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California Supreme Court Set To Untangle Webb

July 7th, 2013

Asbestos personal injury cases have been around for decades, and they show no sign of abating.  They could well be evidence for the supreme ingenuity of the plaintiffs’ bar in devising the first perpetual motion machine.  Workman’s compensation cases offer the prospect of “no-fault” recoveries, but the compensation is often based upon a scheduled award, which in some states may not adequate.  Civil actions, on the other hand, offer the prospect of jackpot recoveries, but the tort law duty is not always applicable, and plaintiffs must show duty, breach, proximate cause, in addition to injury and damages.

A recent California decision illustrates how the tort system has been twisted and tortured to make up for the perceived inadequacies of the workman’s compensation system.  At age 67, William Webb developed pleural mesothelioma.  He and his wife sued several companies, including Special Electric Company, Inc., and some automobile brake suppliers.

Starting in 1969, Webb worked for a plumbing supply company, Pyramid Pipe and Supply (Pyramid), where he regularly handled a Johns-Manville (JM) asbestos pipe, known as Transite.

Special Electric brokered South African crocidolite (blue asbestos) in the United States, including some sales (about 7,000 tons) to JM’s Long Beach, California, facility, which manufactured Transite.  JM sold the Transite to Familian (a pipe supply company), which in turn sold the Transite to plaintiff’s employer, Pyramid .

By the time of trial, only Special Electric and two automobile brake suppliers remained in the case.  A jury heard the case in January and February 2011, in Los Angeles County Superior Court, Case No. BC436063, before the Hon. John Shepard Wiley, Jr.  The brake defendants pointed the finger to the blue asbestos in J-M’s Transite, but then, their courage lagging behind their convictions, they settled during closing arguments.  The jury returned a verdict, for the Webbs, for over $5 million, with allocations of 18% to Special; 49% to JM, 33% to other third parties. Webb v. Special Electric Company, Inc., 214 Cal.App. 4th 595, 153 Cal.Rptr. 3d 882, 888 (2013).

 

PROCEDURAL PRETZELS

Before the case was submitted to the jury, Special Electric moved for a directed verdict on the failure to warn claims because JM had been warned or because the dangers were “obvious and known” to JM, and because Special Electric had no duty to warn downstream, unsophisticated customers when it reasonably relied upon JM to provide warnings.  Id. at 888-889.  The Webbs countered that there was some evidence that not all asbestos shipped to JM had warnings, and that the warnings given to JM were inadequate.  Id. at 889. These counters were  non-responsive to Special Electric’s motions.  The Webbs also argued that there was no finding that Special Electric had reasonably relied upon JM to warn downstream buyers.  Id. This argument also was irrelevant to Special’s legal argument about objective reasonable reliance.

The trial court granted Special’s motions, noting that “[t]elling Johns-Mansville about asbestos is like telling the Pope about Catholicism,” id. at 889, or like “carrying coals to Newcastle,” id. at 895.

Exactly when the trial court ruled on Special’s motions in relation to entry of judgment  is unclear, but the trial court did enter judgment n.o.v. for Special on the failure to warn claims.  The Webbs objected to the lack of written notice and other procedural aspects to the timing of the trial court’s decision.

The Webbs appealed on procedural and substantive grounds.  Special did not file a protective cross-appeal.  The California Court of Appeals, over a trenchant dissent by Judge Rothschild, reversed on both procedural and substantive issues.  Last month, June 12, 2013, the California Supreme Court vacated the intermediate appellate court’s decision and granted review on both the substantive and procedural issues.  Webb v. Special Electric Co., Inc., S209927 Cal. S. Ct. (granting review June 12, 2013).

 

MENDACIOUS HISTORY

Many asbestos cases have been tried in which the issue of who knew what, when, was relevant to the existence of a duty to warn.  The essential nature of a failure to warn case is that the seller has “knowledge” not available to the buyer.  The law addresses this inequality of knowledge by imposing a tort obligation to warn about these hidden or undisclosed hazards. Imposing tort liability for failure to warn often makes sense in the context of a product sold to consumers by sophisticated sellers.  In that context, the imbalance of knowledge will be significant and “actionable.”  In the context of sales of raw materials to large manufacturing concerns, the imbalance will often be in the opposite direction; the buyer will know more about the hazards, and especially about the circumstances of the use of the raw material, than the seller.

Certainly, there are some asbestos cases fall into the category in which the sellers of asbestos-containing products had “secret” knowledge of hazards, which was unknown to the buyers.  There are also some cases in which the parties might dispute whether the seller knew, or should have known, of the undisclosed hazards.

The Webb case may well represent a new generation of asbestos case in which the relevant exposure took place so “late in the day” that the historical evolution of knowledge about asbestos hazards, and the historical inequality of knowledge between sellers and buyers, are irrelevant to the tort law goal of addressing failing to warn.

Special Electric brokered the crocidolite fiber in question to JM, from 1974, until about 1982.  Id. at 898.  JM incorporated this crocidolite into its Transite pipe product, which it supplied to Familian, which in turn supplied Transite to Pyramid.  Special was not the only supplier of crocidolite to JM, and thus it was not clear that any Transite that went to Pyramid actually contained crocidolite brokered by Special.

Mr. Webb thus could possibly not have used Transite, which may have had Special’s crocidolite, before 1974, and probably not before 1975.  The relevant “state of the art” thus was the mid-1970s forward.

The plaintiffs presented an expert witness, Barry R. Horn, MD, who testified that beginning before the 1920s (thus sometime in 1910s), “there was ‘an enormous literature, just huge’, that occupational exposure to asbestos posed a great risk of cancer.” Id. at 900.  Horn is a “regular” plaintiffs’ witness.  He testifies about once a week for asbestos cases, always for plaintiffs.  Testimony of Barry Horn in McGrail v. Thorpe Insulation Co., Superior Ct Calif., Los Angeles Cty. No. BC 363913 (Nov. 11, 2008).  Presumably, Horn has plenty of opportunity to get the historical state-of-the-art knowledge correct; yet, his testimony that there was any literature, let alone “an enormous literature” before the 1920s about the carcinogenicity of any kind of asbestos is blatantly false.  His testimony was also, in the context of the Webb case, blatantly irrelevant.

By 1974, the public, labor, industry, government, and academics had spent over a decade of absorbing, developing, and disseminating information about the hazards of asbestos, and specifically, the cancer-causing nature of asbestos.  By the time JM Transite, which might have contained Special’s crocidolite, could have arrived at Pyramid, Webb’s employer, the cancer hazards of asbestos were discussed on television and radio, written about in newspapers, and testified to in Congress.  Asbestos cancer hazards were the primary issue that galvanized the resolve of organized labor, and drove passage of the Williams-Steiger Act of 1970, 84 Stat. 1590 et seq., 29 U.S.C. 651 et seq., which led to the formation of the federal Occupational Safety & Health Administration (OSHA).  Of course, at the top of OSHA’s priorities in 1971 and 1972, were the formulation and promulgation of regulations on asbestos permissible exposure limits.  The OSHA efforts thus kept public awareness of asbestos hazards at a high level throughout the early 1970s.  By 1975, EPA and OSHA had promulgated regulations that curtailed the use of asbestos, of all types, in the United States.

Asbestos cancer hazards were, by 1974, public knowledge, open and obvious to everyone.  There was no imbalance of knowledge; no hidden or secret knowledge, at issue. Horn’s false testimony about knowledge of cancer risks before the1920s was thus irrelevant to the issues in the Webb case.

 

A MISREPRESENTED MISREPRESENTATION

According to the majority’s opinion, the trial record included evidence that Special had instructed its sales force to market its crocidolite asbestos as “much safer” than other chrysotile asbestos, and even safer than fiberglass.  Webb v. Special Electric Co., Inc., 214 Cal.App. 4th at ___, 153 Cal.Rptr. 3d at 898, 900, 901, 904 (2013).  If Special’s salesmen made this misrepresentation to JM, their lie would have been truly reprehensible.  The evidence, however, does not make sense.  Accepting that such lies were told, the appellate court never mentions whether the lies were told to JM.  If they had been, JM, an owner and operator of chrysotile mines in Canada, would have found the suggestion that crocidolite was safer than chrysotile laughable.  By the mid-1970s, JM was reasonably advocating the relative harmlessness of chrysotile compared to crocidolite.

The majority, however, is dodgy about whether and when the supposed misrepresentation was made to JM.  According to the dissent, there was but one salesman who made these misrepresentations about crocidolite, and he left Special Electric in 1973.  There was no evidence that this salesman had any dealings with JM, and there was no evidence that Special supplied any crocidolite to JM, at its Long Beach facility, before 1974.  Id. at 913 n.8.

Interestingly, the dissent also noted that there was no evidence that Special Electric knew or should have known that crocidolite was more dangerous than other asbestos minerals.  Id.  The omission of such evidence in the record is curious because it would have been easy to have shown, at the relevant time, not only that crocidolite was known to be more dangerous than chrysotile, but that JM was interpreting the available data as showing that crocidolite and amosite were the predominant causes of mesothelioma and that chrysotile did not cause mesothelioma at all.

 

DUTY IS THE COURT’S DUTY TO DEFINE

The Court of Appeals spends a good deal of effort in trying to identify the factual issues for the jury, and the jury’s failure to find in favor of Special Electric on particular factual issues such as:

  • whether all the asbestos shipped to JM had warnings,
  • whether the warnings on the crocidolite brokered by Special were adequate
  • whether Special Electric knew or should have known that JM was unreliable as a conduit for warnings
  • whether Special had undertaken reasonable efforts to warn downstream users

The appellate court took the jury’s verdict to mean that these issues were disputed, and that the Webbs had carried their burden of persuasion on them.  Id. at 895.  The appellate court focused unduly upon whether jury instructions were given to determine whether issues had been raised and resolved by the jury.  The problem is that Special Electric’s motions for directed verdict and for j.n.o.v., would have had to assume the correctness of all plaintiffs’ evidence and inferences.  Its motions were made to obtain a ruling on a question of law, on undisputed facts.  The appellate court’s meanderings thus take it away from the central issues in Special’s motions.

The Court of Appeals declares that Special had a duty, as a matter of law, because it knew that crocidolite was dangerous, and it knew that users, such as Webb, would not know it was dangerous.  Id. at  897.  This formulation, of course, ignores and omits, the essential role of the intermediaries in the case.  The formulation also ignores the realities of the post-1964, post-Selikoff world. Webb may have testified he was unaware of the hazards, but by 1974, such testimony, from someone who worked in a plumbing supply store, is suspect.  In any event, the Court of Appeals simply assumes without evidence that Special would have known that Webb did not know.

Pushed to the wall to find a source of the duty to warn, the Court of Appeals invokes Restatement Second of Torts § 402A, but this section addresses only the selling of goods that are expected to reach the ultimate user without substantial change in their condition.  Id. at 894, citing earlier California intermediate appellate court decisions, Stewart v. Union Carbide Corp., 190 Cal. App. 4th 23, 29, 117 Cal. Rptr. 3d 791 (2010); Jenkins v. T&N PLC, 45 Cal.App. 4th 1224, 1228-1231, 53 Cal.Rptr. 2d 642 (1996).  In the Webb case, there clearly was an expectation that the asbestos fiber would be incorporated into a finished product, and that there was no practicable way for the fiber supplier to warn the ultimate user.

The dissent calls attention to the majority’s misdirections and confusions between law and fact, and points out that California and other courts have generally held that the reliance issue is really not a factual issue to be litigated:

“commerce would be impossible without the operation of such a presumption. When a manufacturer or distributor  has no effective way to convey a product warning to the ultimate consumer, the manufacturer should be permitted to rely on downstream suppliers to provide the warning. ‘Modern life would be intolerable unless one were permitted to rely to a certain extent on others doing what they normally do, particularly if it is their duty to do so’.”

Id. at 908-09 (quoting Restatement Second Torts § 388, com. n) (internal citations omitted).

