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Federal Rule of Evidence 702 Requires Perscrutations — Samaan v. St. Joseph Hospital (2012)

February 4th, 2012

After the dubious decision in Milward, the First Circuit would seem an unlikely forum for perscrutations of expert witness opinion testimony.  Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied, ___ U.S.___ (2012).  See “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence” (Sept. 2, 2011).  Late last month, however, a First Circuit panel of the United States Court of Appeals held that Rule 702 required perscrutation of expert witness opinion, and then proceeded to perscrutate perspicaciously, in Samaan v. St. Joseph Hospital, 2012 WL 34262 (1st Cir. 2012).

The plaintiff, Mr. Samaan suffered an ischemic stroke, for which he was treated by the defendant hospital and physician.  Plaintiff claimed that the defendants’ treatment deviated from the standard of care by failing to administer intravenous tissue plasminogen activator (t-PA).  Id. at *1.  The plaintiff’s only causation expert witness, Dr. Ravi Tikoo, opined that the defendants’ failure to administer t-PA caused plaintiffs’ neurological injury.  Id. at *2.   Dr. Tikoo’s opinions, as well as those of the defense expert witness, were based in large part upon data from a study done by one of the National Institutes of Health:  The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group, “Tissue Plasminogen Activator for Acute Ischemic Stroke,” 333 New Engl. J. Med. 1581 (1995).

Both the District Court and the Court of Appeals noted that the problem with Dr. Tikoo’s opinions lay not in the unreliability of the data, or in the generally accepted view that t-PA can, under certain circumstances, mitigate the sequelae of ischemic stroke; rather the problem lay in the analytical gap between those data and Dr. Tikoo’s conclusion that the failure to administer t-PA caused Mr. Samaan’s stroke-related injuries.

The district court held that Dr. Tikoo’s opinion failed to satisfy the requirements of Rule 702. Id. at *8 – *9.  Dr. Tikoo examined odds ratios from the NINDS study, and others, and concluded that a patient’s chances of improved outcome after stroke increased 50% with t-PA, and thus Mr. Samaan’s healthcare providers’ failure to provide t-PA had caused his poor post-stroke outcome.  Id. at *9.  The appellate court similarly rejected the inference from an increased odds ratio to specific causation:

“Dr. Tikoo’s first analysis depended upon odds ratios drawn from the literature. These odds ratios are, as the term implies, ratios of the odds of an adverse outcome, which reflect the relative likelihood of a particular result.FN5 * * * Dr. Tikoo opined that the plaintiff more likely than not would have recovered had he received the drug.”

Id. at *10.

The Court correctly identified the expert witness’s mistake in inferring specific causation from an odds ratio of about 1.5, without any additional information.  The Court characterized the testimonial flaw as one of “lack of fit,” but it was equally an unreliable inference from epidemiologic data to a conclusion about specific causation.

While the Court should be applauded for rejecting the incorrect inference about specific causation, we might wish that it had been more careful about important details.  The Court misinterpreted the meaning of an odds ratio to be a relative risk.  The NINDS study reported risk ratio results both as an odds ratio and as a relative risk.  The Court’s sloppiness should be avoided; the two statistics are different, especially when the outcome of interest is not particularly rare.

Still, the odds ratio is interesting and important as an approximation for the relative risk, and neither measure of risk can substitute for causation, especially when the magnitude of the risk is small, and less than two-fold.  The First Circuit recognized and focused in on this gap between risk and causal attribution in an individual’s case:

“[Dr. Tikoo’s] reasoning is structurally unsound and leaves a wide analytical gap between the results produced through the use of odds ratios and the conclusions drawn by the witness. When a person’s chances of a better outcome are 50% greater with treatment (relative to the chances of those who were not treated), that is not the same as a person having a greater than 50% chance of experiencing the better outcome with treatment. The latter meets the required standard for causation; the former does not.  To illustrate, suppose that studies have shown that 10 out of a group of 100 people who do not eat bananas will die of cancer, as compared to 15 out of a group of 100 who do eat bananas. The banana-eating group would have an odds ratio of 1.5 or a 50% greater chance of getting cancer than those who eschew bananas. But this is a far cry from showing that a person who eats bananas is more likely than not to get cancer.

Even if we were to look only at the fifteen persons in the banana-eating group who did get cancer, it would not be likely that any particular person in that cohort got it from the consumption of bananas. Correlation is not causation, and a substantial number of persons with cancer within the banana-eating group would in all probability have contracted the disease whether or not they ate bananas.FN6

We think that this example exposes the analytical gap between Dr. Tikoo’s methods and his conclusions.  Although he could present figures ranging higher than 50%, those figures were not responsive to the question of causation. Let us take the “stroke scale” figure from the NINDS study as an example. This scale measures the neurological deficits in different parts of the nervous system. Twenty percent of patients who experienced a stroke and were not treated with t-PA had a favorable outcome according to this scale, whereas that figure escalated to 31% when t-PA was administered.

Although this means that the patients treated with t-PA had over a 50% better chance of recovery than they otherwise would have had, 69% of those patients experienced the adverse outcome (stroke-related injury) anyway.FN7  The short of it is that while the odds ratio analysis shows that a t-PA patient may have a better chance of recovering than he otherwise would have had without t-PA, such an analysis does not show that a person has a better than even chance of avoiding injury if the drug is administered. The odds ratio, therefore, does not show that the failure to give t-PA was more likely than not a substantial factor in causing the plaintiff’s injuries. The unavoidable conclusion from the studies deemed authoritative by Dr. Tikoo is that only a small number of patients overall (and only a small fraction of those who would otherwise have experienced stroke-related injuries) experience improvement when t-PA is administered.”

*11 and n.6 (citing Milward).

The court in Samaan thus suggested, but did not state explicitly, that the study would have to have shown better than a 100% increase in the rate of recovery for attributability to have exceeded 50%.  The Court’s timidity is regrettable. Yes, Dr. Tikoo’s confusing the percentage increased risk with the percentage of attributability was quite knuckleheaded.  I doubt that many would want to subject themselves to Dr. Tikoo’s quality of care, at least not his statistical care.  The First Circuit, however, stopped short of stating what magnitude increase in risk would permit an inference of specifc causation for Mr. Samaan’s post-stroke sequelae.

The Circuit noted that expert witnesses may present epidemiologic statistics in a variety of forms:

“to indicate causation. Either absolute or relative calculations may suffice in particular circumstances to achieve the causation standard. See, e.g., Smith v. Bubak, 643 F.3d 1137, 1141–42 (8th Cir.2011) (rejecting relative benefit testimony and suggesting in dictum that absolute benefit “is the measure of a drug’s overall effectiveness”); Young v. Mem’l Hermann Hosp. Sys., 573 F.3d 233, 236 (5th Cir.2009) (holding that Texas law requires a doubling of the relative risk of an adverse outcome to prove causation), cert. denied, ___ U.S. ___, 130 S.Ct. 1512, 176 L.Ed.2d 111 (2010).”

