The opinion of the court was delivered by: RAMBO
Presently before the court are a number of unresolved evidentiary and discovery matters. On February 12-16 and March 1, 4-5, 1996, the court conducted a "second round"
of in limine hearings related to Defendants' motions to exclude certain of Plaintiffs' expert witnesses. Initially, it was contemplated that this second round would be devoted solely to Plaintiffs' medical causation experts. Due, however, to time constraints and scheduling difficulties during the first round of hearings, issues relating to some of Plaintiffs' dose experts were carried over into the second round. All in limine hearings are now complete, as is all briefing on outstanding discovery and evidentiary matters. Accordingly, the instant memorandum will reach the merits of the following issues: (1) whether Plaintiffs' supplemental expert reports, filed subsequent to the deadlines for filing expert reports, are admissible pursuant to Rules 26 and 37 of the Federal Rules of Civil Procedure; (2) whether the court should reconsider its January 5, 1996 ruling with respect to the proffered testimony of Vladimir Shevchenko; (3) whether, in light of further briefing on the rate of error issue, the court finds the Wing cancer incidence study to be scientifically reliable and therefore admissible; and (4) whether Plaintiffs' experts Olga Tarasenko, David Lochbaum, Bruce Molholt, Theodor D. Sterling, Luis Fajardo, Thomas H. Winters, and Sigmund Felix Zakrzewski should be permitted to testify pursuant to the Federal Rules of Evidence, Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993) and In re Paoli Railroad Yard PCB Litigation, 35 F.3d 717 (3d Cir. 1994).
I. Plaintiffs' Filing of Expert Reports
A. Case Management History
The timeliness issue has recurred in many settings within this litigation and has been particuiarly troubling to the court. Historically, the court has encountered significant difficulty in keeping the parties adhered to any case management order. As a result, there have been close to a dozen "case management orders." 7/10/92 Proposed Schedules of Plaintiffs and Defendants for Taking Cases to Trial; 6/15/93 Case Management Order (setting jury selection for 7/6/94); 11/12/93 Revised Case Management Order (moving jury selection to 10/3/94 at the request of parties); 5/13/94 Order Amending Case Management Schedule (moving jury selection to 4/13/95); 7/28/94 Order (granting Plaintiffs' request for further amendment of pre-trial schedule); 10/14/94 Order (further amending pre-trial schedule at Plaintiffs' request, and noting that absent extreme and compelling circumstances no further amendments will be entertained); 10/19/94 Order (directing parties to submit final joint case management schedule in response to correspondence from counsel); 11/3/94 Order (adopting parties' final joint case management schedule, noting that said order is binding and that it will not be amended absent extreme and compelling circumstances); 5/8/95 Order (moving jury selection to 6/3/96). Much to its own detriment, the court has been flexible and accommodating with respect to the pre-trial schedule.
In November 1994, having grown weary of the parties' inability to comply with set deadlines and fearing that the instant action would languish, the court ordered the parties to draft a final joint case management schedule. On November 3 the court adopted the schedule proposed by the parties and again indicated that the schedule would not be altered absent extreme and compelling circumstances. On May 8, 1995, the court issued an order supplementing the November 1994 case management order to place the case on the June 1996 trial list. Since the entry of the May 8 order, the court, although permitting minor alterations to the schedule, has denied any motion to amend that would effectively remove the case from the June 1996 trial list.
The captioned action, involving approximately 2,000 Plaintiffs, was consolidated under one case number in 1988. To an extent, circumstances beyond the court's control, such as the filing of interlocutory appeals and Congress's amendment of the Price Anderson Act, have stymied the prompt resolution of this action. Nevertheless, a review of the docket reveals that the test cases's torpid progression toward trial is due in part to the parties' willingness to stipulate to extensions of time and alterations of the case management schedule and the court's historical willingness to accommodate such requests.
B. Plaintiffs' Expert Reports
Defendants object to the admission of all of Plaintiffs' expert reports and supplemental affidavits filed subsequent to the court ordered filing deadlines. Although tedious, the following review of Plaintiffs practice in filing expert reports is warranted.
Pursuant to an order dated May 13, 1994, Plaintiffs were to file the expert reports of James Gunckel, Richard Webb and Ignaz Vergeiner not later than August 1, 1994. This order also directed that expert reports on medical causation were to be filed not later than September 1, 1994 and that expert reports on punitive damages were to be filed not later than October 1, 1994. On August 1, 1994, Plaintiffs filed the 6/94 report of Ignaz Vergeiner ("TMI Treatise 1"), and the 5/26/94 and 8/1/94 affidavits of Douglas Crawford-Brown. On August 4, 1994, Plaintiffs filed the 8/1/94 preliminary report of Richard Webb entitled "A Preview Short Synopsis." Thus, the report of James Gunckel was not timely filed on August 1, and the August 4 filing of the Webb "Preview" was both untimely and in contravention of Rule 26(a) (2) of the Federal Rules of Civil Procedure ("The report shall contain a complete statement of all opinions to be expressed and the basis and reasons therefor. . ."). The court was remiss in not striking these filings immediately and, in temporarily overlooking these rule violations, the court may have unwittingly encouraged Plaintiffs' improper conduct. The record reflects that these 1994 filings were only the first in a long stream of improper and untimely filings.
