TORTINI

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

Judicial Notice of Untruths

March 3rd, 2014

Judicial notice is a procedure for admitting facts the truth of which are beyond dispute. A special kind of magically thinking occurs when judges take judicial notice of falsehoods, myths, or lies.

In the federal judicial system, Federal Rule of Evidence 201 addresses judicial notice of adjudicative facts, and provides:

(b) Kinds of Facts That May Be Judicially Noticed. The court may judicially notice a fact that is not subject to reasonable dispute because it:

(1) is generally known within the trial court’s territorial jurisdiction; or

(2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.

Procedurally, Rule 201 provides that a court must take judicial upon the request of a party who has supplied any needed basis for the fact to be noticed.  A court may take notice sua sponte.  Rule 201(c)(1), (2).

In the Chantix litigation, counsel for Pfizer challenged plaintiffs’ expert witness, Curt Furberg, on Rule 702 grounds.  According the MDL judge, the Hon. Inge Prytz Johnson, Pfizer asserted that Furberg’s proferred testimony because the FDA approved Chantix as safe and effective. In re Chantix (Varenicline) Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1285 n.8 (N.D. Ala. 2012).  Citing no authority or text, Judge Johnson announced that “[a]pproval by the FDA is not evidence of the safety of a medication.” Id.

To be sure, safety issue can sometimes arise after initial approval, but before the FDA or the manufacturer and sponsor of the medication can react to the new safety data.  The sweeping statement, however, that the FDA’s approval is not any evidence of safety seems bereft of factual support and common sense.

Judge Johnson went on, however, to invent supporting evidence out of thin air:

“The court takes judicial notice of such things as that at one time, thalidomide was used for morning sickness in pregnant women. Unfortunately, 10,000 children were born with birth defects from it before it was banned. And 50  years elapsed before doctors understood why thalidomide caused limbs to disappear. See e.g. http://www.nytimes.com/2010/03/16/science/16limb.html?pagewanted=all. Similarly, the fact that the FDA at one time approved Vioxx did not prevent the same being removed from the market due to growing concerns that it increased the risk of heart attacks and strokes. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm. Hence, initial approval by the FDA is not proof of the safety of a medication.”

The point about the FDA’s approval not constituting evidence of safety may simply be sloppy writing and reasoning.  In the quote above, perhaps Her Honor merely meant to say that initial approval is not evidence that a medication is safe in view of later obtained data that were not available to the FDA on its review of the new drug application.  If so, fair enough, but the sweeping statement that the initial approval is no evidence of safety ignores the considerable time, cost, and energy that goes into the FDA’s review of safety before agency approves marketing.

More egregious, however, is Judge Johnson’s taking judicial notice of the marketing of thalidomide as though it had some relevancy and probative value for her claim about the inefficacy of the FDA’s safety reviews.[1]  Consider the recent review of the FDA’s handling of thalidomide by Margaret Hamburg, M.D., Commissioner of the U. S. Food and Drug Administration:

“Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States.  As many remember, in the early 1960’s, reports were coming in from around the world of countless women who were giving birth to children with extremely deformed limbs and other severe birth defects.  They had taken thalidomide. Although it was being used in many countries, Dr. Kelsey discovered that it hadn’t even been tested on pregnant animals.”

Margaret Hamburg, “50 Years after Thalidomide: Why Regulation Matters” (Feb. 7, 2012).

Judge Johnson took judicial notice of a non-fact. The FDA never approved thalidomide for use in the United States, back in the 1950s or 1960s.[2]



[1] Judge Johnson’s fantastical history of the FDA was recently cited by plaintiffs’ counsel in the Zoloft birth defects litigation.  See Plaintiffs’ Opposition to Defendants’ Motion to Exclude the Testimony of Anick Berard, Ph.D., at 13 (Filed Feb. 24, 2014), in In re Zoloft (sertraline hydrochloride) Prods. Liab. Litig., Case 2:12-md-02342-CMR Document 713.

[2] Judge Johnson’s errant history may have resulted from her European perspective of the thalidomide tragedy.  Judge Inge Prytz Johnson immigrated from Denmark, where she was born and educated. She became a U.S. citizen in 1978, and a state court judge one year later.  In 1998, she was nominated by President Clinton to the Northern District of Alabama.  In October 2012, Judge Johnson assumed senior status. See Kent Faulk, “U.S. District Judge Inge Johnson goes into semi-retirement” (Oct. 19, 2012) (quoting Judge Johnson as saying that “One thing I like about my job is I don’t have to take sides.”)

“Judges and other lawyers must learn how to deal with scientific evidence and inference.”

March 1st, 2014

Late last year, a panel of 7th Circuit reversed an Administrative Law Judge (ALJ) who had upheld a citation and fine against Caterpillar Logistics, Inc. (Cat).  The panel, in a wonderfully succinct, but meaty decision by Judge Easterbrook, wrote of the importance of judges’ and lawyers’ learning to deal with scientific and statistical evidence. Caterpillar Logistics, Inc. v. Perez, 737 F.3d 1117 (7th Cir. 2013)

Pseudonymous MK, a worker in Cat’s packing department, developed epidcondylitis (tennis elbow).  Id. at 1118. OSHA regulations require employers to report injuries  “the work environment either caused or contributed to the resulting condition”. 29 C.F.R. § 1904.5(a). MK’s work required her to remove items from containers and place items in shipping cartons. The work was repetitive, but MK acknowledged that the work involved little or no impact or force.  Apparently, Cat gave some rather careful consideration to whether MK’s epidcondylitis was work related; it assembled a panel of three specialists in musculoskeletal disorders and two generalists to consider the matter.  The panel, relying upon NIOSH and AMA guidelines, rejected MK’s claim of work relatedness.  Both the NIOSH and the AMA guidelines conclude that repetitive motion in the absence of weight or impact does not cause epicondylitis. Id.

MK called an expert witness, Dr. Robert Harrison, a clinical professor of medicine, at the University of California, San Francisco.  Id. at 1118-1119.  Harrison unequivocally attributed MK’s condition to her work at Cat, but he failed to explain why no one else in Cat’s packing department ever developed the condition.  Id. at 1119.

Harrison acknowledged that epidemiologic evidence could confirm his opinion, but he dismissed such evidence as being able to disconfirm his opinion.  The ALJ echoed Dr. Harrison in holding epidemiologic evidence to be irrelevant:

“none of these [other] people are [sic] MK. Similar to the concept of the ‘eggshell skull’ plaintiff in civil litigation, you take your workers as they are.”

Id. at 1119-20, citing ALJ, at 2012 OSAHRC LEXIS 118 at *32.

Judge Easterbrook found this attempt to disqualify any opposing evidence to lie beyond the pale:

“Judges and other lawyers must learn how to deal with scientific evidence and inference.”

Id. (citing Jackson v. Pollion, 733 F.3d 786 (7th Cir. 2013).

Judge Easterbrook called out the ALJ for misunderstanding the nature of epidemiology and the role of statistics, in the examination of causation of health outcomes that have a baseline incidence or prevalence in the population:

“The way to test whether Harrison is correct is to look at data from thousands of workers in hundreds of workplaces—or at least to look at data about hundreds of worker-years in Caterpillar’s own workplace. Any given worker may have idiosyncratic susceptibility, though there’s no evidence that MK does. But the antecedent question is whether Harrison’s framework is sound, and short of new discoveries about human physiology only statistical analysis will reveal the answer. Any large sample of workers will contain people with idiosyncratic susceptibilities; the Law of Large Numbers ensures that their experience is accounted for. If studies of large numbers of workers show that the incidence of epicondylitis on jobs that entail repetitive motion but not force is no higher than for people who do not work in jobs requiring repetitive motion, then Harrison’s view has been refuted.”

Id. at 1120.

Judge Easterbrook acknowledged that Cat’s workplace evidence may have been a sample too small from which to draw a valid statistical inference, given the low base rate of epicondylitis in the general population.  Dr. Harrison’s and the ALJ’s stubborn refusal, however, to consider any disconfirming evidence, obviating the need to consider sample size and statistical power issues.

Finally,  Judge Easterbrook chastised the ALJ for dismissing Cat’s experience as irrelevant because many other employers will not have sufficient workforces or record keeping to offer similar evidence.  In Judge Easterbrook’s words:

“This is irrational. If the camera in a police car captures the events of a highspeed chase, the judiciary would not ignore that video just because other police cars lack cameras; likewise, if the police record an interrogation, courts will consider that information rather than wait for the day when all interrogations are recorded.”

Id. This decision illustrates why some commentators at places such as the Center for Progressive Reform get their knickers in a knot over the prospect of applying the strictures of Rule 702 to agency fact finding; they know it will make a difference.

As for the “idiosyncratic gambit,” this argument is made all too frequently in tort cases, with similar lack of predicate.  Plaintiffs claim that there may be a genetic or epigenetic susceptibility in a very small subset of the population, and that epidemiologic studies may miss this small, sequestered risk.  Right, and the light in the refrigerator may stay on when you close the door.  Prove it!

The Infrequency of Bayesian Analyses in Non-Forensic Court Decisions

February 16th, 2014

Sander Greenland is a well-known statistician, and no stranger to the courtroom.  I first encountered him as a plaintiffs’ expert witness in the silicone gel breast implant litigation, where he testified for plaintiffs in front of a panel of court-appointed expert witnesses (Drs. Diamond, Hulka, Kerkvliet, and Tugwell).  Professor Greenland has testified for plaintiffs in vaccine, neurontin, fenfluramine, anti-depressant and other pharmaceutical cases.  Although usually on the losing side, Greenland has written engaging post-mortems of several litigations, to attempt to vindicate his positions he took, or deconstruct positions taken by adversary expert witnesses.

