Amicus Curiae Brief — General Electric Co. v. Joiner

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1996

GENERAL ELECTRIC COMPANY,

WESTINGHOUSE ELECTRIC CORPORATION,

AND MONSANTO COMPANY, Petitioners,

Vv.

ROBERT K. JOINER AND KAREN P. JOINER,

Respondents.

BRIEF OF PETER ORRIS, M_D., MPH.

DAVID OZONOFF, M_D., MPH,

JANET S. WEISS, M.D., and

OCAW (OIL, CHEMICAL & ATOMIC

WORKERS INTL. UNION, AFL-CIO)

AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

GERSON H. SMOGER

Counsel of Record

Smoger & Associates, P.C.

The Smoger Law Firm Building

13250 Branch View Lane

Dallas, Texas 75234

(972) 243-5297

Counsel for Amici Curiae

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| BEST AVAILABLE COPY 1

No. 96-188

In the

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1996

' GENERAL ELECTRIC COMPANY,

WESTINGHOUSE ELECTRIC CORPORATION,

AND MONSANTO COMPANY, Petitioners,

Vv.

ROBERT K. JOINER AND KAREN P. JOINER,

Respondents.

BRIEF OF PETER ORRIS, M.D., MPH,

DAVID OZONOFF, M.D., MPH,

JANET S. WEISS, M_D., and

OCAW (OIL, CHEMICAL & ATOMIC

WORKERS INTL. UNION, AFL-CIO)

AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

GERSON H. SMOGER

Counsel of Record

Smoger & Associates, P.C.

The Smoger Law Firm Building

13250 Branch View Lane

Dai 1s, Texas 75234

(972) 243-5297

Counsel for Amici Curiae

i

TABLE OF CONTENTS

Page

STATEMENT OF INTEREST OF AMICICURIAE . |

SUMMARY OF ARGUMENT .................... 2

ARGUMENT

aia «ues bk degdowes cede 3

A. Basic facts relating to PCBs and the City of

ee cic acc 3

B. This Court's holding in Daubert and the standards

for the testimony of experts ............ 5

C. The qualifications of plaintiffs’ experts ........ 7

D. The methodology of differential diagnosis 10

cee k cece bueccc sc ce: 12

F. Occupational exposure of Mr. Joiner ........ 15

G. Biological plausibility and coherence ........ 17

H. The use of observational human studies

EEE eee cance ceeeseces: 19

I. The use of animal studies ................. 24

J. The proper legal test of scientific conclusions is

IN «cos cccccdebacectands 26

K. An expert's opinions should rely on the totality of

the evidence reasonably considered ..... 29

eee ec cenbh pean oesns eas 30

ii

TABLE OF AUTHORITIES

Page

Cases:

Ambrosini v. Labarraque, 101 F.3d 129, 134 (D.C. Cir.

1996), cert. dismissed, 117 S. Ct. 1572 (1997) ........ 27

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986)

edencocdeescdensnseckanensstsenanaasey ete 28

Barefoot v. Estelle, 463 U.S. 880, 902 (1983) ......... 28

Daubert v. Merrell Dow Pharmaceuticals, Inc., 113 §. Ct.

ic cv cceeséuanetet 1,4,5,6,7, 14,20,22,27,29,30

Dickerson, Inc., v. U.S., 875 F.2d 1577, 1583 (11th Cir.

OOEEA. . «:<.cnneanancuneucdsaanieaeieecte. 4

Environmental Defense Fund, Inc. v. Environmental

Protection Agency, 636 F.2d 1267, 1270-71

Fk RRR AES cee ine NSN Se 4

Hall v. Baxter Healthcare Corp. 947 F. Supp. 1387, 1450

PTR ODDIE 25 GH Re 6

In Re Paoli R.R. Yard PCB Litig. 35 F. 3d 717, 780 (3d Cir.

1994), cert. denied, 115 S. Ct. 1253 (1995)5, 10, 12

In the matter of Quanta Resources Corp., 739 F.2d 912, 913

NT Ferrer T rr To eee 4

Kentucky v. Stinger, 482 U.S. 730, 736 (1987) ........ 28

Midlantic Nat'l Bank v. N.J. Dept. of Envtl.Prot., 474 U.S.

-v ' les co: ae 4

iii

Parrott v. Chatham County Hosp. Auth., 145 Ga. App. 2d

269, 270 (1978)

Cir. 1986)

pee bathe ods 66 6c mrtens ch be penta dedenacach cetus 4

Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741, 743

(11th Cir.), cert. denied, 479 U.S. 950 (1986) ......... 15

Yaffe Iron & Metal Co., Inc. v. U § E.P_A., 774 F.2d 1008,

EE Dn wth due wh ous eves cecaces 4

Constitution, statutes, regulations and rules:

A ER ee a ae 25

Draft Toxicological Profile for Polycholorinated Biphenyls.

EE, Sis one 6 hic nica ebneeuietacn ius 25

ie ie it dnd n no ks anh sg en. dener 7

BD WA, BOUO SOOO ooo ccc ccc ccctcccccces 3

15 U.S.C. Section 260S(e(2M(A) ...... 22. ee 5

40 CFR. Section 761.20 (1996) .................... 3

_ EES 25

a gt all pet igre pge aye 5

ee i cnn ania dds wae i 60 ais 7

a cats uclsbetnatentunn 4

15 U.S.C. Section 2605(e(2(A) .................... 4

iv

Draft Toxicological Profile for Polycholorinated Biphenyls.

GBR, DODGE X25 5 CTE, 6 TE 25

EPA Final Guidelines for Carcinogen Risk Assessment, 51

Fed. Reg. 33992, 33995-96 (1986) ................. 19

Integrated Risk Information System (IRIS) ........... 25

40 C.F.R. Section 761.20 (1996) Pidade apamecencesins 3

ie niciin cnadteinicenel 24

ERPS ne tek choy a oF BL - 5

Integrated Risk Information System (IRIS) ........... 25

World Health Organization's International Agency for

Research on Cancer (IARC) .................-00.. 17

Miscellaneous:

" Vater, et. al., A Case Study of Cancer Data Set

Combinations for PCBs, in Regulatory Toxicology and

FE Beane 04.0 66% denen scpeceves 25

Bertazzi, et. al., Cancer Mortality of Capacitor

Manufacturing Workers, in 1] Am.J.Indus.Med. 165 (1987)

‘whe Ome sdnand sb b6 6s che 6664 nea ées 21

Association or Causation?” in Proceedings of the Royal

Society of Medicine, 58:295-300 (1965) ........... 18,30

E. K. Silbergeld, The Role of Toxicology in Causation: A

Scientific Perspective, in 1 Courts, Health Science & the Law

SE MEE... oc cccocesduatbeednatteence ss. 24

Harrison's Principles of Internal Medicine (8th edition,

v

Sate cecnietignsl titiins Dntesralics . sxxn cad 10

Modern Epidemiology (Little-Brown, 1986) .......... 21

Reference Manual on Scientific Evidence at 214 (West 1994)

KECMM Ey MANE RE Co RMN OME EMEs ¢ FUSES Ads orlecais 10

Ronneberg, et al., Mortality and Incidence of Cancer Among

Oil Exposed Workers in a Norwegian Cable Manufacturing

Company, Part 2 Mortality and Cancer Incidence in 1953-84,

in 45 British J. Indus. Med. 595, 601 (1988) ........ 21,22

STATEMENT OF INTEREST OF AMICI CURIAE

Amici are physicians specializing in the field of

preventive and occupational medicine (hereinafter, “occupational

medicine"), as well as an international union composed of

members who benefit from treatment by and consultation with

themselves to the understanding of the health problems

affecting workers in modern society. Neither the physicians

herein nor the Oil, Chemical and Atomic Workers International

Union have any interest in the outcome of this lawsuit.’