On September 15, 1994, one and one-half months after the filing deadline, Plaintiffs filed the 7/6/94 Affidavit of Vladimir Shevchenko. On November 3, 1994, the court entered the final joint case management schedule. This schedule extended the deadline for Plaintiffs' filing of dose and medical causation expert reports to March 1, 1995.
On March 1, Plaintiffs filed the expert "reports"
of the following experts: Armentrout, Crawford-Brown, Gunckel, Hinrichesen, Lochbaum, Shevchenko, Vergeiner, Webb, Wing, Fajardo, Winters, Zakrzewski. On March 14, without leave of court, Plaintiffs supplemented their March 1 filing with the reports of Shevchenko, Tascaev, Kozubov, Popov, Portman, Tarasenko, and Snigiryova. On March 15, again without leave of court, Plaintiffs supplemented their March 1 filing with the report of Bruce Molholt. Finally, on March 29, without leave of court, Plaintiffs filed a third supplement to the March 1 filing adding to the reports of Shevchenko and Zakrzewski. Thus, as of April 1995, Plaintiffs had late-filed a significant portion of their expert reports on dose and medical causation.
In February 1995, the court issued a preliminary memorandum of law related to Defendants' motion in limine to exclude Dr. Molholt's 4/8/93 report, and ordered limited additional briefing with respect to certain of the Paoli II factors.
In re TMI, Mem. Op. at 22 (M.D. Pa. February 14, 1995) ("The court has invited the parties to respond concisely to the issues raised . . . this is not an invitation to deluge the court with paper. Clear, concise, relevant information will assist the court in reaching a just resolution; likewise, the submission of frivolous or irrelevant information will be frowned upon.") As exhibits to their court-ordered filing, Plaintiffs submitted several new expert reports (5/1/95 Molholt; 4/24/95 Kerman; 5/2/95 Kerman; 2/27/95 Crawford-Brown). In September 1995, Plaintiffs, again without leave of court, untimely filed the reports of Theodore Sterling and Ronald Kerman.
The next battery of Plaintiffs' expert reports were filed as exhibits to their opposition to Defendants' motion in limine to exclude Plaintiffs' dose experts. On October 25, Plaintiffs filed as exhibits the updated reports of the following experts: Vergeiner (two separate affidavits dated 10/18/95), Armentrout (10/10/95 Aff.; 10/22/95 Aff.), Gunckel (8/23/95 Aff.), Shevchenko (10/6/95 Aff.), Wing (10/19/95 Aff.), Crawford-Brown (10/20/95 Aff.), Molholt (9/8/95 Aff.; 9/14/95 Aff.). On October 31, with leave of the court,
Plaintiffs' supplemented the record with the following affidavits/new reports: Armentrout (9/20/95 Aff.; 5/11/95 Aff.), Blanch (10/31/95 Aff.), Kerman (10/30/95 Aff.), King (10/30/95 Aff.), Reyblatt (10/31/95 Aff.), Shevchenko (10/6/95 Aff.), Kozubov (9/12/95 Aff.), Smirennyi (10/30/95 Aff.), Wing (10/27/95 Aff.). On January 16, 1996, as exhibits to a brief in opposition to Defendants' motion to compel, Plaintiffs filed the following supplemental affidavits: Crawford-Brown, Ornstein, Purcell, Reyblatt. Finally, during February 1996, Plaintiffs filed the following supplemental affidavits without leave of court: Wing (10/19/95 Aff.; 1/26/96 Aff.; 1/31/96 Aff.; 2/7/96 Aff.), Kozubov (1/30/96 Aff.), Armentrout (2/1/96 Aff.), Milhollin (5/5/96 Aff.), Griffin (1/30/96 Aff.), King (2/16/96 Aff.).
Rule 26(a) (2) of the Federal Rules of Civil Procedure governs the disclosure of expert testimony. In relevant part Rule 26 provides as follows:
( B) Except as otherwise stipulated or directed by the court, this disclosure shall, with respect to a witness who is retained or specially employed to provide expert testimony in the case or whose duties as an employee of the party regularly involve giving expert testimony, be accompanied by a written report prepared and signed by the witness. The report shall contain a complete statement of all opinions to be expressed and the basis and reasons therefor; the data or other information considered by the witness in forming the opinions; any exhibits to be used as a summary of or support for the opinions; the qualifications of the witness, including a list of all publications authored by the witness within the preceding ten years; the compensation to be paid for the study and testimony; and a listing of any other cases in which the witness has testified as an expert at trial or by deposition within the preceding four years.
Fed. R. Civ. P. 26(a) (2)(B). Rule 37 provides for self-executing discovery sanctions where a party fails to disclose information subject to the mandatory disclosure provisions of Rule 26(a). Specifically, Rule 37 states:
( 1) A party that without substantial justification fails to disclose information required by Rule 26(a) . . . shall not, unless such failure is harmless, be permitted to use as evidence at a trial, at a hearing, or on a motion any witness or information not so disclosed.
