lung carcinogens such as tobacco smoke;

3) the role of silica and silicosis in tuberculosis;

4) issues relevant to medical surveillance of silica-exposed workers as set forth in OSHA’s proposed silica standard;

5) the role of the US Government in protecting the health of silica-exposed workers; and

6) international variability in addressing the threat to worker health posed by silicosis.”

Recently, the Collegium updated its website to provide PDF files of some of the conference presentations:

Carol H. Rice, “Silica – old, new and emerging uses result in worker exposure”

Arthur L. Frank, “Silica as a lung carcinogen”

Rodney Ehrlich, “Silica in the head of the snake. Silica, gold mining, and tuberculosis in southern Africa”

Christine Oliver, “Medical surveillance for silica-related disease: the Collegium responds to OSHA’s proposed rulemaking,”

Gregory R. Wagner, “US Government role in recognizing, reducing, and regulating silica risk: 80 years and counting”

Sverre Langard, “Silicosis 300 years after Ramazzini: Eradication in some countries, increased incidence in others”

A poster session chaired by Melissa McDiarmid and Carol Rice, revealingly titled “Sustainable Work 2020 – an advocacy platform for Horizon 2020,” followed. Casey Bartrem asked whether “Asbestos-induced lung cancer in Germany: is the compensation practice in accordance with the epidemiological findings?” Odds are that this presentation was a brief for greater compensation. Xaver Baur of Germany, presented on the “Ethics in the applied sciences: The challenge of preventing corporate influence over public health regulation,” but remarkably no one presented on the challenge of preventing the litigation and compensation industry’s influence over public health regulation.

You won’t find any cutting-edge science in the linked slides, but you will find some interesting revelations. Sverre Langard’s presentation makes the dramatic point that silicosis has been declining, despite the hand waving of OSHA Administrator David Michaels, and the histortions of Rosner and Markowitz. Consider Langard’s slide, based upon CDC data:

And consider the admissions of Arthur Frank, veteran plaintiffs’ expert witness, who acknowledged that:

“until very recently it [silica] was not recognized as a carcinogen.”

True to form, Dr. Frank blamed Selikoff and his other teachers at Mt. Sinai Hospital in New York City, where he trained:

“At Mount Sinai I did not get trained that silica was a carcinogen”

Well, even a scurry of blind squirrels sometimes find their nuts!

[1][1] Some of the names on the list of Fellows and Emeritus Fellows reads like a “Who’s Who” of testifying expert witnesses, consultants, and advocates for the litigation industry:

Henry A. Anderson, Barry Castleman, David C. Christiani, Carl F. Cranor, Devra Lee Davis , John M. Dement, Arthur Frank, Bernard D. Goldstein, Howard Frumkin, Lennart Hardell, Peter F. Infante, Joseph LaDou, Philip Landrigan, Richard A. Lemen, Barry S. Levy, Roberto G. Lucchini, Steven B. Markowitz, Myron A. Mehlman, Ronald L. Melnick, Donna Mergler, Albert Miller, Franklin E. Mirer, Herbert L. Needleman, L. Christine Oliver, David M. Ozonoff, Carol H. Rice, Kenneth D. Rosenman, Sheldon W. Samuels, Ellen K. Silbergeld, Peter D. Sly, Martyn Thomas Smith, Colin L. Soskolne, Leslie Thomas Stayner, Daniel T. Teitelbaum, Laura Welch

Posted in Conflicts of Interest, Expert Witnesses, Silica, State of the Art | Comments Off on Ramazzini Serves Courtroom Silica Science Al Dente

The Unreasonable Success of Asbestos Litigation

July 25th, 2015

In asbestos litigation, the plaintiffs’ bar has apparently invented a perpetual motion machine that feeds on outrage that will never run out. Still, lawyers who have not filled their wallets with legal fees from asbestos cases sometimes attempt to replicate the machine. For the most part, the imitators have failed.

