The opinion of the court was delivered by: RAMBO
1. Basic Concepts of Radiation
2. Radiation Exposure and Dose
3. Principles Relevant to a Nuclear Reactor Accident
a. Pressurized Water Reactors
1. Exposure/Dose Evidence
1. Exposure/Dose Evidence
2. Medical Causation Evidence
C. Plaintiffs' Burden of Proof
D. Application of the Law to the Facts of this Case
1. Were Plaintiffs Exposed to Radiation Released From TMI During the Accident?
2. Was Radiation the Cause of Plaintiffs' Injuries?
On March 28, 1979, a nuclear incident occurred at the Unit 2 reactor of the Three Mile Island nuclear power facility in Dauphin County, Pennsylvania. Among other things, the incident spawned the instant litigation
which has been pending on the court's docket for one decade longer than all but one case on the court's docket.
Due in significant part to the tremendous amount of time and effort expended by the parties and the court over the past year, ten test cases were finally scheduled for trial beginning in June.
In January and April of this year, the court issued a series of Daubert rulings excluding the bulk of Plaintiffs' expert scientific testimony as scientifically unreliable. In re TMI Cases Consol. II, 166 EF.R.D.F 8 (M.D. Pa. 1996) (granting in part Defendants' motions in limine to exclude Plaintiffs' medical causation experts); id. 922 F. Supp. 1038, 1996 WL 166713 (M.D. Pa. 1996) (same); id. 922 F. Supp. 997, 1996 WL 166707 (M.D. Pa. 1996) (granting in part Defendants' motions in limine to exclude Plaintiffs' dose and medical causation experts); id. 910 F. Supp. 200 (M.D. Pa. 1996) (granting in part Defendants' motion in limine to exclude Plaintiffs' dose experts); id. 911 F. Supp. 775 (M.D. Pa. 1996) (same). Defendants now move for summary judgment.
The parties have briefed the issues and Defendants' motion is ripe for disposition. Before reaching the merits of Defendants' motion, however, the court must first address the subsidiary yet important issue of to whom the court's summary judgment ruling will apply. Defendants argue that based upon the way in which they have framed their motion, any ruling by the court should be binding upon all Plaintiffs. Conversely, Plaintiffs argue that the ruling should bind only the test Plaintiffs.
To resolve this issue, the court refers back to its memorandum and accompanying order dated June 15, 1993. Through that order the court adopted Plaintiffs' proposed case management plan and "test plaintiff" approach, and rejected Defendants' case management plan and "track litigation" approach. In its discussion of Plaintiffs' proposed plan, the court noted the following:
Plaintiffs claim that this initial trial would provide a basis for the parties realistically to evaluate their respective cases and promote settlement of this action. Defendants contend that "the 'test-case' approach does not portend to resolve anything except the test cases selected." Therefore, Defendants assert that the initial twelve-Plaintiff
trial would not promote settlement or be otherwise useful.
In re TMI Cases Consolidated II, No. 1:CV-88-1452, mem. op. at 26 (M.D. Pa. June 15, 1993) (footnote added). Defendants now argue that "the fact that the court has scheduled trial for ten 'test case' plaintiffs does not mean that all the pretrial consolidated proceedings, designated with the caption 'All Plaintiffs,'
should . . . be regarded retrospectively as applicable only to those 'test case' plaintiffs." (Defs.' Reply Mem. at 26.) Indeed, the purpose of consolidating an action pursuant to Federal Rule of Civil Procedure 42(a) is to streamline and economize pretrial proceedings so as to avoid duplication of effort, and to prevent conflicting outcomes in cases involving similar legal and factual issues. See In re Prudential Securities Ltd. Partnerships Litigation, 158 F.R.D. 562, 571 (S.D.N.Y. 1994); Bank of Montreal v. Eagle Associates, 117 F.R.D. 530, 533 (S.D.N.Y. 1987).
The court finds that resolution of the issue before it turns on the grounds upon which the court ultimately grants or denies summary judgment. Defendants are correct that to the extent the ruling turns on broad evidentiary issues common to all Plaintiffs, the ruling will be binding upon all Plaintiffs. Likewise, Plaintiffs are correct that insofar as a ruling is based upon a more narrow, Plaintiff-specific inquiry, the ruling will apply only to certain Plaintiffs. The court's reading of documents related to the June 15, 1993 order, in conjunction with subsequent case management orders and evidentiary rulings, indicates that discovery and evidentiary matters were to proceed on an "All Plaintiffs" basis. A contrary intention or result would obviate all benefits of having consolidated the many separate actions. Each Plaintiff's case depends upon expert testimony to prove both exposure and medical causation. Expert discovery is complete, and all expert reports have been filed. Thus, to the extent that the expert testimony of record fails to meet the test Plaintiffs' evidentiary burden at this stage of the litigation, it will fail to meet the same burden as to every Plaintiff. It would be an exercise in futility and a waste of valuable resources to allow the many separate actions consolidated under this caption to proceed if it were clear that the cases could not withstand a motion for summary judgment. Under such circumstances, the court's summary judgment ruling would be applicable to all Plaintiffs.