Fed. R. Civ. P. 37(c) (1). While the Rule itself does not specifically delineate the types of non-disclosure that are harmless, the advisory notes to the 1993 amendment of Rule 37 do provide some guidance as to the type of non-disclosure envisioned as harmless:
Limiting the automatic sanction to violations "without substantial justification," coupled with the exception for violations that are "harmless," is needed to avoid unduly harsh penalties in a variety of situations: e.g., the inadvertent omission from a Rule 26(a) (1) (A) disclosure of the names of a potential witness known to all parties; the failure to list as a trial witness a person so listed by another party; or the lack of knowledge of a pro se litigant of the requirement to make disclosures. In the latter situation, however, exclusion would be proper if the requirement for disclosure had been called to the litigant's attention by either the court or another party.
Advisory Notes to 1993 Amend. Fed. R. Civ. P. 37(c). Although the captioned action was filed prior to the most recent amendment of Rules 26 and 37, the bulk of expert discovery has been conducted subsequent to the 1993 amendments. Accordingly, the court finds that Rules 26 and 37, as amended in 1993, are binding upon the parties.
The Court of Appeals for the Third Circuit, interpreting Rule 37 narrowly, "has been reluctant to approve the exclusion of testimony unless a party has (1) revealed previously undisclosed evidence when trial was either imminent or in progress, or (2) acted in bad faith." Diflorio v. Nabisco Biscuit Co., 1995 U.S. Dist. LEXIS 17060, 1995 WL 710592 at *2 (E.D. Pa. Nov. 13, 1995). Moreover, the Third Circuit has held that lack of diligence does not constitute bad faith. Paoli II, 35 F.3d at 793. Through Paoli II, the Third Circuit signaled the continuing applicability of Meyers v. Pennypack Woods Home Ownership Ass'n, 559 F.2d 894 (3d Cir. 1977), to a district court's Rule 37 analysis. Pursuant to Pennypack, a court must consider:
(1) the prejudice or surprise in fact of the party against whom the excluded witnesses would have testified, (2) the ability of that party to cure the prejudice, (3) the extent to which waiver of the rule against calling unlisted witnesses would disrupt the orderly and efficient trial of the case or of other cases in the court, and (4) bad faith or willfulness in failing to comply with the district court's order[,]
Paoli II, 35 F.3d at 791 (citing Pennypack, 559 F.2d 894), when determining whether to impose Rule 37 sanctions. The discussion below will support the court's finding that (1) Defendants would be prejudiced by the admission of certain of the untimely reports
insofar as the rigorous pre-trial schedule precludes them from having sufficient time to prepare to cross-examine on the late-filed reports; (2) Defendants are unable to cure the prejudice insofar as the court is unwilling to further alter the pre-trial schedule because such alteration would necessitate postponing the trial date; (3) waiver of the Rule 37 sanctions would disrupt the orderly trial of this case as well as a multitude of other cases on the court's docket; and (4) Plaintiffs repeated violation of numerous orders of this court, failure to seek leave of court before filing untimely reports, and "covert" filing of additional reports as exhibits to a variety of unrelated motions rather than "overtly" making supplemental filings, rises to the level of bad faith.
In Paoli II, the Third Circuit reversed the district court's exclusion of testimony contained within an untimely filed expert report. Paoli II, 35 F.3d at 792. The Third Circuit provided the following explanation for finding error with the district court's ruling:
We have great difficulty with the district court's rulings. The prejudice to the defendants here is extremely minimal. Plaintiffs properly identified Dr. DiGregorio as a witness by the March 17 deadline, thus the defendants knew that he was going to testify. They were also aware of the general substance of his testimony and even some of the specifics of his plan for medical monitoring. . . . Moreover, defendants were provided with all of the specifics of Dr. DiGregorio's proposed medical monitoring plan on April 18, only a month after the district court's deadline, four months before the schedule trial date, and 60 days before the deadline the district court has set for ending discovery. Thus, the defendants has abundant time to depose Dr. Digregorio regarding the specifics of his proposed program before the discovery deadline, and the district court could easily have extended the deadline to provide the defendants more time.
Id. The situation facing this court can be distinguished from the above-referenced Paoli II scenario on a number of levels. First, all of the untimely supplemental reports at issue here were filed after the formal close of discovery. Where, as here, discovery was formally open for nearly one decade, and where the court readily accommodated requests for enlargement of the deadlines on a number of occasions, Plaintiffs' failure to timely file expert reports without any justification is inexcusable. second, although it appears that the witnesses whose reports are at issue were identified in a timely fashion, the substance of their testimony was largely unknown to Defendants. The timely filed "preliminary"
reports of many of Plaintiffs experts bear little resemblance to the supplemental reports that Plaintiffs would have this court admit. Compare 4/8/93 Molholt with 3/13/95 Molholt and 5/1/95 Molholt.
Moreover, these supplemental filings continued to be made up to, during, and after both rounds of in limine hearings.
