Opposition Brief — General Electric Co. v. Knight

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OFFICE OF THE Cicnn

In the Supreme ee _—

of the Gited States

OCTOBER TERM, 1990

IN RE: PAOLI RAILROAD YARD PCB LITIGATION

GENERAL ELECTRIC COMPANY,

NATIONAL RAILROAD PASSENGER CORPORATION.

CITY OF PHILADELPHIA, SOUTHEASTERN PENNSYLVANIA

TRANSPORTATION AUTHORITY, MONSANTO COMPANY.

and CONSOLIDATED RAIL CORPORATION, Petitioners.

MARY ALICE KNIGHT, et al., Respondents.

PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

BRIEF IN OPPOSITION TO

PETITION FOR A WRIT

OF CERTIORARI

Harold E. Kohn Arnold E. Cohen*

Joseph C. Kohn John Spelman

KOHN, SAVETT, KLEIN & GRAF, P.-C KLEHR, HARRISON, HARVEY

2400 One Reading Center BRANZBURG & ELLERS

1101 Market Strect 1401 Walnut Street

Philadelphia, PA 19107 Philadelphia, PA 19102

(215) 238-1700 215) 565-6060

Attorneys for Respondents,

Mary Alice Knight, et al

*Counsel of Record

D. Bruce Hanes

POWELL, O'SHEA, HANES & MINEHART

1700 Market Street

Suite 313]

Philadelphia, PA 19103

(215) 972-8200

Attorneys for Respondents

Christopher S. Brown, et al

EEE SE Oe © i BEE Ee

SMITH-EDWARDS-DUNLAP COMPANY, 2667 E. ALLEGHENY AVENUE, PHILADELPHIA, PA 19134 (215) 425-8800

TABLE OF CONTENTS

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COUNTERSTATEMENT OF THE CASE ............

A. ‘lhe Procedural History of this Case has Left a One-

Sided, Incomplete and Hopelessly Flawed Record .

B. The District Court's Decision and the Court of

I re

SUMMART/@r ARGUMENT ..................005.

REASONS FOR DENYING THE WRIT .............

A. The District Court Failed to Articulate the Bases

for its Rulings. Accordingly, the Record is not

Appropriate for Review in this Court .........

B. The District Court's Procedural Errors Required

Reversal by the Court of Appeals ............

C. The Third Circuit's Decision Does Not Conflict

With Decisions of Other Circuits or of this Court .

1. The “Speculative Opinion” Issue ..........

2. The Epidemiology and Animal Studies Issues

D. The Third Circuit Had a Duty to Predict

Whether Pennsylvania Would Adopt a Cause of

Action for Medical Monitoring ..............

E. The Circuits are no Longer Divided on the Val-

idation of a Premature Appeal by a Later Rule

OS PT Pee reer rer ee ree ee

fee ee rere ae eer

ADDENDUM

In re Paoli Railroad Yard PCB Litigation, 916 F.2d

829 (3d Cir. 1990)

TABLE OF AUTHORITIES

CASES: Page

Coal Resources, Inc. v. Gulf & Western Industries, Inc.,

O65 Fad TOE ee Cae ee eee keh aoa dab cea. 14

DeLuca v. Merrell Dow Pharmaceuticals, Inc., No. 89-5572

(Glod Ast. 36;,-TRGEE ccc cocoa ee ee 1]

Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159, 1160

(D.C. Cir.), cert. denied, 111 S. Ct. 370 (1990) 2... 1S

Environmental Defense Fund v. EPA, 598 F.2d 62, (D.C.

ly. FG cn hn nk dc be kee dae eee 3

Environmental Defense Fund v. E PA, 636 F.2d 1267 (D.C.

Cle. FRUBBD o .. ks aie bs cles ee ee es 3, Ad

Erie R.R. Co. v. Tompkins, 304 U.S. 64 (1938) 2.2.02... 8, 19

FirsTier Mortgage Co. v. Investors Mortgage Insurance

Company, 111 S. Ct. G46 (IGBE) .. ee cei. 20)

Hull v. Merck & Co., Inc., 758 F.2d 1474 (11th Cir. 1985) 14

Indian Coffee Corp. v. Procter © Gamble Co., 752 F.2d

$91, $95 (3d Cir.), cert. denied, 474 U.S. 863 (1985) 11, 12

In re Japanese Electronic Products Antitrust Litigation, 723

k.2d 238 (3d Cir. 1983), rev'd sub nom. Matsushita

Electric Industrial Co., Ltd. v. Zenith Radio Corp.,

475 U.S. SiR CIGD o> os san eean awe eee me 22,

In re Paoli Railroad Yard PCB Litigation, 916 F.2d $29

(3d Cie. BQBB. cos sc cas esa eee 6, 8, 13, 14, 19

Lima v. United States, 708 F.2d 502 (10th Cir. 1983) .... . 13

Lore v. Lone Pine Corp., No. L-033706-55 (N.J. Super. Ct.,

Law Div. 1906). iis .06s 055 eee ee 4

Lynch v. Merrill-National Labs., 830 F.2d 1190 (Ist Cir.

OT) 5 on ns o)e oo cu ee 13, 18, 19

McGlinchey v. Shell Chem. Co., $45 F.2d 802 (9th Cir.

BEI) nnn as ack wn som ee ie 14

Merry v. Westinghouse Electric Co., 684 F.Supp. $47

(M.ED. Pa. BO cis cise eee eee 20

TABLE OF AUTHORITIES —( Continued }

CASES: Page

Richardson v. Richardson-Merrell, Inc., 857 F.2d 823

(D.C. Cir. 1988) cert. denied, 110 S. Ct. 218 (1989).

United States v. Downing, 753 F.2d 1224 (3d Cir. 1985) .. 6, 18

Universal Athletic Sales Co. v. American Gym Recreational

& Athletic Equipment Corp., Inc., 546 F.2d 530

Son gy bea oak nae ees ve ek a's 1]

Viterbo v. Dow Chemical Co., 862 F.2d 420 (5th Cir. 1987). 13

Wilson v. Merrell Dow Pharmaceuticals, Inc., 893 ¥.2d

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OTHER:

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yn ce ca on asisie’s ag sive enees 6, 12, 14

a 6, 7.6, 8, 12, 13, 18

es ais) -k sb ake ak V4 6, 7n.6, 8, 12, 13

TE a 7

Nisbet & Sarofin, Rates and Routes of Transport of PCBs in

the Environment, 4 Envil. Health Persp. 21 (1972) .. 17

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—

‘

In the Supreme Court

of the Gnited States

OCTOBER TERM, 1990

IN RE: PAOLI RAILROAD YARD PCB LITIGATION

GENERAL ELECTRIC COMPANY,

NATIONAL RAILROAD PASSENGER CORPORATION,

CITY OF PHILADELPHIA, SOUTHEASTERN PENNSYLVANIA

TRANSPORTATION AUTHORITY, MONSANTO COMPANY,

and CONSOLIDATED RAIL CORPORATION, Petitioners,

MARY ALICE KNIGHT, et al., Respondents.

Petition For A Writ Of Certiorari

To The United States Court Of Appeals

For The Third Circuit

BRIEF IN OPPOSITION TO

PETITION FOR A WRIT

OF CERTIORARI

Respondents, Mary Alice Knight, et al.! (hereinafter re-

1. This brief is filed on behalf of the following individuals: Mabel Brown,

Andre Williams, Sr., Helen V. Narcise, Administratrix of the Estate of John G.

Narcise, deceased, Helen V. Narcise, as personal representative of John G.

Narcise, Helen V. Narcise in her own right, Mary Alice Knight, John Ingram,

Sr., Patricia Ingram, in their own right and as parents and natural guardians of

John Ingram, Jr. and April Ingram in her own right, Matthew Cunningham,

Bessie Cunningham, George Burrell, Priscilla Etheridge Burrell, in their own

right and as parents and natural guardian of Amber Shardai Burrell, a minor

and George Albert Burrell, as parent and natural guardian of Andrew Walker, a

ferred to as “Respondents” or “Plaintifls”) respectfully submit

this Brief in Opposition to the Petition for a Writ of Certiorari

(the “Petition’) filed by Petitioners (also referred to as “Defen-

dants’) and pray that the Court deny the Petition.

OPINION BELOW

Petitioners state that the “original opinion of the Court of

Appeals” is contained in the Appendix to the Petition, at A. La,

and that two amendments to the opinion are contained at A. 86a,

and A. 88a. Petition, at 1.

The opinion reproduced in the Appendix to the Fetition is

not in the form published by the Court of Appeals. Petitioners

have reproduced the slip opinion prior to the correction of

obvious typographical errors, some of which Petitioners have

emphasized with “sic,” and have inserted the language of the

subsequent amendments in the slip opinion in boldface, and

italicized language stricken by the subsequent amendments.

The opinion of the United States Court of Appeals for the

Third Circuit (the “Third Circuit” or “Court of Appeals”) has

been reported at 916 F.2d $29. The final version of the Court of

Appeals opinion is reproduced in the Addendum to this brief

(Ad, —_*). Citations to the Court of Appeals’ opinion in this

brief are to the Addendum attached hereto.

COUNTERSTATEMENT OF THE CASE

A. The Procedural History of this Case has Left a One-

Sided, Incomplete and Hopelessly Flawed Record.

The Petition deliberately omits any mention of the pro-

minor, and Priscilla Etheridge Burrell, as parent and natural guardian of Bobby

George Albert Christian Burrell, a minor, Wallace Darry] Cummins, K. Louise

Jones, Administratrix of the Estate of Harvey N. Jones, Jr., deccased, Charles

W. Stanbach, Executor of the Estate of Charles Stanbach, Jr, deceased and

Charles W. Stanbach as a personal representative of Charles W. Stanbach in his

own right and Susanna Stanbach, Christopher S$. and Jacqueline M. Brown,

Cathlene Brown, Craig A. and Catherine D. Brown, Margherita Barbetta.

Mary Ketta Johnson, Celeste Brown, Clemmon L. Brown, Cloyd H. Brown

and Curtis Brown.

cedural history of this case. That history reveals a record which is

incomplete, skewed and not ripe for review in this Court. The

Third Circuit held that this case should be reversed and re

manded for procedural abuses alone. Ad. 49.

These consolidated actions were filed beginning in April,

1986 by thirty-eight (38) individuals who either worked in or

resided adjacent to the Paoli, Pennsylvania Railroad Yard, (the

“Yard”). Itis conceded that the Yard and surrounding area are

contaminated with polychlorinated biphenyls (PCBs). A38634.

(citations to the Joint Appendix in the Third Circuit are to A7

The Yard is a Superfund clean-up site. On March 5. 1987

NIOSH reported that PCB levels at the Yard “are the highest

encountered during a health evaluation. ASS74.-

On October 24, 1986, Judge Anthony J. Scirica of the

astern District of Pennsylvania consolidated the cases for dis

covery and ordered counsel to submit to the court a deposition

schedule. After lengthy negotiations counsel agreed to a deposi

tion schedule alternating between plaintifly and defendants wit

nesses. Prior to the defendants refusal te proceed with the

depositions, defendants had deposed three of plaintiffs wit

nesses, out of order, and the plaintiffs had concluded the deposi

tion of one defense witness.

In the spring of 1987, defendants unilaterally refused to

proceed with discovery although they had not then moved for a

protective order or a stay of discovery.

On July 24, 1987, plaintiffs filed a motion to enforce the

prior order of court, to compel discovery and for sanctions. On

July 24, 1987, defendants filed a jomnt motion fora case manage

2. PCBs are known toxins. Most major industrial nations including Japan

and the United States have outlawed the manutacture produc thom and wise of

PCBs. 15 U.S.C. 8 2605. Standard medical texts describe the harmtul etheets ot

PCBs on humans. A9362. Numerous scientific articles have been published

detailing the toxic effects of these compounds Sve 49322. AGS25) See also

Environmental Defense Fund 1 EPA. 59S F 2d 62. 65-66 DO) Car 19TS

“PCBs are a group of related Chlorinated hydrocarbons torre toa varnety of

organisms, including man Enetrronmental Defense Fund + EPA] 636

F.2d 1267, 1270 (D.C. Cir 1986) “PCBs are extremely toxic to humans and

wildlite.

ment order.’ Defendants proposed that an order be entered

requiring plaintiffs to set forth a prima facie case, including

expert opinions, before defendants would be required to re-

spond to any discovery. Plaintiffs opposed defendants’ motion.

On August 11, 1987, the Paoli Railroad Yard PCB Litigation

was reassigned to Judge Robert F. Kelly of the United States

District Court for the Eastern District of Pennsylvania, Judge

Scirica having been appointed to the Court of Appeals.

On September 24, 1987, Judge Kelly entered a form of case

management order (“CMO”). The CMO provided plaintiffs with

only limited discovery of defendants for a ninety (90) day period

of time, required plaintiffs to submit expert witness reports, to

answer interrogatories, and stayed all other discovery.? The

CMC also denied all of plaintiffs’ pending motions to compel

discovery and for sanctions filed between July 24 and September

16, 1987.

After entry of the CMO, plaintiffs vigorously pursued the

limited amount of discovery permitted them. They filed two

motions to compel discovery and for sanctions pursuant to Fed.

R. Civ. P. 11, 26, 34 and 37, for defendants’ failure to comply

with discovery requests under the CMO. The district court

denied all of those motions without opinion on January 5, 1988.

The district court later granted defendants motion to take

depositions of plaintiffs expert witnesses. It refused, however, to

require defendants to answer expert interrogatories, ruling that

such discovery was “premature.” Plaintiffs were required to sub-

mit final, expert opinions and to present experts for extended

cross-examination prior to obtaining discovery from defendants.

The case management order was predicated on an unre-

ported decision of a New Jersey State trial court in Lore v. Lone

Pine Corp., No. L-033706-85 (N.J. Super. Ct., Law Div., 1986).

The unfairness of the district court's case management

order was compounded by its failures to enforce the minimal

3. This order was also continuously disobeyed by defendants in two re-

gards. First, defendants did not produce all of the documents they were re-

quired to provide relating to “the nature and quantity of PCBs.” Second, defen-

dants took discovery despite the stay.

requirements which it did impose on the defendants. The dis-

trict court denied, without a hearing and without opinion, plain-

tiffs. motions to compel discovery and compel compliance with

the case management order. Significantly for purposes of the

Petition, the Third Circuit criticized the district court for enter-

ing the CMO. Ad. 49 and 59 n.37.

After plaintiffs submitted their expert opinions under the

CMO, defendants were given leave to take the depositions of the

plaintiffs experts. Defendants then filed a Motion for Summary

Judgment. Plaintiffs opposed the motion on the grounds that

their previously served expert opinions and the additional opin-

ions of experts filed in opposition to the motion raised disputed

issues of fact and that plaintiffs had been denied the opportunity

to complete discovery. See Fed. R. Civ. P. 56(f). The district

court denied the parties’ request for a hearing or oral argument.

The district court also failed to conduct an in limine hearing

before excluding plaintiffs’ expert opinions.*

B. The District Court's Decision and the Court cf Appeals

Reversal.

Despite lengthy affidavits, medical reports, scientific trea-

tises, government publications and reports of qualified experts;

after truncated discovery, and without a hearing of any kind or so

much as oral argument, the district court held that there were no

disputed issues of fact and granted summary judgment in favor of

defendants.

The district court's decision is replete with erroneous evi-

dentiary rulings, lacks the requisite findings, improperly resolves

disputed issues of fact, and is based on an incomplete record.

In reversing and remanding, the Third Circuit has not

departed from established law, or created a split in the circuits.

The Third Circuit has done nothing more than correct a series of

procedural and evidentiary errors, and remand a case for devel-

opment of a full record, with instructions to the district court to

4. Petitioners inaccurately state that plaintiffs opposed an in limine hear-

ing. As the Third Circuit correctly recognized, plaintiffs argued that such a

hearing was premature prior to completion of all discovery. Ad. 49 n.29a.

make the usual findings required by law. The Third Circuit's

decision is perfectly consistent with its prior rulings-—rulings

which the district court ignored. See, e.g., In re Japanese Elec-

tronic Products Antitrust Litigation, 723 F.2d 238 (3d Cir. 1983),

reed sub nom. Matsushita Electric Industrial Co., Ltd. v.

Zenith Radio Corp. 475 U.S. 574 (1986); United States v. Down-

ing, 753 F.2d 1224 (3d Cir. 1985).

SUMMARY OF ARGUMENT

The Petition for a Writ of Certiorari should be denied tor

several fundamental reasons.

First, the district court failed to articulate the basis for its

rulings, or set forth the findings needed for review on appeal.

The Third Circuit struggled to understand precisely what evi-

dence the district court had excluded and the grounds for its

rulings. Because the Court of Appeals was unable to discern the

court’ holdings, it quite properly remanded the case with in-

structions to the district court to employ Rules 403, 702 and 703

of the Fed. R. Evid. and make a record susceptible of review.

The district court also denied plaintiffs the opportunity to

take full discovery, and to contest the opinions submitted by the

defendants. The procedural errors and irregularities committed

by the district court in this case create a muddled and _ in-

complete record which this Court need not and should not

review at this time. The Third Circuit correetly held that these

procedural errors alone warranted reversal and remand of the

case for further proceedings.’ Ad. 49. This Court need not

become embroiled in a matter fraught with plain procedural

abuses, which the Court of Appeals has already corrected. The

issues which petitioners would have this Court believe are

5. Significantly, the Petition ignores the unique factual and procedural

history of the Paoli Railroad Yard PCB Litigation. The Petition does not ap-

prise the Court of the true state of the record, nor of the Court of Appeals:

repeated references to the errors and omissions committed by the district

court. See infra, at 5-10

clearly framed, are in fact, submerged in a murky ocean of

procedural mistakes.°

Because there has not been a final disposition in this matter

and it has been remanded for further proceedings, the case is not

ripe for review in this Court.

In addition to these procedural impediments, the reasons

advanced by Petitioners for granting the petition are groundless.