However, it is our understanding that the distinction between a

trial court's review of the methodology of expert witnesses

rather than an evaluation of the expert's conclusions is

fundamental to this Court's decision in Daubert v. Merrell Dow

Pharmaceuticals, Inc., 113 S. Ct. 2787 (1993), If that is so,

then amici appear on their own behalf to alert this Court to the

grave misunderstanding of the district court below relating to

the methodology routinely employed by practitioners in the field

of occupational medicine. If the flaws in the district court's

methodological analysis are perpetuated, then amici fear that the

rights of injured workers to gain proper redress will be unduly

sacrificed. We believe that we are uniquely qualified to advise

this Court on the proper methodology to be followed by

occupational medicine professionals, because that is the field of

our professional training. Lastly, before we endeavor to request

that this court affirm the decision of the court of appeals or

suggest where the district court erred in its understanding of the

methodology utilized by occupational medicine professionals,

we must confess that we are unqualified to offer this Court

guidance concerning the intricacies of the legal issues presented

' More complete descriptions of amici are set forth in the appendix

bound with this brief. Counsel for all parties have consented to the filing of

this brief. Letters of consent are being filed with the Clerk. No counsel for

any party authored any part of this brief, and no person other than amici

curiae, its members as applicable, or their counsel made any monetary

contribution to the preparation or submission of this brief.

by the petition for certiorari filed in this case.

SUMMARY OF ARGUMENT

In undertaking its duties pursuant to Daubert the district

court misconstrued its role by attempting to evaluate the

conclusions of Plaintiffs’ experts rather than the methodology

that they used. Not only did the district court fail to confine its

role to evaluating the methodology used by Plaintiff's experts,

but it also failed to understand the diagnostic methodology

employed by occupational medicine professionals.

Occupational medicine is a distinct medical discipline

which routinely requires practicing professionais to make

judgments relating to conditions caused by chemical,

used in making these judgments is differential diagnosis, which

in the occupational medicine setting includes a clinical

assessment, a toxicological assessment, an evaluation of all

contributing factors, and then an assessment of the biological

plausibility of any proposed explanation. In this effort to

understand whether any hypothesized causative factor is

may seek guidance from colleagues, in vitro studies, biophysical

data, general scientific knowledge and experience, case reports,

and case conferences, as well as research toxicology and

epidemiology. None of these factors are exclusive and all are

appropriately weighed within the overall matrix of understanding

the proposed relationship.

The appropriate question for the district court below to

have asked was: “Have Plaintiffs’ experts used the proper

methodology of their discipline to assess whether it is

biologically plausible that Mr. Joiner’s exposure to a

carcinogenic mixture of dielectr.c fluids during the course of his

occupation contributed in some way to his early manifestation

of lung cancer at 37, even though the lung cancer was likely

initiated by tobacco products?" Based upon the record before

the district court, the answer would have had to have been in the

affirmative. Whether it is “probable” is for the trier of fact to

ARGUMENT

A. Basic facts relating to PCBs and the City of Thomasville

Pertinent to our understanding is a brief background of

the facts as we understand them to be presented before the

courts below. As stated by the district court, (36a), Appellant

Monsanto manufactured polychlorinated biphenyls (PCBs) from

approximately 1935 to 1977. Indeed, after 1945 Monsanto was

the only manufacturer of PCBs in the United States. Appellants

General Electric Company ("GE") and Westinghouse Electric

Corporation ("Westinghouse") manufactured both electrical

transformers and fire-resistant fluid. From the 1930s to the

1970s, both GE and Westinghouse marketed fire-resistant

dielectrical fluid containing PCBs. GE's product carried the

trade name “Pyranol," while Westinghouse's carried the trade

name “Inerteen."

Throughout the time of Plaintiff Robert Joiner's

employment all of the transformers which the City of

Thomasville purchased from Defendants GE and Westinghouse

used mineral oil-based dielectric fluid which was intended to be

free of PCBs. However, beginning in 1983, the City of

fluid in some of its transformers was contaminated with PCBs.

From 1983 to 1993, the City tested approximately 2,668 of its

transformers and determined that approximately half of the

transformers tested showed PCB contamination.? Of these,

about 2.5% contained very toxic levels of PCBs, i.e. above 500

parts per million ("ppm"), and about 16.7% contained hazardous

levels above 50 ppm.’ The district court then concluded that

? According to the record below, there was also sufficient evidence

for a jury to decide that dielectrical fluid in the transformers contained

PCDFs and PCDDs. On the basis of the fact that issues related to these

chemicals will likely be remanded to the trial court, their toxicology and

carcinogenicity will not be discussed here.

> The Administrator of the Environmental Protection Agency has

determined that any substance containing concentrations of PCBs of 50

parts per million (ppm) or greater represents an unreasonable risk of

injury to health within the United States. 40 C.F.R. Section 761.20

(1996).

"almost one out of every five (i.e., 19.2%) of the transformers

the City tested presented a PCB hazard." (36a-37a)

exceptions, Congress banned the production and sale of PCBs

on January 1, 1978. 15 U.S.C. Section 2605(eX2)(A). Congress

took this action because in its view PCBs ‘present an

unreasonable risk of injury to health of the environment.’ See 15

U.S.C. Section 2605(a)." This Court itself has noted that oil

containing PCBs is a potent carcinogen. Midlantic Nat'l Bank

v. N.J. Dept. of Envtl.Prot., 474 U.S. 494, 497, (1986).*

Indeed, despite numerous decisions by Federal courts

throughout the United States that PCBs are toxic and

Plaintiffs “failed to show by a preponderance of proof that their

admissible under the standards set out in Rule 702 and

explicated in Daubert at 68A.” In coming to this drastic

decision that Mr. Joiner should not be allowed to have a jury of

his peers decide whether his toxic exposure contributed to his

lung cancer, the district court, as will be shown, both utterly

misconstrued the requirements of Daubert as well as the

* This Court's view of the highly toxic nature of PCBs is in accord

with that determined by other circuit and Federal courts. Jn Re Paoli RR.

Yard PCB Litig. 35 F. 34717, 780 (3d Cir. 1994), cert. denied, 115 S. Ct

1253 (1995) (noting “EPA thinks that PCBs have the same carcinogenic

potency as vinyl chloride, which is one of only | 4 chemicals that EPA has

indicated have been proven to be carcinogenic by epidemiological studies”),

Dickerson, Inc., v. U.S., $75 F.2d 1577, 1583 (1 1th Cir. 1989)

(recognizing the well-documented human health and environmental hazard

of PCB exposure), Potomac Elec. Power Co. v. Sachs, 802 F.2d 1527,

1529 (4th Cir. 1986) (holding that PCBS are highly toxic materials), Yaffe

lron & Metal Co., Inc. v. U S EP A., 774 F.2d 1008, 1010 n.1 (10th Cir.

1985) (holding that PCBs are extremely toxic to humans and wildlife, and

pose carcinogenic and other nsks to humans), /n the matter of Quanta

Resources Corp., 739 F.2d 912, 913 n.1 (3d Cir. 1984) (finding that PCBs

are extremely hazardous chemicals and are themselves toxic),

Environmental Defense Fund, Inc. v. Environmental Protection Agency,

636 F.2d 1267, 1270-71 (D.C. Cir. 1980) (holding that PCBs are extremely

toxic to humans and wildlife).

methodology commonly utilized by occupational medicine

professionals in making such assessments.

B. This Court's holding in Daubert and the standards for

the testimony of experts

In June 1992, this Court in Daubert rejected the Frye

"general acceptance” test for scientific evidence, (id. at 2792-

94), and went on to make “some general observations” about

proper admissibility analysis under Fed. R. Evid. 702. (/d. at

2796). In winding up its analysis, this Court explicitly

addressed the narrow focus of Rule 702's scrutiny:

The inquiry envisioned by Rule 702 is, we emphasize, a

flexible one. Its overarching subject is the scientific

validity - and thus the evidentiary relevance and reliability

~ CR ntatacieietien wien | submissi

The focus, of course, must be solely on the principles and

methodology, not on the conclusions that they generate.

(Id. at 2797) (footnote omitted).

