Opposition Brief — DeLuca ex rel. DeLuca v. Merrell Dow Pharmaceuticals, Inc.

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No. 93-711

In The

Supreme Court of the United States

| October Term, 1993

ame

AMY DeLUCA, an infant by her guardian ad litem,

y B

Cindy DeLuca, and Cindy DeLuca and

Ronald DeLuca, individually,

Petitioners,

vs.

MERRELL DOW PHARMACEUTICALS, INC., Dr. Patrick

J. Dwyer, Dr. Teresa Benecki, Dr. Pieter J. Ketelaar,

Dr. Robert E. Sexton, ind. and t/a Pineland Associates,

Respondents.

, *

Petition For Writ Of Certiorari

To The United States Court Of Appeals

For The Third Circuit

BRIEF IN OPPOSITION

SuSAN ScoTT Frank C. Woopsipe III

Riker, DANZIG, SCHERER, Counsel of Record

Hytanp & PErRRETTI DinsmMorE & SHOHL

One Speedwell Avenue 1900 Chemed Center

Morristown, NJ 07962-1981 255 E. 5th St.

(201) 538-0800 Cincinnati, OH 45202-3172

(513) 977-8200

Attorneys for Respondents

December 1, 1993

COCKLE LAW BRIEF PRINTING CO., (800) 225-6964

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QUESTION PRESENTED FOR REVIEW

Whether the court of appeals, in affirming the district

court's holding that proffered expert testimony was unre-

liable as set forth in its findings of fact and conclusions of

law, correctly applied to the particular facts of this case

the standard for admissibility of expert testimony set

forth in Daubert v. Merrell Dow Pharmaceuticals Inc., 509

U.S. __, 113 S. Ct. 2786 (1993).

PARTIES

Merrell Dow Pharmaceuticals Inc. (“Merrell Dow”) is

a wholly-owned subsidiary of Marion Merrell Dow Inc.

as of December 2, 1989. Approximately 70% of the stock

of Marion Merrell Dow Inc. is held by the Dow Chemical

Company. Both Marion Merrell Dow Inc. and the Dow

Chemical Company are publicly held corporations. A

complete list of publicly held subsidiary and affiliates

follows:

The Dow Chemical Company

Arabian Chemical Company Limited

~ DCU/LB TRUST

Destec Energy, Inc.

Dexco Polymers

Dow Chemical Iberica S.A.

Chemtech Royalty Associates, L.P.

DowBrands Espanola S.A.

Crestar Energy Inc.

Fort Saskatchewan Ethylene Storage Limited

Partnership

H-D Tech Inc.

Cromarty Petroleum Company Limited

Petroquimica-Dow S.A. (Petrodow)

Dow Chemical Japan Limited

Ulsan Pacific Chemical Corporation

Epoxital S.R.L.

Safechem Umwelt Service GmbH

DowBrands L.P.

Dow Corning Corporation

Marion Merrell Dow Inc.

Fort Saskatchewan Ethylene Storage

Corporation

Promix System

Dow Kakoh Kabushiki Kaisha

ili

PARTIES —- Continued

Dow Mitsubishi Kasei Limited

Dow Quimica Argentina S.A.

Anticorrosivos Industriales Limitada

Dow-United Technologies Composite

Products Inc.

E] Dorado Terminals Company

Expandite Essex Pty. Limited

Gurit-Essex A.G.

Etoxilados del Plata S.A.

H.D. Polyurethane Company

Joliet Marine Terminal Trust Estate

Lucky Epoxy Limited

Marisub V, Inc.

Carderm Capital L.P.

Marion Merrell Dow K.K.

MDP Holdings Ltd.

PT. Pacific Indomas Plastic Indonesia

Airco Generon Systems LP

DH Compounding Company

DowElanco

Dong Yang Elanco Co. Ltd.

DowElanco B.V.

Elanco Ihara K.K.

P.T. Pacific Chemicals Indonesia

Generon Systems

Generon Systems A.G.

Sumitomo Dow Limited

Zhejiang Pacific Chemical Corporation

TABLE OF CONTENTS

Page

QUESTION PRESENTED FOR REVIEW ............ i

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REASONS FOR DENYING WRIT .................% 4

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TABLE OF AUTHORITIES

Page

Cases

Daubert v. Merrell Dow Pharmaceuticals Inc., 509

US. Wu 299.3. CE Bb Cae ccna ae 4, 5, 6, 7

Goodman v. Lukens, 482 U.S. 656 (1987)............... 7

Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 336

US. 2Fk (RGR isi bedi ee eee eee 6

Kogers v. Lodge, 458 U.S. 613 (9962) 22650 ou cuccannns 7

RULES

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red. KR. BWie: FOZ. 5s css es tka eceawee eee

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STATEMENT OF THE CASE

The infant plaintiff, Amy DeLuca, was born with

limb reduction defects which plaintiffs allege were due to

Mrs. DeLuca’s ingestion of the pharmaceutical product

Bendectin during pregnancy. On remand, the court held a

hearing in accordance with Fed. R. Evid. 104(a). That

hearing ultimately extended over five court days. The

court took extensive testimony from experts offered by

defendant Merrell Dow, including epidemiologists Rich-

ard Monson, M.D., Sc.D.; Nicholas Wright, M.D., M.P.H.;

Steven H. Lamm, M.D.; and Gerald A. Faich, M.D.,

M.P.H.; geneticist Pauline Brenholz, M.D.; and bioche-

mist/pharmacologist Paul Stanley Lietman, M.D., Ph.D.