In one attempt to “correct the record,” Greenland criticized a defense expert witness for stating that Bayesian methods are rarely used in medicine or in the regulation of medicines. Sander Greenland, “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics,” 39 Wake Forest Law Rev. 291, 306 (2004).  According to Greenland, his involvement as a plaintiff’s expert witness in a fenfluramine case allowed him to observe a senior professor in Yale University, who served as Wyeth’s statistics expert, make a “ludicrous claim,” id. (emphasis added), that

“the Bayesian method is essentially never used in the medical literature or in the regulatory environments (such as the FDA) for interpreting study results. . . .”

Id. (quoting from Supplemental Affidavit of Prof. Robert Makuch, App. Ex. 114, ¶5, in Smith v. Wyeth-Ayerst Labs., 278 F.Supp. 2d 684 (W.D.N.C. 2003)). Greenland criticizes Professor Makuch’s affidavit as “provid[ing] another disturbing case study of misleading expert testimony regarding current standards and practice.” 39 Wake Forest Law Rev. at 306.

“Ludicrous,” “disturbing,” “misleading,” and “demonstrably quite false”?  Really?

Greenland notes, as a matter of background, that many leading statisticians recommend and adopt Bayesian statistics.  Id. (citing works by Donald Berry, George Box, Bradley Carlin, Andrew Gelman James Berger, and others). Remarkably, however, Greenland failed to cite a single new or supplemental drug application, or even one FDA summary of safety or efficacy, or FDA post-market safety or efficacy review.  At the time Greenland was preparing his indictment, there really was little or no evidence of FDA’s embrace of Bayesian methodologies.  Six years later, in 2010, the agency did promulgate a guidance that set recommended practices for Bayesian analyses in medical device trials. FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (February 5, 2010); 75 Fed. Reg. 6209 (February 8, 2010); see also Laura A. Thompson, “Bayesian Methods for Making Inferences about Rare Diseases in Pediatric Populations” (2010); Greg Campbell, “Bayesian Statistics at the FDA: The Trailblazing Experience with Medical Devices” (Presentation give by Director, Division of Biostatistics Center for Devices and Radiological Health at Rutgers Biostatistics Day, April 3, 2009).  Even today, Bayesian analysis remains uncommon at the U.S. FDA.

Having ignored the regulatory arena, Greenland purported to do a study of the biomedical journals, “to check the expert’s claim in detail.” 39 Wake Forest Law Rev. at 306. Greenland searched on the word “Bayesian” in the Journal of Clinical Oncology for issues published from 1994-2003, and “found over fifty publications that contain the word in that journal alone.” Greenland does not tell us why he selected this one journal, which was not in the subject matter area of the litigation in which he was serving as a partisan expert witness.  For most the time surveyed, the Journal of Clinical Oncology published 24 issues a year, and occasional supplements. Most volumes contained over 4,000 pages per year.  Finding 50 uses of the word “Bayesian” in over 40,000 pages hardly constitutes resounding evidence to support his charges of “ludicrous,” “misleading,” “disturbing,” and “quite false.”  Greenland further tells us looking at these 50 or so articles “revealed several,” which “had used Bayesian methods to explore statistically nonsignificant results.” 39 Wake Forest Law Rev. at 306-07 & n.61 (citing only one paper, Lisa Licitra et al., Primary Chemotherapy in Resectable Oral Cavity Squamous Cell Cancer: A Randomized Controlled Trial, 21 J. Clin. Oncol. 327 (2003)). So in over 40,000 pages, Greenland found “several” Bayesian analyses, apparently post hoc looks to explore results that did not achieve pre-specified levels of statistical significance. Given the historical evolution of Bayesian analyses at FDA, and Greenland’s own evidence, the posterior odds that Greenland was correct in his charges seem to be disturbingly low.

Greenland tells us that the number of Bayesian analyses could be increased by looking at additional journals, and the Bayesian textbooks he cites.  No doubt this is true, as is his statement that respected statisticians, in prestigious journals, have called for Bayesian analyses to replace frequentist methods. Of course, increasing the scope of his survey, Greenland would be dramatically increasing the denominator of total journal papers with statistical methods.  Odds are that the frequency would remain very low.  Greenland’s empirical evidence hardly contradicts his bête noire for making the quoted purely descriptive statement about the infrequent use of Bayesian analysis in biomedical journals and in regulatory applications.

In lodging charges of ludicrousness, Greenland might have presented a more balanced view from more carefully conducted surveys of the biomedical literature, in the relevant time period.  See, e.g., J. Martin Bland & Douglas G. Altman, “Bayesians and frequentists,” 317 Brit. Med. J. 1151, 1151 (1998) (“almost all the statistical analyses which appear in the British Medical Journal are frequentist”); David S. Moore, “Bayes for Beginners? Some Reasons to Hesitate,” 51 The Am. Statistician 254, 254 (“Bayesian methods are relatively rarely used in practice”); J.D. Emerson & Graham Colditz, “Use of statistical analysis in the New England Journal of Medicine,” in John Bailar & Frederick Mosteler, eds., Medical Uses of Statistics 45 (1992) (surveying 115 original research studies for statistical methods used; no instances of Bayesian approaches counted); Douglas Altman, “Statistics in Medical Journals: Developments in the 1980s,” 10 Statistics in Medicine 1897 (1991); B.S. Everitt, “Statistics in Psychiatry,” 2 Statistical Science 107 (1987) (finding only one use of Bayesian methods in 441 papers with statistical methodology).

Perhaps the balance between frequentist and Bayesian analysis is shifting today, but when Professor Makuch made his affidavit in 2002 or so, he was clearly correct, factually and statistically.

In the legal arena, Bayesian analyses are frequently used in evaluating forensic claims about DNA, paternity, lead-isotopes, and other issues of identification.  Remarkably, Bayesian analyses play virtually no role in litigation of health effects claims, whether based upon medicines, or upon occupational or environmental exposures.  In searching Google scholar and Westlaw I found no cases outside of forensics. Citations to black-swan cases are welcomed.

“Dummkopf! You’re Fired” – Judge Posner on Expert Witness Gatekeeping

February 15th, 2014

“Equity is a roguish thing, for law we have a measure, know what to trust to. equity is according to the conscience of him that is chancellor, and as that is larger or narrower so is equity. ’Tis all one as if they should make the standard for the measure we call a foot, a chancellor’s foot. What an uncertain measure would this be. One chancellor has a long foot, another a short foot, a third an indifferent foot; ’tis the same thing in the chancellor’s conscience.”

John Selden, The Table Talk of John Selden (1689), at 61 (Samuel Harvey Reynolds, ed., Oxford 1892).

*  *  *  *  *  *  *  *

As Equity in days of old varied with the size of the Chancelor’s foot, today the quality of judicial gatekeeping of expert witness opinion testimony varies with the acumen of the trial judge in the area of the challenged witness’s expertise.  In Apple Inc. v. Motorola, Inc., 2012 WL 1959560 (N.D. Ill. 2012), the parties challenged each other’s damages expert witnesses under Federal Rule 702, only to find that the trial judge was considerably more astute than their expert witnesses. When it came to assessing the validity and reliability of the damages opinions, the trial judge was a veritable “big foot,” kicking the courthouse door closed to some dodgy damage calculations.

The Hon. Richard Posner is a judge of the United States Court of Appeals, for the Seventh Circuit.  Judge Posner is also an economist and a stalwart of law-and-economics jurisprudence. In Apple v. Motorola, Judge Posner sat by designation as a trial judge.   Instead of judging whether a trial judge had abused his or her discretion in admitting or excluding expert witness testimony, Judge Posner had to put his own discretion on the line. 

Judge Posner identified the biggest challenge in gatekeeping as:

“distinguish[ing] between disabling problems with the proposed testimony, which are a ground for excluding it, and weaknesses in the testimony, which are properly resolved at the trial itself on the basis of evidence and crossexamination.”

Apple Inc. v. Motorola, Inc., 2012 WL 1959560, *1. Posner cites old caselaw, arguably superseded by the current Rule 702, for the chestnut that:

“the judge should not exclude evidence simply because he or she thinks that there is a flaw in the expert’s investigative process which renders the expert’s conclusions incorrect. The judge should only exclude the evidence if the flaw is large enough that the expert lacks ‘good grounds’ for his or her conclusions.”

Id. (quoting In re Paoli R.R. Yard PCB Litigation, 35 F.3d 717, 746 (3d Cir.1994)). Of course, flawed reasoning or methodology is the essence of what deprives anyone from making an claim to knowledge; this little chestnut is not very nourishing.

Judge Posner does better in “operationalizing” Kumho Tire for making the distinction between flaws that weaken, and those that vitiate, the epistemic bases for opinions.  Whether an expert witness “employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field” is a key test for determining on which side of the distinction a challenged opinion falls. Id. at *2 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999)).

“The Kumho principle implies that an expert witness must provide reasons for rejecting alternative hypotheses ‘using scientific methods and procedure’ and the elimination of those hypotheses must be founded on more than ‘subjective beliefs or unsupported speculation, … .’ ”

Id. at *8 (internal citations omitted).

Posner tempers, and dilutes, Kumho by qualifying the Kumho principle to require a testifying expert to use the same approach as used in the relevant field “if it is feasible for him to do so.” Id. at *3. It is always feasible, but rarely seen, for an expert witness to profess insufficient knowledge, facts, or data to give an opinion. Posner goes further and rewrites the statute, Rule 702, which was designed to keep uncertainty from being masqueraded as certainty:

“when the plaintiff has done his best to prove damages his inability to dispel uncertainty concerning the accuracy of his claim is not fatal. But if an expert witness fails to conduct a responsible inquiry that would have been feasible to conduct, his failure cannot be excused by reference to the principle that speculation is permitted in the calculation of damages; that permission presupposes the exhaustion of feasible means of dispelling uncertainty. Uncertainty is a bad; it is tolerated only when the cost of eliminating it would exceed the benefit.”

Id. at *5.  Sometimes the best efforts to eliminate uncertainty will leave us uncertain.  And the issue of acceptable uncertainty is not necessarily tied to the cost of eliminating it.

Nevertheless, Posner goes on to identify multiple unreasonable assumptions, alternative inferences, missing data, and flawed methods that vitiated most of the opinions before him in Apple v. Motorola.