As such, this Court separated the focus of Rule 702 on

the distinction between the “principles and methodology” used

by an expert, on the one hand, and the “conclusions” thereby

reached by the expert. (Jd. at 2797). Amici believe that this

Court correctly understood that capable scientists may analyze

* In the case of Daubert, Respondent (at 5) argued that the conclusion

of plaintiffs’ facts 0 * ive body of unifi ‘entific’

research” and (at |) asserted the existence of an “overwhelming body of

data that contradict their conclusion." This Court explicitly ignored

Respondent's extensive factual arguments relating to the conclusions of

plaintiffs’ experts,treating them as irrelevant under Rule 702.

* As scientists, we understand that it may be disquieting to non-

screnusts ists tO see scientists on opposing sides disagreeing so markedly

This cut against an implicit essumption that disagreement among

scienusts should be rare, because science is capable of objective, if not

, . : 1 verification. In fact, though. diff of coin

are quit: Common im science, but the arguments are spread out over many

research papers and long ume spans, and they are usually couched in

5

court understood its function. As stated by the court of appeals:

"[iJnstead of viewing the bases of an expert's opinion as a whole

to screen out mere speculation, the district court assessed only

a portion of the studies relied upon by each of the Joiners’

experts, and then excluded the testimony because it drew

different conclusions from the research than did each of the

experts." Indeed, the district court even states that it was

persuaded by the Defendants’ attack on “the conclusions that

Plaintiffs’ experts draw from the studies they cite." (67a) In

evaluating these conclusions, the district court failed to

understand that its role was to look at methodology and

completely ignored the fact that this Court has dictated that the

decision to allow such testimony should weigh broadly in favor

of the proponent of the evidence, consistent with the liberal

thrust of the Federal Rules of Evidence. Daubert at 2794.

As this brief will demonstrate, one of the fundamental

problems in the district court's analysis is that it failed to

determine exactly what the appropriate methodology is for

experts in the field of occupational medicine, assuming instead

that there is a scientifically fixed methodology to which all

experts must subscribe. This is not the case. An epidemiologist

engaged in the practice of observing large populations often will

not make or does not feel capable of making judgments on

careful, if not polite, language. The underlying disagreements thus exist

outside the courtroom as well as inside. It is only because, in a

courtroom, time and space are compressed, and the nuances of language

are erased in the adversary process that the disagreements appear so

stark. (See Hall v. Bar*-+ Healthcare Corp. 947 F. Supp. 1387, 1450

(D. 1996) where ~ i appointed epidemiologist

commissioned to evaluate the admissibility of the opinions of the

plaintiffs’ epidemiologist, Dr. Goldsmith, and the defendant's

epidemiologist, Dr. Ory, concluded: “I believe there is sufficient

screntific data upon which to base the opinions of both Dr. Goldsmith and

Dr. Ory, the principal epidemiology witnesses, and | believe it would be

appropriate to accept both of their testimonies. ... And it is even possible

for reasonable epidemiologists to arrive at diametrically opposed

conclusions, as do Drs. Ory and Dr. Goldsmith, with regards to the

Hennekens study ...”) (Empasis added)

individual issues of causation. If such decisions are made, it is

only through the process of inductive or deductive reasoning.

The experimental toxicologist who conducts research on animals

may not feel competent to extrapolate the results of animal

testing “directly” to humans, and, if obliged to do so, may likely

describe the medical condition at issue as being “consistent with"

findings in animals. However, what the district court failed to

appreciate is that there is a recognized field of medical practice

injuries of individual patients and conditions of work, including

the physical, chemical and psychological hazards of occupation.

In this discipline, practicing professionals routinely make

judgments on a regular basis relating to health concerns caused

by chemical, occupational, and environmental exposure. In

evaluating its assignment under Daubert, it is the methodology

used in this field and the qualifications of its pracitioners that the

district court properly should have evaluated. Amici submit that

Plaintiffs experts are qualified practitioners in the field of

appropriate methodology of their discipline in forming the

opinions they had regarding the etiology of the onset of Mr.

Joiner’s lung cancer.

C. The qualifications of plaintiffs’ experts

The Joiners’ chief experts were Daniel T. Teitelbaum,

M._D., and Arnold Schecter, M.D., M.P.H., both of whom are

practitioners in the fields of preventive and occupational

medicine and clinical toxicology. According to F.R.E. 702, the

first requirement of an expert witness is that the witness must.

have sufficient capacity in his or her field by skill, experience,

training, or education.

Dr. Schecter has substantial experience in the field of

PCBs, PCDFs, and PCDDs, “having devoted the last ten years

of [his] life to the study of dioxins, dibenzofurans and PCBs."

(Affidavit of Arnold Schecter at 7:#18.H). He is a tenured full

professor of medicine at SUNY Binghamton, having previously

served on the faculty at the New Jersey Medical School, SUNY

7

Downstate Medical School and Harvard Medical School. At the

time of his testimony, he had already published over 100 papers

relating to dioxins, dibenzofurans and/or PCBs, many of which

had been subjected to peer review, and were cited both by other

researchers and the World Health Organization. In addition,

Schecter served as a peer reviewer for the ATSDR for their

Toxicological Profile documents on (a) PCBs, (b)

dibenzofurans, and (c) dioxins. As director of the Broome

County (New York) Health Department, he saw first-hand the

public health consequences of PCBs, dibenzofurans and dioxins

when he evaluated exposed residents after a major fire. He

spends about ten percent of his current time seeing patients.

(Dep. at 143:15; Schecter Aff. at 2:#5, 2-3:#6, 5:#14.) He has

(Aff. at 12) and done research on these chemicals in Vietnam,

Russia, China, Cambodia, and the United States. (Dep. at

147:3-11)

According to the record, Plaintiffs’ other medical expert,

Dr. Teitelbaum is a practicing medical toxicologist and

occupational medicine specialist in Denver, Colorado. He has

been an adjunct professor of Environmental Science and

Engineering Ecology at the Colorado School of Mines, teaching

graduate toxicology courses in occupational and environimental

toxicology. He also has been an associate clinical professor of

medicine at the University of Colorado Health Sciences Center.

He was a founder and former director of the Rocky Mountain

Poison Control Center, and of the Physicians Poison

Consultation Service at the University of Colorado Medical

Center. He was a founder of the American Academy of Clinical

Toxicology and the American Board of Medical Toxicology,

serving as the first chairman of the examining board of the

American Board of Medical Toxicology.’ Significantly, during

the course of .. ~ clinical practice he has had substantial clinical

experience in evawating workers exposed to PCBs, having

’ Dr. Teitelbaum also taught two courses on the issues of

and the epidemiology of toxic diseases at the Federal Judicial Center

(Aff. at 2)

interviewed, examined, and treated numerous patients who

were employed in the electrical trades. (Aff. at 3)

According to the courts below, there was no question

that both Drs. Schecter and Teitelbaum were qualified to testify

as practitioners in the fields of preventive and occupational

medicine.’ Indeed, given their vast experience in the area of

PCBs it might even be argued that the threshold for the

admissibility of their opinions should be lowered. (See Jn re

Paoli Railroad Yard Litigation, at 742, noting that one factor to

be considered in evaluating the admissibility of expert scientific

* Defendants employd three experts who were well qualified in thew

regarding the chemicals of concern in this litigation. William J. Waddell,

M_D., an experimental toxicologist at the University of Louisville

Medical School, while having testified in several cases regarding PCBs

(Deposition at 25:10-13), ended his clinical practice at the end of his

residency (id. at 28:9-19), is not licensed to practice medicine in

Kentucky (id at 29:7-9), had no training in occupational medicine or

public health (id. at 33: 16-19), and has never written on PCBs, PCDFs,

or PCDDs (id. at 54: 3-5). Defendants’ second expert, Philip Cole,

MD., Dr. PH, an epidemiologist, who, according to Peutoner, testified

that “he knew of no scientist who believed that [PCBs cause small cell

hung cancer)," J.A. 234-35," has also testified on several occasions

regarding the health effects of PCBs (Deposition 25. 9-12), but has not

practiced clinical medicine since 1974 (id at 31: 20-26) and did not

recall ever writing anything about PCBs, PCDFs, or PCDDs. (id. at 35:

