Medical Expert Witness Forensic Toxicologist | Medical Expert Witness Services & More | Dr. Nachman Brautbar



By Nachman Brautbar, M.D.

Daubert, Joiner, Kumho: Revisited

In a recent editorial in the American Journal of Public Health, (Supplement 1; 2005) Professor Michaels discussed events that occurred after a Daubert Supreme Court decision and its continuous application by some courts (Federal Courts as well as states which adopted Daubert in State Courts). Professor Michaels states, "What began as a well-intentioned attempt to improve 1/4" "has had troubling consequences. "Professor Michaels continues, and essentially states that, "The picture is disturbing:On the basis of the lay judges' ruling, respected scientists have been barred from authoring expert testimony in civil cases, corporate defendants have become increasingly emboldened to cavalierly accused any adversary of practicing 'junk science.'"


Professor Michaels further states that compounding the above problem "the Daubert decision provides no philosophy to help judges identify good science". Dr. Michaels then concludes that "IT IS, THEREFORE, NOT SURPRISING THAT JUDGES ARE NOT BETTER ABLE TO EVALUATE SCIENTIFIC EVIDENCE THAN GROUPS OF JURORS WHO USE A DELIBERATIVE PROCESS TO POOL THEIR COLLECTIVE WISDOM AND ASSESS THE EVIDENCE PRESENTED TO THEM." [Emphasis added]. In other words, if we decide to have judges act as gatekeepers of what a jury is going to hear and what a jury is not going to hear, essentially we as a society will restrict jury's intellectual and evidentiary process, and leave it to the judge, coming closer to a three-judge panel or a one-judge panel in other states, democratic as well as non-democratic (from the American Journal of Public Health). IS THE DAUBERT COURT SAYING THE JURORS ARE NOT INTELLIGENT ENOUGH TO DECIDE AFTER HEARING ALL EVIDENCE AND AFTER CROSS-EXAMINATION OF ALL EXPERTS WHICH ONE IS MORE SENSIBLE AND WHICH ONE IS NOT? Are we not subjecting the whole process of a day in court in front of a jury to inherent biases that we all have, including a judge? But at the same time, while a judge may have inherent biases, twelve jurors selected, according to the jury selection process, may have biases, but not encompassing the whole jury (hopefully), but rather will reach some reasonable balance after deliberating the testimonies of the experts (American Journal of Public Health) [Emphasis added]. If indeed this "Daubertism" of the Court continues, jurors should ask themselves if they are just a rubber stamp for a system decided by a judge? If the trilogy [Tragedy: Daubert, Joiner, Kumho Tire] felt jurors are not competent, then they should have asked Congress to remove the jury system. What good is a jury, if the judge, a non-scientist, makes decisions in science? "Daubertization" of the court is un-American! If the American people agree with this concept, then the jury / trial system is gone!

While Daubert is meant to be more flexible than rule 702, of evidence, it became, unfortunately, a tool to maneuver experts and get well-respected and knowledgeable experts out of the courtroom so that their testimony cannot be presented to the jurors. It is a daily practice to see motions to exclude expert testimony with arguments "that the expert is relying on junk science". Unfortunately, with all due respect to judges and the jury system in our country, some judges fall for this and in some cases exclude well-trained, respected and knowledgeable witnesses and, therefore, damage the party which has been injured or damaged by an exposure to toxic agents, medication or other harmful actions.

Imagine yourself as a judge, trained in law, and suddenly asked to make scientific medical decisions based on a six or eight week course in epidemiology! Imagine the opposite: A doctor, given an eight week course of the law and asked to be a judge. Totally unreasonable! But yet, ongoing daily, Some judges even go to the extent of telling well-trained scientific experts that they, the judge, know better.


General causation in toxic tort cases is whether a substance can be harmful to human beings. Specific causation is whether defendants' substance in fact caused plaintiff's injuries. In a recent editorial (American Journal of Public Health. 2005;95 Suppl 1:S121-8. ), Professor Cranor has explored the issue and concludes that how much each piece of relevant evidence can contribute to an explanation depends on the other evidence available for making such judgments and how the evidence fits together.


