Causation Determination in Workers Compensation and Toxic Tort Cases.

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1 Causation Determination in Workers Compensation and Toxic Tort Cases. Jon T. O Neal, MD, MPH Physicians with minimal knowledge of and no training in medical causation determination are often hired to be expert witnesses. The more respected (and often more expensive) medical clinician, researcher, or teacher brought on to a case, the more surprising it will be during the hearing, arbitration, or trial, when it s revealed that the expert s faulty causation determination was based solely on personal experience and opinion. A recent trilogy of Supreme Court decisions on admissibility of expert testimony has helped clarify the legal aspects of medical causation determination. 1 This article will present a pragmatic overview of medical and legal causation, set a framework for understanding these recent Supreme Court decisions, and help guide selection of physicians that are most able to help lawyers, judges, and juries, make appropriate causation determinations. PART ONE Medical v. Legal Causation In the Workers Compensation arena establishing causation means identifying the most probable cause of a worker s condition or disability, and also demonstrating that it arose out of the work or workplace. 2 Most medical literature uses the term Causation Analysis, while legal literature often uses the term Causation Determination. Medicine analyzes while law must make a determination. A medical causation analysis may provide information critical to a legal causation determination. If this article were written for a medical journal, it would be called Causation Analysis in Occupational and Environmental Medicine. 3 This highlights the subtle, but important differences in medical and legal terminology in these often complicated cases. In the scientific arena, no causal hypothesis can be proven absolutely, no matter how much evidence exists in its favor. 4 A thorough discussion of this statement is beyond the scope of this article, however, it points out a critical problem in medicolegal practice, the law looks to science to prove something, and scientists respond by stating that nothing is, in fact, absolutely provable. Causation in Medicine requires an Analysis; Law requires a Determination. 1 Margaret A Berger, The Supreme Court s Trilogy on the Admissability of Expert Testimony. Reference Manual on Scientific Evidence, Second Edition. Federal Judicial Center, West Group Tee L. Guidotti and Susan G. Rose, Science on the Witness Stand. OEM press Occupational Medicine is the medical specialty dealing with prevention and treatment of illness and injury in workers, i.e., workers compensation cases. Environmental Medicine deals with prevention and treatment of illness and injury caused by exposures in the non-work environment, i.e., toxic tort cases. 4 Philip Cole, The Hypothesis Generating Machine, 4 Epidemiology (1993). 1

2 The Supreme Court, in Daubert v. Merrill Dow Pharmaceuticals, Inc. (1993, henceforth called Daubert), noted that: there are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly and that the Rules of Evidence were designed not for the exhaustive search for cosmic understanding but for the particularized resolution of legal disputes. How then do scientists prove a cause and effect relationship? Epidemiology is the Study of Disease within Human Populations. An epidemiological study that seeks to establish a relationship between agent A (cause) and disease D (effect) does not start by attempting to prove that exposure to agent A causes disease D. Instead, a different hypothesis is made stating that exposure to agent A does not cause disease D. This is called creating the null hypothesis. The Null Hypothesis states that there is NO True Association between an Agent and a Disease. Scientists assume that there is no true association between an agent and a disease. Then they merely disprove the null hypothesis. Disproving the null hypothesis increases the probability that there is, indeed, a true association. Note that a double negative does not absolutely prove a positive. Confusing? You bet. Let s restate this argument. In order to scientifically prove the theory that agent A causes disease D, you must assume that agent A does not cause disease D, then find evidence to disprove that agent A does not cause disease D. You assume a theory is false, then you disprove the false theory. Thus, scientific proof of a theory depends on the falsifiability of the null hyposthesis. To prove the above discussion is complicated, assume the above discussion is not complicated. Reread the above two paragraphs. This disproves (makes false) the statement that this discussion is not complicated. Even Chief Justice Rehnquist, in his dissent in Daubert, which dealt with the admissibility of scientific evidence, confirmed his confusion about this suspect scientific process when he stated: I defer to no one in my confidence in federal judges; but I am at a loss to know what is meant when it is said that the scientific status of a theory depends on its falsifiability, and I suspect some of them will be, too. Is intimate knowledge of this confusing discussion of falsifiability of scientific theory important to the lawyer who is trying to find a medical expert witness to make a medical 2

