No. 95-20492

__________________

BOB T. MOORE and SUSAN MOORE,

vs.

ASHLAND CHEMICAL, INC. and ASHLAND OIL, INC.,

BRIEF OF AMICI CURIAE

Martin S. Kaufman*

Douglas Foster

Edwin L. Lewis, III

ATLANTIC LEGAL FOUNDATION
205 East 42nd Street - 9th Floor
New York, New York 10017
Telephone: (212) 573-1960

Attorneys for Amici Curiae

TABLE OF CONTENTS

Table of Authorities ii

Interest of Amici 1

Statement of the Case 5

Summary of Argument 7

ARGUMENT 8

I. The discipline of clinical medicine is founded on medical science and the scientific principles are the same as in other areas of science 8

II. The majority decision of the three-judge panel was incorrect in limiting the application of the Daubert principles to "Newtonian"science 9

III. Medical science follows the same principles as other sciences 14

IV. The role of epidemiology and toxicology 16

Conclusion 20

TABLE OF AUTHORITIES

page       

FEDERAL CASES

Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed. 2d 469 (1993), on remand 43 F.3d 1311 (9th Cir. 1995), cert. denied ___ U.S. ___,  116 S.Ct. 132 L.Ed.2d 126 (1995)...........passim

General Electric Co.v.Joiner, 1997 WL 764563 (U. S. Supreme Court, December 15, 1997).......... passim

MISCELLANEOUS

Federal Judicial Center, Reference Manual on Scientific Evidence (1994)............. 9, 17, 18

A.B. Hill, "The Environment and Diseases: Association and Causation," 58 Proc. Royal Soc. Med., Sec. Occup. Med. 295 (1965)............... 17, n.7

K. Popper, Conjectures and Refutations: The Growth of Scientific Knowledge (5th ed. 1989)........... 15, n.5

INTEREST OF AMICI

Amici are scientists who have studied the issue of the role that scientific issues play in public affairs and in particular the way in which they can illuminate disputes between different persons or elements of society in the courts of law. Several of the amici submitted a brief in the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) (hereafter "Daubert"), the seminal case discussing the rule for admissibility of expert scientific evidence. Amici support the principles enunciated by the Supreme Court in that case, and believe that those principles should have wide applicability at the interface between science and law and policy.

Amici further believe that the decision of the District Judge Milloy to exclude testimony of Dr. Jenkins in the above case was well within the scope of the guidelines enunciated by the United States Supreme Court in Daubert and further endorsed and explained by the Supreme Court in General Electric Co. v. Joiner, 1997 WL 764563 (United States Supreme Court, December 15, 1997) (hereafter "Joiner").

Robert K. Adair is Sterling Professor of Physics at Yale University and formerly the chairman of the Department of Physics at Yale University. He was previously Associate Director for High Energy and Nuclear Physics of the Brookhaven National Laboratory.

Marcia Angell, M.D. is Executive Editor of the New England Journal of Medicine and Lecturer in Social Medicine at the Harvard Medical School. She is the author of books on pathology and the interplay of science and law, among other subjects.

Patricia A. Buffler is Professor of Epidemiology at the University of California at Berkeley and Dean of the School of Public Heath.

Allan Cormack is a Nobel laureate in Medicine and Physiology and University Professor Emeritus at Tufts University. He is also a recipient of the National Medal of Science.

Leonard D. Hamilton, M.D. is Professor of Medicine at the State University of New York at Stony Brook and Adjunct Professor of Biometry and Epidemiology at the Medical University of South Carolina at Charleston. He received his doctorate in medicine from Oxford University and a Ph.D. in Experimental Pathology from Cambridge University.

Gerald Holton is Mallinkrodt Professor of Physics and Professor of the History of Science at Harvard University. His fields of interest include the theory of science, and he is the author of, among others, books on Science and the Modern Mind (1958); The 20th Century Sciences: Studies in Intellectual Biography (1971); Thematic Origins of Scientific Thought: Kepler to Einstein (2d. Ed. 1988).

Arthur M. Langer is the Director of the Environmental Sciences Laboratory of the Institute of Applied Sciences and Professor of Geology at Brooklyn College of the City University of New York. He was Associate Professor in the Center for Polypeptide and Membrane Research and Associate Professor of Mineralogy at the Mt. Sinai School of Medicine in New York. He has been an editor and member of the editorial board of several scientific journals including Environmental Research, the Journal of Environmental Pathology and Toxicology and the Journal of Environmental Pathology, Toxicology and Oncology.

Joshua Lederberg is a Nobel laureate in Physiology and Medicine for his work in genetics. He is currently president emeritus and university professor and Sackler Foundation Scholar at The Rockefeller University. In addition to the Nobel Prize, he has been awarded the National Medal of Science. In addition to his earned doctorate from Yale University, he has received honorary degrees from numerous prominent universities in the United States and abroad.

