TORTINI

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

Sophisticated Intermediary Defense in Asbestos Cases – Use With Discretion

May 20th, 2019

“Discretion is the better part of valor.” Shakespeare, King Henry the Fourth.

A recent asbestos case illustrates the perils of improvidently asserting a sophisticated intermediary defense, when the alleged injury is mesothelioma, and the years of exposure reach back to the 1940s. In Sawyer v. Union Carbide Corp., Foster Wheeler LLC, pleaded sophisticated intermediary and superseding cause defenses “pro forma,” in a mesothelioma case that involved asbestos exposure from 1948 through the 1970s.[1] Plaintiff moved for partial summary judgment on these two defenses, but rather than withdraw the defenses, Foster Wheeler attempted to present evidentiary support in the form of the employer’s (purchaser’s) knowledge of asbestos hazards. The employer was the Bethlehem Steel Company, at the Bethlehem Steel Sparrows Point Shipyard.

Foster Wheeler certainly was able to show that Bethlehem Steel was aware of the hazards of asbestosis, going back to 1948. If the plaintiff’s alleged injury had been asbestosis, the employer’s knowledge should have sufficed. The injury alleged, however, was mesothelioma. Evidence that the Maritime Commission had warned Bethlehem Steel about the hazards of asbestosis, and to maintain a threshold limit value of 5 million particles per cubic foot, was not particularly germane or helpful in avoiding mesothelioma among employees.

Moving forward two decades, Foster Wheeler was able to show that Bethlehem Steel’s Medical Director, Dr. Paul J. Whitaker, was well aware of the connection between asbestos exposure and mesothelioma, in 1968.[2] This evidence, however, left two decades of exposure, from 1948 to 1968, in which Foster Wheeler had not shown its purchaser was aware of the risk of mesothelioma.

The trial court in Sawyer, however, did not focus on the differential between an asbestosis and a mesothelioma hazard. Instead of noting the lack of knowledge with respect to mesothelioma, the trial court insisted that the supplier must have subjective awareness of the purchaser’s actual knowledge of the relevant hazards. Even the overwhelming evidence of Bethlehem’s awareness of asbestosis hazards throughout the plaintiff’s employment was thus, questionably, deemed irrelevant.

According the trial court, the sophisticated intermediary defense focuses on what “focuses on what the product manufacturer knew and the reasonableness of its reliance on the employer prior to and during the time the workers were exposed.”[3] The Sawyer court took this focus to require a showing that the defendant had actual awareness of the intermediary’s knowledge of the dangers of asbestos exposure. According to the decision, Foster Wheeler failed to establish a basis for having such actual knowledge of Bethlehem Steel’s knowledge.

The Sawyer court’s insistence upon actual awareness is not supported by its citation to the Restatement (Second) of Torts. The relevant provision for sales of products to be used by a third party states that[4]:

“One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier

  • knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
  • has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
  • fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.”

The Restatement’s articulated standard does not call for the seller’s subjective awareness as a necessary condition. Having a reason to believe the user will realize its dangerous condition seems eminently satisfied by a generalized, reasonable belief that purchasers are sophisticated with respect to the product’s use. Foster Wheeler might have improved its evidentiary showing in opposition to plaintiff’s motion, however, by adverting to its own knowledge that there was a prevalent regulatory scheme, including the Walsh-Healy Act, which covered the safety of workers in the use of asbestos. As noted above, this knowledge would not have implicated the hazard of mesothelioma or the means to avoid it in purchasers’ workplaces.

The Sawyer decision offered virtually no support for the proposition that the seller, wishing to avail itself of the sophisticated intermediary defense, must have actual knowledge of the buyer’s awareness of the relevant hazard. Failure to warn liability for a product’s harm is predicated upon negligence law. Almost all civilized jurisdictions require plaintiff to show negligence in such cases.[5] The test for non-obviousness such that a warning might be required under the law is an objective one, which does not turn on the user’s actual knowledge of the hazard.[6]

Although standing on the sophisticated intermediary defense may have been improvident in Sawyer, there are many cases that cry out for dismissal on the strength of the defense. The facts of silica cases, for example, are radically different from early exposure asbestos cases because of the wide diffusion and general equality of knowledge of silica hazards throughout industry, labor, and government.[7]  The dangers of occupational exposure to crystalline silica were so well known that the New York Court of Appeals recognized, seventy years ago, that “[i]t is a matter of common knowledge that it is injurious to the lungs and dangerous to health to work in silica dust.”[8] This pervasiveness of knowledge about the potential hazards of industrial silica exposure has been the basis for many dispositive rulings in silica cases, even when the sellers lacked subjective awareness of the buyer’s state of mind.[9]

Product liability is defined and bounded by the scope of an essential need for warnings in the face of imbalances in knowledge between seller and buyer. When the rationale is not or cannot be satisfied, ignoring the sophisticated intermediary’s knowledge is little more than creating a “duty to pay.” In the context of industrial sales of materials and products to large, sophisticated buyers, the law recognizes that warnings are often unnecessary and even counter-productive when hazards of the materials or products are known to the buyers as well as, if not better than, to the sellers. The so-called sophisticated intermediary defense thus reflects nothing more than the rational limits of liability in situations when the chattel is widely known to be hazardous, and the seller can reasonably rely upon the intermediary to be aware of the hazard and to protect down-stream users, typically employees of the purchaser.

