# Opposition Brief — Bourne, a Minor, by and Through His Parents, Next Friends and Natural Guardians, Bourne v. E.I. Du Pont De Nemours & Co

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 2004
- **Citation:** 543 U.S. 917

## Text

Supreme Court, U.S.
| FILED
(i) JUN 25 2004

No. 03-1586 |_OFFICE OF THE CLERK

IN THE

Supreme Court of the Anited States

ANDREW BOURNE, a minor by and through
his parents, next friends and natural guardians,
CHRIS BOURNE and MAGGIE BOURNE,

Petitioner,

E.I. DUPONT DE NEMOURS & COMPANY,
Respondent.

On Petition for a Writ of Certiorari to the
United States Court of Appeals
for the Fourth Circuit

RESPONDENT’S BRIEF IN OPPOSITION

DAVID B. THOMAS PATRICK W. LEE *
ALLEN, GUTHRIE, MCHUGH, CLIFTON S. ELGARTEN
& THOMAS, PLLC WILLIAM L. ANDERSON
500 Lee Street, East EMMA K. BURTON
Suite 800 CROWELL & MORING LLP
Charleston, W.Va. 25301 1001 Pennsylvania Avenue, N.W.
(304) 345-7250 Washington, DC 20004-2595
(202) 624-2500
* Counsel of Record Counsel for Respondent

WILSON-EPES PRINTING Co., INC. — (202) 789-0096 - WASHINGTON, D. C. 20001

m=] BEST AVAILABLE COPY

QUESTION PRESENTED

Whether the United States Court of Appeals for the Fourth
Circuit correctly affirmed the district court’s decision to
exclude expert testimony where that testimony was based on
speculative extrapolations from in vivo and in vitro studies
that failed to meet the reliability and relevance standards
under Federal Rule of Evidence 702.

(i)

ii
CORPORATE DISCLOSURE STATEMENT
PURSUANT TO RULE 29.6

Respondent E.I. du Pont de Nemours and Company
(“DuPont”) has no parent company, and no publicly held
company owns 10% or more of DuPont's stock. DuPont is a
publicly traded corporation listed on the New York Stock
Exchange.

TABLE OF CONTENTS

PRE OP © PRE EEEY EN ee csnscsessreversessnsscsrsercessosornvenses

RULE 29.6 CORPORATE DISCLOSURE
._s SRSIETETN SESE Sa

Il.

THE DISTRICT COURT PROPERLY EXER-
CISED ITS “GATEKEEPER” FUNCTION IN
FINDING THE PROPOSED METHOD OF
EXTRAPOLATION OF HUMAN TERATO-
GENICITY FROM SINGLE-SPECIES, HIGH
DOSAGE GAVAGE RAT TESTS AND IN
VITRO TESTS UNRELIABLE AND LACK-
oo i a ite ES EE ES eee aD

THE PETITION INCORRECTLY ASSERTS
THAT THE COURT OF APPEALS
CREATED A RULE REQUIRING EPIDE-
MIOLOGY TO BE THE BASIS FOR
EXPERT OPINION TESTIMONY CON-
CERNING CAUSATION IN TOXIC TORT

THERE IS NO CONFLICT BETWEEN TH

DECISION OF THE COURT OF APPEALS
IN THIS CASE AND ANY OTHER
IT siiclidisii eran icdioniniarentntendanerensiniedeumuninanaiien

I actin cin charisshcvsecinsainkaiAbiounboniencwecabaivnsetin

(iii)