10-16). Lastly, William Charles Bailey, M_D., of the University of

Alabama Medical School, a clinical pulmonary specialist with a sub-

specialty in asthma but not in occupational medicine or clinical

toxicology, was not aware of ever treating a patient who had a PCB

exposure (Deposition at 17: 18-22), did not know what Inerteen (Id. 24:

25-26) or Pyranol (id 25: 1-5) even was, and had never written anything

on PCBs or done any hands-on research in the field (25: 12-16). This is

not to argue that these experts are not qualified to testify but rather that

As will be delineated, each doctor reviewed Mr. Joiner’s medical

history, examined the records regarding his illness, personally

interviewed or conducted a physical examination of Mr. Joiner,

to determine the cause of their patients’ injuries. Indeed, The

Federal Judicial Center's Reference Manual on Scientific

Evidence at 214 (West 1994) defines differential diagnosis as

follows:

The method by which a physician determines what disease

process has caused a patient's symptoms. The physician

considers all relevant potential causes of the symptoms and

The clinical method always proceeds in a series of logical

steps. The perceptive student will note certain similarities

between the clinical method and the scientific method. Each

begins with observational data which suggest a series of

10

hypotheses. The latter are tested in the light of further

observations, some of which are made in the clinic and

others in the laboratory. Finally, a conclusion is reached,

which in science is called a theory and in medicine a working

It is thus clear that “differential diagnosis is a well-

recognized, reliable method of medical diagnosis that has

gained" widespread acceptance in the medical community and

"... it is a method that involves assessing causation with respect

to a particular individual." Jn re Paoli RR. Yard PCB

Litigation, at 758. Indeed, if one of the aims of Daubert was

to ensure that experts use the same methodologies inside the

courtroom as they use in their professional capacities outside of

the courtroom, then differential diagnosis is plainly an

appropriate methodology for scientific testimony if not the

required methodology of practitioners of occupational medicine.

The first step taken by a physician in examining a patient

and in attempting to come to a “differential” diagnosis is

logically to make a clinical assessment of the patient, or as Dr.

Teitelbaum described it, “a comprehensive and traditional

occupational medical assessment of Mr. Joiner." (Aff. at 4).

This is normally done through one or all of the following

methodologies: 1) a review of the patient's chart, including, if

possible, medical records from other treating physicians, 2) an

interview with the patient in order to elicit a “history”; 3) a

clinical examination of the patient; and 4) information from

family members and co-workers regarding the patient's

condition. The record is clear that both Drs. Teitelbaum and

Schecter reviewed Mr. Joiner's medical records, personally

conducted extensive interviews, and, in the form of depositions,

gained information from family members and co-workers. ° Dr

* Petitioners emphasize this in their brief (at 5), stating: “Dr. Schecter

concededly had never examined hum at all, and only once had even

spoken to him, J.A. 103-05---in a lawyer's office, ‘to get a feel for what

land of person he was, whether he was a person | would find believable.”

In this recitation of the apparent facts, they neglect to cite from Dr

Schecter's affidavit where he fully describes the nature of his internew

with Mr. Jomer *A | imterviewed Robert Joiner and discussed with him

Teitelbaum carried out a comprehensive and traditional

occupational medical assessment of Mr. Joiner,"* during the

course of which he ascertained "Mr. Joiner's current clinical

condition in order to understand the genesis of his lung cancer."

(Aff. at 5) He also took an extensive medical history.

In undertaking their clinical assessment of Mr. Joiner,

both Drs. Schecter and Teitelbaum also conducted a

toxicological assessment. The goal of this assessment was to

evaluate all potential factors in the etiology of the disease in

question. As has been stated, inquiries were made into Mr.

Joiner’s family history, his social history, and his occupational

history. Potential fartors relating to his disease were identified

and information was gathered relating to the nature, extent,

frequency and duration of any toxic exposures he might have

had which could possibly be implicated in his cancer diagnosis.

At the same time efforts were made to exclude alternative

explanations. (Schecter Aff. at 6-7:#18)

E. The role played by smoking

The logical first step in evaluating any case of lung

including but not limited to other vicums of cancer, his exposure to

potential carcinogens including but not limited to tobacco, his work

history, and his specific tasks at work with special interest in his work

involving transformer repaur " As to physical examinations of Mr Jouer

himself, Dr Schecter chose not to conduct an examunation, “[bjecause

(Mr. Joiner) had a very thorough workup for his ung cancer and had

been under intense medical care for a number of years when [he) sew him

and [he] didn’t want to put him through any more unnecessary hardship

and {he} didn't feel the need for it." (Dep. of Schecter at 34: 16-20)

"Petitioners in their brief before this Court (at 36) indicate that “Dr.

Teatelbaumn also had talked with respondent only once, also at the lawyers

office, without details he described what he did to be ‘as complete an

exammation as one could do not working in one’s own office.” While it

should not matter where the examination conducted by Dr. Tetelbaum

took place, Dr. Teitelbaum's affidavit ai 4 indicates that the exammation

took place in the offices of Northside Internists and Endocrinologists in

Atlanta, Georgia.

12

6) “cigarette smoking is so strong a risk factor for lung cancer

genetically predisposed to developing the disease. On the basis

of this information, both Drs. Schecter’ and Teitelbaum

conchuded that it was more likely than not that Mr. Joiner’s lung

cancer was initiated’? by exposure to tobacco products.”

"' Petitioners in their b rief attempt to impeach Dr. Schecter by making

it appear that in his deposition he admitted the connection between Mr

Jommer’s smoking and his hung cancer, but that he deceived the court in his

affidavit. They even note that “the Court of Appeals appeared unaware

that in his deposition Dr. Schecter had conceded that... ‘Mr. Joiner's lung

cancer was equally linked to cigarette smoke and PCB exposure” They

accomplish this by quoung his affidavit out of context and leaving out the

following statement: | believe that Robert Jomer’s exposure to PCB

contamunated muneral ou) chelectnc fluud served as a promotional effect or:

his hung cancer cells, probably initiated by cigarette exposure years

before and caused him to contract hung cancer at the very young age of

37. (Affidavit of Dr. Schecter at 6:17)

"2 In cancer initiation, a minute change in the inhertable matenal of

the cell (a mutation in the DNA) is reproduced each time the cell divides.

If that imiual alteration is such that the cell is changed from a normal to a

malignant phenotype, then each of the progeny cells wil] also exhibit

malignant behavior. After many cell divisions there may be a sufficient

mass of mabgnant cells (a tumor) to disrupt the structure and function of

the body and produce the symptoms and signs of the disease we cal!

cancer. As stated by the district court, “The imitiator can be any number

of things including, but not limited to, tobacco smoke." (39a)

13

However, the question of causation which faces

practitioners of occupational medicine rarely resolves simply. In

this case in particular, some questions remained unanswered by

tobacco. Although there definitely “was some risk of lung

cancer [for Mr. Joiner] because he was a smoker ..., the

likelihood of his developing lung cancer at age 37 on a statistical

basis [would be] extremely small." (Aff. of Teitelbaum at 7-8;

Aff. of Schecter at 6:#17) “If you compared the lung cancer

rates at age 60, which are around 400 per 100,000 person years,

with lung cancer rates in the 30's, which are almost too low to

detect, somewhere around 10 to 15 per 100,000... it's pretty low

risk, but it's there.” (Aff. of Teitelbaum at 8) under these

circumstances, the proper methodology for physicians

specializing in occupational medicine would be to attempt to

contributed to the early appearance of Mr. Joiner’s cancer.“

" If the putative agent of concern in this litigation were tchacco,

one would guess that the Daubert analysis would not go any further and the

differential diagnosis would have been sufficient to pass the district court's

scrutiny without need to review epidemiological or toxicological data This

stems not from "general acceptance” in science but rather general

acceptance of supposed “public knowledge." Though Dr. Teitelbaum

himself subscribes to the belief that Mr. Jomer’s lung cancer more likely

than not was initiated by smoking, this opinion is based on the totality of the

evidence and not statistical epidemiological analysis per se: “A remote

smoking history of 8 pack years can only be considered a minimal risk

factor for the causation of hung cancer. Such a history cannot be associated

with any particular cell type of lung cancer So few lung cancers at this age

have been collected in the literature that no statistically meaningful analysis

of histological type at age 37 is possible.“ (Teitelbaum Aff at 8)

“ Both scientifically and legally there seems to be 4 fundamental

misunderstanding by Petiuoners and many amici es to what Drs.