Although not limited by the trial court, plaintiffs offered

only one witness on the issue of causation, Dr. Alan K.

Done, plus a second witness, Dr. Shanna Swan (an epi-

demiologist), whose role was limited to rendering an

opinion on Dr. Done’s use of epidemiology. The district

court found that Dr. Swan:

did not independently verify the data included

on Dr. Done’s chart, did not check his calcula-

tions and did not check to see if Dr. Done cor-

rectly extracted the data from the articles as to

which he made no calculations. Swan Test., Tr.

7/12/91, at 7-14. Dr. Swan merely commented

on Dr. Done’s methodology as he described it

and “took as a given that he did what he said he

did.” Swan Test., Tr. 7/12/91, at 9-21.

(15a, J 32 footnote omitted.)! Given the absence of an

independent opinion on causation by Dr. Swan, the

district court’s inquiry properly focused on the methodol-

ogy of Dr. Done.

Dr. Done conceded that the authors of the over 30

published studies on Bendectin had concluded that their

studies failed to demonstrate an association between

Bendectin and limb reduction defects, (13a, J 24), but

contended that his reanalysis of the studies according to

his own methodology established an association beiween

Bendectin and birth defects, (13a-14a, J 28). The district

court found that the methodology used by Dr. Done in

making his calculations and presenting his data was not

standard epidemiologic methodology, and was so replete

with error that it was completely unreliable. The court

found that defense experts Dr. Richard Monson, Dr.

Nicholas Wright, and Dr. Steven Lamm, as well as plain-

tiffs’ own expert, Dr. Shanna Swan, all testified that they

could not replicate Dr. Done’s recalculations in many

cases, (16a, J 36), and specifically found that:

Dr. Swan, plaintiffs’ epidemiologist and statisti-

cian, could not verify the accuracy of Dr. Done’s

calculations. In addition, she testified that she

was frequently unable to determine the precise

methodology used by Dr. Done in selecting data

to calculate relative risks and confidence inter-

vals, and in actually calculating those intervals.

1! All citations in this Statement of the Case are to the

Appendix attached to the Petition for Writ of Certiorari.

(38a, J 18.) The court further found that the method used

by Dr. Done was not in conformance with any known

methodology:

[t]he defense experts as well as Dr. Swan testi-

fied that the precise method used by Dr. Done in

making some of his calculations was a mystery

and was not in conformance with any known

methodology.

(l6a, I 35.)

The methodological errors of Dr. Done included cal-

culating relative risks outside of the confidence intervals,

(17a, J 37), calculating two different relative risks from

the same study, (17a, { 38), inflating certain relative risks,

(17a-18a, {YJ 40-42; 19a, J 48; 20a, Tf 53, 54), incorporat-

ing data not relating to the Bendectin ingested by Mrs.

DeLuca, (20a-21a, {YJ 56, 59), and treating preliminary

drafts as if they were final studies, (21a, {J 61, 62). Dr.

Done also selectively included and excluded data,

(24a-25a, [J 76-83), improperly weighed data, (25a-26a,

W1 84-88), presented confidence intervals in a misleading

manner, (27a-28a, {¥ 92-97), and made numerous other

errors and misstatements on his graphs, worksheets, and

charts, (28a-30a, {J 98-103; 30a-31a, YY 108-113). The

district court accordingly found Dr. Done’s methodology

to be unreliable under Fed. R. Evid. 702.

The district court also found that Dr. Done relied on

data not reasonably relied upon by experts in the field of

epidemiology, (22a-23a, {Y 68-75; 42a-44a, FY 33-38). It

therefore also found that Dr. Done’s testimony was addi-

tionally excludable under Fed. R. Evid. 703.

The case was fully briefed before the Third Circuit

Court of Appeals. After briefing was completed, the court

of appeals stayed disposition of the matter pending this

Court’s decision in Daubert v. Merrell Dow Pharmaceuticals

Inc. After the decision in Daubert was issued, see 509 U.S.

__, 113 S. Ct. 2786 (1993), the Third Circuit Court of

Appeals requested supplemental briefing by the parties

on the applicability of the Daubert decision to the facts of

this case. In subsequently affirming the district court’s

opinion, the court of appeals noted that it had considered

both Daubert and the parties’ supplemental briefs before

rendering its decision. (4a.)

REASONS FOR DENYING WRIT

This Court fully considered and addressed the stan-

dards governing the admissibility of scientific evidence in

another Bendectin case in a recent opinion issued on June

28, 1993. Daubert v. Merrell Dow Pharmaceuticals Inc., 509

U.S. __, 113 S. Ct. 2786 (1993). The Third Circuit’s opin-

ion in the instant case specifically states that it considered

Daubert and the parties’ supplemental briefs addressed to

that case in affirming the decision of the district court. It

is respectfully submitted that plaintiffs have failed to

offer the slightest basis for revisiting the same issue of

admissibility of scientific evidence in the wake of

Daubert.