Judge Posner applies the Kumho principle in the context of damages with a series of counterfactual Gedanken experiments.  He asks what if the plaintiff’s expert witness were working for the defendant (and vice versa), and charged with ascertaining the lowest cost to avoid infringing the plaintiff’s patent.  If the expert submitted the most expensive approach, or an extremely speculative, answer, the defendant would indeed fire the expert: “Dummkopf! You’re fired.” Id. at *9. And if the expert offered unverified evidence that came from an interested, adverse party, the expert’s opinion would again be worthy of no consideration.

Judge Posner is at home in the world of assessing economic damages, and as a “Chancellor,” he proved to have a very big foot indeed. The parties’ expert witnesses came up short on almost every damages opinion examined.

Not all evidentiary issues can be resolved by Judge Posner’s economic reductionism as neatly as the damages issues in this patent infringement case.  Posner’s approach is less satisfying in the context of health effects litigation, where expert witnesses will often have the option of proclaiming inadequate knowledge or method to ascertain general or specific causation.  Still Posner’s Gedanken experiments are contagious.  Suppose we were confronted with a birth defect case in which plaintiffs claimed that the mother’s use of a medication in early pregnancy caused the child’s birth defect.  It is generally conceded that most such birth defects have no known cause, but the plaintiffs’ expert witnesses contend that they have conducted a differential etiology and ascribed causation of the baby’s defect to the mother’s use of the defendant’s   medication.  Suppose there was a serious economic (or life-and-death) consequence to the expert’s opinion.  If the defect were drug-induced, there was no surgical or other correction, but if the defect were “idiopathic,” it could be readily repaired surgically.  Would the expert witness, acting as a treating physician, withhold the treatment because he was “reasonably medically certain” that the defect was caused by the drug?  I don’t think so.  Dr. Dummkopf, you’re fired!

Pennsylvania Workers Regain Their Right of Action in Tort against Employers for Latent Occupational Diseases

February 14th, 2014

Worker’s compensation legislation was part of great compromise in the rough-and-tumble battles between labor and management in the first few decades of the last century.  In virtually every state, employers had a common law duty to provide a reasonably safe workplace.  In tort litigation, however, employers enjoyed several powerful affirmative defenses:  contributory negligence, the fellow-servant rule, and assumption of risk.  Workers enjoyed increasingly sympathetic juries and generous damage awards.  Worker’s compensation statutes made recovery for most injuries a certainty, with schedules of damages that were deeply discounted from what might be had in a jury trial. In return for well-nigh absolute liability, employers gained certainty of outcome, reduction of administrative costs, and immunity to tort liability for all but intentional harms.

After World War II, tort law began to change dramatically.  Contributory negligence gave way to comparative negligence.  Assumption of risk defenses were curtailed, and the fellow-servant rule was severely modified or abandoned.  Labor was feeling buyers’ remorse over the workman’s compensation deal.

In 1965, the American Law Institute adopted § 402A which provided for “Special Liability of Seller of Product for Physical Harm to User or Consumer,” based upon concerns of unequal knowledge of defects and latent hazards of products sold to consumers. Liability followed for harm caused by a product irrespective of privity of contract or warranty, and even if “the seller has exercised all possible care in the preparation and sale of his product.” Restatement (Second), Torts § 402A (2)(a),(b) (1965).

Section 402A was inspired by tort cases in New Jersey and California, involving consumer products, but the Restatement was quickly, and unthinkingly, applied to sales made to large manufacturing employer-purchasers in which there was no real inequality of knowledge between seller and purchaser, or hidden or latent hazard in the product or material. (Think about how knowledgeable the United States Navy was about the hazards of asbestos insulation products it bought for ship building.) Section 402 became the vehicle for injured workers to ditch their capped damages in worker’s compensation court, and to put their cases back in front of juries, with the prospect of unlimited awards for non-economic damages.

In the workers’ compensation era, very few injured workers succeeded in making out intentional torts that would overcome their employers’ immunity to suit. Late last year, however, Pennsylvania workers regained their common law right to sue employers for negligence and other torts, for occupational diseases that manifest more than 300 weeks after last employment. Section 301(c)(2) of the Pennsylvania’s Workman’s Compensation Act, 77 P.S. § 411(2) removes these delayed manifested occupational disease claims from the scope of the Act. Since the Act’s inception, most courts have held that late manifestation (over 300 weeks) deprived the claimant of a recovery under the Act, but did not remove the employer’s immunity from suit. In an opinion issued in November 2013, Justice Todd, writing for herself and four other justices, held that the statute’s exclusion of late-manifesting occupational diseases (after 300 weeks) does not leave claimants without a remedy; the statute simply removes the latent disease cases from the purview of the Act, and returns them to the vicissitudes of common law litigation. Tooey v. AK Steel Corp., 81 A.3d 851 (2013).

The Tooey decision has profound implications for how occupational disease litigation claims will be litigated.  For decades, Pennsylvania juries were treated to a faux spectacle that suggested that plaintiffs, with claimed occupational diseases, were the “victims,” of remote suppliers’ failure to warn, when in reality their diseases were largely or totally the result of employer and employee negligence. Not only will plaintiffs sue their employers, but third-party vendors will seek contribution or indemnification from negligent employers. Employers will assert comparative negligence and assumption of risk defenses, which will give the lie to the plaintiffs’ claims of inadequate warnings from the remote suppliers.  Just possibly, Tooey will let the truth come out.

The Capture of the Public Health Community by the Litigation Industry

February 10th, 2014

The American Public Health Association (APHA) is a significant organization ostensibly committed to the improvement of public health. Among its many activities, the APHA publishes a journal, the American Journal of Public Health.  Here is how the APHA describes itself and its activities to advance public health:

“The American Public Health Association champions the health of all people and all communities. We strengthen the profession of public health, share the latest research and information, promote best practices and advocate for public health issues and policies grounded in research. We are the only organization that combines a 140-plus year perspective, a broad-based member community and the ability to influence federal policy to improve the public’s health.”

How could anyone be against the APHA?

A dubious development in the APHA’s history was its evolution as a tool of the litigation industry.  In 2004, after several years of lobbying, agents of the litigation industry managed to push a policy statement past the Association’s leadership, to condemn the requirement of evidence-based reasoning in federal courts in the United States.

The litigation industry’s victory is memorialized in the “Final Minutes of Meetings of the APHA Governing Council, ” held in November 2004, when the industry’s attack on evidence-based science and data transparency, known as “Policy Number: 2004-11 Threats to Public Health Science,” was adopted as an APHA policy statement.

“2004-11” was published in the American Journal of Public Health and is still available on the APHA website, as Policy Number: 2004-11 Threats to Public Health Science.  I have excerpted contentions and recommendations from the APHA policy, in the left column of the chart, below.  My comments are on the right.

 

APHA Policy

Comment

“Acknowledging that within science, absolute proof and perfect information are rare;” Notice the false dichotomy between absolute proof and perfect information and the entire remaining spectrum of scientific information.  This dichotomization has been part of the litigation strategy of passing off hypotheses, preliminary conclusions, unreplicated findings, etc., as though they were acceptable bases for causal conclusions.
“Recognizing that special interests have exploited the nature of science, specifically scientific uncertainty, to delay protective legal and/or regulatory action;” Notice the asymmetry of the accusations; the APHA apparently has no concern for “special interests” that exploit the nature of science by passing off hypotheses as conclusions, and seek to accelerate protective legal and regulatory action by manufacturing faux scientific conclusions.
“Acknowledging that some public health decisions must be made in the absence of perfect scientific information;” “Le mieux est l’ennemi du bien.” But isn’t the good also the enemy of the shabby, dodgy, and fraudulent? Notice again the false dichotomy between “perfect” information and everything else, as though our failing to achieve the perfect opens the door to the worst. True, of course, that sometimes action is needed on incomplete records, but such action is rarely needed for compensation claims.
“Recognizing that special interests, under the guise of a call for “sound science” have sponsored and promoted changes in public policy that have weakened and continue to threaten public health protections;” If the call for sound science cannot be sustained, then this rhetorical gambit will blowback hard on those “special interests.”  Why are these putative scientists, at APHA, so afraid of sound science?
“Recognizing that special interests have challenged highly regarded public health research and researchers, and inappropriately characterized established scientific methods as ‘junk science’;” Mon Dieu!  How cheeky of those special interests.  See the discussion of Dr. Barry S. Levy, below.
“Recognizing that the Daubert decision has propagated misinterpretations and misapplications of scientific principles relied upon throughout the public health sciences, such as insisting that any epidemiologic study that is relied on to support causation demonstrate a twofold increase in risk as well as a reliance on significance testing to determine which scientific findings are to be allowed as evidence;” This contention misunderstands the basic nature of evidence law. Studies, whether they have statistically significant results, or not, are rarely admissible in evidence.  What is admissible, or not, are opinions of duly qualified expert witnesses, who explain and justify the epistemic warrant for their opinions.  With respect to general causation opinions, expert witnesses will often have to show that they have properly ruled out chance, bias, and confounding to arrive at a causal conclusions.  Significance testing can be abused, in both directions, but the APHA ignores the need for having some quantitative approach to assess random variability. As for relative risks greater than two, the APHA is correct that general causation may often be found with small relative risks, but the attribution of causation in an individual claimant often can be made only on probabilistic inferences that will require relative risks greater than two, or even larger.
“Recognizing that special interests are engaged in a campaign to extend Daubert’s reach to those states that have not embraced prescriptive definitions of scientific reliability.” So the APHA makes common cause with those “special interests,” which would abolish all limits on the admissibility of expert witness opinions, and all normative assessments of scientific research.  This position ignores the prescriptive aspect of methodology, and the nature of epistemic warrant in a methodology.

 

What follows from these contentions? 