Were the instant action a less complex lawsuit, the court would be more inclined to find Plaintiffs' Rule 26 violations harmless. See In re Ford Motor Co. Bronco II Products Liability Litigation, 1996 U.S. Dist. LEXIS 753, 1996 WL 28517 (E.D. La. January 23, 1996) (noting that "compliance with the disclosure requirements is particularly important in complex cases"); United States v. Davis, 1993 WL 525591 at *1 (D.R.I. April 16, 1993) ("At trial in this case, expert witnesses are expected to testify about complex scientific and technical issues . . . . To adequately prepare for trial, each side must have detailed, final information regarding opposing expert witnesses' testimony and the theories and documents upon which the expert will rely.") Under the unique circumstances of this case, however, Plaintiffs' Rule violations have prejudiced Defendants' ability to adequately prepare their case for trial, and have effected this court's ability to manage the case. In re Ford Motor Co., 1996 U.S. Dist. LEXIS 753, *5, 1996 WL 28517 at *2 ("Plaintiffs noncompliance has caused inconvenience to both the defendant and the court. As a result, it is difficult to find plaintiffs' conduct "harmless" within the meaning of Rule 37(c) (1) and to unconditionally exempt plaintiffs from the harsh sanction which Rule 37 advocates."). The administrative ramifications of this court's decision to set a June 1996 trial date are enormous. Accommodating the parties for two rounds of in limine hearings required clearing the court's calendar for most of November 1995, part of February 1996, and part of March 1996. Further, the court has cleared its calendar for the months of June, July and part August 1996 for trial in this matter. The court's docket, aside from the instant action, is substantial. Making the resolution of this case a priority has caused numerous other litigants, who are equally deserving of their "day in court," to be inconvenienced.
The court is resolute in its belief that had it done nothing to prod this case to trial, motions for further extension of the discovery deadlines would still be being filed. Nevertheless, because the court has taken such drastic measures to ensure that this matter does finally go to trial, the court must be somewhat rigid in its adherence to the pre-trial schedule. Knowing in advance that this would be the case, the court permitted the parties to participate in drafting the final pre-trial schedule. The court adopted the parties' proposed schedule in its entirety and set a firm trial date. Further, the court repeatedly admonished the parties that once the schedule was put in place it would not be altered absent extreme and compelling circumstances. See, e.g. 10/14/94 Order; 11/3/94 Order. Finally, the court has not been entirely inflexible with all deadlines, allowing alteration of the final pre-trial schedule where such alteration would not effect the set trial dates.
Related and equally important to the question of whether the untimely filings should be admitted is Plaintiffs' consistent inability to articulate any substantial justification for their inability to timely file complete expert reports. Plaintiffs' counsel simply argue that there has been no prejudice to Defendants because trial is still several months away, and that they are doing everything within their power to comply with the court's rigorous pre-trial schedule. (Pls.' Findings at 69 ("Even assuming that this information was submitted untimely, the Court can find no prejudice to the defendants").) These responses are unavailing as the court finds that Plaintiffs have offered no substantial justification for their untimely filings, and admission of certain of Plaintiffs' supplemental filings would prejudice Defendants. R.C.M. Exec. Gallery Corp. v. Rols Capital Co., 1996 U.S. Dist. LEXIS 639, *4, 1996 WL 30457 at *2 ("defendants are prejudiced if they are unable to rely on court-imposed deadlines, and judicial efficiency is impaired if such deadlines are ignored with impunity"); Heflin v. City of Chicago, 1996 U.S. Dist. LEXIS 672, *20, 1996 WL 28238 at *8 (N.D. Ill. Jan 22, 1996) ("Defendants argument that their is still time to [conduct discovery] . . . before trial is unavailing. The court will not circumvent Rule 37's inducement for full compliance with Rule 26(a) (2) and disrupt . . . trial preparation without substantial justification.").
In Sierra Club v. Cedar Point Oil Co., Inc., 73 F.3d 546 (5th Cir. 1996), the United States Court of Appeals for the Fifth Circuit recently upheld a district court's exclusion of incomplete and untimely filed expert reports under circumstances similar to those here. Finding that the district court did not abuse its discretion in excluding the expert testimony, the Fifth Circuit Court made the following observations:
[Plaintiff] even appears at times to admit that it did not comply with the discovery order by stating that it was "impossible" to comply and that their experts "did all they could do" under the circumstances. The reasons for noncompliance, however, are relevant to the separate issue of whether the sanction imposed was appropriate. On the other hand, a violation of an order is a violation of an order, regardless of the reasons therefor.
Id. at 571 n.46. In commenting upon the propriety of excluding the testimony as a sanction for the discovery violations, the appellate court noted that "while a continuance would have given [the defendant] . . . more time to review the late disclosures, such a measure 'would neither punish [plaintiff] . . . for its conduct nor deter similar behavior in the future.'" Id. at 573 (quoting Bradley v. United States, 866 F.2d 120, 126 (5th Cir. 1989)).
The court finds the facts of the instant case to be as compelling as both Sierra Club and Paoli. Plaintiffs have consistently flaunted filing deadlines with imputiny, and have failed to meet the most basic Rule 26 disclosure requirements.