In an effort to apply Supreme Court Rule 10. 1(a) to this case,

and define a “split in the Circuits,” Petitioners have grossly

mischaracterized the record and decision below, and have failed

to recognize the fact-sensitive nature of the various Court of

Appeals’ decisions concerning admissability of expert testimony.

The district court impermissably weighed the credibility of the

various experts on a motion for summary judgment under Fed.

R.Civ. P. 56, excluded testimony without a hearing and without

making findings, and issued an opinion which is conclusory and

vague. The Court of Appeals properly and emphatically reversed

and remanded the case for further proceedings. The Third Cir-

cuit did not depart from established precedent—it enforced

those precedents.

Even if there were a clear conflict in the circuits over

admissability of expert opinions under Rule 703 (which there is

not) and this Court was inclined to resolve that conflict, the

incomplete record and numerous procedural problems in this

case make it an inappropriate vehicle to address such conflict.

With respect to the medical monitoring claim, it cannot be

6. The Court of Appeals summarized its decision as follows:

We conclude that the district courts evidentiary rulings must be set

aside for a number of reasons. One problem with the district courts

rulings is procedural. The court not only failed to give plaintifls an

adequate opportunity to present their factual and legal contentions

on evidentiary issues, but it also ruled on an inadequate factual rec-

ord and it failed adequately to articulate the bases for its rulings. It

also failed to follow the protocols established by the jurisprudence of

this court for evidentiary rulings governed by Fed. R. Evid. 702 and

703.

Ad. 14.

seriously disputed that a federal court sitting in diversity may,

indeed “must,” predict whether the state's highest court would

recognize a claim under that state's law. Erie R.R. Co. cv.

Tompkins, 304 U.S. 64 (1938); In re Paoli Railroad Yard PCB

Litigation, 916 F.2d 829, 849 (3d Cir. 1990). Petitioners request

for this Court to grant review of this insubstantial issue is based

solely upon their dislike of the Third Circuit's prediction of

Pennsylvania law and should be denied.

Finally, Petitioner's contention concerning Rule 54(b) Fed.

R. Civ. P. is insubstantial and without merit.

REASONS FOR DENYING THE WRIT

A. The District Court Failed to Articulate the Bases for its

Rulings. Accordingly, the Record is not Appropriate for

Review in this Court.

The writ should be denied for a fundamental reason. As

simply stated by Judge Becker at the outset of the Court of

Appeals’ decision, “[the district court] failed to articulate the

bases for its rulings.” Ad. 14. In short, the court below correctly

noted, “we cannot affirm what we cannot review.’ Ad. 57. It is,

therefore, premature at best for this Court to review this matter.

The district court's failure to state the grounds for its various

rulings, or to make the findings required by law, are noted

throughout the Court of Appeals decision. Indeed, the Court of

Appeals was in many instances struggling to understand just

what it was that the district court decided. These errors (or more

precisely, these omissions) required reversal. Even if this Court

is inclined to address the level of scrutiny required by Rules 702

and 703 of the Federal Rules of Evidence—and Respondents

submit that it is not necessary to do so—this record of unarticu-

lated rulings and missing findings does not provide a proper case

in which to do so. ,

The Court of Appeals dismay at the record left it by the

district court is expressed throughout its opinion:

—“In a number of instances, the district court did not

articulate whether it was excluding expert opinion as an

evidentiary matter or was merely ascribing little weight to it

in its summary judgment analysis.” Ad. 13 n.3

—“The district court failed adequately to articulate the

bases for its rulings.” Ad. 13.

—With respect to exclusion of evidence of animal studies,

the “[district] court neither detailed the ‘very convincing

evidence ... nor explained why the relevancy of the stud-

ies pertains to their reliability under Rule 703. The opinion

is similarly silent as to precisely which expert opinions it

meant to exclude in this manner.” Ad. 33.

—“The court’ consideration of the Yusho and Yu Cheng

studies as possible bases for expert opinions as to causation

is similarly abbreviated.” Ad. 33.

—"|T|he court did not state which of the expert opinions

were tainted by reliance on these studies or which opinions

offered in rebuttal suggested a ‘consensus conclusion

Ad. 33._

—"... the court never explained the basis for its decision to

exclude Barsotti’s opinion.” Ad. 34.

—"The court’ analysis of other experts including doctors,

Zahalsky, DiGregorio, Shubin and Allen, was comparable

in that it ... failed to make definitive admissibility find-

ings. Ad. 34.

—|T\|he court did not declare these observations to be

grounds for excluding the opinions {of Drs. Nisbet and

Simon], and did not even state whether it excluded these

opinions. Ad. 35.

—"It is not clear from the opinion whether this statement is

mere dicta, or is intended to exclude the testimony under

Rule 702. The district court made similarly cryptic indict-

ments of Dr. Barsottis jand| Dr. Zahalskys qualifica-

tions... . Ad. 35 n.15.

—‘“However, the court did not explicitly state that it was

excluding Calesnicks testimony, much less why it might be

excluding it.’ Ad. 36.

—“ Whether the court intended a Rule 402 relevancy exclu-

sion [regarding Dr. Nicholson's testimony] is unclear.” Ad.

36 n.17.

—"‘Again, it is unclear whether the court was excluding this

evidence, and if so, for lack of qualification or on some other

ground. Ad. 38.

Petitioners statement that this case “starkly frames, on a

fully developed record,” (Pet., at 12), the scope of expert testi-

mony, ignores the clear language of the Third Circuit's decision.

This record is neither developed nor clear and certainly not one

upon which this Court should resolve fundamental legal issues

under the Federal Rules of Evidence.

B. The District Courts Procedural Errors Required Re-

versal by the Court of Appeals.

The Third Circuit held that the district court's failure to

afford plaintiffs full discovery and an opportunity to confront

defendants experts required reversal on this basis alone. Ad.

48-49. In light of these procedural deficiencies, this case pro-

vides neither a complete nor crystallized record. Accordingly.

the writ should be denied.

The CMO prevented plaintiffs from discovering defendants

expert opinions and “to contest the reasonableness of the data

and techniques relied on by defendants experts.’ Ad. 49.

Compounding these restrictions was a case manage-

ment order which arguably did not give plaintiffs an

adequate opportunity to discover defendants’ expert

positions. Of particular significance, is the plaintiffs

inability to contest the reasonableness of the data and

techniques relied on by defendants experts.

Ad. 49.

As the Third Circuit noted in the above quoted passage, the

case management order was not the only procedural problem in

this case. The case management order merely compounded the

district court's failure to provide an adequate process.

The district court also failed to conduct any hearing on the

Motion for Summary Judgment. Indeed, it rejected the requests

of both sides for oral argument.

As the Third Circuit emphasized, the district court “failed

to conduct an in limine hearing before excluding the expert

evidence. *

The adversarial process upon which our legal system is

based assumes that a fact finder will give the parties an

adequate opportunity to be heard; if it does not, it

cannot find facts reliably. Thus, the detailed factual

record requirement, firmly entrenched in our jurispru-

dence, Japanese Electronics, supra; Indian Coffee

Corp. v. Procter & Gamble, 752 F.2d 891, 895 (3d Cir. )

cert. denied, 474 U.S. 863 (1985); DeLuca v. Merrell

Dow Pharmaceuticals, Inc., No. 89-5572 (filed Aug.

16, 1990), requires adequate process at the evidenciary

stage, particularly when a summary judgment may

flow from it. The district court did not afford that

process here.

More precisely, ... the district court did not give the

plaintiffs sufficient opportunity to explore the issues

upon which they were ultimately denied relief.

Ad. 48-49.

These errors alone, the Third Circuit correctly concluded,

warranted reversal. Ad. 49. These procedural flaws should be

remedied before review in this Court is considered.

C. The Third Circuit's Decision Does Not Conflict With

Decisions of Other Circuits or of This Court.

The Third Circuit's decision does not conflict with estab-

lished decisions. On the contrary, it merely corrected the district

courts departure from established rules of procedure and evi-

dence. Universal Athletic Sales Co. v. American Gym Recrea-

tional & Athletic Equipment Corp., Inc., 546 F.2d 530 (3d Cir.

7. Petitioners argue repeatedly that plaintiffs opposed an in limine hear-

ing. That argument is legally irrelevant, and deliberately misconstrues plain-

tiffs position in the trial court. Plaintiffs opposed an in limine hearing at that

time on the grounds it was premature. As the Third Circuit correctly recog-

nized, plaintiffs “did not want >» be forced into jan in limine hearing} betore

their discovery was complete.” Ad. 49 n. 29a.

1976), cert. denied, 430 U.S. 984 (1977); Indian Coffee Corp. v.

Procter & Gamble Co., 752 F.2d 891 (3d Cir.) cert. denied, 474

U.S. 863 (1985); In re Japanese Electronic Products Antitrust

Litigation, supra.

Each of the so-called “inter-Circuit conflicts” Petitioners

point to is, upon closer examination, nothing more than a crea-

tion of these Petitioners. The cases Petitioners rely upon simply

have different outcomes, not different interpretations of Fed. R.

Evid. 403, 702 and 703. And, the different outcomes can be

explained by the different scientific knowledge or chemical com-

pounds involved. Many cases are wholly immaterial to the “toxic

tort’ field as they involve exclusion of damage testimony in

antitrust and other commercial litigation. The fact that in some

cases expert testimony is excluded, while in this case, the court

reversed and remanded for further development of the record,

does not create a “conflict between the circuits,” which this

Court need address.

1. The “Speculative Opinion” Issue.

Petitioners cite, without discussion, nine decisions, from six

courts of appeals and one district court which they contend

conflict with the Third Circuit's decision. Petitioners argue that

most circuits prohibit introduction of speculative opinions, while

the Third Circuit has now embraced “speculative opinions.”

Significantly, Petitioners can only speak in generalities. They do

not point to any specific holding of the Third Circuit permitting

“speculative” testimony.

The Third Circuit did not rule that “speculative opinions”

are admissable. The Third Circuit did not rule that “anything

goes in toxic tort cases, as Petitioners state. Rather, the court

carefully considered the evidence, see Ad. 18 to 32, and the

district court's opinion and remanded the case so that the district

court could make the usual and customary analysis and findings

required by Rules 403, 702 and 703. Ad. 48, 64 & 69. (“Those

rulings that do implicate facts or data which are the basis for

expert opinions may be reconsidered in the remanded proceed-

ings .... ) (emphasis supplied).

The Third Circuit observed that “most of the data upon

which the plaintiffs experts rely is ‘of a type reasonably relied

upon by experts in the particular field,’ Fed. R. Evid. 703, and

thus admissable .. . °° Ad. 48 n.29. This is not a departure from

Rule 703 jurisprudence but the reiteration of it. Significantly for

purposes of this Petition, the Third Circuit noted that “plaintiffs’

experts may be using their data in an unreliable manner . . .

fand].. . the evidence may be excludable on that basis.” Id. The

court invited the district court to focus its analysis on this Rule

702 issue. Rather than grant a license for admission of spec-

ulative evidence, the Third Circuit required a systematic and

focused scrutiny of that evidence, consistent with Rules 403, 702

and 703.

All of the cases cited by Petitioners can be harmonized with

the Third Circuit's decision. None are in conflict with the instant

case. Lynch v. Merrill-National Labs., 830 F.2d 1190 (Ist Cir.

1987) and the other cases involving the drug Bendectin present a

different factual setting due to an entirely different body of

scientific knowledge. The different outcomes in the Bendectin

cases are attributable to a different state of scientific knowledge,

not different law. See discussion of epidemiology issue, section

C.2—infra.

In Viterbo v. Dow Chemical Co., 862 F.2d 420 (5th Cir.

1987) the court excluded testimony ofa physician after reviewing

the information upon which his opinion was based. The doctor

relied only upon an incomplete oral history from the plaintiff'and

one study linking the substance in question to cancer in rats.

The plaintiff did not have cancer. Nothing in the Paoli Railroad

Yard PCB Litigation decision would alter that result.

In Lima v. United States, 708 F.2d 502 (10th Cir. 1983) the

court upheld the exclusion of testimony of an expert epidemi-

ologist. The holding of Lima is narrow. The expert based his

opinion on one document—a summary of a survey of area hospi-

tals conducted by the plaintiff—which was excluded as hearsay.

Because the basis of the testimony was inadiissable, the expert

8. The Third Circuit was, therefore, atilizing the accepted Rule 703 stan-

dard. That decision cannot be characterized as “in conflict” with those of other

circuits or of this Court.

could not testify. The decision in Hull v. Merck & Co., 758 F.2d

1474 (11th Cir. 1985) is equaliy narrow.’ The court excluded, at

trial, deposition testimony of a physician who testified that he

had “assumed” significant exposure to a chemical and “assumed”

it had caused the illness. The plaintiffs’ experts in Paoli Railroad

Yard PCB Litgation made no such assumptions. They reviewed

medical records, detailed questionnaires, results of blood and

liver tests, results of immune function tests and the entire body

of scientific literature before reaching their conclusions.

In an effort to create the appearance of a split in the circuits,

Petitioners have deliberately mischaracterized the evidence.

The discussion of the Plaintiffs evidence, including a partial

review of the expert's opinions (and of Defendants’ attack upon

them) in the Court of Appeal’s opinion presents an evenhanded

narrative of the record. Ad. 18-32.

Salient points from the record are summarized here.

1. The Opinion of Dr. Herbert E. Allen

Dr. Herbert E. Allen is an Environmental and Analytical

Chemist, with a Ph.D. from the University of Michigan in

environmental chemistry awarded in 1974. A9268. He is cur-

rently the Director of the Environmental Studies Institute and a

Chemistry Professor at Drexel University in Philadelphia, Penn-

sylvania. He has published numerous scholarly articles.

A9281-87. Dr. Allen opined that plaintiffs were exposed to ele-

vated PCB levels from the yard. 49257.

Dr. Allen also opined that the heat-producing operations

such as welding and cutting of contaminated equipment, and the

burning of PCB contaminated railroad ties at the Yard converted

PCBs to furans (“PCDF’) and dioxins (“PCDD”). Id.!° Employ-

Y. The remaining cases Petitioners suggest are in conflict with the Third

Circuit are even more remote. McGlinchey v. Shell Chem. Co., 845 F.2d 802

(9th Cir. 1988) involved testimony of an economist on damages in an antitrust

case. Coal Resources, Inc. v. Gulf & Western Industries, Inc., 865 ¥.2d 761

(6th Cir. 1989) also involved economic testimony concerning damages in a com-

mercial dispute.

10. Defendants seek to distinguish the Yusho and Yu Cheng incidents

because of the existence of PCDDs and PCDFs in those exposures. Plaintiffs

have been exposed to these chemicals from Paoli as well. The Third Circuit

noted that the district court failed to consider this evidence. Ad 47-48.

ees have stated that these activities occurred at the Yard.

Dr. Allen opined that runoff from the Yard caused PCB

contamination in the soil in the adjacent residential community.

This opinion was corroborated by experts retained by Petitioner

Conrail, (see, the WAPORA report which noted that PCBs were

“migrating offsite via storm water runoff) and by the Environ-

mental Protection Agencys (“EPA”) soil test results. A859],

A9231, A9121-29. The highest PCB concentrations in residential

soils occurred in yards adjacent to the Yard, which exceeded

1000 mg/kg. A9255.

Contamination also occurred by the airborne transport of

PCB contaminated dust. A9255. Two airborne samples un-

affected by runoff showed contamination of 9 mg/kg (at 6 Rolling

view) and 13 mg/kg (at 105 Central Avenue). A9256.

Dr. Allen concluded that the residents had been exposed to

elevated PCB concentrations since approximately 1940, when

extensive PCB use began at the Yard. His opinions are consistent

with the scientific literature concerning airborne PCBs and with

the NIOSH study of the Paoli Yard.

The Opinion of Dr. Deborah A. Barsotti

Dr. Deborah A. Barsotti is a toxicologist, who received a

Ph.D. in pathology from the University of Wisconsin Medical

School in 1980, and is qualified to interpret human clinical tests.

A4658, A4978. She has authored at least six major publications

on the toxicity of PCBs. A4664. Her studies are cited in the

Congressional Record and legislative debates on the Toxic Sub-

stances Control Act. 122 Cong. Rec. 8281. She was an Assistant

Professor and Coordinator of the Toxicology Program at the

Philadelphia College of Pharmacy and Science. See A4944,

A4659. She is presently the Chief of the Research Analysis

Branch of the Agency for Toxic Substance and Disease Registry

of the United States. A4658, A4899, A4936.

Dr. Barsotti has performed studies on humans exposed to

PCBs and related compounds in the United States and in the Far

East. A4953, A4961-63, A4976.

Dr. Barsotti personally evaluated plaintiffs) medical and

clinical records, personal data, including residence and employ-

ment histories, and exposures to other substances including

tobacco and alcohol, A4921; she personally inspected the Yard

and the adjoining neighborhood; and reviewed governmental

and scientific reports including results of soil samples at the

Yard. A8999. Dr. Barsotti also supervised PCB serum evalua-

tions, gas chromatograph studies on plaintiffs bleed, and liver

function tests on plaintiffs. A8997.

Dr. Barsotti opined that plaintiffs’ exposure to PCBs at Paoli

was a substantial factor in bringing about their injuries.

A8985-9009. Dr. Barsotti found that the residents’ clinical condi-

tions were consistent with the totality of scientific and medical

evidence regarding the toxic properties of PCBs. A9000-09.

The Opinion of Dr. Arthur C. Zahalsky

Plaintiffs also submitted to the district court the opinion of

Arthur Zahalsky, Ph.D., an immunologist. A9011-9070. Dr.

Zahalsky received his doctorate from New York University in

microbiclogy in 1967. A3433a, A9056. He is a tenured professor

teaching courses in immunology and a laboratory course in

immuno-parasitology at Southern Illinois University, A5874,

A5292, where he was the Chairman of the Facility of Biological

Sciences from 1971-1974. A3433a. He has received numerous

research grant awards, and has sponsored the research of many

graduate degree candidates. A3433b-2. Dr. Zahalsky has au-

thored several publications.