Teitelbaum and Schecter were attempting to articulate For imstance,

amicus, Marcia Angeil, at 5 states.

"Exposure to high levels of PCBs cannot be the sole cause of lung

cancer, even if it plays some role, since people not so exposed also

develop lung cancer. And exposure to high levels of PCBs do not

mvanably cause lung cancer, since most people so exposed remain

healthy. Thus, the most that could be true is that PCBs may

14

F. Occupational exposure of Mr. Joiner

The logical first step in the analysis of occupational

exposure was for Drs. Teitelbaum and Schecter to take

co-workers and family members. As Mr. Joiner’s job involved

a substantial amount of time working on electrical transformcrs,

a videotape of the working conditions of Mr. Joiner in repairing

electrical transformers was viewed and the results of testing

done on the transformers was evaluated. (Schecter Dep. at; see

e.g. 16:10, 17:14-20, 18:8, 18:1-.5, 33:4-13, 37:17-19)

Consistent with this review is the following summary of

Mr. Joiner’s work. (35a-37a) From the date of his being hired

in 1973, Mr. Joiner was called upon to service transformers

primarily when they had failed for one reason or another. The

shop in which transformer repair was performed was below

grade at the main offices of the electric company and had no

forced ventilation, so and any vapors that were heavier than air

remained in the workplace throughout the work day. When a

transformer was in need of repair, Mr. Joiner would open it up,

contribute to lung cancer -- that is, they might be a "nsk factor”

(something that increases the chance of developing a disease)”

(emphasis in the original)

But, this is precisely the point and exactly what Drs. Teitelbaum and

Schecter are stating The only material issue both scientifically and

legally is whether defendants’ products affected Mr. Joiners body in a

way so as t© contribute to that hung cancer by accelerating it or promoting

it. Under Georgie law, 2 plaintiff is not required to show that the

defendant's tortious conduct was the sole, primary, or initiating cause of

any of his injuries. In causes of action requiring medical proof of

causation, it is enough for the plaintiff to show, to a “reasonable degree

of medical certainty," Parroa v. Chatham County Hosp. Auth., 145 Ga.

App. 2d 269, 270 (1978), Wells v. Ortiho Pharmaceutical Corp., 788

F.2d 741, 743 (11th Cir.), cert. denied, 479 U.S. 950 (1986), that a

defendant's tortious conduct contributed to the mix of preexisting factors

that together ultimately caused or, st minimum, accelerated his injunes.

It is even immaterial whether defendants’ products would have caused

Joier’s hung cancer absent an alternative exposure to tobacco or whether

he would have eventually developed cancer anyway Georgia law

protects Mr. Joiner from any tortious conduct that would cause him to

develop hung cancer sooner than he otherwise would have

15

drain out the dielectric fluid, bake the transformer dry, test the

transformer for proper operation, make repairs, and then refill

the transformer with fresh mineral oil dielectric fluid. The

process of repairing transformers required that Mr. Joiner stick

his hands into the dielectric fluid to perform necessary repairs

and disassembles. The next step required the separation of the

core of the transformer from the tank so that it could be dried,

Joiner to the dielectric fluid. In order to dry the transformer, a

process, the dielectric fluid which was contained in the

transformers was heated, to the point of smoking, for several

days with football field lights until the core was dry. At no time

were any precautions taken to prevent inhalation, ingestion, or

absorption of the dielectric fluid.

The obvious conclusion drawn by Drs. Teitelbaum and

Schecter from this information was that Mr. Joiner likely

ingested, absorbed, and inhaled substantial quantities of PCBs

from the fifty-three percent of the City of Thomasville's

transformers that were contaminated. He ingested these when

they splashed onto his face, or touched his hands to his mouth

in any way; he inhaled them during the bake-out process when

the football field lights were used to vaporize the dielectric

fluids; and he absorbed them through his unprotected skin when

he reached into the transformers to disable them while the

dielectric fluid was still in the tank.

From the analysis of this occupational history, Drs.

Teitelbaum and Schecter came to the conclusion that Mr. Joiner

had been exposed to substantial quantities of PCBs,’* as well as

“Petitioners have pointed to the fact that when Mr. Joiner’s blood was

that he only had levels that would be considered background, i.e. that

"PCBs in small amount are detectable at ‘normal’ or ‘background’ levels

in most human beings and animals in North America." Pet. Brf. at 2.

First, to call levels “normal” or “background” is an interesting euphemism

employed by the defendants who are aware that PCBs would not exist on

this planct at all nor be inside each of our bodies if they had not been

intentionally manufactured and marketed by companies such as

16

PCDF and PCDD contaminants, during the course of his work.

At the same time they were aware that there is a substantial

body of literature regarding the harmful effects of these

chemicals.""* The question which they then faced is whether it

was biologically plausible that Mr. Joiner's occupational

exposure to PCBs had affected the disease process of his cancer.

G. Biological plausibility and coherence

At this point, the question properly raised by an

occupational medicine professional is: “Was it biologically

plausible that Mr. Joiner’s heavy exposure to a likely

carcinogenic mixture of dielectric fluids during the course of his

occupation contributed in some way to the early manifestation

at the age of 37 of his lung cancer?” In attempting to answer

this question, the occupational medicine professional has no

choice but to make a judgment -- to recognize that perfect

congruence with the individual study question at hand and the

limited fund of available information seldom permits one to be

able to do more than extrapolate from all available evidence in

Petitioners herein. Further, the district court (42a) relied on Dr.

Schecter’s expertise in analyzing these samples:

"No study has been documented that examines subjects who have

experienced weight loss associated with cancer, chemotherapy

as well as been subjected to excessive PCB, dioxin or dibenzofuran

exposure. As a result, there is no control group to which Robert

Joiner can be compared... Adipose levels which are low do not mean

that higher levels did not exist at earlier times. This is because PCBs

are metabolized and excreted from the body over time."

In fact, Dr. Schecter stated at his deposition that what he found

“remarkable about this man is after the weight loss and weight gain and

level [was] so high for him." (Dep. Dr. Schecter at 81).

‘6 Ore form of PCDD, TCDD, has recently been classified as one of

the very few recognized “human carcinogens." This was announced in a

press release on February 14, 1997 by the World Health Organization's

International Agency for Research on Cancer (IARC). The conclusion

was based on the fact that it was found that TCDD was “increasing the

overall risk of lung cancer and all cancers combined."

17

~~,

e

order to evaluate an association. In conducting this evaluation,

perhaps the first requirements of that analysis is whether the

association is both "biologically plausible" and “coherent."'’ As

to “plausibility"", the question specifically raised here is

whether, given all that is known about Mr. Joiner’s history, may

the available scientific evidence lead one to believe that it is

“plausible” that an association between Mr. Joiner's early

manifestation of lung cancer and PCBs might exist? The

second factor to be viewed is "coherence," i.e. does the putative

association between Mr. Joiner's lung cancer seriously conflict

with the generally known facts of the natural history and biology

of the disease of lung cancer.