In accordance with the discussion that follows, the court will grant Defendants' motion for summary judgment on the ground that Plaintiffs have failed to present evidence sufficient to create a material factual dispute on the issue of dose, and therefore, have failed to state their prima facie case. Because the court finds the quantum of Plaintiffs' expert evidence on the issue of dose to be insufficient, and because no Plaintiff will be able to state a prima facie case without adequate dose evidence, the instant ruling is binding upon all Plaintiffs.
The consolidated claims in this case were initially filed shortly after the TMI incident in the state and federal courts of Pennsylvania, New Jersey and Mississippi. Since the initial filings, these cases have traveled to and from the Supreme Court, the Third Circuit Court of Appeals, and several district courts on numerous occasions. Moreover, jurisdictional questions related to these actions prompted Congress to amend the Price Anderson Act to ensure federal court jurisdiction, see S. Rep. 100-218, 100th Cong. 2d Sess., 1988 U.S.C.C.A.N. 1476, 1488 (noting that the TMI litigation provided the impetus for amending the federal jurisdiction section of the Act). A brief review of the consolidated claims' meandering journey to this court is warranted.
In the mid and late 1980s, based upon the assertion that Plaintiffs' claims arose under the Price Anderson Act, Pub. L. No. 85-256, 71 Stat. 576 (codified as amended in various sections of title 42 of the United States Code), Defendants removed Plaintiffs' state court actions to federal courts in Pennsylvania and Mississippi. On appeal, the Third Circuit found that because the Nuclear Regulatory Commission ("NRC") had determined that the TMI incident did not constitute an "extraordinary nuclear occurrence,"
the TMI claims did not arise under the provisions of the Price-Anderson Act. Stibitz v. General Pub. Utils. Corp., 746 F.2d 993 (3d Cir. 1984), cert. denied, 469 U.S. 1214, 84 L. Ed. 2d 334, 105 S. Ct. 1187 (1985); Kiick v. Metropolitan Edison CO., 784 F.2d 490 (3d Cir. 1986). As such, the Third Circuit ruled that this court lacked jurisdiction to hear the actions. Stibbitz, 746 F.2d at 997; Kiick, 784 F.2d at 494-95. Pursuant to that rulings, this court remanded those actions originally filed in state court, and transferred those actions originally filed in federal court, to the appropriate state courts.
Following this court's remand and transfer of cases to state courts, Congress amended the Price-Anderson Act. 42 U.S.C. § 2001 (Price-Anderson Amendments Act of 1988). The amendment retroactively provided a federal forum for all claims arising out of any nuclear incident, whether or not that incident was declared to be an "extraordinary nuclear occurrence." 42 U.S.C. § 2210(n) (2). Original jurisdiction was conferred upon district courts located where the incident occurred, and provision was made for the removal of any action previously filed or currently pending in state court. § 2210(n) (2). Subsequently, the constitutionality of the Act's federal forum provision was upheld in In re TMI Litigation Cases Consol. II, 940 F.2d 832 (3d Cir. 1991), cert. denied, 503 U.S. 906 (1992). Pursuant to § 2210(n) (2), all remaining claims were then consolidated in this court.
On January 26, 1993, Defendants moved for summary judgment on all pending personal injury claims on the element of duty of care. Defendants argued that to prove liability, Plaintiffs would need to demonstrate that Defendants violated their duty of care by exposing each Plaintiff to radiation in excess of .5 rem. See infra at 11-12 (defining "rem"). On February 18, 1994, this court issued a memorandum and order denying Defendants' motion. The Third Circuit affirmed this court's ruling in part, holding that "the duty of care is measured by whether defendants released radiation in excess of the levels permitted by [10 C.F.R.] §§ 20.105 or 20.106, as measured at the boundary of the facility, not whether each plaintiff was exposed to those excessive radiation levels." In re TMI Litig. Cases Consol, II, 67 F.3d 1103, 1117-18 (3d Cir. 1995), cert. denied, 116 S. Ct. 1034 (1996).