In Daubert, this Court held that the Federal Rules of

Evidence, rather than the “Frye test” or “general accep-

,tance” standard, govern the admissibility of scientific

expert testimony. The Court in Daubert directed trial

judges to closely scrutinize proffered scientific_expert

testimony:

[t]o the contrary, under the Rules the trial judge

must ensure that any and all scientific testimony

or evidence admitted is not only relevant, but

reliable.

509 U.S. at ___, 113 S. Ct. at 2795. This Court also noted its

confidence in the ability of federal judges to fulfill that

responsibility.

Faced with a proffer of expert scientific tes-

timony, then, the trial judge must determine at

the outset, pursuant to Rule 104(a), whether the

expert is proposing to testify to (1) scientific

knowledge that (2) will assist the trier of fact to

understand or determine a fact in issue. . . . We

are confident the federal judges possess the capacity

to undertake this review.

509 U.S. at __, 113 S. Ct. at 2796. (footnotes omitted)

(emphasis added). In this case the trial court judge and

the judges sitting on the court of appeals have demon-

strated that this confidence is well placed.

Although plaintiffs’ Statement of the Case attempts

to create the impression that a legal issue exists by means

of a distinction between methodology and Dr. Done’s

application of methodology, it is clear in this case that

this is a distinction without a difference. The methodol-

ogy that must be found reliable is not what experts say

they are doing but what they actually do. The concurrent

finding of the lower courts in this case was that Dr.

Done’s actual analysis, riddled with numerous indefens-

ible missteps (as recounted above), bore no recognized

relation to a reliable method of analyzing data for pur-

poses of scientific inference. This is not a case, therefore,

involving a legitimate scientific debate between reliable

schools of thought about the conclusions that may prop-

erly be drawn from experiments, statistics, or other

methods of analysis that are themselves accepted as

valid. Accordingly, the lower courts’ rejection of Dr.

Done’s testimony as inadmissible, far from crossing the

line into areas presenting jury questions, followed pre-

cisely the reliability approach contemplated by this

Court’s interpretation of Fed. R. Evid. 702 in Daubert. See

Daubert, 509 U.S. at __, 113 S. Ct. at 2797 (focus must be

on “principles and methodology, not on the conclusions

that they generate”).

In sum, the issue presented by the petition is in

reality nothing more than a factual inquiry as to whether

the record below is sufficient to support the lower court's

findings as to the unreliability of plaintiffs’ proffered

scientific expert testimony. Petitioners seek a review of

the evidence in a case where the district court made 120

detailed and specific findings of fact and 41 separate

conclusions of law after a five day Rule 104(a) hearing.

All three judges on the court of appeals concurred in the

affirmance of the district court’s decision, and all thirteen

judges sitting on the court of appeals concurred in the

denial of plaintiffs’ petition for a rehearing by the court

en banc.

It has been held that this Court “cannot undertake to

review concurrent findings of fact by two courts below in

the absence of a very obvious and exceptional show of

error.” Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 336

U.S. 271, 275 (1949). The Graver ruling was cited with

approval in Goodman v. Lukens Steel Co., 482 U.S. 656

(1987), which found:

[t]he Court of Appeals did not set aside any of

the District Court’s findings of fact that are rele-

vant to this case. That is the way the case comes

to us, and both courts below having agreed on

the facts, we are not inclined to examine the

record for ourselves absent some extraordinary

reason for undertaking this task.

Id. at 665; see also Rogers v. Lodge, 458 U.S. 613, 623 (1982)

(noting this Court’s reluctance “to disturb findings of fact

concurred in by two lower courts”). No “obvious and

exceptional” or “extraordinary” showing of error is pres-

ent here; to the contrary, the unreliability of plaintiffs’

expert testimony is fully supported by a voluminous

record.

Rule 10.1 of the Rules of the Supreme Court sets forth

the “character of reasons” that will be considered in

determining whether to grant a writ of certiorari.

Although Rule 10.1 states that its guidelines for the grant-

ing of a petition for a writ of certiorari are “neither

controlling nor fully measuring the Court’s discretion,” it

is worthy of note that the Daubert decision resolved all

prior conflicts among the circuits, and none of the other

reasons for granting a writ set forth in Rule 10.1 apply to

this case. Rule 10.1, moreover, specifically requires that

the granting of the writ be limited to cases where there

are “special and important reasons,” which are not pres-

ent here.

It is respectfully submitted that the petition for writ

of certiorari should be denied because the petition pri-

marily seeks a review of the factual record, there is no

conflict among the circuits, and there are no “special and

important reasons” as required by Rule 10.1 to grant

plaintiffs’ petition.

CONCLUSION

For the foregoing reasons, the petition for writ of

certiorari should be denied.

Respectfully submitted,

SusAN Scott FRANK C. Wooopsipe III