“Therefore, APHA:”

“Opposes legislation or administrative policies that attempt to define the characteristics of valid public health science, or dictate prescriptive scientific methodologies; and” Admittedly, defining good science is very difficult, but the law often works like science as defining health as the absence of disease.  There are obviously some well-known pathologies of scientific method, and it hardly seems extravagant to urge courts to avoid flaws, fallacies, and fraud.  
“Supports the efforts of other scientific organizations to promote the government’s ability to utilize the best available science to protect the public’s health; and” Of course, sometimes the “best” available science is rather shabby. 
“Urges friend of the court briefs that address the problem inherent in the adoption of Daubert and Daubert-like court rulings, the application of Daubert in regulatory proceedings, and when judges misinterpret scientific evidence in their implementation of the Daubert ruling.” We do not see many APHA-types deploring jury verdicts that offend scientific sensibilities; and so the APHA’s urging here seems again rather one-sided and partisan.  The fact, however, that judges’ misinterpretations of scientific evidence can be criticized publicly is one of the key differences that separates judicial gatekeeping from the black box of jury determinations.

In 2005, the APHA published, in its journal, APJH, a special supplement, “Scientific Evidence and Public Policy,” with

“academic analysis of the conflicts arising in the use of science in regulatory, civil and criminal proceedings. This special issue examines how recent developments in the legal and regulatory arenas have emboldened corporations involved in civil litigation and regulatory proceedings to accuse adversaries of practicing ‘junk science’.”

Apparently, the APHA was not, and is not, concerned with the emboldening the  litigation industry and its efforts to subvert the truth-finding function of civil litigation. 

David Michaels served as the guest editor for the APJH supplement.  Michaels repeated many of the contentions of the 2004 Policy Statement, above, and he added some new ones of his own:

  • Judges are no better than juries in assessing scientific evidence.
  • Scientists evaluate all the evidence by applying a “weight-of-the-evidence” approach.
  • Uncertainty in science is normal and does not mean the underlying science flawed.

David Michaels, “Editorial: Scientific Evidence and Public Policy,” 95 (Supp. 1) Am. J. Pub. Health S5 (2005). These are all serious half truths.  Many judges are quite astute when evaluating scientific evidence, but even the lowest aptitude judges must give articulated reasons for their decisions, which opens up a public process of comment, correction, and criticism.  Juries vote in secret, without having to explain or justify their verdicts.  Scientists, metaphorically speaking, weigh evidence, as do non-scientists, but this opaque metaphor hardly explicates the process of how scientists arrive at conclusions about causal relationships.  And uncertainty is a condition of many scientific fields, but the error lies in trying to pass off tentative, uncertain, preliminary observations and findings as knowledge.

Michaels sees the development of judicial gatekeeping as favoring “the powerful,” and hurting “the weak and vulnerable.” Id. Michaels did not seem to mind if his editorial recommendations favored the litigation industry and hurt the truth.  He now heads up the Occupational Health & Safety Administration.

Here is how Michaels and the APHA described the funding for the AJPH supplement:

“Support for the supplement was provided through unrestricted funding to the Project on Scientific Knowledge and Public Policy (SKAPP) from the Common Benefit Litigation Trust, a fund established by court order in the Silicone Gel Breast Implant Products Liability Litigation. SKAPP is an initiative of scholars that examines the application of scientific evidence in the legal and regulatory arenas. SKAPP is based at the George Washington University School of Public Health and Health Services; more information is available at www.DefendingScience.org.”

See APHA website <http://www.apha.org/about/news/pressreleases/2005/05arenas.htm>, last visited on February 10, 2014.

This pseudo-disclosure is perhaps the most fraudulent aspect of the entire APHA enterprise.  The Common Benefit Trust was a fund that was held back from settlement monies paid by defendants in the silicone gel breast implant litigation.  The Trust was nothing more than the Plaintiffs’ Steering Committee’s war chest, from which it could advance litigation goals within MDL 926 (silicone breast implant cases).  Ironically, the appointment of neutral, court-appointed expert witnesses led to the triumph of “sound science,” and the collapse of the plaintiffs’ counsel house of cards.  Rather than returning their litigation expense fund to the claimants, the plaintiffs’ counsel found a more worthwhile recipient — SKAPP — to advance their litigation goals, if not for MDL 926, then for the next MDL, and the next, and the next….  See SKAPP A LOT; and Conflicted Public Interest Groups.

* * * * * * *

The same year that the APHA published the SKAPP-inspired and funded challenges to Federal Rules of Evidence 702, the APHA awarded its most prestigious award, the Sedgwick Medal, to a physician whose opinions had routinely been found to be unreliable and irrelevant in various litigation industry efforts. “Barry Levy Wins APHA’s Oldest and Most Prestigious Award, the Sedgwick Medal.” (December 11, 2005).

Perhaps the APHA had Levy in mind when it complained that “special interests have challenged highly regarded public health … researchers….”  Dr. Levy seems to have less favorable accolades 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).[1] Interestingly, Judge Jack’s opinion was not mentioned in the APHA press release for Dr. Levy’s award ceremony.



[1] See 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). See also 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); Mallozzi v. Ecosmart Technologies, Inc., 2013 WL 2415677, No. 11-CV-2884 (SJF)(ARL) (E.D.N.Y. May 31, 2013).

Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff

January 4th, 2014

Dr. Selikoff had a general practice clinic in Paterson, New Jersey, in the 1950s, when his practice and his litigation support efforts were noticed by the asbestos insulation workers’ union.  Wikipedia, “Irving Selikoff” (last visited Jan. 4, 2014).  According to Wikipedia, “[t]he new cohort (asbestos workers) were still a small fraction of the clinic’s patient list,” but Selikoff noticed a surprising incidence of pleural mesothelioma, within a few years of opening his practice.  The Wiki authors seem deliberately vague about the date of Selikoff’s, and the union’s notice.  Most authors recognize the late Chris Wagner for the discovery of a high rate of mesothelioma, at least among those exposed to crocidolite asbestos. See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).  Perhaps the vagueness is due to the realization that notice to Selikoff was notice to the union and its membership.

New Jersey lawyer Jon Gelman recounts how his father, also a New Jersey lawyer, involved Dr. Selikoff, back in 1954, as an expert witness in the “original 17” UNARCO (Union Asbestos and Rubber Co.) asbestos worker claims.  According to Gelman, these claims were successfully litigated with Selikoff’s services, in front of the New Jersey Division of Workers’ Compensation.  Jon L Gelman, “Dr. Yasunosuke Suzuki, A Pioneer of Mesothelioma Medical Research” (Nov. 23, 2011). Gelman does not report what diseases were involved in the 17 claims, arising out of the Paterson factory that used mostly amosite asbestos from South Africa. See Herbert Seidman, Irving J. Selikoff, and Steven K. Gelb, “Mortality Experience of Amosite Asbestos Factory Workers : Dose-Response Relationships 5 to 40 Years After Onset of Short-Term Work Exposure,” 10 Am. J. Indus. Med. 479 (1986).

Over the 20 years following the UNARCO 17,  Selikoff went on to have an active testimonial career, always testifying for the claimant, always testifying against the employer or the supplier.[1]  In 1972, Andrew Haas, President of the asbestos workers union thanked Selikoff for his frequent expert witness testimony on behalf of union members. Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972) (cited by Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003)).

Some of the positions that Selikoff took as a partisan expert witness suggest that he was outrunning his headlights.  For instance, in the mid-1960s, Selikoff testified in New York proceedings, in support of a union member, who had died of colon cancer.  Although Selikoff has little or no experience as an epidemiologist, he provided the “expert witness” support for the death claim based upon the very crude data from his insulator cohort study.  Here is how the union magazine heralded the compensation victory, made possible by Selikoff’s advocacy:

“The research into health hazards of insulation workers developed by the members of Local No. 12 and Local No. 32 has resulted in widening the basis of compensation claims in New York State.

Until now, the courts have been reluctant to accept many of the conditions to which insulation workers are prone, as related to employment. However, facts produced during the research investigations of Dr. 1. J. Selikoff, Dr. J. Churg, and Dr. E. Cuvler Hammond of the Environmental Sciences Laboratory of the Mt. Sinai Hospital in New York are resulting in a changing of this picture.

In the last two or three years, a number of decisions have been handed down in the courts of New York and New Jersey acknowledging that not only pneumoconiosis (asbestosis) occurring among insulation workers is compensable, but that also lung cancer and mesothelioma of the chest or mesothelioma of the abdomen should also be compensated.

A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population.

Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the Workman’s Compensation Board reviewed the matter and agreed with the Referee’s judgement and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”

“Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966).

The claimed association between colon cancer and asbestos was dubious at the time of Selikoff’s testimony, and became more so as time went on.  Nonetheless, colon cancer was important issue of compensation for the union membership.   Smoking was highly prevalent among the insulators, who had a high rate of lung cancer.  Colorectal cancer was the leading cause of cancer mortality among non-smokers in the general population, and Selikoff’s efforts to get the insulators to stop smoking was going to shift cancer mortality, naturally, to colorectal cancer. Adding colorectal cancer to the list of “compensable diseases” became an important part of the union’s (and the litigation industry’s) compensation strategy. Selikoff dug in, publishing and republishing the data from the insulator cohort study, which was uncontrolled for smoking and other risk factors. See, e.g., Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for his causal conclusion between asbestos and all gastrointestinal cancers).

More sophisticated epidemiologists consistently rejected the Selikoff conclusion on asbestos and colon cancer, which grew out of Selikoff’s litigation activities.  Richard Doll & Julian Peto, Asbestos: Effects on health of exposure to asbestos 8 (1985) (“In particular, there are no grounds for believing that gastrointestinal cancers in general are peculiarly likely to be caused by asbestos exposure.”)  The litigation efforts of the unions, the litigation industry, and the army of testifying physicians organized by Dr. Selikoff, kept the asbestos-colorectal cancer issue in play in the courts, despite ever increasing data against the conclusion.  Finally, four decades after the asbestos insulation union magazine’s notice about Selikoff’s success in a colon cancer case, the Institute of Medicine weighed in on the issue, to find the evidence inconsistent and insufficient to support a causal conclusion. Jonathan Samet, et al., Institute of Medicine, Asbestos: Selected Health Effects (2006).

