TORTINI

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

Two Articles of Interest in JAMA – Nocebo Effects; Medical Screening

February 12th, 2012

Two articles in this week’s Journal of the American Medical Association (JAMA) are of interest to lawyers who litigate, or counsel about, health effects.

One article deals with the nocebo effect, which is the dark side of the placebo effect. Placebos can induce beneficial outcomes because of the expectation of useful therapy; nocebos can induce harmful outcomes because of the expectation of injury. The viewpoint article in JAMA points out that nocebo effects, like placebo effects, result from the “psychosocial context or therapeutic environment” affecting a patient’s perception of his state of health or illness. Luana Colloca, MD, PhD, and Damien Finniss, MSc Med., “Nocebo Effects, Patient-Clinician Communication, and Therapeutic Outcomes,” 307 J. Am. Med. Ass’n 567, 567 (2012).

The authors discuss how clinicians can inadvertently prejudice health outcomes by how they frame outcome information to patients. Importantly, Colloca and Finniss also note that the negative expectations created by the nocebo communication can take place in the process of obtaining informed consent.

The litigation significance is substantial because the creation of negative expectations is not the exclusive domain of clinicians. Plaintiffs’ counsel, support and advocacy groups, and expert witnesses, even when well meaning, can similarly create negative expectations for health outcomes. These actors often enjoy undeserved authority among their audience of litigants or claimants. The extremely high rate of psychogenic illness found in many litigations is the result. The harmful communications, however, are not limited to plaintiffs’ lawyers and their auxiliaries. As Colloca and Finniss point out, nocebo effects can be induced by well-meaning warnings and disclosure of information from healthcare providers to patients. Id. at 567. The potential to induce negative harms in this way has the obvious consequence for the tort system: more warnings are not always beneficial. Indeed, warnings themselves can bring about harm. This realization should temper courts’ enthusiasms for the view that more warnings are always better. Warnings about adverse health outcomes should be based upon good scientific bases.

*************

The other article from this week’s issue of JAMA addresses the harms of screening. Steven H. Woolf, MD, MPH, and Russell Harris, MD, MPH, “The Harms of Screening: New Attention to an Old Concern,” 307 J. Am. Med. Ass’n 565 (2012). As I pointed out on these pages, screening for medical illnesses carries significant health risks to patients and ethical risks for the healthcare providers. See “Ethics and Daubert: The Scylla and Charybdis of Medical Monitoring” (Feb. 1, 2012). Bayes’ Theorem teaches us that even very high likelihood ratios for screening tests will yield true positive cases swamped by false positive cases when the baseline prevalence is low. See Jonathan Deeks and Douglas Altman, “Diagnostic tests 4: likelihood ratios,” 329 Brit. Med. J. 168 (2004) (Providing a useful nomogram to illustrate how even highly accurate tests, with high likelihood ratios, will produce more false than true positive cases when the baseline prevalence of disease is low).

The viewpoint piece by Woolf and Harris emphasizes the potential iatrogenic harms from screening:

physical injury from the test itself (as in colonic perforations from colonoscopy);

cascade of further testing, with further risk of harm, both physical and emotional;

anxiety and emotional distress over abnormal results;

overdiagnosis; and

the overtreatment of conditions that are not substantial threats to patients’ health

These issues should have an appropriately chilling effect on judicial enthusiasm for medical monitoring and surveillance claims. Great care is required to fashion a screening plan for patients or claimants. Of course, there are legal risks as well, as when plaintiffs’ counsel fail to obtain the necessary prescriptions or permits to conduct radiological screenings. See Schachtman “State Regulators Impose Sanction for Unlawful Silicosis Screenings,” 17(13) Wash. Leg. Fdtn. Legal Op. Ltr. (May 25, 2007). Caveat litigator.

Posted in Causation, Medical monitoring, Scientific Evidence | No Comments »

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 »

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 »

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
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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.

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

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

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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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 »

A Rule of Completeness for Statistical Evidence

December 23rd, 2011

Witnesses swear to tell the “whole” truth, but lawyers are allowed to deal in half truths. Given this qualification on lawyers’ obligation of truthfulness, the law prudently modifies the law of admissibility for writings to permit an adverse party to require that written statements are not yanked out of context. Waiting days, if not weeks, in a trial to restore the context is an inadequate remedy for these “half truths.” If a party introduces all or part of a writing or recorded statement, an adverse party may ” require the introduction, at that time, of any other part — or any other writing or recorded statement — that in fairness ought to be considered at the same time.” Fed. R. Evid. 106 (Remainder of or Related Writings or Recorded Statements). See also Fed. R. Civ. Pro. Rule 32(a)(4) (rule of completeness for depositions).