Dr. Zahalsky opined that plaintiffs suffered immune system

injury.

Dr. Zahaisky personally inspected the Yard and the residen-

tial area surrounding it, reviewed plaintiffs) medical records,

their PCB exposure history, PCB blood serum results, liver

function test results, various government and scientific articles.

He supervised a battery of immune system tests and con-

cluded, based on these test results and medical histories, that

plaintiffs have sustained immune system damage.

The Opinion of Dr. Harry Shubin

Dr. Shubin is a physician with approximately fifty years of

experience diagnosing and treating patients. He examined cer-

tain plaintiffs, and reviewed laboratory test results and certain

medical records. He was also familiar with the extent of PCB

contamination at Paoli, including EPA’s removal of PCB tainted

soil from the plaintiffs residences. Dr. Shubin diagnosed cardio-

vascular disorders, including hypertension, respiratory ail-

ments, and neurological disorders resulting from the plaintiffs’

exposure to PCBs in Paoli. A9071-77. In so doing, Dr. Shubin

ruled out other causes of the plaintiffs’ illnesses, noting that the

resistance of their symptoms to known treatments led him to

believe that there was a persistent environmental cause of the

disorders.

The Opinion of Dr. Benjamin Calesnick

Dr. Benjamin Calesnick is a medical doctor affiliated with

the Hahnemann Hospital in Philadelphia, Pennsylvania. Dr.

Calesnick has performed physical examinations of plaintiffs and

has performed blood tests and chemical screens. It is his opinion

that plaintiffs require medical monitoring as a consequence of

their exposure to PCBs at Paoli. A9107-08.

The Opinion of Dr. Ian C. T. Nisbet

Dr. Nisbet has been recognized as a leading expert on PCB

toxicity for more than ten years. See Environmental Defense

Fund v. EPA, 598 F.2d 62, 70 (D.C. Cir. 1978). He has testified

as an expert on PCBs on behalf of the federal government. See A

8761-65. He has published numerous scholarly articles on PCBs.

See e.g., Nisbet & Sarofin, Rates and Routes of Transport of

PCBs in the Environment, 4 Envtl. Health Persp. 21 (1972).

He squarely controverted the defendants expert's opinions

that PCBs do not pose health hazards and that these plaintiffs did

not have elevated levels of PCBs. !!

11. In one of many errors reversed by the Third Circuit, the district court

discounted Dr. Nisbet's test@Qnony. The Third Circuit noted, however, that the

district court did not articulate a legal ground for excluding the testimony, and

made no findings which it could review. Ad. 35. In addition to Dr. Nisbet,

plaintiffs submitted an affidavit from Dr. Simon which corroborated Nisbet's

conclusions.

The Opinion of Dr. Nicholson

Dr. Nicholson received his Ph.D. from the University of

Washington in 1960 and is currently employed as a professor of

community medicine at Mt. Sinai School of Medicine in New

York. He has published more than seventy (70) articles. A. 9373,

9385. Nicholson’ affidavit directly contradicted defendants’ ex-

perts opinions on two fundamental points: (1) epidemiologic

studies do support the conclusion that PCBs cause adverse

health effects in humans and (2) animal research does have

relevance to issues of causation of disease in humans. A. 9374. !2

A fair reading of the record discloses that there is no split in

the circuits.

2. The Epidemiology and Animal Studies Issues.

Each of the cases Petitioners cite in support of the proposi-

tion that “[s]everal Circuits have developed a rule that ‘toxic tort’

causation opinions’ must be supported by “epidemiological

studies” involved claims that the drug Bendectin caused birth

defects. Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159, 1160

(D.C. Cir.), cert. denied, 111 S$. Ct. 370 (1990); Richardson v.

Richardson-Merrell, Inc., 857 F.2d 823, 832 (D.C. Cir. 1988)

cert. denied, 110 S. Ct. 218 (1989); Wilson v. Merrell Dow

Pharmaceuticals, Inc., 893 F.2d 1149, 1155 (10th Cir. 1990):

Lynch v. Merrell-National Labs., 830 F.2d 1190, 1194 (ist Cir.

1987). These cases do not establish a broad rule for all “toxic tort”

cases. All that they hold is that in light of the scientific knowl-

edge surrounding the drug Bendectin, the expert opinions of-

fered in those cases were unreliable.

The First Circuit summarized the scientific knowledge con-

cerning Bendectin in Lynch v. Merrell-National Laboratories,

supra:

12. The district court excluded the Nicholson affidavit under Rule 702 of

the Federal Rules of Evidence as presenting “novel scientific theory.” The

Third Circuit reversed on the ground, inter alia, that the district court did not

make the specific findings required by United States v. Downing, 753 F.2d

1224 (3d Cir. 1985). On remand, the district court will have the opportunity to

make findings pursuant to a more fully developed record.

Stimulated by the suspicion, extensive epidemiological

studies were undertaken. Researchers examined Ben-

dectin in relation to birth defects and attempted to

determine if there was a correlation between the use of

Bendectin and the defects from which a conclusion of

causation might be drawn. These studies were con-

ducted by Australians, Americans, Enghishmen, and

Germans. The researchers were specialists in a variety

of fields from gynecology, public health, embryology,

and teratology, to epidemiology proper. The re-

searchers had every motive to detect a malignant drug

inflicting horrible injuries. The first studies began in

1963; studies are still being published in 1986. No

correlation, much less a causal connection, has been

demonstrated between the use of Bendectin and limb

reduction.

§30 F.2d at 1193-94. Lynch has been followed by other courts.

There are no such findings with respect to PCBs. On the

contrary, plaintiffs experts pointed to epidemiological studies

supporting their opinions. The line of cases cited by Petitioners

are limited to Bendectin claims and are not in conflict with In re

Paoli Railroad Yard PCB Litigation.

Petitioners suggestion of a conflict between the circuits on

the use of animal studies is equally flawed. The cases cited by

Petitioners pertain to Bendectin where there is an uncon-

troverted body of human epidemiology. That is not the case with

PCB research.

D. The Third Circuit Had a Duty to Predict Whether

Pennsylvania Would Adopt a Cause of Action for Medi-

cal Monitoring.

The Third Circuit sitting in a diversity action must predict

whether Pennsylvanias highest court, if confronted with the

question, would recognize the existence of a claim for medical

monitoring. Erie R.R. Co. v. Tompkins, 304 U.S. 64 (1938). The

Third Circuit carefully weighed the evidence on the question

and the decisional law of other circuits on the point. The Third

Circuit court also considered other relevant Pennsylvania au-

thority. Ad. 39-41 citing inter alia, Merry v. Westinghouse Elec-

tric Co., 684 F.Supp. $847 (M.D. Pa. 1988). Then, properly

concluded that Pennsylvania would recognize the existence of

the tort. While other circuits may have predicted that other

jurisdictions may have acted otherwise, Petitioners can point to

no decision of any court which precluded the Third Circuit from

making the prediction of state law which it did.

E. The Circuits are no Longer Divided on the Validation

of a Premature Appeal by a Later Rule 54(b) Judge-

ment.

This Court, in FirsTier Mortgage Co. v. Investors Mortgage

Insurance Company, 111 S. Ct. 648 (1991), has resolved the split

in the cases pertaining to premature notices of appeal. By its

holding in FirsTier, this Court has brought the minority of

circuits into line with the common sense approach to the curing

of a premature notice of appeal by a subsequent Fed. R. Civ. P.

54(b) certification.

FirsTier has put to rest the question of how the word

‘decision’ in Rule 4(a)(2) is to be defined: “. .. under the Rule, a

premature notice of appeal relates forward to the date of entry of

a final ‘judgment’ only when the ruling designated in the notice

is a decision’ for the purposes of the Rule.” 111 S. Ct. at 652,

n.4. If the disposition of a case ultimately becomes a final judg-

ment, that disposition constitutes a ‘decision’ under Rule 4(a)(2).

As a result, a premature notice of appeal ripens when judgmeni

is entered. “Once judgment is entered, the Rule treats the

premature notice of appeal ‘as filed after such entry.” Id. at 652.

After FirsTier, the conflict in the circuits has been resolved

CONCLUSION

For the reasons stated above, the writ should be denied.

Respectfully submitted.

Harold E. Kohn

Joseph C. Kohn

KOHN, SAVETTE, KLEIN & GRAF, P.C.

2400 One Reading Center

110] Market Street

Philadelphia, PA 19107

(215) 238-1700

Arnold E. Cohen*

John Spelman

KLEHR, HARRISON, HARVEY

BRANZBURG & ELLERS

1401 Walnut Street

Philadelphia, PA 19102

(215) 568-6060

Attorneys for Respondents,

Mary Alice Knight, et al.

D. Bruce Hanes

POWELL, O'SHEA, HANES & MINEHART

1700 Market Street

Suite 3131

Philadelphia, PA 19103

(215) 972-8290

Attorneys for Respondents,

Christopher S. Brown, et al.

*Counsel of Record

ADDENDUM

een ae

“seal a ia aa aaaa a eimee

Ad.-1

In re PROLI RAILROAD YARD PCB LITIGATION.

BROWN, Christopher S. and Brown, Jacqueline Michell, h/w

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“Conrail”)

CITY OF PHILADELPHIA, United States of America,

Christopher Brown, Appellant.

In re PRPOLI RAILROAD YARD PCB LITIGATION.

BROWN, Cathlene

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Cathlene Brown, Appellant.

In re PROLI RAILROAD YARD PCB LITIGATIO®.

BROWN, Craig A. and Brown, Catherine D. h/w

MONSANTO COMPANY, Southeastern Periusylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Craig Brown, Appellant.

Ad. -2

In re PAROLI RAILROAD YARD PCB LITIGATION.

BARBETTA, Margherita

Vv.

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Margherita Barbetta, Appellant.

In re PROLI RAILROAD YARD PCB LITIGATION.

JOHNSON, Mary Retta

Vv.

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Mary Retta Johnson, Appellant.

In re POLI RAILROAD YARD PCB LITIGATION.

BROWN, Celeste

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Celeste Brown, Appellant.

Ad. -3

In re PROLI RAILROAD YARD PCB LITIGATION.

BROWN, Clemmon L.

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Clemmon L. Brown, Appellant.

In re PPOLI RAILROAD YARD PCB LITIGATION.

BROWN, Cloyd H.

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

vV.

CITY OF PHILADELPHIA, United States of America,

Cloyd H. Brown, Appellant.

In re PPOLI RAILROAD YARD FCB LITIGATION.

BROWN, Curtis

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and-Consolidated

Rail Corporation (“CONRAIL”)

CITY OF PHILADELPHIA, United States of America,

Curtis Brown, Appellant.

Ad. -4

In re PPOLI RAILROAD YARD PCB LITIGATION.

REID, William Jr., and Reid, William Jr., Executor of the

Estate of Reid, Minni, Deceased

Vv.

MONSANTO COMPANY, Southeastern Pennsylvania

Transportation Authority (“SEPTA”), National Railroad

Passenger Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

OW.

UNITED STATES of America,

William Reid, Jr., Appellant.

In re PAOLI RAILROAD YARD PCB LITIGATION.

BROWN, Mabel, Individually and on behalf of all others

similarly situated

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”); National Railroad Passenger

Corporation (“Amtrak”); and Consolidated Rail

Corporation (“CONRAIL”)

UNITED STATES of America, Roy F. Wester, Inc.,

General Electric Company, the Budd Company and

Westinghouse Electric Corporation,

Mabel Brown, Appellant.

Ad.-5

In re PROLI RAILROAD YARD PCB LITIGATION.

WILLIAMS, Andre, Sr., Individually and on behalf of all

others similarly situated

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”); National Railroad Passenger

Corporation (“Amtrak”); Consolidated Rail Corporation

‘“CONRAIL”); Monsanto Company; General Electric

Company; The City of Philadelphia,

Andre Williams, Sr., Appellant.

In re PROLI RAILROAD YARD PCB LITIGATION.

NARCISE, Helen V., Administratrix of the Estate of Narcise,

John G., deceased, Narcise, Helen V. as personal representa-

tive of Narcise, John G., Narcise, Helen V. in her own right

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”); National Railroad Passenger

Corporation (“Amtrak”); Consolidated Rail Corporation

(“CONRAIL”); Monsanto Company (“Monsanto”);

General Electric Company (“GE”); City

of Philadelphia (“Philad<lphia”)

Vv.

UNITED STATES of America,

Helen V. Narcise, Appellant.

Ad.-6

In re PAROLI RAILROAD YARD PCB LITIGATION.

KNIGHT, Mary Alice

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”); National Railroad Passenger

Corporation (“Amtrak”); Consolidated Rail Corporation

(“CONRAIL”); Monsanto Company (“Monsanto”);

General Electric Company (“GE”); City

of Philadelphia (“Philadelphia”)

Vv.

UNITED STATES of America,

Mary Alice Knight, Appellant.

In re PROLI RAILROAD YARD PCB LITIGATION.

INGRAM, John Sr., and Ingram, Patricia in their own right

and as parents and natural guardians of Ingram, John Jr., and

Ingram, April in her own right

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA’”); National Railroad Passenger

Corporation (“Amtrak”); Consolidated Rail Corporation

(“CONRAIL”); Monsanto Company (“Monsanto”);

General Electric Company (“GE”); City

of Philadelphia (“Philadelphia”)

Vv.

UNITED STATES of America,

John Ingram, Sr. and Patricia Ingram, Appellants.

Ad.-7

In re PROLI RAILROAD YARD PCB LITIGATION.

CUNNINGHAM, Matthew and Cunningham, Bessie

MONSANTO COMPANY and Southeastern Pennsylvania

Transportation Authority (“SEPTA”) and National Railroad

Passenger Corporation (“Amtrak”) and Consolidated

Rail Corporation (“CONRAIL”),

Matthew and Bessie Cunningham, Appellants.

In re PROLI RAILROAD YARD PCB LITIGATION.

BURRELL, George Albert and Priscilla Etheridge, in their

own right, and Burrell, George Albert and Burrell, Priscilla

Etheridge, as parents and natural guardian of Burrell, Amber

Shardai, a minor, and Burrell, George Albert, as parent and

natural guardian of Walker, Andrew, a minor, and Burrell,

Priscilla Etheridge, as parent and natural guardian of Burrell,

Bobby George Albert Christian, a minor,

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”), and National Railroad Passenge:

Corporation (“Amtrak”), and Consolidated

Rail Corporation (“CONRAIL”)

¥v.

UNITED STATES of America,

George Albert Burrell and Priscilla Etheridge Burrell,

Appellants.

Ad.-8

In re PPOLI RAILROAD YARD PCB LITIGATION.

CUMMINS, Wallace Darryl

Vv.

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”); and National Railroad Passenger

Corporation (“Amtrak”), and Consolidated Rail Corporation-

(“CONRAIL”)

UNITED STATES of America,

Wallace Darryl Cummins, Appellant.

In re PAOLI RAILROAD YARD PCB LITIGATION.

JONES, K. Louise, Administratrix of the Estate of Jones,

Harvey N. Jr., Deceased and Jones, K. Louise as Personal

Representative of Jones, Harvey N. Jr., and Jones,

K. Louise in Her Own Right

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”), National Railroad Passenger

Corporation (“Amtrak”) and Consolidated

Rail Corporation (“CONRAIL”)

UNITED STATES of America, City of Philadelphia,

K. Louise Jones, Appellant.

Ad.-9

In re PROLI RAILROAD YARD PCB LITIGATION.

STANBACH, Charles W., Executor of the Estate of Stanbach,

Charles, Jr., deceased and Stanbach, Charles W., as a

personal representative of Stanbach, Charles W. in

his own right and Stanbach, Susanna

Vv.

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA”), and National Railroad Passenger

Corporation (“Amtrak”), and Consolidated Rail Corporation

(“CONRAIL”) and Monsanto Company (“Monsanto”)

CITY OF PHILADELPHIA,

Charles and Susanna Stanbach, Appellants.

In re PROL! RAILROAD YARD PCB LITIGATION.

BUTLER, William; Butler, Theresa; Simpson, Marvin L.;

Simpson, Allen K.; Simpson, Karen R.; Simpson, Donald E.;

and Jackson, Bryan M.

SOUTHEASTERN PENNSYLVANIA TRANSPORTATION

AUTHORITY (“SEPTA’); National Railroad Passenger

Corporation (“Amtrak”); and Consolidated

Rail Corporation (“CONRAIL”)

UNITED STATES of America, City of Philadelphia,

William Butler, Theresa Butler, Marvin L. Simpson, Allen K.

Simpson, Karen R. Simpson, Donald E. Simpson and Bryan

M. Jackson, Appellants.

Nos. 88—1973 to 88—1992, 89-1070 to 89-1079 and 89-1097.

Ad.-10

United States Court of Appeals, Third Circuit.

Argued Sept. 8, 1989.

Decided Sept. 20, 1990.

As Amended Oct. 29, 1990.

As Amended Nov. 23, 1990.

Rehearing and Rehearing In Banc Denied Nov. 23, 1990.

Suits were brought by 38 persons who had either worked in

or lived adjacent to railyard seeking damages resulting from

exposure to PCBs. Following consolidation, the United States

District Court for the Eastern District of Pennsylvania, Robert

F. Kelly, J., 706 F.Supp. 358, granted summary judgment in

favor of the defendants on all claims except for those for property

damage and response costs under CERCLA, and the plaintiffs

appealed. The Court of Appeals, Becker, Circuit Judge, held

that: (1) cause of action for medical monitoring is cognizable in

Pennsylvania to cover cost of periodic medical examinations

needed to protect against exacerbation of latent diseases brought

about by exposure to hazardous substances; (2) exclusion of

plaintiffs expert opinion evidence in toxic tort case on ground

that it was not based on facts or data reasonably relied upon by

experts in the field would be set aside where trial court failed to

adequately articulate what facts it relied on in making its legal

determination; and (3) genuine issues of material fact existed as

to whether plaintiffs had been exposed to PCBs to a greater

extent than others, whether plaintiffs had an injury and whether

PCBs were cause of that injury, precluding summary judgment

in favor of defendants.

