# Opposition Brief — General Electric Co. v. Knight > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385009_1681%3A3 ## Record - **Collection:** Supreme Court brief - **Document type:** Opposition Brief - **Published:** January 1, 1991 - **Citation:** 499 U.S. 961 ## Text 4 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. V. 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 ee a ae ee yy" ee I ic kine c kcu ue wcucwes 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) bo 6 19 20 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 il 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). 1S 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 NS RD eee 1s OTHER: Ne ea kes a bse 45 a0 ke ww nee 3 ee 15 eg a Gy a bv e vee eee ae en eee nes 4 ee ae a kek ka cd ees ee awe 4 ry a sy Wik wie ay vive es bs eee ne ws 4 Ny han yn eke ks oo 4 haan aed. 4:s ae bon oo ovo oe os , 4 rN kG Cay oe oo ase sv wh ev vee 8 8 2, 1,8 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 - - -? 7 4 > 7 7 n - 7 ~ cal - =) i - ~_ - ~~ — ad i i i o a ‘ 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, V. 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 9 - 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. oO 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. 6 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 7 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. 8 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 i] 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- 10 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. 1] 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. 12 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 13 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. 14 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. 15 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- 16 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 17 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. 18 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. 19 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 20 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 2] 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 v. MONSANTO COMPANY, Southeastern Pennsylvania Transportation Authority (“SEPTA”), National Railroad Passenger Corporation (“Amtrak”), and Consolidated Rail Corporation (“Conrail”) V. CITY OF PHILADELPHIA, United States of America, Christopher Brown, Appellant. In re PRPOLI RAILROAD YARD PCB LITIGATION. BROWN, Cathlene v. MONSANTO COMPANY, Southeastern Pennsylvania Transportation Authority (“SEPTA”), National Railroad Passenger Corporation (“Amtrak”), and Consolidated Rail Corporation (“CONRAIL”) v. 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 v. MONSANTO COMPANY, Southeastern Periusylvania Transportation Authority (“SEPTA”), National Railroad Passenger Corporation (“Amtrak”), and Consolidated Rail Corporation (“CONRAIL”) v. 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”) v. 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”) v. CITY OF PHILADELPHIA, United States of America, Mary Retta Johnson, Appellant. In re POLI RAILROAD YARD PCB LITIGATION. BROWN, Celeste v. MONSANTO COMPANY, Southeastern Pennsylvania Transportation Authority (“SEPTA”), National Railroad Passenger Corporation (“Amtrak”), and Consolidated Rail Corporation (“CONRAIL”) V. CITY OF PHILADELPHIA, United States of America, Celeste Brown, Appellant. Ad. -3 In re PROLI RAILROAD YARD PCB LITIGATION. BROWN, Clemmon L. v. MONSANTO COMPANY, Southeastern Pennsylvania Transportation Authority (“SEPTA”), National Railroad Passenger Corporation (“Amtrak”), and Consolidated Rail Corporation (“CONRAIL”) v. CITY OF PHILADELPHIA, United States of America, Clemmon L. Brown, Appellant. In re PPOLI RAILROAD YARD PCB LITIGATION. BROWN, Cloyd H. v. 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 v. MONSANTO COMPANY, Southeastern Pennsylvania Transportation Authority (“SEPTA”), National Railroad Passenger Corporation (“Amtrak”), and-Consolidated Rail Corporation (“CONRAIL”) v. 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 v. SOUTHEASTERN PENNSYLVANIA TRANSPORTATION AUTHORITY (“SEPTA”); National Railroad Passenger Corporation (“Amtrak”); and Consolidated Rail Corporation (“CONRAIL”) v. 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 v. 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 v. 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 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 case.'