What accounts for the unreasonable success of asbestos litigation? Unlike pharmaceutical litigation, exposure does not require a prescription. Although asbestos insulators and applicators experienced the most exposure, other trades and occupations worked with, or near, asbestos materials. Anecdotal testimony of exposure suffices in almost every case. Add para-occupational exposure, and the sky’s the limit for the class of potential plaintiffs. See Lester Brickman, “Fraud and Abuse in Mesothelioma Litigation,” 88 Tulane L. Rev. 1071 (2014); Peggy Ableman, “The Garlock Decision Should be Required Reading for All Trial Court Judges in Asbestos Cases,” 37 Am. J. Trial Advocacy 479, 488 (2014).

Then there is the range of diseases and disorders attributable to asbestos. Excessive exposure to asbestos minerals cause non-malignant pleural plaques and thickening, as well as lung fibrosis, asbestosis. Some asbestos minerals cause mesothelioma, and despite a differential in potency among some of the minerals (between amosite and crocidolite), the general and specific causation of mesothelioma is often uncontested. Furthermore, lung cancer in the presence of asbestosis may be the result of interaction of asbestos exposure and cigarette smoking. Plaintiffs’ counsel and The Lobby have expanded the list of attributable diseases to include non-pulmonary cancers, only to find some defendants willing to pay money on these claims as well.

In addition to the ease of claiming, or manufacturing, exposure, and the willing cooperation of the occupational medical community in supporting medical causation, asbestos litigation is a lightning rod for moral outrage in the courtroom. Plaintiffs claim that “industry” knew about the hazards of asbestos, including its carcinogenicity, long before warnings appeared. Defending the knowledge claim requires nuanced explanation of shifting standards for establishing causality as epidemiology developed and was applied to putative asbestos-related cancer outcomes, as well as changing views about the latencies of asbestos-related diseases.

Every once in a while, plaintiffs’ and defense counsel[1], the media[2], the academy[3], and the insurance industry[4] ask whether “silica” is the next asbestos. Although the prospects have been, and remain, dim, plaintiffs’ counsel continue to try to build their litigation palace on sand, with predictably poor results. See Kimberley A. Strassel, “He Fought the Tort Bar — and Won,” Wall St. J. (May 4, 2009).

There are many serious disanalogies between asbestos and silica litigation. One glaring difference is the inability to summon any outrage over suppressed or nondisclosed knowledge of alleged silica cancer hazards. The silica cancer state of the art, written by those who are lionized in the asbestos litigation – Hueper, Schepers, and Hardy, along with NIOSH and the Surgeon General, all appropriately denied or doubted silica as a cause of lung cancer. See below. When the IARC shifted its views in the 1990s, under the weight of determined advocacy from some partisans in the occupational medicine community, and with the help from some rather biased reviews, industry promptly warned regardless of the lack of scientific support for the IARC’s conclusion. The manufacturing of faux consensus and certainty on silica and lung cancer is an important counter to the incessant media stories about the manufacturing of doubt on topics such as climate change.

[1] Robert D. Chesler, James Stewart, and Geoffrey T. Gibson, “Is Silica the Next Asbestos?” 176 N.J.L.J. 1 (June 28, 2004); Mark S. Raffman, “Where Will Silica Litigation Go?” 1 LJN Silica Legal News 1 (2005); Chris Michael Temple, “A Case for Why Silica Litigation Is Not the ‘Next Asbestos’,” LJN Product Liability Law & Strategy (2004).

[2] Jonathan D. Glater, “Suits on Silica Being Compared To Asbestos Cases,” N.Y. Times (Sept. 6, 2003).

[3] Michelle J. White, “Mass Tort Litigation: Asbestos,” in Jürgen Georg Backhaus, ed., Encyclopedia of Law and Economics 1 (2014); Melissa Shapiro, “Is Silica the Next Asbestos? An Analysis of the Silica Litigation and the Sudden Resurgence of Silica Lawsuit Filings,” 32 Pepperdine L. Rev. 4 (2005).

[4] “Is silica the new asbestos?” The Actuary (2005).

Historical Statements – – State-of-the-Art

Maxcy, ed., Rosenau Preventive Medicine and Hygiene 1051 (N.Y., 7th ed. 1951) (“Thus, there is no evidence that lung cancer is related in any way to silicosis.”)