In attempting to arrive at an answer to these questions,

the occupational medicine specialist has many sources of

'’ In 1965 Sir Austin Bradford Hill offered nine viewpoints which he

believed might be "consider{ed] before deciding that the most likely

interpretation of it is causation.” These were listed as: 1) strength of the

association, 2) consistency of the association; 3) specificity of the

association, 4) temporality, 5) biological gradient (dose-response), 6)

plausibility, 7) coherence, 8) experiment, and 9) analogy. In laying out

these “nine different viewpoints,” he accompanied them with the

following caution: “What I do not believe -- and this has been suggested

— 1s that we can usefully lay down some hard-and-fast rules of evidence

that must be obeyed before we accept cause and effect. None of my nine

effect hypothesis and none can be required as a sine qua non. What they

can do, with greater or less strength, is to help us to make up our minds

on the fundamental question — is there any other way of expiaining the set

of facts before us, is there any other answer equally, or more, likely than

cause and effect." [299] “Plausibility” and “coherence” are singled out

here, because they are factors which are evaluated before the review of

the specific evidence or data sets is begun. (Sir Autstin Bradford Hill,

"The Environment and Disease: Association or Causation?” in

Proceedings of the Royal Society of Medicine, 58:295-300 (1965)).

" Sir Austin Bradford Hill does, however, indicate that "This is a

feature I am convinced we cannot [always] demand. What is biologically

plausible depends on the biological knowledge of the day. ... In short, the

association we observe may be one new to science or medicine and we must

not dismiss it too light-heartedly as just too odd. As Sherlock Holmes

advised Dr. Watson, ‘when you have eliminated the impossible, whatever

remains, however improbable, must be the truth.” /d at 298.

18

information to sift through. For instance, Dr. Schecter knew

from his toxicological assessment that Mr. Joiner likely was

exposed to PCBs through inhalation and he knew from his

experience as a scientist that PCBs "tend to accumulate in lung

tisue.” (Aff. at 7:#18J) Other types of information which might

be available to an occupantional medicine physician include, but

are not limited to, discussions with colleagues, in vitro studies,

biophysical data, general scientific knowledge and experience,

case reports, and case conferences. Of course, they also include

the observational work of epidemiologists and the experimental

work of research toxicologists, But it must be cautioned that

epidemiology and research toxicology, albeit very important,

have their own limitations and should not be relied upon to the

exclusion of all other evidence.

H. The use of observational human studies: epidemiology

If one were to compare differential diagnosis to a trial,

one would describe clinical and toxicological assessment as

direct evidence, while epidemiology (and research toxicology)

would be akin to circumstantial evidence. By its very nature,

epidemiology is not designed to answer questions of individual

causation. As stated by amicus, Marcia Angell,

"[e]pidemiologic studies yield information about probable risk

factors in populations, not in individuals. They provide

information average risks in the average person in the

population."(at 9D.) Moreover, epidemiological investigations

are limited by the questions which are asked, i.e. the study

protocol. Although a given study may be both well-designed

and well-conducted, rarely can one expect the study question of

an epidemiological investigation to be perfectly congruent with

the question that is raised subsequently regarding an issue of

individual causation. Indeed, even in the best of light,

"[e]pidemiological studies are inherently capable of detecting

only comparatively large increases in the relative risk... .

Negative results cannot prove the absence of [risk]... ." EPA

Final Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg.

33992, 33995-96 (1986).

The subject of Mr. Joiner’s exposure provides a perfect

19

question of whether, for those who smoke and were exposed to

PCBs there is a hastening in the mean date of diagnosis of small

cell lung cancer (promotion) or a significant increase in the

numbers of the study population ever so diagnosed (initiation).

However, in the real world, time, money, and available study

populations’ do not allow such questions to be asked, much less

answered, with particularity to the facts of any specific incident

of individual causation.

Despite these inherent limitations the district court

inappropriately viewed epidemiology as a sine qua non for legal

probability. Thus, the district court assigned to itself the role of

studies presented to it. The district court weighed the evidence

from Monsanto's own in-house study which, according to the

district court, showed a risk of lung cancer that was three times

greater than expected, (64a) but then accepted the conclusion

of the defendants that it should be disregarded because it was

not “statistically significant."”° The district court then accepted

" The obvious weakness of epidemiology is that we cannot

experiment on humans so our study populations must come as we find

them. In the case of PCBs, comparable study populations are not easily

located. Monsanto has been the only manufacturer of PCBs in the

United States since World War II which limits the number of studies that

may be performed in this country on manufacturing cohorts. Moreover,

sunce these chemucals are now ubiquitous in our environment, having

been ingested by each and every one of us, it is impossible to find an

unexposed control population.

** As expressed by the epidemiologist Kenneth Rothman in his

amicus brief to this Court in Daubert, at 6.: “The result of using

significance testing as the criterion for decision making is that the focus

1s Changed from the information presented by the observations themselves

© conjecture about the role chance could have played in bringing about

those observations." [emphasis in original]. Rothman is the author of a

20

that the study by Bertazzi, et. al., Cancer Mortality of Capacitor

Manufacturing Workers, in 1] Am.J.Indus.Med. 165 (1987),

demonstrates an increase of lung cancer above expectations in

PCB workers, but without even reading the study itself (63a

n.27) rejected the study on the basis of Bertazzi's conclusion

that although lung cancer deaths were above expectations, the

never been suggested before" (63a) -- even though the district

court knew that the risk had been suggested before by

Monsanto's own in-house studies, which was

unknown to Bertazzi, et. al. The district court then discounts

the study by Ronneberg, et al., Mortality and Incidence of

Cancer Among Oil Exposed Workers in a Norwegian Cable

Manufacturing Company, Part 2 Mortality and Cancer

Incidence in 1953-84, in 45 British J. Indus. Med. 595, 601

(1988), regarding Norwegian cable workers, because the study,

while definitely referring to a statistically significant increase in

that the cable workers were exposed to mineral oils but dbes not

specifically define the nature of that exposure. (65a) The

district court excluded this study knowing that PCBs were

commonly found in such mineral oils (they were even found in

the mineral oils of the City of Thomasville which were supposed

to be free of PCBs) and that mineral oils themselves were the

products sold by the Defendants to the City of Thomasville.

This is not to say that there is no merit at all to these

individual criticisms directed to each such study by the

that all studies be critiqued. Furthermore, none of the studies

were designed to answer the specific question raised by Mr.

Joiner’s cancer and inevitably every study may be faulted for its

inability to answer such sui generis questions. For instance, in

accepting the defendant's criticisms of the study by Ronneberg,

the district court points out that the study was “confounded by

standard text, Modern Epidemiology (Little-Brown, 1986), and Editor-

in-Chief of the journal Epidemiology.

21

os exposure to cigarette smoke." While in a typical study it

would be expected that a researcher would attempt to exclude

cigarette smoking as a risk factor,” in the case of Mr. Joiner he

would appropriately be a part of the study population of

workers who both smoked and were exposed to PCBs.”

When it is accepted that each epidemiological study --

and even the very best studies — will be subjected to appropriate

criticism as to the appropriateness of their application to issues

of individual causation, then one can understand that the real

question to be raised before this Court is who the proper entity

is to evaluate these studies in light of the questions raised. The

district court, obviously, assigned that responsibility to itself

rather than to the jury. As stated by the court of appeals: “In

ruling the Joiners’ expert testimony inadmissible, ... the district

court... accepted defendants’ criticisms of the conclusions

reached in those studies, stating that "the studies simply do not

support the experts’ position that PCBs more probably than not

promoted Joiner's lung cancer."” (at 12a, emphasis in the

2! The Ronneberg study does indicate that the results cannot be

accounted for by excess smoking alone.

As Dr. Teitelbaum stated in his Affidavit at p. 22: “A study of

transformer oil exposed workers was observed. Ten deaths from lung

cancer were observed where 3.9 were expected. Nine of the cases of

lung cancer occurred 20 or more years after first employment, where 2.7

would have been expected yielding a P value of 0.01, a highly significant

result."