Astonishingly, the Court of Appeals states that it is

“not called upon to confront whether it would have been difficult or even impossible for Special Electric to effectively warn consumers of its asbestos, as the trial court apparently concluded. That question was not made an issue at trial. Special Electric offered no evidence that it would have been difficult or impossible to warn Webb, nor evidence that it had even considered that question. Special Electric did not request that the jury be instructed that a finding of reasonable efforts on its part would satisfy its duty to warn. Finally, Special Electric failed to request a finding by the jury, either that it could not reasonably have acted to warn Webb, or that it had acted reasonably in failing to do so.”

Id. at 902.  Of course, the question identified by the majority was exactly the question that Special Electric was asking the trial court to decide, and which was decided. The appellate court’s immersion in the jury instructions obscures

the legal issue that was before the trial court. The appellate court majority went as far as declaring that its holding was limited to the trial factual issues:

“We do not hold that an asbestos-supplier’s duty to warn users of its asbestos cannot be obviated by proof that the users needed no warning, or that its duty may not be discharged by a showing of reasonable efforts to provide warnings, or by reasonable reliance upon others to do so. The effect of the trial court’s ruling was to hold that—as a matter of law—Special Electric had no duty to warn foreseeable users of the dangers of its asbestos, even though Special Electric knew or should have known that those foreseeable users would be unaware of the dangers.

The conclusion that Special Electric had no such duty, or that its duty was discharged as a matter of law, is unjustified by the law and is contrary to the record in this case.”

Id. at 903.

The dissent seized upon the majority’s failure to engage with the actual evidence at hand, and the arguments that were made.  The majority had acknowledged that:

“No one in this appeal doubts that Johns–Manville was a sophisticated user of asbestos, who needed no warning about its dangers.”

Id. at 895.  This, of course, was the issue, and none of the collateral factual issues that were submitted to the jury, or not submitted to the jury, detracted from the legal significance of this judicially noticeable fact.  By ignoring this material fact, the majority was able to persuade itself:

“that it can be a tort to fail to tell someone something they already know, and that it can also be a tort to fail to impose on someone a contractual duty to do something they already have a tort duty to do.”

Id. at 906 (Rothschild, J., dissenting).

The dissent appropriately emphasized that plaintiffs conceded at trial, and in oral argument on appeal, that Special Electric did not owe a warning directly to Mr. Webb.  Id. at 907.  The plaintiffs’ theory was that Special Electric should have contractually obligated JM to provide warnings on products that incorporated Special’s crocidolite.  Id. at 908.  This theory, however, is counter to central principles that permit persons to presume that others will know and comply with the law.  Such a contractual requirement would have been unsupported  by consideration.  A contract that required anything else other than the buyer’s compliance with the law would have been void.  Moreover, the suggestion that brokers and sellers of raw materials should dictate such terms of their contracts with corporate behemoths such as JM is unrealistic in the extreme.

 

QUESTIONABLE TESTIMONY FROM JM EMPLOYEE

A former JM employee testified that Special Electric’s brokered crocidolite did not have warnings until 1980 or 1981, and that no one from Special visited JM to inspect JM’s use of warnings on finished products going out to market.  Id. at 900.  This unnamed employee further testified that JM was “evil,” and “started to panic” in the mid-1970s, when it became a target for personal injury lawsuits.  Id.   The questionable provenance of this testimony was not discussed, but the veracity of the testimony is doubtful.

The Court of Appeals notes that correspondence from 1975, shortly after Special began brokering fiber to JM, from Special’s president, showed that Special was concerned with potential liability, and that it had been discussing the need to identify the bags as containing hazardous materials.  The contemporaneous evidence thus casts doubt on the 30+ year recall that Special’s asbestos had no warnings in the 1970s.  The Court of Appeals takes the 1975 correspondence as “indicating” that warnings were not given before 1975, and then embellishes that some JM employees were unaware of asbestos dangers until the mid-1970s.  The correspondence, however, has a much less sinister interpretation.  The fiber was being brokered.  Special was not mining, milling, and bagging the fiber, which came from South Africa.  The bags of crocidolite fiber may well have lacked warnings, but U.S. law required warnings on asbestos by 1975.  Special understandably taking steps to ensure that JM did what the law required it, as both an employer, and a seller, to do.  The Court of Appeals’ inference that there were no warnings given before 1975 is, at best, irrelevant given that Mr. Webb did not begin to handle JM Transite pipe that might have had Special’s brokered crocidolite until the mid-1970s.

 

SUPREME COURT REVIEW

Both majority and dissent do not discuss the regulatory structure that was in place in California, and in the United States.  Employers had (and still have) a duty to notify employees of the dangerous materials that they handle, and to instruct them on the use of safety equipment.  The entire discussion of knowledge of hazards proceeds without taking notice that the country was a decade past the most sensationalistic exposes of asbestos cancer hazards.   Perhaps these deficiencies reflect the abridgments of the record that occur in judicial opinion writing.  Even if the record is spotty on many of these facts, the California Supreme Court, and parties, can supply many of these facts by judicial notice.

The opening brief in this appeal was due July 12, 2013, but Special’s counsel filed a request for an extension until September 10.  Let’s hope that the Supreme Court does not delay restoring rationality to the law of product warnings.  The time has come to state that the duty to warn must be based upon the seller’s knowledge, actual or constructive, of hazards unknown to the buyer.

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Trevor Ogden’s Challenge to the Lobby’s Hypocrisy

July 6th, 2013

Trevor Ogden, the editor of the Annals of Occupational Hygiene, addressed sharing of underlying research data in an editorial, a few years ago.  See Trevor Ogen, “Data Sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth,” 53 Ann. Occup. Hyg. 651 (2009). Ogden was responding to attacks on industry-sponsored research and demands that the exposure data from such studies be made available as a condition of publication in the Annals.

Ogden reported that he was sympathetic, to an extent, with the attack on industry bona-fides, but that editorial board discussions raised several issues with data sharing:

“(1) The researcher puts a lot of effort into getting good exposure data and may have plans for their further use; also access to the unpublished data can be an asset in getting further grants.

(2) It takes time and effort to prepare data for publication, and in the short term the people who do this to make their data available are not the ones who benefit by their availability.

(3) There may be problems with confidentiality and liability for the workplaces where the measurements were obtained.

(4) The data may be misused; in particular, they may be reinterpreted by those with a commercial interest in undermining the conclusions drawn by the original researchers.”

Id. at 652.

Had Ogden stopped there, he might have been spared the unceremonious attacks by members of “The Lobby,” but he went further to point out that some of the accusers (David Michaels; McCullogh & Tweedale) were guilty of their own rhetorical excesses.

While acknowledging that industry has taken errant positions or distorted research data on occasions, Ogden thought it was important to note that:

“industry is not always wrong, and campaigners can overlook this because it is easier to identify the paymaster than judge the science.”

* * * *

“It is a mistake if we think that because the industry helped pay for the study and has exploited the findings in its propaganda, the results must necessarily be wrong—life, including science, is not this simple.”

Id. at 653 -54.

Ogden offered, as a scientist would, further alternative explanations for why industry-sponsored scientific research appears to yield results favorable to the sponsor:

“It seems that an industry-sponsored study is much more likely to find results favourable to industry, but this may partly or wholly be because non-industry researchers find it harder to publish negative or inconclusive results. Scientific studies must be judged primarily on the quality of the evidence, not on who pays for them.”

Id. at 654. Ogden might well have opened his mind to the possibility that some government agency and academic scientists may well be biased in favor of finding outcomes that support greater agency regulation and control of occupational and environmental exposures. In any event, Ogden interpreted the situation to require skepticism of all positions, both pro- and anti-industry:

“This is not a very encouraging picture. It looks as if we cannot trust industry, and its critics are not very reliable either.”

Ogden would thus not let any side off the hook when it came to disclosures of potential conflicts of interest:

“Declarations of interest in publications are essential, especially if the authors are likely to be involved in legal testimony. Failure to offer this must be treated very seriously.”

Id. at 655.

Even Ogden’s more modest alternative explanation and his balanced comments provoked shouts of outrage from “the Lobby.” See “The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013).  Ogden, however, gave them ample space in which to voice their disagreements. See Celester Monforton, Colin Soskolne, John Last, Joseph Ladou, Daniel Teitelbaum , Kathleen Ruff, “Comment on: Ogden T (2009) ‘data sharing, federal rule of evidence 702, and the lions in the undergrowth’,” 54 Ann. Occup. Hyg. 365 (2010); Barry I. Castleman, Fernand Turcotte, Morris Greenberg, “Comment on: Ogden T (2009) ‘Data sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth’,” 54 Ann. Occup. Hyg. 360 (2010).

The remarkable thing about the Lobby’s letters to the editor is that they scolded industry for conflicts of interests, but failed to reveal their own.  Celeste Monforton, for instance, declared her academic affiliations, but overlooked her connection with an anti-Daubert advocacy organization that is funded by left-over common-benefit trust fund money from the silicone gel breast implant litigation. See SKAPP A LOT (April 30, 2010). Monforton and all her co-authors did, however, report their membership in the Rideau Institute on International Affairs, a Canadian “non-profit” organization, established in 2007. They failed, however, to disclose that the Rideau Institute engages in lobbying and advocacy efforts for trade unions and “non-profits.”  See Rideau Institute website  (“The Rideau Institute is an independent research, advocacy, and consulting group based in Ottawa. It provides research, analysis and commentary on public policy issues to decision makers, opinion leaders and the public.”).  Several of Monforton’s co-authors have testified, some frequently, for the litigation industry (plaintiffs) in occupational and environmental exposure cases.  Daniel Thau Teitelbaum, for instance, was an early testifier in the silicone breast implant litigation, and was the subject of analysis in General Electric Co. v. Joiner, 522 U.S. 136 (1997).

Barry Castleman’s letter is even more offensive to its own stated principles of extirpating conflicted science.  Castleman has been part of the litigation industry’s expert witness army in asbestos cases for over three decades.

Ogden’s statement of the problem was insightful, even if not definitive.  His suggestion that “hostile” analysts should be kept from access to underlying data ignores the intense need for this access in areas of science that inform litigation and regulation.  As George A. Olah pointed out in his Nobel Prize address, scientists need adversaries to keep them creative, focused, and accurate. Ogden’s call for disclosure of interests, “especially if the authors are likely to be involved in legal testimony,” ignores that litigants on both sides need access to scientific expertise on the issues that drive litigation and regulatory battles.  More distressingly, however, Ogden’s journal let his interlocutors slide on their obligation to disclose their deep financial and positional conflicts of interests.

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EPA Research on Ultrafine Particulate Matter

June 26th, 2013

White Hat Bias

Hyping environmental and so-called toxic risk has gone on so long that many Americans have no sense of the truth when it comes to the causal consequences of personal, occupational, and environmental exposures.  Recently, I listened to a lecture given by Judge Calibresi of the Second Circuit.  In the course of talking about regulatory prohibitions and tort-law incentives, he told of his visit to the late Professor Bickel, who had then just been diagnosed with brain cancer.  In his lecture, Judge Calibresi stated that he knew that Bickel’s brain cancer was caused by his smoking, and went on to muse whether banning smoking would have saved his friend’s life.  Judge Calibresi’s ruminations upon the nature of regulation and tort law were profound; his cursory hipshot about what caused his friend’s terminal illness, juvenile.

Some years ago, a science journalist published an account of how dire predictions of asbestos deaths had not come to pass.  Tom Reynolds, “Asbestos-Linked Cancer Rates Up Less Than Predicted,” 84 J. Nat’l Cancer Instit. 560 (1992)

Reynolds quoted one scientist as saying that:

“the government’s exaggeration of the asbestos danger reflects a 1970s’ Zeitgeist that developed partly in response to revelations of industry misdeeds.  ‘It was sort of the “in” thing to exaggerate … [because] that would be good for the environmental movement’….  ‘At the time it looked like you were wearing a white hat if you made these wild estimates. But I wasn’t sure whoever did that was doing all that much good.”