3 causation determination? No. What may be important is that the lawyer know enough about this to ask a prospective medical expert witness these questions: Can you produce published articles showing epidemiologic evidence that exposure A could cause disease D? What is the Null Hypothesis? Does the published article adequately disprove the Null Hypothesis? If your prospective expert witness, when asked the above questions, stares blankly back at you without comment, snows you with illogical answers, or states only I know definitely that your client has disease D, he or she may not be the ideal expert witness to help you with medical causation determination. In contrast, legal causation has two elements: Cause in fact and proximate cause. 5 Cause in fact is a necessary condition, and can be identified by a simple test: Would the adverse outcome have been avoided but for the presence of the cause? Proximate cause is the particular event or factor that initiated the chain of events leading to injury or damage. Physicians, like a lay jury, may not understand the meaning of these legal terms. If your prospective expert medical witness, when asked about cause in fact and proximate cause, smiles and answers I know all about them, he or she may be a professional expert witness trying to sound folksy. Association v. Causation Association is the statistical relationship between two or more variables or events. 6 Events are associated when they occur more or less frequently than would be expected by chance. When an agent has no apparent effect on the presence or absence of a disease, the agent and disease are considered to be not associated. When a disease occurs less frequently than would be expected by chance, implying a preventive role for the agent (as would occur with vaccination), the agent and disease as considered to have a negative association. Association is NOT Equivalent to Causation. Many things are associated with each other, but do not have a causal relationship. Smoking is associated with lower socio-economic status, however, smoking does not cause lower socio-economic status. The presence of an association in no way implies that an observed relationship is one of cause and effect. 7 One of the primary objectives in epidemiology (remember, the study of disease in human populations) is to evaluate whether an association between exposure and disease is causal. A Goal of Epidemiology is to Prove or Disprove 5 Science on the Witness Stand. 6 Reference Guide on Epidemiology. Reference Manual on Scientific Evidence, second edition. Federal Judicial Center, West Group Charles H. Hennekens, Julie E. Buring. Epidemiology in Medicine. Little, Brown,

4 Causal Association between an Agent and Disease. Three questions come up when an epidemiologic study is used in legal disputes: 1. Do the results of the study show an association between an agent and disease? 2. What sources of error in the study could have caused inaccurate findings? 3. If an agent is associated with disease, is the relationship causal? It doesn t matter if an epidemiologic study presented in a legal dispute shows a positive, negative, or no association, the opposing side will try to show there were errors in the study which resulted in inaccurate findings, and that the study does not prove your point. Error in Epidemiological Studies The results of an epidemiologic study may reflect a true causal association between exposure to an agent and development of a disease, however, it is possible that the findings were erroneous. Problems with studies may be due to errors in design, measurement, or interpretation. The main causes of study design error in epidemiologic studies are: Chance Bias Confounding Error due to Chance Findings in a study may be due simply to chance (called random variation). Since most studies sample a portion of a population, random variation from sample to sample may cause error. The larger the sample size, the larger the probability the sample represents the whole population. The smaller the sample size, however, the larger the probability that the sample does not represent the whole population, and thus the greater the probability that findings are due to chance. In medicine, a Case Report presents the clinical findings in one patient, usually with some type of disease. An epidemiologic study, however, may present the findings of hundreds or thousands of people with the same disease. A single case report that suggests a causal association between an agent and a disease has a much great probability of the association being due to chance than in a large epidemiologic study. Case reports are very important in medicine, especially when evaluating a new disease, however, because of the small sample size, there is a large probability that a possible association between agent and disease is due to chance. Early AIDS case reports suggested an association with AIDS, homosexual men, and the use of poppers (amyl nitrate, a recreational drug). Early epidemiologic studies quickly revealed that use of poppers was not causally associated with AIDS. Later epidemiologic studies revealed that homosexuality is not causally associated with AIDS, but that unsafe sexual practices, whether homosexual or heterosexual, and IV drug use with unclean needles was. 4

5 If a medical expert witness provides only a case or a few case reports that suggest a casual association between exposure and disease, or states his or her causation determination is based only on personal experience and opinion, there is a high probability that the findings are due to chance and may be erroneous. In Daubert, the Supreme Court found that a key question to be answered in determining if a scientific theory will assist the trier of fact will be whether it can be (and has been) tested. Case reports and physician s opinions based only on personal experience can not be tested. Additionally, Daubert noted the courts should consider the known or potential rate of error. How do you measure chance (a potential error in interpretation of findings) in a study? The role of chance in a study is assessed by measuring statistical significance. Statistical significance is usually measured with a P value, which is defined as the probability that an observed effect in a study occurred by chance alone, given that there is no true relationship between an agent and disease. P Value = Probability that a study showed an agent caused a disease, when no true causal association exists. Scientists rather arbitrarily set a chance of 1 in 20 (5 percent, or 0.05) as the acceptable level of error in most studies. 8 A P Value less than or equal to 0.05 is considered statistically significant, that is, there is no more than a 1 in 20 probability that an observed association between an agent and disease is due to chance. A P Value of greater than 0.05 means that chance cannot be excluded as a likely explanation for the observed association, and is not considered statistically significant. P Value < or = 0.05, Statistically Significant (Results due to Chance < 5% of time) P Value > 0.05, Not Statistically Significant (Results due to Chance > 5% of time) If an acceptable level of chance in studies is set at 1 in 20, when you assess 100 different studies, 5 of them may have significant findings due to chance alone. A prospective medical expert who presents one study showing association between an agent and a disease with statistical significance with a P Value of 0.05 may be presenting the 1 in 20 or so studies where the association is merely due to chance. A confidence interval can also be used to assess statistical significance. A confidence interval is a range of values calculated from the study results, within which the true value 8 The acceptance of chance in causal association varies with risk. Many people would buy a $100 lottery ticket with a 1 in 10 chance of winning $1,000. Few people would get on an airplane that had a 1 in 1,000 chance of crashing. P Values can be set at different levels, such as 0.01 (1 in 10), or 0.01 or (1 in 100), depending on the level of chance that would be acceptable in the study. But epidemiologic studies normally set statistical significance at a P Value less than or equal to 0.05 (one in 20.) 5