In his essay, Professor Cranor describes animal studies. In that discussion, he states, "Judges, however, reviewing the scientific foundation of expert testimony, have been overcritical of animal studies, failed to understand them, or dismissed them outright for what appeared to be poor reasons. "While animal studies are not mathematically a certain guide to the toxicity of substances in humans (and animal studies are not required by the law of thoughts), they are, however, scientifically relied on for identifying carcinogens and other toxic agents. Professor Cranor states that animal studies can cause a problem for non-scientists who may be mislead by superficial physical differences between animals and humans (rodents are smaller, have fair whiskers, funny noses, tail, lesser brain and behave differently) and even by some biological differences (size, life span, metabolic rate, and some different organs), while overlooking important and deep biological similarities. In his review (see above), Dr. Cranor describes well-respected, nationally-recognized scientists who employed animal studies in identifying carcinogenicity. For example, he describes the late David Rall, former head of the National Institute of Environmental Health Sciences, when he noted that "experimental evidence to date suggests that there are more physiologic, biochemical, and metabolic similarities between laboratory animals and humans than there are differences. "Furthermore, respected organizations such as The National Institute of Environmental Health Sciences, the National Cancer Institute, the National Institute for Occupational Safety and Health, the University of North Carolina, the International Agency for Research on Cancer have concluded that EXPERIMENTAL RESULTS, IN PARTICULAR LONG-TERM CARCINOGENICITY TESTS, HAVE PROVEN TO BE VALID PREDICTORS OF HUMAN RISK. (For reference, Tomatis, I. et al., Avoided and avoidable risks of cancer. Carcinogenesis. 1997 Jan;18(1):97-105).

Therefore, animal studies belong to assessing generic as well as specific causation, and have been addressed so in the Federal Manual for Federal Judges (Reference Manual on Scientific Evidence, page 200). Unfortunately, not too many of the judges that I have seen, have followed this understanding [as far as the importance of animal studies].


Case studies are not mathematical certain guides to causal relationship, some are good studies, others are poor. Some studies merely report an association between exposure to a drug, poison, etc., and the onset of disease without analysis and explaining the methodologies they have used to describe the importance of the case study in the disease process [American Journal of Public Health, above].

The World Health Organization and the U.S. Institute of Medicine both use case studies as evidence in making causation inference (especially about reaction to drugs, poisons, but also about carcinogens). Indeed, they have explicit criteria by which to judge when case studies constitute evidence for human causation (International Agency for Research on Cancer:monograph 8, studies of cancer in humans). Professor Cranor in his manuscript, cited above, concludes that when judges decide whether studies can assist the jury in coming to its decision and thus be put in evidence, they too must consider whether the case studies provide good support of causality. So that, at least based on Professor Cranor's manuscript (which I agree with) if a judge is going to dismiss a case study, then the judge should be familiar with the standards of accepting or rejecting case studies from a point of view of science and medicine and not just because a case study is "only a case study," or because a case study does not agree with another expert's opinion.


In toxic tort cases, the issue of admissibility of experts' opinion is not whether the expert relies on literature which is well-accepted in the community or whether experts' opinion is in line with the opposing experts' opinion, but rather, as eloquently described in Kumho Tire Corporation vs. Carmichael, (526 US 127, 1999), is whether the scientific experts' reasoning about the phenomenon falls within range where respectable scientists could reasonably disagree.

So the defense counsel's motion to exclude, based on "accepted in the medical community," is irrelevant and essentially deviates from the Kumho Tire discussion and statement. What is general acceptance? General acceptance by whom? General acceptance by how many and from where? Is it general acceptance by a group of 100 physicians practicing a specific specialty? Who has done those studies to show general acceptance, or lack of such? So that the approach is that of Kumho Tire approach on whether the scientific experts' reasoning falls within the range where respectable scientists could reasonably disagree. (Substantial parts of the discussion here are adopted from the paper by Cranor, referenced above.)