 Id. at *11.

Although the citation to Texas law with its requirement of a doubling of a relative risk is welcome and encouraging, the Court seems to have gone out of its way to muddle its holding.  First, the Young case involved t-PA and a claimed deviation from the standard of care in a stroke case, and was exactly on point.  The Fifth Circuit’s reliance upon Texas substantive law left unclear to what extent the same holding would have been required by Federal Rule of Evidence 702.

Second, the First Circuit, with its banana hypothetical, appeared to confuse an odds ratio with a relative risk.  The odds ratio is different from a relative risk, and typically an odds ratio will be higher than the corresponding relative risk, unless the outcome is rare.  See Michael O. Finkelstein & Bruce Levin, Statistics for Lawyers at 37 (2d ed. 2001). In studies of medication efficacy, however, the benefit will not be particularly rare, and the rare disease assumption cannot be made.

Third, risk is not causation, regardless of magnitude.  If the magnitude of risk is used to infer specific causation, then what is the basis for the inference, and how large must the risk be?  In what way can epidemiologic statistics be used “to indicate” specific causation?  The opinion tells us that Dr. Tivoo’s reliance upon an odds ratio of 1.5 was unhelpful, but why?  The Court, which spoke so clearly and well in identifying the fallacious reasoning of Dr. Tivoo, faltered in identifying what use of risk statistics would permit an inference of specific causation in this case, where general causation was never in doubt.

The Fifth Circuit’s decision in Young, supra, invoked a greater than doubling of risk required by Texas law.  This requirement is nothing more than a logical, common-sense recognition that risk is not causation, and that small risks alone cannot support an inference of specific causation.  Requiring a relative risk greater than two makes practical sense despite the apoplectic objections of Professor Sander Greenland.  See “Relative Risks and Individual Causal Attribution Using Risk Size” (Mar. 18, 2011).

Importantly, the First Circuit panel in Samaan did not engage in the hand-waving arguments that were advanced in Milward, and stuck to clear, transparent rational inferences.  In footnote 6, the Samaan Court cited its earlier decision in Milward, but only with double negatives, and for the relevancy of odds ratios to the question of general causation:

“This is not to say that the odds ratio may not help to prove causation in some instances.  See, e.g., Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11, 13–14, 23–25 (1st Cir.2011) (reversing exclusion of expert prepared to testify as to general rather than specific causation using in part the odds ratio).”

Id. at n.6.

The Samaan Court went on to suggest that inferring specific causation from the magnitude of risk was “theoretically possible”:

“Indeed, it is theoretically possible that a particular odds ratio calculation might show a better-than-even chance of a particular outcome. Here, however, the odds ratios relied on by Dr. Tikoo have no such probative force.“

Id. (emphasis added).  But why and how? The implication of the Court’s dictum is that when the risk ratio is small, less than or equal to two, the ratio cannot be taken to have supported the showing of “better than even chance.” In Milward, one of the key studies relied upon by plaintiff’s expert witness reported an increased risk of only 40%.  Although Milward presented primarily a challenge on general causation, the Samaan decision suggests that the low-dose benzene exposure plaintiffs are doomed, not by benzene, but by the perscrutation required by Rule 702.

Posted in Causation, Rule 702, Scientific Evidence, statistical evidence | No Comments »

Ethics and Daubert: The Scylla and Charybdis of Medical Monitoring

February 1st, 2012

Build a courtroom and they will come. The floodgates argument, all too quickly rejected by the judiciary, proved all too true in West Virginia. West Virginia built a courtroom that would entertain multiple claims from virtually every West Virginian. This jurisprudential hospitality offers medical monitoring that requires no predicate present injury. Bower v. Westinghouse Electric Corp., 522 S.E.2d 424 (W.Va. 1999).

Everyone is exposed to hazardous substances and to medications with potential side effects. In West Virginia, almost everyone is a potential plaintiff in a medical monitoring case.

Universal health care may be attainable, after all, funded by the manufacturers of predominately beneficial products. Almost heaven West Virginia, indeed. Type 2 diabetes mellitus, or adult-onset diabetes, is a devastating disease that results from uncontrolled blood sugars. The medical complications of diabetes are extensive and well known: blindness, gangrene, kidney failure, heart attack, stroke, liver disease, and others. The costs of this medical care are staggering, and diabetics are among the neediest patients in our health care system. Imagine if the “compensation goals” of the tort system could be subverted to provide medical monitoring to diabetic patients. If possible anywhere, it would seem West Virginia would be the most likely candidate.

Between March 1997 and March 2000, many Type 2 diabetics achieved control of their blood sugars with the help of a new oral medication, Troglitazone (Rezulin®).  Troglitazone modifies the Type 2 diabetic patient’s resistance to insulin. The drug effectively reduces blood sugar, and it avoids the need for exogenous insulin. Most life-saving drugs have side effects, and Troglitazone is no exception. Physicians, knowledgeable about Troglitazone’s efficacy and its potential for rare, idiosyncratic liver toxicity, prescribed the drug to help their patients gain control over their blood sugar levels and to avoid the serious complications of diabetes. In March 2000, the manufacturer of Troglitazone voluntarily withdrew the drug from the market. Adverse publicity over liver toxicity and the availability of two other more recent glitazones, which initially had the appearance of a safer adverse event profile, had shifted the risk-benefit balance against Troglitazone.

No one can be surprised that Rezulin plaintiffs sought class certification in West Virginia state court; nor can anyone, in view of Bower, be surprised that asymptomatic plaintiffs sought medical monitoring as a remedy, within the context of the class action. Observers unfamiliar with the weakness of the Rezulin plaintiffs’ scientific proofs might, however, be surprised at the plaintiffs’ failure, initially at the trial court level, to win class certification in West Virginia, for a medical monitoring class. In re West Virginia Rezulin Litigation, W.Va. Cir.Ct., Civil Action No. 00-C-1180H, Amended Order Denying Class Certification (Dec. 12, 2001) (Hutchison, J.), 2001 WL 1818442 (Dec 13, 2001).

The West Virginia trial court’s rejection of the proposed Rezulin medical monitoring class is remarkable for many reasons. Some commentators regard West Virginia law as the outer limits of medical monitoring jurisprudence.  In the Rezulin case, however, Judge John Hutchison delivered a thorough, analytical opinion, which demonstrated that the liberal West Virginia criteria for a medical monitoring remedy cannot be satisfied as easily as once thought. Among the notable holdings were the trial court’s insistence that:

(1) the monitoring proponents adduce epidemiologic evidence that the exposure at issue can actually cause the latent injury for which monitoring is sought;

(2) the proponents of monitoring identify highly sensitive tests, which when deployed on the exposed population that has a relatively high prevalence of the latent injury, will have a high predictive value; and

(3) the proposed monitoring will allow for early preventive care.