6 is likely to fall, while the width of the interval indicates random error. It is usually expressed as a percentage and an interval. A confidence interval gives more information than just a P Value, and is usually expressed as a percentage (traditionally 95%) and an interval. A 95% confidence interval means that if a study was repeated 100 times, the true value would be in the interval 95/100 times. If this is confusing, don t worry, here s what s important to know: Error Due to Bias A Confidence Interval that includes a Relative Risk of 1.0 (explained later) is Not Statistically Significant, Results of the study May be due to Chance. Bias is systematic error in the design or conduct of a study. Selection bias occurs when participants are selected for a study with bias (for example: someone at high risk of developing a disease is selected over someone with low risk of developing a disease.) Observation bias occurs when participants in a study are observed with bias, and occurs when observers interpret information on participants differently (interviewer bias) or subjects report events differently than they happened (recall bias.) Inaccuracies in the collection of data are inevitable, and it is difficult or impossible to quantitatively measure bias in an epidemiologic study. The inability to measure bias (producing study error) is another reason that a scientific hypothesis can not be absolutely proven. Error Due to Confounding Confounding occurs in a study when an observed association (or lack of association) is due to the mixing of effects between an agent, the disease, and a third factor that is associated with the agent and independently affects the risk of developing the disease. The important point is that confounding can lead to overestimation or underestimation of the true association between an agent and disease. Early studies showed an association between drinking coffee and mouth and throat cancer. It was theorized that hot fluid somehow caused cellular damage resulting in development of cancer. More thorough investigation showed that many coffee drinkers also smoked cigarettes, and that most of the cancer found is these studies was attributable to smoking. The coffee drinking studies were in error because of confounding due to smoking. Is intimate knowledge of the above causes of errors in epidemiologic studies important to lawyers selecting expert medical witnesses? No. What may be important is that they ask a prospective expert witness if the published and peer-reviewed articles he or she has prove that exposure A causes disease D. If the answer is no, the prospective expert witness does not have a strong case. If the answer is yes then ask these questions about the articles: How does chance, bias and confounding affect the study results? 6

7 Is the P Value in the study less than 0.05, or does the 95% Confidence Interval in the study include a Relative Risk of 1.0? If a prospective expert witness, when asked the above questions, stares blankly back, he or she may not be the ideal expert witness to help with medical causation determination. Burden of Proof v. Relative Risk In most workers comp and toxic tort cases, the plaintiff bears the burden of proving both causation-in-fact and proximate cause. Actually, the plaintiff must show that a casual relationship more likely than not exits between an exposure and a disease. In civil cases, the plaintiff s burden of proof usually requires a preponderance of evidence, which can also be defined as greater than 50% chance that the exposure resulted in the disease. How do studies determine how strongly an agent is associated with a disease? Strength of association is measured by different terms for different types of studies. Relative Risk, Odds Ratio 9, and Attributable Risk 10 are all measurements of strength of association in studies. Relative Risk (RR), grossly simplified, can be looked at as the number of cases of disease in an exposed group divided by the numbers of cases of disease in an unexposed group. 11 Relative Risk = # with disease with exposure # with disease without exposure If the Relative Risk is 1.0 (the # with disease with exposure is the same as the # with disease without exposure) there is no association between exposure and disease. 12 For studies of smoking and lung cancer, the Relative Risk is about 10, which means about 10 times more people develop lung cancer who smoke, compared to those who develop lung cancer and don t smoke. A Relative Risk of 2.0 means twice as many cases of disease occurred in those exposed compared to those unexposed, which implies (from the legal perspective) a 50% likelihood that disease was caused by exposure. A relative risk greater than 2.0 would 9 Odds Ratio is used in a case-control study, and is a type of relative risk. 10 Attributable Risk is the amount of disease in exposed individuals that can be attributed to the exposure. 11 Relative Risk is actually the rate in the exposed divided by the rate in the unexposed. Incidence rate is defined as the number of new cases of disease that develop during a specific period of time divided by the number of persons in the study. 12 Relating back to statistical significance, if a Relative Risk of 1.0 is included in a Confidence Interval in a study, it s possible that there is no association between exposure and disease exits, and that an observed association may be due to chance, and is not considered statistically significant. 7