Because of the shift in knowledge about the causal relationship between amphibole asbestos and mesothelioma, asbestos product cases would appear unlikely applications for sophisticated intermediary defenses, at least until the knowledge of mesothelioma hazards became widely prevalent. Because of the  change in the state of the art with respect to asbestos hazards, asbestos cases involve substantial factual and legal differences from other hazardous material cases. The singular facts of some of the asbestos cases include an extreme imbalance between supplier and some purchasers in their respective knowledge of asbestos hazards. Accordingly, jurisdictions that have embraced the sophisticated intermediary defense have thus treated asbestos cases, with pre-OSHA exposures, differently from other occupational exposure cases.[10]

The OSH Act of 1970, which created OSHA, was fueled in large part by wide-spread awareness and concern about asbestos exposure and occupational cancers, such as mesothelioma. In asbestos cases involving only post-1969 asbestos exposures, courts have upheld the applicability of the sophisticated intermediary defense. Thus a federal trial court in Kentucky, applying Indiana law, granted summary judgment to a respirator manufacturer, on the basis of the sophisticated intermediary defense, in a post-OSHA asbestos lung cancer case.[11] Similarly, a Virginia state trial court, notwithstanding the application of Virginia law in the Willis and Oman federal cases upheld the sophisticated intermediary defense as a complete legal defense for asbestos sales after 1970.[12] The decisions in these asbestos cases with only post-1970 asbestos exposure emphasized the equality of knowledge of asbestos hazards, which distinguished them from earlier asbestos cases involving companies such as Johns-Manville, which had been found to suppress or hide information from purchasers and workers.[13]


[1] Sawyer v. Union Carbide Corp., Civil No. CCB-16-118, 2019 U.S. Dist. LEXIS 72215 at *33; 2019 WL 1904882 (D. Md. April 29, 2019).

[2] Sawyer at *36.

[3] Sawyer at *36 (quoting Willis v. Raymark Indus., Inc., 905 F.2d 793, 797 (4th Cir. 1990)).

[4]  § 388 Chattel Known to Be Dangerous for Intended Use, Restatement (Second) of Torts (1965).

[5] Under New York law, for instance, the duty to warn in strict liability is identical in nature and scope as the duty in negligence. Martin v. Hacker, 83 N.Y. 1, 8 n.1 (1993). New York law acknowledges that there is no meaningful distinction between negligent and strict liability failure to warn claims. See Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir. 1991) (New York law) (“Failure to warn claims purporting to sound in strict liability and those sounding in negligence are essentially the same.”). See also Rainbow v. Albert Elia Bldg. Co., 49 A.D.2d 250 (4th Dept. 1974) (distinguishing manufacturing and design defects, and permitting “reasonableness” defenses, including state-of-the-art defenses, to the latter in strict products liability), aff’d, 56 N.Y.2d 550 (1981). On the equivalence between negligence and product liability for failure to warn, New York law is aligned with the law of most states. See Restatement (Third) of Torts: Products Liability § 2, and comment I (1998); Restatement (Second) of Torts § 388 & comment n (1965); Restatement (First) of Torts § 388, comment 1 (1934).

[6] The standard for the open and obvious defense, which is many respects is a variant of the sophisticated intermediary defense, is an objective one, based on what would be obvious to the ordinary person. See Plante v. Hobart Corp., 771 F.2d 617, 620 (1st Cir. 1985) (“Where the danger involved in using a product is obvious and apparent, discernible by casual inspection, a supplier is not negligent in failing to warn of that danger.”); Fleck v. KDI Sylvan Pools, Inc., 981 F.2d 107, 119 (3d Cir. 1992) (“[W]hether a danger is open and obvious is an objective inquiry, not dependent upon the actual knowledge of the user or his actual awareness of the danger.”); Glittenberg v. Doughboy, 491 N.W.2d 208, 213 (Mich. 1992) (“Determination of the ‘obvious’ character of a product- connected danger is objective.”).

[7] See Linda Regis, “Frame the Sandbox to Sandblasting: Regulation of Crystalline Silica,” 17 Pace Envt’l L. Rev. 207, 208 n. 8 (1999); Richard Ausness, “Learned Intermediaries and Sophisticated Users: Encouraging the Use of Intermediaries to Transmit Product Safety Information,” 46 Syracuse L. Rev. 1185, 1205-07 (1996); Kenneth Willner, “Failures to Warn and the Sophisticated User Defense,” 74 Va. L. Rev. 579 (1988); Victor Schwartz & Russell Driver, “Warnings in the Workplace: The Need for a Synthesis of Law and Communication Theory,” 52 U. Cin. L. Rev. 38 (1983).

[8] Sadowski v. Long Island RR., 292 N.Y. 448, 456 (1944) (emphasis added). A few years later, the United States Supreme Court concurred and quoted Sadowski. Urie v. Tompkins, 337 U.S. 163, 190 (1949).