© In the court's view, all three Downing factors weighed 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 Weinsteins Evidence, © 702{03}, at 702-35) (“helpfulness turns 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 all meta-analyses; they question “the way in which Dr. Nicholson applied ‘meta-analysis. ~ There is some evidence that “half the time you shouldn't believe meta- analysis,” Naylor, Two Cheers for Meta-Analysis: Problems and Opportunities in Aggregating Results of Clinical Trials, 135 Can. Med. Ass'n J. 891, 894 (1985), quoted in Appellee’s Br. at 64 and n. 55, but that does not mean that meta-analyses are neces- sarily in error. It means that they are, at times, used in circum- stances in which they should not be. (7! The district court excluded Dr. Nicholson's report under Ad. -55 the reliability prong of Downing because “Dr. Nicholson's report has not been peer-reviewed or accepted by anybody in particu- lar, even the Ontario Ministry of Labor” (for whom it was done). In reaching this conclusion, the district court relied on an affida- vit by one of the defense experts which stated that Dr. Nicholson's claim that his report has been peer-re- viewed is inaccurate in the sense that the term ‘peer review is used by the scientific community. In fact, | am unaware that the report has ever been subjected to pre-publication review, and the report has never been published in the scientific literature. This is an adequate ground for excluding the testimony. First, “the Federal Rules of Evidence contain no requirement that an experts testimony be based upon reasoning subjected to peer- review and published in the professional literature.” DeLuca, 911 F.2d at 954. See also Brock v. Merrell Dow Pharmaceuticals, Inc., 874 F.2d 307, 313, modified per curiam 884 F.2d 166 (5th Cir. 1989), cert. denied, — U.S. ——, 110 $.Ct. 1511, 108 L. Ed.2d 646 (1990). Second, Dr. Nicholson’s own affidavit states that his report was reviewed by cooperating researchers and the Industrial Diseases Standards Panel. Moreover, Dr. Nisbet's affidavit demonstrates that he reviewed Dr. Nicholson's work and found it to be “a balanced assessment.” What we have, therefore, is a record that shows significant disagreement about whether this particular meta-analysis is reli- able. But that too may implicate the Downing standard. If the allegation is that a reliable methodology was so altered as to skew the methodology itself, Downing would be the appropriate vehi- cle for evaluation. However, if the challenged procedure is more accurately described as an application of an accepted meth- odology, it is not the proper subject of a Rule 702—based exclu- sion, but is rather the subject of cross-examination of the expert and resolution by the jury. See DeLuca, 911 F.2d at 955 n. 15. Assuming that Dr. Nicholson's meta-analysis is the proper subject of Downing scrutiny, the district court's decision is want- ing, because it did not make explicit enough findings on the reliability of Dr. Nicholson's meta-analysis to satisfy Downing. Ad. -56 We decline to define the exact level at which a district court can exclude a technique as sufficiently unreliable. Reliability indicia vary so much from vase to case that any attempt to define such a level would most likely be pointless. Downing itself lays down a flexible rule. What is not flexible under Downing is the require- ment that there be a developed record and specific findings on reliability issues. Those are absent here. Thus, even if it may be possible to exclude Dr. Nicholson's testimony under Downing, as an unreliable, skewed meta-analysis, we cannot make such a determination on the record as it now stands. Not only was there no hearing, in limine or otherwise, at which the bases for the opinions of the contesting experts could be evaluated, but the experts were also not even deposed. All of the expert evidence was based on affidavits. Assuming that the district court excluded what it thought to be an application of an accepted methodology, it did so on the basis of a credibility judgment—i.e., it believed defendants experts that Dr. Nicholson's meta-analysis was not reliable, and disbelieved plaintiffs experts who said that it was. This approach runs afoul of DeLuca, 911 F.2d at 955 n. 15, because credibility determinations are normally the province of the jury. If no reasonable person could believe Dr. Nicholson's brand of meta- analysis, it would presumably be excludable, but we doubt that to be the case here. Under all of these circumstances, we cannot uphold, on this record, the exclusion of Dr. Nicholson's testi- mony. We turn to the court's exclusion of the testimony under the third Downing factor (the connection or “fit” between the re- search and the factual issues in the case). Dr. Nicholson's re- search suggests