8 imply that a plaintiff s disease was more likely than not (greater than 50% chance) caused by the exposure, and this has been interpreted as meeting the legal burden of proof. 13, 14 Must you, the lawyer, understand the intricacies of Strength of Association measurements in epidemiologic studies? No. What may be important is that you ask a prospective expert witness: Does the study you re presenting, and which I m basing my case on, show a Relative Risk greater than 2.0, which would meet the burden of proof in many civil courts? PART TWO Admissibility of Expert Testimony Three recent Supreme Court decisions dealt with the admissibility of expert testimony. 15 The Daubert Decision In 1993, the Supreme Court decided Daubert v. Merrell Dow Pharmaceuticals, Inc, a toxic tort case where the petitioners, representing minor children born with serious birth defects, alleged that the defects had been caused by the mother s ingestion of Bendectin, an antinausea drug. The petitioners presented eight experts who concluded that Bendectin can cause birth defects. Their conclusions were based on in vitro (test tube) and in vivo (live) animal studies, pharmacological studies showing structural similarities between Bendectin and other substances known to cause birth defects, and reanalysis of previously published epidemiological (human statistical) studies. The respondant s medical expert, however, had reviewed more than 30 published studies involving over 130,000 patients, and noted that not one published study in human beings had found Bendectin to cause birth defects. The District Court granted the respondant s motion for summary judgement, noting that given the vast amount of epidemiological data concerning Bendectin, expert opinion which is not based on epidemiological (human) evidence is not admissible to establish causation. In vitro cell studies, animal studies, and chemical structure analysis alone can not establish causation in humans. The petitioner s reanalysis of previously published studies (that found no causal like between Bendectin and birth defects) were ruled in 13 The use of scientifically reliable epidemiological studies and the requirements of more than a doubling of the risk strikes a balance between the needs of our legal system and the limits of science. Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 718 (Tex ) 14 Relative risk greater than 2.0 support[s] an inference that the exposure was the probable cause of the disease in a specific member of the exposed population. Landrigan v. Celotex Corp., 605 A.2d 1079, 1087 (N.J ) 15 Margaret A. Berger, The Supreme Court s Trilogy on the Admissibility of Expert Testimony. Reference on Scientific Evidence, Second Edition. Federal Judicial Center, West Group

9 admissible because they had not been published or subjected to peer review. The Court of Appeals also rejected the petitioner s reanalyses as they were unpublished, not subjected to the normal peer review process and generated solely for use in litigation. The Supreme Court noted that a key question to be answered is whether a scientific theory can and has been tested. Scientific methodology today is based on generating hypotheses and testing them to see if they can be falsified; indeed, this methodology is what distinguishes science from other fields of human inquiry 16 Simply put, the status of a scientific theory is based on its testability (as determined by its falsifiability, which, of course, is not so simply put.) The Supreme Court also noted that another pertinent consideration is whether the theory has been subjected to peer review and has been published. They commented, however, that peer review and publication does not necessarily correlate with reliability, and that some new and innovative theories will not have been published. Additionally, consideration should be given to the known or potential error rates and standards controlling the scientific technique s operation. In summary, the Daubert decision notes that the court should consider admissibility of a scientific theory based, non-exclusively, on these four factors: Testibility Peer review and publication Potential rate of error Standards for controlling operation Prior to Daubert, many courts used the general acceptance test, which was based on the so-called Frye test. The Frye test originated in a 1923 decision dealing with the admissibility of evidence based upon a systolic blood pressure deception test, a crude liedetector test. Because the deception test had not gained standing and recognition (general acceptance) by scientific authorities, evidence from the test s results was ruled inadmissible. For many years, the Fry general acceptance test was the exclusive test for admitting expert scientific testimony. However, the Frye test was considered to be superseded by the Federal Rules of Evidence, which was enacted by Congress in In Daubert, the Supreme Court agreed that Frye had been superceded by adoption of the Federal Rules of Evidence (general acceptance was not the exclusive admissibility test), however, they also noted that general acceptance of a scientific theory can yet have a bearing on an inquiry. Another of the important themes in Daubert is that the trial court is the gatekeeper and should act to screen proffered expertise, ensuring that what is admitted is not only relevant, but reliable. The majority opinion in Daubert noted that the court has not only the power, but the obligation to be a gatekeeper. Thus courts should look seriously at the above-mentioned four factors when considering the admissibility of scientific evidence. If these non-exclusive criteria are not adequately met, the court, acting as a gatekeeper 16 Green 645 9