[9] 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); Smith v. Walter C. Best, Inc., 927 F.2d 736 (3d Cir. 1990) (applying Ohio law in a silica foundry case); Bergfeld v. Unimin Corp., 319 F.3d 350 (8th Cir. 2003) (applying Iowa law to affirm summary judgment); Haase v. Badger Mining Corp., 266 Wis. 2d 970 (Wis. Ct. App. 2003), aff’d, 274 Wis. 2d 143 (2004); Damond v. Avondale Industries, 718 So. 2d 551 (La. App. 1998) (affirming summary judgment for a silica supplier on a worker’s claims for silicosis from sandblasting, which if not done carefully, can be an extremely hazardous); Cowart v. Avondale Indus., 792 So. 2d 73 (La. Ct. App. 2001) (holding that the sophisticated user defense was dispositive in a foundry workplace, which was sophisticated about the potential hazards of its silica use); Bates v. E.D. Bullard Co., 76 So.3d 111 (La.App. 2011) (affirming summary judgment for silica suppliers); Phillips v. A.P. Green Refractories Co., 428 Pa. Super. 167, 630 A.2d 874 (1993), aff’d on other grounds, Phillips v. A-Best Products Co., 542 Pa. 124, 665 A.2d 1167 (1995) (lack of proximate cause for claimed failure to warn).

[10] Virginia law, which governed the Willis case cited by the Sawyer court is illustrative. Compare Oman v. Johns-Manville Corp., 764 F.2d 224 (4th Cir. 1985) (applying Virginia law, which embraces § 388, but refusing to apply the doctrine because the employer was unaware of asbestos hazards during plaintiffs’ employment before 1964), cert. denied sub nom. Oman v. H.K. Porter, 474 U.S. 970 (1985), with Beale v. Hardy, 469 F.2d 213 (4th Cir. 1985) (holding that Section 388 was a complete defense in silicosis cases under Virginia law). Michigan, another industrialized state with well-developed case law, also illustrates the disparate treatment of asbestos cases. Compare Russo v. Abex Corp., 670 F. Supp. 206, 208 (E.D. Mich. 1987) (holding that “asbestos-containing product manufacturers have an absolute duty to warn because of the unique and patent dangers of asbestos”) with Jodway v. Kennametal, Inc., 207 Mich. App. 622, 525 N.W.2d 883 (Mich. Ct. App. 1994) (applying Section 388 in hard-metal (cobalt) lung disease case); Kudzia v. Carboloy Division, 190 Mich. App. 285, 475N.W.2d 371 (1991) (same), aff’d, 439 Mich. 923, 479 N.W.2d 679 (1992); Tasca v. GTE Products Corp., 175 Mich. App. 617, 438 N.W.2d 625 (Mich. Ct. of App. 1989) (same). See also Antcliff v. State Employees Credit Union, 414 Mich. 624, 640 (1982); Ross v. Jaybird Automation, Inc., 172 Mich. App. 603, 607 (1988); Rasmussen v. Louisville Ladder Co., Inc., 211 Mich. App. 541, 547-48 (1995); Portelli v. I.R. Construction Products Co., 218 Mich. App. 591, 599 (1996); Mills v. Curioni, 238 F. Supp. 876, 894-96 (E.D. Mich. 2002).

[11] Triplett v. Minnesota Mining & Mfg. Co., 422 F. Supp. 2d 779 (W.D. Ky. 2006).

[12] Bean v. Asbestos Corporation, Ltd., 1998 WL 972122 (Va. Cir. Ct. 1998).

[13] See also Gottschall v. General Electric Co., 2011 U.S. Dist. LEXIS 151563 (E.D. Pa. Dec. 8, 2011) (MDL 875) (California law; granting summary judgment when the Navy’s knowledge of asbestos hazards was equal to that of defendant), rev’d, No. 14-15379, 14-15380, 2016 U.S. App. LEXIS 17248 (9th Cir. 2016).

Specious Claiming in Multi-District Litigation

May 2nd, 2019

In a recent article in an American Bar Association newsletter, Paul Rheingold notes with some concern that, in the last two years or so, there has been a rash of dismissals of entire multi-district litigations (MDLs) based upon plaintiffs’ failure to produce expert witnesses who can survive Rule 702 gatekeeping.[1]  Paul D. Rheingold, “Multidistrict Litigation Mass Terminations for Failure to Prove Causation,” A.B.A. Mass Tort Litig. Newsletter (April 24, 2019) [cited as Rheingold]. According to Rheingold, judges historically involved in the MDL processing of products liability cases did not grant summary judgments across the board. In other words, federal judges felt that if plaintiffs’ lawyers aggregated a sufficient number of cases, then their judicial responsibility was to push settlements or to remand the cases to the transferor courts for trial.

Missing from Rheingold’s account is the prevalent judicial view, in the early going of MDL of products cases, which held that judges lacked the authority to consider Rule 702 motions for all cases in the MDL. Gatekeeping motions were considered extreme and best avoided by pushing them off to the transferor courts upon remand. In MDL 926, involving silicone gel breast implants, the late Judge Sam Pointer, who was a member of the Rules Advisory Committee, expressed the view that Rule 702 gatekeeping was a trial court function, for the trial judge who received the case on remand from the MDL.[2] Judge Pointer’s view was a commonplace in the 1990s. As mass tort litigation moved into MDL “camps,” judges more frequently adopted a managerial rather than a judicial role, and exerted great pressure on the parties, and the defense in particular, to settle cases. These judges frequently expressed their view that the two sides so stridently disagreed on causation that the truth must be somewhere in between, and even with “a little causation,” the defendants should offer a little compensation. These litigation managers thus eschewed dispositive motion practice, or gave it short shrift.