Id. at 562.  Reynolds’ quote captures the nature of “white-hat” bias, a form of political correctness applied to issues that really depend upon scientific method and data for their resolution.  Perhaps the temptation to overstate the evidence against a toxic substance is unavoidable, but it diminishes the authority and credibility of regulators entrusted with promulgating and enforcing protective measures.

White-Hat Bias & Black-Hat Ethics

I recently came across a disturbing article in the Environmental Health Perspectives, a peer-reviewed journal, supported by the National Institute of Environmental Health Sciences, National Institutes of Health, United States Department of Health and Human Services.  The article detailed a case report of an individual woman experimentally exposed to ultrafine particulate matter (PM 2.5) in a test chamber.  Andrew J. Ghio, Maryann Bassett, Tracey Montilla, Eugene H. Chung, Candice B. Smith, Wayne E. Cascio, and Martha Sue Carraway, “Case Report: Supraventricular Arrhythmia after Exposure to Concentrated Ambient Air Pollution Particles,” 120 Envt’l Health Perspect. 2275 (2012) [Ghio article].  There were no controls.

The point of the case report was that a person exposed to PM 2.5, experimentally, experienced a “cardiac event,” (atrial fibrillation or AFib) which resolved after cessation of exposure.  The experiment was conducted in a federal agency facility, Environmental Public Health Division, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Chapel Hill, North Carolina.

The authors stated that the experiment had the approval of the University of North Carolina School of Medicine Committee on the Protection of the Rights of Human Subjects. Given that the EPA has made extraordinary claims about the harmfulness of PM 2.5, including heart disease, lung disease, and cancers, and that there was no imaginable benefit to the subject from participating in the experiment, this experiment seemed dubious indeed.  The narrative of the case report, however, reveals even more disturbing information about the potential improprieties of the human experiment.

The PM Chamber

The human guinea pig was 58 years old.  Her age is significant. Although the authors claim that AFib is uncommon among those under 60, it does increase with age.  The human subject in the published experiment was close to the age at which AFib is no longer uncommon, and she was unwell to begin with.

The case report notes that the human subject had previously participated in the same exposure “protocol” without “complications.”  The report does not explain why this human subject was returning to the EPA center for being placed in a “chamber,” and being exposed sequentially to “filtered air and concentrated ambient particles (CAPs).” The implied suggestion is that she was a likely candidate to experience a “cardiac event” eventually from repeated exposures in the PM 2.5 chamber.

The “Subject”

The human subject was not well.  Although she was asymptomatic on the day of the experimental exposure to CAPs, she had a history of osteoarthritis and hypertension.  The latter condition was being treated with an angiotensin-converting enzyme inhibitor and a diuretic (10 mg. lisinopril and 12.5 mg. hydrochlorothiazide).  The subject had had surgeries for hernia repair, cholecystectomy, and knee arthroplasty. She was a little over 5 feet 6 inches tall, and obese, weighing over 230 pounds, with a 45 inch waist.

In addition to her chronic hypertension, morbid obesity, and musculoskeletal disease, the subject also had a family and personal history of heart disease.  Her father had died from a myocardial infarction, at the age of 57.  Immediately before the experimental exposure, a Holter monitor showed evidence of increased supraventricular ectopy, with 157 ± 34 premature atrial contractions/hour.

The investigators do not tell us how the experimental exposure relates to typical urban exposures, or to EPA regulatory standards, guidelines, or recommendations.  About 23 minutes after exposure to CAPs started (filter weight, 112 μg/m3; particle number, 563,912/cc), the human subject developed a “nonsustained atrial fibrillation that quickly organized into atrial flutter.”  The woman remained asymptomatic, and her EKG showed that she spontaneously reverted to a normal sinus rhythm.

The investigators acknowledge that there are many risk factors for AFib, and that the subject had several of them: hypertension, obesity, and possibly family history.  The woman had a history of premature atrial contractions, which may have increased her risk for AFib.

Despite this rich clinical background, the authors claim, without apparently trying very hard, that there was no “obvious” explanation for the subject’s arrhythmia while in the chamber.  They argue, however, that the exposure to PM 2.5 was causal because the arrhythmia began in the chamber, and resolved when the subject was removed from exposure.  The argument is rather weak considering that the subject may have been stressed by the mere fact of placement in a chamber, or being wired up to monitors.  See, e.g., Luana Colloca, MD, PhD, and Damien Finniss, MSc Med., “Nocebo Effects, Patient-Clinician Communication, and Therapeutic Outcomes,” 307 J. Am. Med. Ass’n 567, 567 (2012). The authors of the PM 2.5 case report acknowledge that “coincident atrial fibrillation cannot be excluded,” but they fail to deal with the potentially transient nature of AFib.

Human experimentation requires a strong rationale in terms of helping the experimental participant.  What was the rationale for this human experiment?  Here is what the EPA investigators posit:

“Although epidemiologic data strongly support a relationship between exposure to air pollutants and cardiovascular disease, this methodology does not permit a description of the clinical presentation in an individual case. To our knowledge, this is the first case report of cardiovascular disease after exposure to elevated concentrations of any air pollutant.”

Ghio at 275. The authors seemed to be saying that we know that PM 2.5 causes cardiovascular disease, but we wanted to be able to describe a person in the throes of a cardiovascular event brought on by exposure. See also Andrew J. Ghio, Jon R. Sobus, Joachim D. Pleil, Michael C. Madden, “Controlled human exposures to diesel exhaust,” 142 Swiss Med. Weekly w13597 (2012).

The Whole Truth

The Ghio article mentions only the one woman who experienced the mild, transient AFib.  A reader might wonder whether she was the only test subject.  Why was she retested after a previously incident-free experience in the chamber? How many other people were subjected to this protocol?

What is remarkable is that the authors claim not only an “association,” but causality, in a totally uncontrolled experiment, and without ruling out chance, bias, or confounding.  The article is both deficient in scientific methodological rigor, and dubious on ethical principles.

EPA – Hoisted With Its Own Petard

What I did not realize when I read this experimental case report is that the article had been a cause célèbre of the anti-regulatory right.  The EPA had walked right onto an ethical landmine by first sponsoring this research, and then by relying upon it to support a regulatory report. Steven Milloy editorialized about the EPA research, followed by a FOIA investigation. In September 2012, a regulatory watchdog group filed a lawsuit to strike an EPA report, which was based in part upon the questionable research.

Milloy’s strategy was designed to impale the EPA on the horns of a dilemma:

“I accused EPA of either: (1) conducting unethical human experimentation or exaggerating the dangers of fine airborne particulate matter (PM2.5). It must be one or the other; it can’t be neither, according to EPA’s own documents.”

Steven Milloy, “Did Obama’s EPA relaunch Tuskegee experiments?” (April 24, 2012).  The EPA had branded diesel particulate, which was used in the experiments, as “carcinogenic” and “lethal,” even from short exposures.  Accordingly, if the EPA were sincere, it should have never conducted the experiment documented in Environmental Health Perspectives.  If the agency believed that PM 2.5 was innocuous, then it unethically exaggerated and overstated its dangers.

In course of his FOIA initiative, Milloy did obtain answers to some of the questions I had from reading the Ghio article.  There were apparently about 40 human subjects, who were subjected to PM 2.5 exposure in chambers fed by diesel exhaust or other sources.  The exposure levels were upwards of 20 times what the EPA labeled a “permissible” level.  Of course, the EPA is positionally committed to a “linear, no-threshold” model of carcinogenesis, which makes any exposure to a substance it “knows” to cause cancer ethically improper.

The information from the FOIA requests puts the Ghio article in an extremely bad light.  The human subject on whom the authors reported had run about 40 other people through their chamber without ill effect, but failed to mention these cases.  The consent forms and IRB documents show that the investigators were specifically interested in “vulnerable” patients, who had diabetes, asthma, etc.  The fair inference is that the investigators wanted to provoke an anecdote that would support their causal narrative, which they believed had already been established with epidemiologic evidence.  This seems like a scientific hat trick: bad science, bad ethics, and bad publication practice.

The lawsuit did not fare well.  Predictably, it foundered on the lack of final agency action, and the lack of standing.  On January 31, 2013, Judge Anthony J. Trenga dismissed the complaint, after having previously denied a temporary restraining order.  The American Tradition Institute Environmental Law Center v. U.S. EPA, Case 1:12-cv-01066-AJT-TCB (E.D. Va. 2013).  While legally correct, the opinion is blandly devoid of any sense of ethical concern.

From a brief search, there does not appear to be an appeal to the Fourth Circuit in the works.  Of course, there were no personal injuries alleged in the ATI lawsuit, and the human subject in the Ghio article has appeared not to have sued.  Despite the lack of legal recourse, the science “right” is up in arms over EPA duplicity.  In a recent publication, Milloy and a co-author, quote former EPA Administrator Lisa Jackson, at a congressional hearing:

“Particulate matter causes premature death. It’s directly causal to dying sooner than you should.”

When Representative, now Senator, Edward J. Markey asked, “How would you compare [the benefits of reducing airborne PM2.5] to the fight against cancer?” Jackson answered hyperbolically:

“If we could reduce particulate matter to healthy levels, it would have the same impact as finding a cure for cancer in our country.”

Steve Milloy & John Dale Dunn, “Environmental Protection Agency’s Air Pollution Research: Unethical and Illegal?” 17 J. Am. Phys. & Surg. 109 (2012) (quoting Jackson).  The FOIA and other background materials from this EPA posturing can be found on one of Milloy’s websites.

Sadly, I found the answers raised by the Ghio article only because of the anti-regulatory activism of Milloy and the American Tradition Institute.  The white-hat bias remains a potent force in regulatory agencies, and in scientific laboratories.

Posted in Causation, Scientific Misconduct, Underlying Data | Comments Off on EPA Research on Ultrafine Particulate Matter

A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation

June 21st, 2013

Weitz & Luxenberg P.C. v. Georgia-Pacific

Earlier this month, the First Department of the New York Appellate Division upheld a trial court’s ruling that a former manufacturer of an asbestos-containing product, Georgia-Pacific LLC (G-P), must produce underlying data from eight published research studies, funded by the company.  These studies apparently addressed health outcomes from the use of the company’s product, a joint compound, or from its chrysotile asbestos component.  The trial court had also ordered an in camera review of various other documents on G-P’s privilege log.  Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013)

The appellate court accepted that G-P had funded the eight studies as part of its legal defense to asbestos personal injury litigation.  The studies at issue involved recreating G-P’s asbestos-containing joint compound to assess biopersistence and pathogenicity of its (past) chrysotile content.  According to the Appellate Division’s opinion, G-P was closely involved in the development of the published articles.  G-P’s Director of Toxicology and Chemical Management, Stewart Holm, became a contractor to provide “consulting services” to G-P’s in-house counsel.  Both Holm and in-house counsel were involved in pre-publication review of the articles.

G-P claimed attorney-client and work-product privilege to resist production of documents that reflected communications with consulting experts or legal staff.  The Special Master directed an in camera review of documents on G-P’s privilege log, and the production of the underlying data and materials from the studies.  The motion court refused G-P’s motions to vacate the Special Master’s recommendations, and to reconsider.

The trial and appellate court rulings seem fairly straightforward except that the appellate court omitted serious consideration of the existence and scope of the privilege, and focused upon the applicability of the crime-fraud exception.  This exception requires that the legal advice, sought to be protected, involves some fraudulent scheme or wrongful conduct, but the court seemed all too willing to engage in an analysis of the applicability of the exception before it considered whether the privilege applied in the first place.   