10 can refuse to admit the evidence. The Daubert majority opinion closing summary noted that general acceptaince is not a necessary precondition to the admissibility of scientific evidence, that the trial judge is assigned the task of ensuring that an expert s testimony both rests on a reliable foundation and is relevant to the task at hand, and that pertinent evidence based on scientifically valid principles will satisfy those demands. The judgment of the Court of Appeals was vacated, and the case was remanded for further proceedings consistent with the opinion. The Joiner Decision In 1997, the Supreme Court decided General Electric Co. v. Joiner, a toxic tort case where the petitioner was a long-time smoker with a family history of lung cancer and claimed his exposures to polychlorinated biphenyls (PCBs) had promoted his development of lung cancer. Even though there were four epidemiological studies presented, the trial court found these studies insufficient, and applied the Daubert criteria, excluded the plaintiff s expert s opinions, and granted the defendant s motion for summary judgment. The court of appeals reversed the decision because the Federal Rules of Evidence governing expert testimony display a preference for admissibility. The Supreme Court examined the record, determined that the plaintiff s experts had been properly excluded because the studies relied upon were not sufficient to support the conclusion that Joiner s PCB exposure contributed to his cancer, then reversed the decision without remanding the case. The Court concluded that the plaintiff s expert s causation opinions were merely speculation, and that it was never explained how the experts extrapolated their opinions from animal studies to the plaintiff s (human) exposure. The Joiner decision noted that a court may conclude that there is simply too great an analytical gap between the data and the opinion proferred. The Joiner decision reinforced Daubert by again noting that the trial court should act as the gatekeeper in determining admissibility of scientific evidence. The Kumho Decision In 1999, the Supreme Court decided Kumho Tire v. Carmichael, a non-toxic tort case, in which plaintiffs brought suit after a tire blew out on a minivan, resulting in the death of one person and serious injuries to others. The plaintiff s expert witness, an expert in tirefailure analysis, concluded by visual analysis that the blowout was caused by defective tire manufacture or design. There was no evidence presented that other experts, papers, or articles supported the tire-failure expert s theory. The district court concluded that the Daubert gatekeeping obligation applied to both scientific knowledge and technical analysis. The district court held that the tire-failure expert s methodology did not meet the Daubert criteria, excluded the expert s testimony, and granted the defendant s motion for summary judgment. The court of appeals reversed the decision stating that Daubert applies only to scientific testimony. The Supreme Court held that the trial court s gatekeeping obligation applies 10

11 not only to testimony based on scientific knowledge, but extends also to testimony based on technical and other specialized knowledge. Simply put, the Court stated that a court s gatekeeping obligation extends to all expert testimony. The Court concluded that the trial court had not abused its discretion when excluding the tire-failure expert s testimony, and reversed the opinion of the appeals court, thus allowing the exclusion of the expert witness. Justice Breyer s Kumho opinion states that we can neither rule out, nor rule in, for all cases and for all time the applicability of the factors mentioned in Daubert, nor can we now do so for subsets of cases categorized by category of expert or by kind of evidence. Too much depend upon the particular circumstances of the particular case at issue. In Kumho, the Court found that the Daubert factors may bear on a judge s gatekeeping determinations, and that these factors may or may not be pertinent, depending on the nature of the issue, the expert s particular expertise, and the subject of his testimony. The Kumho decision extended the trial judge s gatekeeping obligation related to expert testimony as first discussed in Daubert, to include all expert testimony, and endorsed a flexible, non-doctrinaire approach that requires district courts to focus upon the particular circumstances of a case. Kumho did not say the Daubert factors are irrelevant, but that they may or may not be pertinent. Daubert, Joiner, and Kumho, have helped clarify the admissibility of expert testimony, however, battles over admissibility will continue, particularly related to toxic tort cases. PART THREE Finding an Expert Witness who can make an Appropriate Medical Causation Determination Most physicians have no training in and little understanding of medical causation determination. Medical school teaches physicians mainly to diagnose and treat. Causation may be discussed in terms of infectious disease; ie, this bacteria causes this disease. Med students may learn about Koch s postulates, criteria developed in the midnineteenth century to help determine the cause of an infectious disease. In order to prove an organism causes disease using Koch s postulates, these criteria must be met: The organism must be found in all cases of the disease. 2. The organism must be isolated from patients with the disease and grown in culture. 3. The cultured organism must produce the disease when inoculated into a susceptible host. 17 Science on the Witness Stand. 11

12 Alas, though Koch s postulates work well for microbiological organisms that cause a single disease, they are useless in most workers compensation or toxic tort cases, where the agent of concern may be a chemical or other non-organism exposure (like heat, radiation, noise, or cumulative trauma.) Let s restate this: The infectious disease model of causation taught in medical school is useless in most workers compensation or toxic tort cases. 18 Most residency trained and specialty board certified physicians have no training in and little understanding of medical causation determination. 19 In general, practicing surgeons, be they orthopedic surgeons, neurosurgeons, or ophthalmologists, are not terribly concerned with causation. They diagnose, then treat a problem (often with surgery.) The diagnosis of a type of tumor, and the removal of that tumor is not dependent on the surgeon making an appropriate medical causation determination. With the exception of infectious disease, most practicing physicians (internists, emergency room, family practice, obstetrician/gynecologist, etc) are not terribly concerned with causation. Determining the cause of an acute myocardial infarction (MI, or heart attack) is not a high priority for ER docs, they re busy trying to diagnose and treat the problem. Determining that a patient s morbid obesity is more likely than not to be the cause of an MI is not that important while acutely treating the MI. 20 With infectious diseases, determining the agent of causation is important in order to identify the bacteria or virus, so the patient can be treated with the appropriate antibiotic or antiviral. You treat with antibiotics in order to prevent further infection. This brings up a major point, in medicine: Determining Causation is Important in order to Prevent Illness or Injury In order to prevent an illness or injury, you must know what caused the illness or injury. Prevention is thus directly linked to causation. Most practicing physicians do not have the training, knowledge, or time to discuss prevention with their patients, they are, again, busy diagnosing and treating. However, there is a medical specialty that deals with preventing illness and injuries, it s called Preventive Medicine. 18 Infectious disease is important in some workers compensation or toxic tort cases, examples being workrelated HIV or hepatitis infection, Legionnaire s disease, or tuberculosis. However, doctors do not now normally inject these organisms into susceptible humans to prove causation. Because HIV infection has not met all of Koch s criteria (it s unethical to inject HIV into a susceptible individual) there are still some people who do not believe that HIV causes AIDS. 19 The exception being physicians residency trained in Preventive Medicine. 20 Multiple factors, such as obesity, hypertension, elevated cholesterol, diabetes, family history, smoking, lack of exercise, etc., increase risk for having an MI. ER docs, while evaluating a patient with an acute MI, have more important things to do than determine causation, they are diagnosing and treating the problem and trying to save a life. 12