2 Without explanation the district court also failed to review a

number of the studies relied upon by Drs. Teitelbaum and Schecter. As is

stated by the court of appeals: In addition, each doctor utilized numerous

Teitelbaum referred to several additional studies which he utilized in

forming his views. Among those not mentioned by the district court were

22

define a relationship of a putative ca. cinogen to small cell lung

cancer in particular, as death certificates rarely define death

more particularly than lung cancer. Indeed, any review of the

literature to achieve a perfect fit will inevitably be reduced to the

absurd. In the case of Mr. Joiner, if the fit required of

epidemiological studies is that of small cell lung cancer in 37

year old men in Thomasville who smoked but were never

exposed to any carcinogens other than PCBs, then one can

readily see that no applicable epidemiological study could ever

studies by researchers Gustavsson and Hogsted, findings of the International

Program on Chemical Safety (“IPCS") World health Organizauon Critenion,

and 'a whole series of [epidemiological studies) listed in [the World Health

Organization) document.’

Similarly, in addition to the studies mentioned in the distnct court's

opinion, Schecter relied, in part, upon ‘recent work such as that of

Dr. George Lucier and colleagues at the National Institute of

Health,’ IARC studies, International Agency on Cancer at the

World Health Organization,’ studies by ‘Dr James Huff of the

National Institute of Health,’ the Zober and Theiss studies from

Germany, and also Manz’s study on European workers... In this

case, the Joiners’ experts discussed the studies of at least thirteen

different researchers, and referred to several reports of the World

Health Organization that address the question of whether PCBs

cause cancer.”

L. The use of animal studies

When an occupational medicine professional reviews

arumal studies, the search similarly is for biological plausibility,

i.e. does the research toxicology aid in the overall conclusion of

a plausible association. This is because, in theory, experimental

studies are designed to demonstrate a biologically plausible

mechanism by which injury could occur, as the existence of such

an effect in other species or test systems may reasonably aid in

explaining what has been observed in humans upon whom such

tests cannot be performed. See E. K. Silbergeld, The Role of

Taxicology in Causation: A Scientific Perspective, in 1 Courts,

Health Science & the Law 374, 381 (1991).

ig Obviously, though, just as with epidemiology, there are

limitations to the use of animal studies when it comes to

evaluating issues of individual causation. For instance, unless

the study is performed to replicate the particular individual

human experience (and then it will be subjected to criticism for

being the product of litigation), it is unlikely that existing animal

studies will closely recreate all of the conditions upon which

issues of individual causation rest. However, this does not

mean that we should ignore the results of animal studies "since

animals may differ from people in their response,” as is indicated

by amicus Marcia Angell at 8. Even Petitioners’ own expert, Dr.

William J. Waddell, indicates that using animals to extrapolate

to humans “is accepted and is appropriate and proper.”

(Deposition of Waddell at 32:14-15]

As is evidenced in virtually all federal regulations dealing

with toxic risk assessments, experimental data based on studies

of animals are a critical element of the process of assessing the

Se a ene er cnneene en aeenwend

exposures and in attempting to comprehend the

relationship between exposures and certain adverse outcomes in

humans.” In the courtroom, in the governmental regulatory

process, and in science generally these studies all serve the same

™* See,e.g, 42 Fed. Reg 6532 (1977) (proposed and final discharge

standards for PCBs based on animal carcinogenicity).

24

purpose. They do not demonstrate actual causation themselves,

but, if “plausible,” they allow us to draw reasonable inferences

from their results. If an experimental animal study demonstrates

a mechanism for carcinogenicity, then it both makes it more

plausible that the same will occur in the human model and it

elucidates for us a possible mechanism of action for our

evaluation.

In this sense, the district court and various amici have

seemed to misconstrue what was gained from the animal

experimentation in the Anderson studies.” Amici curiae, Bruce

N. Ames, et ail., (at 18) support the decision of the trial court to

reject the studies on the basis that: “[tJhe animal studies

plaintiffs’ experts relied upon were not indicative of a link

between PCB exposure and Joiner’s type of cancer because the

conditions of the mice (huge doses, direct injection, use of

initiator chemicals) were not similar to the nature of Joiner's

exposure - his ‘dose’ was far smaller, and plaintiffs’ experts have

not identified an ‘initiator’. Those tests did not mimic human

exposures." Obviously, it is easily recognized that there was

hardly complete congruence between these experimental studies

and Mr. Joiner's specific exposure. Given the practical

® Of course, there are other animal studies which have displayed the

carcinogenic properties of PCBs. “Based on the observations of liver

tumors in several studies of rats fed vanous commercial mixtures of

PCBs in the diet and on suggestive evidence for carcinogenicity in

humans (reviewed in (ATSDR) (1992)). Draft Toxicological Profile

for Polycholorinated Biphenyls. (U.S. EPA) (1994). Integrated Risk

Information System (IRIS). The U.S. EPA has classified PCB modures

as probable human carcinogens.” Vater, et. al., A Case Study of Cancer

Data Set Combinations for PCBs, in Regulatory Toxicology and

Pharmacology, 22:2 (1995)

%* Of course, this is not entirely accurate, as both Drs. Teitelbaum

specifity, which seems to be required by these amici, is not an absolute

for cause] inference. Indeed, even for cigarette smoke, there 1s no

priori method to predict exactly which sites will be affected mn a

partoular species, or perhaps even in an individual Cigarettes will cause

lung cancer in one person, bladder cancer in another, emphysema in &

third, and leave another relatively unharmed.

25

requirements of animal experimentations it would be shocking

if there was. The point of these studies seems to be missed. The

fact that the studies did demonstrate an increase of lung tumors

related to PCBs makes it more “plausible” that Mr. Joiner's lung

cancer may be related to his PCB exposure. Whether it makes

it more “probable” is hopefully, for the jury to decide.

J. The proper legal test of scientific conclusions is cross-

examination

Ultimately, the determination of the proper methodology

to use and the evidence to consider depends on the question

which is being asked. Petitioners and the amici who support

Petitioners seek the trial court to answer the following question:

"Does the available toxicological and epidemiological data on

PCBs more probably than not to a reasonable degree of

medical certainty support the conclusion that PCBs cause small

cell lung cancer so that that testimony may be presented to the

jury?” They support the district court when it answered "no" to

this question. Yet, for the district court to answer this question

necessarily required that it make a factual determination .

regarding the evidence presented to it. We believe that the

question that it needed to address was: “Have Plaintiffs’ experts

used the proper methodology of their discipline to assess

whether it is biologically plausible that Mr. Joiner's heavy

exposure to a carcinogenic mixture of dielectric fluids during the

course of his occupation contributed in some way to his early

manifestation of lung cancer at the age of 37, even though his

lung cancer was likely initiated by cigarette smoke?" To this

question, on the basis of the very same epidemiological and

toxicological evidence, the trial court should answer "yes"

without having to evaluate the actual conclusions being drawn

by the experts from the data they rely upon. As the D.C.

Circuit has explained, “there is nothing in Daubert to suggest

that judges become scientific experts, much less evaluators of

the persuasiveness of an expert's conclusion." Ambrosini v.

Labarraque, 101 F.3d 129, 134 (D.C. Cir. 1996), cert.

dismissed, 117 S. Ct. 1572 (1997).

26

The further question of “whether it was more probable

than not" is properly left to the jury to decide. And the proper

technique to be utilized by the opponents of Plaintiff's position

to challenge that conclusion is through cross-examination rather

than motions to the court for relief.”

It is in this sense that amici herein agree with what this

Court stated in Daubert:

"[C}ross-examination, presentation of contrary evidence,

and careful instruction on the burden of proof, rather than

wholesale exclusion ... is the appropriate means by which

evidence based on valid principles may be challenged (at

means of attacking shaky but admissible evidence."(at 13

Ii.)