Frederick Seitz is President Emeritus, and formerly President, of The Rockefeller University, a leading medical research institution. In addition to an earned Ph.D. in physics, he has been awarded 30 honorary degrees from such institutions as Princeton University, Northwestern, University of Michigan, Brown, N.Y.U. and University of Pennsylvania. He has received numerous awards for his work as a scientist and educator including the National Medal of Science, the Franklin Medal, the Department of Defense Distinguished Service Award and the

American College of Physicians Edward R. Loveland Memorial Award. He served two terms as president of the National Academy of Sciences and has been Chairman of the Board of the Sloan-Kettering Institute for Cancer Research.

Dimitrios Trichopoulos, M.D. is Chairman of the Department and Professor of Epidemiology at the Harvard School of Public Health. He is a member of 12 American, European or international scientific societies. He was chairman of the European Economic Community Health Group and the European Economic Community AIDS Group. His research work has contributed to the discovery of the role of passive smoking in the cause of lung cancer and chronic obstructive lung disease, the etiology of hepatocellular carcinoma, the quantification of the

association between psychological stress and heart disease and the identification of dietary and other risk factors in the etiology of cancer and other diseases.

James D. Watson is a Nobel laureate in Medicine (1962)(with F. H. C. Crick and M. H. F. Wilkins), and co-discoverer of the structure of DNA. Dr. Watson has also been awarded the John Collins Warren Prize of the Massachussets General Hospital, the Albert Lasker Prize of the Public Health Association, the John J. Carty Gold Medal of the National Academy of Sciences, and the Presidential Medal of Freedom. He earned his Ph.D. in Zoology, and has been awarded numerous honorary degrees. He is director and president of the Cold Spring Harbor Laboratory of the National Institutes of Health.

James D. Wilson is Senior Fellow at Resources for the Future. He holds a Ph.D. in organic chemistry. He has been a member of numerous scholarly organizations and panels, including the National Academy of Sciences Committee on Risk Characterization, the United States Environmental Protection Agency Peer Review Panel on "Carcinogen Risk Assessment Guidelines Revision," the United Nations FAO/WHO Joint Expert Committee on Food Additives. He is a Fellow of the Society for Risk Analysis.

Richard Wilson is Mallinckrodt Professor of Physics and former Chairman of the Department of Physics at Harvard University. He is a member of numerous committees and is consultant to numerous government and academic institutions including the Physics Advisory Board of the National Science Foundation, a member of the Breeder Reactor Safety Committee of the Energy Research and Development Administration, a consultant to the Los Alamos, Oakridge and Lawrence Livermore laboratories, chairman of the Visiting Committee on Radiation Medicine, Massachusetts General Hospital and Director of the Sakharov Foundation. He is a fellow or member of the American Physical Society and the American Academy of Arts and Sciences.

STATEMENT OF THE CASE

Plaintiffs-Appellants in this case are a man and his wife who claim that Mr. Moore suffers from reactive airways dysfunction syndrome, resulting from inhalation of chemicals he was delivering for his employer, Ashland Chemical, Inc. To establish a causal link between the diagnosis and the exposure to Ashland’s chemicals, plaintiffs proffered the testimony of two clinical doctors, Dr. Antonio Alvarez and Dr. Daniel Jenkins. The district court admitted all of Dr. Alvarez’ testimony, but excluded Dr. Jenkins’ proffered testimony about causation under Fed.R.Evid. 702 and 403. The jury rendered a verdict for defendants. Plaintiffs appealed, and a divided panel of this Court reversed and remanded, holding that the district court erred in applying the Daubert criteria to the proffered testimony as to causation of Dr. Jenkins. According to the Dennis opinion, Daubert standards apply only to "hard Newtonian" [sic] science, but not to clinical medicine. Moore v. Ashland Chemical, Inc., 1997 WL 644054 at *10-*11 (5th Cir., Oct. 20, 1997).

SUMMARY OF ARGUMENT

The three-judge panel’s majority fails to apply Daubert, which has been elaborated upon in Joiner v. General Electric Co., 1997 WL 764563 (United States Supreme Court, Dec. 15, 1997) (hereafter "Joiner"). The opinion of Judge Dennis is based on a fundamental mischaracterization of Daubert and a flawed perception of medicine.

Daubert itself, and Joiner which followed, apply the "Daubert factors" to medical science and specifically the issue of causation of disease. The Supreme Court has not suggested that those principles or the scientific method itself are limited to "hard Newtonian" science.