In November of 1995, and in February and March of 1996, this court conducted extensive Daubert hearings related to Plaintiffs' dose and medical causation experts. In January and April of 1996, this court issued several memoranda of law and accompanying orders granting the majority of Defendants' motions in limine. As these opinions, hundreds of pages in aggregate length, detail the court's reasoning, the court will not restate that reasoning here. In brief, however, the court notes that despite finding the vast majority of Plaintiffs' experts to be well qualified, the court found many of their opinions to be based upon methodologies that were scientifically unreliable and upon data that a reasonable expert in the field would not rely upon. Accordingly, in the exercise of its "gatekeeping" function, the court found it necessary to exclude much of Plaintiffs' proffered expert testimony. On April 19, 1996, Defendants filed the instant motion for summary judgment on the issues of dose and medical causation.
B. Scientific Background9
1. Basic Concepts of Radiation
Atoms are the smallest unit of an element, and are composed of three types of particles: protons, neutrons and electrons. They may be stable or unstable. Unstable atoms emit surplus energy from the nucleus in a process known as radioactive decay. The energy emitted through radioactive decay is radiation. See generally, Allen v. United States, 588 F. Supp. 247, 260-87 (D. Utah 1984) (providing exhaustive discussion of basic principles of radiation and nuclear physics).
For the purposes of this lawsuit, there are three basic types of ionizing radiation. An alpha particle is composed of two neutrons and two protons . . . . A beta ray is a single electron. A gamma ray is a photon, or bundle of energy which contains some of the properties of both matter and light.
Johnston v. United States, 597 F. Supp. at 384 (emphasis added). Gamma radiation is short wave length electromagnetic radiation spontaneously emitted by a nucleus during certain radioactive decays. (7/12/95 Aff. of John Fraizer at P 14.) It has a high penetrating ability and can pass through the human body. In the instant action, Plaintiffs allege gamma ray exposure from xenon, radioactive iodine, and to a lesser extent, krypton.
Scientists quantify radiation in the following manner:
as radiation passes through air, it can be measured by counting the number of ionized particles it produces. The quantity "exposure" has been historically defined as the number of electrical charges produced in a unit mass of air and measured in units of roentgens (R). . . . As radiation penetrates any material, its energy is absorbed and released by the constituent atoms. The absorbed energy per unit mass of material is termed the absorbed dose. The old unit of absorbed dose was the rad, defined as 100 ergs of energy per gram of material. . . . The effects of radiation on any material, including biological materials such as tissue, depend on the magnitude of the absorbed dose.
International Advisory Committee, "The International Chernobyl Project, Technical Report," at 20 (IAEA 1991)(hereinafter "Chernobyl Report"). The rad has been replaced by the international unit, the "gray" (Gy). One gray is equal to 100 rads. Another relevant dosimetric quantity is the "rem" (roentgen equivalent man). One rem is equal to one thousand millirems (mrems). The rem has been replaced by the international unit the "sievert" (Sv). One sievert equals (100,000 mrems). Because much of the TMI literature predates the conversion to international units, the court will use rad and rem quantities to insure consistency with materials being cited.
2. Radiation Exposure and Dose
three of the six radiation sources, namely radiation from occupational activities, nuclear power production (the fuel cycle), and miscellaneous environmental sources (including nuclear weapons testing fallout), contributed negligibly to the average effective dose equivalent, i.e., less than 0.01 millisievert (mSv)/year (1 mrem/year).
A total average annual effective dose equivalent of 3.6 mSv (360 mrem)/year to members of the U.S. population is contributed by the other three sources: naturally occurring radiation, medical uses of radiation, and radiation from consumer products. By far the largest contribution (82%) is made by natural sources, two thirds of which is caused by radon and its decay products. Approximately equal contributions to the other one-third come from cosmic radiation, terrestrial radiation, and internally deposited radionuclides. The importance of environmental radon as the largest source of human exposure has only recently been recognized.
The remaining 18% of the average annual effective dose equivalent consists of radiation from medical procedures (x-ray diagnosis, 11% and nuclear medicine, 4%) and from consumer products (3%). The contribution by medical procedures is smaller than previously estimated. For consumer products, the chief contributor is, again, radon in domestic water supplies, although building materials, mining, and agricultural products as well as coal burning also contribute. Smokers are additionally exposed to the natural radionuclide polonium-210 in tobacco, resulting in the irradiation of a small region of the bronchial epithelium to a relatively high does . . . that may cause an increased risk of lung cancer.
BIER V at 18-19. The Johnston court also made the following interesting observations regarding natural background radiation:
In order to make these units of measurement more meaningful, it is of interest to note what doses some common experiences yield. The earth in Florida gives a person living there a dose of approximately 23 mrem per year. If a person lives there for 64 years, he will receive a dose of 64 X 23 mrem = 1472 mrem from Florida dirt in a lifetime. This is equal to 1.472 rem. If another person lives in Colorado for 64 years, he will receive a dose of 64 X 90 mrem = 5760 mrem from Colorado dirt in a lifetime. This is equal to 5.76 rem. In 1970, approximately 129,000,000 Americans were exposed to x-rays for medical or dental purposes . . . . The average American by age 64 will receive about 6.5 rem of radiation from x-rays. Consequently, total [(lifetime)] doses of approximately 12 rem would be common for a [64 year old] Colorado resident who had normal exposure to dirt and x-rays.