Rheingold cites five recent MDL terminations based upon “Daubert failure,” and he acknowledges other MDLs collapsed because of federal pre-emption issues (Eliquis, Incretins, and possibly Fosamax), and that other fatally weak causal MDL claims settled for nominal compensation (NuvaRing). He omits other MDLs, such as In re Silica, in which an entire MDL collapsed because of prevalent fraud in the screening and diagnosing of silicosis claimants by plaintiffs’ counsel and their expert witnesses.[3] Also absent from his reckoning is the collapse of MDL cases against Celebrex[4] and Viagra[5].

Rheingold does concede that the recent across-the-board dismissals of MDLs were due to very weak causal claims.[6] He softens his judgment by suggesting that the weaknesses were apparent “at least in retrospect,” but the weaknesses were clearly discernible before litigation by the refusal of regulatory agencies, such as the FDA, to accept the litigation-driven causal claims. Rheingold also tries to assuage fellow plaintiffs’ counsel by suggesting that plaintiffs’ lawyers somehow fell prey to the pressure to file cases because of internet advertising and the encouragement of records collection and analysis firms. This attribution of naiveté to Plaintiffs’ Steering Committee (PSC) members does not ring true given the wealth and resources of lawyers on PSCs. Furthermore, the suggestion that PSC member may be newcomers to the MDL playing fields does not hold water given that most of the lawyers involved are “repeat players,” with substantial experience and financial incentives to sort out invalid expert witness opinions.[7]

Rheingold offers the wise counsel that plaintiffs’ lawyers “should take [their] time and investigate for [themselves] the potential proof available for causation and adequacy of labeling.” If history is any guide, his advice will not be followed.


[1] Rheingold cites five MDLs that were “Daubert failures” in the recent times: (1) In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Prods. Liab.  Litig. (MDL 2502), 892 F.3d 624 (4th Cir. 2018) (affirming Rule 702 dismissal of claims that atorvastatin use caused diabetes); (2) In re Mirena IUD Products Liab. Litig. (Mirena II, MDL 2767), 713 F. App’x 11 (2d Cir. 2017) (excluding expert witnesses’ opinion testimony that the intrauterine device caused embedment and perforation); (3) In re Mirena Ius Levonorgestrel-Related Prods. Liab. Litig., (Mirena II), 341 F. Supp. 3d 213 (S.D.N.Y. 2018) (affirming Rule 702 dismissal of claims that product caused pseudotumor cerebri); (4) In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 858 F.3d 787 (3d Cir. 2017) (affirming MDL trial court’s Rule 702 exclusions of opinions that Zoloft is teratogenic); (5) Jones v. SmithKline Beecham, 652 F. App’x 848 (11th Cir. 2016) (affirming MDL court’s Rule 702 exclusions of expert witness opinions that denture adhesive creams caused metal deficiencies).

[2]  Not only was Judge Pointer a member of the Rules committee, he was the principal author of the 1993 Amendments to the Federal Rules of Civil Procedure, as well as the editor-in-chief of the Federal Judicial Center’s Manual for Complex. At an ALI-ABA conference in 1997, Judge Pointer complained about the burden of gatekeeping. 3 Federal Discovery News 1 (Aug. 1997). He further opined that, under Rule 104(a), he could “look to decisions from the Southern District of New York and Eastern District of New York, where the same expert’s opinion has been offered and ruled upon by those judges. Their rulings are hearsay, but hearsay is acceptable. So I may use their rulings as a basis for my decision on whether to allow it or not.” Id. at 4. Even after Judge Jack Weinstein excluded plaintiffs’ expert witnesses’ causal opinions in the silicone litigation, however, Judge Pointer avoided having to make an MDL-wide decision with the scope of one of the leading judges from the Southern and Eastern Districts of New York. See In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996). Judge Pointer repeated his anti-Daubert views three years later at a symposium on expert witness opinion testimony. See Sam C. Pointer, Jr., “Response to Edward J. Imwinkelried, the Taxonomy of Testimony Post-Kumho: Refocusing on the Bottom Lines of Reliability and Necessity,” 30 Cumberland L. Rev. 235 (2000).

[3]  In re Silica Products Liab. Litig., MDL No. 1553, 398 F. Supp. 2d 563 (S.D. Tex. 2005).

[4]  In re Bextra & Celebrex Marketing Sales Practices & Prod. Liab. Litig., 524 F. Supp. 2d 1166 (N.D. Calif. 2007) (excluding virtually all relevant expert witness testimony proffered to support claims that ordinary dosages of these COX-2 inhibitors caused cardiovascular events).

[5]  In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071 (D. Minn. 2008) (addressing claims that sildenafil causes vision loss from non-arteritic anterior ischemic optic neuropathy (NAION)).

[6]  Rheingold (“Examining these five mass terminations, at least in retrospect[,] it is apparent that they were very weak on causation.”)