The Selikoff acolytes, a/k/a “The Lobby,” will review this narrative as “Shooting the messenger: the vilification of Irving J. Selikoff.” Wikipedia, “Irving Selikoff” (last visited Jan. 4, 2014) (citing Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Serv. 619 (2007)).

This view is curious and incorrect for several reasons. First, it is curious that the cited authors, labor historians McCulloch and Tweedale, have themselves taken the liberty to attack important scientists for their litigation .  Last year, these authors published their “vilification” of Dr. Anthony Lanza, for having participated in the defense of some litigation cases arising out of the Gauley Bridge tunnel construction.  See Jock McCulloch and Geoffrey Tweedale, “Anthony J. Lanza, Silicosis and the Gauley Bridge ‘Nine’,” 26 Social History of Medicine (2013), in press.  See alsoBritish Labor Historians Belaboring American Labor History – Gauley Bridge”(Oct. 14, 2013) (pointing out errors in McCulloch and Tweedale’s account of Gauley Bridge).

Second, the Selikoff acolytes are incorrect because the historical facts of Selikoff’s involvement are important for an understanding of how some opinions, such as the notion that asbestos causes colorectal cancer, gained currency in lay and professional communities. These views may have been less attractive to the media and to judges if they had known that Selikoff was such an active worker for the litigation industry, as far back as the early 1950s.

One interesting example of how important judges misunderstood Selikoff’s activities comes from no less an astute observer than Judge Jack Weinstein, who held Selikoff up as an “independent, emiment scientist,” who eschewed the courtroom for the laboratory. See, e.g., Hon. Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995) (“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”)  Weinstein was demonstrably wrong in this assessment, just as anyone who held up Lanza as never becoming involved in litigation activities would have been wrong.

Third, this information is important in understanding the evolution of the scientific community’s views about disclosing conflicts of interest.  None of Selikoff’s articles disclosed funding from the unions, or his testimonial activities on behalf of the unions and their allied attorneys.  For some reason, Selikoff’s heirs, who have continued to follow and to publish about the health outcomes among the asbestos insulation workers, feel that they are exempt from prevailing views about disclosure.

Dr. Steven Markowitz is the lead author on an update of the lung cancer mortality data of asbestos insulators. Steven B. Markowitz, Steven M. Levin, Albert A. Miller, and Alfred Morabia, “Asbestos, asbestosis, smoking, and lung cancer. New findings from the North American insulator cohort,” 188 Am. J. Respir. Crit. Care Med. 90 (2013).  Dr. Markowitz testifies widely for plaintiffs in asbestos personal injury cases.  See, e.g., Wannall v. Honeywell International Inc., 2013 WL 1966060 (D.D.C. May 14, 2013) (excluding Markowitz’ testimony as unreliable). A review of the disclosure statements for the authors of the 2013 asbestos insulator cohort study shows that Dr. Markowitz declared no consultations that could be a potential conflict of interest. SeeThe Mt. Sinai Catechism” (June 7, 2013); and “More Hypocrisy Over Conflicts of Interest,” (Dec. 4, 2010) (detailing failures of Selikoff acolytes, Castleman, Lemen, and Frank, in disclosing litigation activities when presenting on related issues to professional societies).

Fourth, there is a recent trend by the litigation industry to claim that failure of defense expert witnesses to make disclosures of their ties to companies constitutes fraud.  Indeed, last spring, the New York Appellate Division affirmed a trial court’s decision to conduct an in camera inspection of documents underlying research studies sponsored and funded by Georgia Pacific. Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013). 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.” 2013 WL 2435565, at *4.  SeeA Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013).

The claim of fraud was perhaps as tenuous as the assertion of the attorney-client privilege.  For  instance, some of the alleged fraudulent conduct was nothing more than an alleged failure to disclose fully the nature of the relationship between the sponsor, Georgia Pacific, and one of the authors:

“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.”

2013 WL 2435565, at *4.  If this evidence be sufficient to show fraud, there will be many parties and expert witnesses in trouble, including the reputation of Dr. Selikoff, and his influence on asbestos litigation and regulation in this country, and abroad.

Finally, this information is important to counteract the distortions of the Selikoff acolytes.  Consider for instance the current entry for Selikoff in Wikipedia.  Wikipedia, “Irving Selikoff” (last visited Jan. 4, 2014):

“Part of the contrary perspective was presented by a Nathan A. Schachtman, an adjunct lecturer at the Columbia Law School. He suggested that Selikoff and his supporters may have organized ‘a lopsided medical conference, arranged for the conference to feature defendant’s expert witnesses, set out to give short shrift to opposing points of view, invited key judges to attend the conference, and paid for the judges’ travel and hotel expenses’. This quote from Schachtman came from a web site he maintained, unlike the quote from McCulloch and Tweedale, whose comments were published only after being accepted by reviewers for a refereed academic journal.“Nathan A. Schachtman”. www.law.columbia.edu. Columbia Law School. Retrieved September 16, 2013.”

While ’tis true that this humble blogger’s posts are not peer reviewed, what is interesting is that the acolytes did not, and could not, counter on the merits.

What is more, my account of “Selikoff and his supporters” did not recount that they “may have organized ‘a lopsided medical conference, arranged for the conference to feature defendant’s expert witnesses, set out to give short shrift to opposing points of view, invited key judges to attend the conference, and paid for the judges’ travel and hotel expenses’.”  My account documented that Selikoff and his supporters did, in fact, do these things.  Actually, they were previously documented in litigation and reported by the courts that held that one of the judges who improvidently had attended Selikoff’s Third Wave Conference had to disqualified from presiding over an asbestos class action.  In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992); see Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself so as to Preserve the Appearance of Justice under 28 U.S.C.§ 455,” 38 Vill. L. Rev. 1219 (1993); W.K.C. Morgan, “Asbestos and cancer: history and public policy,” 49 Br. J. Indus. Med. 451, 451 (1992)

The point here is not to villify Selikoff but to gain historical perspective and understanding of the enthusiasms that went into creating the largest mass tort in American legal history. Selikoff was an important player in the passion play of products liability litigation, but it is time to substitute history for hagiography.



[1] Bradshaw v. Twin City Insulation Co. Ltd., Industrial Court of Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., E. D. Michigan Southern Division, Civ. Action No. 29433 (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Commonwealth Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973).  Selikoff also participated as a testifying witness for the government, in United States v. Reserve Mining Co. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D.Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D.Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Minnesota v. Reserve Mining Co., 420 U.S. 1000, 95 S.Ct. 1441, 43 L.Ed.2d 758 (1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D.Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

 

The Historical Intersection of Law and Epidemiology: Miller v National Cabinet (NY Court of Appeals 1960)

January 3rd, 2014

The history of statistics, epidemiology, and products liability are intertwined in ways that call for greater attention.  The 1950s and 1960s witnessed increasingly sophisticated statistical approaches to epidemiologic evidence. Starting in 1950, and continuing throughout the 1950s, Sir Richard Doll and Sir Austin Bradford Hill began their epidemiologic exploration of lung cancer among smokers. See, e.g., Richard Doll & A. Bradford Hill, “Smoking and Carcinoma of the Lung,” 2 Br. Med. J. 739 (1950); Richard Doll & A. Bradford Hill, “The mortality of doctors in relation to their smoking habits; a preliminary report,” 1 Br. Med. J. 1451 (1954).  In 1955, Sir Richard Doll published his important paper that suggested an association between asbestosis and lung cancer.  Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,”  12 Br. J. Indus. Med. 81 (1955).  No disparity between observed and expected rates of lung cancer was observed among workers without asbestosis. Measures of p-values were used to assess the strength of the evidence against a null hypothesis of no association. As important an advance as was Doll’s paper, and as careful an investigator as he was, it is remarkable that Doll neglected to consider the potential role of smoking in producing the excess lung cancer rates among the factory workers with asbestosis. 

Starting in the 1960s, Dr. Irving Selikoff began publishing his epidemiologic studies of American asbestos insulators. See, e.g., Irving J. Selikoff , Jacob Churg,  and E. Cuyler Hammond, “Asbestos exposure and neoplasia,” 188 J. Am. Med. Ass’n 22 (1964). Selikoff neglected to stratify his observational data by the presence or absence of clinical asbestosis (although his later studies suggested that there was a very high prevalence of asbestosis after 20 years from first employment).  In addition, these insulator studies used crude measures of smoking, which lumped the very rare non-smoking insulators in with those who “never smoked regularly.”

In 1965, Sir Austin Bradford Hill published his lecture to the Royal Society of Medicine, in which he gave a spirited defense of inferring causality from observational epidemiologic studies. Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965). Hill was justly proud of the success of observational epidemiology, at least for very large effect sizes that made residual confounding and bias unlikely.

The same years as Hill’s lecture, the American Law Institute published the Restatement (Second) of Torts, with its controversial Section 402A. Before 1965, employee-plaintiff lawsuits against remote suppliers of raw materials and products to employers were a rarity in American law.  Bradford Hill’s lecture on causal assessments of “clear-cut” statistical associations came just as epidemiologic, statistical evidence was working its way into tort cases involving smoking and lung cancer.  Not surprisingly, some of the first uses of epidemiologic evidence occurred in cases involving claims that tobacco caused lung cancer. See, e.g., Lartigue v. R.J. Reynolds Tobacco Co., 317 F.2d 19 (1963) (affirming defense verdict in case noted for plaintiffs’ use of epidemiologic evidence) (“The plaintiff contends that the jury’s verdict was contrary to the manifest weight of the evidence. … The jury had the benefit of chemical studies, epidemiological studies, reports of animal experiments, pathological evidence, reports of clinical observations, and the testimony of renowned doctors. The plaintiff made a convincing case, in general, for the causal connection between tobacco and cancer and, in particular, for the causal connection between Lartigue’s smoking and his cancer. The defendants made a convincing case for the lack of any causal connection.”), cert. denied, 375 U.S. 865 (1963), and cert. denied, 379 U.S. 869 (1964).