Reversed and remanded.

D. Bruce Hanes, Friedman and Hanes, Philadelphia, Pa.,

for Christopher Brown, Cathlene Brown, Craig Brown, Mar-

gherita Barbetta, Mary Retta Johnson, Celeste Brown, Clem-

mon L. Brown, Cloyd Brown, Curtis Brown, appellants.

James C. Sargent, Jr., Lamb, Windle & McErlane, P.C.,

West Chester, Pa., for William Reid, appellant.

Ad.-1]

Geoffrey L. Beauchamp, Wisler, Pearlstine, Talone, Craig

& Garrity, Norristown, Pa., Kenneth Roos (argued), Joseph Don-

ley, Kittredge, Kaufman & Donley, Philadelphia, Pa., for

William Butler, Theresa Butler, Marvin L. Simpson, Allen K.

Simpson, Karen R. Simpson, Donald E. Simpson and Bryan M.

Jackson, appellants.

Charlotte E. Thomas, Arnold E. Cohen (argued), John H.

Spelman, Andrew O. Schiff, Klehr, Harrison, Harvey,

Branzburg, Ellers & Weir, and Harold E. Kohn, Joseph C.

Kohn, Kohn, Savett, Klein & Graf, Philadelphia, Pa., for Mabel

Brown, Andre Williams, Sr., Helen V. Narcise, Mary Alice

Knight, John and Patricia Ingram, Matthew and Bessie Cun-

ningham, George Albert Burrell, Priscilla Etheridge, Wallace

Darry! Cummins, K. Louise Jones, Charles W. Stanbach, ap-

pellants.

Michael H. Malin (argued), James D. Shomper, Jeanne

Proko-Elkins, White and Williams, Philadelphia, Pa., for Mon-

santo Co., appellee.

Roger F. Cox (argued), Jerome R. Richter, George J.

Krueger, Jay W. Eisenhofer, Blank, Rome, Comisky & Mc-

Cauley, Philadelphia, Pa., for Southeastern Pennsylvania

Transp. Authority (“SEPTA’), appellee.

John G. Kester (argued), John W. Vardaman, Jr., Mark A.

Srere, Diana L. Schacht, Williams & Connolly, Washington,

D.C., Harry A. Short, Jr., Stephen M. McManus, Liebert,

Short, Fitzpatrick & Hirshland, Philadelphia, Pa., for General

Elec. Co., appellee.

Richard J. Gold, First Deputy City Sol., Joy J. Bernstein,

Deputy City Sol., City Solicitor’s Office, Philadelphia, Pa., for

City of Philadelphia, appellee.

David Richman, Katherine Kramer Laird, Pepper, Hamil-

ton & Scheetz, Philadelphia, Pa., for Consolidated Rail Corp.

(“CONRAIL”), appellee.

Richard A. Kraemer, Nancy H. Resnick, Margolis, Edel-

stein, Scherlis, Sarowitz & Kraemer, Philadelphia, Pa., for Na-

tional Rail Passenger Corp. (‘AMTRAK’), appellee.

Richard F. Kingham, Bruce N. Kuhlik, Marjorie E. Powell,

Ad.-12

Covington & Burling, Washington, D.C., for American Tort

Reform Assn, amicus curiae.

Denis V. Brenan, Morgan, Lewis & Bockius, Philadelphia,

Pa., for American Council on Science and Health, Inc., amicus

curiae.

C. James Zeszutek, Michael R. Bucci, Jr., Thorp, Reed &

Armstrong, Pittsburgh, Pa., for The Pennsylvania Defense In-

stitute, amicus curiae.

Stephen M. Shapiro, John E. Muench, Kathleen M. Hen-

nessey, Mayer, Brown & Platt, Chicago, Ill., for The Chamber of

Commerce of The U.S., The Chemical Mfrs. Ass'n, The Nat.

Ass'n of Mfrs., The Business Roundtable, and The Product Lia-

bility Advisory Council, Inc., amicus curiae.

Robert C. Barnard, Sara D. Schotland, Cleary, Gottlieb,

Steen & Hamilton, Washington, D.C., for American Industrial

Health Council, amicus curiae.

Thomas W. Brunner, Laura A. Foggan, Frederick S. Ansell,

Wiley, Rein & Fielding, Washington, D.C., for American Ins.

Assn, amicus curiae.

Leonard W. Schroeter, Schroeter, Goldmark & Bender,

Seattle, Wash., Jerry S. Cohen, Anthony Z. Roisman, Richard S.

Lewis, Cohen, Milstein & Hausfeld, Washington, D.C., tor Trial

Lawyers for Public Justice.

Arthur H. Bryant, Trial Lawyers for Public Justice, Wash-

ington, D.C., for American Public Health Assn, et al., amicus

curiae.

Arnold Levin, David J. Perlman, Levin, Fishbein, Sedran

& Berman, Philadelphia, Pa., Lee C. Swartz, Hepford, Swartz,

Menaker & Morgan, Harrisburg, Pa., for James D. Carrigan,

amicus curiae.

Before BECKER, MANSMANN and NYGAARD, Cicruit

Judges.

OPINION OF THE COURT

BECKER, Circuit Judge.

This is a toxic court case brought by some thirty-eight

persons who have either worked in or lived adjacent to the Paoli

Ad.-13

railyard, an electric railcar maintenance facility at the western

terminus of the noted Paoli Local, which serves the Philadelphia

Main Line. The plaintiffs’ primary claim is that they have con-

tracted a variety of illnesses as the result of exposure to poly-

chlorinated biphenyls, better known as PCBs. PCBs are toxic

substances which, as the result of decades of PCB use in the

Paoli railcar transformers, can be found in extremely high con-

centrations at the railyard and in the ambient air and soil. The

defendants are Monsanto Corporation, the nation’s leading man-

ufacturer of PCBs (marketed under the trade name “Aroclor ):

General Eiectric Company, manufacturer of the transformers;

Amtrak, owner of the railyard site since 1976; Conrail, which

operated the facility between 1976 and 1983; the Southeastern

Pennsylvania Transit Authority (SEPTA), which has operated the

facility since 1983; and the City of Philadelphia, which owns

some of the railroad cars at the facility. !

This opinion addresses an appeal by all plaintiffs from the

grant of summary judgment by the district court in favor of all

defendants on all claims except those for property damage and

response costs under CERCLA.2 706 F.Supp. 358. We direct our

attention principally to a series of pretrial evidentiary rulings by

which the district court apparently excluded? the bulk of the

expert reports and testimony upon which plaintiffs relied to

establish (1) that they were subject to an abnormally high level of

PCB exposure, and (2) that this exposure caused them harm.

Because the grant of summary judgment inexorably flowed from

1. The district court's subject matter jurisdiction was founded primarily

upon 28 U.S.C. § 1331 (federal question) because of the inclusion of claims

under the Comprehensive Environmental Response, Compensation, and Lia-

bility Act (CERCLA), 42 U.S.C. §§ 9601-75, and the Federal Emplovers’ Lia-

bility Act (FELA), 45 U.S.C. § 51-60. The court also exercised pendent juris-

diction over various state law claims. Several plaintiffs initially filed their claims

in Pennsylvania courts, but these claims were removed under 25 U.S.C. §

144 i(c).

2. The district court certified the matters before us as final judgments

See Fed. R.Civ. P. 54 (b).

3. In anumber of instances, the district court did not articulate whether it

was excluding expert opinion as an evidentiary matter or was merely ascribing

little weight to it va its summary judgment analysis.

Ad.-14

these evidentiary rulings, if they are set aside, so must be the

summary judgment. Our scrutiny of the rulings will focus not

only upon their legal foundations, but also on the procedures by

which they were made and the adequacy of their articulation.

We conclude that the district court's evidentiary rulings

must be set aside for a number of reasons. One problem with the

district court's rulings is procedural. The court not only failed to

give plaintiffs an adequate opportunity to present their factual

and legal contentions on evidentiary issues, but it also ruled on

an inadequate factual record and it failed adequately to articulate

the bases for its rulings. It also failed to follow the protocols

established by the jurisprudence of this court for evidentiary

rulings governed by Fed. R. Evid. 702 and 703.

Other problems with the district court opinion are substan-

tive. The court applied too stringent a standard to the qualifica-

tion of experts under Rule 702. The court also erred in its

applicatiun of the Downing test for the admissibility of novel

scientific evidence (under Rule 702). Given these improper evi-

dentiary exclusions, we cannot affirm the district court’s sum-

mary judgment ruling. If the improperly excluded evidence is

considered, the record contains genuine issues of material fact

on the toxic tort issues.

A number of other discrete legal issues are also before us on

appeal. These include the viability of plaintiffs claims to recover

the costs of periodic medical examinations necessary to protect

against the development of latent diseases caused by their ex-

posure to PCBs (“medical monitoring’) under Pennsylvania law;

the propriety of the district court's refusal to permit certain

plaintiffs voluntarily to dismiss their complaint so as to proceed

at a later time when their apparently sub-clinical injuries man-

ifest themselves; and the availability to SEPTA of a lack of notice

defense under 42 Pa.Cons.Stat.Ann. § 5522. We find that the

district court abused its discretion in refusing to permit the

voluntary dismissal without prejudice of certain plaintiffs’

claims, and that the court erred as a matter of law in its analysis

of both the medical monitoring and SEPTA notice issues. For all

these reasons, we must reverse the grant of summary judgment

and remand for further proceedings.

Ad.-15

I. PROCEDURAL HISTORY

Plaintiffs filed their complaints in the district court for the

Eastern District of Pennsylvania beginning in April 1986. The

complaints alleged a variety of theories of recovery, including

claims based upon CERCLA, common law tort, and the medical

monitoring doctrine. The twenty-one actions before us on this

appeal were consolidated. On September 24, 1987, in response

to a motion by defendants, the district court filed a case manage-

ment order which provided a schedule for conducting further

discovery and filing summary judgment motions. 4

The defendants filed a joint motion for summary judgment.°

After plaintiffs answered the motion, attorneys on both sides

requested oral argument. In a letter dated October 28, 1988, the

court denied these requests, stating that oral argument would be

unnecessary “[b]ecause the issues contained in those motions

have been thoroughly and extensively briefed and because I have

been working with this case for over a year... .’ The court also

failed to conduct in limine hearings regarding the admissibility

of the plaintiffs’ expert testimony, notwithstanding defendants’

summary judgment strategy that depended largely on exclusion

of that testimony under Fed.R. Evid. 702, 703 and 403.

4. The order contained the following four mandates:

1. Defendants will answer discovery efforts by the Plaintiffs directed

to reveal the quantity and nature of PCBs used at the Paoli Railyard and

the health effects on Defendants’ employees of exposure to PCBs. This

Discovery is to be completed by December 23, 1987.

2. Plaintiffs will then answer discovery efforts by the Defendants

directed to reveal whether the Plaintiffs have suffered personal injury

and whether the injury is caused by exposure to PCBs caused by the

Defendants. This Discovery is to be completed by March 22, 1988.

3. All other discovery is to be stayed meanwhile.

4. Any Summary Judgment Motions, to be made by the Defen-

dants, are to be filed by April 21, 1988.

5. Throughout the course of discovery, individual parties filed numerous

motions for summary judgment or dismissal with respect to discrete issues.

However, for purposes of this appeal our discussion will center on the joint

motion for summary judgment. Other motions will be discussed where they

are directly relevant to issues on appeal—for example, the Butler plaintiffs’

motion for dismissal without prejudice and defendant SEPTA’s separate motion

for summary judgment under a governmental notice statute.

Ad.-16

On November 28, 1988, the district court granted defen-

dants’ joint motion for summary judgment against all plaintiffs on

the personal injury claims. The court's order was accompanied

by an opinion, discussed below in Part IV, concentrating on the

exclusion of plaintiffs’ expert testimony. These appeals followed.

Il. APPELLATE JURISDICTION

[1] Defendants make a number of attacks upon our appel-

late jurisdiction, all of which we find without merit, and only one

of which warrants extended discussion: did the original notice of

appeal in ten of the cases fail to identify the appealing parties

with the specificity required by Torres v. Oakland Scavenger

Co., 487 U.S. 312, 108 $.Ct. 2405, 101 L.Ed.2d 285 (1988)?6 In

Torres, the notice ot appeal was captioned, “Joaquin Moreles

Bonilla, et al., Plaintiffs in intervention.” The body of the notice

named fifteen of the sixteen putative appellants, but not Torres.

The Court concluded that the notice was insufficient to specify

Torres as an appellant, and that he was therefore barred from

pursuing his appeal for failing to comply with the requirements

of Fed.R.App.P. 3(c). See 487 U.S. at 317-18, 108 S.Ct. at

2409-10.

We recently had the opportunity to construe Torres in Dura

Systems, Inc. v. Rothbury Investments, Ltd., 886 F.2d 551 (3d

Cir. 1989), cert. denied, — U.S. —~, 110 S.Ct. 844, 107

L.Ed.2d 838 (1990), in which we held that a consent order,

entered after a notice of appeal but within the period required

for timely notice of appeal, could confer jurisdiction over parties

6. Although a number of the appeals were premature, Fed. R.Civ. P. 54(b),

the prematurity was cured by the subsequent Rule 54(b) certification. See

Dowling v. City of Philadelphia, 855 F.2d 136, 158 (3d Cir. 1988); Cape May

Greene, Inc. v. Warren, 698 F.2d 179, 184-85 (3d Cir. 1983); Richerson cv.

Jones, 551 F Ad 918, 922 (3d Cir. 1977). We reject defendants’ claim that this

holding is inconsistent with Griggs v. Provident Consumer Discount Co., 459

U.S. 56, 103 $.Ct. 400, 74 L.Ed.2d 225 (1982) (per curiam), which held that

the filing of a post-judgment motion under Fed. R.Civ.P. 50(b), 52(b), or 59

destroys an otherwise effective notice of appeal. Unlike Griggs, this case in-

volves no such post-judgment motion.

: Ad.-17

not explicitly named in the notice of appeal. See id. at 555. We

summarized the applicable principles as follows:

In formulating its holding, the /Torres/ Court made

clear that Rules 3 and 4 of the Federal Rules of Appellate

Procedure create a jurisdictional threshold, and that the

requirements of the two rules may not be abrogated for

“good cause shown” under Fed.R.App.P. 2. Moreover, the

fact that Rule 3 excuses “informality of form or title” in a

notice of appeal does not forgive compliance with the Rule's

requirements: “[p]ermitting imperfect but substantial com-

pliance with a technical requirement is not the same as

waiving the requirement altogether as a jurisdictional

threshold.” Although the Torres court mandated compliance

with the specificity requirement of Fed. R.App.P. 3(c), it

recognized that:

the requirements of the rules of procedure should be

liberally construed and that ‘mere technicalities should

not stand in the way of consideration of a case on the

merits. Thus, if a litigant files papers in a fashion that is

technically at variance with the letter of a procedural

rule, a court may nonetheless find that the litigant has

complied with the rule if the litigant’s action is the func-

tional equivalent of what the rule requires.

This approach mirrors the practice sanctioned in the Ad-

visory Committee Notes to the 1979 amendment to

Fed. R.App.P. 3(c), which cites with approval cases holding

that, “so long as the function of notice is met by the filing of

a paper indicating an intention to appeal, the substance of

the rule has been complied with.”

Id. at 554-55 (footnote and citations omitted).

Applying those principles here, it is not clear that plaintiffs’

notice of appeal in the ten referenced cases, in its original form,

was insufficient. For example, the original notice appears to have

served as a “functional equivalent” of the requirements of Rule

3(c) because it mentions the docket numbers and surnames of

the cases then before the district court. Indeed, correspondence

Ad.-18

from defense counsel confirms that no party was misled by the

notice, and that all parties presumed it to include all plaintiffs

referenced under the relevant docket numbers.

At all events, any impediment that might have existed was

removed by a January 6, 1989, letter, just two days after the Rule

54(b) certification, from counsel for the subject plaintiffs to the

clerk of this court, with copies to all counsel, identifying in detail

the parties to the appeal. The letter is analogous to the consent

order in Dura Systems in that the letter was filed within the

period allowed for appeal. The “Court's directive to construe the

rule ‘liberally,’ and to avoid a construction that would allow ‘mere

technicalities to bar consideration of a case on the merits” id.

(quoting Torres, 108 S.Ct. at 2408) compels this result.7 Accord

Masquerade Novelty, Inc. v. Unique Industries, Inc. 912 F.2d

663 (3d Cir. 1990) (attorney appearance form and civil appeal

information statement filed within time limit constitute ade-

quate notice).

Ill. THE SUMMARY JUDGMENT RECORD

A. The Plaintiffs Submissions

Plaintiffs set out to prove that their personal injuries were

proximately caused by their exposure to the PCBs that defen-

dants permitted to contaminate the area surrounding the Paoli

Railyard. Their case depends upon expert testimony pertaining

to exposure and causation. The attorneys for different plaintiffs

employed different expert witnesses, and it is therefore conve-

nient, in discussing the record before us, to categorize plaintiffs

according to which counsel represents them.

Of the ten cases in which plaintiffs are represented by

Kohn, Savett, Klein & Graf, P.C., or Klehr, Harrison, Harvey,

Branzburg, Ellers & Weir, (the “Kohn/Klehr plaintiffs”), nine

answered discovery with the opinions of three experts: Dr. Her-

bert Allen, Dr. Deborah Barsotti, and Dr. Arthur Zahalsky. In

7. Our recent decision in Cruz v. Melendez, 902 F.2d 232 (3d Cir. 1990),

is not to the contrary. That case, like Torres, stands only for the proposition

that, without further explanation proffered in a timely fashion, the designation,

“et al.,” is insufficient to provide the required notice.

ens alla

Ad.-1i9

the tenth Kohn/Klehr case, Cunningham, and in the Reid case,*

Dr. Harry Shubin submitted an opinion on the question of

causation. In the nine cases in which plaintiffs are represented

by D. Bruce Hanes, expert testimony was offered solely by Dr.

G. John DiGregorio. The remaining plaintiffs offered no expert

testimony.