[7] See Elizabeth Chamblee Burch & Margaret S. Williams, “Repeat Players in Multidistrict Litigation: The Social Network,” 102 Cornell L. Rev. 1445 (2017); Margaret S. Williams, Emery G. Lee III & Catherine R. Borden, “Repeat Players in Federal Multidistrict Litigation,” 5 J. Tort L. 141, 149–60 (2014).

Good Night Styrene

April 18th, 2019

Perri Klass is a pediatrician who writes fiction and non-fiction. Her editorial article on “disruptive chemicals,” in this week’s Science Section of the New York Times contained large segments of fiction.[1]  The Times gives Dr. Klass, along with Nicholas Kristof and others, a generous platform to advance their chemophobic propaganda, on pesticides, phthalates, bisphenols, and flame retardants, without the bother of having to cite evidence. It has been just two weeks since the Times published another Klass fear piece on hormone disrupters.[2]

In her Science Times piece, Klass plugged Leonardo Trasande’s book, Sicker, Fatter, Poorer: The Urgent Threat of Hormone-Disrupting Chemicals to Our Health and Future . . . and What We Can Do About It (2019), to help wind up parents about chemical threats everywhere. Trasande, is “an internationally renowned leader in environmental health” expert; his website tells us so. Klass relies so extensively upon Trasande that it is difficult to discern whether she is presenting anything other than his opinions, which in some places she notes he has qualified as disputed and dependent upon correlational associations that have not established causal associations.

When it comes to recyclable plastic, number 6, Klass throws all journalistic caution and scientific scruple aside and tells us that “[a] number 6 denotes styrene, which is a known carcinogen.”[3] Known to whom? To Trasande? To Klass? To eco-zealots?

The first gaffe is that number 6 plastic, of course, is not styrene; rather it is polystyrene. Leaching of monomer certainly can occur,[4] and is worth noting, but equating polystyrene with styrene is simply wrong. The second gaffe, more serious yet, is that styrene is not a “known” carcinogen.

The International Agency for Research on Cancer, which has been known to engage in epistemic inflation about carcinogenicity, addressed styrene in its monograph 82.[5] Styrene was labeled a “2B” carcinogen, that is possible, not probable, and certainly not “known.” Last year, an IARC working group revisited the assessment of styrene, and in keeping with its current practice of grade inflation bumped styrene up to Group 2A, “probably carcinogenic to humans” based upon limited evidence in human being and sufficient evidence in rats and close relatives.[6] In any event, the IARC Monograph number 121, which will address styrene, is under preparation.

A responsible journalist, or scientist, regulator, or lawyer, is obligated however to note tha “probably” does not mean “more likely than not” in IARC-jargon.[7] Given that all empirical propositions have a probability of being true, somewhere between 0 and 100%, but never actually equal to 0 or 100%, the IARC classifications of “probably” causing cancer are probably not particularly meaningful.  Everything “probably” causes cancer, in this mathematical sense.[8]

In the meanwhile, what does the scientific community have to say about the carcinogenicity of styrene?

Recent reviews and systematic reviews of the styrene carcinogenicity issue have mostly concluded that there is no causal relationship between styrene exposure and any form of cancer in humans.[9] Of course, the “Lobby,” scientists in service to the litigation industry, disagree.[10]


[1]  Perri Klass, “Beware of Disruptive Chemicals,” N.Y. Times (April 16, 2019).

[2] Perri Klass, “How to Minimize Exposures to Hormone Disrupters,” N.Y. Times (April 1, 2019).

[3]  Klass (April 16, 2019), at D6, col. 3.

[4]  See, e.g., Despoina Paraskevopoulou, Dimitris Achiliasa, and Adamantini Paraskevopoulou, “Migration of styrene from plastic packaging based on polystyrene into food simulants,” 61 Polymers Internatl’l 141 (2012); J. R. Withey, “Quantitative Analysis of Styrene Monomerin Polystyrene and Foods Including Some Preliminary Studies of the Uptake and Pharmacodynamics of the Monomer in Rats,” 17 Envt’l Health Persp. 125 (1976).

[5]  IARC Monograph No. 82, at 437-78 (2002).

[6]  IARC Working Group, “Carcinogenicity of quinoline, styrene, and styrene-7,8-oxide,” 19 Lancet Oncology 728 (2018).

[7]  The IARC Preamble definition of probable reveals that “probable” does not mean greater than 50%. See also “The IARC Process is Broken” (May 4, 2016).

[8] See Ed Yong, “Beefing With the World Health Organization’s Cancer Warnings,” The Atlantic (Oct 26, 2015).

[9]  Boffetta, P., Adami, H. O., Cole, P., Trichopoulos, D. and Mandel, J. S., “Epidemiologic studies of styrene and cancer: a review of the literature,” 51 J. Occup. & Envt’l Med. 1275 (2009) (“The available epidemiologic evidence does not support a causal relationship between styrene exposure and any type of human cancer.”); James J. Collins & Elizabeth Delzell, “A systematic review of epidemiologic studies of styrene and cancer,” 48 Critical Revs. Toxicol. 443 (2018)  (“Consideration of all pertinent data, including substantial recent research, indicates that the epidemiologic evidence on the potential carcinogenicity of styrene is inconclusive and does not establish that styrene causes any form of cancer in humans.”).

[10] James Huff & Peter F. Infante, “Styrene exposure and risk of cancer,” 26 Mutagenesis 583 (2011).