This “rule of completeness” has its roots in the common law, and in the tradition of narrative testimony. The Advisory Committee notes to Rule 106 comments that the rule is limited to “writings and recorded statements and does not apply to conversations.” The Rule and the notes ignore that the problematic incompleteness might be in the form of mathematical or statistical evidence.

Confidence Intervals

Consider sampling estimates of means or proportions. The Reference Manual on Scientific Evidence (2d ed. 2000) urges that:

“[w]henever possible, an estimate should be accompanied by its standard error.”

RMSE 2d ed. at 117-18.

The new third edition dilutes this clear prescription, but still conveys the basic message:

“What is the standard error? The confidence interval?

An estimate based on a sample is likely to be off the mark, at least by a small amount, because of random error. The standard error gives the likely magnitude of this random error, with smaller standard errors indicating better estimates.”

RMSE 3d ed. at 243.

The evidentiary point is that the standard error, or the confidence interval (C.I.), is an important component of the sample statistic, without which the sample estimate is virtually meaningless. Just as a narrative statement should not be truncated, a statistical or numerical expression should not be unduly abridged.

Of course, the 95 percent confidence interval is the estimate (the risk ratio, the point estimate) plus or minus 1.96 standard errors. By analogy to Rule 106, lawyers should insist that the confidence interval, or some similar expression of the size of the standard error, be provided at the time that the examiner asks about, or the witness gives, the sample estimate. There are any number of consensus position papers, as well as guidelines for authors of papers, which specify that risk ratios should be accompanied by confidence intervals. Courts should heed those recommendations, and require parties to present the complete statistical idea – estimate and random error – at one time.

One disreputable lawyer trick is to present incomplete confidence intervals. Plaintiffs’ counsel, for instance, may inquire into the upper bound of a confidence interval, and attempt to silence witnesses when they respond with both the lower and upper bounds. “Just answer the question, and stop volunteering information not asked.” Indeed, some unscrupulous lawyers have been known to cut off witnesses from providing the information about both bounds of the interval, on the claim that the witness was being “unresponsive.” Judges who are impatient with technical statistical testimony may even admonish witnesses who are trying to make sure that they present the “whole truth.” Here again, the completeness rule should protect the integrity of the fact finding by allowing, and requiring, that the full information be presented at once, in context.

Although I have seen courts permit the partial, incomplete presentation of statistical evidence, I have yet to see a court acknowledge the harm from failing to apply Rule 106 to quantitative, statistical evidence. One court, however, did address the inherent error of permitting a party to emphasize the extreme values within a confidence interval as “consistent” with the data sample. Marder v. G.D. Searle & Co., 630 F.Supp. 1087 (D.Md. 1986), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987)(per curiam).

In Marder, the plaintiff claimed pelvic inflammatory disease from a IUD. The jury was deadlocked on causation, and the trial court decided to grant the defendant’s motion for directed verdict, on grounds that the relative risk involved was less than two. Id. at 1092. (“In epidemiological terms, a two-fold increased risk is an important showing for plaintiffs to make because it is the equivalent of the required legal burden of proof—a showing of causation by the preponderance of the evidence or, in other words, a probability of greater than 50%.”)

The plaintiff sought to resist entry of judgment by arguing that although the relative risk was less than two, the court should consider the upper bound of the confidence interval, which ranged from 0.9 to 4.0. Id. So in other words, the plaintiff argued that she was entitled to have the jury consider and determine that the actual value was actually 4.0.

The court, fairly decisively, rejected this attempt to isolate the upper bound of the confidence interval:

“The upper range of the confidence intervals signify the outer realm of possibilities, and plaintiffs cannot reasonably rely on these numbers as evidence of the probability of a greater than two fold risk. Their argument reaches new heights of speculation and has no scientific basis.”

The Marder court could have gone further by pointing out that the confidence interval does not provide a probability for any value within the interval.

Multiple Testing

In some situations, completeness may require more than the presentation of the size of the random error, or the width of the confidence interval. When the sample estimate arises from a study with multiple testing, presenting the sample estimate with the confidence interval, or p-value, can be highly misleading if the p-value is used for hypothesis testing. The fact of multiple testing will inflate the false-positive error rate.