The Appellate Division held that the plaintiffs had made a sufficient “showing of a factual basis adequate to support a good faith belief by a reasonable person that in camera review of the materials may reveal evidence to establish the claim that the crime-fraud exception applies.” Slip op. at 4.  Here is how the appellate court described the plaintiffs’ claim that the attorney-client privilege had been lost:

“Holm co-authorized nearly all of the studies, which were intended to cast doubt on the capability of chrysotile asbestos to cause cancer. On the two articles that he did not co-author, he [*4]and GP’s counsel participated in lengthy ‘WebEx conferences’ in which they discussed the manuscripts and suggested revisions. Despite this extensive participation, none of the articles disclosed that GP’s in-house counsel had reviewed the manuscripts before they were submitted for publication. Two articles falsely stated that ‘[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript’. For articles lead-authored by David M. Bernstein, Ph.D., and co-authored by Holm, the only disclosure was that the research was ‘sponsored’ or ‘supported’ by a grant from GP. The articles did not disclose that Holm was specially employed by GP for the asbestos litigation or that he reported to GP’s in-house counsel. Furthermore, there were no grant proposals, and Dr. Bernstein was hired by GP on an hourly basis. Nor did the articles reveal that Dr. Bernstein has been disclosed as a GP expert witness in NYCAL since 2009, that he had testified as a defense expert for Union Carbide Corporation in asbestos litigation, or that he had been paid by, and spoken on behalf of, the Chrysotile Institute, the lobbying arm of the Quebec chrysotile mining industry. Although GP belatedly endeavored to address the inadequacies of certain of its disclosures, its corrections failed to acknowledge its in-house counsel’s participation and did not make clear that Dr. Bernstein’s testimony as an expert witness preceded the publication of the first GP reformulated joint compound article in 2008.”

The court was obviously concerned that G-P in-house counsel was involved in the publication process, and that this involvement was not disclosed. Slip at 4, citing United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D. D.C. 2006) (applying fraud-crime exception to tobacco industry), aff’d in relevant part, 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S.Ct. 3501 (2010).

What Appellate Division appeared to overlook is whether the attorney-client privilege applied in the first place.  In her initial recommendation, Special Master Laraine Pacheco gave careful consideration to the logically prior question whether the disputed materials were “legal” such that any privilege even attached to the disputed materials in the first place. See Recommendation of Special Master at 3, citing United States Postal Serv. v. Phelps Dodge Ref. Corp., 852 F. Supp. 156, 160 (E.D.N.Y. 1994) (“Defining the scope of the privilege for in-house counsel is complicated by the fact that these attorneys frequently have multi-faceted duties that go beyond traditional tasks performed by lawyers. . . . Needless to say, the attorney-client privilege attaches only to legal, as opposed to business, services. The communication must be made to the attorney acting in her capacity as counsel. If the communication is made to the attorney in her capacity as a business adviser, for example, it ought not be privileged”); In re Grand Jury Subpoena, 599 F.2d 504, 511 (2d Cir. 1979) (“Participation of the general counsel does not automatically cloak the investigation with legal garb”). The Special Master seemed to think that there was no privilege, which stood in need of an exception.

The Special Master also noted that no privilege attaches to materials that were intended for ultimate publication: 

 “New York of course accepts the unremarkable proposition that if a client communicates to the lawyer with the intent that the communication is to be released to the public, that communication is not privileged.”

Recommendation at 3, citing In re New York Renu with Moistureloc Prod. Liability Litig. , 2008 U.S. Dist. LEXIS 88515, at *5, 14 (D.S.C. May 8, 2008) (applying New York law) (relying on Michael M. Martin, et al., New York Evidence Handbook  318 (2d ed. 2002)).  Furthermore, there was a question whether G-P had waived its privilege claim by selectively producing some documents that it wanted to put into the record of the case.  Id.  The Special Master’s points appear important and persuasive, but the Appellate Division skipped over them in order to address the exception, which assumes that the privilege applies in the first place.

American Law Institute (ALI), The Law Governing Lawyers § 68 (1998). The mere participation of in-house counsel is not dispositive of the question.  The privilege applies to communications made for the purpose of obtaining legal advice. In-house lawyers are often consulted for advice on non-legal issues.  Courts have thus been drawn in to controversies over sorting out whether the communication was engaged in for purpose of obtaining “legal assistance.” ALI § 72. The law acknowledges that communications may have multiple purposes and motives, but the predominant function of the communication must relate to legal advice if it is to retain its privileged status. ALI § 72, comment c.

In Burton v. R.J. Reynolds Tobacco Co., both the magistrate and district judges accepted, as a general principle:

 “An analysis of scientific data may be the subject of a privileged communication. To establish that such communications are protected by the attorney-client privilege there must be a connection between the scientific information which is the subject of the communication and the rendering of legal advice.”

200 F.R.D. 661, 668 (D. Kan. 2001). The court, however, proceeded to analyze the disputed claims of privilege and rejected most of them on grounds that the attorney communications were not in response to requests for legal advice. For instance, the court rejected the claim of privilege for a memorandum, written by an RJR scientist who assisted RJR patent lawyers as a scientific paralegal. The RJR scientist commented on “patentability,” but the court found that the document primarily concerned scientific research with no connection to the rendering of legal advice. Id. at 670. Even stingier was the court’s interpretation of a memorandum from RJR’s CEO to its general counsel, which discussed outside counsel’s recommendation that the company “should fund additional medical research in order to gain additional facts that [it]] can use to defend [itself] against [its] critics.” The court characterized the referenced advice as relating to public relations advice, not legal counsel. Id. at 672.

In the Vioxx MDL, Judge Fallon struggled with the issue whether many of activities of in-house counsel were truly “legal,” especially when the attorney communications were comments and edits of “scientific reports, articles accepted for publication in noted journals, and research proposals,” or word choice comments in scientific articles and study proposals. In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 800, 802 (E.D.La. 2007)(“We could not see the legal significance of these comments… .”).

Merck advanced a theory that the pharmaceutical industry was so pervasively regulated that the court should assume that its in-house lawyers were providing legal advice in making such comments and edits. Special Master Rice, a noted privilege scholar appointed to review the privilege claims, and Judge Fallon, never accepted Merck’s blanket rationale, although they did acknowledge that some service, initially appearing to be non-legal (such as “commenting upon and editing television ads and other promotional materials”) could in fact be legal advice when understood in the context of the pharmaceutical industry’s regulatory framework. Id. (citing Vodra et al., “The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges,” 61 Food & Drug L.J. 623 (2006)).

Concerned that such a blanket justification would seriously curtail discovery, the Special Master and the MDL Court insisted that Merck, in claiming a privilege, carry its burden to show that each document was, in fact, a confidential communication of legal advice. Id. The Special Master professed to be receptive to Merck’s evidence that, in the context of the highly regulated pharmaceutical industry, in-house counsel’s extensive changes and commentary to technical and scientific matters were legal services. Id. at 811-12.  Judge Fallon, quoting from the Special Master Rice’s report, noted that:

 “The responsive communication from the attorney is protected only to the extent that the response reveals the content of the client’s prior confidential communication.”

In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 795 (E.D.La. 2007).  As a result, an attorney’s transmission to the client of information obtained from third-parties is not privileged. Id. at 796. Similarly, the derivative nature of the privilege may lead to a refusal to apply it to in-house lawyers’ line edits of a non-privileged document, which was circulated to other corporate employees outside the legal department. Id.

The Vioxx analysis shows that the presumption that in-house or outside (or out-house) counsel are writing to provide legal advice, in response to client communications can be lost.  When the communications at issue are not for the purpose of providing legal advice, there may well be no protection under the attorney-client privilege.  In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 797 n. 12 (E.D. La. 2007)(quoting Special Master Rice, who was quoting from his treatise at § 7.28). See also . In re Seroquel Prods. Liab. Litig., 2008 WL 1995058, at* 6- 7 (M.D. Fla. 2008) (rejecting “pervasive regulation” theory, and relying heavily upon Judge Fallon’s analysis in Vioxx).

The Appellate Division’s enthusiasm for accepting the existence of the privilege in Georgia-Pacific, and to except its application by the crime-fraud exception, is deeply troubling because the court left unclear exactly what G-P’s crime or fraud was.  Perhaps G-P had failed to disclose some of the above-quoted facts in its discovery, but the anemic disclosures are all-too-common in most publications.  They are hardly a crime.  No provision of the penal code was cited.  Although some of the suggested conduct is unseemly, it is not clearly a fraud.

The only supposed falsehood was that “[t]wo articles falsely stated that ‘[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript’.”  Slip op. at 4.  The recited “good faith” belief does not suggest that G-P designed or analyzed the studies.  It is unclear whether G-P’s in-house counsel’s participation in a Webex conference realistically could be considered “preparing” a manuscript.  The court’s vague accusations leave unclear exactly what G-P did to design the study, analyze the data, or prepare the manuscript.  Such vague accusations would hardly pass the strictures of Federal Rule of Civil Procedure 9(b) (“Fraud or Mistake; Conditions of Mind. In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”)

Work Product Protection

The Appellate Division’s decision was on firmer ground with respect to rejecting G-P’s asserted work-product protection for attorney mental impressions, writings, trial preparation materials, and the like.  As the court noted, there is a strong public interest in having disputes resolved on the basis of complete, accurate information.  Slip op. at 6, citing In re American Tobacco Co., 880 F.2d 1520, 1529 (2d Cir 1989).  Of course, in the American Tobacco case, the Second Circuit upheld a subpoena (previously quashed by New York state courts) against Dr. Selikoff’s Environmental Sciences Department, at the Mt. Sinai School of Medicine.

In the case on appeal, the court noted that G-P had admitted to commissioning the studies in anticipation of litigation, and to having its trial counsel or its expert witnesses use the studies at trial.  Slip op. at 6.  The appellate court also held that the plaintiffs’ substantial need for the underlying data and related materials, and the prejudice from being denied access, were obvious.  The appellate court cast a broad, but not an unlimited net, for materials that would have to be produced.  “[T]he data, protocols, process, conduct, discussion, and analyses underlying these studies” must be produced, but not “any internal communications that portray its attorneys’ or consultants’ notes, comments or opinions.” Slip op. at 7.  The court identified the rationale for requiring production:

 “A significant expenditure of time and money would be required to duplicate the studies, if they could be exactly duplicated at all, whereas scrutiny of the underlying data may provide a permissible manner in which to attack the findings that would be consistent with the intent of the CMO to minimize the cost of and streamline discovery.”

Id.  Indeed, the lesson of the American Tobacco case, cited by the court, is that a party’s need and entitlement to underlying data and materials trumps even an independent researcher’s claim of “scholar’s privilege” or proprietary interest in data.  Litigants are entitled to everyman’s and everywoman’s evidence, even if they are scientists.  Courts may have to fashion protection to protect some of the scientists’ interests, but the wholesale denial of access to underlying data from published studies is, and should be, a relic of the past.

It is reflective of the Zeitgeist that the appellate court couched some of its rationale in corporation bashing:

 “Large corporations often invest strategically in research agendas whose objective is to develop a body of scientific knowledge favorable to a particular economic interest or useful for defending against particular claims of legal liability.”

Slip op. at 6, quoting from In re Welding Fume Prods. Liability Litig., 534 F.Supp. 2d 761, 769 n.10 (N.D. Ohio 2008). Well the litigation industry, a.k.a. the plaintiffs’ bar, similarly invests in its research agenda, as evidenced in any number of litigations, including asbestos, silicone, welding cases, etc.  More important, the plaintiffs’ bar has powerful interest proxies, such as support groups, labor unions, so-called public-interest groups, and captured governmental agencies, which are frequently involved in advocacy science.  The need for access to underlying data, protocols, questionnaires, research materials is not limited to plaintiffs or defendants in litigation.

Eight Articles

A Pubmed search turned up exactly eight articles for <S.E. Holm and asbestos>.  Two of the articles at issue did not have Holm as an author, so the following list is not identical to the eight articles at issue.

1. Exposures from chrysotile-containing joint compound: evaluation of new model relating respirable dust to fiber concentrations.

Brorby GP, Sheehan PJ, Berman DW, Bogen KT, Holm SE.

Risk Anal. 2013 Jan;33(1):161-76.