10
14

iv
TABLE OF AUTHORITIES

CASES

Ambrosini v. Labaraque, 101 F.3d 129 (D.C. Cir
1996)....ccccssscsssscccssssssssesseessneeessesesseessenssnsnsensoes®
Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378 (4th
Cir, 1995)....cccccccccoscsssesevsersccnvereseessessrsensvsennesavers
Bourne y. E.L DuPont de Nemours & Co., 189 F.
Supp. 2d 482 (S.D.W. Va. 2002)...
Bourne v. E.L DuPont de Nemours, No. 02 1469,
slip op. (4th Cir. Jan. 27, 2004) (per curium)....
Brock v. Merrell Dow Pharm., Inc., 874 F.2d 307
(Sth Cir.), modified on reh’g, 884 F.2d 166
(1989)......cssccsssessssseeessscecsereensseseersssseneesseaneseceess
Cavallo v. Star Enterprise, 100 F.3d 1150 (4th
Cir. 1996).......ccccccssscsscvesssenccenseesesossssoncessnsesesenes
Daubert v. Merrell Dow Pharm., Inc., 43 F.3d
1311 (Oth Cir, 1995) ....ceceseeeseeeeseeeeseeeetenneeeees
Daubert v. Merrell Dow Pharm., Inc., 509 U.S.
579 (1993)..ccsccscssesseseeseeeereeeeeeseeeesesssersneeneneeneenes
DePyper y. Navarro, No. 83-303467-NM, 1995
WL 788828 (Mich. Cir. Ct. Nov. 27, 1995),
aff'd, No. 191949, 1998 WL 1988927 (Mich.
NOv. 6, 1999) .....scccsccssscsssesesseesreesseeseesessonsnesseeens
Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159

(D.C. Cir. 1990)....cccceceeeeeereseeseeseeeeeteeenenenenenenes
Elkins v. Richardson-Merrell, Inc., 8 F.3d 1068
(6th Cir. 1993) ....secsceceeceeeeeerenseeseeeeseeneneneneneenes
Ferebee y. Chevron Chemical Co., 736 F.2d
1529 (D.C. Cir. 1984) ...ceceeeseereeseseeeeseseneenenees
Kumho Tire Co. v. Carmichel, 526 U.S. 137
(1999).....cccssssssesecssssseeeeseeeteeessessenessessenseseeneesees

Lynch v. Merrell-National Lab., 830 F.2d 1190
(Ast Cir, 1987)... ccccceseecesetseseesereeseneeneenennensens
National Bank of Commerce v. Dow Chem. Co.,
965 F. Supp. 1490 (E.D. Ark. 1996), aff'd, 133
F.3d 1132 (8th Cir. 1998)... eeeeseesseeereeereenees

Page
#2, 13

11

passim

2

12

6

12

A SD

Vv
TABLE OF AUTHORITIES—Continued

Page
Oxendine v. Merrell Dow Pharm., Inc., No. 82-
1245, 1996 WL 680992 (D.C. Super. Ct. Oct.
Dh, RR i iccimcnsitticrintiimnmomaen 6
Raynor v. Merrell Pharm, Inc., 104 F.3d 137]
SC. C8, FIM ivkcccitniimiomumaanand 12
Richardson v. Richardson-Merrell, Inc., 857 F.2d
S23 Le, TB hicosetectinicmcerniniseaicn 1Z, ¥2
Turpin v. Merrell Dow Pharm., Inc., 959 F.2d
ESOP Cite Cle. FIED encccteerecesirtvceiaramnnis 12, 13
Wade-Greaux v. Whitehall Labs., Inc., 874 F.
Supp. 1441 D.V.1., aff'd, 46 F.3d 1120 (3d Cir.
PG niciccrcieeioninnncnnvpaaiiaddanaaimmtien 6, 11-12
Wilson v. Merrell Dow Pharm., 893 F.2d 1149
CFO Che, FRI ic esiccciexeperncsannipcinscriicnrseneconcoen 12
RULE
Pen. TB TR rccicccsiiccemmncaan: 1,15
OTHER AUTHORITIES
Robert L. Brent, Utilization of Animal Studies to
Determine the Effects and Human Risks of
Environmental Toxicants (Drugs, Chemicals,
and Physical Agents), Pediatrics 113:984, 987
CDG iin scisisiinaniviaidencncnaviniciesiisaananmnamimenie 6-7, 11
James L. Schardein, Chemically Induced Birth
Defects (3d ed. Rev. 2000) ...........c.cssrsressssscesees 6, 11

Anthony R. Scialli, 4 Clinical Guide to Repro-
ductive and Developmental Toxicity (1992)......4, 6, 11

Thomas H. Shepard, “Proof” of Human
Teratogenicity, Teratology 50: 97-98 (1994)..... 6, 11

Thomas H. Shepard, Catalog of Teratogenic

Agents (10th €d. 2001)......cccsesoscsorvseessesserreseassees 6, 11
Thomas H. Shepard, Catalog of Teratogenic
Agents (Sth ed. 1998)..............ccscrcccrcssereseerenseses 6

vi
TABLE OF AUTHORITIES—Continued

Page
James G. Wilson, Embryotoxicity of Drugs in
Man, in the Handbook of Teratology (1977)
(James C. Wilson and F. Clarke Fraser, eds.).... 1]

IN THE

Supreme Court of the United States

No. 03-1586

ANDREW BOURNE, a minor by and through
his parents, next friends and natural guardians,
CHRIS BOURNE and MAGGIE BOURNE,

Petitioner,

Vv.