In his excellent paper, Professor Cranor discusses the Supreme Court's decision in the Joiner case (General Electric Corporation vs. Joiner, 522US136, 1997). While the 11th Circuit has agreed with the plaintiff that all evidence has to be taken into account, the Supreme Court's decision in Joiner, that assessment of each piece of evidence should be done for how well it is supported and how well it supports the ultimate conclusion, "the Supreme Court seems to reject standard scientific inferences. "Indeed, Justice Stevens, in defense of that opinion, recognized the science of inferences to best explanation (he called them weight of the evidence arguments), and would have re-amended the case for hearing on whether all plaintiff evidence is in support of this explanation of Mr. Joiner's lung cancer satisfied the requirements of the admissibility in that case (General Electric Corporation vs. Joiner, 522US136, 1997). Professor Cranor further states, "The court's opinion in Joiner risks misleading lower courts, inviting similar mistakes and rejections of particular evidence of having a chilling effect on the courts to review scientific evidence in the same way that scientists do." Indeed, fortunately enough, several Supreme Courts of the state of the union have rejected the idea of Daubert and Joiner. Indeed, this statement is in my opinion mirrored in the North Carolina Supreme Court decision (Holverton v. Arai Helmet, No. 282PA03, 358 NC, 440, 597, S.E. 2d G74) in the case, the court opined:

The most recent supreme court of North Carolina case (Holverton v. Arai Helmet, No. 282PA03, 358 NC, 440, 597, S.E. 2d G74) demonstrates the trouble the North Carolina Supreme Court had with the concept of asking a judge to be a scientist. "Few judges possess the academic credentials or the necessary experience and training in scientific disciplines to separate contemporary high quality, intricate scientific research from research that is flawed. "In that same decision, the North Carolina Supreme Court said "Those who predicted that trial judges would flex their gatekeeper muscles to exclude vast quantities of plaintiff's proposed expert causation opinion testimony in product liability cases have turned out to be right.

In agreement with Professor Cranor, the stature of inference to the best explanation explains why, in a particular case before a court, there may be evidence that individually does not support the claim that exposure to a substance makes a causal contribution to disease, but when pieced together with other evidence in a scientifically plausible way does support the conclusion. How well the various pieces of evidence fit together is what matters in supporting a causal inference.


In his most recent essay, Cranor (reference cited above) describes the scientific reliance on case studies to assert causation, when there is temporal relationship and other cases are ruled out as opposed to some courts who reject up-front case studies.

The example that Professor Cranor gives is that of an anesthesiologist who was repeatedly exposed to halothane (anesthesia agent) and has developed hepatitis. On at least five other occasions over six years, each time he was exposed to halothane he developed hepatitis. He then recovered when no longer exposed. The anesthesiologist requested a re-challenge with halothane to determine that indeed halothane is the cause. A re-challenge caused an acute attack of hepatitis within 24 hours. As a result, the authors of the case study concluded, "It is highly probable halothane was responsible for the recurrence attacks of hepatitis in this case. "Based on the case study, the Institute of Medicine endorsed these findings based on the temporal relationship and ruling out other causes. Unfortunately, a Federal Court district judge in California refused to admit a plaintiff's expert in a case concerning halothane-induced hepatitis. The Honorable Judge excluded the expert because "such case reports are not reliable scientific evidence of causation. "According to the analysis by Cranor, the judge's ruling might have indicated that he was concerned only with the evidence before him, but his use of "such" conveyed wider condemnation, and his view has been widely repeated as a reason for rejecting all case studies as evidence. This type of ruling by judges who are not trained in medicine (6 years medical school, 1 year internship, 3 years residency) is in my opinion a message to juries: We may need you only for some issues, because "I the judge know better than the average jury. "It is also puzzling at best that this judge's decision is contrary to the Federal Manual on Scientific Evidence year 2000 (case reports do have value in the general analysis). Some judges continue to reject temporal proximity between exposure and disease as showing causation, despite cases such as that of the anesthesiologist (Klutskin, G. et al., Recurrent Hepatitis Attributable to Halothane Sensitization in an Anesthetist, New England Journal of Medicine, 1969, Volume 280:515-522). Cranor further analyzes that judge's decision, "A judge may not have understood the range of case studies, descriptive case studies (which may not be good evidence for toxicity) and more analytical case studies, to rule out other explanations. The latter use all other available evidence to assess whether a case study probably or certainly shows causation."