2. More on the dynamics of dust generation: the effects of mixing and sanding chrysotile, calcium carbonate, and other components on the characteristics of joint-compound dusts.

Berman DW, Brorby GP, Sheehan PJ, Bogen KT, Holm SE.

Ann Occup Hyg. 2012 Aug;56(7):852-67.

3. Chamber for testing asbestos-containing products: validation and testing of a re-created chrysotile-containing joint compound.

Sheehan PJ, Brorby GP, Berman DW, Bogen KT, Holm SE.

Ann Occup Hyg. 2011 Aug;55(7):797-809.

4. Quantification of the pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite-asbestos following short-term inhalation exposure.

Bernstein DM, Rogers RA, Sepulveda R, Donaldson K, Schuler D, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2011 Jun;23(7):372-91.

5. Potential artifacts associated with historical preparation of joint compound samples and reported airborne asbestos concentrations.

Brorby GP, Sheehan PJ, Berman DW, Bogen KT, Holm SE.

J Occup Environ Hyg. 2011 May;8(5):271-8.

6. The pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite asbestos following short-term inhalation exposure: interim results.

Bernstein DM, Rogers RA, Sepulveda R, Donaldson K, Schuler D, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2010 Sep;22(11):937-62.

7. Re-creation of historical chrysotile-containing joint compounds.

Brorby GP, Sheehan PJ, Berman DW, Greene JF, Holm SE.

Inhal Toxicol. 2008 Sep;20(11):1043-53.

8. A biopersistence study following exposure to chrysotile asbestos alone or in combination with fine particles.

Bernstein DM, Donaldson K, Decker U, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2008 Sep;20(11):1009-28.

I thank William Ruskin for calling my attention to this interesting case in his blog post about the Weitz & Luxenberg v. Georgia-Pacific case.

Posted in Underlying Data | Comments Off on A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation

Federal Rule of Evidence 106 Applied to Statistical Evidence

June 18th, 2013

Watching your expert witness harassed by an unfair crossexamination, without protection from the trial judge, is one of the most frustrating, annoying, and enraging events in trial.  Not so long ago, I had the experience of having a lawyer put a chart together during his crossexamination of an expert witness. The crossexaminer took the upper bound of each confidence interval, and asked “Based upon this study, the true relative risk could be as high as X?”  When the witness, naturally and properly pointed out that the study data were also compatible with a relative risk as low as Y, the lower bound of the confidence interval, the crossexaminer whined that the witness was not being responsive, with the trial court’s chiming in to curb the expert’s reasonable desire to have a complete, correct answer.

Watching events such as this crossexamination has led me to believe that there really should be a rule of completeness for statistical evidence.  If sampling is random and unbiased, a point estimate may be the best estimate of the true value of a mean or a proportion, but that estimate may be rather crummy if the random error is large.  Presenting the sample statistic without some idea of the standard error seems wrong, but is there a remedy?

Statistical evidence did not play much of a role in the development of common law evidence, but the law is concerned with the sort of contextual accuracy that was being abused by the crossexamination of the expert witness, above.  The Federal Rules provide for completeness in at least two contexts.  Federal Rule of Evidence 106 provides:

“Remainder of or Related Writings or Recorded Statements

If a party introduces all or part of a writing or recorded statement, an adverse party may require the introduction, at that time, of any other part — or any other writing or recorded statement — that in fairness ought to be considered at the same time.”

A similar rule governs depositions presented in court.  Federal Rule of Civil Procedure 32(a)(4).

As the Advisory Committee notes to Rule 106 point out, Rule 106 is based upon two basic considerations:

“The first is the misleading impression created by taking matters out of context. The second is the inadequacy of repair work when delayed to a point later in the trial. …  The rule does not in any way circumscribe the right of the adversary to develop the matter on cross-examination or as part of his own case.”

Rule 106, Advisory Committee Notes (internal citations omitted).

When “in fairness” should an omitted portion be considered contemporaneously?  Here is how the Seventh Circuit put the matter in the more mundane context of a writing:

“To determine whether a disputed portion is necessary, the district court considers whether

(1) it explains the admitted evidence,

(2) places the admitted evidence in context,

(3) avoids misleading the jury, and

(4) insures fair and impartial understanding of the evidence.”

United States v. Velasco, 953 F.2d 1467, 1475 (7th Cir.1992).

Presentation of a point estimate should be accompanied by a measure of its variability; “[w]henever possible, an estimate should be accompanied by its standard error.” Reference Manual on Scientific Evidence at 117-18 (2d ed. 2000).  Similarly, trial courts should be vigilant against permitting a party to use the upper or the lower bound of a confidence interval to paint a misleading picture of “what the evidence shows.”

 

Posted in Scientific Evidence | Comments Off on Federal Rule of Evidence 106 Applied to Statistical Evidence

Power in the Reference Manual for Scientific Evidence

June 15th, 2013

The Third Edition of the Reference Manual on Scientific Evidence (2011) [RMSE3ed] treats statistical power in three of its chapters, those on statistics, epidemiology, and medical testimony.  Unfortunately, the treatment is not always consistent.

The chapter on statistics has been consistently among the best and most frequently ignored content of the three editions of the Reference Manual.  The most recent edition offers a good introduction to basic concepts of sampling, random variability, significance testing, and confidence intervals.  David H. Kaye & David A. Freedman, “Reference Guide on Statistics,” in RMSE3ed 209 (2011).  Kaye and Freedman provide an acceptable non-technical definition of statistical power:

“More precisely, power is the probability of rejecting the null hypothesis when the alternative hypothesis … is right. Typically, this probability will depend on the values of unknown parameters, as well as the preset significance level α. The power can be computed for any value of α and any choice of parameters satisfying the alternative hypothesis. … Frequentist hypothesis testing keeps the risk of a false positive to a specified level (such as α = 5%) and then tries to maximize power. Statisticians usually denote power by the Greek letter beta (β). However, some authors use β to denote the probability of accepting the null hypothesis when the alternative hypothesis is true; this usage is fairly standard in epidemiology. Accepting the null hypothesis when the alternative holds true is a false negative (also called a Type II error, a missed signal, or a false acceptance of the null hypothesis).”

Id. at 254 n.106

The definition is not, however, without problems.  First, it introduces a nomenclature issue likely to be confusing for judges and lawyers. Kaye and Freeman use β to denote statistical power, but they acknowledge that epidemiologists use β to denote the probability of a Type II error.  And indeed, both the chapters on epidemiology and medical testimony use β to reference Type II error rate, and thus denote power as the complement of β, or (1- β).  See Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” in RMSE3ed 549, 582, 626 ; John B. Wong, Lawrence O. Gostin, and Oscar A. Cabrera, Abogado, “Reference Guide on Medical Testimony,” in RMSE3ed 687, 724.  This confusion in nomenclature is regrettable, given the difficulty many lawyers and judges seem have in following discussions of statistical concepts.

Second, the reason for introducing the confusion about β is doubtful.  Kaye and Freeman suggest that statisticians usually denote power by β, but they offer no citations.  A quick review (not necessarily complete or even a random sample) suggests that many modern statistics texts denote power as (1- β).  See, e.g., Richard D. De Veaux, Paul F. Velleman, and David E. Bock, Intro Stats 545-48 (3d ed. 2012); Rand R. Wilcox, Fundamentals of Modern Statistical Methods 65 (2d ed. 2010).  At the end of the day, there really is no reason for the conflicting nomenclature and the likely confusion it engenders.  Indeed, the duplicative handling of statistical power, and other concepts, suggests that it is time to eliminate the repetitive discussions, in favor of one, clear, thorough discussion in the statistics chapter.

Third, Kaye and Freeman problematically refer to β as the probability of accepting the null hypothesis when elsewhere they more carefully instruct that a non-significant finding results in not rejecting the null hypothesis as opposed to accepting the null.  Id. at 253.  See also Daniel Rubinfeld, “Reference Guide on Multiple Regression,“ in RMSE3d 303, 321 (describing a p-value > 5% as leading to failing to reject the null hypothesis).

Fourth, Kaye and Freedman’s discussion of power, unlike most of their chapter, offers advice that is controversial and unclear:

“On the other hand, when studies have a good chance of detecting a meaningful association, failure to obtain significance can be persuasive evidence that there is nothing much to be found.”

RMSE3d at 254. Note that the authors leave open what a legal or clinically meaningful association is, and thus offer no real guidance to judges on how to evaluate power after data are collected and analyzed.  As Professor Sander Greenland has argued, in legal contexts, this reliance upon observed power (as opposed to power as a guide in determining appropriate sample size in the planning stages of a study) is arbitrary and “unsalvageable as an analytic tool.”  See Sander Greenland, “Nonsignificance Plus High Power Does Not Imply Support Over the Alternative,” 22 Ann. Epidemiol. 364, 364 (2012).

The chapter on epidemiology offers similar controversial advice on the use of power:

“When a study fails to find a statistically significant association, an important question is whether the result tends to exonerate the agent’s toxicity or is essentially inconclusive with regard to toxicity.93 The concept of power can be helpful in evaluating whether a study’s outcome is exonerative or inconclusive.94  The power of a study is the probability of finding a statistically significant association of a given magnitude (if it exists) in light of the sample sizes used in the study. The power of a study depends on several factors: the sample size; the level of alpha (or statistical significance) specified; the background incidence of disease; and the specified relative risk that the researcher would like to detect.95  Power curves can be constructed that show the likelihood of finding any given relative risk in light of these factors. Often, power curves are used in the design of a study to determine what size the study populations should be.96”

Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” RMSE3ed 549, 582.  Although the authors correctly emphasize the need to specify an alternative hypothesis, their discussion and advice are empty of how that alternative should be selected in legal contexts.  The suggestion that power curves can be constructed is, of course, true, but irrelevant unless courts know where on the power curve they should be looking.  The authors are correct that power is used to determine adequate sample size under specified conditions, but again, the use of power curves in this setting is today rather uncommon.  Investigators select a level of power corresponding to an acceptable Type II error rate, and an alternative hypothesis that would be clinically meaningful for their research, in order to determine their sample size. Translating clinical into legal meaningfulness is not always straightforward.

In a footnote, the authors of the epidemiology chapter note that Professor Rothman has been “one of the leaders in advocating the use of confidence intervals and rejecting strict significance testing.” RMSE3d at 579 n.88.  What the chapter fails, however, to mention is that Rothman has also been outspoken in rejecting post-hoc power calculations that the epidemiology chapter seems to invite:

“Standard statistical advice states that when the data indicate a lack of significance, it is important to consider the power of the study to detect as significant a specific alternative hypothesis. The power of a test, however, is only an indirect indicator of precision, and it requires an assumption about the magnitude of the effect. In planning a study, it is reasonable to make conjectures about the magnitude of an effect to compute study-size requirements or power. In analyzing data, however, it is always preferable to use the information in the data about the effect to estimate it directly, rather than to speculate about it with study-size or power calculations (Smith and Bates, 1992; Goodman and Berlin, 1994; Hoening and Heisey, 2001). Confidence limits and (even more so) P-value functions convey much more of the essential information by indicating the range of values that are reasonably compatible with the observations (albeit at a somewhat arbitrary alpha level), assuming the statistical model is correct. They can also show that the data do not contain the information necessary for reassurance about an absence of effect.”

Kenneth Rothman, Sander Greenland, and Timothy Lash, Modern Epidemiology 160 (3d ed. 2008).  See also Kenneth J. Rothman, “Significance Questing,” 105 Ann. Intern. Med. 445, 446 (1986) (“[Simon] rightly dismisses calculations of power as a weak substitute for confidence intervals, because power calculations address only the qualitative issue of statistical significance and do not take account of the results already in hand.”)

The selective, incomplete scholarship of the epidemiology chapter on the issue of statistical power is not only unfortunate, but it distorts the authors’ evaluation of the sparse case law on the issue of power.  For instance, they note:

“Even when a study or body of studies tends to exonerate an agent, that does not establish that the agent is absolutely safe. See Cooley v. Lincoln Elec. Co., 693 F. Supp. 2d 767 (N.D. Ohio 2010).  Epidemiology is not able to provide such evidence.”