May Mayers, “Industrial Cancer of the Lungs,” 4 Compensation Medicine 11, 12 (1952) (“Nevertheless, silicosis is not, apparently associated with, or productive of, lung cancer, whereas asbestosis very probably is.”) (Chief, Medical Unit, Division of Industrial Hygiene and Safety Standards, N.Y. Dep’t of Labor)

Geritt Schepers, “Occupational Chest Diseases,” Chap. 33, p. 455, ¶3, in A. Fleming, et al., eds., Modern Occupational Medicine (Phila. 2d ed. 1960) (“Lung cancer, of course, occurs in silicotics and is on the increase. Thus far, however, statistical studies have failed to reveal a relatively enhanced incidence of pulmonary neoplasia in silicotic subjects.”)

Spencer, Pathology of the Lung (1962) (“Silicosis and lung cancer inhaled silica, unlike asbestos, does not predispose to the development of lung cancer.”)

Wilhelm Hueper, Occupational and Environmental Cancers of the Respiratory System at 2-6 (N.Y. 1966) (“The bulk of the available epidemiologic evidence on the association of silicosis and lung cancer supports the view of a mere coincidental role of silicosis in this combination. *** From the evidence on hand, it appears that a well advanced silicosis does not seem to furnish a favorable soil for the development of cancer of the lung.”) (chief of the National Cancer Institute)

Harriet L. Hardy, “Current Concepts of Occupational Lung Disease of Interest to the Radiologist,” 2 Sem. Roentgenology 225, 231-32 (1967) (“cancer of the lung is not a risk for the silicotic. It is a serious risk following asbestos exposure and for hematite, feldspar, and uranium miners. This means that certain dusts and ionizing radiation alone or perhaps with cigarette smoke act as carcinogens.”)

Raymond Parkes, Occupational Lung Disorders 192 (London 1974) (“Bronchial carcinoma occasionally occurs in silicotic lungs but there is no evidence of a causal relationship between it and silicosis; indeed the incidence of lung cancer in miners with silicosis is significantly lower than in non-silicotic males.”)

Kaye Kilburn, Ruth Lilis, Edwin Holstein, “Silicosis,” in Maxcy-Rosenau, Public Health and Preventive Medicine, 11th ed., at 606 (N.Y. 1980) (“Lung cancer is apparently not a complication of silicosis.”)

Robert Jones, “Silicosis,” Chap. 16, in W. Rom, et al., eds., Environmental and Occupational Medicine 205 (Boston 1983) (“The weight of epidemiologic evidence is against the proposition that silicosis carries an increased risk of respiratory malignancy.”)

W. Keith C. Morgan & Anthony Seaton, eds., Occupational Lung Diseases 266 (1984) (“It is generally believed that silicosis does not predispose to lung cancer. * * * On balance, it seems unlikely that silicosis itself predisposes to lung cancer.”)

1 Anderson’s Pathology at 910b (1985) (“There is no evidence that silica increases the risk of lung cancer, nor does it enhance tobacco induced carcinogenesis.”)

U.S. Dep’t of Health and Human Services, The Health Consequences of Smoking – Cancer and Chronic Lung Disease in the Workplace: A Report of the Surgeon General at 348, Chapter 8 “Silica‑Exposed Workers” (1985) (“the evidence does not currently establish whether silica exposure increases the risk of developing lung cancer in men.”)

J. Cotes & J. Steel, Work-Related Lung Disorders 156 (Oxford 1987) (“The inhalation of silica dust does not contribute to malignancy.”)

NIOSH Silicosis and Silicate Disease Committee, “Diseases Associated With Exposure to Silica and Non-fibrous Silicate Minerals,” 112 Arch. Path. & Lab. Med. 673, 707 (1988) (“Epidemiologic studies have been conducted in an effort to assess the role of silica exposure in the pathogenesis of lung cancer. *** Thus, the results are inconclusive … .”)