Epidemiologic and statistical evidence in tort cases has become a commonplace, even when it is distorted and abused by litigants and judges. Recent decisions involving claims that benzene caused various cancers are illustrative.  See, e.g., Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009) (granting motion to exclude opinions that substantially distorted epidemiologic evidence under the vague rubric of “weight of the evidence”), rev’d, 639 F.3d 11 (1st Cir. 2011) (closing off scrutiny of expert witness’s abuse of epidemiologic evidence in one of the most controversial, reactionary decisions involving federal gatekeeping decisions of recent years), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012). See also David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013); “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (Sept. 2, 2011); “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence” (Sept. 2, 2011)

Given the problematic Milward decision, we might wonder what challenges to benzene-leukemia cases looked like just before Hill’s defense of inferring causality from observational studies began to infuse the witches’ brew of Rule 402A. What did statistical evidence look like before Hill’s paper?  In court cases, typically, statistical evidence was presented crudely or not at all.

In 1960, there was little opportunity to challenge causation opinions on admissibility grounds; rather sufficiency of the evidence to support a verdict or judgment was the primary means to gain review of an adverse decision.  Case reports of leukemia in workers very heavily exposed to benzene appeared in the 1920s, but it was not until the 1960s that analytical epidemiologic evidence (case-control and cohort studies) of association between leukemia and benzene were published. See generally Deborah Glass, Christopher Gray, Damien Jolley, Carl Gibbons, and Malcolm Sim, “The health watch case – control study of leukemia and benzene: the story so far,” 1076 Ann. N.Y. Acad. Sci. 80-89 (2006).  Thus, when the New York Court of Appeals decided a case involving a claim of benzene-induced leukemia, in 1960, the judicial decision was driven largely by the absence of specific quantification of risk of leukemia among workers occupationally exposed to benzene.[1]  Miller v. National Cabinet Co., 8 N.Y.2d 277, 281, 168 N.E.2d 811, 813, 204 N.Y.S.2d 129, 132, modified on other grounds, 8 N.Y.2d 1025, 70 N.E.2d 214, 206 N.Y.S.2d 795 (1960). The New York high court wrestled with the formalistic aspects of the expert witnesses’ testimony, including whether they expressed themselves in terms of “possibilities” or “probabilities.” Miller, 8 N.Y.2d at 284, 168 N.E.2d  at 814-15, 204 N.Y.S.2d at 134.

Focusing in one of the more knowledgeable of plaintiffs’ expert witnesses, Dr. Reznikoff, the Miller court was impressed that this witness disclaimed any intent to support an inference, from statistical analyses, to the plaintiff’s decedent.  Id. at 283. Furthermore, the court suggested that Reznikoff’s evidence might have been sufficient were it not for concession:

“I am sorry I can’t give you any statistics, but we don’t have them.”

Id. at 283.  The court appeared also to be concerned that Reznikoff’s approach provided no mechanistic insight or understanding into why many cases of  leukemia followed benzene exposure. Id.  

Reznikoff’s qualifications to speak to the subject were not dispositive of the question; the court was looking for data that were not available in the 1950s, when the case was tried:

“Not every supposition of a witness concerning what might be has the force of evidence, even though he has been licensed to practice medicine. If the witness is unfamiliar with any statistical data in the medical literature or in his own practice to give an inkling either to himself or to the court or board of how high the incidence of these cases is in situations of this kind, then the doctor’s assumption that it is ‘quite high’ is without significance. The lack of any kind of statistical data, which in the absence of scientific understanding is all that there would be to go on, is the more inexplicable if the claim is well founded in view of the large number of persons who die of leukemia and of workers in industry who are exposed to benzol. If there were any observed correlation between the two, it is certain that a physician of Dr. Reznikoff’s standing would be in possession of the information.”

Id. at 283-84. The court did not excuse the claimant’s evidentiary display with the indulgent, “this was the best evidence available,” when the evidence was inadequate.  Nor did the court engage in soothsaying that causality would someday be demonstrated.  We might feel some frustration today, looking back, that the court missed this opportunity, but case reports, and even case reports and epidemiologic studies, have generated many false-positive associations.  Clearly, more is required, and the New York Court of Appeals recognized the necessity for more.

Traumatic Cancers Distinguished

In 1960, the courts still indulged the proto-scientific opinion that traumatic injury caused cancer.[2]  Some medical writers supported this opinion, but by 1960, the opinion was already falling out of favor due to an improved understanding of carcinogenesis.

There is much irony, therefore, in the Miller court drawing’s an invidious distinction between Reznikoff’s proto-epidemiologic evidence and traumatic cancer cases that were still prevalent in the 1960s.  Id. at 285-86. In the traumatic cancer cases, in the 1960s, and even in the 1970s, courts sustained verdicts for cancer claimants who had shown that their cancers were diagnosed very shortly after a traumatic blow to the precise portion of the body where cancer manifested. The Miller court referred to these traumatic cancer cases as presenting the kind of causal inferences that could be understood and made by judges and juries.  Today, 40 years later, we see those causal inferences as mostly rubbish, based upon incorrect, inadequate, and discarded theories of carcinogenesis.

The prospect of cancer cases sustained by epidemiologic (statistical) evidence clearly troubled the New York court:

“The courts have been confronted before with cancer cases, and this is not likely to be the last. This is not an isolated situation. Questions of causation are common to actions based on warranty, tort or workmen’s compensation proceedings. Would, for example, evidence that there are 4 to 11 times as many cases of lung cancer among cigarette smokers as among nonsmokers be sufficient to establish a cause of action for breach of warranty in the sale of cigarettes? … There appear to be no decisions upholding causation in so complex a variety of the disease as leukemia. The cancer decisions in the courts where recovery has been allowed have dealt almost entirely with trauma, and there only in instances where the trauma occurred in the spot in the body where the pre-existing cancer was and the symptoms of its aggravation were immediately apparent … . In all of those cases the immediacy of the symptoms of aggravation of the cancer by a traumatic injury suffered in the area where the cancer was located was accepted as a substitute for scientific evidence or understanding of cause and effect. Absent that, damage claims of this nature have been dismissed on the law for lack of evidence of causation.”

Id. at 285-86 (internal citations omitted). The Miller court went on to note that New York law required that the cancer must develop at the exact location of the injury.  Furthermore, latency between the traumatic blow and the clinical recognition of the cancer was fatal to the claim, even in the face of opinion testimony that a plaintiff’s cancer was a “very slow growing” tumor.  Today, we understand that latency between first-exposure and clinical manifestation is necessitated by the length of induction periods and the doubling time of solid tumor cancers.  As a result of the Miller court’s reliance upon some dodgy notions of cancer causation, it held that Mr. Miller’s latency period disqualified the case from the immediate impact rule of traumatic cancer cases. Id. at 287-88 (distinguishing Hagy v. Allied Chemical & Dye Corp., 122 Cal. App. 2d 361, 265 P.2d 86 (1953), which involved a diagnosis of laryngeal cancer following immediately upon exposure to sulfuric acid mists).

The majority in Miller further expressed its concern that the understanding of cancer causation was marked by such uncertainty that the mere possibilities of chemical carcinogenesis should not be tolerated in this and similar cases:

“… [F]or so long as the causes of a disease — like cancer — are unknown to science, everyone contracting the disease could secure medical testimony that it is ‘possible’ that the disease is contracted from a wide variety of causes, choosing in each instance the particular possibility having the greatest promise of holding liable some responsible defendant. Any cancer expert could readily state that cancer could be caused by virus infection or by exposure to automobile exhaust fumes, sunlight, radiation, smog, smoking, hormone imbalance or according to any other theory which has been entertained by researchers or specialists as a possibility. Is a malpractice suit pending against some doctor who has given cortisone or ACTH as medicine? Then appears a medical witness who testifies that possibly cancer is caused by hormone imbalance induced thereby. Is it an action for breach of an implied warranty in the sale of cigarettes? Then the medical witness will testify that cigarettes could be a cause of lung cancer. Is it X ray or working in a garage where there have been exhaust fumes? Then the ‘possibility’ doctrine is adapted to creating questions of fact in those fields — and the same with benzol exposure and leukemia. Such a doctrine would overturn the rule that the burden is on the party asserting that a disease is based on actionable facts to prove causation. It would mean that, wherever such a cause is possible, the burden rests on the opposite party to prove that the disease resulted from something else. Consequently, for so long as the causes of the disease are unknown to medical science, the claimant or plaintiff can always recover — if the trier of the fact is favorably disposed — since no one can prove that the disease had other causes. This is a perversion of the normal rule that the disease must have resulted from the occupation and that the burden of proving causation is upon the party asserting it. The law does not intend that the less that is known about a disease the greater shall be the opportunity of recovery in court.”

Id. at 289.

The Miller decision provoked a dissent, mostly on formalistic grounds.  Id. at 290. The dissenting judges asserted, without much analysis, that there was substantial evidence to support causality. Given that qualified expert witnesses showed up for the claimant seemed sufficient on this score for the dissenters.  To the extent that the claimant’s expert witnesses expressed themselves in terms of possibilities, the dissenters opined that possibilities are sufficient, especially in the context of workman’s compensation cases, in which the burden of proof standards are lower than in common law civil liability cases.

The majority opinion stands as an eloquent expression of concern about the need for quantitative evidence of statistical risk in chemical exposure cancer cases. The court also presciently saw what would become a plague of litigation involving claims of cancer causation.  In 1960, for benzene and leukemia, the evidence was clearly, even by the standards of the day, inadequate, and the claimant’s expert witnesses were appropriately modest about what inferences could be drawn both with respect to general and specific causation.  The 1970s would witness a growing immodesty among available expert witnesses, as well as an explosive growth in the techniques and applications of analytical epidemiology to many problems, including the relationship between benzene and leukemia.