RMSE3d at 582 n.93; id. at 582 n.94 (“Thus, in Smith v. Wyeth-Ayerst Labs. Co., 278 F.Supp. 2d 684, 693 (W.D.N.C. 2003), and Cooley v. Lincoln Electric Co., 693 F. Supp. 2d 767, 773 (N.D. Ohio 2010), the courts recognized that the power of a study was critical to assessing whether the failure of the study to find a statistically significant association was exonerative of the agent or inconclusive.”)

Here Green, Freedman, and Gordis shift the burden to the defendant and make the burden one of absolute certainty in the product’s safety.  This is not a legal standard. The cases they cite amplify the error. In Cooley, for instance, the defense expert would have opined that welding fume exposure did not cause parkinsonism or Parkinson’s disease.  Although the expert had not conducted a meta-analysis, he had reviewed the confidence intervals around the point estimates of the available studies.  Many of the point estimates were at or below 1.0, and in some cases, the upper bound of the confidence interval excluded 1.0.  The trial court expressed its concern that the expert witness had inferred “evidence of absence” from “absence of evidence.”  Cooley v. Lincoln Elec. Co., 693 F. Supp. 2d 767, 773 (N.D. Ohio 2010).  This concern, however, was misguided given that many studies had tested the claimed association, and that virtually every case-control and cohort study had found risk ratios at or below 1.0, or very close to 1.0.  What the court in Cooley, and the authors of the epidemiology chapter in the RSME3d have lost sight of, is that when the hypothesis is repeatedly tested, with failure to reject the null hypothesis, and with point estimates at or very close to 1.0, and with narrow confidence intervals, then the claimed association is probably incorrect.  See, e.g., Anthony J. Swerdlow, Maria Feychting, Adele C. Green, Leeka Kheifets, David A. Savitz, International Commission for Non-Ionizing Radiation Protection Standing Committee on Epidemiology, “Mobile Phones, Brain Tumors, and the Interphone Study: Where Are We Now?” 119 Envt’l Health Persp. 1534, 1534 (2011) (“Although there remains some uncertainty, the trend in the accumulating evidence is increasingly against the hypothesis that mobile phone use can cause brain tumors in adults.”).

The Cooley court’s comments have some validity when applied to a single study, but not to the impressive body of exculpatory epidemiologic evidence that pertains to welding fume and Parkinson’s disease.  Shortly after the Cooley case was decided, a published meta-analysis of welding fume or manganese exposure demonstrated a reduced level of risk for Parkinson’s disease among persons occupationally exposed to welding fumes or manganese.  James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012).

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Improper Claims That Studies Lack Power, Made Without Specifying An Alternative Hypothesis

June 14th, 2013

The Misuse of Power in the Courts

A claim that a study has low power is meaningless unless both the alternative hypothesis and the level of significance are included in the statement.  See Sander Greenland, “Nonsignificance Plus High Power Does Not Imply Support Over the Alternative,” 22 Ann. Epidemiol. 364 (2012); Sander Greenland & Charles, Poole, “Problems in common interpretations of statistics in scientific articles, expert reports, and testimony,” 51 Jurimetrics J. 113, 121-22 (2011).

Power can always be assessed as low by selecting an alternative hypothesis sufficiently close to the null. A study, using risk ratios, which has high power against an alternative hypothesis of 2.0, may have very low power against an alternative of 1.1. Because risk ratios greater than two are often used to attribute specific causation, measuring power of a study against an alternative hypothesis of a doubling of risk might well be a reasonable approach in some cases.  For instance, in Miller v. Pfizer, 196 F. Supp. 2d 1062, 1079 (D. Kan. 2002), aff’d, 356 F. 3d 1326 (10th Cir.), cert. denied, 543 U.S. 917 (2004), the trial court’s Rule 706 expert witness calculated the power of a study to exceed 90% probability to detect a doubling of risk in a pooled analysis of suicidality in clinical trial data of an anti-depressant.  Report of John Concato, M.D., 2001 WL 1793169, *9 (D.Kan. 2001). Unless a court was willing to specify the level at which it would find the risk ratio unhelpful or not probative, such as a relative risk greater than two, power analyses of completed studies are not particularly useful.

Plaintiffs’ counsel rightly complain when defendants claim that a study with a statistically “non-significant” risk ratio greater than 1.0 has no probative value. Although random error (or bias and confounding) may account for the increased risk, the risk may be real. If studies consistently show an increased risk, even though all the studies have reported p-values > 5%, meta-analytic approaches may very well help rule out chance as a likely explanation for the increased risk. The complaint that a study, however, is underpowered, without more, does not help plaintiff establish an association; nor does the complaint establish that the study provides no useful information.

The power of a study depends upon several variables, including the size of the alternative hypothesis, the sample size, the expected value and its variance, and the acceptable level of probability for false-positive findings, which level is reflected in the pre-specified p-value, α, at which level the study’s findings would be interpreted as not likely consistent with the null hypothesis. The lower α is set, the lower will be the power of a test or a study, all other things being equal.  Similarly, moving from a two-tailed to a one-tailed test of significance will increase power.  Courts have acknowledged that both Type I and Type II errors, and the corresponding α and β, are important, but they have overlooked that Type II errors are usually less relevant to the litigation process. See, e.g., DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F.2d 941, 948 (3d Cir. 1990).  A single study that failed to show a statistically significant difference in the outcome of interest does not support a conclusion that the outcome is not causally related to the exposure under study.  In products liability litigation, the parties are typically not assigned a burden of proving the absence of causation.

In the Avandia litigation, plaintiffs’ key claim is that the medication, an oral anti-diabetic, causes heart attacks, even though none of the several dozen clinical trials found a statistically significant increased risk. Plaintiffs’ expert witnesses argued that all the clinical trials of Avandia were “underpowered,” and thus the failure to find an increased risk was a Type II (false-negative) error that resulted from the small size of the clinical trials. The Avandia MDL court, considering Rule 702 challenges to plaintiffs’ expert witness opinions, accepted this argument:

“If the sample size is too small to adequately assess whether the substance is associated with the outcome of interest, statisticians say that the study lacks the power necessary to test the hypothesis. Plaintiffs’ experts argue, among other points, that the RCTs [randomized controlled trials] upon which GSK relies are all underpowered to study cardiac risks.”

In re Avandia Mktg., Sales Practices & Prods. Liab. Litig., 2011 WL 13576, at *2 (E.D. Pa. 2011) (emphasis in original). The Avandia MDL court failed to realize that the power argument was empty without a specification of an alternative hypothesis. For instance, in one of the larger trials of Avandia, the risk ratio for heart attack was a statistically non-significant 1.14, with a 95% confidence interval that spanned 0.80 to 1.63. P.D. Home, et al., Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD), 373 Lancet  2125 (2009). This trial, standing alone, thus had excellent power against an alternative hypothesis that Avandia doubled the risk of heart attacks; such an alternative hypothesis would clearly be rejected based upon the RECORD trial. On the other hand, an alternative hypothesis of 1.2 would not be. The confidence interval, by giving a quantification of random error, conveys results reasonably compatible with the study estimate; the claim of “low power” against an unspecified alternative hypothesis, conveys nothing.

Last year, in a hormone therapy breast cancer case, the Eight Circuit confused power with β, and succumbed to plaintiff’s expert witness’s argument that he was justified in ignoring several large, well-conducted clinical trials and observational studies because they were “underpowered,” without specifying the alternative hypothesis he was using to make his claim:

“Statistical power is ‘the probability of rejecting the null hypothesis in a statistical test when a particular alternative hypothesis happens to be true’. Merriam–Webster Collegiate Dictionary 973 (11th ed. 2003). In other words, it is the probability of observing false negatives. Power analysis can be used to calculate the likelihood of accurately measuring a risk that manifests itself at a given frequency in the general population based on the sample size used in a particular study. Such an analysis is distinguishable from determining which study among several is the most reliable for evaluating whether a correlative or even a causal relationship exists between two variables.”

Kuhn v. Wyeth, Inc., 686 F.3d 618, 622 n.5 (8th Cir. 2012), rev’g, In re Prempro Prods. Liab. Litig., 765 F. Supp. 2d 1113 (W.D. Ark. 2011). The Kuhn court’s formulation, “in other words,” is incorrect.  Power is not the probability of observing false negatives; it is the probability of correctly rejecting the null in favor of a specified alternative hypothesis, at a specified level of significance probability.  The court’s further discussion of “accurately measuring” mischievously confuses one aspect of statistical power concerned with random variability, with study validity.  The 8th Circuit’s opinion never discusses or discloses what alternative hypothesis the plaintiff’s expert witness had in mind when disavowing certain studies as underpowered.  I suspect that none was ever provided, and that the judges missed the significance of the omission.  The courts would seem better off using the confidence intervals around point estimates to assess the statistical imprecision in the observed data, rather than improper power analyses that fail to specify a legally significant alternative hypothesis.

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Sympathy for the Diablo — Peppermint Barry vs Spicy Seafood Pasta

June 12th, 2013

Barry S. Levy is a physician, author, performer, and political activist.   Dr. Levy is a past president of the American Public Health Association, which conferred upon him its oldest and most prestigious award, the Sedgwick Memorial Medal, in 2005, for his outstanding achievements in public health.

Levy has been received other, less favorable notice from trial and appellate judges.  For instance, one federal judge found Levy engaged in a dubious enterprise to manufacture silicosis claims in Mississippi.  In re Silica Products Liability Litigation, 398 F. Supp. 2d 563, 611-16, 622 & n.100 (S.D. Texas 2005) (expressing particular disappointment with Dr. Barry Levy, who although not the worst offender of a bad lot of physicians, betrayed his “sterling credentials” in a questionable enterprise to manufacture diagnoses of silicosis for litigation). See also Schachtman, Silica Litigation: Screening, Scheming & Suing; Washington Legal Foundation Critical Legal Issues Working Paper Series No. 135 (Dec. 2005) (exploring the ethical and legal implications of the entrepreneurial litigation in which Levy and others were involved).

Unfortunately, In re Silica was not an isolated case.  See, e.g., Lofgren v. Motorola, Inc., 1998 WL 299925, No. CV 93-05521 (Ariz. Super. Ct., Maricopa Cty. June 1, 1998); Harman v. Lipari, N.J. L. Div. GLO-L-1375-95, Order of Nov. 3, 2000 (Tomasello, J.) (barring the use of Barry Levy in class action for medical monitoring damages); Castellow v. Chevron USA, 97 F.Supp. 2d 780, 793-95 (S.D. Tex. 2000); Knight v. Kirby Inland Marine Inc., 482 F.3d 347 (5th Cir. 2007); Watts v. Radiator Specialty Co., 990 So. 2d 143 (Miss. 2008); Aurand v. Norfolk So. Ry., 802 F.Supp.2d 950 (2011).

Now, once again, right here in River City, Dr. Levy has stepped out of bounds, and has been stripped of his mantle of testifying expert witness.  Mallozzi v. Ecosmart Technologies, Inc., 2013 WL 2415677, No. 11-CV-2884 (SJF)(ARL) (E.D.N.Y. May 31, 2013).

Over the course of a few minutes, plaintiff Velio Mallozi applied a “couple of ounces” of EcoSmart Organic Home Pest Control product to the foundation of his home, and a few squirts inside.  The product used, EcoSmart, contains plant oils, including one percent peppermint oil.  Id. at *1.  Mallozi did not experience any acute ill effects from his organic pest control efforts, and later went to dinner at an [unidentified] Italian restaurant, where he enjoyed a meal of “spaghetti with seafood.”  Id. at *10.  Perhaps seafood diablo, but Judge Feuerstein doesn’t say.