E.I. DUPONT DE NEMOURS & COMPANY.
Respondent.

On Petition for a Writ of Certiorari to the
United States Court of Appeals
for the Fourth Circuit

RESPONDENT?’S BRIEF IN OPPOSITION

STATEMENT OF THE CASE

This is a products liability case in which Petitioner Andrew
Bourne alleges that his ocular and other birth defects were
caused by his mother’s dermal exposure to Benlate while she
was pregnant. Benlate is a plant fungicide manufactured by
DuPont and sold worldwide for more than 30 years.

Pursuant to Federal Rule of Evidence 702, DuPont
moved to exclude the testimony of Petitioner’s causation
experts, Drs. Howard and Tackett. DuPont explained that
Drs. Howard’s and Tackett’s asserted methodology for deter-
mining the human teratogenicity of a substance was specula-

2

tive, scientifically invalid, unreliable, and not relevant. Fol-
lowing briefing, and agreement by the parties that the record
was complete and a hearing was not needed, the district court
granted DuPont’s motion without a hearing.

In a Memorandum Order dated January 11, 2002, the dis-
trict court held that Petitioner’s experts’ method of attempting
to extrapolate causation of human birth defects from single-
species, high dose gavage animal (rat) and in vitro (cell
culture) studies was neither reliable nor relevant. Petitioner
then requested, without objection from DuPont, that the
evidentiary deposition of an epidemiologist, Dr. Ozonoff—
another designated expert of Pefitioner—be made a part of
the record and considered by the court. After granting
Petitioner's request and considering Dr. Ozonoffs testi-
mony,’ the district court reissued its Memorandum Order,
revised in minor respects to reflect its further consideration of
Dr. Ozonoff’s testimony, and granted DuPont’s motion to
exclude on the same basis set forth in its original order. See
Bourne v. E.I. DuPont de Nemours & Co., 189 F. Supp. 2d
482, 496-501 (S.D.W. Va. 2002), Pet. App. at 71-84. Absent
proof of causation for Petitioner’s claim, the district court
granted DuPont’s motion for summary judgment and dis-
missed the case.

Petitioner appealed to the United States Court of Appeals
for the Fourth Circuit. The court of appeals concluded that in
“excluding the proffered testimony, the district court properly
exercised its ‘gate-keeper’ function by focusing on the
methodology employed by the expert rather than the conclu-
sions they reached ... we can not say that the district court
abused its discretion.” See Bourne v. E.1. DuPont de
Nemours, No. 02-1469, slip op. at 6 (4th Cir. Jan. 27, 2004)

' As the January 11, 2002, order reflects, the district court had already
considered Dr. Ozonoffs views (based on an earlier discovery
deposition). See January 11, 2002 Memorandum Order at 21-23.

3

(per curium), Pet. App. at 7. On that basis the Fourth Circuit
affirmed the decision of the district court excluding the
testimony of Drs. Howard and Tackett. /d. Petitioner filed a
petition for rehearing which was denied on February 23,
2004.

This petition followed.
REASONS FOR DENYING WRIT

The Court should decline to grant the petition for a writ of
certiorari. The district court properly exercised its “gate-
keeper” function in finding that the Petitioner's experts’
proposed method of extrapolation of human teratogenicity
from single-species, high dosage gavage rat tests and in vitro
tests was unreliable and lacked “fit.” This case does not
present the question that Petitioner advertises—even assu:a-
ing that such a question would warrant certiorari. Contrary to
Petitioner’s assertions, the court of appeals’ decision does not
require “positive” epidemiology as a basis for expert opinion
testimony concerning causation in a toxic tort case. Even if
the court of appeals had required “positive” epidemiology in
this case, such a holding would not conflict with the decisions
of other federal courts of appeal in teratology cases.

I. THE DISTRICT COURT PROPERLY EXER-
CISED ITS “GATEKEEPER” FUNCTION IN
FINDING THE PROPOSED METHOD OF
EXTRAPOLATION OF HUMAN. TERATO-
GENICITY FROM SINGLE-SPECIES, HIGH
DOSAGE GAVAGE RAT TESTS AND IN VITRO
TESTS UNRELIABLE AND LACKING IN “FIT”.