Indeed, the Circuit Court decision in the Westberry case and the Curtis case recognize the importance of temporal relationship and alternative causation [Westberry v Gislaved Gummiab, United States Court of Appeals for the 4th Circuit, No. 98-1540 (L), 05/99] and [Mike Curtis, et al. v. M&S Petroleum, Inc.; et al. United States Court of Appeals, Fifth Circuit. No. 97-60685. May 13, 1999. 174 F.3d 661. 1999 WL 249146].

Furthermore, both scientists and judges need to remember that the identification of vinyl chloride monomer as a cause for rate kidney cancer was based on three case studies initially, which were later followed by additional case studies from occupational physicians, which triggered animal experimentation. If one would have to adhere to the unreasonable standards, applied by some courts, then science, medicine would be stalled, and the reader may end up going to a doctor for a certain malady related to the usage of certain medication, and be dismissed because there are "no epidemiological studies of statistical significance". Let me tell you: in the practice of medicine we do rely on case reports!!


Lack of epidemiological studies should not be dismissive of causation. Cranor (American Journal of Public Health. 2005;95 Suppl 1:S121-8) states that if judges believed, for example, that epidemiological evidence were readily available, it is not surprising that they would reject plaintiff's experts who are not presenting it. Cranor further states, "Perhaps judges have been spoiled by robust evidence offered by the defendants in the Bendectin cases, anticipating comparable evidence in every case."

The problem with lack of studies is that most chemical substances (and there are hundreds and thousands) enter commerce, subject only to post-market regulatory laws. Little or no pre-market testing occurs ((American Journal of Public Health. 2005;95 Suppl 1:S121-8). If then the chemicals cause harm, victims may sue, but they face extremely difficult barriers to bring their case to trial about their injuries. Furthermore, substances screened under pre-market statutes are usually tested in a very limited fashion that is insufficient to identify risk with a large heterogenous population which would be exposed to those substances. (Indeed, we are now seeing under our eyes evolving the Vioxx saga (N Engl J Med. 2005 Jun 23;352(25):2576-8). Cranor further concludes, and I agree, as many others in the field that in those cases where industry has not produced the necessary studies to create the epidemiological statistical standards demanded by some courts, "Judges who impose scientifically mistaken or overly stringent admissibility barriers..."There is little reason for firms to investigate their own products as it becomes easier to avoid a tort law trial by challenging a panel of experts at an admissibility hearing. "Cranor's paper further concludes, "For judges not to intrude on litigant's seventh amendment rights to jury trial, which may happen when they mistakenly exclude before trial particular scientific testimony, they should recognize the fact of reasonable scientific disagreement that can easily exist between respectable experts. Courts, in addition to understanding the nature of scientific inferences and a variety of scientific evidentiary patterns, must also recognize that conscientious, respectable scientists exercising their scientific judgment, can legitimately come to conclusions that differs with one another without being charlatans..." [Emphasis added]


Because the defendant would certainly hire scientists for multiple disciplines with biases favoring their positions, cross-examination process and presentation of relevant contrary evidence or opinions by the defendants' expert to the jury is the fairer way of revealing testimony that is reliable and credible. The dismissal of expert testimony prior to the trial based on the possibility of mistaken perception of a trial judge is inconsistent with our national principal of equal and impartial justice for all citizens. Consider the situation in which a Daubert motion is made and by which a judge decides that the plaintiff's expert witness in a toxic tort case is relevant and reliable. Shouldn't the judge automatically then determine that the opinion of the defendants' expert witness (that would claim that the defendants' products or agents released into the environment are not harmful to human health) are also reliable and relevant? If the latter opinions are not found to be reliable, then presumably the judge will exclude their testimony as evidence to be presented before jury (taken from the recent paper by Ronald L. Melnick entitled "A Daubert Motion:Legal Strategy to Exclude Essential Scientific Evidence in Toxic Tort Litigation" (published in The American Journal of Public Health, 2005, Volume 95 supplement, pages 30-34). Dr. Melnick further states in his paper, "Why shouldn't a jury be allowed to hear all of the relevant scientific evidence and opinions regarding adverse health effects that may result when a company pollutes the environment or workplaces of U.S. citizens? Because the plaintiff carried the burden of proof in toxic tort litigation, dismissal of expert testimony affects plaintiffs more than it does defendants. Thus, the application of Daubert in jury trials tips the scales of justice strongly in favor of defendants, who may have adversely affected the health of others through negligence or irresponsible emission or manufacture of harmful agents." [Emphasis added]. I cannot agree more with Dr. Melnick, and I believe that his paper mirrors the decision of North Carolina Supreme Court in the case of citations, as well as the paper cited above, Michaels and Monforton, American Journal of Public Health, 2005.