In determining whether the class plaintiffs had met the criteria for medical monitoring, Judge Hutchison did not face any significant evidentiary gatekeeping responsibility. The trial court did not have to ponder the contours of any reliable epidemiologic studies. The court found no epidemiologic studies to show that Rezulin can cause latent injury months or years after the drug is discontinued.

Similarly, the court did not have to delve into any evidentiary thicket of contradictory scientific proof to determine whether the proposed medical monitoring program was based upon reliable scientific and medical methods. The court found that most of the proposed tests had low sensitivity, and that there were no diagnostic tests that can determine whether any liver injury was caused by Rezulin. Given the many other causes of liver diseases among the plaintiff class members, there was no evidence of any prevalence of latent injury from Rezulin. Without an assessment of prevalence of latent injury, any proposed test would have little or no positive predictive value. The proposed program failed for lack of substantial evidentiary support.

The court was further impressed by the riskiness of the proposed monitoring program. The proposed tests, lacking sensitivity and specificity, were likely to result in many “false positives,” which in turn would lead to liver biopsies.  (Indeed, false positives would likely swamp any true positives if any there should be). Liver biopsies, however, are painful, invasive, and carry a small, but definite, risk of death. Furthermore, the court found that the proposed tests would not facilitate medical interventions that could prevent or resolve the detected problem.

This failure to obtain class certification for medical monitoring is noteworthy for more than the narrow case holdings. There is intriguing obiter dictum. The court noted that one of the plaintiffs’ expert witnesses admitted that the proposed monitoring program was an “experiment.” The court found this admission directly relevant to the plaintiffs’ failure to produce epidemiologic evidence that the substance at issue could actually cause latent injury. Apparently, the plaintiffs’ witness was advocating implementation of the monitoring program so it might yield the evidence that the class must proffer before it could obtain the monitoring remedy. The court readily dismissed this Alice in Wonderland insistence upon “[s]entence first—verdict afterwards.” The court showed little patience for the “stuff and nonsense” of trying to satisfy the criterion of epidemiologic evidence with the anticipated results that would come from the proposed monitoring program itself.

Implicit in the trial court’s rejection of evidentiary bootstrapping is a larger, ethical concern. There is something unsettling about a court-ordered medical monitoring program that is an “experiment.” Class certification decisions are complicated enough without having to endorse experimentation on human beings. Perhaps the suggestion of human experimentation chilled any residual enthusiasm for the notion that medical monitoring might otherwise be a suitable judicial remedy for achieving corrective justice in a mass tort case.

And yet there is an “experimental” aspect to many, if not most, proposed monitoring programs. Little or no clinical experience is available to support the claimed benefits of many proposed large, lifelong monitoring regimes. Indeed, such programs are not wholly benign. The potential harms of monitoring, some of which were acknowledged in Judge Hutchison’s opinion, are significant.

The imposition of potentially harmful monitoring should, indeed, trouble our courts and cause their reticence in embracing monitoring as a remedy. Courts need to confront the ethical implications that flow from the experimental nature of many medical monitoring proposals.

Proposals for monitoring differ from expert witness opinion that is typically offered in personal injury cases involving present injuries. Physician witnesses, at the request of the parties, usually examine claimants, evaluate and diagnose their conditions, and opine about prognosis and etiology. Although such witnesses use their medical experience, training, and knowledge, they generally are not acting within the context of a patient-physician relationship. Adams v. Harron, 191 F.3d 447, 1999 WL 710326 (4th Cir. 1999). In the usual personal injury case, physician witnesses are not advocating medical interventions; at most, they are endorsing or criticizing the reasonable medical necessity of medical plans of treating physicians.  In medical monitoring class actions, however, physician expert witnesses advocate medical interventions for people they have often never met and have never evaluated.

Recommendations for preventive health measures carry risks of harm, and these risks must provoke ethical scrutiny of the proposed monitoring. The offering of an opinion that a plaintiff, or a class of plaintiffs, should receive medical monitoring is the practice of medicine. As part of medical practice, the presentation of such opinions is subject to ethical constraints, which courts should observe and foster. Medico-legal opinions that recommend preventive interventions represent a significant involvement in the claimant’s actual medical care. Screening or monitoring recommendations must acknowledge and avoid the highly individualized risks of harm and the essential need for informed consent to protect individual autonomy.

Physicians who prepare medical monitoring litigation plans cannot absolve themselves of ethical and professional responsibility by disclaiming the existence of physician-patient relationships. Such physicians are not practicing mere courthouse medicine; they are engaged in medical practice, as defined by the American Medical Association, AMA Policy H-265.993, and in the sense that they are seeking to control future medical interventions for the class members.  Physicians who propose medical monitoring or screening for claimants thus operate under the ethical constraints of avoiding harm, providing benefits, and respecting individual patient autonomy. The medical community recognizes that good intentions notwithstanding, monitoring can be harmful. “[P]reventive therapies can give rise to anticipatory anxiety, side effects, the stress of false-positive results and an unhealthy preoccupation with disease.” Huston, “The Perils of Prevention,” 154 Canadian Med. Ass’n J. 1463 (1996). Other potential adverse effects of monitoring include deriving false assurances of health and being labeled as “sick.” Marshall, “Prevention. How Much Harm? How Much Benefit? 3. Physical, Psychological and Social Harm,” 155 Canadian Med. Ass’n J. 169 (1996).

Furthermore, some screening programs will detect true-positive results with little or no clinical significance.  For example, in cancer screening, some nodules detected will be benign. Other nodules may be extremely indolent malignancies, which would never become aggressive, metastatic growths. Indeed, such masses, picked up in screening, might regress before they would have been otherwise detectable. Screening programs must come to grips with the vagaries of the diseases and conditions that are the subject of the monitoring. The potential for harm, from monitoring, may be increased by the litigation setting, in which people are encouraged to become invested in illness seeking behaviors.

Given the potential for harm, physician witnesses who advocate monitoring face ethical and evidentiary burdens to establish the efficacy and benefit of the planned screening. At a minimum, class members will have to be properly advised, and will have to be given informed consent. The process of obtaining consent must accommodate the intensely personal and individualized judgments about the risks of monitoring.

Well-established criteria for evaluating public health interventions are available and employed by such agencies and groups as the United States Preventive Task Force, the Canadian Task Force on the Periodic Health Examination, the Cochrane Collaboration, and others.  The existence of generally accepted evaluative criteria has obvious implications for determining the admissibility of monitoring proposals under either Daubert or Frye standards. Expert witnesses, in this ethically sensitive area, must be held to the same intellectual rigor that would be employed to evaluate monitoring or screening programs in the field of public health. Pitfalls, fallacies, and methodological error are abundant in the field of preventive medicine. Marshall, “Prevention. How Much Harm? How Much Benefit? 2. Ten Potential Pitfalls in Determining the Clinical Significance of Benefits,” 154 Canadian Med. Ass’n J. 1837 (1996). Even well-intentioned advice, such as counseling routine mammography in women, has been the subject of heated controversy and intense methodological debate. Ernster, “Mammograms and Personal Choice,” The New York Times (Feb. 14, 2002).   Courts must acknowledge that if a proposed preventive program does not satisfy generally accepted criteria for medical interventions and does not have proven benefits that clearly outweigh the potential harms, medical monitoring becomes a court-sanctioned human experiment.