As the district court observed, “Drs. Howard and Tackett
have derived their general causation theory, that benomyl is
teratogenic to humans, based solely upon in vivo rat gavage
studies and in vitro tests.” Bourne, 189 F. Supp. 2d at 495,
Pet. App. at 71. The district court then identified the scien-

4

tific and factual shortcomings of the methodology that they
had used. These included:

Significant differences between species in terato-
genic response to chemicals. /d. at 496-97, Pet. App.
73-75.

Petitioner's experts’ disavowal of and inability to
explain the results of benomyl tests on two other
animal species—rabbit and mouse—that showed no
ocular birth defects in the offspring. /d. at 496-97,
Pet. App. at 73-75.

The absence of tests on species closely related to
humans. /d. at 496-97, Pet. App. at 72-75.

The use of high dosages in the rat tests, far in ex-
cess of human exposures. /d. at 498-99, Pet. App. at
76-78.

In vitro test exposures at high levels for 24 hours, far
in excess of human exposures. /d. at.498-99, Pet.
App. at 76-78.

A mode of exposure, direct injection into the stom-
achs of rats, unlike the human dermal exposure that
was at issue in this case. /d. at 498-500, Pet. App. at
76-83.

Petitioner’s experts’ unfounded rejection of human
data contrary to their position. /d. at 493, 495, 497,
Pet. App. at 72-73, 75-77, 80-83.

The district court discussed the fact that teratologists (and
other courts) have rejected in vivo animal and in vitro tests as.

a basis for finding human teratogenicity in birth defect cases.

2

? See also Anthony R. Scialli, A Clinical Guide to Reproductive and
Developmental Toxicity at 60-61 (1992) (teratologists do not accept posi-
tive results in animal tests as proof of human teratogenicity because there
are (1) species differences in the pharmacokinetics/handling of chemicals
(difference in absorption, distribution, metabolism, elimination); (2) spe-
cies differences in fetal and embryo susceptibility, and (3) differences in

5

Id. at 496-97, Pet. App. at 73-77. This analysis of the facts,
science, and law relating to the methodology employed by
Petitioner’s experts—extrapolation of human teratogenicity
from single-species, high dosage gavage animal tests and in
vitro tests—is precisely the kind of “gate-keeping”
contemplated by this Court’s Daubert decision. The court of
appeals opinion recognizes that the district court’s “well-
reasoned opinion” reflects the type of “gate-keeping” that this
Court’s decisions mandate. See Bourne, slip. op. at 6, Pet.
App. at 7.

Il. THE PETITION INCORRECTLY ASSERTS
THAT THE COURT OF APPEALS CREATED A
RULE REQUIRING EPIDEMIOLOGY TO BE
THE BASIS FOR EXPERT OPINION TESTI-
MONY CONCERNING CAUSATION IN TOXIC
TORT CASES.

Petitioner asserts that this case presents the question
“whether Daubert requires positive epidemiology to support a
finding of causation in a toxic tort case.” Petition at 7. That
assertion misstates the holdings of both the district court and
the court of appeals. Neither court held that epidemiological
evidence was a prerequisite to expert opinion testimony on
causation in such cases.

The district court did not require epidemiological evidence
as a basis of expert opinion testimony offered as proof of
causation in this case. Rather, the district court focused on
the specific methodology employed by Drs. Howard and
Tackett—extrapolation of human teratogenicity from rat
gavage tests and extrapolation of human teratogenic dose
levels from in vitro cell tests—and held that such extrapola-
tion was unreliable and irrelevant. Bourne, 189 F. Supp. 2d
at 496, 497-54 (Pet. App. 72, 73-84). Epidemiological evi-

the dose and route of exposure (e.g., gavage v. dermal) as between
humans and laboratory test animals).