an increased risk of cancer of the liver, biliary tract and gall bladder. Because none of the plaintiffs have any of those ailments yet, the district court found Dr. Nicholson's research immaterial. We reject this reasoning, because Dr. Nicholson's affidavit suggests that proof of an increased risk of liver cancer is probative of an increased risk of other forms of cancer. Furthermore, as we explain infra, the district court's rejection of the medical monitoring claim must be reversed, and therefore the increased risk of the cancers that Dr. Nicholson Ad. -57 documents is material to the factual dispute in this case. If plaintiffs can prove that they are at an increased risk for these cancers, because of exposure to defendants’ products, then they may be able to prove that they are entitled to have defendants bear the increased medical monitoring costs incurred by those who are at an increased risk of cancer. Thus, the third Downing factor (the “fit”) is also met, further supporting our conclusion that the district court's exclusion of Dr. Nicholson's expert opin- ion, on the present record, must be set aside. 3. Scientific Techniques of Other Experts Defendants criticize the scientific data and/or method of most of plaintiffs other experts, including Drs. Allen, Barsotti, Zahalsky, Shubin, and DiGregorio. See supra at 840-841. These attacks are forceful, and we cannot say, at this point, that they are without merit. However, neither can we at this point accept those contentions, because to the extent that the attacks are grounded on Rule 703, there has not been adequate process under Japanese Electronics, and to the extent that they are grounded on Rule 702, there has not been adequate record development and factfinding under Downing. That effort was not expended here. We cannot affirm what we cannot review; hence, to the extent that the summary judgment was based upon putative but unspoken exclusionary rulings, we must reverse and remand. D. Exclusion under Rule 403 [8] As noted supra Section VAQ, it is not clear that the court actually excluded any opinions under Rule 403. The court at one point suggests that it is excluding all of the plaintiffs expert opinions under Rules 703 and 403, but it is not clear how or why. What is apparent is that the district court did not conduct the careful balancing required by Rule 403 and the jurisprudence of this court. See, e.g., United States v. Downing, 753 F.2d 1224, 1243 (3d Cir. 1985) (declining to decide the Rule 403 question where the district court neither mentioned Rule 403 on the record nor “conducted the balancing required by that rule”); Ad.-58 United States v. Long, 574 F.2d 761, 770 (3d Cir.) (Adams, J., concurring), cert. denied, 439 U.S. 985, 99 S.Ct. 577, 58 L.. Ed.2d 657 (1978). In Downing, although declining to prescribe any mandatory procedures for trial courts to follow in making preliminary ad- missibility determinations, we recognized that “the most effi- cient procedure that the district court can use . . . is an in limine hearing.” Downing, 753 F.2d at 1241. We again decline to set forth mandatory rules for the trial court. However, we suggest that in complex litigation such as this, where there are numerous experts presenting voluminous testimony on the cutting edge of scientific research, an in limine hearing may be a very useful tool in conducting both the inquiry and the factfinding and balanc- ing, which are the hallmarks of Rules 703 and 403 respectively. Moreover, we stress that pretrial Rule 403 exclusions should rarely be granted. As we recently noted in DeLuca, “if testimony survives the rigors of Rule 702 and 703... . , Rule 403 is an unlikely basis for exclusion.” 911 F.2d at 957. Excluding evidence as being more prejudicial than probative at the pretrial stage is an extreme measure that is rarely necessary, because no harm is done by admitting it at that stage. Ifa court believes evidence is irrelevant, it need only say say so and discount it accordingly when it makes its summary judgment determination. However, a court cannot fairly ascertain the po- tential relevance of evidence for Rule 403 purposes until it has a full record relevant to the putatively objectionable evidence. We believe that Rule 403° is a trial-oriented rule. Precipitous Rule 403 determinations, before the challenging party has had an opportunity to develop the record, are therefore unfair and improper. In sum, we hold that in order to exclude evidence under Rule 403 at the pretrial stage, a court must have a record complete enough on the point at is [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385009_1681%3A3. Public record. Not legal advice.