Here is the relevant language from Kaye and Freedman’s chapter on statistics, in the Reference Manual (3d ed.):

“4. How many tests have been done?

Repeated testing complicates the interpretation of significance levels. If enough comparisons are made, random error almost guarantees that some will yield ‘significant’ findings, even when there is no real effect. To illustrate the point, consider the problem of deciding whether a coin is biased. The probability that a fair coin will produce 10 heads when tossed 10 times is (1/2)¹⁰ = 1/1024. Observing 10 heads in the first 10 tosses, therefore, would be strong evidence that the coin is biased. Nonetheless, if a fair coin is tossed a few thousand times, it is likely that at least one string of ten consecutive heads will appear. Ten heads in the first ten tosses means one thing; a run of ten heads somewhere along the way to a few thousand tosses of a coin means quite another. A test—looking for a run of ten heads—can be repeated too often.

Artifacts from multiple testing are commonplace. Because research that fails to uncover significance often is not published, reviews of the literature may produce an unduly large number of studies finding statistical significance.¹¹¹ Even a single researcher may examine so many different relationships that a few will achieve statistical significance by mere happenstance. Almost any large dataset—even pages from a table of random digits—will contain some unusual pattern that can be uncovered by diligent search. Having detected the pattern, the analyst can perform a statistical test for it, blandly ignoring the search effort. Statistical significance is bound to follow.

There are statistical methods for dealing with multiple looks at the data, which permit the calculation of meaningful p-values in certain cases.¹¹² However, no general solution is available… . In these situations, courts should not be overly impressed with claims that estimates are significant. …”

RMSE 3d ed. at 256-57.

When a lawyer asks a witness whether a sample statistic is “statistically significant,” there is the danger that the answer will be interpreted or argued as a Type I error rate, or worse yet, as a posterior probability for the null hypothesis. When the sample statistic has a p-value below 0.05, in the context of multiple testing, completeness requires the presentation of the information about the number of tests and the distorting effect of multiple testing on preserving a pre-specified Type I error rate. Even a nominally statistically significant finding must be understood in the full context of the study.

Many texts and journals recommend that the Type I error rate not be modified in the paper, as long as readers can observe the number of multiple comparisons that took place and make the adjustment for themselves. Most jurors and judges are not sufficiently knowledgeable to make the adjustment without expert assistance, and so the fact of multiple testing, and its implication, are additional examples of how the rule of completeness may require the presentation of appropriate qualifications and explanations at the same time as the information about “statistical significance.”

Posted in Scientific Evidence, statistical evidence | No Comments »

The Integrity of Facts in Judicial Decisions

December 21st, 2011

One of the usual tasks of an appellate judge’s law clerk is to read the record – the entire record. In my clerking experience, the law clerk who had the assignment for a case in which the judge was writing an opinion was responsible for knowing every detail of the record. The judge believed that fidelity to the factual record was an absolute.

Not so for other appellate judges. See, e.g., Jacoby, “Judicial Opinions as “Minefields of Misinformation: Antecedents, Consequences and Remedies,” University Public Law and Legal Theory Working Papers Paper 35 (N.Y. 2006).

Some important cases turn on facts misunderstood or misrepresented by appellate courts. A few days ago, Kyle Graham blogged about a startling discovery in the Summers v. Tice case, which is covered in every first-year torts class. Kyle Graham, “Summers v. Tice: The Rest of the Story” (Dec. 1, 2011).

Summers v. Tice, 33 Cal.2d 80, 199 P.2d 1 (1948), is a leading California tort law case that shifted the burden of proof on causation to the two defendants. The rationale for shifting the burden was the gross negligence of both defendants, and the plaintiff’s faultless inability to identify which of the two defendants, Simonson or Tice, was responsible for shooting the plaintiff with a shotgun in their ill-fated quail hunt.

Professor Graham did something unusual: he actually read the record of the bench trial. It turns out that the facts were different from, and much more interesting than, those presented by the California Supreme Court. Simonson admitted shooting Summers, and implicated Tice. Tice denied shooting. The trial judge resolved credibility issue against Tice, although it seems to have been a close issue.

More important, Tice testified that his gun was loaded with No. 6 shot, whereas Simonson had used No. 7.5 shot. Summers admitted that the pellets had been given to him after his medical treatment, but he could not find them at the time of trial. Had he kept the pellets, Summers would have been able to distinguish between the gunfeasors.