13 Preventive Medicine seeks to Prevent Illness and Injuries in Humans The American Board of Preventive Medicine recognizes three specialties: General Preventive Medicine, Aerospace Medicine, and Occupational and Environmental Medicine. General Preventive Medicine deals mainly with public health, preventing and treating sexually transmitted diseases, tuberculosis, lung cancer from smoking, etc., in the general population. Aerospace Medicine deals with preventing and treating problems caused by the effects of flying and high altitude on pilots and aircrew. Occupational and Environmental Medicine deals with preventing and treating illness and injury caused by the workplace or exposures in the general environment. Since all workers compensation cases deal with the workplace, and most toxic tort cases deal with exposures related to the workplace or general environment, Occupational and Environmental Medicine physicians are the specialists most appropriate for overall evaluation of these cases. Unfortunately, there are relatively few trained and board certified Occupational and Environmental medicine physicians in the United States. 21 There are so few Occupational and Environmental Medicine physicians practicing in this country that most judges, arbitrators, jurors, lawyers, lay people, in fact, probably most nurses and physicians do not know this medical specialty exists. 22 So Whom to Use as an Expert Witness? Consider contacting a respected 23 physician in the medical specialty that deals with the diagnosis and treatment of the disease or injury of concern. If the case is about a 21 There are currently less than 25 Occupational and Environmental Medicine (OEM) residencies in the United States, and most of these have only between 1 and 4 residents per year, resulting in only about 60 new OEM physicians graduating per year. There are many more physicians who are board certified in OEM, who have not had formal residency training, but who became board certified based on experience and testing. However, the vast majority of work-related injuries are treated by primary care physicians (family practice or ER) that have no formal training or certification in OEM. These often very skilled providers of work-related injury care may have little knowledge of or no training in preventive medicine or causation determination. 22 Employers and workers will certainly know there are doctors treating workers compensation cases (often called the company doctor, since in many states, the company can direct care to specific providers) but will not know that there is residency training in this area. 23 Respect may be based on training, experience, position, such as chairman of a department or head of a residency, or on publication of papers on the specific topic, etc. In almost all cases, you ll want someone who is residency trained and board certified in their specialty. It doesn t look good when an opposing attorney grills your expert witness and finds out they are not residency trained nor board certified. This is another reason why Occupational and Environmental Medicine physicians aren t used as expert witnesses often, as the majority of physicians practicing this specialty are not residency trained nor board certified, and would no be considered qualified by a judge to be an expert. 13

14 miscarriage thought due to a chemical exposure, contact an obstetrician/gynecologist. If it s about asthma contact a pulmonologist or allergist. If it s about possible carpal tunnel contact a hand surgeon. 24 If it s about leukemia contact an oncologist, etc. This respected medical specialist should confirm the correct diagnosis and treatment in the patient. If the diagnosis or treatment is found to be in error, there may be grounds for a malpractice case. If the diagnosis is confirmed and the treatment is found to be appropriate, you must request a medical causation determination. Hire a Physician Specialist to evaluate Diagnosis and Treatment The million dollar question is, Was the disease or injury caused by exposure in the workplace or environment? 25 Often the whole case rests upon answering this question. But be warned, you ve hired someone who has nothing to lose if they incorrectly attribute a specific disease to specific agent or exposure. A physician will not lose his or her medical license for making an erroneous causation determination. Causation determination is not diagnosing or treating. Causation determination is not considered practicing medicine, therefore there can be no medical malpractice. There is No Malpractice for Faulty Causation Determination So the high priced respected medical specialist you ve hired has little personally to lose if they falsely state exposure to an agent caused a disease or injury. The will not lose their medical license, their malpractice insurance will not go up, they will not get reprimanded by the state medical society. In workers compensation cases, stating the illness or injury was caused by exposure at work may result in quicker and higher medical reimbursement. Alas, since no causal hypothesis can be proven absolutely, it s impossible to absolutely prove exposure to an agent is safe, or absolutely prove exposure to an agent is dangerous, and really no way to prove that an expert s causation determination is faulty. You may have spent many months, and tens of thousands of dollars preparing a workers compensation or toxic tort case, hired the most respected medical specialist in the area who has stated exposure to agent A caused disease D, and your expert witness testimony may be ruled inadmissible. How do you avoid this? Back to part one, ask your respected medical specialist to answer the question: 1. Can you produce published articles showing epidemiologic evidence that exposure A could cause disease D? 24 Many primary care providers misdiagnose carpal tunnel syndrome, considering any wrist area tendonitis as carpal tunnel syndrome. 25 Actually, it s often the multi-million dollar question. Toxic tort cases are often settled for tens of millions of dollars. 14