Arthur Frank, “Epidemiology of Lung Cancer, in J. Roth, et al., Thoracic Oncology, Chap. 2, at p. 8 (Table 2-1), 11 (Phila. 1989) (omitting silica from list of lung carcinogens) (“The question of the relationship of coal mining to the development of lung cancer has been frequently considered. Most evidence points to cigarette smoking among coal miners as the major causative factor in the development of lung cancer, and neither a recent84 nor a British study of lung cancer among coal miners has found any relationship to occupational exposure.”)

Posted in Asbestos, Historian Testimony, Silica, Sophisticated User, State of the Art | Comments Off on The Unreasonable Success of Asbestos Litigation

Professor Bernstein’s Critique of Regulatory Daubert

May 15th, 2015

In the law of expert witness gatekeeping, the distinction between scientific claims made in support of litigation positions and claims made in support of regulations is fundamental. In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y. 1984) (“The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one”), aff’d 818 F.2d 145 (2d Cir. 1987), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988). Although scientists proffer opinions in both litigation and regulatory proceedings, their opinions are usually evaluated by substantially different standards. In federal litigation, civil and criminal, expert witnesses must be qualified and have an epistemic basis for their opinions, to satisfy the statutory requirements of Federal Rule of Evidence 702, and they must have reasonably relied upon otherwise inadmissible evidence (such as the multiple layers of hearsay involved in an epidemiologic study) under Rule 703. In regulatory proceedings, scientists are not subject to admissibility requirements and the sufficiency requirements set by the Administrative Procedures Act are extremely low[1].

Some industry stakeholders are aggrieved by the low standards for scientific decision making in certain federal agencies, and they have urged that the more stringent litigation evidentiary rules be imported into regulatory proceedings. There are several potential problems with such reform proposals. First, the epistemic requirements of science generally, or of Rules 702 and 703 in particular, are not particularly stringent. Scientific method leads to plenty of false positive and false negative conclusions, which are subject to daily challenge and revision. Scientific inference is not necessarily so strict, as much as ordinary reasoning is so flawed, inexact, and careless. Second, the call for “regulatory Daubert” ignores mandates of some federal agency enabling statutes and guiding regulations, which call for precautionary judgments, and which allow agencies to decide issues on evidentiary display that fall short of epistemic warrants for claims of knowledge.

Many lawyers who represent industry stakeholders have pressed for extension of Daubert-type gatekeeping to federal agency decision making. The arguments for constraining agency action find support in the over-extended claims that agencies and so-called public interest science advocates make in support of agency measures. Advocates and agency personnel seem to believe that worst-case scenarios and overstated safety claims are required as “bargaining” positions to achieve the most restrictive and possibly the most protective regulation that can be gotten from the administrative procedure, while trumping industry’s concerns about costs and feasibility. Still, extending Daubert to regulatory proceedings could have the untoward result of lowering the epistemic bar for both regulators and litigation fact finders.

In a recent article, Professor David Bernstein questions the expansion of Daubert into some regulatory realms. David E. Bernstein, “What to Do About Federal Agency Science: Some Doubts About Regulatory Daubert,” 22 Geo. Mason L. Rev. 549 (2015)[cited as Bernstein]. His arguments are an important counterweight to those who insist on changing agency rulemaking and actions at every turn. As an acolyte and a defender of scientific scruples and reasoning in the courts, Bernstein’s arguments are worth taking seriously.

Bernstein reminds us that bad policy, as seen in regulatory agency rulemaking or decisions, is not always a scientific issue. In any event, regulatory actions, unlike jury decisions, are not, or at least should not be, “black boxes.” The agency’s rationale and reasoning are publicly stated, subject to criticism, and open to revision. Jury decisions are opaque, non-transparent, potentially unreasoned, not carefully articulated, and not subject to revision absent remarkable failures of proof.

One line of argument[2] pursued by Professor Bernstein follows from his observation that Daubert procedures are required to curtail litigation expert witness “adversarial bias.” Id. at 555. Bernstein traces adversarial bias to three sources:

(1) conscious bias;

(2) unconscious bias; and

(3) selection bias.