Moreover, Plaintiffs have had from 1979 to 1995 to find expert witnesses to support their case. As such, the court finds suggestion that Plaintiffs experts have been pressed for time to ring hollow. Additionally, as the court discussed at length above, the court finds that admission of the untimely filed supplemental reports would prejudice Defendants and further disrupt the efficient functioning of this court.
Based upon the foregoing, the court finds adequate grounds, pursuant to Federal Rules of Civil Procedure 26 and 37, to exclude from the record certain supplemental expert reports filed without leave of court subsequent to the court ordered filing deadlines. (See also Pls.' Answer to Defs' Motn. to Preclude any Additional Reports or Related Testimony from Richard Webb at 4 ("it is the flouting of a court's scheduling order that typically produces a severe sanction").) Looking solely at the conduct of Plaintiffs' counsel, the court finds it appropriate to exclude all expert reports filed subsequent to court-ordered filing deadlines. This, however, would result in an effective dismissal of much of Plaintiffs' case, and such a result is unduly harsh to Plaintiffs themselves who have had nothing to do with counsels' flagrant abuse of the discovery process and disregard of court orders.
The court has fashioned sanctions pursuant to Rule 37(b) and (c) which account for counsels' unacceptable conduct without unduly punishing Plaintiffs' for the transgressions of counsel. This court's power to fashion such sanctions is broad. The court has already discussed the nature its power to impose sanctions pursuant to Rule 37 of the Federal Rules of Civil Procedure. Underscoring this statutory authority is the court's inherent authority to impose sanctions for misconduct. As the Supreme Court observed in Chambers v. NASCO, Inc., 501 U.S. 32, 115 L. Ed. 2d 27, 111 S. Ct. 2123 (1991) :
Id. at 43 (citations omitted). "'By controlling an attorney's conduct, the court fulfills the duty it owes to its own preservation, to members of the general public, and to those members of the profession who do cooperate and are in sympathy with proper administration of the law.'" Grace v. Center for Auto Safety, 155 F.R.D. 591, 601 (E.D. Mich. 1994) (footnote omitted). Because of the potency of the sanctions available, the imposition of sanctions is a matter that cannot be taken lightly by the court. Chambers, 501 U.S. at 44. Further, the court must exercise restraint in imposing sanctions. Id.
This court's January 5 order detailed the court's rationale for excluding certain "new" expert reports which Plaintiffs sought to file on the eve of the first round of in limine hearings. Upon publication of this order, there could be no question in the minds of Plaintiffs' counsel that continued filing of supplemental affidavits containing new methods and information, without leave of court, was prohibited. As such, the court will exclude from the record all supplemental affidavits filed after January 5, 1996.
Fed. R. Civ. P. 37 (b) and (c). All supplemental affidavits and reports filed subsequent to the March 1, 1995 filing deadline but prior to January 5, 1996, and whose admissibility has not previously been ruled upon by this court, shall be admitted.
Additionally, the court will issue a separate order to show cause why monetary sanctions should not be imposed against certain of Plaintiffs' counsel. Counsel will be afforded the opportunity to respond at that time. Chambers, 501 U.S. at 50 (court must "comply with the mandates of due process, both in determining that the requisite bad faith exists and in assessing fees").
II. Defendants' Motion for Reconsideration of the Court's January 5, 1996 Memorandum as it Pertains to Vladimir Shevchenko
On January 22, 1996, Defendants filed the instant motion for reconsideration. The motion has been briefed by the parties and is ripe for disposition. "The purpose of a motion for reconsideration is to correct manifest errors of law or fact or to present newly discovered evidence." Harsco v. Zlotnicki, 779 F.2d 906, 909 (3d Cir. 1985) (citation omitted), cert. denied, 476 U.S. 1171, 90 L. Ed. 2d 982, 106 S. Ct. 2895 (1986). Therefore, a court may properly grant a party's motion for reconsideration in any of the following circumstances: "(1) the development of an intervening change in the law, (2) the emergence of new evidence not previously available, or (3) the need to correct a clear error of law or prevent a manifest injustice." Cohen v. Austin, 869 F. Supp. 320, 321 (E.D. Pa. 1994) (citations omitted). Because Defendants have raised important, though not entirely availing, challenges to the court's January 5, 1996 ruling, the court will reach the merits of Defendants motion for reconsideration.
A. Dr. Snigiryova's Cytogenetic Analysis
1. Factual Error Regarding Hershey Medical Center Controls
Defendants argue that the court misapprehended certain hearing testimony to reach the erroneous conclusion that Dr. Snigiryova compared her study results with a Hershey Medical Center control group. Defendants and Plaintiffs agree that the court incorrectly identified the Hershey control group with the Snigiryova cytogenetic analysis rather than with Dr. Tarasenko's immune study. The court's review of the record indicates that the court did incorrectly associate the Hershey Medical Center control group with the Snigiryova study. The issue then, is whether this factual error by the court alters its legal ruling with respect to the Snigiryova cytogenetic analysis.