The guiding principles and corollaries for human experimental research can be found in several sources, including The Nuremberg Code, Permissible Medical Experiments, World Medical Association, “Declaration of Helsinki’s Ethical Principles for Medical Research Involving Human Subjects,” 284 J. Am. Med. Ass’n 3043 (Dec. 20, 2000), as restated on several occasions, regulations of the Food and Drug Administration, Protection of Human Subjects, 21 C.F.R. § 50.25; and the Department of Health and Human Services, 45 C.F.R. § 46.

Informed consent is the absolute requirement for any human medical experimentation. Regulations and guidelines of various federal and state agencies and medical organizations, however, place further limitations on the course of permissible experimental design.  The Declaration of Helsinki, for instance, requires that the research design be clearly set out in an experimental protocol, which has been approved by an independent ethical review committee. The proposed medical research

“must conform to generally scientific principles, [and] be based on a thorough knowledge of the scientific literature….”

Declaration of Helsinki, ¶11 (2000). Permissible Medical Experiments, supra. Daubert and Frye thus become ethical imperatives, as well as legal requirements, before any serious consideration can be given to a medical monitoring program.

In all likelihood, no court, if it really thought about the matter, would want to serve as an Institutional Review Board, and to sit in judgment of an experimental protocol. The realization that the proposed remedy is itself an experiment should suffice to quash any advocacy for the result. Indeed, an awareness of the ethical problems entailed by poorly supported medical monitoring programs must guide and propel courts to be vigilant in their gatekeeping responsibilities.  Much of the earlier case law on monitoring developed before the principles and implications of Daubert could be realized in monitoring cases, and these older judgments must be questioned in the light of these ethical and evidentiary concerns.

Judge Hutchison’s decision to deny certification for a Rezulin medical monitoring class obviated consideration of the ethical and evidentiary problems posed by monitoring remedies. The clear absence of proof to support the remedy for the Rezulin plaintiffs avoided debate over how to protect the informed consent process when the personal perception of the risks of monitoring will be perceived differently by each class member.

The paradisiacal Appalachian dream, however, did not last very long.

The Supreme Court of West Virginia did not appear to be concerned by the ethics of human experimentation or the need for showing a basis in evidence for the reliability or accuracy of screening tests.  Chief Justice Starcher, writing for a unanimous court, reversed and remanded the case to proceed as a class action.  The Supreme Court’s opinion was a mechanical recitation of class action rules, interpreted to disallow any preliminary inquiry into the merits of the suit. In re West Virginia Rezulin Litig., 585 S.E.2d 52 (W.Va. 2003).  The word “ethics” does not appear in the Supreme Court’s opinion. The Nuremberg Code was nowhere in sight.

Perhaps most medical monitoring class action battles are now behind us, given that federal courts have come to their senses and have generally disallowed class actions for this remedy.  The cases on the book, however, represent ethically dubious judgments, which call for condemnation from the medical and legal community.  Courts must take stock of the certainty that many medical monitoring schemes will produce far more false positive cases than true positive cases, and widespread fear, anxiety, and harm from unnecessary medical interventions.  See generally Christopher P. Guzelian, Bruce E. Hillner, and Philip S. Guzelian, “A Quantitative Methodology for Determining the Need for Exposure-Prompted Medical Monitoring,” 79 Indiana L. J. 57 (2004).

[An earlier version of this post was published under the same title in Industrywide Liability News (Spring 2002)]

Posted in Medical monitoring, Rule 702, Scientific Evidence | No Comments »

The United States Government’s Role in the Asbestos Mess

January 31st, 2012

More Asbestos History

The role of the United States government in the asbestos mess is relatively unexplored historical territory.  Anti-asbestos zealots, including the “Lobby,” and the plaintiffs bar, have demonized industry for the failure to control asbestos health hazards.  The truth is very different.  (The term, “the Lobby,” comes from the insightful article by the late Prof. Liddell:  F. D. K. Liddell, “Magic, Menance, Myth and Malice,” 41 Ann. Occup. Hyg. 3 (1997).  Liddell’s article should be required reading for all judges with an asbestos docket, as well as all policy makers and legislators who tackle asbestos issues.)

Back in 2007, Walter Olson, wrote an important essay on government and risk, “Dangerous When In Power” Reason (Mar. 2007). Olson later followed up on this theme at Point of Law, where he wrote about “The U.S. Navy and the asbestos calamity.”  Olson published some observations I shared with him at the time:

“In the mid-1970s, amidst economic turmoil and declining military budgets, the US Navy found itself with a big problem. Payments to civilians under the FECA (Federal Employees Compensation Act), a statute that gives civilian employees of shipyards the equivalent of workers’ compensation benefits, came right out of the Navy’s budget for shipbuilding. The Navy had no insurance for FECA payments, and suddenly it found itself facing a large uptick in the number of claims made by civilians for asbestos-related injuries.

About the same time, many states adopted some version of strict product liability, some stricter than others. None was likely stricter than Pennsylvania’s version.

The FECA gives the government liens against any recovery in third-party actions. The JAG lawyers, faced with a blooming docket of FECA cases, started to encourage the workers compensation plaintiffs’ lawyers to file third-party actions. Indeed, in Philadelphia, the lawyers who stepped into the forefront of asbestos personal injury actions had been workers comp lawyers with a large FECA docket (Gene Locks; Joe Shein).

The cruel irony of the FECA (or workers’ comp) statutes is that the employer pays regardless of fault, that the employer can’t be sued in civil actions, and that the employer can recover ~80% of its payments from settlements or judgment proceeds from a civil defendant.

Ultimately, the plaintiffs’ bar found that recoveries and settlements were too certain to encumber themselves and their clients with government liens, and they stopped filing their FECA cases altogether.

The government’s role in fueling the explosion of asbestos civil actions has never, to my knowledge, been discussed in the media. When I was a young lawyer, my first trials were in defense of companies that were dragged into litigation over having sold asbestos products to the Navy, often pursuant to government specifications. These cases, filed in the late 1970s, up for trial in the mid-1980s, often had a letter in the claimant’s personnel file from the JAG officer, noting that the man had been diagnosed with asbestosis and urging him to seek legal counsel to consider a civil suit against the Navy’s suppliers. Unfortunately, I don’t have any of these documents anymore, but they may not be too difficult to obtain.

What a story is hidden away in those old files! Not only did the Navy know of the asbestos hazards, hide them from its civilian workers, but when those workers got sick, the Navy turned on its outside suppliers by encouraging its workers to sue the suppliers, while hiding behind the exclusive remedy provision of the FECA.”