Dr. Herbert Allen received his doctorate in environmental

chemistry from the University of Michigan in 1974. He is cur-

rently employed as a professor of chemistry at Drexel University,

where he serves as the director of Drexel’s Environmental Stud-

ies Institute. Allen has published numerous scholarly articles.

His primary role was to testify to the Kohn/Klehr plaintiffs’

exposure to the Paoli Railyard’s elevated PCB levels.

Initially, Allen noted the “extremely high levels” of PCBs in

soil samples taken from the neighborhood adjacent to the yard.

He explained that runoff from the railyard caused contamination

in the soil on Central Avenue, with the highest concentrations of

PCBs being found in residential yards adjacent to the railyard.

Central Avenue samples contained concentrations as high as 577

mg/kg, while some residential yard concentrations were as high

as 1000 mg/kg. Dr. Allen opined that the high concentrations of

PCBs found deep in the soil indicated a discharge of extremely

high amounts of PCBs. He also noted specifically that certain

“heat-producing” operations, such as the welding and cutting of

contaminated equipment and the burning of contaminated rail-

road ties, which employees testified had occurred at the yard,

could have converted PCBs into other toxins such as PCDD’s

(dioxins) and PCDF’s (furans). This testimony is particularly

significant in view of the conclusion of certain of plaintiffs’ prof-

fered studies that exposure to PCDFs can cause numerous ad-

verse health effects, see infra at 843.

Relying on his knowledge of the scientific literature, his

own testing, the testimony of employees, and a scientific formula

which he had devised, Dr. Allen calculated the amount of PCBs

in plaintiffs bodies based on the amount of PCBs in the soil.

8. Appellant William Reid, Jr., is separately represented by James C.

Sargent, Jr.

P| | -

Ad. -20

Among other things, he relied on the affidavit of an employee

named Kraljevich who stated that the use of heat-producing

tools caused PCBs to “hang in the air like a fog,” and that leaking

transformers caused foul PCB odors to permeate the air. Allen

then concluded that neighborhood residents had been exposed

to elevated PCB concentrations since approximately 1940. Al-

though unable to quantify the extent of plaintiffs’ exposure,

Allen opined that the residential plaintiffs may have been ex-

posed to air containing more than 10° g/m3 of PCBs, while

railyard employees may have sufiered even greater exposure.

Deborah A. Barsotti, Ph.D., offered expert opinions on

both exposure and causation for the Kohn/Klehr plaintiffs. Dr.

Barsotti, a toxicologist, received her doctorate in pathology from

the University of Wisconsin Medical School in 1980, and is

qualified to interpret human clinical tests. She has published a

number of articles on the toxicity of PCBs, and her work has

been cited in the Congressional Record and in legislative de-

bates on the Toxic Substances Control Act. She is currently

employed as the Chief of the Research Analysis Branch of the

Agency for Toxic Substance and Disease Registry (ATSDR) of the

United States Government.

Barsotti based her opinions regarding exposure on her re-

view of the relevant scientific literature and on her own gas

chromatography testing. She explained that PCBs may be ab-

sorbed into the body by oral ingestion, through the skin, or by

inhalation, and that PCBs are transported through the body in

blood, and eventually redistributed to fat and organs containing

fat. She concluded that the plaintiffs had in fact ingested PCBs.

A major part of Dr. Barsottis exposure testimony consisted of

her attempt to show, through gas chromatography tracing, that

the PCBs to which plaintiffs were exposed came specifically from

the Paoli Railyard. She did this by comparing chromatographic

tracings of plaintiffs blood to similar tracings from soil at Paoli.

She then attempted to match certain “early emerging peaks,” (in

plaintiffs blood tests which she testified related) to particular

PCB isomers.

Barsotti used the results of these tests, along with medical

and clinical records from the plaintiffs, to buttress her testimony

Ad. -21

regarding causation. In determining causation, she also person-

ally inspected the railyard, and reviewed, inter alia, the Kral-

jevich affidavit, published reports and studies, and soil samples

taken from the yard. She concluded that plaintiffs’ exposure to

PCBs at Paoli was a substantial factor in causing their particular

injuries, including elevations in triglyceride, cholesterol, and

liver enzyme levels.

Also testifying with respect to causation for the Kohn/Klehr

plaintiffs was Arthur C. Zahalsky, Ph.D., who received his doc-

torate in microbiology from New York University in 1967. Dr.

Zahalsky is a professor at Southern Illinois University, where he

teaches courses in immunology and human diseases. However,

he has spent the majority of his time in the past few years in his

consulting business, which specializes in providing scientific

consultation for litigation.

Dr. Zahalsky offered his opinion that plaintiffs have suffered

immune system injuries as a result of their exposure to PCBs at

Paoli. He testified that as a general proposition, PCBs damage

the immune systems of humans and animals because they alter

the cell production and replenishment rate of immune cells, and

impair the survivability of those cells. Basing his opinion on a

personal inspection of the railyard and surrounding area, a re-

view of plaintiffs: medical records and PCB exposure history, and

various laboratory test results and published reports, Dr.

Zahalsky concluded that plaintiffs have sustained immune sys-

tem damage, and that exposure to PCBs at Paoli was a substan-

tial factor in causing such damage. Zahalsky submitted a list of 82

studies upon which he relied in formulating his opinion. A

number of these studies discussed two notorious incidents of

human beings ingesting contaminated rice oil. These incidents,

which took place in Japan in 1968 and Taiwan in 1979, are

referred to as the “Yusho” and “Yu Cheng” incidents. The oil

was tainted with large quantities of Kaneclor, a Japanese analog

of Aroclor that contains significant amounts of PCDFs, as well as

PCBs.

Harry Shubin, M.D., an internist, offered opinions on the

issue of causation in the Cunningham and Reid cases. In for-

mulating his opinion, Dr. Shubin examined the plaintiffs and

Ad. -22

reviewed medical records and lab test results. He cited numer-

ous published studies and reports on which he claims to have

relied. Shubin was also informed that the EPA had removed

PCB-contaminated soil from the Cunninghams’ residence. He

diagnosed plaintilis as suffering from a variety of illnesses and

harmful conditions, and concluded that these conditions were

caused by exposure to PCBs.

The nine plaintiffs represented by D. Bruce Hanes relied

on the testimony of G. John DiGregorio, M.D., Ph.D. Dr.

DiGregorio is a clinical pharmacologist who received a degree

from Hahnemann University. The Hanes plaintiffs, residents of

properties adjacent to the railyard, claim to have been injured

because defendants permitted PCBs to flow onto these proper-

ties, thereby causing plaintiffs to inhale PCB dust and ingest

fruits and vegetables grown in the soil of their PCB-contami-

nated gardens. In formulating his opinions as to these plaintiffs,

Dr. DiGregorio relied on medical history questionnaires filled

out by plaintiffs themselves, laboratory tests revealing abnormal

PCB blood levels in certain plaintiffs,? and scientific literature on

the harmful effects of PCBs to both humans and animals. He

performed no physical examinations. He opined that five of the

nine Hanes plaintiffs suffered from specific injuries caused by

PCBs; that all nine suffered from anxiety of contracting diseases

in the future based on their exposure to PCBs; and that all nine

were at increased risk of contracting future diseases because of

their exposure. DiGregorios testimony as to exposure was based

largely on the statements of plaintiffs themselves and the results

of laboratory tests revealing abnormal blood burdens of PCBs in

various plaintiffs.

Although these expert witnesses were the only ones whose

9. The issue of what constitutes a “normal” or “background” PCB ex-

posure level is sharply contested. The district court adopted the findings of a

study conducted by the Agency for Toxic Substance and Disease Registry

(ATSDR), concluding that “the geometric mean serum concentration of popula-

tions having no known unusual source of PCB exposure range between 4.2 ppb

(parts per billion) and 6.4 ppb.” The Hanes plaintiffs point out that at least four

of its number have tests showing a body burden of PCBs higher than the court-

accepted background level—Hanes Br. at 16 n. 2.

Ad. -23

opinions were discovered pursuant to the case management

order, they are not the only experts upon whom the plaintiffs

rely. In response to the defendants joint motion for summary

judgment, plaintiffs submitted the affidavits of four additional

experts: Ian C.T. Nisbet, Ph.D.; Robert K. Simon, Ph.D.; Ben-

jamin Calesnick, M.D.; and William J. Nicholson, Ph.D.

Dr. Nisbet, who received his Ph.D. in physics from

Cambridge University in 1958, currently serves as the president

of a scientific consulting firm. He has published numerous arti-

cles in the fields of human exposure to chemicals and the assess-

ment of associated health risks. Dr. Nisbet submitted an affidavit

containing his opinions that (1) the defendants estimates of the

background PCB exposure level in the United States, as well as

the studies upon which these estimates were based, are mis-

taken; (2) the correct background level, which should be deter-

mined by an adipose to blood ratio calculation, is much lower;!°

(3) many plaintiffs exposures exceed the lower level; and (4)

there are serious health hazards posed by exposure to PCBs.

Dr. Simon, who describes himself as “a professional indus-

trial hygienist, toxicologist, and forensic analytical chemist,”

received his Ph.D. from the University of Maryland. The opin-

ions contained in Dr. Simon's affidavit closely parallel those

expressed by Dr. Nisbet, with varying degrees of emphasis.

Dr. Calesnick is a pharmacologist who received his medical

degree in 1944 from Hahnemann Medical College, where he

currently serves as a professor of medicine and as the director of

Hahnemanns Division of Human Pharmacology. His resume

lists one hundred published articles, as well as numerous aca-

demic and professional honors. Dr. Calesnick performed phys-

ical examinations and several laboratory tests on the Kohn/Klehr

plaintiffs. He concluded summarily in his affidavit that these

10. This method of calculating blood levels of PCB exposure from mea-

sured levels of exposure in human adipose tissue was employed in the National

Human Adipose Tissue Survey (NHATS study). The NHATS study concluded

that only 10% of the United States population has blood levels greater than 5

ppb. Thus, the plaintiffs submit, a blood level greater than 5 ppb should be

considered high. Dr. Simon also opined that the NHATS study emploved the

proper method of measuring the background level.

Ad. -24

plaintiffs require medical surveillance as a consequence of their

exposure to PCBs at Paoli.

The final affidavit offered in response to the summary judg-

ment motion was that of Dr. Nicholson, a physicist who received

his Ph.D. from the University of Washington in 1960 and is

currently employed as a professor of community medicine at

Mount Sinai School of Medicine in New York City. He has

published over seventy articles and has served on various profes-

sional and governmental committees. Nicholson's affidavit ad-

vances two major theses: (1) contrary to the assertions of defen-

dants and their experts, the epidemiologic studies conducted to

date do support a conclusion that PCBs are causally associated

with adverse health effects to humans; and (2) defendants and

their experts are incorrect in asserting that animal car-

cinogenicity studies have little relevance for estimating car-

cinogenicity in humans.

In order to support his first thesis, Dr. Nicholson conducted

a “meta-analysis,” in which he combined the results of numer-

ous epidemiologic surveys in order to achieve a larger sample

size, adjusted the results for differences in testing techniques,

and drew his own scientific conclusions. Specifically, he con-

cluded that the results of the various surveys, considered as a

whole, show that exposure to PCBs can cause liver, gall bladder

and biliary tract disorders. Nicholson maintains that this is true

even though none of the individual surveys supports such a

conclusion when considered in isolation.

B. The Defendants Submissions

Defendants view of the case, as encapsulated in their joint

motion for summary judgment, is that plaintiffs “failed to submit

competent evidence creating a genuine issue of material fact

concerning either of two essential elements on which plaintiffs

bore the burden of proof: abnormal exposure, and causation.”

Appellees Br. at 36. In support of this assertion, defendants

adopted a two-pronged approach. First, they vigorously attacked

plaintiffs expert testimony and sought to have it excluded under

Fed. R. Evid. 702, 703, and 403. Second, defendants submitted

studies and expert testimony of their own on both exposure and

Ad. -25

causation issues. Because the case was resolved at the summary

judgment stage, where credibility determinations are inap-

propriate, the latter evidence is significant only insofar as it

relates, within the contours of our Rule 7C3 jurisprudence, to

whether certain of plaintiffs’ expert opinions should have been

excluded because they were not based on facts or data reason-

ably relied on by experts in the field.

On the question of exposure, defendants attack the opinions

vf both Dr. Allen and Dr. Barsotti. Defendants submit that Dr.

Allen's testimony should not be considered because his data and

methodology were unreliable. They assert that Dr. Allen ig-

nored the actual measured body samples of PCB exposure, and

instead attempted to calculate exposure levels from levels of

PCBs in the soil by using a formula “of his own devising.” Dr.

Allen's opinion is unhelpful, defendants say, because he was

unable to provide “an exact calculation of the PCB dose received

by the inhabitants.” Further, defendants submitted the affidavit

of a physical chemist and chemical hazard control specialist, Neil

Jurinski, Ph.D., who expressed the view that Dr. Allen's soil-to-

air migration hypotheses were “pure speculation unsupported

by the data available or by scientific principles,” and that they

“were not arrived at by using accepted scientific methods.”

Dr. Barsotti, who sought to show that plaintiffs were ex-

posed to PCBs that came specifically from the Paoli Railyard,

was subjected to similar methodological criticism for her “fin-

gerprinting’ method of gas chromatography. Defendants con-

tend that Dr. Barsotti lacked experience in reviewing chro-

matographic tracings of human blood for evidence of PCBs,

pointing out that Barsotti had never before attempted to com-

pare soil chromatograms with human blood chromatograms.

They further criticize Barsotti for having claimed to be able to

match “early emerging peaks’ in certain PCB isomers, because

she later conceded that it was impossible for her to do so, having

failed to use the proper equipment. Defendants also attack

Barsottis procedures as impossible to replicate, because she

kept virtually no record of either her procedures or the basis for

her conclusions. She was, they note, unable to identify any

particular soil sample which was compared with any particular

Ad. -26

plaintiff; neither could she produce the specific chromatograms

she used to compare plaintiffs: PCB blood levels to those of the

unexposed population or at the railyard.

Defendants further attack Dr. Barsottis opinions because,

although she could not “think of anybody” who had ever done

the analysis she purported to do in this case, she pursued her

own methods, and ignored the body of existing data, “including

the Public Health Service's Paoli Study, which concluded that it

was scientifically impossible to determine that the Paoli Yard

rather than the environment in general was the source of the

residents exposure.’ Appellee’s Br. at 19. In addition, defen-

dants presented their own expert, Dr. Raymond Harbison, a

professor of toxicology and pharmacology, who concluded that

“Dr. Barsotti lacks the requisite experience in reading and inter-

preting human and soil chromatograms to be able to perform the

type of analysis that she purported to perform,” and that “if in

fact Dr. Barsotti did what she claims, she would be the first

person to do this.” With regard to the validity of Barsotti’s

experimental procedures, Dr. Harbison opined that it is impos-

sible to identify the source of such low PCB levels, that the

equipment used could not support Barsotti’s analysis, and that

the experiments lacked control and have not been replicated. He

therefore dismissed Barsottis results as being scientifically in-

valid.

Defendants also attacked Barsottis opinions on causation,

claiming that because she is not a physician, she is unqualified to

make the differential medical diagnoses that defendants assert

are critical to a finding of causation. Further, they argue that it

was inappropriate for Dr. Barsotti to offer opinions on causation

without ever having physically examined a single plaintiff. They

point out that each of her nineteen scientific reports, which

represent her conclusions on nineteen plaintiffs, is identical for

the first fourteen pages. Barsotti described this as “boiler plate

background information” on PCBs. Each report then contains

only one or two additional paragraphs, which list the alleged

injuries of the individual plaintiff and conclude “to a reasonable

scientific certainty’ that they were caused by PCBs.

In support of their challenge to Dr. Barsottis expertise and

Ad. -27

conclusions, defendants offered the affidavits of their own ex-

perts.!! These experts concluded generally that Dr. Barsotti is

not qualified to form opinions on medical causation, that the

opinions she Jid form lack evidentiary support and would not

withstand review by experts in the field, and that her opinions

are therefore not based upon known science or medicine. Defen-

dants also assail Dr. Barsotti’s opinion that plaintiffs, including

one two-year-old child, suffer from increased fear of illness and

are emotionally distressed. They note that she offered this opin-

ion, having spoken only to one plaintiff over the telephone, and

without having met or examined any of the plaintiffs. Further,

defendants contend that she performed no psychiatric evalua-

tions or tests, and that she is unqualified to do so. 2

Defendants took a similar tack in attempting to discredit the

opinions of Dr. Zahalsky, attacking first his qualifications as an

expert, and then challenging the bases for his scientific opinions

that plaintiffs had suffered immune system damage as a result of

having been exposed to PCBs. Insofar as Dr. Zahalsky’s creden-

tials are concerned, defendants point out that he claimed a

specialty in immunology, but had completed only one graduate-

level course that included immunology. Zahalsky conceded his

lack of expertise in epidemiology, toxicology, and medicine, and

11. The experts were Anthony J. Triolo, PhD., professor of pharmacology

at Jefferson Medical College; Dr. Gio Batta Gori, an epidemiologist and tox-

icologist whe directs the National Health Policy Center; Eddy A. Bresnitz,

M.D., a professor of medicine and epidemiology at the Medical College of

Pennsylvania; and Arnold L. Brown, M.D., Dean of the University of Wiscon-

sin Medical Center.

12. Defendants also attacked with specificity the opinions that Dr. Bar-

sotti offered with respect to each individual plaintiff. Vor instance, they ob-

served that she attributed plaintiff Patricia Ingram’s asthma to PCB exposure,

even though no one else has ever claimed that PCBs can cause asthma, and

even though Ingram has a family history of asthma. They point out that Barsotti

lists PCBs as a substantial factor in causing Charles Stanbach’s stomach cancer,

although Stanbach died at age 66, leaving no medical records indicative of PCB

exposure. They also criticize her for not attempting to rule out the many ge-

netic, dietary, and socioeconomic risk factors which could have contributed to

his disease. Finally, defendants contend that this failure to rule out alternative

causes renders useless Barsottis testimony that PCBs caused certain ailments

of seven other plaintiffs.