Johnston, 597 F. Supp. at 389-90 (internal citations omitted) (citing BEIR III).
The effect of radiation exposure upon a human being is controlled by a number of variables. For example, the effects depend "not only on the absorbed dose, but also on the type and energy of the radiation causing the dose." Chernobyl Report at 20. In addition, the likelihood of observing effects will depend upon the tissue or organ irradiated and the degree of sensitivity of that tissue or organ to radiation. Id.
b. Quantifyinq Dose/Dose Reconstruction
When considering the potential biological effects of exposure to ionizing radiation, it is necessary to consider the pathway through which the radiation entered the body.
Chernobyl Report at 31. Among other reasons, the pathway of exposure is important because it provides key information regarding potential exposure. For example, where exposure is internal, from ingestion of a radionuclide, exposure will continue for the life of the radionuclide and will be highest in those organs most susceptible to exposure from the radionuclide ingested. See National Resource Council, Radiation Dose Reconstruction for Epidemiologic Uses 41-3 (1995); see infra at 20-21 (discussing authoritative materials upon which this handbook is based).
Two categories of effects may be observed following exposure to ionizing radiation: deterministic effects and stochastic effects. Deterministic effects of exposure to radiation arise from cell death. When a threshold number of cells within a given tissue or organ are killed, "there will be clinically observable pathological conditions such as a loss of tissue function or a consequential reaction as the body attempts to repair the damage. If the tissue is vital and is damaged sufficiently, the end result will be death." Annals of the ICRP, ICRP Publication 60, "1990 Recommendations of the International Commission on Radiological Protection" at 14 (1991) (hereinafter "ICRP 60").
Acute radiation syndrome,
for example, is a deterministic effect of radiation exposure. Stochastic effects occur when the irradiated cell is modified rather than killed. Chernobyl Report at 39-40. The modified cell replicates itself, and over time, may develop into cancer. The risk of contracting cancer as a result of radiation exposure increases in relation to the dose of radiation to which a person is exposed. See generally, Chernobyl Report at 40-41 ("Fatal cancer risk factor following exposure to relatively low doses delivered at low dose rates is smaller than the values assessed for high doses at high dose rates."); BEIR V at 20-24 (discussing radiobiological concepts impacting on biological consequences of a given dose of radiation). Accordingly, to determine the effect that radiation exposure will have on a person, it is necessary to quantify the dose of the exposure. The following dosimetric quantities are used within the field of health physics to express exposure:
Absorbed dose: The amount of radiation energy that is absorbed per kilogram of tissue. It is expressed in grays (Gy).
Equivalent dose: The absorbed dose weighted for the harmfulness of different radiations (by radiation weighting factors) to take into account the different types of radiation and their energies. It is expressed in sieverts (Sv), with submultiples of millisieverts (mSv) . . . . For most practical applications, the radiation weighting factor is unity; that is, the numerical values for absorbed dose and equivalent dose will be equal.
Effective dose: The equivalent dose weighted for the susceptibility of harm of different human tissues. It is a (modified) equivalent dose and is also expressed in sieverts.
Although uncertainties remain, the last decade has seen tremendous advances in what is known about radiation induced cancers. See BEIR V at 1 ("Since the completion of the 1980 BEIR III report, there have been significant developments in our knowledge of the extent of radiation exposures from natural sources and medical uses as well as new data on the late health effects of radiation in humans . . . . Furthermore, advanced computational techniques and models for analysis have become available for radiation risk assessment."). Long term studies on the survivors of Hiroshima and Nagasaki, British akylosing spondylitis patients treated with radiation therapy, and other persons exposed to radiation via nuclear weapons testing or occupational exposures, have increased the body of knowledge regarding the health effects of radiation exposure. See United Nations Committee on the Effects of Atomic Radiation ("UNSCEAR"), "Sources and Effects of Ionizing Radiation" at Appendix F, p. 620 (1993) (hereinafter "UNSCEAR 1993").
Based upon these advances, and relying upon the findings of these authoritative compilations, the National Research Council in 1995 published a comprehensive handbook on the mechanics of dose reconstruction. Radiation Dose Reconstruction for Epidemiologic Uses (1995) (hereinafter "Radiation Dose Reconstruction ").
analysis consists of estimating the magnitude of releases to the environment of radionuclides and the periods over which they were ...