6

dence would present a way of bridging the gap the court
correctly saw in Petitioner's methodology in assessing
causation, but nowhere did it hold that epidemiology was
mandated. It held that what was presented by Petitioner’s
experts was not acceptable because it was unreliable and
irrelevant. The court of appeals, without referring to epi-
demiology at all, approved the district court opinion as “well
reasoned” an4 held that that “the district court properly exer-
cised its ‘gate-keeper’ function by focusing on the method-
ology employed by the experts rather than the conclusion
they reached.” Bourne, slip. op. at 6, Pet. App. at Sa

3 While it was not the basis for the district court’s exclusion of
Drs. Howard’s and Tackett’s opinion testimony or the basis for the court
of appeals’ decision affirming that exclusion, the absence of any human
evidence of Benlate teratogenicity reflects a major methodological failure
in the derivation of Petitioner’s experts’ opinions. The generally ac-
cepted, peer reviewed, methodology employed by clinical teratologists
requires positive human studies to establish human teratogenicity of a
substance, as numerous trial courts have recognized. See Wade-Greaux v.
Whitehall Labs., Inc., 874 F. Supp. 1441, 1451 (D.V.L), aff'd, 46 F.3d
1120 (3d Cir. 1994); National Bank of Commerce v. Dow Chem. Co., 965
F. Supp. 1490, 1497 n. 14, 1499-1500 (E.D. Ark. 1996), aff'd, 133 F.3d
1132 (8th Cir. 1998); DePyper v. Navarro, No. 83-303467-NM, 1995 WL
788828, at *32 (Mich. Cir. Ct. Nov. 27, 1995), aff'd, No. 191949, 1998
WL 1988927 (Mich. Nov. 6, 1999); Oxendine v. Merrell Dow Pharms.,
Inc., No. 82-1245, 1996 WL 680992, at *7 (D.C. Super. Ct. Oct. 24,
1996).

Daubert and Kumho establish that, in assessing the reliability of expert
testimony, a trial court should look to the principles of the discipline or
field in which the opinion is being offered. Kumho Tire Co. v. Carmichel,
526 US. 137, 152 (1999); Daubert v. Merrell Dow Pharm., Inc., 509 U.S.
579, 591-95 (1993); see also Cavallo v. Star Enterprise, 100 F.3d 1150,
1159 (4th Cir. 1996) (Daubert factors “require that the methodology and
reasoning used by a witness have a significant place in the discourse of
experts in the field.”) The field of teratology requires epidemiology for a
determination that a substance is a human teratogen. See, ¢.g., Thomas
H. Shepard, “Proof” of Human Teratogenicity, Teratology 50: 97-98
(1994); Thomas H. Shepard, Catalog of Teratogenic Agents at xxiv (10th

7

The Petition does not address the actual holding of the
court of appeals or the holdings of the district court which
were affirmed by the court of appeals. Nor does the Petition
state a question for review that arises from those decisions.
The lack of connection between the arguments of Petitioner
and the holdings of the courts below is apparent from the
following comparison:

‘Actual District Court Hold-
ings Affirmed By The Cou

Petitioner’s Argument As To
What The District Court and

Court of Appeals Held Of Appeals .

“Nonetheless, the principal “(T]he extrapolations of

reason the District Court
excluded the testimony of
Drs. Howard and Tackett
was their reliance on
Dr. Ozonoff's conclusion
that these epidemiological
studies were flawed and
irrelevant.” (Petition at 8)

“fY]Jet the District Court

Drs. Howard and Tackett,
from high-dosage, single
species in vivo testing and
lengthy benomyl exposure
in vitro testing, to conclude
that benomyl is a human
teratogen and to establish
the levels at which it is
alleged to be teratogenic,

are neither reliable, pursu-
ant to the first prong of
Daubert, nor relevant, un-
der the second prong.”

used Ozonoff’s analysis of
the existing Benlate epide-
miology as the primary

ed. 2001); James L. Schardein, Chemically Induced Birth Defects, at
43-44 (3d ed. Rev. 2000), quoting Thomas H. Shepard, Catalog of
Teratogenic Agents (8th ed. 1998); Robert L. Brent, Utilization of Animal
Studies to Determine the Effects and Human Risks of Environmental
Toxicants (Drugs, Chemicals, and Physical Agents), Pediatrics 113:984,
987 (2004). If the district court and the court of appeals had recognized
such a requirement for expert testimony on the human teratogenicity of a
substance, that ruling would have been correct and would not have been
an abuse of discretion. The lower courts in this case did not, however,
reach that issue and they need not have done so. It was a sufficient basis
for their decisions that they examined the methodology in fact used by
Drs. Howard and Tackett, rejecting it as unreliable and irrelevant.

basis to exclude Howard
and Tackett’s testimony.”
(Petition at 13)