In the January 5 ruling, this court noted the following:
With respect to the proffered cytogenetic testimony, Defendants raise an issue related to the propriety of the control group. Defendants contend that the cytogenetic analysis is flawed because Professor Shevchenko and Dr. Snigiryova did not employ a contemporaneous and geographically proximate control group. . . . Plaintiffs did, however, present testimony which showed that the historical Russian controls used by Professor Shevchenko and Dr. Snigiryova had background dicentric counts virtually identical to those of a control group measured at Hershey Medical Center in Hershey, Pennsylvania. (Tr. at 705.) The court finds that Plaintiffs have come forward with sufficient evidence to demonstrate that their control group, while not contemporaneous and geographically proximate, is adequate.
In re TMI Cases Consolidated II, 911 F. Supp. 775, 816 (M.D. Pa. 1996). The court must now determine whether, absent corroboration with a Pennsylvania control group, the control group utilized by Dr. Snigiryova was adequate. Defendants contend that Dr. Snigiryova's control sample was inadequate and improper. Plaintiffs, to the contrary, argue that the literature supports the use of non-contemporaneous, geographically diverse control groups. Specifically, Plaintiffs refer the court to their in limine exhibit 72, Cytoqenetic Study in Lymphocytes from Children Exposed to Ionizing Radiation After the Chernobyl Accident, 319 Mutation Research 55, 57 (1993) ("Chernobyl Accident "), and their in limine exhibit 73, Novel Biodosimetry Methods Applied to Victims of the Gioania Accident, 60 Health Physics 72, 75 (1994) ("Gioania Accident "). The court finds Plaintiffs reliance on these articles to be somewhat misplaced as the articles lend only tangential support to the argument that Plaintiffs advance.
The Chernobyl Accident study, which used a geographically diverse (Italian) control group in its cytogenetic analysis of Byelorussian children, noted the following:
We are fully aware of the fact that these "control" children are characterized by a very different ethnic, life style, health, and dietary background. However, the problem could not be otherwise solved due to the circumstance that no children from other areas of Byelorussia were sent to Italy and that even their health and dietary conditions would have been different from those of the subjects analyzed. Unfortunately, no cytogenetic data concerning children from the same localities prior to the accident are available.
Id. at 57. This statement supports Plaintiffs argument insofar as it demonstrates that a scientific study, that relied on a geographically diverse control group because a geographically proximate control was unavailable, was accepted for publication. The court, however, finds reliance on this study problematic.
First, Plaintiffs have placed no evidence on the record which tends to show that it was difficult or impossible for a geographically proximate control group to be utilized with respect to the instant study. Dr. Snigiryova's report, filed March 15, 1995, offers no explanation as to why she found it necessary to use Russian rather than American control values. it was only following Defendants' in limine challenge that Dr. Snigiryova filed a second report, dated September 25, 1995, that addressed the control issue While Dr. Snigiryova's September report indicates that there is some support in the literature for her control values, the court cannot help but wonder whether this is merely a post hoc attempt to defend the methodology she employed. The court finds the issue of whether Dr. Snigiryova carefully considered the selection of an appropriate. control group prior to beginning her study to bear directly upon the reliability of her methodology. Were she to have selected a control group because of time pressures related to this litigation, rather than because the group was scientifically the most appropriate control, such a selection would clearly flaw her methodology. A statement made by Dr. Snigiryova in her September report underscores this and other of the court's concerns:
The aim of our work has not been to conduct extensive cytogenetic examinations of the population living in the neighborhood of TMI. Such work is time-consuming and expensive. The task facing us was to make a conclusion on the presence/absence of the action of radiation as a result of the accident at the TMI nuclear power station by comparing the level of cytogenetic disorders in the population from the examined region and in clinically healthy people living on [sic] the uncontaminated territory.
9/25/95 Snigiryova Rpt. at 1. Although Dr. Snigiryova's stated purpose was not to perform "extensive cytogenetic examinations," Plaintiffs seem to view her study somewhat differently. "Plaintiffs contend that the level of dicentrics in blood drawn from TMI residents, as determined by Dr. Snigiryova, is sufficiently high to conclude that accident exposures caused doses to these individuals in excess of 100 rems." (Pls.' Brief in Op. to Defs.' Motn. in limine to Exclude Pls.' Dose Experts at 164.) Dr. Shevchenko has taken a limited study whose purpose was merely to show the presence or absence of chromosomal aberrations, and used the findings to calculate a dose. As will be discussed below, this methodology is scientifically problematic. Moreover, it appears from the quoted statement that Dr. Snigiryova presumed that the TMI area was contaminated. Whether the TMI area was or is contaminated is a central issue in this lawsuit, and a question that has remained largely unanswered in the scientific community for nearly two decades. Accordingly, it would be highly inaccurate and seemingly unscientific to base a study upon the unproven assumption that the TMI area is or was contaminated.