Most fundamentally, this Court has emphasized over and

over again that the role of the jury may not be denigrated

through the use of “trial on affidavits"” as was true in the within

7 ‘Ultimately, we must look at why there is such a substantial

controversy over the use of observational epidemiology and research

toxicology, and why Petitioners and the amici urge that the district

court review these studies in detail in the absence of clinical evaluation,

onal er @ matied gechsienis GBmeutiel

diagnosis. In other words, why are Petitioners so ardently defending the

right of the district court to prevent a jury from undertaking a review of

the evidence presented. Is it that they feel that jurors are incompetent to

make such evidentiary determinations? Is it that they are fearful that

jurors might be duped by misinformation? Or is it that they are afraid that

jurors will conclude that their products caused or contributed to the

injuries alleged?

* This comment is especially relevant to the case below. As the

the court with a copy of the studies cited in the briefs ... The court, for the

most part, has had to rely on the excerpts from the studies that the parties

have provided in their briefs.” (63a n.27)

27

weighing of the evidence, and the drawing of legitimate

inferences from the facts are jury functions." Anderson v.

routinely in the American Judicial system, both civil and

criminal." Barefoot v. Estelle, 463 U.S. 880, 902 (1983)

(citation omitted). This Court has indicated that “the

the "greatest legal engine ever invented for the discovery of

truth." Kentucky v. Stinger, 482 U.S. 730, 736 (1987).

3 Petitioners underestimate the value of cross-

examination in the context of a trial in which all of the evidence

is before the trier of fact, whether it be judge or jury.

expert's conclusion, instead, almost anything the expert has

done, said, or written is open to examintion. For example, on

cross-examination an expert witness can be subject to close

questioning not only on the basis of the specific sources of his or

her testimony, but can be impeached by anything he or she had

TN ae cena canna His or her

motives and credentials can be scrutinized in ways unimaginable

—

28

K. An expert's opinions should rely on the totality of the

evidence reasonably considered

In conclusion, it is our view that the appellate court

correctly concluded that: "[o]pinions of any kind are derived

from individual pieces of evidence, each of which by itself might

not be conclusive, but when viewed in their entirety are the

building blocks of a perfectly reasonable conclusion." It is only

through assessing the entirety of the evidence in the context of

the injured worker's circumstances that an occupational

cannot be micro-managed; it must be reviewed in context and as

a part of the totality of the evidence. Clearly, all Syrms of

. Hifi data are subject to criticism on one ground or another,

regarding causation if the various approaches are used with an

understanding of their power and their limitations.” As stated

by Sir Austin Bradford Hill:

All scientific work is incomplete - whether it be

observational or experimental. All scientific work is liable

to be upset or modified by advancing knowledge. That

does not confer upon us a freedom to ignore the

knowledge we already have, or to postpone the action that

it appears to demand at a given time. ... [I]n passing from

association to causation I believe in 'real life’ we shall have

to consider what flows from that decision. On scientific

grounds we should do no such thing. The evidence is

there to be judged on its merits and the judgment (in that

sense) should be utterly independent of what hangs upon

it - or who hangs because of it. But in another and more

practical sense we may surely ask what is involved in our

decision. In occupational medicine our object is usually to

take action. If this be operative cause and that be

® Marcia Angell, an epidemiologist, in her amicus brief at 20 agrees

with this in principle: “In reaching a decision about causation, the crucia!

consideration is the totality of evidence. (Citation omitted) Each study

should be considered as part of a mosaic of information that taken

together yields the answer to a scientific question."

29

deleterious effect, then we shall wish to intervene to

abolish or reduce death or disease. (Bradford Hill at 295,

300 (1965)).

Amici submit that it is at the core of the very nature of

our judicial system that we should do no less. Statutes of

limitations and repose can place an equally severe time

constraint on the ability of injured workers to gain redress. The

need for proper medical intervention and the payment of medical

bills will not wait. For ever more complete information or

better, more particularized studies. If the evidence to be

submitted is biologically plausible, if the methodology used in

gathering that evidence is that used by practitioners in the field,

then it should be submitted to the trier of fact. Otherwise, the

newly framed and individualized Daubert approach portends

severe inequity for injured claimants, as litigants with similar

complaints may be subjected by different "gatekeeping" judges

to substantially different evidentiary standards and validation

processes.”

CONCLUSION

The judgment of the court of appeals should be affirmed.

Respectfully submitted.

GERSON H. SMOGER

Counsel of Record

* On this basis, this Court's review of the question presented is

perhaps the most important question which could be addressed. In trial

courts throughout the country motions based upon Daubert, if

successful, invariably result in the granting of summary judgment. An

appellate court reviewing a decision to exclude testimony is almost

always reviewing the dismissal of the entire underlying claim. If this

Court accepts the standard of review of these decisions as being an abuse

of discretion or, worse, clearly erroneous, then it is issuing a salvo in

favor of the trial judge rather than the jury as the true trier of fact. In very

real terms, four separate judges have now reviewed the evidence

presented by Drs. Teitelbaum and Schecter. Two found that it should be

presented to the jury and two found that it shouldn't -- is there any better

reason than this to state that the powers of the jury should not be usurped?

30

APPENDIX

The Of, Chemical & Atomic Workers Intl. Union (OCAW)

is an organization representing more ‘than 90,000 men and

women. Although OCAW was originally founded to represent

oil and chemical workers, who still make up the majority of its

membership, the union has grown to include workers in a wide

range of energy, chemical, pharmaceutical, and allied industries.

Peter Orris received his MPH degree from Yale University in

1970 and his M.D. from Chicago Medical School in 1975. He

is licensed to practice medicine in the state of Illinois and is a

Diplomat of the American Board of Preventive Medicine in

Occupational Medicine. Currently he has appointments as the

medical director of Corporate Health Services, Northwest and

as Professor of Preventive and Internal Medicine at Rush

University College of Medicine. He also serves as Director of

the Health Hazard Evaluation Program, University of Illinois

School of Public Health and Illinois Department of Health; as

the director of Research and Interdisciplinary Projects, Great

Lakes Center for Occupational and Environmental Health and

Safety, University of Illinois School of'Public Health; and as an

County Hospital. Among his many publications, he has written

on the health effects of PCBs.

David Ozonoff received his MD. degree from Cornell

University Medical College in 1967 and his MPH from Johns

Hopkins School of Hvgiene and Public Health in 1968. In 1977

he became the first chair of Boston University's Department of

Environmental Health in the new School of Public Health (a

position he still holds). He currently holds the rank of Professor

in the School of Public Health and Professor in the School of

Medicine. His research work centers on health effects to

communities of various kinds of toxic exposures, especially from

hazardous waste sites; new approaches to understanding the

results of small case-control studies; and the effects of exposure

misclassification in environmental epidemiology. He has been

principal or co-investigator of a number of major studies of

waste sites, including the Silresim Superfund site and a large

case-control cancer study on Otis Air Force Base. He is

currently the Principal Investigator of a Cooperative Agreement

between Association of Schools of Public Health and ATSDR

studying data needs for health assessment around DOE sites.

pte ea tye dada cre nay teaptomnsn 5 areonah

effort to understand basic scientific problems

connected) «iits tin Padieedh Gpsdllied Wiedintan Sindee ty’ the

National Institute of Environmental’ Health Sciences. In

addition, he is the Medical Director of the Boston

Environmental Hazards Center, a joint effort of the Department

of Environmental Health and the Boston Veterans

Administration Medical Center.

Janet S. Weiss received her M.D. in 1979 from Jefferson

Medical College in Philadelphia, PA with honors in medicine and

pathology. She is a Diplomate of the American Board of

Medical Toxicology, a Diplomate of'the American Board of

Preventive Medicine in Occupational Medicine and Medical

Toxicology, a Diplomate of the American Board of Pathology

and a Diplomate of the American Board of Toxicology. She is

an Assistant Clinical Professor of Medicine at the University of

Califorma, San Francisco's Department of Occupational and

Environmental Medicine, and has consulted widely on issues of

occupational medicine and medical toxicology for numerous

governments, medical clinics, and pharmaceutical companies

while maintaining a private practice in.clinical toxicology. She

has an extensive publication history in medical surveillance for

occupational and environmental hazards.