[1] A decade or two later, the scientific community recognized high levels of exposure to benzene as a cause of certain kinds of leukemia, by virtue of epidemiologic studies. See, e.g., Fusun Yaris, Mustafa Dikici, Turhan Akbulut, Ersin Yaris, Hilmi Sabuncu, “Story of benzene and leukemia: epidemiologic approach of Muzaffer Aksoy,” 46 J. Occup. Health 244 (2004); Abdul Khalade, Maritta S Jaakkola, Eero Pukkala and Jouni JK Jaakkola, “Exposure to benzene at work and the risk of leukemia: a systematic review and meta-analysis,” 9 Envt’l Health 31 (2010).  See also Michael D. Green, The Paradox of Statutes of Limitations in Toxic Substances Litigation, 76 Cal. L. Rev. 965, 974 (1988).

[2] William B. Coley & Norman L. Higinbotham, “Injury as a Causative Factor in the Development of Malignant Tumors,” 98 Annals of Surgery 991 (1933); Shields Warren, “Minimal Criteria Required to Prove Causation of Traumatic or Occupational Neoplasms,” 117 Annals of Surgery 585 (April 1943); Shields Warren, “Criteria Required to Prove Causation of Occupational or Traumatic Tumors,” 10 U. Chi. L. Rev. 313, 318-20 (1943); Russell & Clark, “Medico-Legal Considerations of Trauma and Other External Influences in Relationship to Cancer,” 6 Vand. L. Rev. 868, 875 (1953); Arden R. Hedge, “Can a Single Injury Cause Cancer?” 90 California Medicine 55 (1959); Auster, “The Role of Trauma in Oncogenesis: A Juridical Consideration,” 175 J. Am. Med. Ass’n 940, 949 (1961); Comment, “Sufficiency of Proof in Traumatic Cancer Cases,” 46 Cornell L.Q. 581, 581-82 (1961); Comment, “Sufficiency of Proof in Traumatic Cancer: A Medico-Legal Quandary,” 16 Arkansas L. Rev. 243, 256 67 (1962); Dyke, “Traumatic Cancer,” 15 Clev.Mar. L. Rev 472, 484-94 (1977).  See also Comment, “Judicial Attitudes Towards Legal and Scientific Proof of Cancer Causation,” 3 Columbia J. Envt’l L. 344, 354-68 (1977).

 

The Not-So-Elite Defense Bar’s Approach to Gatekeeping

January 2nd, 2014

A couple of months ago, Professor David Bernstein posted to the Volokh Conspiracy, a short piece about some of the missteps and mistakes committed by “elite defense counsel” in litigating expert witness issues.  See David Bernstein, “The Elite Defense Bar and Expert Evidence” (Nov. 6, 2013).  Professor Bernstein makes some interesting points about questionable positions taken by “elite defense counsel” (read: “highly paid, large firm lawyers”).  For instance, according to Bernstein:

1. elite defense lawyers missed the boat early on by arguing that statistical evidence (observational epidemiology) was inadmissible or insufficient to prove general or specific causation;

2. defense counsel missed the significance of the Supreme Court’s opinion in Daubert;

3. defense counsel continued to press for Frye rule in state courts, although the Frye rule had been shown inadequate and unavailing as a rule to control medical causation opinions; and

4. defense bar has grown soft on Rule 702.

Although the charges seem at points overstated, Bernstein has presented an important indictment of the defense bar.  At the very least, the charges deserve a full exploration by a wider audience. Defense lawyers who are self-critical about their practice should certainly be concerned that someone as persistently pro-702 has taken aim at them.

On the first point, many of the early scientific causation battles were fought in tobacco litigation, in which defendants and their counsel were forced to deny and contest the obvious, the causal role for tobacco in carcinogenesis, at all costs.  The tobacco defense bar, however, should not be confused with the defense bar, generally.  Defense lawyers in Bendectin, silicone, and asbestos cases developed arguments against specious use of epidemiologic evidence, as well as sophisticated, affirmative use of epidemiologic evidence to show lack of association.  Even so, we should keep in mind that it often requires a large body of epidemiologic evidence to show “no association,” and it is not the defense’s burden to do so. 

The use of statistical or probabilistic evidence for inferring specific causation has been, and remains, problematic. See, e.g., Richard Doll, “Proof of Causality: Deduction from Epidemiological Observation,” 45 Perspectives in Biology & Medicine 499, 500 (2002) (“That asbestos is a cause of lung cancer in this practical sense is incontrovertible, but we can never say that asbestos was responsible for the production of the disease in a particular patient, as there are many other etiologically significant agents to which the individual may have been exposed, and we can speak only of the extent to which the risk of the disease was increased by the extent of his or her exposure.”) Notwithstanding the controversy, defense counsel and some astute judges have understood the indeterminate nature of statistical evidence for specific causation, and have advanced a pragmatic position of resolving specific causation controversies against plaintiffs when risk ratios failed to exceed two. See, e.g., In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 836 (E.D.N.Y. 1984) (“A government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship.  A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him. … This means that at least a two-fold increase in incidence of the disease attributable to Agent Orange exposure is required to permit recovery if epidemiological studies alone are relied upon.”), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988).

Early use of meta-analysis by plaintiffs’ expert witnesses elicited generalized attacks on meta-analysis by defense counsel.  See, e.g., In re Paoli Railroad Yard PCB Litigation, 706 F. Supp. 358, 373 (E.D. Pa. 1988) (Kelly, R., J.) (excluding plaintiffs’ expert witness Dr. William Nicholson and his testimony based upon his unpublished meta-analysis of health outcomes among PCB-exposed workers), rev’d 916 F.2d 829, 856-57 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991).  Again, it took some time for the defense to understand the potency of meta-analysis in synthesizing and presenting a summary point estimate that essentially rules out any meaningful play of chance. In the silicone gel breast implant litigation, one defense expert witness conducted and published his meta-analysis of autoimmune disease outcomes. Otto Wong, “A Critical Assessment of the Relationship between Silicone Breast Implants and Connective Tissue Diseases,” 23 Regulatory Toxicol. & Pharmacol. 74 (1996).  When the MDL 926 court got around to appointing court-appointed expert witnesses, they too picked up on the approach and made meta-analyses the hallmark of their reports. See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction:  A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998)”; Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000).

On the second charge, many defense lawyers missed, and continue to miss, the significance of a shift to evidence-based scientific testimony, as opposed to the authority-based worldview.  When I first started trying cases, senior trial lawyers instructed me not to engage plaintiffs’ expert witnesses on substantive issues, but to limit cross-examination to “collateral attack” on bias and related issues.  The problem that I saw was that when both sides limited the attack to the other side’s expert witness’s bias, the plaintiffs won because juries were often all too willing to think the worst of defense experts, and forgive plaintiffs’ experts.  Nothing short of dramatically confronting the jury with the rubbish, inconsistencies, and incoherence spouted by the plaintiffs’ expert witnesses worked.  I quickly learned to ignore the old timers’ advice, and most of them have now dropped off.

Bernstein gives the example of the Dow Corning lawyers’ declining the Ninth Circuit’s invitation to reframe their appeal in Hopkins v. Dow Corning, 33 F.3d 1116 (9th Cir. 1994), after the Supreme Court handed down Daubert.  He may well be right about that case, but the lawyers may have been inhibited by positions that they had taken earlier in the case, before the Supreme Court breathed life into Rule 702.  Still, the Hopkins decision remains a derelict on the jurisprudential sea of expert witness law. Truth be told, there are other cases that turned out badly because of overstated or poorly framed defense arguments. 

As for their persistent affection for Frye, the defense lawyers referenced by Bernstein certainly lacked imagination, and maybe even a full measure of zeal.  The Frye case had never proven itself to be an important defense against specious expert witness opinion testimony on medical causation issues.  Daubert held out the promise that trial judges would actually have to engage with the evidence, rather than counting noses for “general acceptance,” or kicking the can, after hearing qualifications. I still recall how my colleagues and friends viewed Daubert, in 1993.  Bristol Myers Squibb and other companies were inundated by silicone breast implant cases, and plaintiffs had managed to snucker a few juries into returning large verdicts against the defendants.  Daubert was a lifeline, a way to focus trial judges’ attention on the plaintiffs’ expert witnesses and the fatally flawed, even fraudulent scientific studies that had found their way into the peer-reviewed journals, and into the courtroom.

What has happened to Daubert?  Well, of course, it is no longer Daubert, but now a much more potent statutory rule, Federal Rule of Evidence 702, as amended in 2000, and recently “restylized.”  Professor Bernstein may be on to something in calling out the hubris of big firm lawyers, who think that their prowess in  litigating scientific issues comes from charging high fees.  The sad truth is that the level of scientific and statistical acumen of lawyers generally, whether at the bench or at the bar, is low.  There is much work for law schools to do to change this situation. 

There are other forces at work in creating the phenomena described by Professor Bernstein.  Many product liability cases involve multiple defendants.  Defending such cases from the defense perspective is often like herding house cats.  Every defense counsel thinks he or she knows the best course; no one wants to do anything that raises the profile of his client or increases the cost of defense. Furthermore, products liability defense work has become increasingly “commoditized” in the last two decades.  Clients and third-party payors increasingly impose budgets that do not allow defense lawyers sufficient time to develop the necessary expertise and learning to discover, understand, and challenge plaintiffs’ scientific expert witnesses fully and effectively. There is, sadly and unfortunately, a contingent of defense lawyers who would rather see speculative claims flourish and mature into full-scale litigation, with lots of trials and appeals (and large fees), than to see specious claiming pretermitted by pre-trial judicial gatekeeping.