Spoliation anyone? Missing evidence? Adverse inference?

Even if the trial judge was unimpressed with Tice’s denial of having discharged his shotgun, Tice’s lack of credibility could not turn into affirmative evidence that he had used number 7.5 shot, as had Simonson. This was a contested issue, on which the plaintiff could have adduced evidence. The plaintiff’s failure to do so was the result of his own post-accident carelessness (or worse) in not keeping important evidence. Tice’s testimony on the size of the shot in his gun was undisputed, even if the trial court thought that he was not a credible witness.

Thus, on the real facts, the shifting of the burden of proof, on the rationale that the plaintiff was without fault for his inability to produce evidence against Summers or Tice, was quite unjustified. The plaintiff was culpable for the failure of proof, and there was no affirmative evidence that the two potential causative agents were indistinguishable. The defendants were not in a better position than the plaintiff to identify who had been the cause of plaintiff’s wounds.

The trial court’s credibility assessment of Tice, for having denied a role in shooting, did not turn the absence of evidence into affirmative evidence that both defendants used the same size pellets in their shotguns. What makes for a great law school professor’s hypothetical was the result of an obviously fallacious inference, and a factual fabrication, borne of sloppy judicial decision making.

We can see a similar scenario play out in the New Jersey decisions that reversed directed verdicts in asbestos colorectal cancer cases. Landrigan v. Celotex Corp., 127 NJ. 404, 605 A2d 1079 (1992); Caterinicchio v. Pittsburgh Corning Corp., 127 NJ. 428, 605 A.2d 1092 (1992). In both cases, the trial courts directed verdicts, assuming arguenda that asbestos can cause colorectal cancer (a dubious proposition), on the ground that the low relative risk cited by plaintiffs’ expert witnesses (about 1.5) was factually insufficient to support a verdict for plaintiffs on specific causation. Indeed, the relative risk suggested that the odds were about 2 to 1 in defendants’ favor that the plaintiffs’ colorectal cancers were not caused by asbestos.

The intermediate appellate courts affirmed the directed verdicts, but the New Jersey Supreme Court reversed and remanded both judgments on curious grounds. According to the Court, there were other probative factors that the juries could have used to make out specific causation:

“Dr. Wagoner did not rely exclusively on epidemiological studies in addressing that issue. In addition to relying on such studies, he, like Dr. Sokolowski, reviewed specific evidence about decedent’s medical and occupational histories. Both witnesses also excluded certain known risk factors for colon cancer, such as excessive alcohol consumption, a high-fat diet, and a positive family history. From statistical population studies to the conclusion of causation in an individual, however, is a broad leap, particularly for a witness whose training, unlike that of a physician, is oriented toward the study of groups and not of individuals. Nonetheless, proof of causation in toxic-tort cases depends largely on inferences derived from statistics about groups.”

Landrigan, 127 N.J. at 422. The NJ Supreme Court held that the plaintiffs’ failure to show a relative risk in excess of 2.0 was not fatal to their cases, when there was other evidence that the jury could consider, in addition to the relative risks.

Well, actually there was no expert witness support for the assertion. Completely absent from the evidentiary displays in both the Landrigan and Caterinicchio cases was any evidence, apart from plaintiffs’ expert witnesses’ hand waving, that a higher relative risk existed among the subcohort of asbestos insulators who had had heavier exposure or who had concomitant pulmonary disease. There was no evidence that those exposed workers who lacked “excessive alcohol consumption, a high-fat diet, and a positive family history” had any increase risk. Indeed, the Selikoff study relied upon extensively by plaintiffs’ expert witnesses failed to make any adjustment for the noted risk factors, as well as for the greater prevalence of smoking histories among the insulators than among the unexposed comparator population. The Court turned the absence of evidence into the factual predicate for its holding that defendants were not entitled to judgment.

Now that’s judicial activism.

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Silica Science – Junk Science is Not Limited to The Courts

December 12th, 2011

“Clowns to the left of me; Jokers to the right; here I am, stuck in the middle with you.”

David Michaels, head of OSHA, back in October, was testifying at a House congressional oversight hearing, “Workplace Safety: Ensuring a Responsible Regulatory Environment.” The Congressmen were inquiring into OSHA’s enforcement and regulatory initiatives on several fronts, including silica exposures.