Issues of causation of disease are resolved in medicine using the methodology outlined in Daubert: formulating an hypothesis, testing the hypothesis, subjecting the hypothesis to review and testing by others through publication and peer review, and, if appropriate, refinement of the hypothesis.

I. The discipline of clinical medicine is founded on medical science and the scientific principles are the same as in other areas of science

The decision of the Court in this case, written by Circuit Judge Dennis joined by District Judge Fallon, but dissented from by Judge Davis, is based on the propositions that clinical medicine is not a "hard science," that its methodology is not that of "hard science," and that consequently the evidentiary standards enunciated by the Supreme Court in Daubert v Merrell Dow Pharmaceuticals are not applicable. 126 F.3d 682.

Until the revolutionary scientific discoveries of the 19th and 20th centuries, medical practice was generally restricted to folk medicine and proscriptive religious and cultural tenets and limited by uneven knowledge and religious beliefs. As modern, empirical science took into its province the human body and its ills, "medicine" came to refer to the aggregate of scientific fields related to prevention and treatment of disease, as well as maintenance of health.

II. The majority decision of the three-judge panel was incorrect in limiting the application of the Daubert principles to "Newtonian" science

The clinical practice of medicine involves the application of scientific knowledge and is subject to the same evidentiary standards as any other testimony relating to science or the application of scientific principles or data. This conclusion was clearly the basis of two Supreme Court opinions: In Daubert the Court emphasized that a trial judge "must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable" (at 589), going on to state that "reliability" in this context means not only consistency of results but also what scientists term "validity" or correspondence to reality (at 590, note 9).

Judge Dennis restricts the scientific method to "hard" or "Newtonian" (sic) scientific knowledge. There is nothing in the Supreme Court's statements in Daubert, Joiner, or in any of the major discussions of the philosophy of science to justify this false view of medical science.

In attempting to make a distinction between "hard" science and clinical medicine Judge Dennis failed to observe the similarity with respect to the type of expert evidence offered, but rejected, in the two cases decided by the US Supreme Court -- Daubert and Joiner. Both Daubert and Joiner were cases involving medical science and the causation of the plaintiff’s condition; in both cases the issue on appeal was the correctness of rejection by the district court of proffered testimony as to causation. In Daubert the issue was whether the deformities of plaintiffs’ child were caused by the alleged mutagenic effects on fetuses of the drug Bendectin taken by their mothers during pregnancy. In Joiner the issue was whether the plaintiff's exposure to fumes from polychlorinated biphenyls (PCBs) caused or contributed to his small cell lung carcinoma. The similarity of the evidentiary issues in the case at bar to the issues in Daubert and Joiner is, in fact, quite remarkable.

1. Has the theory been tested or can it be tested? In other words, is it falsifiable?

2. Has the theory been peer reviewed and published?

3. What is the known or potential risk of error?

4. Has the theory been generally accepted in the relevant scientific community?

5. Is the theory based on facts or data of a type reasonably relied upon by experts in the field.

6. Does the testimony have probative value that is greater than, or not outweighed by, a danger of unfair prejudice, confusion of issues, or misleading the jury.

Daubert, 509 U.S. at 593-594.

In Joiner, recently decided by the Supreme Court, the issue was whether the claimed exposure to PCBs was a cause of the admitted disease. Joiner also was a case which, like this case, is about causation. In Joiner proffered expert testimony by two physicians was excluded by the trial court and the Supreme Court, reversing the Court of Appeals for the Eleventh Circuit, agreed that it was correctly excluded because it was not "reliable." In both of those cases, the experts for the plaintiffs had not shown that their research or their review of the literature was applicable to the issue of causation in humans of the disease contracted by the plaintiff.

conclusions and methodology are not entirely distinct from one another. Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. . . . That is what the District Court did here, and we hold that it did not abuse its discretion in so doing."

___ U.S. ___ , 1997 WL 764563 at *6.

We respectfully submit that Judge Dennis erred in making the distinction between medical science and "hard" science. Indeed if any distinction is to be made it must be that the Daubert rules do apply to medical science, but that their application to a "hard science" such as chemistry has not been definitively addressed.

Judge Dennis’ statement that clinical medicine has different goals, subject matter, conditions of study and well developed methodology from what they call hard sciences is erroneous. In attempting (erroneously) to justify this statement, they quote Professor Alvan R. Feinstein that "in contrast the care and treatment of the patient is the ultimate, specific act that distinguishes the clinical physician." While amici do not disagree with this, they do disagree with the implication that this means abandonment of the scientific method. In particular, this excerpt does not stand for the proposition that there is a difference in appropriate scientific method when there is a discussion of attribution of a disease to a cause and where the care and treatment of the individual patient is not the goal. Amici refrain from commenting in more detail on this reference, which seems to them taken out of its context by Judge Dennis, because they understand that Professor Feinstein is presenting his own views to the court in a separate amicus curiae brief.