Another factor that may have stunted the gatekeeping process is the growth of federal (and state) multi-district litigation (MDL).  By centralizing the pre-trial handling of large, multi-plaintiff tort litigation in the hands of a single judge, the MDL process has raised the stakes for the trial judge gatekeeping.  The MDL judge is no longer deciding a single case, but the fate of thousands of claimants.  The Rule 702 process suffers in several ways.  First, many MDL judges are clearly intimidated by the life-or-death control they have over hundreds, if not thousands, of claims.  These judges may well now be inclined to deny the Rule 702 challenges, in the fond hope that juries and appellate courts will take care of the problem. Second, there is no longer the incremental decision making of case-by-case exploration of the issues.  There are economies of scale, to be sure, but the single MDL judge cannot learn from previous trial judges’ decisions and records.  The evolutionary approach of the common-law is undermined by the efficiencies of MDL procedure. Third, the MDL process blunts one of the virtues of judicial gatekeeping in requiring the transparent statement of reasons for the grant or denial of a Rule 702 motion to exclude expert evidence.  By the time the scientific, legal academic, and legal practitioner communities can weigh in on the gatekeeping process, the Rule 702 decision is a fait accompli, in the form of a single judicial decision. Compare  In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.) (denying defendant’s Rule 702 motions with respect to plaintiffs’ expert witnesses’ opinions that Avandia causes heart attacks) withFDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2013) (re-evaluating evidence that Avandia does not increase risk of heart attacks).  See alsoLearning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011).

Not surprisingly, plaintiffs’ counsel have gotten better at dressing up weak and fatally flawed evidence as “inference to the best explanation,” or “weight of the evidence” evaluations that have the appearance without the reality of scientific conclusions. And as evidenced by the Third Edition of the Reference Manual on Scientific Evidence, and many recent 702 decisions in the Circuits (and Matrixx Initiatives in the Supreme Court), the federal judiciary has lost its will and its way in applying Rule 702. An activist core of federal trial and appellate courts have shown increasing hostility and outright disregard for the gatekeeping process, and a willingness to disregard the language of the statute, Supreme Court precedent, and sound scientific and statistical methodology.  Rule 702 in its present form is a strong rule, but unfortunately it is neutralized in the hands of weak judges who cannot or will not explore the intricate methodological issues raised by Rule 702 and 703 motions.

The phenomenon identified by Professor Bernstein may be real, but like many natural (and unnatural) phenomena, the causes are not always easily discerned. The phenomenon and its causes are worth a deeper exploration.

Gastwirth on the Wells Case

December 27th, 2013

One of the high points of 2013 for me was the Practicing Law Institute seminar on expert witness gatekeeping.  I am indebted to my co-chair David Cohen, and the talented participants, Dr. David Garabrant, Joe Cecil, Mary Wells, and Mike Williams.  I learned a great deal from all of them, even when we disagreed.

At the seminar, which addressed the slippage in the federal judiciary’s fidelity to Rule 702 text and principles, Joe Cecil kindly reminded me of Professor Gastwirth’s contribution on the Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262, 298 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986).  Joseph L. Gastwirth, “The need for careful evaluation of epidemiological evidence in product liablility cases: a reexamination of Wells v. Ortho and Key Pharmaceuticals,” 2 Law, Probability and Risk 151 (2003).

The Supreme Court recently reinvigorated the Wells case, and like Frankenstein’s monster, it walks again.  Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011).  See alsoMatrixx Unloaded.”  As a result of the Matrixx decision, I revisited the untoward Wells decision several times this year. SeeWells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; and here, here, here, here, and here.  Joe’s reminder, however, provoked me to look one more time at Wells, through the lens of Gastwirth’s review.

Gastwirth is a well-known statistician, not a lawyer.  His article undertakes some interesting sensitivity analyses of the potential role of one known confounder in the epidemiologic studies of spermicides and birth defects, cited by witnesses in Wells. Not surprisingly, Gastwirth confuses important legal concepts, when he contends that science and law have different goals because science has the luxury of waiting for additional studies to resolve indeterminate datasets.  Gastwirth at 154. Gastwirth suggests that in law, causality determinations turn on fairness, but in science, they turn on the truth.  Gastwirth offers no support for his assertion, and there is much law to the contrary.  Federal Rule of Evidence 102, for instance, explains the “Purpose” of the Federal Rules and how they should be construed:

“These rules should be construed so as to administer every proceeding fairly, eliminate unjustifiable expense and delay, and promote the development of evidence law, to the end of ascertaining the truth and securing a just determination.”

Truth does count, at least in some courts, and it is hard to imagine a case in which the goals of truth and justice are bifurcated. Gastwirth sees law courts as unable to avoid judgment when the evidentiary display is weakly developed or not replicated, but he is wrong.  Courts can, do, and should avoid permitting judgments based upon indeterminate datasets.

Gastwirth also contends that the duty to warn in tort is based upon a possibility of causation, and he opines that this is perfectly satisfactory.  Gastwirth at 155.  Gastwirth cites the Restatement (Third) a/Torts for his view, but the Restatement does not couch the duty to warn as predicated upon merely possible risk:

“A defendant will not be liable under an implied warranty of merchantability for failure to warn about risks that were not reasonably foreseeable at the time of sale or could not have been discovered by way of reasonable testing prior to marketing the product. A manufacturer will be held to the standard of knowledge of an expert in the appropriate field, and will remain subject to a continuing duty to warn of risks discovered following the sale of the product at issue.”

Id. (emphasis added).  Gastwirth fails to explain why the epistemic standard of the Restatement should be diluted to include merely possible risks; nor does he explain why the law should impose a duty because a minority of so-called experts claim knowledge of the existence of a risk, whether potential or known.

Risks are based upon known causal relationships, viewed ex ante rather than post hoc.  Gastwirth attempts to defend the Wells decision on the basis that the trial judge, Judge Shoob, could have correctly found a possible risk, but this was not then or now the standard for imposing a duty to warn.  Even if possibilities were the basis for a duty to warn, the courts in Wells had to find sufficient evidence of cause in fact between the spermicidal jelly and the birth defect present in the infant plaintiff.  No merely possible risk could have satisfied this burden, and Gastwirth avoids this important issue in his review.  Ultimately, Gastwirth fails to come to grips with how the Wells courts artificially distinguished two causation standards – warning-harm and product-harm.  Gastwirth at 184.

When courts are required to work with an epistemic standard for evaluating opinions about causal claims, they will often confront sincere beliefs supported by “putative” justifications, but which turn out to be untrue.  The obvious implication is that the causal opinions were not “true” when offered, and the asserted, putative justification was no justification at all.  Twenty years post-Daubert should have made our courts more sensitive to the pathology of claiming, or pathoepistemology, as I call it.

Although Gastwirth is intent to show that the district and circuit court decisions in Wells were reasonable given the record evidence at the time of their decisions, Gastwirth’s defense is tepid at best. Gastwirth concedes that the plaintiffs’ evidence in the Wells case was not very convincing, and he is quick to point out that he does not conclude that spermicides cause limb reduction defects (although he does believe that the data were sufficient for his idiosyncratic diluted duty-to-warn legal standard:

 “The epidemiological evidence in the Wells case surely was not very convincing and it is understandable that scientists and legal scholars might desire stronger scientific evidence before holding a defendant liable. What seems unfortunate is the lack of discussion of the part of the record most supportive of the legal decisions from the published criticisms.201 While it is reasonable to ask how much evidence should be required before a warning is required, is it fair to rely on studies that were published after the time of exposure to assess the producer’s duty at the time?”

Gastwirth at 184-85.  The equivocation in this passage between assessing causation for a duty to warn and for product harm is typical of Gastwirth’s confusion throughout this article.  As noted, Gastwirth appears to believe it is sufficient to show the plausibility of the causal relationship such that the trial court’s findings of a duty to warn, and a breach of that duty, were reasonably supported:

“It should be stressed that our examination of the studies does not conclude that exposure to spermicides causes limb reduction defects. 202 Indeed, the studies published in the 1980s are sensitive to the potential effect of unmeasured known potential risk factors that were not controlled for in the analysis. Many studies observed that it is difficult to rule out small but meaningful risks given their sample size or that more studies including potential confounding variables be carried out before a scientific conclusion can be reached.203

Gastwirth at 185 & n.202.  So small increased risks were difficult to rule in or rule out, but then how can a judgment for plaintiffs be sustained unless, as I have shown elsewhere, Judge Shoob improperly placed the burden of proof upon the defendant?  The studies published in the 1980s may have been sensitive to the potential effect of unmeasured and uncontrolled known potential risks, but Judge Shoob clearly was not sensitive to the problem at all.

Other problems abound. The studies involved in the Wells case not only failed to account for the few known confounders at the time, but they could not and did not sort out the residual confounding.  Gastwirth concedes the point in a footnote, in which he cites a paper by Professor Gary Shaw on the role of multivitamin use in preventing birth defects. See Gastwirth at 185 & n. 202 (citing Shaw et al., “Maternal Periconceptional Use of Multivitamins and Reduced Risk for Conotruncal Heart Defects and Limb Deficiencies Among Offspring,” 59 Am. J. Med. Genetics 536 (1995) (showing that children of mothers who had taken vitamins and folic acid had a 30-35% lower risk of limb defects).  Gastwirth sees the discovery of causes not previously controlled for in the spermicide/birth defect studies of the 1980s as example of the differences between scientific and legal judgments.  Another way to look at such discoveries is to impose some standard of intellectual modesty upon courts in basing their findings upon speculative causal claims.

Gastwirth’s casual dismissiveness of the need for replication in a legal standard of causation is difficult to square with his acknowledgment that early studies often prove misleading about the existence of a true risk.  Gastwirth, for instance, acknowledges that later publications quite commonly do not support initial hypotheses.  Gastwirth at 179, 184 (citing Michael B. Bracken, “Spermicidal Contraceptives and Poor Reproductive Outcomes: The Epidemiologic Evidence Against an Association,” 151 Am. J. Obstet. & Gyncecol. 552, 555 (1985)).  Gastwirth channels the anti-manufacturer Zeitgeist for his claim that “firms” may not report studies that show risk, but he ignores the pervasive, prevalent practice of academic and advocacy scientists’ not publishing negative studies in the first place, and even later in the natural history of scientific controversies.

Ultimately, however, Gastwirth’s own judgment is a self-fulfilling prophecy of how the law and science should part company over false-positive assertions of causality.  Fortunately, the law has evolved in a different direction, towards convergence of scientific and legal modes of assessing causal claims.  Now judges must evolve as well.

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