15 If your respected medical specialist can not provide a single published epidemiologic article 26 showing evidence that exposure A could cause disease D, chances are this specialist s testimony would not be considered admissible. If an appropriate published article is presented showing evidence that exposure A could cause disease D, then ask the specialist the remaining 6 questions from part 1 about the article, beginning with What is the Null Hypothesis? Asking these questions fulfills much of the criteria for admissibility set forth in Daubert, including testability, peer review and publication, potential rate of error, and general acceptance. Besides contacting a prospective medical expert witness in the specialty related to the illness (ie, oncology, obstetrics, surgery), I d encourage you to consider another option. Consider hiring an experienced Occupational and Environmental Medicine physician 27 to review the appropriate textbooks and articles and make a causation determination as to whether or not a specific illness is possibly caused by a specific agent. Hire an Occupational and Environmental Medicine Physician to make a Causation Determination Experienced Occupational and Environmental Medicine physicians may not be experts in diagnosing and treating a specific illness, however, they are experts in causation determination (remember it s a preventive specialty, you can t prevent something unless you understand what causes it.) Your physician specialist will be an expert in diagnosis and treatment, but may not be an expert in caution determination (excluding infectious disease, you can expertly diagnose and treat something without knowing what caused it.) 28 I was motivated to write this article because I have consulted on numerous cases where, unfortunately, lawyers had hired expert witnesses who had made faulty causation determinations. These poor 29 lawyers were totally flustered when my evaluation and report showed that, contrary to their other specialty expert s opinion, there were 26 A single case report published in a medical journal does not establish causation, it may not even establish association, a case report is merely the presentation of a case. However, if the case report presents a new disease, or a possible new cause of a disease, care reports may be very valuable. Because a new hypothesis, which may be presented for the first time in a case report, may not be peer reviewed or testable, the Supreme Court, in Daubert, recognizes that, in practice, a gatekeeping role for the judge, no matter how flexible, inevitably on occasion will prevent the jury from learning of authentic insights and innovations. The Court thus acknowledges that recently discovered diseases or new causation theories may in fact be real, but will not meet the admissibility criteria set forth in Daubert. 27 Being somewhat biased, I d recommend contacting a physician that is residency trained and board certified in OEM, however, someone that s not residency trained but board certified, or simply experienced in OEM may suffice. In a legal situation, it would be almost unthinkable to contact a surgeon or obstetrician who was not both residency trained and board certified in their specialty to give medical advice. 28 Actually, we don t know the cause of most tumors and cancers. 29 Poor meaning both unfortunate and not wealthy. They d spent thousands of dollars to get medical expert opinions that were, quite frankly, wrong. 15

16 absolutely no testable, peer reviewed and published studies that proved or disproved, or general acceptance that agent A caused disease D in their client. Based on my experience, I d recommend any lawyer to consult with an experienced Occupational and Environmental Medicine physician before taking on a complicated workers compensation or toxic tort case. If there s no evidence to support causation, it doesn t really matter what high-priced medical specialist you hire to confirm diagnosis or treatment, their opinion on causation may be faulty, resulting in a judge, acting as a gatekeeper, ruling your expert testimony inadmissible. It may take an experienced Occupational and Environmental Medicine physician only a couple hours to review a case, review the published literature, and make an initial causation determination. Some physicians take between one to four hours to initially review a case and literature then make a verbal report. A verbal report is then made so that the initial opinion is not discoverable in court. Often these initial opinions do not support the stance the lawyer who hired the expert witness desires, and by giving a verbal report, this contradictory information is not available to be included in the record. If the initial verbal report supports the stance the lawyer desires, then a formal written report may be requested, which may take a few or many hours depending on the complexity of the case. 30 Non-Physician Expert Witnesses There are three other groups of non-physicians that are frequently used as expert witnesses in workers compensation and toxic tort cases and may be involved in causation determination; toxicologists, epidemiologists, and industrial hygienists. 31 Toxicology is the study of poisons (toxins) and their effects on organisms. Toxicologists usually do studies (experiments) at the cellular level, or with animals. Rarely do toxicological studies directly involve humans, since it s relatively unethical to willingly expose humans to a known or suspected poison. 32 Results of toxicological studies done at the cellular level or in animals, must then be extrapolated to humans. Studies done involving animals often use high-dose exposure to toxins, which maybe irrelevant and unreliable when extrapolated down to low-dose exposures in humans. The District Court, in Daubert, stated that expert opinion which is not based on epidemiological evidence is not admissible to establish causation. Thus, the animal-cell studies, live-animal studies, and chemical-structure analyses on which petitioners had relied could not raise by themselves a reasonably disputable jury issue regarding causation. Toxicologic studies, by themselves and without epidemiologic support, do not establish caution. 30 This written report may cost a few hundred or a few thousand dollars, but whether it supports or does not support the case, it may save hundreds of thousands of dollars in further legal costs, or result in millions of dollars in judgments. 31 Toxicologists and epidemiologists are often also physicians. However, they are frequently non-physician PhDs. Industrial hygienists are rarely also physicians. 32 Toxicological studies directly involving humans mainly involve medicinal drugs. 16