The historical mythology of asbestos and its hazards was created in large measure with the active cooperation of the government and asbestos plaintiffs’ lawyers.  The government, acting through the plaintiffs’ bar, was able to keep its weapons budgets intact, by minimizing its own losses on FECA payments.  We should probably thus regard the asbestos litigation as an early form of the parens patriae suits that have become a commonplace.

In the late 1960s, some of the asbestos insulation manufacturers that were still in business, created their own mythology. In litigating the early,  Navy-inspired, failure-to-warn claims, these insulation manufacturers advanced the unfounded view that the dangerousness of asbestos to end users was somehow not known before Dr. Irving Selikoff publicized the hazard, with his work in 1964. The insulators union’s publication, Asbestos Worker, shows an awareness of the hazard before then; indeed, the union’s appreciation of the hazard was in large measure the reason that the union approached Selikoff to conduct epidemiologic studies on their membership. The U.S. Navy was also well aware of the hazards (and thus did not need to be warned by anyone), as can be seen in an article entitled “Asbestosis” by Capt. H.M. Robbins & W.T. Marr in the October 1962 issue of the Navy’s Safety Review.  See also Walter Olson, “Asbestos awareness pre-Selikoff,” (Oct. 19, 2007).

Recently, a defense expert witness, Dr. Dennis Paustenach, published an historical review on the evolution of knowledge about asbestos.  Kara Franke & Dennis Paustenbach, “Government and Navy knowledge regarding health hazards of Asbestos: A state of the science evaluation (1900 to 1970),” 23(S3) Inhalation Toxicology 1 (2011) (available for download free of charge).

Here is the authors’ abstract:

“We evaluated dozens of published and unpublished documents describing the knowledge and awareness of both the scientific community and governmental entities, particularly the US Navy, regarding the health hazards associated with asbestos over time. We divided our analysis into specific blocks of time: 1900–1929, 1930–1959, and 1960–1970. By 1930, it was clear that high occupational exposure to asbestos caused a unique disease (asbestosis). Between about 1938 and 1965, a considerable amount of exposure and epidemiology data were collected by various scientific and government organizations. Between 1960 and 1970, mesothelioma was clearly linked to exposure to amphibole asbestos. Nonetheless, the Navy continued to require the use of asbestos-containing materials on ships, but also recommended that proper precautions be taken when handling asbestos. We concluded that the Navy was arguably one of the most knowledgeable organizations in the world regarding the health hazards of asbestos, and that it attempted to implement procedures that would minimize the opportunity for adverse effects on both servicemen and civilians. Finally, it is apparent from our research that through at least 1970, neither the military nor the private sector believed that the myriad of asbestos-containing products considered “encapsulated” (e.g. gaskets, brakes, Bakelite) posed a health hazard to those working with them.”

The subject is well covered territory, but the article approaches its subject matter from the perspective of what was known by the United States Navy, which may well have been singlehandedly responsible for exposing the greatest number of men and women to asbestos in the United States.  Back in the 1980s, Dr. Sam Forman covered a similar theme, but only through War War II.  See Samuel A. Forman, “U.S. Navy Shipyard Occupational Medicine Through World War II,” 30 J. Occup. Med. 28 (1988).

The focus on the Navy is a welcome change from the conspiratorial histories of Brodeur, Castleman, Rosner, and others whose writings suggest that “industry,” more or less specifically defined, withheld material knowledge from its customers.  In the case of the Navy, the withholding may have gone the other way around.

I leave it to readers to judge the bona fides and Franke and Paustenbach’s historical essay, but from my perspective, the article generally hits a more balanced and better supported view of the asbestos state of the art.

The article is, however, not without problems.

Here are some things that were either left out, or given incomplete or inadequate emphasis:

1. The Navy’s work rules that required asbestos insulation to be removed from its packaging on shore, before being taken on board ships.  This work rule deprived ship-board workers of the benefit of warnings.  (Whether package warnings could have made any difference to control exposures that required technical personnel with exposure measuring equipment is a whole other matter.)

2. The Navy had effective knowledge of working conditions through its ownership and control of the workplace.  In this respect, the Navy’s knowledge of the hazards created in its shipyards was vastly greater than that of remote suppliers.

3.  The Navy’s had no workers’ compensation budget per se.  Money paid to civilian employees under the Federal Employees’ Compensation Act (FECA) came directly from the Navy’s general revenues.  Navy legal counsel encouraged FECA plaintiffs’ counsel to sue the Navy’s vendors under emerging doctrines of strict liability.  In some states, such as Pennsylvania and New Jersey, the vendors, sued in strict liability, often could not point to the Navy’s negligence as a defense because the Navy was immune from a civil suit.

There are historical nits to pick with Franke’s article, as well.  Consider:

“the elevated risk of lung cancer was first formally discovered by Doll in 1955 (Doll, 1955).”

Id. at 2.  What does it mean to discover something formally?  Doll certainly did not present a mathematical proof, with Q.E.D. at the bottom line.  The men who had lung cancer in Doll’s cohort also had asbestosis, and his study suggested that there was a relationship between the diffuse interstitial pulmonary fibrosis and lung cancer, and not necessarily an association with the lighter, more intermittent exposures sustained by insulators.  Furthermore, although Doll’s cohort was impressive at the time, he had no control for smoking.  This oversight was remarkable given that Doll was working on the epidemiology of smoking and lung cancer at the very time he published his cohort study of asbestos factory workers.

And consider the authors’ statement:

“Crocidolite was not frequently used in products … .”

Id. at 3 (citing Rachel Maines, Asbestos and Fire (New Brunswick 2005). The authors do not provide a specific page reference so it is difficult to evaluate their citation of Professor Maines.  What is known, however, is that crocidolite was used in transite pipe and board products, as well as other products, used throughout the United States, including Navy shipyards.  After Johns-Manville went into bankruptcy, shipyard workers miraculously experienced a sudden, permanent loss of memory about their use of JM products.  A careful review of the pre-JM-bankruptcy testimony of key shipyard workers, however, shows that “big blue” was in Navy shipyards.

Posted in Historian Testimony, Sophisticated User | 4 Comments »

Discovery into the Origin of Historian Expert Witnesses’ Opinions

January 30th, 2012

As every trial lawyer in America knows, the Federal Rules of Civil Procedure were recently changed to protect expert witness draft reports and lawyer-expert witness communications from discovery.  See Rule 26. Duty to Disclose; General Provisions Governing Discovery (amended effective December 2010).

In particular, Rule 26(b) (4)(B), and (C) provides:

(4)(B) Trial-Preparation Protection for Draft Reports or Disclosures. Rules 26(b)(3)(A) and (B) protect drafts of any report or disclosure required under Rule 26(a)(2), regardless of the form in which the draft is recorded.