This is the same David Michaels who used to be a hired expert witness for plaintiffs in toxic tort cases. See “David Michaels’ Public Relations Problem,” (Dec. 2, 2011).

Not surprisingly, when the questioning turned to silica, Michaels played the cancer card: crystalline silica is a “known” human carcinogen.

Republican congressman Larry Bucshon (R-IN), a surgeon when he is not holding forth in Congress, found the talk of cancer to be provocative. Buchson scolded Michaels:

“I don’t like it when people use buzz words that try to get people’s attention, and cancer is one of those.”

* * * * *

“…I’m a thoracic surgeon, so I want to focus a little bit on what you said earlier as it relates to silica dust. I’m curious about your comment about silica-dust related lung cancer, because I’ve been a thoracic surgeon for 15 years and I’ve done a lot of lung cancer surgery, and I haven’t seen one patient that’s got it from silica dust.”

A fascinating exchange for several reasons.

First, we could expect Michaels to play the cancer card, just as he has in his role as plaintiffs’ expert witness. As we will see, his cancer evidence is not far fetched, although it is also not particularly convincing.

Second, the junk science from Congressman Buchson is distressing. As a physician, he should know better that his experience in surgery has no relevance at all to the question whether crystalline silica can cause lung cancer.

Back in 1996, a working group of the World Health Organization’s International Agency for Research on Cancer (IARC) voted to reclassify crystalline silica, the most ubiquitous mineral on the face of Planet Earth, a known human carcinogen. Michaels recited this “evidence,” but he failed to mention that the evidence was conflicting, as were the votes of the working group. The response of the scientific community to the IARC pronouncement was highly critical. See Patrick A. Hessel, John F. Gamble, J. Bernard L. Gee, Graham Gibbs, Francis H.Y. Green, W. Keith C. Morgan, and Brooke T. Mossman, “Silica, Silicosis, and Lung Cancer: A Response to a Recent Working Group Report,” 42 J. Occup. Envt’l Med. 704 (2000).

The vote of the working group was very close; indeed, the swing of a single vote would have changed the outcome. One of the working group members later wrote:

“Some equally expert panel of scientists presented with the same information on another occasion could of course have reached a different verdict. The evidence was conflicting and difficult to assess and such judgments are essentially subjective.”

Corbett McDonald & Nicola Cherry, “Crystalline Silica and Lung Cancer: The Problem of Conflicting Evidence,” 8 Indoor Built Environment 121, 121 (1999). Remarkably, this panel member explained his decision to vote for reclassification as follows:

“The basic problem was that the evidence for carcinogenicity was conflicting – generally absent in situations of high and widespread exposure and strong only in a few rather special occupations. The advice by the IARC to consider hazard rather than risk did much to resolve the difficulty.”

Id. at 125. I suspect that the evidence for a difference in meaning between “hazard” and “risk” is even more tenuous and conflicting than the evidence in favor of carcinogenicity.

IARC classifications, however, take on a life of their own. They are an invitation to stop thinking, and to stop analyzing the evidence. Federal bureaucrats and staff scientists love them for exactly this reason: they can hide behind the authority of the WHO without having to work on reviewing the evidence, or updating their judgment when new studies come out.

It should not be surprising, therefore, that the National Institutes of Health’s National Toxicology Program (NTP), working off the WHO decision, recognized crystalline silica as a human carcinogen. Other groups followed in lock step. Other agencies and medical groups followed.

What you will not hear from Michaels or his followers is that when the National Institute for Occupational Safety and Health conducted the largest mortality study on the issue, it found a decreased lung cancer risk among men who actually had sufficient silica exposure to develop silicosis. See Geoffrey Calvert, et al., “Occupational silica exposure and risk of various diseases: an analysis using death certificates from 27 states of the United States,” 60 Occup. Envt’l Med. 122 (2003). Cf. “Congressman tells OSHA chief not to use “buzz” words like cancer.” (Oct. 10, 2011).

To give the devil his due, at least Michaels had “some” evidence to support his pronouncement, even if the evidence was incomplete and contradicted by other important evidence. Congressman Bucshon’s recitation of his experience as a surgeon was completely off the mark. His staffers obviously failed him in their research, and Bucshon’s reliance upon his own anecdotal experience was quite inappropriate to rebut the dubious judgment of the OSHA Administrator.

Some people might describe the exchange between Bucshon and Michaels as resembling two monkeys playing chess. I think of it as exemplifying the scientific illiteracy in all three branches of our government.