Id. Conscious bias stems from deliberate attempts by “hired guns” to deliver opinions that satisfy the lawyers who retained them. The problem of conscious bias is presented by “hired guns” who will adapt their opinions to the needs of the attorney who hires them. Unconscious biases are the more subtle, but no less potent determinants of expert witness behavior, which are created by financial dependence upon, and allegiance to, the witness’s paymaster. Selection bias results from lawyers’ ability to choose expert witnesses to support their claims, regardless whether those witnesses’ opinions are representative of the scientific community. Id.

Professor Bernstein’s taxonomy of bias is important, but incomplete. First, the biases he identifies operate fulsomely in regulatory settings. Although direct financial remuneration is usually not a significant motivation for a scientist to testify before an agency, or to submit a whitepaper, professional advancement and cause advocacy are often powerful incentives at work. These incentives for self-styled public interest zealots may well create more powerful distortions of scientific judgment than any monetary factors in private litigation settings. As for selection bias, lawyers are ethically responsible for screening their expert witnesses, and there can be little doubt that once expert witnesses are disclosed, their opinions will align with their sponsoring parties’ interests. This systematic bias, however, does not necessarily mean that both side’s expert witnesses will necessarily be unrepresentative or unscientific. In the silicone gel breast implant litigation (MDL 926), Judge Pointer, the presiding judge, insisted that both sides’ witnesses were “too extreme,” and he was stunned when his court-appointed expert witnesses filed reports that vindicated the defendants’ expert witnesses’ positions[3]. The defendants had selected expert witnesses who analyzed the data on sound scientific principles; the plaintiffs had selected expert witnesses who overreached in their interpretation of the evidence. Furthermore, many scientific disputes, which find their way into the courtroom, will not have the public profile of silicone gel breast implants, and for which there may be no body of scientific community opinion from which lawyers could select “outliers,” even if they wished to do so.

Professor Bernstein’s offered taxonomy of bias is incomplete because it does not include the most important biases that jurors (and many judges) struggle to evaluate:

random errors;

systematic biases;

confounding; and

cognitive biases.

These errors and biases, along with their consequential fallacies of reasoning, apply with equal force to agency and litigation science. Bernstein does point out, however, an important institutional difference between jury or judge trials and agency review and decisions based upon scientific evidence: agencies often have extensive in-house expertise. Although agency expertise may sometimes be blinded by its policy agenda, agency procedures usually afford the public and the scientific community to understand what the agency decided, and why, and to respond critically when necessary. In the case of the Food and Drug Administration, agency decisions, whether pro- or contra-industry positions are dissected and critiqued by the scientific and statistical community with great care and relish. Nothing of the same sort is possible in response to a jury verdict.

Professor Bernstein is not a science nihilist, and he would not have reviewing courts give a pass to whatever nonsense federal agencies espouse. He calls for enforcement of available statutory requirements that agency action be based upon the “best available science,” and for requiring agencies to explicitly separate and state their policy and scientific judgments. Bernstein also urges greater use of agency peer review, such as occasionally seen from the Institute of Medicine (soon to be the National Academy of Medicine), and the use of Daubert-like criteria for testimony at agency hearings. Bernstein at 554.

Proponents of regulatory Daubert should take Professor Bernstein’s essay to heart, with a daily dose of atorvastatin. Importing Rule 702 into agency proceedings may well undermine the rule’s import in litigation, civil and criminal, while achieving little in the regulatory arena. Consider the pending OSHA rulemaking for lowering the permissible exposure limit (PEL) of crystalline silica in the workplace. OSHA, and along with some public health organizations, has tried to justify this rulemaking on the basis of many overwrought claims of the hazards of crystalline silica exposure at current levels. Clearly, there are some workers who continue to work in unacceptably hazardous conditions, but the harms sustained by these workers can be tied to violations of the current PEL; they are hardly an argument for lowering that current PEL. Contrary to the OSHA’s parade of horribles, silicosis mortality in the United States has steadily declined over the last several decades. The following chart draws upon NIOSH and other federal governmental data:

Silicosis deaths, crude and age-adjusted death rates, for U.S. residents age 15 and over, 1968–2007

from Susan E. Dudley & Andrew P. Morriss, “Will the Occupational Safety and Health Administration’s Proposed Standards for Occupational Exposure to Respirable Crystalline Silica Reduce Workplace Risk?” 35 Risk Analysis (2015), in press, doi: 10.1111/risa.12341 (NIOSH reference number: 2012F03–01, based upon multiple cause-of-death data from National Center for Health Statistics, National Vital Statistics System, with population estimates from U.S. Census Bureau).