“But in affirming the Dis-
trict Court’s decision, the
Fourth Circuit, . . . implic-
itly overruled its own ear-
lier decisions holding that
epidemiological — support
was not a prerequisite to
establishing causation in
toxic tort cases.” (Petition
at 7)

(Bourne, 189 F. Supp. 2d
at 496, Pet. App. at 72)

“The court concludes that
Drs. Howard and Tackett
have failed to offer suffi-
cient support for the other-
wise suspect single species
in vivo tests and in vitro
tests to render method-
ologically sound an extra-
polation of human terato-
genicity.” (Bourne, 189
F. Supp. 2d at 497-98, Pet.
App. at 76)

“Moreover, the rat gavage
studies and the in vitro
tests relied upon by
Drs. Howard and Tackett,
using injections of high-
levels of benomyl directly
into the stomach of rats
and high-level in vitro
dosing of cells of both rats
and humans in benomy] for
24 hours, do not ‘fit? with
the facts of the case as
alleged.” (nuurne, 189
F.Supp. 2d at 498, Pet.
App. at 76)

The district court, in arriving at its conclusions, discussed
some of the reasons that teratologists do not accept extra-
polation of human teratogenicity from animal and in vitro
tests. See Bourne, 189 F. Supp. 2d at 496-98, Pet. App. at 72-
77; see also discussion, supra, at 3-4. In the context of that
discussion, the district court noted as well that, “in the

Ere

9

absence of other strong indicators of the reliability of in vivo
and in vitro tests, including supporting epidemiological
studies, testing on closely related species, and the use of
comparable dosages, courts have overwhelmingly found un-
reliable the methodology of extrapolating human teratogenic-
ity from in vivo and in vitro tests.” Bourne, 189 F. Supp. 2d
at 496, Pet. App. at 73. In other words, the court properly
recognized that the type of testing done here involving ultra-_
high doses given to rats by gavage, is not generally accepted
as a basis for extrapolating human teratogenicity under the
standards of the relevant discipline. Rather, teratologists
require additional indicia of reliability, including epidemic-
ology. See supra notes 2 and 3. The district court’s factual
observations that teratologists and other courts reject extrapo-
lation of human teratogenicity from single-species, high
dosage gavage animal tests and in vitro tests are not holdings
by the district court that epidemiology is an essential basis for
expert opinion offered to prove causation in a case involving
toxic torts; they are recognition that such extrapolation is
not generally accepted in the field of teratology Signifi-
cantly, Petitioner cites no case under Daubert an Rule 702
challenging the court’s observation that other courts, like
teratologists, do not accept such extrapolation.

Nor was the district court’s additional observation that the
existing Benlate epidemiological evidence is contrary to
Petitioner’s position, (id. at 497 & n.23, Pet. App. at 75 &
n.23), a holding that epidemiology is affirmatively required to
demonstrate causation."

* The district court’s determination that Drs. Howard’s and Tackett’s
rejection of Benlate epidemiological studies—which find no association
between Benlate exposure and birth defects—was unfounded, Bourne,
189 F. Supp. 2d at 493, Pet. App. 30, does not constitute a holding by the
district court that epidemiology is a prerequisite to proof of causation.
The district court ruling that Drs. Howard’s and Tackett’s rejection of
epidemiology that is contrary to their position is unfounded—the sole
focus of the Petition—is irrelevant to whether Petitioner’s experts could

10

The court of appeals’ affirmance of the district court’s
actual holdings does not convert these separate factual obser-
vations by the district court into rulings by the court of
appeals that epidemiology is a prerequisite to opinion testi-
mony on causation in toxic tort cases. Petitioner has mis-
characterized the basis for the district court’s holding on the
unreliability and lack of “fit” of Drs. Howard’s and Tackett’s
methodology. The Petition ignores the fact that the opinion of
the court of appeals says nothing, explicitly or implicitly,
about the place of epidemiology in proving causation in toxic
tort cases. Petitioner’s stated questions for review do not arise
from and are unrelated to the court of appeals decision in

this case.

Ill. THERE IS NO CONFLICT BETWEEN THE
DECISION OF THE COURT OF APPEALS IN
THIS CASE AND ANY OTHER CIRCUIT.

There is no circuit conflict.