(C) Trial-Preparation Protection for Communications Between a Party’s Attorney and Expert Witnesses. Rules 26(b)(3)(A) and (B) protect communications between the party’s attorney and any witness required to provide a report under Rule 26(a)(2)(B), regardless of the form of the communications, except to the extent that the communications:

(i) relate to compensation for the expert’s study or testimony;

(ii) identify facts or data that the party’s attorney provided and that the expert considered in forming the opinions to be expressed; or

(iii) identify assumptions that the party’s attorney provided and that the expert relied on in forming the opinions to be expressed.

In some ways, this amendment was a retrograde step.  Although protecting drafts and communications from discovery helps ease the expense and inconvenience of working with expert witnesses, the amendment also serves to protect unscrupulous lawyers and expert witnesses who work in concert to present tendentious opinions.

In the sciences, tendentious opinions will ultimately be embarrassed by future facts, but in the field of history, the interpretative narratives are often unfalsifiable and malleable.  Discovery into the creative process of historian expert witnesses’ opinions needs to be complete and thorough.

Consider the consider the case of Barry Castleman, who has testified for decades for the asbestos litigation industry, on historical issues in asbestos personal injury cases.  Back in 1986, when Castleman was still “researching” his opinions, he received a letter from plaintiffs’ lawyer, Tom Hart:

 

Mr. Barry Castleman                                                                                   January 9, 1986
1722 Linden Avenue
Baltimore, Maryland 21217

RE: Kenneth Lynch

Dear Barry:

As a follow-up to our conversation on January 6, 1986, I have reviewed our files and find that we do not have a file on Kenneth Lynch. Apparently I was provided with some of these papers indirectly. I seem to recall that the attorneys from California came to South Carolina and conducted the search for Kenneth Lynch’s papers.

We have not been eager to pursue this due to our understanding that Dr. Lynch was not convinced that asbestos was a cause of cancer. Despite his earlier publications, he remained personally reluctant to state that asbestos was causally related to the formation of cancers until some time in the late 1950’s or early 1960’s. This indecision on his part would be contrary to our best interests in the asbestos litigation and, accordingly, we have discouraged other counsel from exploring this further.

Since we do not have the specific documents you need, perhaps Marcia Hughes could provide them to you from Dick Gerry’s office in San Diego.

With best regards, I am

Very truly yours,

Thomas H. Hart, III

 

Dr. Lynch was a well-known South Carolina pathologist, who, along with Dr. William Smith, published a case report of lung cancer in a patient with asbestosis.  See Kenneth M. Lynch & William A. Smith, “Pulmonary asbestosis III: carcinoma of lung in asbestosilicosis,” 23 Am. J. Cancer 56 (1935).  Plaintiffs’ counsel were eager to over interpret this case report as showing an association, which was beyond the ability of a single, uncontrolled case to do.

The new Rule can be seen to have a few holes in it.  Discovery is permitted into facts or data provided by counsel, and which were considered by the expert witness.  Discovery is also permitted into the identity of assumptions given by the directing counsel, and relied upon by the expert witness.  The letter from Hart to Castleman above, however, illustrates that important insights may result from suggestions, implicit or explicit, not to look at certain facts.

Posted in Conflicts of Interest, Historian Testimony, Trial Procedure, Underlying Data | No Comments »

Ethics and Statistics

January 21st, 2012

Chance magazine has started a new feature, the “Ethics and Statistics column, which is likely to be of interest to lawyers and to statisticians who work on litigation issues.  The column is edited by Andrew Gelman.  Judging from the Gelman’s first column, I think that the column may well become a valuable forum for important scientific and legal issues arising from studies used in public policy formulation, and in reaching conclusions that are the bases for scientific expert witnesses’ testimony in court.

Andrew Gelman is a professor of statistics and political science in Columbia University.  He is also the director of the University’s Applied Statistics Center.   Gelman’s inaugural column touches on some issues of great importance to legal counsel who litigate scientific issues involving scientific studies:  access to underlying data in the studies that are the bases for expert witness opinions.  See Andrew Gelman, “Open Data and Open Methods,” 24 Chance 51 (2011).

Gelman acknowledges that conflicts are not only driven by monetary gain; they can be potently raised by positions or causes espoused by the writer:

“An ethics problem arises when you are considering an action that

(a) benefits you or some cause you support,

(b) hurts or reduces benefits to others, and

(c) violates some rule.”

Id. at 51a.

Positional conflicts among scientists whose studies touch upon policy issues give rise to “the ethical imperative to share data.”  Id. at 51c.  Naming names, Professor Gelman relates an incident in which he wrote to an  EPA scientist, Carl Blackman, who had presented a study on the supposed health effects of EMF radiation.   Skeptical of how Blackman had analyzed data, Gelman wrote to Blackman to request his data to carry out additional, alternative statistical analyses.  Blackman answered that he did not think these other analyses were needed, and he declined to share his data.

This sort of refusal is all too common, and typical of the arrogance of scientists who do not want others to be able to take a hard look at how they arrived at their conclusions.  Gelman reminds us that:

“Refusing to share your data is improper… .”

* * * *

“[S]haring data is central to scientific ethics.  If you really believe your results, you should want your data out in the open. If, on the other hand, you have a sneaking suspicion that maybe there’s something there you don’t want to see, and then you keep your raw data hidden, it’s a problem.”

* * * *

“Especially for high-stakes policy questions (such as the risks of electric power lines), transparency is important, and we support initiatives for automatically making data public upon publication of results so researchers can share data without it being a burden.”

Id. at 53.

To be sure, there are some problems with sharing data, but none that is insuperable, and none that should be an excuse for withholding data.  The logistical, ethical, and practical problems of data sharing should now be anticipated long before publication and the requests for data sharing arrive.

Indeed, the National Institutes of Health requires data sharing plans to be part of a protocol for a federally funded study.  See Final NIH Statement on Sharing Research Data (Feb. 26, 2003). Unfortunately, the NIH’s implementation and enforcement of its data-sharing policy is as spotty as a Damien Hirst painting.  See “Seeing Spots” The New Yorker (Jan. 23, 2012).

Posted in Conflicts of Interest, Data Sharing, Rule 702, Scientific Evidence, statistical evidence | No Comments »

Tortini – Guilt-Free Pastry

January 16th, 2012

Well, I have blogged over 100 posts on Tortini.  I have had the gratification of seeing some of these posts quoted, approvingly and disapprovingly, in print publications, as well as in other blogs.   More important, the blog has put me in contact with some very interesting people, who have generously shared ideas, comments, and criticisms — all grist for my blogging mill.

Up till now, I have not made my blog interactive; I have not set up the blog to permit comments from readers.   I have avoided this level of on-line, immediate interactivity with my readers mostly to avoid the pressure of having to monitor the blog closely.  As the quasi-publisher, I feel a responsibility to make sure that the comments were legitimate “fair comment,” and not defamatory rubbish, or worse.