We do say, affirmatively, that the issue of medical causation follows the general principles of scientific investigation, and the Daubert criteris should apply.

III. Medical science follows the same principles as other sciences

The necessary attribute of any scientific theory, including a medical theory of causation, is "falsifiability," that is whether it can be tested. This was emphasized by Sir Karl Popper, a philosopher of science quoted by the Supreme Court in Daubert (509 U.S. at 593). If a scientist, whether physical scientist or physician, has a theory, it is useful only if it is falsifiable or testable; an important mechanism for permitting others to try to "falsify" one scientist’s hypotheses is by publication and peer review. Even if one were to accept the idea (which the amici do not) that entirely different scientific principles apply to diagnosis and treatment of disease than to other sciences, this would not apply to the study of causation.

Amici submit that there is no basis for different treatment of medical evidence and "hard" science evidence.

IV. The role of epidemiology and toxicology

One of the erroneous ideas that is implied in Judge Dennis’ opinion is that all physicians are expert in assigning causation and also that assigning causation is the prerogative of the medical profession (i.e., persons who hold the "Doctor of Medicine" or "M.D." degree or its equivalent). There are of course many ways of subdividing the large field that is modern medicine. Here we subdivide it into three roughly separable parts: Diagnosis, Treatment, and Assignment of Causation. An expert in one may not be an expert in another. The usual role in which the lay public (including by this term scientists in other disciplines and lawyers) see a medical practitioner is in the first two of these: diagnosis in an individual patient of a disease and treatment thereof. In the case under discussion, the issue is not whether a witness is an expert in diagnosis and treatment. The issue is whether he is expert in, and proffers reliable testimony in, the field of assignment of causation. Individuals with degrees in biology, chemistry, epidemiology, pharmacology, physiology, toxicology and many other disciplines in addition to medicine can and do conduct relevant research and form viable hypotheses about the causation of disease in this context.

One of the main ways of determining causation is to study a group of people with the same disease, and endeavor to discover a common link between them that might explain the disease. This is the field called epidemiology. But it is not enough that there be a statistical association between the hypothesized cause and the disease. There are well defined scientific principles that are used to evaluate whether a statistical "association" that is found should be considered to be "causal." In epidemiological terminology, if the relative risk, or "Risk Ratio," was very large, there is a greater likelihood that a particular exposure causes a particular disease. See Reference Manual at 147-148.

It would be inappropriate for a court to allow the introduction of "scientific" evidence on medical causation without evidence also being proffered on the principles themselves, the logic behind them, and the degree to which the proffered testimony satisfies the criteria of epidemiology with regard to causation.

Even if it is accepted that a particular agent or mixture of agents can cause a particular disease, it does not follow that the inverse is true: that the particular disease is always caused by that particular agent. In deciding upon causation, therefore, it is necessary to consider the relative roles of all possible causes of the disease in question, even if some of those causes are unknown. This procedure can be bypassed logically only if there is evidence that the only possible cause of the disease is the one being considered, and no cases of the disease have ever appeared in the absence of this specific cause. That is manifestly not the case with reactive airway disease syndrome, which Dr. Jenkins admitted could be caused by bronchitis or smoking, both of which the plaintiff experienced prior to his exposure to the accused chemical.

In the absence of such evidence of specificity, it is well accepted that some estimate of the relative probabilities must be made. The probability of Causation can be related to the risk of an individual getting the disease from a given dose by the formula:

Probability of Causation = (Risk calculated from exposure to the particular agent)

(Risk calculated from all causes)

When the risk calculated from the exposure to a particular agent is greater than the risk from exposure to all causes, which happens when the risk ratio is greater than two. For example, the probability that a particular lung cancer was caused by cigarette smoking can be has high as 90% for heavy smokers, with a risk ratio of 10 or 20. As amici understand the record in this case, no such evidence was proffered by Dr. Jenkins and therefore the trial judge did not abuse his discretion in excluding his testimony as to causation.

CONCLUSION

For the foregoing reasons, amici respectfully submit that this Court should reverse the decision of the three-judge panel.

Dated: January 13, 1997

Respectfully submitted,

_________________________________

MARTIN S. KAUFMAN,
Counsel of Record

ATLANTIC LEGAL FOUNDATION
205 East 42nd Street - 9th Floor
New York, New York 10017
(212) 573-1960

Attorneys for Amici Curiae

Robert K. Adair, Marcia Angell, Allan Cormack, Leonard D. Hamilton, Gerald Holton, Arthur Langer, Joshua Lederberg, Frederick Seitz, Dimitrios Trichopoulos, James D. Watson, James D. Wilson and Richard Wilson