Litigation Science – In re Zambelli-Weiner

April 8th, 2019

Back in 2001, in the aftermath of the silicone gel breast implant litigation, I participated in a Federal Judicial Center (FJC) television production of “Science in the Courtroom, program 6” (2001). Program six was a round-table discussion among the directors (past, present, and future) of the FJC, all of whom were sitting federal judges, with two lawyers in private practice, Elizabeth Cabraser and me.1 One of the more exasperating moments in our conversation came when Ms. Cabraser, who represented plaintiffs in the silicone litigation, complained that Daubert was unfair because corporate defendants were able to order up supporting scientific studies, whereas poor plaintiffs counsel did not have the means to gin up studies that confirmed what they knew to be true.2 Refraining from talking over her required all the self-restraint I could muster, but I did eventually respond by denying her glib generalization and offering the silicone litigation as one in which plaintiffs, plaintiffs’ counsel, and plaintiffs’ support groups were all involved in funding and directing some of the sketchiest studies, most of which managed to find homes in so-called peer-reviewed journals of some sort, even if not the best.

The litigation connections of the plaintiff-sponsored studies in the silicone litigation were not apparent on the face of the published articles. The partisan funding and provenance of the studies were mostly undisclosed and required persistent discovery and subpoenas. Cabraser’s propaganda reinforced the recognition of what so-called mass tort litigation had taught me about all scientific studies: “trust but verify.” Verification is especially important for studies that are sponsored by litigation-industry actors who have no reputation at stake in the world of healthcare.

Verification is not a straightforward task, however. Peer-review publication usually provides some basic information about “methods and materials,” but rarely if ever do published articles provide sufficient data and detail about methodology to replicate the reported analysis. In legal proceedings, verification of studies conducted and relied upon by testifying expert witnesses is facilitated by the rules of expert witness discovery. In federal court, expert witnesses must specify all opinions and all bases for their opinions. When such witnesses rely upon their own studies, and thus have had privileged access to the complete data and all analyses, courts have generally permitted full inquiry into the underlying materials of relied-upon studies. On the other, when the author of a relied-upon study is a “stranger to the litigation,” neither a party nor a retained expert witness, courts have permitted generally more limited discovery of the study’s full data set and analyses. Regardless of the author’s status, the question remains how litigants are to challenge an adversary’s expert witness’s trusted reliance upon a study, which cannot be “verified.”

Most lawyers would prefer, of course, to call an expert witness who has actually conducted studies pertinent to the issues in the case. The price, however, of allowing the other side to discover the underlying data and materials of the author expert witness’s studies may be too high. The relied-upon studies may well end up discredited, as well as the professional reputation of the expert witness. The litigation industry has adapted to these rules of discovery by avoiding, in most instances, calling testifying expert witnesses who have published studies that might be vulnerable.3

One work-around to the discovery rules lies in the use of “consulting, non-testifying expert witnesses.” The law permits the use of such expert witnesses to some extent to facilitate candid consultations with expert witnesses, usually without concerns that communications will be shared with the adversary party and witnesses. The hope is that such candid communications will permit realistic assessment of partisan positions, as well as allowing scientists and scholars to participate in an advisory capacity without the burden of depositions, formal report writing, and appearances at judicial hearings and trials. The confidentiality of consulting expert witnesses is open to abuse by counsel who would engage the consultants to conduct and publish studies, which can then be relied upon by the testifying expert witnesses. The upshot is that legal counsel can manipulate the published literature in a favorable way, without having to disclose their financial sponsorship or influence of the published studies used by their testifying expert witnesses.

This game of hiding study data and sponsorship through the litigation industry’s use of confidential consulting expert witnesses pervades so-called mass tort litigation, which provides ample financial incentives for study sponsorship and control. Defendants will almost always be unable to play the game, without detection. A simple interrogatory or other discovery request about funding of studies will reveal the attempt to pass off a party-sponsored study as having been conducted by disinterested scientists. Furthermore, most scientists will feel obligated to reveal corporate funding as a potential conflict of interest, in their submission of manuscripts for publication.

Revealing litigation-industry (plaintiffs’) funding of studies is more complicated. First, the funding may be through one firm, which is not the legal counsel in the case for which discovery is being conducted. In such instances, the plaintiff’s lawyers can truthfully declare that they lack personal knowledge of any financial support for studies relied upon by their testifying expert witnesses. Second, the plaintiffs’ lawyer firm is not a party is not itself subject to discovery. Even if the plaintiffs’ lawyers funded a study, they can claim, with plausible deniability, that they funded the study in connection with another client’s case, not the client who is plaintiff in the case in which discovery is sought. Third, the plaintiffs’ firm may take the position, however dubious it might be, that the funding of the relied-upon study was simply a confidential consultation with the authors of that study, and not subject to discovery.

The now pending litigation against ondansetron (Zofran) provides the most recent example of the dubious use of consulting expert witnesses to hide party sponsorship of an epidemiologic study. The plaintiffs, who are claiming that Zofran causes birth defects in this multi-district litigation assigned to Judge F. Dennis Saylor, have designated Dr. Carol Luik as their sole testifying expert witness on epidemiology. Dr. Luik, in turn, has relied substantially upon a study conducted by Dr. April Zambelli-Weiner.4

According to motion papers filed by defendants,5 the plaintiffs’ counsel initially claimed that they had no knowledge of any financial support or conflicts for Dr Zambelli-Weiner. The conflict-of-interest disclosure in Zambelli-Weiner’s paper was, to say the least, suspicious:

The authors declare that there was no outside involvement in study design; in the collection, analysis and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.”