Ad. -28

admitted that because he is not a medical doctor, he is not

qualified to examine patients, perform clinical tests, or render

differential diagnoses.

At his deposition, Dr. Zahalsky offered diagnoses of im-

mune system damage in a number of plaintiffs, even though he

had not tested any of the plaintiffs, and instead simply assumed

that plaintiffs had elevated PCB exposure. He admitted that his

opinions could be validated only by a series of tests that he

designed, and further noted that these tests had not yet been

performed. In attempting to show the lack of scientific approval

for the proposition that PCBs damage the immune system,

defendants point to Zahalsky’s own somewhat cryptic statement

that if his tests should support such a conclusion, “then I will

have done something with the clinical immunologists that has

not yet been done.”

Defendants also noted that all of the studies relied upon by

Zahalsky were either animal studies or human studies arising

from the Yusho and Yu Cheng incidents. Defendants argue that

reliance upon the Yusho and Yu Cheng studies is scientifically

inappropriate because the PCB contamination in those incidents

was intermingled with exposure to and ingestion of PCDFs,

which defendants characterize as a far more toxic chemical.

Indeed, even one of plaintiffs’ experts opined that the toxicity of

PCDFs is “500 to 2000 times greater” than that of PCBs. Fur-

ther, they rely on a Public Health Service comment that there

appears to be general agreement in the scientific community

that PCDFs “contributed significantly” to the adverse health

effects analyzed in the Yusho and Yu Cheng studies. Moreover,

Zahalsky was generally unable to specify supporting authorities

for his opinions, and often simply assumed that the existence of

symptoms in plaintiffs evidenced exposure to PCBs. Zahalsky

himself characterized his opinion as a “hypothesis” or “statement

of expectation.”

Defendants also submitted an affidavit signed by twelve

physicians and scientists who had reviewed all existing medical

and scientific knowledge regarding PCBs. The affidavit criticized

Zahalsky’s results, noting that “one may not conclude to a reason-

able degree of medical and scientific certainty that PCBs can

> so toll

Ad. -29

cause immune system disorders.” Several of the individual de-

fense experts then criticized Zahalsky’s work directly. One ex-

pert stated that because Zahalsky is neither an immunologist nor

a medical doctor, he is not qualified to diagnose human illness.

Another expert decried as false the claim that the scientific

literature supported Zahalskys position, and asserted that

Zahalsky's attempted extrapolations from the existing literature

were “scientifically improper.” Zahalskys methodology was de-

scribed as “scientifically inadmissible” because of its failure to

obtain basic data, its lack of control groups, and its inadequate

histories. And one expert opined that “[njo doctor would rely on

the tests described in the Zahalsky affidavit for any purpose

whatsoever. ”

Defendants likewise criticized the opinions of Dr. Shubin,

who offered causation testimony in the Cunningham and Reid

cases. Defendants objected to Shubin’s conclusions that plain-

tiffs injuries were caused by PCBs because: (1) his diagnosis

conflicted with diagnoses of other physicians who had previously

examined plaintiffs, and (2) his diagnosis was based on a method

that improperly assumed the injuries to be caused by PCBs. As

with Dr. Barsotti, defendants also registered more particular

complaints regarding the individual diagnoses. When Shubin

cited PCBs as the cause of Matthew Cunningham's hyperten-

sion, defendants argued that he had failed to consider other

factors, including Cunningham's family history of hypertension,

his obesity, and his high blood sugars. In addition, Shubin was

unable to point to any studies showing a direct causal rela-

tionship between PCB exposure and hypertension. Shubin at-

tributed Cunningham's Parkinson's Disease and eventual death

to PCB exposure, even though previous doctors had determined

the Parkinson's Disease to have been caused by the use of

psychotropic drugs, and even though Shubin did not know the

circumstances of Cunningham’s death.

Defendants cited similar flaws in Shubin’s diagnoses of

Bessie Cunningham and William Reid. Shubin concluded that

Ms. Cunningham’ four spontaneous abortions were related to

PCB exposure, although he knew neither the circumstances

surrounding the abortions, nor even when in the past forty years

Ad. -30

they had occurred. Shubin opined that a host of illnesses al-

legedly suffered by William Reid were the result of PCB ex-

posure, although he found no PCBs in Mr. Reid’s blood, and did

not rule out other possible causes, such as smoking. Defendants

also objected to Shubin’s reliance on animal studies and the

Yusho and Yu Cheng incidents.

Some of the same experts who criticized Dr. Barsotti’s work

also criticized Dr. Shubin’s. They characterized his opinions as

“conjectural guesses.” which “fail adequately to consider multi-

ple etiologic factors, as well as obvious differential diagnoses,”

and “would not withstand review by a qualified panel of his

peers.” One expert stated that because Shubin’s opinions “have

no basis in factual observation or in a plausible hypothesis, {they

are| devoid of scientific justification.”

Similarly suspect, according to defendants, are the opinions

of Dr. DiGregorio, whom defendants criticize for offering a

“certain” opinion that plaintiffs suffered from anxiety and fear of

future harm as a result of PCB exposure, even though he never

conducted a mental status examination, took a psychiatric his-

tory, or reviewed any medical records. Indeed, DiGregorio ac-

knowledged that his diagnoses were only preliminary, and that

further testing would have to be conducted. In his own words,

DiGregorio saw each plaintiff only “for a brief period of time,”

“never reviewed any medical records of anyone,” and was unable

“to establish any physical findings yet.” He nevertheless offered

the opinion, with respect to five of the plaintiffs, that “until

otherwise proven,’ whatever ailments they had were caused by

PCBs. Defendants argue strenuously that these opinions are

improper, not only because they are based on insufficient infor-

mation, but also because, in every case, the doctor failed to rule

out other possible causes for the injuries. They view the failure

to conduct a conclusive differential diagnosis as a fatal flaw in

DeGregorios opinion.

Defendants also objected to the opinions set forth in each of

the four supplemental affidavits offered by plaintiffs in response

to the joint motion for summary judgment. Defendants criti-

cized Dr. Nisbet as being unqualified to offer an opinion that

was, in any event, unsupported. Nisbet's attempt to use a con-

version factor to determine PCB blood level from adipose tissue

Ad.-3}

levels was, defendants argue, indefensible because it was based

on no published or peer-reviewed studies, and is in fact contra-

dicted by both the Public Health Service's Toxicological Profile,

and plaintiffs own expert, Dr. DiGregorio. Defendants charac-

terize Nisbet's method as “assumptions plus arithmetic,” and

assert that his conversion factor is proven wrong by physical

evidence that plaintiffs whose blood levels and adipose tissue

levels were measured did not reflect the blood levels that would

have been expected using Nisbet's ratio to extrapolate from

tissue burden. See Appellees’ Br. at 88-89 n. 88. Defendants also

apply these criticisms to the opinions of Dr. Simon, whose

testimony overlapped with that of Dr. Nisbet.

Defendants roundly criticize Dr. Calesnick’s opinion on

medical monitoring as an “eleventh-hour’” affidavit that was no

more than a “one-sentence conclusion asserting simply, with no

reasons whatsoever, that ‘these Plaintiffs have been exposed to

PCBs,’ and that there was ‘a potential for them to sustain injuries

from PCB exposure. ” Id. at 93 n. 93, 39. Defendants object to

the admission of this testimony as (1) conclusory and unsup-

ported; (2) improper opinion testimony because Calesnick was

not formally offered as an expert; and (3) irrelevant because

Pennsylvania law does not recognize a cause of action for the cost

of medical monitoring. Id. at 94.

Finally, defendants challenge the affidavit of Dr. Nicholson,

who claimed that the results of his “meta-analysis” established a

causal connection between PCB exposure and various of the

plaintiffs injuries. Defendants submit that Nicholson's submis-

sion is irrelevant because none of the plaintiffs alleges injuries for

which Nicholson proffered a causal connection. More impor-

tantly, defendants argue that Nicholson's entire concept of meta-

analysis, for which the only cited support is a non-peer-reviewed

pamphlet written by Nicholson himself, is scientifically flawed.

Nicholson's study found a causal connection between PCB ex-

posure and human illness even though none of the studies he

reviewed in compiling the meta-analysis revealed such a connec-

tion.!? Defendants offered a counteraffidavit stating that by omit-

13. One of the studies did suggest a possibility that PCB exposure in high

doses may cause skin irritation.

Ad. -32

ting from his review data that was inconsistent with his conclu-

sions, Nicholson had produced a scientifically invalid study.

IV. THE DISTRICT COURT'S OPINION

The district court's opinion is devoted primarily to a discus-

sion of the opinions of plaintiffs experts. The court seems to have

envisioned plaintiffs experts as relying on three primary sources

for their testimony: (1) animal studies purporting to show the

deleterious health effects of PCBs; (2) studies employing data

from the Yusho and Yu Cheng studies; and (3) their own opin-

ions and research. With one or two exceptions explained below,

the court analyzed this evidence pursuant to Fed. R. Evid. 703,

which provides that facts or data not otherwise admissible in

evidence may nevertheless serve as the basis for an expert opin-

ion if the information is “of a type reasonably relied upon by

experts in the particular field in forming opinions or inferences

upon the subject.” The court appears to have excluded the bulk

of the expert opinion under Rule 703.

With regard to the animal studies, the court's analysis was

bifurcated, discussing first whether it could look beyond an

experts assertion that his opinion is reasonably relied upon by

experts in the field, and second whether animal studies are a

proper basis for an opinion about causation. The court answered

the first question readily, concluding that an expert's opinion on

the reasonableness of his or her own data could not be dis-

positive or Rule 703's limitation would be meaningless. In reach-

ing this conclusion, the court distinguished this court's opinion

in In re Japanese Electronic Products Antitrust Litigation, 723

F.2d 238 (3d Cir. 1983), rev'd on other grounds sub nom., Mat-

sushita Elec. Ind. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574,

106 S.Ct. 1348, 89 L.Ed.2d 538 (1986), which held, inter alia,

that a court may not ignore an expert’ uncontradicted testimony

that his opinions are “of a type reasonably relied upon by experts

in the field.” [d. at 276. The court reasoned that, unlike Japanese

Electronics, in the present case “we have very convincing evi-

dence on the record that says that these studies are irrelevant.”

Apparently relying on that evidence, the court proceeded to

Ad. -33

exclude the animal studies. However, the court neither detailed

the “very convincing evidence” indicating that the studies are

“irrelevant,” nor explained why the relevancy of the studies

pertains to their reliability under Rule 703. The opinion is

similarly silent as to precisely which expert opinions it meant to

exclude in this manner.

The court's consideration of the Yusho and Yu Cheng stud-

ies as possible bases for expert opinions as to causation is simi-

larly abbreviated. The court's holding is found in the following

two sentences:

It does seem clear that the consensus conclusion from the

scientific literature is that the diseases that occurred in the

victims of these incidents were caused by the ingestion of

highly toxic PCDFs with their food and is not evidence of

the effects of PCBs. Therefore, for the same reasons as

addressed above regarding animal studies, I will exclude

from evidence any expert opinion based on studies of the

Yusho or Yu Cheng incidents.

Again, the court did not state which of the expert opinions were

tainted by reliance on these studies or which opinions offered in

rebuttal suggested a “consensus conclusion” indicating unre-

liability.

After excluding these two significant sources of evidence,

the court turned to its third category, plaintiffs’ experts’ own

research results not based on animal studies or the Yusho and Yu

Cheng incidents. Before analyzing in a particularized manner

the opinions of the individual experts, it noted that:

Even if I found that plaintiffs’ experts{’] testimony reached

the level of being probative, | would rule to exclude it on

the basis of Rule 703 and 403 as “unhelpful” and more

prejudicial than probative.

Nonetheless, the opinion considered each of the individual ex-

pert opinions, beginning with that of Dr. Barsotti.

The court noted that Dr. Barsotti:

finds PCB caused hypertension and asthma even in people

Ad. -34

who have family histories of hypertension and asthma. She

finds that PCBs caused the plaintiffs’ emotional distress,

despite the fact that her area of expertise has nothing to do

with emotional diseases and she has only talked to one of

the plaintiffs. She claims that, by studying the plaintiffs’

medical histories, she has excluded other causes of these

diseases, but she is not a medical doctor and is not trained

in differential diagnosis

Although certain factual findings may be implicit in the court's

discussion (for example, that some plaintiffs have family histories

of hypertension and asthma, and that Barsotti talked with only

one plaintiff), the court never explained the basis for its decision

to exclude Barsotti’s opinion. !4

The court’s analysis of other experts, including doctors

Zahalsky, DiGregorio, Shubin and Allen, was comparable in that

it elucidated the potential flaws in the doctors’ testimony but

failed to make definitive admissibility findings. However, the

court gave more detailed consideration to the affidavits filed by

plaintiffs in response to the summary judgment motion, includ-

ing the opinions of Dr. Nisbet and Dr. Simon. The court pro-

vided a summary of both doctors’ attacks on the ATSDR study,

and criticized their opinions as follows:

Dr. Simon does not give a basis for his statement that the

background PCB blood burden can be calculated from the

[National Human Adipose Tissue Survey]. Drs. Simon and

Nisbet evidently believe that their blood to adipose tissue

formula is over the number of studies that defendants cite

that indicate a PCB blood background amount directly by

measuring it. However, the only reason they give for not

believing them is that the NHATS is more recent. However,

the NHATS ended in 1983 and some of the defendants’

14. An exception to this observation is the court's exclusion of Dr. Bar-

sottis opinion “tracing” the PCBs in the plaintiffs: bodies to the Paoli railyard

through gas chromatography. In that instance, the court made clear that Bar-

sottis testimony would be excluded because she “is not a chemist,” and such

conclusions are therefore “beyond the scope of her expertise.” But see infra

note 19.

”

Ad. -35

studies are more recent than that. Neither doctor cites any

study that measures PCBs in the blood directly or cites a

basis for calculating blood burden from adipose tissue bur-

den. Further, there are some plaintiffs in our case who have

had both blood tests and adipose tissue tests and they do

not reflect the 20 to 250 times relationship that these ex-

perts claim.

Nonetheless, the court did not declare these observations to be

grounds for excluding the opinions, and did not even state

whether it excluded these opinions. !°

The court next addressed the affidavit of Dr. Nicholson,

whose “meta-analysis” it analyzed under the “novel scientific

evidence’ standards of United States v. Downing, 753 F.2d 1224

(3d Cir. 1985). Downin,; requires that admissible scientific tech-

niques be reliable, be of a sort that will not mislead juries, and

have a sufficient connection to the particular factual issues in the

against admission of the affidavit. The court reasoned that:

[t]he reports of defendants experts advance convincing rea-

sons why meta-analysis as a technique, and this meta-analy-

sis in particular, is not reliable. Dr. Nicholson's report has

not been peer-reviewed or accepted by anybody in particu-

lar, even the Ontario Ministry of Labor [for whom the

report was compiled]. There is a possibility that Dr. Nich-

olson’ testimony would confuse the jury becaus@ of its

scientific nature and his credentials so they would make

more of it than it actually deserved.

The third factor is the most influential in this determi-

nation. The conclusion of Dr. Nicholson's report is that

i5. The quoted passage is immediately followed by the court's reflection

that “I feel compelled to note further that I see nothing in Dr. Nisbet's curricu-

lum vita that would qualify him to testify as an expert in this area.” It is not

clear from the opinion whether this statement is mere dicta, or is intended to

exclude the testimony under Rule 702. The district court made similarly cryp-

tic indictments of Dr. Barsotti’s qualifications to make psychiatric diagnosis and

Dr. Zahalsky’s qualifications to perform differential diagnoses.

16. For a more complete discussion of Downing, see Part VI.C2 below.

Ad. -36

there was “substantial evidence for a causal association be

tween excess risk of death from cancer of the liver, biliary

tract and gall bladder and exposure to PCBs.” Dr. Nich-

olson’s report could not be the basis for anyone to say with

reasonable degree of scientific certainty that some particu-

lar person’ disease, not cancer of the liver, biliary tract or

gall bladder, was caused by PCBs.

It would thus appear that the district court intended to exclude

Nicholson's affidavit as based upon an inadmissible scientific

technique. !“

The last expert the court considered is Dr. Calesnick, who

testified that the plaintiffs he examined have the potential to

suffer harm from PCB exposure, and should therefore be moni-

tored regularly to protect their health. The court characterized

Calesnick’s testimony as being “strikingly similar to the opinion

offered in Martin v. Johns-Manville Corp. and ruled inadmissible

by the Pennsylvania Supreme Court.’!> It then noted that be-

cause Martin “was an asbestos case, and it has been epidemio-

logically proved that asbestos exposure can cause cancer, that

doctor might have had more of a basis for his opinion.” However,

the court did not explicitly state that it was excluding Calesnick’s

testimony, much less why it might be excluding it. Indeed, later

in the opinion, the court barred the entire medical monitoring

claim, stating that “the testimony of Dr. Calesnick and the other

plaintiffs experts who testiflied] regarding the risk of future

injury is insufhcient to support it under Pennsylvania law.’ This

comment suggests that Calesnick’s opinion was admitted, but

17. The court added that “even if Dr. Nicholson's testimony was admissi-

ble despite being a novel scientific technique, it would be difficult to under-

stand how it was relevant.” Whether the court intended a Rule 402 relevancy

exclusion is unclear.

18. In Martin, 508 Pa. 154, 164-65, 494 A.2d 1088, 1094 (1985), the court

excluded a doctor's testimony that, based on the plaintiff's “history of exposure

to asbestos together with his one bloodspitting episode” the plaintiff might

have had cancer at the time the doctor examined him. That testimony, the

court ruled, was “not probative of the fact for which appellee now says it is

offered, i.e., that appellee faced a substantially increased risk of contracting

cancer.” Id. at 165, 494 A.2d at 1094.

Ad. -37

did not raise a genuine issue of fact deemed “material,”

Fed. R.Civ. P. 56(c), under Pennsylvania law.