First, the court of appeals’ decision in this case does not
require that expert testimony concerning causation in toxic
tort cases be based on “positive” epidemiology. The appellate
opinion says nothing on that subject. Nor does its affirmance
of the district court decision implicitly or “effectively”
suggest that result as Petitioner argues. The district court
decision excluding the testimony of Drs. Howard and Tackett
is based on the fact that their methodology—extrapolation of
human teratogenicity from single-species, high dosage
gavage animal tests and in vitro tests—is unreliable and
irrelevant; it is not based on the failure of the experts in this
case to rely on “positive” epidemiology. The opinion of the
district court does not say or imply that the court is requiring

properly extrapolate human teratogenicity from rat and in vitro tests.
Such extrapolation is not a reliable methodology in the field of teratology
and the district court properly so held. See id. at 497 n.21, Pet. App. at

75 n.21.

11

experts to base their opinions on “positive” epidemiology in
order to prove causation in toxic tort cases. The court of
appeals decision cannot, therefore, be in conflict with
decisions of other circuits regarding lack of need for “posi-
tive” epidemiology in some toxic tort cases.

Second, even if the Fourth Circuit had required “positive”
epidemiology, such a holding would not conflict with the
decisions of other federal courts of appeal in feratology cases.
In evaluating the circuit conflict issue that Petitioner seeks to
raise, it is important to distinguish teratology cases from other
toxic tort cases. Some fields of science or medicine involved
in other toxic torts may not in fact rely heavily or at all on
epidemiology.” That is not the case with respect to teratology.
The generally accepted methodology for determining human
teratogenicity of a substance involves: (1) identifying a
specific pattern of malformation associated with exposure to
the substance; (2) consistent human studies (epidemiology)
and occurrence of the specific pattern of malformation;
(3) repeated positive animal tests in multiple species at doses
and routes of exposure similar to those involved in human
exposures; (4) in vitro tests identifying a mechanism of
action; and (5) biological plausibility that the agent’s mecha-
nism of action could cause the pattern of defects associated
with exposure.”

* See, e. g., Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378 (4th Cir. 1995)
(where issue was_whether liver damage was caused by Tylenol/alcohol
consumption or by herpes, epidemiology was unnecessary and a meth-
odology consisting of identifying a history of Tylenol/alcohol use, labora-
tory tests showing presence of Tylenol in blood, and microscopic exami-
nation of liver tissue samples to confirm whether tissue damage was or
was not characteristic of damage caused by Tylenol was acceptable for
diagnostic purposes concerning causation).

-° See Thomas H. Shepard, “Proof” of Human Teratogenicity, Tera-
tology 50:97-98 (1994); Thomas H. Shepard, Catalog of Teratogenic
Agents at xxiv (10th ed. 2001); Robert L. Brent, Utilization of Animal
Studies to Determine the Effects and Human Risks of Environmental

12

The case law of the various circuits is uniform in acknowl-
edging that epidemiology is an essential basis for expert
opinion testimony concerning causation in feratology cases.’
Thus, even if the Fourth Circuit decision in this case were
interpreted to require that expert opinion in the field of
teratology be supported in part by epidemiology, that inter-
pretation would create no conflict among the circuits.

Third. none of the cases cited by Petitioner demonstrate
any controversy about the role of epidemiology in teratology
cases. With two exceptions, those cases do not involve
expert testimony in the field of teratology. One exception is
Ambrosini® While it is a teratology case, it provides
Petitioner no support for his argument that there is a conflict
in the circuits. In Ambrosini, there was “positive” epidemiol-
ogy indicating an association between the type of drug in-
volved, a progestin, and birth defects; the plaintiff's expert so
asserted in an affidavit filed in opposition to a motion for

Toxicants (Drugs, Chemicals, and Physical Agents), Pediatrics 103:984,
987 (2004); James L. Schardein, Chemically Induced Birth Defects at 44
(3d ed. Rev. 2000); Anthony R. Scialli, 4 Clinical Guide to Reproductive
and Developmental Toxicology at 60, 65, 84 (1992); James C. Wilson,
Embryotoxicity of Drugs in Man, in the Handbook of Teratology at 311-
12 (1977) (James C. Wilson and F. Clarke Fraser, eds.); Wade-Greaux,
Inc., 874 F. Supp. at 1450-55; National Bank of Commerce v. Dow Chem.
Co., 965 F. Sups. at 1497 n. 14, 1499-1500; see also cases cited in note 7,
infra.