After the seafood spaghetti meal, Mallozi experienced a serious bout of laryngopharyngeal reflux (LPR).  With sympathy for the diablo, Mallozi sued only EcoSmart, on the claim that his inhaling some spray, with its 1% peppermint oil, caused his LPR.

The Mallozis sought out B.S. Levy to support the claimed relationship.  Levy did not disappoint.  He rendered a report that asserted that the few minutes of inhaling minor amounts of peppermint oil causes relaxation of the lower esophogeal sphincter, and consequently LPR.  Id. at *5.  Levy relied upon four articles to support this claim, but Judge Feuerstein refused to accept the claim of support, at face value.  Her Honor reviewed each study, only to find that the exposures that were associated with relaxation of G.I. smooth muscle, for a short period of about 20 minutes, were trials of ingested peppermint oil, at significantly greater doses, over lengthy periods of observation.  Id. at *6.  The studies individually and collectively did not support Levy’s opinion.

One of the papers on Levy’s reliance list was a case report of a patient that suffered burns in her mouth from ingestion of pure peppermint oil. The court found that this case report, involving large doses of pure peppermint oil, with an outcome different from claimed by Mallozi, was irrelevant.  Id. Even if it were construed to offer some support, the anecdotal nature of the case report, lacking controls, renders the report an unreliable basis for a causal conclusion.  Id.

The trial court found that B.S. Levy’s analysis ignored the crucial roles of dose, duration, route of exposure, and the nature of plaintiff’s condition, LPR.   Id. at *8.  The court held that Levy’s opinion did not satisfy the requirements of Rule 702.  The plaintiffs failed to show that Levy’s opinion was supported sufficiently by facts or data, and they failed to show that his opinion was the product of applying reliable methods and principles.  Id.

Judge Feuerstein, having found that Levy’s opinion on general causation between EcoSmart and LPR was bereft of validity, could have stopped without addressing specific causation.  Such an approach would have had the virtue of judicial economy, but would have left out some delicious facts.  Levy purportedly used some sort of differential etiology to infer the cause of plaintiff’s LPR, but he omitted meaningful consideration of plaintiff’s having had a history of severe severe gastroesophageal reflux disease (GERD), which predated his bout of LPR.  Indeed, plaintiff’s GERD had been so severe that he had been previously hospitalized for GERD after ingesting coffee and donuts.   Judge Feuerstein found Levy’s iterative disjunctive syllogism invalid for having failed to address the prior history of GERD, and the intervening role of the pasta and seafood dinner, in bringing on the LPR.  Id. at *10-11.

The Material Safety Data Sheet Ploy

Judge Feuerstein also demonstrated a careful understanding of the meaning and role of the Material Data Safety Sheet (MSDS).  EcoSmart’s MSDS contained a warning that some sensitive persons may experience dizziness or irritation of their nasal passages, and that ingestion may cause GI irritation.  Id. at *13.  Dr. Levy had embraced this MSDS language as an “admission,” but he did not analyze the sources of information or their validity.  The MSDS warning, as required by law, addresses the potential hazard of the ingredient, peppermint oil, irrespective of dose, concentration, or route of administration.  Id., citing Moore v. Ashland Chem. Inc., 151 F.3d 269, 278 (5th Cir.1998); Turner v. Iowa Fire Equip. Co., 229 F.3d 1202, 1209 (8th Cir.2000); Ingram v. Solkatronic Chem., Inc., No. 04–CV–0287, 2005 WL 3544244, at *6 (N.D.Okla. Dec. 28, 2005)).

The Treating Physician Echo

Apparently one of Mr. Mallozzi’s treating physicians joined the fray with echoes of Levy’s opinion.  Judge Feuerstein recognized that treating physicians are subject to the requirements of Rule 702, and that a me-too opinion deserved the me-too result.  Id. at *13, citing Davids v. Novartis Pharm. Corp., 857 F.Supp. 2d 267, 280 (E.D.N.Y. 2012).

Pasta and Peppermints

Bad sense, innocence, cripplin’ my mind.
Old medical records I just can’t find.
Too much Cajun spice, and I forgot about GERD.
Incense and peppermints, haven’t you heard?
But who cares, it’s just litigation.
Lots to win, but nothing to lose.

Incense and peppermints, meaningless claims.
Turn on, drop in, toxins are all the same

Throw your pride to the side; it’s what you must do.

Daubert is politics; 702.
A yardstick for lunatics, your point of view.
The court cares what games you choose.
You have lots to win, but nothing to lose

(adapted from, and with apologies to, Strawberry Alarm Clock)

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State of the Art — Tasing in the Dark

June 11th, 2013

In American product liability litigation, there are two causation requirements:  warnings causation and factual causation.  The law imposes a duty to warn of risks, and the alleged failure to warn must have some connection with the plaintiff’s use of the product in such a way as to have caused him harm.  If an adequate warning, whatever that is, would have protected plaintiff from the harm, then there is the requisite nexus between the alleged failure to warn and plaintiff’s harm.

The product must also, however, be a factual cause of the harm.  For instance, a really scary warning that promised death and destruction might have kept the plaintiff from using the product, but still, the product itself must have caused the harm, for the plaintiff to satisfy the factual causation requirement.

The history of the last 50 years or so of American products liability law has been a narrative of unending assault on causation, both with respect to warnings causation, and to medical or factual causation.  Plaintiffs have sought to dilute, eliminate, create presumptions for, and shift the burden of proof of, both causation requirements.

The duty to warn arises, understandably, when the seller or manufacturer has knowledge that the product can cause harm, and the buyer lacks this knowledge.  For various reasons, sloppiness, ideology, or advocacy, some writers neglect the requirement that the buyer must lack the knowledge of the danger.  Quod vanum et inutile est, lex non requirit.  The law does not require what is vain and useless.  This principle of equity and law still informs the law of product liability, through doctrines and rules such as sophisticated user and sophisticated intermediary.

The duty to warn was traditionally couched in terms of a duty to impart knowledge, actual or constructive, or a connection between a foreseeable use of the product and a serious harm.  The plaintiffs’ bar’s war on causation has sought to lower the epistemic standard for both warning and factual causation.  There are too many cases to cite for the proposition that sellers must warn of potential risks as well as actually known or knowable risks.  This erosion would be harmless but for the similar erosion in standards of medical or factual causation, and the attempts to abandon meaningful standards of expert witness causation opinions.

It is thus refreshing to see the Ninth Circuit hold that California’s law of duty to warn applies to only to known or knowable risks.  Last year, the Court of Appeals held that a Taser manufacturer had no duty to warn of the risk that repeated shocks administered by its products could lead to death by inducing metabolic acidosis, given the state of the art at the time the product was manufactured. In Rosa v. Taser International, Inc., 684 F.3d 941 (9th Cir. 2012) , the Rosa’s son died after being “tased” by police officers.  The autopsy report attributed death to ventricular arrhythmia, caused by Michael Rosa’s having used methamphetamine, along with the police’s use of Tasers.  Expert witnesses postulated the mechanism of causation between tasing and death was metabolic acidosis, which consists of increased lactic acid levels, which in turn increased the risk of cardiac arrest.

The Rosas sued Taser International, Inc., the manufacturer of the “stun guns” on theories of strict liability and negligent failure to warn the purchasers, the police, of the dangers of the product.  (They did not sue the meth manufacturer or retailer.) The Rosas argued that Taser had a duty to warn of any risk, “no matter how unsubstantiated,” even if based upon speculative or conjectural statements, or inadequate studies.  Id. at 946.  The Court Appeals decisively rejected a duty to warn on this inconclusive evidentiary display.

The Ninth Circuit held that California law conditions the duty to warn on a high epistemic standard of knowledge, actual or constructive.  Id. at 946.  The manufacturer must warn of a “particular risk … known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.” Id. (quoting from Conte v. Wyeth, Inc., 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299, 310 (2008) (emphasis added by the Circuit Court).

Noting that the California courts have not articulated epistemological principles for knowledge of hazards that must find their way into warnings, the court, in Rosa, noted some accepted considerations.  First, ignorance is not a defense. ‘‘[A] manufacturer is held to the knowledge and skill of an expert in the field; it is obliged to keep abreast of any scientific discoveries and is presumed to know the results of all such advances.’’ Id. at 946 (citing Carlin v. Superior Court, 13 Cal.4th 1104, 56 Cal. Rptr.2d 162, 920 P.2d 1347, 1351 n. 3 (1996)).

Second, a manufacturer need not warn of “every report of a possible risk, no matter how speculative, conjectural, or tentative.” Id. (internal citations omitted).  A duty to warn of every possible risk would have the counter-productive result of diluting the effect of specific warnings of real risks, by “inundat[ing the public] indiscriminately with notice of any and every hint of danger.” Id.

The Rosas relied upon four peer-reviewed articles to argue that Taser had a duty to warn. Id. at 497. The Ninth Circuit looked past the fact of mere publication and peer review, to the actual nature and content of the relied-upon articles.  Some of the publications did not address stun guns, but two did, although in speculative ways.  See Raymond Fish & Leslie A. Geddes, “Effects of Stun Guns and Tasers,” 358 The Lancet 687 (2001).  The second publication was a Department of Defense report, which predated Michael Rosa’s death, but was not generally available until after his death.  John M. Kenny, et al., Human Effects Advisory Panel, Report of Findings Sticky Shocker Assessment (1999).  The court doubted whether such a report, unavailable to defendant, could be the predicate for defendant’s duty warn.  In any event, the content of the 1999 report was itself speculative, and merely concluded that  “deaths following Taser[] use may be due to acidosis.” Kenny at 31. The report did not state a causal conclusion, and it qualified its dataset as limited by small size.  Kenny at 32.

Taser added relevant warnings, six years after Michael Rosa’s death, and the Rosas sought to capitalize upon the warnings as admissions of some sort.  Id. at 948.  The Court of Appeals rebuffed this argument, not only on the basis of subsequent remedial measure, but also on the basis of “state of the art,” which requires that the evidence of the harm, which forms the basis for the duty to warn, be known or knowable at the time of marketing of the product.  Id.

In Rosa, the available evidence that might constitute “knowledge” of a harm shifted between the time of injury, and the time of litigation.  In latent disease litigation, the shift in evidence can be extreme, and hence the importance of “state of the art” as a limit to the duty to warn.

Can the evidence for a knowledge claim regress?  If what was in the medical literature at some earlier time turned out to be false later, then it would seem that it was never “knowledge” in the first place.  Still, plaintiffs would likely rely upon the older apparent knowledge to claim that it created a duty to warn.  For instance, in asbestos litigation, plaintiffs have claimed, since the late 1970s, that asbestos exposure causes gastrointestinal (GI) cancer.  The plaintiffs’ claims were supported  by Dr. Selikoff and his cadre of Mt. Sinai testifying physicians and scientists, and many textbooks and review articles stated, without qualification, that asbestos caused GI cancer.  In 2006, however, the Institutes of Medicine convened a committee to review non-pulmonary cancers and asbestos, and concluded that the studies, accumulated over 35 years since Dr. Selikoff’s ipse dixit, did not support a conclusion that asbestos causes colorectal cancer.  Institute of Medicine of the National Academies, Asbestos: Selected Health Effects (2006).  If the claim is unsupported in 2006, it was not established at times past, despite the assertions of plaintiffs and their partisan expert witnesses in litigation, and in publications.

Another example of the uneven path of knowledge is the claim that silica causes lung cancer.  Early writers suggested this hypothesis on the basis of flawed evidence, but the claim came to be rejected when astute authors realized that the lung cancer mortality experience of uranium miners was determined by their exposure to ionizing radiation, not to silica.  Starting in the 1980s, however, a group of advocate scientists started to press for recognition of silica itself as a lung carcinogen, and these scientists narrowly succeeded, by a deeply divided vote, in an IARC working group vote in 1996.  This IARC classification put crystalline silica into category I, but the rationale for this classification was soon thereafter shown to be lacking.  See Patrick A. Hessel, John F. Gamble, J. Bernard L. Gee, Graham Gibbs, Francis H.Y. Green, W. Keith C. Morgan, and Brooke T. Mossman, “Silica, Silicosis, and Lung Cancer: A Response to a Recent Working Group Report,” 42 J. Occup. Envt’l Med. 704 (2000).  A seller of crystalline silica should, under the Rosa case, be well within its rights not to warn of a risk of lung cancer.  The reality is that the litigation system is way too uncertain and even capricious, leading most companies to have warned of lung cancer “risk” from the mid-1980s, forward.