The decline in silicosis mortality is all the more remarkable because it occurred in the presence of stimulated reporting from silicosis litigation, and misclassification of coal workers’ pneumoconiosis in coal-mining states.

The decline in silicosis mortality may be helpfully compared with the steady rise in mortality from accidental falls among men and women 65 years old, or older:

Yahtyng Sheu, Li-Hui Chen, and Holly Hedegaard, “QuickStats: Death Rates* from Unintentional Falls† Among Adults Aged ≥ 65 Years, by Sex — United States, 2000–2013,” 64 CDC MMWR 450 (May 1, 2015). Over the observation period, these death rates roughly doubled in both men and women.

Is there a problem with OSHA rulemaking? Of course. The agency has gone off on a regulatory frolic and detour trying to justify an onerous new PEL, without any commitment to enforcing its current silica PEL. OSHA has invoked the prospect of medical risks, many of which are unproven, speculative, and remote, such as lung cancer, autoimmune disease, and kidney disease. The agency, however, is awash with PhDs, and I fear that Professor Bernstein is correct that the distortions of the science are not likely to be corrected by applying Rule 702 to agency factfinding. Courts, faced with the complex prediction models, with disputed medical claims made by agency and industry scientists, will do what they usually do, shrug and defer. And the blow back of the “judicially approved” agency science in litigation contexts will be a cure worse than the disease. At bottom, the agency twisting of science is driven by policy goals and considerations, which require public debate and scrutiny, sound executive judgment, with careful legislative oversight and guidance.

[1] Even under the very low evidentiary and procedural hurdles, federal agencies still manage to outrun their headlights on occasion. See, e.g., Industrial Union Department v. American Petroleum Institute, 448 U.S. 607 (1980) (The Benzene Case); Gulf South Insulation v. U.S. Consumer Product Safety Comm’n, 701 F.2d 1137 (5th Cir. 1983); Corrosion Proof Fittings v. EPA, 947 F2d 1201 (5th Cir 1991).

[2] See also David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27, 31 (2013); David E. Bernstein, “Expert Witnesses, Adversarial Bias, and the (Partial) Failure of the Daubert Revolution,” 93 Iowa L. Rev. 451, 456–57 (2008).

[3] Judge Pointer was less than enthusiastic about performing any gatekeeping role. Unlike most of today’s MDL judges, he was content to allow trial judges in the transferor districts to decide Rule 702 and other pre-trial issues. See Note, “District Judge Takes Issue With Circuit Courts’ Application of Gatekeeping Role” 3 Federal Discovery News (Aug. 1997) (noting that Chief Judge Pointer had criticized appellate courts for requiring district judges to serve as gatekeepers of expert witness testimony).

Posted in Rule 702, Scientific Evidence, Silica | Comments Off on Professor Bernstein’s Critique of Regulatory Daubert

Another Confounder in Lung Cancer Occupational Epidemiology — Diesel Engine Fumes

June 13th, 2012

Researchers obviously need to be aware of, and control for, potential and known confounders. In the context of investigating the etiologies of lung cancer, there is a long list of potential confounding exposures, often ignored in peer-reviewed papers, which focus on one particular outcome of interest. Just last week, I wrote to emphasize the need to account for potential and known confounding agents, and how this need was particularly strong in studies of weak alleged carcinogens such as crystalline silica. See Sorting Out Confounded Research – Required by Rule 702. Yesterday, the World Health Organization (WHO) added another “known” confounder for lung cancer epidemiology: diesel fume.