Next, the Chernobyl Accident article undermines the validity of Professor Shevchenko's dose estimates based on the cytogenetic study. The summary preceding the article indicates the following: "due to the very low fraction of dicentrics, because of the time elapsed from the accident and the relatively low doses of exposure, radiobiological dosimetry is not possible for these children." Id. at 55. The article goes on to attribute the presence of chromosomal aberrations to the fact that the children have likely been exposed to continuing low-level ionizing radiation remaining from the accident. Id. at 59. Thus, as much as this article may lend support to the notion that the use of geographically diverse control groups is proper under certain circumstances, it detracts support from the proposition that Professor Shevchenko or Dr. Snigiryova could make a reliable dose estimate based upon a cytogenetic analysis performed fifteen years after the alleged exposure to radiation.
The court's review of relevant scientific literature has produced no clear guidance as to whether contemporaneous and geographically proximate control samples are essential to a scientifically reliable study. The International Chernobyl Project studies conducted in the aftermath of the Chernobyl accident included dicentric chromosome analyses. Findings of those studies showed that "the frequency of aberrations in control areas was surprisingly high . . . . Reasons for this high frequency are unclear; however, the background rate of aberrations among different populations has been shown to be variable. Future studies on this subject are certainly worthwhile." International Advisory Committee Technical Report, The International Chernobyl Project 298 (IAEA 1991) (emphasis added). This statement seems to be representative of present scientific opinion on this issue. Thus, the court is placed in the uncomfortable position of making a determination as to the propriety of a particular scientific methodology where the relevant scientific community has yet to reach agreement on that very issue.
Based upon the foregoing, the court must find that the failure to use a contemporaneous, geographically proximate control group goes to the weight of Professor Shevchenko's testimony. This finding is rooted in the court's interpretation of the relevant scientific literature. The court reads this literature to recommend the use of contemporaneous and geographically proximate control groups; however, the court does not find that the absence of such control groups renders a study invalid per se. Defendants motion for reconsideration will be denied as to this narrow issue. While the court has found that the choice of control groups has not in itself rendered the cytogenetic analysis scientifically unreliable, the court will discuss below certain aspects of the proffered testimony that the court, upon review, has found to be scientifically unreliable. Defendants
Defendants contend that the court made several legal errors in evaluating the admissibility of Dr. Snigiryova's cytogenetic analysis. Specifically, Defendants argue that the court erred in ruling that Professor Shevchenko's testimony is admissible in light of the following: (1) pursuant to Paoli II, any step that renders the expert's methodology unreliable renders the testimony inadmissible, therefore, Dr. Snigiryova's failure to employ an appropriate control group renders testimony regarding the cytogenetic analysis inadmissible; (2) Dr. Snigiryova's failure to employ the FISH method in her dose reconstruction renders her methodology hopelessly flawed and thus inadmissible; and, (3) the court reached improper conclusions based upon its analysis of several of the Paoli II factors. The court's discussion above refutes Defendants' first assignment of error. Discussion of the remaining arguments is necessary.
a. The Fluorescence In Situ Hybridization Technique
The scientific literature pertaining to use of cytogenetic analysis as a method of dose reconstruction supports the proposition that dose reconstruction through cytogenetic analysis becomes less accurate and effective as time progresses following the date of exposure. See, e.g., National Research Council, Radiation Dose Reconstruction 59 (National Academy Press 1995) ("Radiation Dose Reconstruction ") ("Among the most sensitive markers for radiation exposure is the enumeration of unstable chromosome aberrations. If this marker is measured within a year after exposure there will be little decay and the sensitivity will allow it to serve as a good dosimeter.") The decline in effectiveness as time passes arises because unstable chromosome aberrations disappear over time. Dr. Snigiryova explained in her report that the number of chromosome aberrations will decrease by approximately fifty percent within three to five years following exposure to ionizing radiation. 3/15/95 Snigiryova Rpt. at 1, 7-8. Recently, a technique known as fluorescence in situ hybridization ("FISH") has been developed. The FISH method is more effective than traditional cytogenetic analysis in reconstructing dose when significant time has elapsed since the date of exposure. Radiation Dose Reconstruction at 59 ("The disadvantages associated with unstable markers are avoided when stable markers, such as reciprocal translocations measured by fluorescent in situ hybridization, are used.") The method has been described as follows:
In this technique, the DNA is thermally denatured to provide single strands of DNA. These targeted strands are incubated with nontarget DNA probes that bind to the DNA sequences that are homologous. The target DNA is stained, and the nontarget DNA is counterstained. Under a fluorescence microscope the target DNA appears yellow, and the nontarget DNA appears red. In the case of a translocation, the affected DNA strand will appear to be partially red and partially yellow. This method detects only a fraction of the translocations, so that it is necessary to apply a multiplication factor to estimate total translocation frequency.
(Defs.' Ex. 155 (Fred A. Mettler, Jr., M.D. and Arthur C. Upton, M.D., Medical Effects of Ionizing Radiation 65 (2d ed. 1995).) Defendants' contend that the court erred in finding Dr. Snigiryova's cytogenetic analysis to be scientifically reliable despite the fact that the court recognized that "[Professor] Shevchenko failed to employ the only recognized method for performing dose reconstruction through a cytogenetic method after a long lapse of time." (Defs.' Brief in Supp. of Motn. for Reconsid. at 7.) Plaintiffs' claim that Professor Shevchenko did perform a "supplemental verification" of the results of the cytogenetic analysis using the FISH method. Further, Plaintiffs argue that because the court prohibited testimony on this issue at the in limine hearings, the court cannot now base its finding on a lack of record evidence as to this issue.