What is encouraging about Rosa is its implicit recognition that the Rule 702 factors for reliable scientific opinion are very much in play when evaluating historical scientific opinion, which is asserted to be the basis for a duty to warn.  The more typical “state of the art” decisions simply pass over validity and reliability of historical statements and conclusions, with a grand gesture that everything published serves to provide “notice” of a potential hazard.  This usual approach begs the question, however, whether there was a sound basis for a conclusion that the product was known to cause the harm alleged in the pending case.  The scientific nature of the historical determination may mean that historians, lacking in scientific credentials, will be inappropriate witnesses to support historical claims of knowledge of risks.  The Rosa court’s insistence upon historical study and conclusion validity and correctness requires a careful review of the historical epistemic claim in view of the full historical and contemporary record.

In the Rosa case itself, the claim of failure to warn failed as a result of a fair analysis of the extant evidence for the claim at the time of marketing of the Taser. The post-marketing shift in the epistemic basis for the failure-to-warn claim was irrelevant to the Rosas’ case.  Perhaps the warnings vel non on the methamphetamine used by Michael Rosa would have been a better predicate for the lawsuit?

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The Mt. Sinai Catechism

June 7th, 2013

There are mythologies in science as there in religion.  Back in the day, Dr. Irving Selikoff invented a catchy catechism about synergistic interaction between asbestos and smoking in producing lung cancer.  Selikoff’s study of insulators advanced lung cancer point estimates for asbestos alone, for smoking alone, and for asbestos and smoking together:  5-10-50, which became incorporated in innumerable textbooks, articles, expert witness reports, and court opinions.

E. Cuyler Hammond, Irving J. Selikoff,  and Herbert Seidman, “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. 473, 487 (1979).  Selikoff tells us that each insulator, starting in 1961, answered “a detailed questionnaire,” and later, repeat questionnaires on their smoking histories.  Id. at 475.

“Of the 8220 men who answered the questionnaire, 891 (11%) said that they had never smoked regularly; 488 (6%) had a history of pipe or cigar smoking but never smoked cigarettes regularly and; 6841 (83%) were either current or ex-cigarette smokers. Some of the cigarette smokers also smoked pipes or cigars or had done so in the past.”

Id. at 481.

The 5 supposedly represented the relative risk of asbestos exposure alone in insulators who did not smoke; the 10 supposedly represented the relative risk of smoking alone in the non-insulator general population of smokers; and the 50 represented the relative risk of insulators who had smoked.  Selikoff claimed that his data supported a multiplicative model of synergistic interaction between smoking and asbestos exposure.

Like other mythologies, there was a good bit of exaggeration and fabrication in Selikoff’s story. First, the non-smoking relative risk was based upon the observed risk ratio among insulators who “never smoked regularly.”  Smoking data were collected by survey, and the actual questionnaires and definition have never been published or provided by Selikoff and his colleagues.  Even taken at face value, “never smoked regularly” is not the same as non-smoker.  Adding that the insulators union was widely engaged in personal injury litigation, and that the membership had a strong motive to downplay their smoking histories, this exposure information becomes suspect.

The non-asbestos smoking lung cancer point estimate (10) was equally dubious.  The ten-fold risk statistic represented an average smoking lung cancer risk in the first Cancer Prevention Survey (CPS-1).  The insulators who smoked were rarely average smokers, and the CPS-1 point estimate was superseded within a couple of years by the new, revised CPS-II overall smoking lung cancer point estimate that was greater than twenty.  The CPS-II results were published in the 1980s and early 1990s, but Selikoff and his protégés contained to testify to the 5-10-50. See, e.g., Shopland, “Smoking-Attributable Cancer Mortality in 1991: Is Lung Cancer Now the Leading Cause of Death Among Smokers in the United States?” 83 J. Nat’l Cancer Inst. 1142 (1991).

These problems and others led astute authors to note their dissent from the simplistic multiplicative model.  F. Douglas K. Liddell, “The Interaction of Asbestos and Smoking in Lung Cancer,” 45 Ann. Occup. Hyg. 341 (2001) (“Both cigarette smoke and inhaled asbestos fibres can cause lung cancer, but the assessment of how these agents act in combination is a matter of great difficulty.”)

Despite the serious problems with the multiplicative model, Selikoff’s wanton republication of the 5-10-50 data, and the popularity of these data with testifying expert witnesses and regulating agencies, cemented their use in litigation. Consider, for instance, how the orthodoxy infiltrated the ostensibly neutral Reference Manual on Scientific Evidence, which proclaimed the multiplicative synergy of smoking and asbestos in its second edition:

“Occupational asbestos exposure in nonsmokers increases the risk of lung cancer by a factor of about five, from about 11 per 100,000, for nonsmoking industrial workers not exposed to asbestos to about 58 per 100,000 for nonsmoking asbestos workers; a significant smoking history increases the rate of lung cancer by a factor of at least ten. See U.S. Surgeon Gen., U.S. Dep’t of Health & Human Servs., The Health Consequences of Smoking: Cancer and Chronic Lung Disease in the Workplace 216 (1985); see also Rodolfo Saracci, “The Interactions of Tobacco Smoking and Other Agents in Cancer Etiology,” 9 Epidemiologic Revs. 175, 176–80 (1987). Because the effects of smoking and asbestos are multiplicative for lung cancer, the population of smoking asbestos workers has a lung cancer incidence of 5 times 10, or 50 times the background rates, rather than the 15-fold increase predicted by adding the separate risks. See U.S. Surgeon Gen., U.S. Dep’t of Health & Human Servs., supra, at 216–17.”

Mary Sue Henifin, Howard M. Kipen, and Susan R. Poulter, “Reference Guide on Medical Testimony,” in Federal Judicial Center, Reference Manual on Scientific Evidence 439, 476 & n. 136 (2d ed. 2000).  Dr. Kipen was a protégé of Dr. Selikoff.  The reference to the multiplicative mantra was eliminated from the Third Edition of the Reference Manual.

Back in April of this year, some other Selikoff protégés were busy trying to rehabilitate the 5-10-50 mantra, with a new study. Science Daily earnestly reported news of the new study as though it were ground breaking.  See “Asbestos Exposure, Asbestosis, and Smoking Combined Greatly Increase Lung Cancer Risk” (Apr. 12, 2013)  (reporting on the in-press version of Steve Markowitz, Stephen Levin, Albert Miller, and Alfredo Morabia, “Asbestos, Asbestosis, Smoking and Lung Cancer: New Findings from the North American Insulator Cohort,” Am. J. Respir. & Critical Care Med. (2013)).  Interestingly, only Stephen Levin, who died over a year ago, is listed as affiliated with the Mt. Sinai School of Medicine.  Although some of the other authors had previous affiliations with Mt. Sinai, they are now listed at the Center for the Biology of Natural Systems, Queens College – CUNY.

Science Daily quotes lead author Markowitz as saying that “[t]he interactions between asbestos exposure, asbestosis and smoking, and their influence on lung cancer risk are incompletely understood.”  It seems unlikely that this new article will shed much light on the problem.   The authors claim to apply and extend Selikoff’s approach from previous publications.  This new publication thus incorporates the serious problems that had afflicted Selikoff’s papers, especially his use of CPS-I to provide a point estimate for smoking alone (the alleged 10 in the 5-10-50 theory).  Here is the abstract of the paper:

“Rationale

Asbestos, smoking, and asbestosis increase lung cancer risk in incompletely elucidated ways. Smoking cessation among asbestos-exposed cohorts has been little studied.

Objectives

To measure the contributions of asbestos exposure, asbestosis, smoking and their interactions to lung cancer risk in an asbestos-exposed cohort, and to describe their reduction in lung cancer risk when they stop smoking.

Methods

We examined lung cancer mortality obtained through the National Death Index for 1981-2008 for 2,377 male North American insulators for whom chest x-ray, spirometric, occupational and smoking data were collected in 1981- 1983 and for 54,243 non-asbestos exposed blue collar male workers from Cancer Prevention Study II for whom occupational and smoking data were collected in 1982.

Measurements and Main Results

Lung cancer caused 339 (19%) insulator deaths. Lung cancer mortality was increased by asbestos exposure among non-smokers [rate ratio = 3.6 (95% CI: 1.7-7.6)], by asbestosis among non-smokers [rate ratio = 7.40 (95% CI, 4.0-13.7], and by smoking without asbestos exposure [rate ratio = 10.3 (95% CI, 8.8-12.2)]. The joint effect of smoking and asbestos alone was additive [rate ratio = 14.4 (95% CI, 10.7-19.4)] and with asbestosis, supra-additive [rate ratio = 36.8 (95% CI, 30.1-46.0)]. Insulator lung cancer mortality halved within 10 years of smoking cessation and converged with that of never-smokers 30 years following smoking cessation.

Conclusions

Asbestos increases lung cancer mortality among non-smokers. Asbestosis further increases the lung cancer risk and, considered jointly with smoking, has a supra-additive effect. Insulators benefit greatly by quitting smoking.”

The big news that Steven Markowitz did not trumpet in the press releases was that in the absence of asbestosis, there was no multiplicative interaction.  The asbestos-alone (point estimate) is still suspect.  The paper characterizes this point estimate as applying to non-smokers without asbestosis, but given this group’s history of equivocating between “never smoked regularly” and “non-smoker,” and the difficulty in obtaining accurate smoking histories from men enmeshed in litigation over respiratory claims, the asbestos-alone point estimate remains doubtful.  Curiously, the smoking histories were collected in 1981-83, but there is no mention of any attempt to verify the histories against smoking histories provided by the study participants in earlier versions of Selikoff’s studies on the insulators.

Similarly, the smoking-alone point estimate is incredible.  The authors purport to draw the smoking-alone risk ratio from CPS-II; yet the risk ratio presented (10.3) is less than half that reported in multiple publications of the CPS-II study.  Markowitz and colleagues cite to two papers for the 10.3 point estimate; neither appears to support this number.  Steven Stellman & Lawrence, “Smoking habits and tar levels in a new American Cancer Society prospective study of 1.2 million men and women,” 76 J. Nat’l Cancer Inst. 1057 (1986); Michael Thun, Eugenia Calle, Carmen Rodriguez, and Phyllis Wingo, “Epidemiological research at the American Cancer Society. 9 Cancer Epidemiol. Biomarkers & Prevention 861 (2000).  I would welcome contradiction from anyone who can find the point estimate in the cited papers.

Consider one of the most recent publications, which drew upon CPS-II data, in the New England Journal of Medicine.  For men who were current smokers, compared with men who never smoked, the relative risk of lung cancer mortality was 24.97. Michael Thun, Brian Carter, Diane Feskanich, Neal D. Freedman, Ross Prentice, Alan D. Lopez, Patricia Hartge, and Susan M. Gapstur, “50-Year Trends in Smoking-Related Mortality in the United States,” 368 New Engl. J. Med. 351 (2013).

The Markowitz, Levin, Miller paper is still “in press.”  There is still time for the editors to take a closer look.  There is also time for the editors to insist upon a disclosure of the authors’ conflicts of interest. See, e.g., Wannall v. Honeywell Internat’l, Inc., Civ. Action No. 10-351 (BAH), 2013 U.S. Dist. LEXIS 68523 (D.D.C. May 14, 2013) (discussing Markowitz’s participation as an expert witness).

Posted in Causation, Conflicts of Interest, Expert Witnesses, Scientific Evidence | Comments Off on The Mt. Sinai Catechism

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