As an organization TTi reports receiving funds from plaintiff law firms involved in ondansetron litigation and a manufacturer of ondansetron.”

According to its website, TTi

is an economically disadvantaged woman-owned small business headquartered in Westminster, Maryland. We are focused on the development, evaluation, and implementation of technologies and solutions that advance the transformation of data into actionable knowledge. TTi serves a diverse clientele, including all stakeholders in the health space (governments, payors, providers, pharmaceutical and device companies, and foundations) who have a vested interest in advancing research to improve patient outcomes, population health, and access to care while reducing costs and eliminating health disparities.”

According to defendants’ briefing, and contrary to plaintiffs’ initial claims and Zambelli-Weiner’s anemic conflicts disclosure, plaintiffs’ counsel eventually admitted that “Plaintiffs’ Leadership Attorneys paid $210,000 as financial support relating to” Zambelli-Weiner’s epidemiologic study. The women at TTi are apparently less economically disadvantaged than advertised.

The Zofran defendants served subpoenas duces tecum and ad testificandum on two of the study authors, Drs. April Zambelli-Weiner and Russell Kirby. Curiously, the plaintiffs (who would seem to have no interest in defending the third-party subpoenas) sought a protective order by arguing that defendants were harassing “third-party scientists.” Their motion for protection conveniently and disingenuously omitted, that Zambelli-Weiner had been a paid consultant to the Zofran plaintiffs.

Judge Saylor refused to quash the subpoenas, and Zambelli-Weiner appeared herself, through counsel, to seek a protective order. Her supporting affidavit averred that she had not been retained as an expert witness, and that she had no documents “concerning any data analyses or results that were not reported in the [published study].” Zambelli-Weiner’s attempt to evade discovery was embarrassed by her having presented a “Zofran Litigation Update” with Plaintiffs’ counsel Robert Jenner and Elizabeth Graham at a national conference for plaintiffs’ attorneys. Judge Saylor was not persuaded, and the MDL court refused Dr. Zambelli-Weiner’s motion. The law and the public has a right to every man’s, and every woman’s, (even if economically disadvantaged) evidence.6

Tellingly, in the aftermath of the motions to quash, Zambelli-Weiner’s counsel, Scott Marder, abandoned his client by filing an emergency motion to withdraw, because “certain of the factual assertions in Dr. Zambelli-Weiner’s Motion for Protective Order and Affidavit were inaccurate.” Mr. Marder also honorably notified defense counsel that he could no longer represent that Zambelli-Weiner’s document production was complete.

Early this year, on January 29, 2019, Zambelli-Weiner submitted, through new counsel, a “Supplemental Affidavit,” wherein she admitted she had been a “consulting expert” witness for the law firm of Grant & Eisenhofer on the claimed teratogenicity of Zofran.7 Zambelli-Weiner also produced a few extensively redacted documents. On February 1, 2019, Zambelli-Weiner testified at deposition that the moneys she received from Grant & Eisenhofer were not to fund her Zofran study, but for other, “unrelated work.” Her testimony was at odds with the plaintiffs’ counsel’s confession that the $210,000 related to her Zofran study.

Zambelli-Weiner’s etiolated document production was confounded by the several hundred of pages of documents produced by fellow author, Dr. Russell Kirby. When confronted with documents from Kirby’s production, Zambelli-Weiner’s lawyer unilaterally suspended the deposition.

Deja Vu All Over Again

Federal courts have seen the Zambelli maneuver before. In litigation over claimed welding fume health effects, plaintiffs’ counsel Richard (Dickie) Scruggs and colleagues funded some neurological researchers to travel to Alabama and Mississippi to “screen” plaintiffs and potential plaintiffs in litigation for over claims of neurological injury and disease from welding fume exposure, with a novel videotaping methodology. The plaintiffs’ lawyers rounded up the research subjects (a.k.a. clients and potential clients), talked to them before the medical evaluations, and administered the study questionnaires. The study subjects were clearly aware of Mr. Scruggs’ “research” hypothesis, and had already promised him 40% of any recovery.8

After their sojourn, at Scruggs’ expense to Alabama and Mississippi, the researchers wrote up their results, with little or no detail of the circumstances of how they had acquired their research “participants,” or those participants’ motives to give accurate or inaccurate medical and employment history information.9

Defense counsel served subpoenas upon both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and all statistical analyses. Racette and Washington University resisted sharing their data and materials with every page in the Directory of Non-Transparent Research. They claimed that the subpoenas sought production of testimony, information and documents in violation of:

(1) the Federal Regulations set forth in the Department of Health and Human Services Policy for Protection of Human Research Subjects,

(2) the Federal regulations set forth in the HIPPA Regulations,

(3) the physician/patient privilege,

(4) the research scholar’s privilege,

(5) the trade secret/confidential research privilege and

(6) the scope of discovery as codified by the Federal Rules of Civil Procedure and the Missouri Rules of Civil Procedure.”