’ See Raynor v. Merrell Pharm, Inc., 104 F.3d 1371, 1375 (D.C. Cir.
1997); Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1321 (9th Cir.
1995) (Daubert II); Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159 (D.C.
Cir. 1990); Wilson v. Merrell Dow Pharm., 893 F.2d 1149, 1154 (10th
Cir. 1990); Brock v. Merrell Dow Pharm., Inc., 874 F.2d 307, 313 (Sth
Cir.), modified on reh'g, 884 F.2d 166 (1989), Richardson v. Richardson-
Merrell, Inc., 857 F.2d 823, 830-31 (D.C. Cir. 1988); Lynch v. Merrell-
National Lab., 830 F.2d 1190 (Ist Cir. 1987); cf Elkins v. Richardson-
Merrell, Inc., 8 F.3d 1068, 1071 (6th Cir. 1993); Turpin v. Merrell Dow
Pharm., Inc., 959 F.2d 1349, 1360 (6th Cir. 1992).

8 4mbrosini v. Labaraque, 101 F.3d 129 (D.C. Cir 1996).

13

summary judgment.’ Ambrosini specifically relied on the fact
the plaintiff experts had based their conclusions concerning
causation of birth defects on “human” (epidemiological)
evidence.'!° Thus, anything the Ambrosini court may have
said about the lack of necessity for epidemiology’ | was dicta
unrelated to the decision in the case. Indeed, in Ambrosini
the D.C. Circuit discussed its prior Richardson decision with
approval.'? That case held that animal tests, in vitro tests, and -
recalculated epidemiology studies that are at odds with the
underlying epidemiology studies are not relied on by experts
in the field of teratology.

The only other teratology case cited by Petitioner to
suggest a conflict in the circuits, Turpin, is not about “posi-
tive” epidemiology or about failure of plaintiff experts to rely
on “positive” epidemiology to prove causation in a teratology
case.'> The epidemiology in that case was 35 negative stud-
ies relied on by defendant to demonstrate no causal relation
between the drug Bendectin and birth defects. Turpin did not
hold that plaintiff experts need not rely on epidemiology;
rather, Turpin held that defendant’s epidemiology studies in
that case were not so conclusive that they warranted grant of
summary judgment for defendant. “

The Fourth Circuit has not yet addressed the issue whether
epidemiology is a required basis of expert testimony concern-
ing causation in a teratology case. Neither of the Fourth
Circuit cases cited by Petitioner to suggest a conflict within

9 Id. at 132, 136, 139.
10 Td. at 141.

'! The material quoted by Petitioner as if it were from Ambrosini is
actually from another case, Ferebee v. Chevron Chemical Co., 736 F.2d
1529 (D.C. Cir. 1984), which is not a teratology case.

\2 Ambrosini, 101 F.3d at 138, 140.

'3 Turpin v. Merrell Dow Pharm., Inc., 959 F.2d 1349 (6th Cir. 1992).
* Id. at 1353-57.

14

the Fourth Circuit’s own case law—Westberry and Benedi—
are teratology cases. Thus, there would be no conflict in the
Fourth Circuit’s own case law even had the court of appeals
in this case required that expert testimony in teratology cases
be based in part on epidemiology."

CONCLUSION
The petition for writ of certiorari should be denied.

Respectfully submitted,

DAVID B. THOMAS PATRICK W. LEE *
ALLEN, GUTHRIE, MCHUGH, CLIFTON S, ELGARTEN

& THOMAS, PLLC WILLIAM L. ANDERSON
500 Lee Street, East EMMA K. BURTON
Suite 800 CROWELL & MORING LLP
Charleston, W.Va. 25301 1001 Pennsylvania Avenue, N.W.
(304) 345-7250 Washington, DC 20004-2595

(202) 624-2500

* Counsel of Record Counsel for Respondent

June 25, 2004

'S Petitioner's argument (at 20-21) that the “disparate decision” of the
Florida Supreme Court in Castillo “cr[ies] out for intervention by this
Court” to provide guidance and promote uniformity ignores the fact that
Castillo was decided under the Frye standard while the decision in this
case was guided by Rule 702 and the Daubert standard. Uniformity of
decisions under Frye and under Daubert cannot be expected because of
the differences in the two rules and thus, Petitioner's argument from
Castillo does not support a writ of certiorari.

I |

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386020_1707%3A1. Public record. Not legal advice.