Recently, Professor Deborah Mayo posted a good portion of my post, The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest on her blog. The post attracted the attention of a critic who described my post with a mixed metaphor:  “meretricious garbage.”  I responded on Mayo’s website, but the exchange made me realize that there are plusses and minuses to opening up a blog to comments.

I think for my part, I will continue Tortini as I have been doing.  If I have given offense, personally, professionally, or intellectually, I invite you to write to me.  Let me know whether you are willing to have me post your comments.  I am certainly open to posting opposing points of view on Tortini.

Posted in Uncategorized | No Comments »

Beware the Academic-Publishing Complex!

January 11th, 2012

Today’s New York Times contains an important editorial on an attempt by some congressmen to undermine access to federally funded research.  See Michael B. Eisen, “Research Bought, Then Paid For” New York Times (January 11, 2012).  Eisen’s editorial alerts us to this attempt to undo a federal legal requirement that requires federally funded medical research be made available, for free, on the National Library of Medicine’s Web site (NLM).

As a founder of the Public Library of Science (PLoS), which is committed to promoting and implementing the free distribution of scientific research, Eisen may be regarded as an “interested” ora  biased commentator.  Such a simple-minded ascription of bias would be wrong. The PLoS has become an important distribution source of research results in the world of science, and competes with the publishing oligarchies:  Elsevier, Springer, and others.  The articles of the sort that PLoS makes available for free are sold by publishers for $40 or more.  Subscriptions from these oligarchical sources are often priced in the thousands of dollars per year. Eisen’s simple and unassailable point is that the public, whether the medical profession, patients and citizens, students and teachers, should be able to read about the results of research funded with their tax monies.

“[I]f the taxpayers paid for it, they own.”

The United States government and its employees do not enjoy copyright protections for their creative work (and they do not), neither should their contractors.

Public access is all the more important given that the mainstream media seems so reluctant or unable to cover scientific research in a thoughtful and incisive way.

The Bill goes beyond merely unraveling a requirement of making published papers available free of charge at the NLM.    The language of the Bill, H.R.3699, the Research Works Act, creates a false dichotomy between public and private sector research:

 “SEC. 2. LIMITATION ON FEDERAL AGENCY ACTION.

No Federal agency may adopt, implement, maintain, continue, or otherwise engage in any policy, program, or other activity that—

(1) causes, permits, or authorizes network dissemination of any private-sector research work without the prior consent of the publisher of such work … .”

Work that is conducted in private or in state universities, but funded by the federal taxpayers, cannot be said to be “private” in any meaningful sense.  The public’s access to this research, as well as its underlying data, is especially important when the subject matter of the research involves issues that are material to public policy and litigation disputes.

Who is behind this bailout for the private-sector publishing industry?  Congressman Darrell Issa (California) introduced the Bill, on December 16, 2011.  The Bill was cosponsored by Congresswoman Carolyn B. Maloney, the Democratic representative of New York’s 14th district.  Oh Lord, Congresswoman Maloney represents me!  NOT.  How humiliating to be associated with this regressive measure.

This heavy-handed piece of legislation was referred to the House Committee on Oversight and Government Reform.  Let us hope it dies a quick death in committee.  See Michael Eisen, “Elsevier-funded NY Congresswoman Carolyn Maloney Wants to Deny Americans Access to Taxpayer Funded Research” (Jan. 5, 2012).

Posted in Conflicts of Interest, Data Sharing, Peer Review | No Comments »

The Will to Ummph

January 10th, 2012

It has become très chic to criticize and dismiss the concept of statistical significance.

The new Reference Manual on Scientific Evidence contains a sly reference and endorsement to a book by the two would-be statistics experts who submitted an amicus brief to the Supreme Court in Mattrix Initiatives v. Siracusano:

“For a hypercritical assessment of statistical significance testing that nevertheless identifies much inappropriate overreliance on it, see Stephen T. Ziliak & Deidre N. McCloskey, The Cult of Statistical Significance (2008).”

Michael D. Green, D. Michael Freedman, and Leon Gordis, ” Reference Guide on Epidemiology” 549, 579, in Federal Judicial Center and National Research Council, Reference Manual on Scientific Evidence (3d ed. 2011).

The Reference Manual authors are, in fact, hypo-critical of the rhetoric of Ziliak and McCloskey.  I have previously written at some length of these authors’, and brief writers’, submission to the Supreme Court, and their subsequent harrumph in Significance.  See The Matrixx Oversold; Matrixx Unloaded; The Matrixx – A Comedy of Errors; Matrixx Galvanized – More Errors, More Comedy About Statistics; and Ziliak Gives Legal Advice — Puts His Posterior On the Line (June 2, 2011).

To date, I have not addressed Ziliak and McCloskey’s book-length treatment of statistical significance, and their demonization of Sir Ronald Fisher, their beatification of William Gossett, and the need for a measure of “ummph: The Cult of Statistical Significance.  Thankfully, Professor Deborah Mayo, a professor of statistics and philosophy, has delivered the coup de grâce to Ziliac & McCloskey, in her interesting and timely blog, Error Statistics Philosophy.   See, e.g., Part 2 Prionvac: The Will to Understand Power (October 3, 2011); and Part 3: Prionvac: How the Reformers Should Have done Their Job (October 4, 2011).

Mayo’s “will to understand power” is a nice play on Nietzsche, and a rebuke of Ziliak and McCloskey’s strident call  for a measure of “ummph.”  Most of their argument is beside the point for the current practice of epidemiology, which insists upon reporting a measure of “effect” size, as well as statistical precision in a confidence interval.  The Reference Manual‘s citation to Ziliak & McCloskey’s book thus badly misses the point and the errors of the book’s criticisms of significance.

Mayo’s posts should remove any sense of need or desire to obtain and read Ziliac & McCloskey’s book.  You can safely wait until Cult shows up in on the discount rack, or in the recycling pile.

Posted in statistical evidence | No Comments »

Defendants’ Petition for Certiorari in Milward – DENIED

January 9th, 2012

The Supreme Court reported this morning that the defendants petition for certiorari in U.S. Steel Corp. v. Milward, Docket No.. 11-316, was denied.

While unfortunate for the parties involved, the denial was not a surprise.  The Supreme Court does not sit to review factual errors and distortions, such as those that pervaded the First Circuit’s decision below.  Furthermore, most of the justices are at sea when it comes to scientific evidence, as shown by Justice Sotomayor’s incredible discussion of causal concepts, in Mattrix Initiatives v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309 (2011).  See “Matrixx Unloaded.”

Indeed, there were great dangers involved in seeking this discretionary review in the Supreme Court.  As I have written, the SKAPP-a-lites have larded up the most recent edition of the Reference Manual on Scientific Evidence with language that could easily be marshaled in favor of a loosey-goosey interpretation of Rule 702.  See “Reference Manual on Scientific Evidence v3.0 – Disregarding Study Validity in Favor of the ‘Whole Gamish’.”