17 If no studies in human beings support the findings, testimony of a toxicologist may be consider not admissible. Epidemiologists study the relationship between agents and disease in humans, and are frequently used as expert witnesses, however, you can count on the opposing side trying to discount specific studies due to error caused by chance, bias, or confounding. The big problem with using epidemiologists as expert witness is that epidemiologic studies look at disease in human populations. Any result from a population must be extrapolated down to an individual. Epidemiologic studies certainly confirm that the relative risk of getting lung cancer is 10 times higher for smokers compaired to non-smokers, but these studies can not predict if you ll get lung cancer, or if you have lung cancer, absolutely confirm that you got lung cancer from smoking. Even if an epidemiologic study showed a relative risk of 2.0 of getting some disease after some exposure, maybe 45% of people with the disease did not have exposure. Imagine making a faulty causation determination 45% of the time, it could happen that often when results of a group study are extrapolated down to an individual. Epidemiologist who present studies that are not testable, peer-reviewed and published, or that do not have general acceptance, may be considered not admissible. Industrial Hygienists measure the presence and level of substances, such as chemicals, radiation, noise, mold, dust, or fumes, etc. You may hire the top medical specialist in the country that confirms the diagnosis and treatment of disease D your client. You may hire the top Occupational and Environmental medicine physician in the country that confirms that agent A can cause Disease D in your client. But if you can not prove that agent A was present, and your client was, indeed, exposed to agent A, there is no case. Disease D can not be caused by Agent A if Agent A was not present. A discussion of error in industrial hygiene sampling and reporting is beyond the scope of this article, however, if a certified industrial hygienist (CIH) was used there s a good chance there is no significant error in sampling. There are four question to be answered when evaluating an occupational or environmental exposure: 1. Is the agent present? 2. Is there a route of exposure for the agent (air, dust, water, food)? 3. Did the agent get into or on the body? 4. If in the body, did the agent cause effects? Industrial hygienists can answer questions 1 and 2. Physicians can answer questions 3 and 4. If question 1 or 2 are negative, questions 3 and 4 are not relevant. If there is no agent present, or no route of exposure for an agent to get into the body, the agent can not have caused a disease. If an industrial hygienist finds that there is no agent present, or there is no route of exposure for the agent, medical expert testimony is irrelevant. If there is no agent present, or no route of exposure, 17

18 there is no causation. For example, asbestos is present in many buildings in the United States. Samples from insulation or walls confirms the presence of asbestos. If the insulation or walls are in good shape (the asbestos is encapsulated) there may be no asbestos present in air sampling or dust sampling. If air and dust sampling is negative, there is no route of exposure for asbestos to get into or on a human body, and there is no risk of asbestosrelated disease from working in or living in the area. However, if the insulation or walls are damaged (friable), asbestos may be present in the air or dust, which could be inhaled or swallowed resulting in asbestos-related disease (mesothelioma or asbestosis.) In this case the agent is present, and there are routes of transmission (air and dust.) Unfortunately, many workers compensation or toxic tort cases move forward without documenting the presence of the agent of concern and the route of exposure. Closing An Industrial Hygienist should Investigate the Presence of an Agent and the Route of Exposure. Causation determination is critical in both workers compensation and toxic tort cases. Causation is not the same as association. Medical and legal definitions of causation are different, which has created problems with medical expert testimony in the courts. Three recent Supreme Court decisions addressing the admissibility of expert witnesses and studies dealing with medical causation determination, have shed some light on the subject, but left some questions unresolved. The testimony of toxicologist s may be not admissible if the experiments are not supported by human studies. The testimony of epidemiologists or physician experts that is based on studies that are not testable, peer reviewed and published, or of general acceptance in the medical community, may be not admissible. Industrial hygienist should be used to confirm the presence of an agent and the route of transmission. If neither of these are confirmed, there is no causation. Physician specialists are usually used as expert witnesses to determine diagnosis and treatment, however, they may not be the best expert for causation determination, which may be best analyzed by an Occupational and Environmental Physician trained in Preventive Medicine. 18

19 Special thanks to James Brown, Esq. Jon T. O Neal, MD, MPH, received his MD from the University of Kansas School of Medicine, and completed a residency in Occupational and Environmental Medicine and a Masters of Public Health at Harvard. He is board certified in Occupational and Environmental medicine, and is a Fellow in the American College of Occupational and Environmental Medicine. 19

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