Thus, the court appears to have excluded almost all of

plaintiffs expert testimony. The Yu Cheng, Yusho and animal

studies appear to have been excluded as not reasonably relied on

by experts in the field under Rule 703, and the opinions of

various experts appear to have been excluded either on the same

grounds or because the district court found them to be un-

qualified under Rule 702. Dr. Nicholson's testimony was ex-

cluded as based upon an unreliable scientific technique under

Rule 702.

Having concluded its discussion of the evidentiary issues,

the court turned its attention to the summary judgment motion

itself, positing that in order to survive a motion for summary

judgment, plaintiffs must establish a genuine issue of fact with

respect to their prima facie case, which the court defined as

including the following tour elements:

1) that defendants released PCBs into the environment; 2)

that plaintiffs somehow ingested these PCBs into their

bodies; 3) that plaintiffs have an injury; 4) that PCBs are the

cause of that injurv.

The first element was uncontested. Observing that the

second question depends on whether the plaintiffs have been

exposed to PCBs to a greater degree than has the general popu-

lation, the cuurt analyzed the issue as follows:

Either plaintiffs are right and they have more PCBs in their

bodies than the rest of us, or defendants are right and they

do not. If they do have an unusually high amount of PCBs,

circumstantial evidence indicates where they came from.

However, the only legally admissible evidence in this

case is that they do not. The plaintiffs have certainly failed

to carry their burden to prove that they do. For the reasons

discussed above, plaintiffs evidence to the contrary is inad-

missible. Since the plaintiffs cannot demonstrate that they

have been more heavily exposed to PCBs than the general

population, they cannot recover.

Ad. -38

With respect to the third issue, whether plaintiffs have an injury,

the court concluded that “plaintiffs must point to some health

problem that they have or they are out of court under Pennsylva-

nia law. If the best they can do is possibility of future harm,

emotional distress, or the mere fact that they have PCBs in their

body, then those plaintiffs cannot recover.”

Finally, the opinion divided the fourth issue, causation, into

three separate considerations. First, the court stated, without

particularization, that plaintiffs’ expert opinions on causation

were inadmissible because they lacked a sufficient scientific

foundation. It is unclear whether the court meant to exclude all

of the plaintiffs experts on this basis. Second, the court noted

that many of these experts “seem to have very little formal

academic training in the areas in which they testify,” thereby

raising the question whether these experts “really are experts.”

However, the court concluded that because defendants failed to

attack the experts systematically and neglected to brief the

question, the issue would not be considered.!9 Third, the court

pointed out that plaintiffs’ experts, for the most part, did not

provide testimony eliminating other possible causes of the vari-

ous afflictions, i.e. differential diagnoses. None of the plaintiffs’

medical doctors rendered differential diagnoses, and plaintiffs’

experts who did were Ph.D.’s, who, the court declared, are not

trained or qualified to conduct differential diagnoses. Again, it is

unclear whether the court was excluding this evidence, and if so,

for lack of qualification or on some other ground.

After dealing briefly with a number of miscellaneous issues

(cliscussed below in Parts VIII and IX), the court concluded the

opinion with a series of short paragraphs specifying the injury

claims of each individual plaintiff, but granting summary judg-

ment to defendants on all claims. In sum, the district court

opinion appears to have excluded almost all of the plaintiffs’

evidence and determined whether plaintiffs, with almost none of

19. This holding seems in tension with the explicit exclusion of Dr. Bar-

sottis testimony on these same grounds, see supra note 14 and accompanying

text, and the comments about the qualifications of Drs. Nisbet and Zahalsky,

see supra note 15.

Ad. -39

their evidence left in the record, met their burden on the

contested issues of exposure to PEBs, injury, and causation. Not

surprisingly, given the consequent lack of evidence, the court

found that the plaintiffs have not met their burden on any of

these issues. It therefore granted summary judgment for defen-

dants.

V. MEDICAL MONITORING

[2] Because it bears on the question of what evidence is

admissible, we turn first to the viability of certain plaintiffs

“medical surveillance,” or “medical monitoring,” claims, by

which plaintiffs sought to recover the costs of periodic medical

examinations that they contend are medically necessary to pro-

tect against the exacerbation of latent diseases brought about by

exposure to PCBs. Neither the Pennsylvania Supreme Court nor

the Pennsylvania Superior Court has decided whether a demon-

strated need for medical monitoring creates a valid cause of

action.2° Therefore, sitting in diversity, we must predict whether

the Pennsylvania Supreme Court would recognize a claim for

medical monitoring under the substantive law of Pennsylvania

and, if so, what its elements are. See Erie R.R. Co. v. Tompkins,

304 U.S. 64, 58 S.Ct. 817, $82 L.Ed. 1188 (1938).

Medical monitoring is one of a growing number of non-

traditional torts that have developed in the common law to

compensate plaintiffs who have been exposed to various toxic

substances.?! Often, the diseases or injuries caused by this ex-

20. The one Pennsylvania trial court to have considered this type of claim

allowed it to proceed. See Habitants Against Landfill Toxicants v. City of York,

No. 84—S—3820 (Pa. York Co. May 20, 1985), 15 Envtl.L. Rep. 20,937 (allowing

an action seeking relief in the form of a medical surveillance trust fund). For the

reasons expressed below in note 22, we believe that Peterman v. Techalloy Co.,

Inc., 29 Pa. D. & C.3d 104 (Mont.Co. 1982), a Pennsylvania trial court decision,

which denied reliet, is distinguishable because plaintiffs in that case requested

relief in the form of a trust fund for future medical expenses, including, pre-

sumably, medical treatment, not just medical surveillance.

21. See generally Note, The Inapplicability of Traditional Tort Analysis to

Environmental Risks: The Example of Toxic Waste Pollution Victim Compensa-

tion, 35 Stan. L. Rev. 575, 576-78 (1983) (collecting cases); Note Medical Sur-

veillance Damages: A Solution to the Inadequate Compensation of Toxic Tort

Victims, 63 Ind.L.]. 549 (1985) (same).

Ad. -40

posure are latent. This latency leads to problems when the

claims are analyzed under traditional common law tort doctrine

because, traditionally, injury needed to be manifest before it

could be compensable. Thus, plaintiffs have encountered bar-

riers to recovery which “arise from the failure of toxic torts to

conform with the common law conception of an injury.” Note,

Medical Surveillance Damages, supra note 21, at 852.

Nonetheless, in an effort to accommodate a society with an

increasing awareness of the danger and potential injury caused

by the widespread use of toxic substances,”? courts have begun

to recognize claims like medical monitoring, witch can allow

plaintiffs some relief even absent present manifestations of phys-

ical injury. More specifically, in the toxic tort context, courts

have allowed plaintiffs to recover for emotional distress suffered

because of the fear of contracting a toxic exposure disease, see,

e.g., Sterling v. Velsicol Chemical Corp., 855 F.2d 1188, 1206

(6th Cir.1988) (applying Tennessee law), the increased risk of

future harm, see generally Note, Decreasing the Risks Inherent

in Claims for Increased Risk of Future Disease, 43 U.Miami

L. Rev. 1081 (1989), and the reasonable costs of medical monitor-

ing or surveillance, see, e.g., Ayers v. Township of Jackson, 106

N.J. 557, 525 A.2d 287 (1987); Burns v. Jaquays Mining Corp.,

156 Ariz. 375, 752 P.2d 28 (Ct.App.1988); Merry v. Wes-

tinghouse Electric Corp., 684 F.Supp. 847 (M.D. Pa. 1988); Vil-

lari _v. Terminix International, tnc., 663 F.Supp. 727

(E. D. Pa. 1987).

22. The necessity of addressing problems of toxic exposure become pav-

ticularly important with the coatinued widespread use of chemicals in Ameri-

can industrial and agricultural development. One commentator has pointed

out that:

there are approximately 50,000 hazardous waste sites nationwide. In all,

over 65,000 chemicals are in commercial use today which have not been

tested for their effects on human health or the environment. According to

varying estimates, workplace exposure to hazardous substances alone ac-

counts for from five percent to as much as thirty-eight percent of all can-

cers.

Note, Medical Surveillance Damages: Using Common Sense and the Common

Law to Mitigate the Dangers Posed by Environmental Hazards, 12 Harv.En-

vtl. L. Rev. 265, 265 (1988) (footnote omitted).

23. In addition, several courts have modified the traditional rules dis-

Ad. -41

It is easy to confuse the distinctions between these various

non-traditional torts. However, the torts just mentioned involve

fundamentally different kinds of injury and compensation. Thus,

an action for medical monitoring seeks to recover only the quan-

tifrable costs of periodic medical examinations necessary to de-

tect the onset of physical harm, whereas an enhanced risk claim

seeks compensation for the anticipated harm itself, proportion-

ately reduced to reflect the chance that it will not occur. We

think that this distinction is particularly important because the

Pennsylvania Supreme Court has expressed some reluctance to

recognize claims for enhanced risk of harm. In Martin v. Johns-

Manville Corp., 508 Pa. 154, 494, A.2d 1088 (1985), The Court

made clear that a plaintiff in an enhanced risk suit must prove

that future consequences of an injury are reasonably probable,

not just possible. Id. at 165 n. 5, 494 A.2d at 1094 n. 5.

Martin does not lead us to believe that Pennsylvania would

not recognize a claim for medical monitoring, however. First,

the injury that the Court was worried about finding with reason-

able probability in Martin is different from the injury involved

here. The injury in an enhanced risk claim is the anticipated

harm itself. The injury in a medical monitoring claim is the cost

of the medical care that will, one hopes, detect that injury.24 The

former is inherently speculative because courts are forced to

anticipate the probability of future injury.

The latter is much less speculative because the issue for the

jury is the less conjectural question of whether the plaintiff

needs medical surveillance. Second, the Pennsylvania Supreme

cussed above to better serve in the toxic tort context. See, e.g., Ayers, 106 N.].

at 584, 525 A.2d at 300 (stating that “neither the statute of limitations nor the

single controversy rule should bar timely causes of action in toxic-tort cases

instituted after discovery of a disease or injury related to tortious conduct,

although there has been prior litigation between the parties of different claims

based on the same tortious conduct).

24. Once the injury is detected, the plaintiff may or may not have a cause

of action against the same defendant for the injury itself, See generally Note,

Claim Preclusion in Modern Latent Disease Cases: A Proposal for Allowing

Second Suits, 103 Harv. t. Rev. 1989 (1990). Because that situation is not before

us, we do not reach it.

Ad. -42

Court's concerns about the degree of certainty required can

easily be accommodated by requiring that a jury be able reason-

ably to determine that medical monitoring is probably, not just

possibly, necessary.

Defining injury in this way is not novel. In Friends for All

Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816

(D.C.Cir. 1984), the court, in recognizing a claim for medical

monitoring damages for children exposed to the depressuriza-

tion of an airplane cabin, noted that “i]t is difficult to dispute

that an individual has an interest in avoiding expensive diag-

nostic examinations just as he or she has an interest in avoiding

physical injury.” Id. at $26. See also Laxton v. Orkin Exterminat-

ing Co., 639 §.W.2d 431 (Tenn. 1982) (ingestion of contaminated

water requiring testing held to be injury in itself, even though

ingestion found to be harmless).

Similarly, in Askey v. Occidental Chemical Corp., 102

A.D.2d 130, 477 N.Y.S.2d 242 (1984), the court analyzed the

issue as follows:

Damages for the prospective consequences of a tortious

injury are recoverable only if the prospective consequences

may with reasonable probability be expected to flow from

the past harm. Consequences which are contingent, spec-

ulative, or merely possible are not properly considered in

ascertaining damages. If a plaintiff seeks future medical

expenses as an clement of consequential damage, he must

establish with a degree of reasonable medical certainty

through expert testimony that such expenses will be in-

red

ly heht of the foregoing, it would appear that under the

red here persons exposed to toxic chemicals ema-

g fr the landfill have an increased risk of invisible

we and a present cause of action for their

«recover all “reasonably anticipated” conse-

s wees. The tuture expense of medical monitor-

recoverable consequential damage provided

an establish with a reasonable degree of

tant, that such expenditures are “reasonably

to be incurred by reason of their exposure.

Ad. -43

Id. at 136-37, 477 N.Y.S.2d at 247 (citations omitted). Thus, the

appropriate inquiry is not whether it is reasonably probable that

plaintiffs will suffer harm in the future, but rather whether

medical monitoring is, to a reasonable degree of medical cer-

tainty, necessary in order to diagnose properly the warntng signs

of disease. .

Federal district courts, sitting in diversity, have addressed

the medical monitoring issue under Pennsylvania law. In Villari

v. Terminix International, Inc., 663 F.Supp. 727 (E.D. Pa. 1957),

the court allowed plaintiffs, who had presented sufficient medi-

cal evidence of present physical injuries resulting from exposure

to an allegedly carcinogenic pesticide, to recover the costs of

future medical surveillance. Id. at 735. The court required a

showing of present physical injury and expressly refused to

follow Ayers, which it characterized as holding that “the cost of

25. Our research has yielded only two cases in which courts have pur-

ported to disallow recovery based on a medical monitoring theory. Both cases

are distinguishable. In Rheingold v. E.R. Squibb & Sons, No. 74 Civ. 3420

(S.D.N.Y. Oct. 8, 1975), the court rejected a class action claim for what might

more accurately be called “medical management” damages. Plaintiffs, who had

used DES during pregnancy, sought to establish a fund to finance the periodic

examinations of plaintiffs affected female offspring, as well as, inter alia, the

medical treatment of “such girls as develop or show any propensity toward

development of {vaginal cancer or other related conditions|.” Id. at 7. This

remedy is far broader than a mere claim for medical monitoring as we have

defined it. Moreover, to the extent that the Rheingold court interpreted New

York law as requiring actual injury as a prerequisite to recovery, such reasoning

is seriously called into question by subsequent New York state appellate court

decisions to the contrary, see Askey, 102 A.D.2d at 130. 477 N-Y.S.2d at 242

In Morrissy v. Eli Lilly & Co., 76 Ul. App.3d 753, 32 Hl Dec. 30, 394

N.E.2d 1369 (1979), the plaintiffs explicitly characterized their claims as re-

questing, inter alia, that defendants “establish and maintain a fund of mone,

reasonably calculated to compensate all class members for such medical ex-

penses which have been and will continue to be incurred due to the phys-

iological damage done by DES,” id. at 757, 32 Ill Dec. at 34, 394 N. F.2d at

1373. The court held that “[t}he nexus thus suggested between exposure to

DES in utero and the possibility of developing cancer or other injurious condi-

tions in the future is an insufficient basis upon which to recognize a present

injury. Id. at 761, 32 Il Dec. at 37, 394 N.B.2d at 1376. However, as in

Rheingold, the plaintiffs’ request in Morrissy was for treatment as well as moni-

toring. Thus, it is inapposite to the case at bar.

Ad. -44

future medical monitoring is a proper element of damages when-

ever medical testimony establishes the need for future monitor-

ing. Id. at 735 n. 5. However, because the plaintiffs in Villari

had demonstrated sufficient physical injury, the question

whether the cause of action could be sustained without it was not

squarely raised.

Villaris putative physical injury requirement was rejected

in Merry v. Westinghouse Electric Corp., 684 F.Supp. 347

(M.D.Pa.1988). In Merry, property owners whose wells aad

been contaminated by toxic substances sought recovery for, inter

alia, the cost of medical surveillance. In denying defendant's

motion for summary judgment, the court agreed with Villari that

“a plaintiff need not exhibit symptoms of a disease before medi-

cal surveillance is sought,” id. at 849, but disagreed to the extent

that Villari required “physical injury before a claim for future

medical monitoring can be maintained.” Id. (emphasis in origi-

nal). Consequently, Merry suggested that a medical monitoring

action could be premised upon proof of exposure to hazardous

substances resulting in the potential for injury and the need for

early detection and treatment. Id. at 850.

We agree with Merry, and predict that the Supreme Court

of Pennsylvania would follow the weight of authority and recog-

nize a cause of action for medical monitoring established by

proving that:

1. Plaintiff was significantly exposed to a proven hazardous

substance through the negligent actions of the defendant.

2. As a proximate result of exposure, plaintiff suffers a

significantly increased risk of contracting a serious latent

disease.

3. That increased risk makes periodic diagnostic medical

examinations reasonably necessary.

4. Monitoring and testing procedures exist which make the

early detection and treatment of the disease possible and

beneficial.

These factors would, of course, be proven by competent expert

testimony, see Ayers, 106 N.J. at 606, 525 A.2d at 312.

The policy reasons for recognizing this tort are obvious.

Medical monitoring claims acknowledge that, in a toxic age,

Ad.-45

significant harm can be done to an individual by a tortfeasor,

notwithstanding latent manifestation of that harm. Moreover, as

we have explained, recognizing this tort does not require courts

to speculate about the probability of future injury. It merely

requires courts to ascertain the probability that the far less costly

remedy of medical supervision is appropriate. Allowing plaintiffs

to recover the cost of this care deters irresponsible discharge of

toxic chemicals by defendants and encourages plaintiffs to cetect

and treat their injuries as soon as possible. These are conven-

tional goals of the tort system as it has long existed in Penn-

sylvania.?>*

Having established the applicable standard, we discuss be-

low, in Part VII, whether summary judgment was properly

granted for the defendants on the medical monitoring claim.

VI. EVIDENTIARY ISSUES

A. Introduction

To the extent that the district court actually excluded the

bulk of plaintiffs’ expert opinion evidence, our threshold ques-

tion is whether it did so properly. As we have explained supra, at

times, the text of the district court opinion, which attacks many

of plaintiffs’ expert opinions without formally excluding them,

suggests that the court was merely describing, net excluding,

the testimony. However, at other times, the court appears to

have excluded most if not all of the testimony. In view of the

court's “bottom line,” we will assume that the court excluded the

challenged evidence. If these exclusions were proper, summary

judgment would doubtless be appropriate because exclusion of

the opinions would effectively eviscerate plaintiffs case. How-

ever, whether that evidence was properly excluded at this stage

of the proceedings is quite another question. We address first

the adequacy of the district court's Fed. R. Evid. 703 analysis. We

25a. In light of the statute of limitations problems caused by Pennsylvania

law against splitting causes of action, we intimate no view as to whether a

plaintiff who sues for medical monitoring must forego his or her claim tor

damages if and when the disease ultimately manitests itself.