I am not aware of any statistical studies which have been done on Federal Court judges in the country throughout the nation. Nevertheless, from what I have read so far, I have not seen that a substantial number of Honorable Judges in Federal Court have had as many years of experience in epidemiology, toxicology, public health and medicine as compared to the majority of the well-respected experts that I have seen in my career on both sides of the issue. So that with all due respect to Honorable Federal Judges, and in this case also State Court Judges, handing them the judgment of what they believe is good science and not good science is erroneous at best, and extremely unjust to us as American citizens as well as experts, whether you testify on the side of the plaintiff or defendant. These feelings and opinions of mine, I believe, are mirrored in the case of Bonner (Katie Bonner vs. ISP Technogies Inc., United States Court of Appeals, eighth circuit, 2001, 259, F.3d 924).


ONE SHOULD NOT FORGET THAT THE SUPREME COURT IN THE KUMHO TIRE CASE (526 US 127, 1999) HAS CLEARLY STATED THAT, "IN THE COURTROOM, THE SAME LEVEL OF INTELLECTUAL RIGOR THAT CHARACTERIZES THE PRACTICE OF AN EXPERT IN A RELEVANT FIELD) SHOULD BE EMPLOYED AND UTILIZED [Emphasis added]. "Coming back to the example at the beginning of this writing of mine, a medical doctor diagnosing a disease and providing treatment uses rigorous medical science, medical training, medical experience and medical judgment, and such should be the method used in the courtroom, at least based on Kumho Tire, and not unreasonable importance on 'doubling of the risk' or 'epidemiological studies'."


There is no question in my mind that in many cases, at least that I am aware of, exclusion of expert witnesses from testifying based on Daubert maneuvers has been done by judges who, from what I have investigated, do not have substantial experience in either practicing medicine, practicing medical toxicology, or practicing occupational medicine. Just because you do not have a scientific paper on a certain product which has never been studied or just because the expert cannot adhere to the "rigorous statistical requirement of Daubert", as we have seen above, is not a reason to exclude an expert witness, when this witness (medicine and medical toxicology) has used the methodology used by experts in the field:history (if available and practical), examination, review of records, review of Material Safety Data Sheets, review of environmental data, ruling out other causes, and heavily relying on the clinical history with temporal relationship (North Carolina case and Bonner case, as well as Westberry and Curtis cases). [Westberry v. Gislaved Gummiab, United States Court of Appeals for the 4th Circuit, No. 98-1540 (L), 05/99] and [Mike Curtis, et al. v. M&S Petroleum, Inc.; et al. United States Court of Appeals, Fifth Circuit. No. 97-60685. May 13, 1999. 174 F.3d 661. 1999 WL 249146 ].


The opponents and proponents of a scientific testimony for the jury ought to be careful. As stated by Professor Carl Johnson (University of Minnesota Law School, 1999, Roscoe Rogan environmental law essay contest), there is ample potential for abuse by both plaintiff and defendant. Plaintiffs may use junk science to promote a tentative claim while defendants may try to bury legitimate scientific evidence to protect industry from costs of using chemicals in the modern world.

Valid Scientific Theory

In order for a scientific theory to be used, it must survive and be proven. First, a theory is derived through induction from observations, or data from studies. The next step is a prediction derived from the theory by deduction. Then the scientists test this theory using some methodology. Finally, the data are tested against the prediction/theory so that the methodology used is the determining factor. In real life, patient experimentation is illegal (other than clinical studies with informed consent and Institutional Research Board). Therefore, for the medical expert, clinical observations, case reports, toxicology studies and epidemiology, if available, are among the methods used. Epidemiological evidence IS NOT required before a hypothesis is considered valid scientific evidence. [Brock v. Merrell Dow Pharmaceutical Inc., 874 F2d 307,313, 5th Circ. 1989]. Experimental toxicology in conjunction with epidemiology, although rare, is the best method for valid science. However, this combination is rarely perfect!Bradford Hill [ Proc R Soc Med 1965, 58:295-300].