This issue highlights the problems that the court has encountered in dealing with Plaintiffs' continual "supplemental" reports. The court prohibited testimony on the FISH method at the hearings based upon its finding that the timely filed expert reports of Professor Shevchenko and Dr. Snigiryova did not contain any substantive discussion of a utilization of the FISH method to verify the results of Dr. Snigiryova's cytogenetic analysis. Dr. Snigiryova's discussion of the FISH method in her initial report was confined to the following statements:
The problem of the estimation of dose radiation using the cytogenetic data is very problematically [sic] in this situation. Firstly [sic] this is connected with a long period after TMI accident. In such situation it seems necessary to estimate stable chromosome aberration in lymphocytes of peripheral blood, using FISH method . . . .
3/15/95 Snigiryova Rpt. at 8. She again briefly raised the issue in response to an in limine challenge by Defendants. 2/25/95 Snigiryova Rpt. at 6 ("More detailed information about these people will come from the analysis of frequency of stable translocations using FISH method."). Professor Shevchenko's 2/21/95 "Final" Report briefly alluded to the FISH method as follows:
The problem of estimation of an absorbed dose on the basis of results of cytogenetic analysis is important. The lymphocytes with unstable chromosome aberrations (dicentrics and rings are referred to this group) are gradually goes out [sic] from peripheral blood because of a renovation of a pool of lymphocytes. . . . The latter figure follows from a ratio between unstable (dicentrics and rings) and stable (translocations) chromosome aberrations revealed by FISH-method. Unfortunately so far we don't know a ratio between stable and unstable chromosome aberrations for persons suffered from TMI accident . . . .
2/21/95 Shevchenko Rpt. at 6-7. In his October 6, 1995 report, filed in response to Defendants' in limine challenge, Dr. Shevchenko indicated "the dose estimate of 0.6-2 Gy for this group given in my Final report of February 21, 1995 can be defined more exactly after a cytogenetic analysis of stable chromosome aberrations using the FISH-method." 10/6/95 Shevchenko Rpt. at 22.
The evidence before the court demonstrates that the number of unstable chromosome aberrations decrease over time. The evidence further shows that cytogenetic analysis is a reliable means of reconstructing dose when done shortly after the time of exposure; and, that the FISH method is an accurate means of reconstructing dose when longer time periods have elapsed since exposure. Plaintiffs' experts conducted a traditional cytogenetic analysis on blood samples collected from TMI residents. These blood samples were taken approximately fifteen years after the alleged exposure. Both Dr. Snigiryova and Professor Shevchenko state in their reports that this time lapse is problematic in the context of reconstructing a dose. Both experts also agree that the TMI blood samples should be analyzed using the FISH method to obtain an accurate dose estimate. Contrary to the record evidence, Plaintiffs argue that their experts can quantify the dose of ionizing radiation allegedly received by TMI residents based solely upon the traditional cytogenetic analysis performed fifteen years after the presumed date of exposure.
Neither Professor Shevchenko nor Dr. Snigiryova analyzed the TMI blood samples using the FISH method prior to the November 1995 in limine hearings. Their reports indicate that they are presently re-analyzing the blood samples using the FISH method, and that these results will validate their findings from the general cytogenetic analysis. This argument distorts the letter and spirit of the Federal Rules of Civil Procedure beyond recognition. Final reports of Plaintiffs' dose experts, containing a complete statement of the methodologies employed and the basis for the opinions, were due March 1, 1995. Had Plaintiffs produced the actual findings of a study using the FISH method on the TMI blood samples at the November in limine hearings, the court would likely have admitted those findings and allowed Defendants wide latitude to cross-examine.
That Plaintiffs only recognized the importance of conducting the FISH analysis after the filing deadlines passed is not sufficient justification for admitting such evidence one year after the filing deadline and four months after the in limine hearings on dose concluded.
Based upon the foregoing, the court will grant Defendants' motion for reconsideration with respect to Professor Shevchenko's dose estimates. While Professor Shevchenko will be permitted to testify as to the cytogenetic analysis performed and as to the findings regarding the presence or absence of chromosome aberrations, Professor Shevchenko will not be permitted to give a quantified dose estimate based upon the cytogenetic analysis. The court finds that the methodology employed by Dr. Shevchenko to arrive at his dose estimate is scientifically unreliable when performed fifteen years after the alleged exposure to radiation.
B. Professor Shevchenko's Tree Study
Under Daubert's interpretation of Rule 104(a), a district court facing a proffer of scientific expert testimony must as a preliminary matter assess whether the reasoning or methodology underlying the expert's testimony is scientifically valid. The court accomplishes this "by considering all relevant factors that may bear on the reliability of the proffered evidence. The reliability requirement, however, should not be applied too strictly. Helpfulness to the trier of fact remains the ultimate touchstone of admissibility. If the expert has "good grounds" for the testimony, the scientific evidence is deemed sufficiently reliable. A ...