What is needed is not Supreme Court review, but a thorough dismemberment of the philosophy behind the Circuit’s decision in Milward, and the wayward, or the Milward, trend towards anything goes in the latest edition of the Reference Manual on Scientific Evidence.  See “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence.”

It was shame and humiliation that drove the Daubert decision in the Supreme Court, and ultimately the revision of Federal Rule of Evidence 702.   When the Courts suddenly realized that the scientific community was looking at their aberrant judgments,  they changed up.  The silicone gel breast implant litigation illustrates the phenomenon of how the courts react to the medical and scientific communties’ condemnation.

The Milward decision calls for a similar collateral attack on the unprincipled use of so-called “weight of the evidence” thinking.  Some evidence, after all, is a mere feather’s weight, and not an appropriate basis for a scientific conclusion.

FW: Defendants’ Petition for Certiorari in Milward – DENIED

Inbox
 x

Nathan A. Schachtman
11:37 AM (12 minutes ago)
to me

From: Nathan A. Schachtman [mailto:Nathan@SchachtmanLaw.com]
Sent: Monday, January 09, 2012 11:22 AM
To: ‘Nathan A. Schachtman’
Subject: Defendants’ Petition for Certiorari in Milward – DENIED

The Supreme Court reported this morning that the defendants petition for certiorari in U.S. Steel Corp. v. Milward, Docket No.. 11-316, was denied.

While unfortunate for the parties involved, the denial was not a surprise.  The Supreme Court does not sit to review factual errors and distortions, such as those that pervaded the First Circuit’s decision below.  Furthermore, most of the justices are at sea when it comes to scientific evidence, as shown by Justice Sotomayor’s incredible discussion of causal concepts, in Mattrix Initiatives v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309 (2011).  See “Matrixx Unloaded.”

http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf

http://schachtmanlaw.com/matrixx-unloaded/

Indeed, there were great dangers involved in seeking this discretionary review in the Supreme Court.  As I have written, the SKAPP-a-lites have larded up the most recent edition of the Reference Manual on Scientific Evidence with language that could easily be marshaled in favor of a loosey-goosey interpretation of Rule 702.

What is needed is not Supreme Court review, but a thorough dismemberment of the philosophy behind the Circuit’s decision in Milward, and the wayward, or the Milward, trends towards anything goes in the latest edition of the Reference Manual on Scientific Evidence.  See “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence.”

http://schachtmanlaw.com/milward-unhinging-the-courthouse-door-to-dubious-scientific-evidence/

The courts need to be made to feel ashamed of their judgments with respect to scientific matters.

It was the shame and humiliation of Bendectin litigation and others that moved the Court in Daubert, and later Joiner.

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Posted in Rule 702, Scientific Evidence | No Comments »

The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest

December 28th, 2011

Conflicts of interest (COI), real or potential, have become a weapon used to silence the manufacturing industry in various scientific debates and discussions.  Other equally “interested” parties, labor unions, advocacy groups, and consultants to the other industry – the litigation industry – have used conflicts and ethical claims to silence the manufacturing industry and to engage in unfettered false scientific speech. The public, unwilling and untrained to look at evidence on the merits, is conditioned to accepting an allegation of COI as the end of the discussion on scientific issues.

Recently, journalist Shannon Brownlee criticized the FDA for its suggestion that the agency was having difficulty in finding experts who cleared the agency’s conflict-of-interest prohibitions.  Brownlee explicitly contended that she could easily find “unbiased” scientists who could advise the agency on drug and device issues.

Shannon Brownlee, “Is There an Independent Unbiased Expert in the House” (Aug. 3, 2011).

Indeed, Brownlee sent FDA Commissioner Margaret Hamburg a list of allegedly neutral experts who could advise the agency.  Brownlee gave everyone on her list a clean bill of ethical health, and has published the list on multiple occasions, both on the website Healthnewsreview.org, and a few years ago, in the British Medical Journal:  Jeanne Lenzer & Shannon Brownlee, “Is there an (unbiased) doctor in the house?” 337 Brit. Med. J. 206 (2008).

Brownlee tells us that journalists from respectable print media, including the New York Times, and the Wall Street Journal, have requested the list, apparently to contact the “unbiased” experts to help investigate news stories about drugs and medical devices.  What the gullible may not appreciate is that the list fallaciously is based upon only one exclusionary criterion:  having consulted for the pharmaceutical industry.  The list omits other important COI exclusionary criteria, such as having consulted for the litigation industry, or having taken erroneous, unwarranted, and ideologically driven positions on scientific issues.

What litigation industry?  Brownlee may have missed the fact that plaintiffs’ lawyers represent a huge financial interest in obtaining compensation for others, with 40 percent of the proceeds going to themselves.  This litigation industry thrives, even with Dickie Scruggs in prison, and Stanley Chesley in disrepute.

In today’s litigation environment, with aggregation of claims in federal multi-district cases, plaintiffs’ counsel stand to profit in the billions from scientific positions espoused by their expert witnesses.

Who are the litigation industry expert witnesses on Brownlee’s list?  Here are some obvious candidates:

Peter R. Breggin, MD, psychiatrist, clinical psychopharmacologist, independent author and scientist; Founder and Director Emeritus, International Center for the Study of Psychiatry and Psychology

Adriane Fugh-Berman, MD, Professor, Department of Physiology and Biophysics, Georgetown University Medical Center; Director, PharmedOut.org

Curt Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine

Joseph Glenmullen, MD, Clinical instructor in psychiatry, Harvard Medical School

Bruce Psaty, MD, PhD, Professor, Medicine & Epidemiology, University of Washington Cardiovascular Health Research Unit

Also on the list were well-known anti-industry zealots, who focus almost exclusively on the manufacturing industry, while ignoring or endorsing the excesses and unwarranted claims of the litigation industry:

Lisa Bero, PhD, Professor, University of California, San Francisco U.S.

Sheldon Krimsky, PhD, Tufts University & Council for Responsible Genetics

Sidney Wolfe, MD, Director, Health Research Group of Public Citizen.

Now some people may claim that the litigation industry consultants, and the anti-industry zealots, take their positions not to please their sponsors, or to pursue lucrative opportunity, but because they fervently believe the positions that they take. But then why not give the pharmaceutical industry consultants the same benefit of the doubt?  Indeed, why not move beyond COI allegations to creating lists of scientists and physicians who have demonstrated proficiency in advancing evidence-based judgments that have withstood the test of time?

This anti-industry hypocrisy manifests not only in assertions of conflicts of interest, but also in calls for industry to disclose all underlying data from industry-funded or sponsored studies, while taking a protectionist stance on all other underlying data.

Let’s hope that in 2012, industry fights back, and evidence regains its primary role in resolving scientific disputes.

Posted in Conflicts of Interest, Scientific Evidence | 1 Comment »

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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.