According to the International Agency for Research on Cancer (IARC), a division of the WHO, a working group of international experts voted to reclassify diesel engine exhaust as a “Group I” carcinogen. IARC: Diesel engines exhaust carcinogenic (2012). This classification means, in IARC parlance, that ” there is sufficient evidence of carcinogenicity in humans. Exceptionally, an agent may be placed in this category when evidence of carcinogenicity in humans is less than sufficient but there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the agent acts through a relevant mechanism of carcinogenicity.” The Group was headed up by Dr. Christopher Portier, who is the director of the National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry at the Centers for Disease Control and Prevention. Id.

The reclassification removes diesel exhaust from its previous categorization as a Group 2A carcinogen, which is interpreted “as probably carcinogenic to humans.” Diesel exhaust has been on a high-priority list for re-evaluation since 1998, as result of epidemiologic research from many countries. The Working Group specifically found that there was sufficient evidence to conclude that diesel exhaust is a cause of lung cancer in humans, and limited evidence to support an association with bladder cancer. The Group rejected any change in classification of gasoline engine exhaust from its current IARC rating as “possibly carcinogenic to humans. (Group 2B).”

Unlike other IARC Working Group decisions (such as crystalline silica), which were weakened by close votes and significant dissents, the diesel Group’s conclusion was unanimous. The diesel Group appeared to be impressed by two recent studies of lung cancer in underground miners, released in March 2012. One study was in a large cohort, conducted by NIOSH, and the other was a nested case-control study, conducted by the National Cancer Institute (NCI). See Debra T. Silverman, Claudine M. Samanic, Jay H. Lubin, Aaron E. Blair, Patricia A. Stewart , Roel Vermeulen, Joseph B. Coble, Nathaniel Rothman, Patricia L. Schleiff , William D. Travis, Regina G. Ziegler, Sholom Wacholder, Michael D. Attfield, “The Diesel Exhaust in Miners Study: A Nested Case-Control Study of Lung Cancer and Diesel Exhaust,” J. Nat’l Cancer Instit. (2012)(in press and open access); and Michael D. Attfield, Patricia L. Schleiff, Jay H. Lubin, Aaron Blair, Patricia A. Stewart, Roel Vermeulen, Joseph B. Coble, and Debra T. Silverman, “The Diesel Exhaust in Miners Study: A Cohort Mortality Study With Emphasis on Lung Cancer,” J. Nat’l Cancer Instit. (2012)(in press).

According to a story in the New York Times, the IARC Working Group described diesel engine exhaust as “more carcinogenic than secondhand cigarette smoke.” Donald McNeil, “W.H.O. Declares Diesel Fumes Cause Lung Cancer,” N.Y. Times (June 12, 2012). The Times also quoted Dr. Debra Silverman, NCI chief of environmental epidemiology, at length. Dr. Silverman, who was the lead author of the nested case-control study cited by the IARC Press Release, noted that her large study showed that long-term heavy exposure to diesel fumes increased lung cancer risk seven fold. Dr. Silverman described this risk as much greater than that thought to be created by passive smoking, but much smaller than smoking two packs of cigarettes a day. She stated that “totally” supported the IARC reclassification, and that she believed that governmental agencies would use the IARC analysis as the basis for changing the regulatory classification of diesel exhaust.

Silverman’s nested case-control study appears to have been based upon careful diesel exhaust exposure information, as well as smoking histories. The study also searched and analyzed for other potential confounders, which might be expected to be involved in underground mining:

“Other potential confounders [ie, duration of cigar smoking; frequency of pipe smoking; environmental tobacco smoke; family history of lung cancer in a first-degree relative; education; body mass index based on usual adult weight and height; leisure time physical activity; diet; estimated cumulative exposure to radon, asbestos, silica, polycyclic aromatic hydrocarbons (PAHs) from non-diesel sources, and respirable dust in the study facility based on air measurement and other data (14)] were evaluated but not included in the final models because they had little or no impact on odds ratios (ie, inclusion of these factors in the final models changed point estimates for diesel exposure by ≤ 10%).”

Silverman, et al., at 4. The absence of an association between lung cancer and silica exposure is noteworthy in a such a large study of underground miners.

Posted in Causation, Risk and Risk Factor, Rule 702, Scientific Evidence, Silica | Comments Off on Another Confounder in Lung Cancer Occupational Epidemiology — Diesel Engine Fumes