Ad. -46

then turn to the district court’s Rule 702 determinations. and

then to its rather abbreviated reliance on Rule 403.

B. Evidence Excluded under Rule 703

1. Factual Inquiry

(3] Although it stops short of giving the basis for a number

of its rulings, the district court appears to have found that much

of plaintiffs’ expert opinion evidence, includingfhe animal stud-

ies and the Yusho and Yu Cheng incidents, was unreliable and

excludable under Rule 703.26 However, its analysis did not track

the Rule 703 protocols established by this court in In re Japanese

Electronic Products, 723 F.2d 238 (3d Cir. 1983), rev'd on other

grounds sub nom., Matsushita klectrical Industrial Co., Ltd. v.

Zenith Radio Corp., 475 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d

538 (1986).

In Japanese Electronics, the district court had excluded

expert testimony under both Rules 702 and 703, and granted

summary judgment in favor of defendants. Reversing those rul-

ings, this court took the opportunity to provide the district

courts with guidance in approaching such situations. Of specific

relevance here is its holding that, in determining for purposes of

Rule 703 whether the informational basis of an expert opinion is

of a type reasonably relied upon by experts in the field, “[{t|he

proper inquiry is not what the court deems reliable, but what

experts in the relevant discipline deem it to be.’ Id. at 276.

Further, the court noted emphatically that “as a matter of law,

the district court must make a factual inquiry and finding as to

what data experts in the field find reliabie. There is no discretion

to forbear from making this inquiry and finding.” Id. at 277. “[A]

factual determination under Rule 104(a). . . must be made when

there is a factual dispute over such reliance.” Id. at 276.

Japanese Electronics does not require that the “factual in-

26. Fed. R. Evid. 703 states: The facts or data in the particular case upon

which an expert bases an opinion or inference may be those perceived by or

made known to the expert at or before the hearing. If of a type reasonably

relied upon by experts in the particular field in forming opinions or inferences

upon the subject, the facts or data need not be admissible in evidence.

Ad. -47

quiry take the form of an in limine or other hearing. It does

make clear, however, that the district court must have a proper

and reviewable foundation for making its admissibility findings.

We can identify po such foundation here. With respect to the

animal studies, the court seems to have excluded the expert

testimony because it had “very convincing evidence on the

record that says that these studies are irrelevant.” However, the

court did not make specific reference to the evidence in the

voluminous record it has chosen to credit, did not reveal the

theory on which it has rejected opinions to the contrary, and did

not identify which opinions it means to exclude in this manner.

Thus, we have no way of evaluating the district court's legal

conclusion that the evidence was inadmissible under Rule 703.

because we do not know what facts it relied on in making its legal

determination. Moreover, it is not clear that the court was not

merely choosing between opinions as opposed to excluding

plaintiff's opinion on evidentiary grounds.?*

The court's treatment of the Yusho and Yu Cheng incidents

as a basis for expert testimony was similarly flawed. It stated that

its decision to exclude opinions based on these incidents was

compelled by a “finding” that “the consensus conclusion from

the scientific literature is that the diseases that occurred in the

victims of these incidents were caused by the ingestion of highly

toxic PCDFs with their food and is not evidence of the effects of

PCBs. '*> The court did not, however, specify what scientific

literature or which consensus conclusion it was referring to, nor

did it say which opinion it was excluding as inconsistent with the

consensus conclusion. Moreover, the court did not even consider

27. As noted, the court may have meant to exclude the animal studies as

irrelevant under Rule 402 because, even if they showed correlation between

PCBs and animal disease, they were not probative of a connection between

PCB exposure and human disease. However, it made no such definitive ruling.

28. As just noted with regard to the animal studies, the courts reasoning

with regard to these two incidents seems to follow a relevancy rationale, not a

Rule 703 unreliability rationale. There is no indication that the data from Yusho

and Yu Cheng is unreliable. The court's concern appears to be more grounded

in whether a study regarding the effect of PCDFs is relevant to this proceed-

ing.

Ad.-48

the record evidence that certain plaintiffs may have been ex-

posed to PCDFs as well as PCBs.

For the foregoing reasons, the district court's evidentiary

exclusions under Rule 703 cannot pass muster and must be set

aside. Those rulings that do implicate facts or data which are the

basis for expert opinion may be reconsidered in the remanded

proceedings pursuant to the Japanese Electronics meth-

odology. 9

2. Process

[4] Closely related to the question whether the district

court conducted an appropriate and adequate factual inquiry is

the question whether the court provided the plaintiffs with

sufficient process for defending their evidentiary submissions.

The adversarial process upon which our legal system is based

assumes that a fact finder will give the parties an adequate

opportunity to be heard; if it does not, it cannot find facts

reliably. Thus, the detailed factual record requirement, firmly

entrenched in our jurisprudence, Japanese Electronics, 723 F.2d

at 238; Indian Coffee Corp. v. Procter & Gamble, 752 F.2d 891,

895 (3d Cir.), cert. denied, 474 U.S. 863, 106 S.Ct. 180, 88

iL. Ed.2d 150 (1985); DeLuca v. Merrell Dow Pharmaceuticals,

Inc., 911 F.2d 941 (3d Cir.1990), requires adequate process at

the evidentiary stage, particularly when a summary judgment

may flow from it. The district court did not afford that process

here.

More precisely, notwithstanding the complexity of the mat-

ter, and the voluminous nature of the expert opinions, the

district court did not give the plaintiffs sufficient opportunity to

29. Although, for the reasons explained, factfinding is a prerequisite to

definite conclusions, it appears to this court that most of the data upon which

plaintiffs experts rely is “of a type reasonabiy relied upon by experts in the

particular field,” Fed.R. Evid. 703, and thus admissible under Rule 703. How-

ever, even if admissible under Rule 703, plaintiffs’ experts may be using their

data in an unreliable manner. As we explain infra, that is a Rule 702 question

and much of plaintiffs: evidence may be excludable on that basis.

Ad. -49

explore the issues upon which they were ultimately denied

relief. First, the court failed to conduct an in limine hearing.?%*

Second, it denied oral argument on the evidentiary issues and

on the related summary judgment motion. Compounding these

restrictions was a case menagement order which arguably did

not give plaintiffs an adequate opportunity to discover defen-

dants’ experts’ positions.°° Of particular significance is the plain-

tiffs’ inability to contest the reasonableness of the data and

techniques relied on by defendants experts. Having no fore-

knowledge of the direction that the district court's opinion might

take, the plaintiffs should have been given an opportunity to be

heard on the critical issues before being effectively dispatched

trom court. An in limine hearing would have been quite manage-

able. At least some process should have been devised to afford

plaintiffs a surrogate for that trial scenario where the equivalent

evidentiary exclusion and adverse judgment might occur. On

this ground alone, the summary judgment would have to be set

aside.

C. Evidence Excluded under Federal Rule of Evidence 702

As noted, the district court apparently made the bulk of its

exclusionary rulings under Rule 703. However, the court did, on

several occasions, invoke Rule 702 either explicitly or implicitly.

We deal now with those exclusions.

The court's Rule 702 exclusions can generally be divided

29a. The plaintiffs did not request an in limine hearing and in fact opposed

it on the grounds that it was premature, i.e., they did not want to be forced into

it before their discovery was complete. We emphasize, however, that the man-

agement of complex litigation may not be relegated to the lawyers but at all

times remains the responsibility of the court. See Manual for Complex Litiga-

tion 2d § 20.1.

30. By its terms, the case management order granted plaintiffs three

months within which to conduct discovery limited to “the quantity and nature

of the PCBs used at the Paoli Railyard and the health effects cn Defendants

employees of exposure to PCBs.” This was to be followed by defendants’ discov-

ery of the evidence comprising plaintiffs’ prima facie case on causation. All

other discovery, including discovery by plaintiffs of defendants’ experts, was

stayed, and plaintiffs motions to compel such discovery were denied.

Ad. -50

into two categories: (1) rejection of the witness as unqualified to

give expert testimony in the relevant field;}! and (2) rejection of

the expert because, however qualified, he or she was relying on

an unreliable scientific technique. The district court here made

both kinds of Rule 702 exclusions.

1. Expert Witness Qualifications

[5] The court appears to have excluded much of Dr. Bar-

sottis testimony on the grounds that she is neither a chemist

qualified to present an opinion based on gas chromatography

tracing nor a medical doctor qualified to present her opinion on

what caused the plaintiffs’ emotional and physical injuries. Simi-

larly, the court appears to have excluded much of Dr. Zahalsky's

testimony regarding the effect of PCBs on human beings be-

cause “he is not trained in differential diagnosis. °° The court also

noted that “Dr. Nisbet's curriculum vita {did not} qualify him to

testify as an expert” in the area of whether the ATSDR study

(which indicated that the level of PCBs in the plaintiff's body was

typical of the American population) was accurate.

The district court's insistence on a certain kind of degree or

background is inconsistent with our jurisprudence in this area.

The language of Rule 702 and the accompanying advisory com-

mittee notes make clear that various kinds of “knowledge, skill,

experience, training, or education, Fed. R. Evid. 702, qualify an

expert as such. Interpreting the rule liberally, we recently held

that a safety specialist who had received a masters degree in

safety education and a doctorate in human factors and product

safety design, could testify on whether the failure of the forklift

manufacturer to put seatbelts in the forklift caused the death of

the operator of a forklift which overturned, notwithstanding the

fact that the expert was not an engineer. Habecker v. Copperloy

31. As pointed out, supra note 19, these exclusionary holdings cannot be

reconciled with the courts later statement that the question of plaintiffs’ wit-

nesses qualification as experts would not be addressed by the opinion.

32. We note that most, if not all, of the evidence supporting Dr

Zahalskv’s conclusions regarding causation are based on the Yusho and Yu

Cheng studies. If those studies are excluded under Rule 703, then Dr.

Zahalskys quahfications as an expert may not be important.

Ad.-51

Corp., 893 F.2d 49 (3d Cir. 1990). See also Knight v. Otis Ele-

vator Co., 596 F.2d $4 (3d Cir. 1979) (expert may testify that

unguarded elevator buttons constitute a design defect despite

that expert's lack of a specific background in the design and

manufacture of elevators); Hammond v. International Harvester

Co., 691 F.2d 646 (3d Cir. 1982) (engineer, whose only qualifica-

tions were sales experience in the field of automotive and agri-

cultural equipment and teaching high school automobile repair,

was nevertheless permitted to testify in products liability action

involving tractors).

Dr. Barsotti, a toxicologist with a Ph.D in Pathology, has

conducted extensive research in the toxicology of PCBs, and

currently serves as the Chief of the Research Anaiysis Branch of

the Agency for Toxic Substance and Disease Registry of the

United States. Dr. Zahalsky has a Ph.D. in slicrobiology from

New York University and teaches courses in immunology and

human diseases. Dr. Nisbet has a Ph.D. in Physics from

Cambridge University and has published numerous articles in

the field of human exposure and the health risks attendant upon

that exposure. In light of the liberal Rule 702 expert qualification

standard, we hold that the district court abused its discretion

in excluding portions of Drs. Barsotti, Zahalsky and Nisbet's

testimony simply because the experts did not have the degree or

training which the district court apparently thought would be

most appropriate.

2. Meta-Analysis

[6] As noted, the district court also used Rule 702 to exclude

the testimony of Dr. Nicholson because the court found that Dr.

Nicholson's “meta-analysis” was an inadmissible novel scientific

technique. Meta-analysis involves combining the results of dif-

ferent epidemiological studies done by other scientists, and re-

analyzing the combined data to see if the data, in toto, renders

different results than the individual studies done with a smaller

data sample. Dr. Nicholson's meta-analysis is particularly impor-

33. Decisions to exclude expert opinion evidence under Rule 702 are

reviewed for abuse of discretion. Knight, 596 F 2d at ST

Ad. -52

tant in this case because it is one of the tew pieces of direct

evidence indicating that PCBs actually cause disease. If there is

no evidence of causation in the record, then the plaintiffs cannot

survive a motion for sumimary judgment.

Because the defendants challenge the technique of meta-

analysis itself, in evaluating Dr. Nicholson's testimony the court

properly invoked the standard announced by this court in United

States v. Downing, 753 F.2d 1224 (3d Cir. 1985), for analyzing

expert testimony based on novel scientific techniques.** How-

ever, the court's analysis under the Downing standard was inade-

quate.

We begin our Downing analysis with the frank recognition

that the determination whether expert testimony depends on a

reliable “scientific technique,” to be analyzed under Rule 702,

or whether the basis for testimony is “facts or data. . . of a type

34. As we explained in Downing, a technique should be considered

“novel” for purposes of Rule 702 whenever its reliability is not so well estab-

lished as to warrant recognition by judicial notice. Id. at 1234.

35. Downing requires a court that is

ruling upon the admission of (novel) scientific evidence, i.e., evidence

whose scientific fundaments are not suitable candidates for judicial notice,

[to] conduct a preliminary inquiry focusing on (1) the soundness and relia-

bility of the process or technique used in generating the evidence, (2) the

possibility that admitting the evidence [will] overwhelm, confuse, or mis-

lead the jury, and (3) the proffered connection between the scientific re-

search or test result to be presented, and particular disputed factual issues

in the case.

id. at 1237 (footnote omitted).

We dismiss out of hand the district court's finding, under the second prong

of Downing, that “Dr. Nicholson’s testimony would confuse the jury because of

its scientific nature and his credentials so they would make more of it than it

actually deserved.” What the second prong of Downing flags for concern is “a

technique which has ‘assume[d] a posture of mythic infallibility. ~ Downing,

753 F.2d at 1239 (quoting United States v. Addison, 49% F.2d 741, 744 (D.C.

Cir. 1974)). In other words, 2 technique that the jery will automatically assume,

either because of its notoriety or its elaborate presentation, to be completely

reliable, needs to be scrutinized by the court. Dr. Nicholson's meta-analysis

does not fall into that category. His scientific presentation is not notably differ-

ent than that of any other of the experts offered in this case—by either side. It

Dr. Nicholson can be excluded under the second prong of Downing, then so

could most of the experts in the case.

Ad. -53

reasonably relied upon by experts in the particular field,” to be

analyzed under Rule 703, see supra, is ofttimes subtle if not

strained. It can be difficult to determine whether the putative

problem with scientific evidence lies in the underlying data itself

or the method by which the data is analyzed. Non-scientifically

trained courts are at a disadvantage in trving to categorize so-

phisticated scientific data.

Though our recent decision in DeLuca v. Merreil Dow

Pharmaceuticals, Inc., 911 F.2d 941 (3d Cir.1990), does not lay

the problem to rest, and the courts must grapple with it on a

case-by-case basis, DeLuca announces an important rule by

making clear that when it is a scientist's methodology that is

being attacked, in contrast to the data relied on, the court must

analyze the reliability of that methodology under Downing (and

Rule 702). As Judge Stapleton explained: “Rule 703 is satisfied

once there is a showing that an expert's testimony is based on the

type of data a reasonable expert in the field would use in render-

ing an opinion on the subject at issue; it does not address the

reliability or general acceptance of an expert's methodology.” Id.

at 953.

For purposes of this case, we agree with the district court

that Dr. Nicholson's “meta-analysis” should be analyzed as a

scientific technique under Downing. Defendants do not assert

that the data that Dr. Nicholson used is not “relied upon by

experts in the particular field,” Fed.R.Evid. 703. Indeed, the

human epidemiological studies which Dr. Nicholson used in his

meta-analysis are the same studies that defendants’ experts use

to show that PCBs do not cause human disease. Instead, defen-

dants charge that meta-analysis is too unreliable to be accepted

by a court. Thus, it is the reliability analysis that is critical here.

As we explained in Downing, the “helpfulness” require-

ment in Rule 702 “implies a quantum of reliability beyond that

required to meet a standard of bare logical relevance,” Downing,

753 F.2d at 1235. See also DeLuca, 911 F.2d at 957 (quoting 3

on whether the expert's ‘technique or principle [is] sufficiently

reliable so that it will aid the jury in reaching accurate results’ ”).

However, the reliability requirement must not be used as a tool

: Ad. -54

by which the court excludes all questionably reliable evidence.

The Federal Rules of Evidence “embody a strong and undenia-

ble preference for admitting any evidence having some potential

for assisting the trier of fact and tor dealing with the risk of error

through the adversary process.” DeLuca, 911 F.2d at 956 (citing

Barefoot v. Estelle, 463 U.S. 880, 899 & 901 n. 7, 103 S.Ct.

3383, 3397 & 3398 n. 7, 77 L.Ed.2d 1090 (1983); Downing, 753

F.2d at 1241: and 3 Weinstein’s Evidence § 702{02|—[{03]). There-

fore, in making reliability determinations, courts must err on the

side of admission rather than exclusion.

At some point, however, even with the balance weighted as

it is towards admissibility, courts must determine at what level

evidence becomes “reliable enough.” We think that the fact that

the Rules Committee did not draft rules which provide that

evidence need be 95% or 85% or even 51% accurate is signifi-

cant. Instead, Congress seems to have understood, as the cases

and the commentators reflect, that “{t|he reliability inquiry . . .

[must be] flexible and may turn on a number of factors.” Down-

ing, 753 F.2d at 1238. Applying that logic to this case, it is clear

that if there were evidence in this record that meta-analysis is

inaccurate as a mode of analysis—that the concept of combining

raw data from different independent studies and re-analyzing it

in total does not render accurate results—then there might be

grounds for excluding meta-analysis.

There is no such evidence, however. As plaintiffs point out,

hundreds of meta-analyses are done each year, Appellants Br. at

92. Indeed, notwithstanding the principle thrust of defendants’

reliability argument before this court, defendants own experts

do not question the reliability of

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