David Michaels’ Public Relations Problem

Posted in Conflicts of Interest, Scientific Evidence | No Comments »

Scientific American(s) and the other 99%

December 7th, 2011

If you have an interest in the history of science, especially as it plays out in the so-called state-of-the-art defense in products liability litigation, you may find the following offer helpful. For the remainder of the month, Scientific American, which is now published by Nature, is making its archived issues, 1845-1909, available free of charge.

There is more fascinating than to read what people were thinking, saying, and writing, at times past. Most of what we think we know about the past is filtered by historians rather than being obtained by accessing primary sources. The Scientific American archive is a useful corrective measure, especially in the contentious area of health-effects litigation.

Here are some of the interesting historical insights. In 1871, 140 years ago, Scientific American ran an article on the ill-health effects of smoking. “To smoke or not to smoke,” Scientific American 375 (Dec. 9, 1871). Here are some highlights:

“M. Beau notices eight cases of angina pectoris caused by the use of tobacco.

Professor Lizars records several cases of cancer of the tongue and lips caused by the use of the pipe. The writer has known one such ill stance, and never wishes to see another example of such terrible suffering resulting from a worse than useless habit.”

These pronouncements might not pass muster under today’s evidence-based medicine, but they were astute observations in need of testing, in 1871.

Not all the medical observations and claims were equally prescient. Our forebears were not immune from the idiocies and enthusiasms of medical quackery. Cancer remedies seemed to be a particular focus of much unenlightened attention:

“Col. Ussery, of the parish of De Soto, informs the Editor of the Caddo Gazette that he fully tested a remedy for this troublesome disease, recommended to him by a Spanish woman, a native of the country. The remedy is this: Take an egg and break it, then pour out the white, retaining the yolk in the shell, put in salt and mix with the yolk as long as it will receive it, stir them together until the salve is formed, put a portion of this on a piece of sticking plaster and apply it to the cancer about twice a day. He has made the experiment twice in his own family with complete success.”

“Remedy for Cancer,” Scientific American 298 (June 12, 1847).

Or this forerunner of the clinical trial:

“The Tuscaloosa Observer says it has seen it stated, more than once, that the common cranberry was efficacious in the cure of cancer, but have never, until very recently, been an eye-witness to the fact. Mr. Middleton Belk, residing within four or five miles of this city, who was afflicted with a cancer on the nose for the last eight years, was induced to try cranberries applied as a poultice; and to his great joy and satisfaction, has experienced a perfect and radical cure. We mention this fact at the instanee of Mr. Belk, who is desirous that others suffering under the same affliction, may avail themselves of this simple, but valuable remedy.”

“Cranberries a Cure for Cancer,” 3 Scientific American 408 (Sept. 9, 1848). Another article, three years later, touted mineral naptha as a cancer cure. “Mineral Naptha,” 6 Scientific American 243 (April 19, 1851).

The pages of Scientific American document the rise of asbestos use and the growing awareness of asbestos’ great utility to help control and prevent fire and burns. For instance, in 1876, the magazine described the utility of asbestos in roofing materials and in pipecovering. “The Industrial Uses of Asbestos,” Scientific American 258 (April 22, 1876).

A few years later, an article described the widespread use of asbestos in industrial applications, both in Europe and in the United States:

“For some time past Toope’s covering for steam surfaces has been in use in England, giving great satisfaction and receiving the indorsement of many prominent English engineers. The business of manufacturing and selling it is conducted there by a limited company located in London.
In this country Mr. Charles Toope, manufacturing agent, having an office and works at 353 East 78th street, New York City, is making and introducing the covering. The covering is readily applied, requires no previous preparation, and when in place is permanent, being incapable of injury by jarring or pounding.”

“Felt and Asbestos Covering for Steam Surfaces,” Scientific American 357 (December 4, 1880). [353 East 78th is right around the corner from me. I doubt that many of the residents of this mid-rise apartment building know that an asbestos factory once graced their property.] See also “The Prevention of Fires in Theaters,” 35 Scientific American 401 (Dec. 23,1876); “Insulated Coverings for Pipes, Boilers, Etc.,” 59 Scientific American 355, 355 (Dec. 8, 1888).

Posted in Historian Testimony, Scientific Evidence | No Comments »

TORTINI

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

FW: Defendants’ Petition for Certiorari in Milward – DENIED Inbox x

FW: Defendants’ Petition for Certiorari in Milward – DENIED

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