After a long discovery fight, the MDL court largely enforced the subpoenas.10 The welding MDL court ordered Racette to produce

a ‘limited data set’ which links the specific categories requested by defendants: diagnosis, occupation, and age. This information may be produced as a ‘deidentified’ data set, such that the categories would be linked to each particular patient, without using any individual patient identifiers. This data set should: (1) allow matching of each study participant’s occupational status and age with his or her neurological condition, as diagnosed by the study’s researchers; and (2) to the greatest extent possible (except for necessary de-identification), show original coding and any code-keys.”

After the defense had the opportunity to obtain and analyze the underlying data in the Scruggs-Racette study, the welding plaintiffs retreated from their epidemiologic case. Various defense expert witnesses analyzed the underlying data produced by Racette, and prepared devastating rebuttal reports. These reports were served upon plaintiffs’ counsel, whose expert witnesses never attempted any response. Reliance upon Racette’s study was withdrawn or abandoned. After the underlying data were shared with the parties to MDL 1535, no scientist appeared to defend the results in the published papers.11 The Racette Alabama study faded into the background of the subsequent welding-fume cases and trials.

The motion battle in the welding MDL revealed interesting contradictions, similar to those seen in the Zambelli-Weiner affair. For example, Racette claimed he had no relationship whatsoever with plaintiffs’ counsel, other than showing up by happenstance in Alabama at places where Scruggs’ clients also just happened to show up. Racette claimed that the men and women he screened were his patients, but he had no license to practice in Alabama, where the screenings took place. Plaintiffs’ counsel disclaimed that Racette was a treating physician, which acknowledgment would have made the individual’s screening results discoverable in their individual cases. And more interestingly, plaintiffs’ counsel claimed that both Dr. Racette and Washington University were “non-testifying, consulting experts utilized to advise and assist Plaintiffs’ counsel with respect to evaluating and assessing each of their client’s potential lawsuit or claim (or not).”12

Over the last decade or so, best practices and codes of conduct for the relationship between pharmacoepidemiologists and study funders have been published.13 These standards apply with equal force to public agencies, private industry, and regulatory authories. Perhaps it is time for them to specify that the apply to the litigation industry as well.


1 See Smith v. Wyeth-Ayerst Labs. Co., 278 F. Supp. 2d 684, 710 & n. 56 (W.D.N.C. 2003).

2 Ironically, Ms. Cabraser has published her opinion that failure to disclose conflicts of interest and study funding should result in evidentiary exclusions, a view which would have simplified and greatly shortened the silicone gel breast implant litigation. See Elizabeth J. Cabraser, Fabrice Vincent & Alexandra Foote, “Ethics and Admissibility: Failure to Disclose Conflicts of Interest in and/or Funding of Scientific Studies and/or Data May Warrant Evidentiary Exclusions,” Mealey’s Emerging Drugs Reporter (Dec. 2002).

3 Litigation concerning Viagra is one notable example where plaintiffs’ counsel called an expert witness who was the author of the very study that supposedly supported their causal claim. It did not go well for the plaintiffs or the expert witness. See Lori B. Leskin & Bert L. Slonim, “A Primer on Challenging Peer-Reviewed Scientific Literature in Mass Tort and Product Liability Actions,” 25 Toxics L. Rptr. 651 (Jul. 1, 2010).

4 April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019).

5 Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

6 See Branzburg v. Hayes, 408 U.S. 665, 674 (1972).

7 Affidavit of April Zambelli-Weiner, dated January 9, 2019 (Doc. No. 1272).

8 The plaintiffs’ lawyers’ motive and opportunity to poison the study by coaching their “clients” was palpable. See David B. Resnik & David J. McCann, “Deception by Research Participants,” 373 New Engl. J. Med. 1192 (2015).

9 See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006) (a largely duplicative report of the Alabama welders study).

10 See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette’s Alabama study on welding and parkinsonism).

11 Racette sought and obtained a protective order for the data produced, and thus I still cannot share the materials he provided asking that any reviewer sign the court-mandated protective order. Revealingly, Racette was concerned about who had seen his underlying data, and he obtained a requirement in the court’s non-disclosure affidavit that any one who reviews the underlying data will not sit on peer review of his publications or his grant applications. See Motion to Compel List of Defendants’ Reviewers of Data Produced by Brad A. Racette, M.D., and Washington University Pursuant to Protective Order, in In re Welding Fume Products Liab. Litig., MDL No. 1535, Case 1:03-cv-17000-KMO, Document 1642-1 (N.D. Ohio Feb. 14, 2006). Curiously, Racette never moved to compel a list of Plaintiffs’ Reviewers!

12 Plaintiffs’ Motion for Protective Order, Motion to Reconsider Order Requiring Disclovery from Dr. Racette, and Request for In Camera Inspection as to Any Responses or Information Provided by Dr. Racette, filed in Solis v. Lincoln Elec. Co., case No. 1:03-CV-17000, MDL 1535 (N.D. Ohio May 8, 2006).

13 See, e.g., Xavier Kurz, Susana Perez‐Gutthann, and the ENCePP Steering Group, “Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP),” 27 Pharmacoepidem. & Drug Safety 245 (2018).

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.