What is a Cause?

The cause of a disease is considered to be an "event condition" characteristic or a combination of several factors. These factors lead to increased susceptibility to a disease that, when combined with exposure to a toxic agent, will produce the physiologic response that will cause the disease.

Relative Risk

(From Margaret Berger, upsetting the balance between adverse interests: The impact of the Supreme Court 64 Law & Contemp. Probs 289 Spring/Summer 2001)

Some courts in the country will deny an expert's testimony, despite the expert's qualifications, sound methodology, and epidemiological studies, because the epidemiological studies do not show doubling of the risk (OR>2). This approach by some courts fails to understand reaching the conclusion of attributable risk depends on a number of assumptions that do not necessarily hold true in all cases and that cannot be verified given our present state of knowledge. Underlying a requirement that relative risk must exceed 2.0 is an improbable assumption that background risk are independent of the risks posed by a substance in question and can therefore be calculated separately [Sander Greenland & James M. Robins, Epidemiology, Justice and the Probability of Causation, 40 Jurimetrics J. 321, 326-327, 2000]. Indeed many respectable, qualified and well-studied scientists reject such a model [Greenland & Robins, above]. Furthermore, the insistence on a relative risk of at least 2.0 is insensitive to the relationship between exposure and the incidence time of developing a particular disease. It is possible that the background cases [who will cause the OR to be less than 2] the disease years earlier also because of the same exposure." The doubling of the risk rule is a legal invention that creates a hard and fast rule that disposes of cases efficiently but rests on assumptions that cannot be valid at this time. "How can a court dismiss an epidemiological study, with an OR <>? This is a serious erosion of the standards of testability courts have set! "No assumptions". Furthermore, the refusal to allow experts to testify about epidemiological studies with an OR of 2 or less is questionable from an evidentiary point of view [Berger, above]. [Emphasis added]


Many courts make the epidemiological mistake regarding doubling of the risk despite the fact that there is valid scientific literature demonstrating the cause and effect. Example: Benzene can cause CML (chronic myelogenous leukemia). There is plenty of literature for that notion. But yet and despite the literature, some courts demand "doubling of the risk", which is incorrect. Daubert II required doubling of the risk when scientific literature was not available. The demanding of doubling of the risk in cases where literature does support a causation nexus, is contradictory to Daubert!


Some of the judges such as Honorable Judge Kozinski (9th Circuit), felt "that Daubert pushed judges too far in the realm of scientist regarding cutting edge technology. "And, with no knowledge, practice or specialized training, judges will have to decide who is a better expert and who can testify to me. This clearly seems outrageous! Why not have the judge undergo six months of training in medical school and become doctors of medicine? Where is this ending? Will it take a Daubert motion to throw out the testimony of a military general as "junk science"? Or will it take the death of a senator's son from benzene poisoning? What will it take to go back to democracy in court, where a plaintiff has his day in court. Do the corporations and their allies, and politicians really believe juries lack the same understanding that an untrained judge has? After all, the average judge has no more practice in science than the average juror.


A possible cause becomes probable when in the absence of other causes and reasonable explanations. Therefore, generic causation, temporal relationship, biological plausibility, and differential diagnosis become the probable cause.

In summary, we as professionals in medicine need to educate the judicial system. After all, taking a crash course of toxic tort litigation (4 weeks) does not make a judge an expert in medicine. I wonder how many Federal judges have practiced medicine. I would like to see these data (perhaps the National judicial center has these data?)

(A major portion of this paper has been adopted and is quoting the American Journal of Public Health, 2005.)

Dr. Brautbar is a board-certified internist and nephrologist, and certified in forensic medicine. If you are interested in retaining Dr. Brautbar for forensic and expert witness testimony services, please submit the Contact Form.

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