The opinion of the court was delivered by: WEINSTEIN
MEMORANDUM, ORDER, AND JUDGMENT
Defendants, seven chemical companies, have moved to dismiss or in the alternative for summary judgment. Plaintiffs are Vietnam veterans and members of their families who have opted out of the class previously certified by the court pursuant to Rule 23(b)(3) of the Federal Rules of Civil Procedure. In re "Agent Orange" Product Liability Litigation, 100 F.R.D. 718 (E.D.N.Y.), mandamus denied, 725 F.2d 858 (2d Cir.), cert. denied, U.S. , 104 S. Ct. 1417, 79 L. Ed. 2d 743 (1984). They allege that as a result of the veterans' exposure to Agent Orange, a herbicide manufactured by the defendants, they suffer from various health problems.
Defendants contend that they are entitled to judgment dismissing the claims asserted against them because of each plaintiff's conceded inability to identify the individual manufacturer of the Agent Orange to which a given veteran was exposed, inapplicability of any alternative theory of liability that would overcome that inability, the government contract defense, and inability of any plaintiff to prove that his or her injuries were caused by Agent Orange.
Plaintiff Vietnam veterans do suffer. Many deserve help from the government. They cannot obtain aid through this suit against private corporations.
These issues have been discussed extensively in the court's Preliminary Memorandum and Order on Settlement, In re "Agent Orange" Product Liability Litigation, 597 F. Supp. 740, 876-78 (E.D.N.Y. 1984) (citing opinions published in this litigation), and the reader is respectfully referred to it for elaboration. See also, e.g., In re "Agent Orange" Product Liability Litigation, 603 F. Supp. 239 (E.D.N.Y. 1985) (actions against government by veterans, wives and children dismissed on law and for failure to prove causation).
The most serious deficiency in plaintiffs' case is their failure to present credible evidence of a causal link between exposure to Agent Orange and the various diseases from which they are allegedly suffering. Various other reasons why the motion for summary judgment must be granted are set forth below.
The mere fact that this case involves claims of negligence does not preclude granting summary judgment. See, e.g., Haugen v. United States, 492 F. Supp. 398, 400 (E.D.N.Y.), aff'd without opinion, 646 F.2d 560 (2d Cir. 1980); INA Aviation Corp. v. United States, 468 F. Supp. 695, 699 (E.D.N.Y.), aff'd without opinion, 610 F.2d 806 (2d Cir. 1979). Nevertheless, the practice is somewhat unusual. We have, therefore, set out below in some detail the facts and an analysis of the cases bearing on the matter.
II. PROCEDURAL BACKGROUND
The claims of 281 servicepersons who have opted out of the class are embodied in sixteen different cases. One case began the Agent Orange litigation with the filing of a 162-page complaint in this district on February 19, 1979. Dowd v. Dow Chemical Co., Civil Action No. 79-467. The others were consolidated in this court for pretrial proceedings by the Judicial Panel on Multidistrict Litigation ("MDL Panel"). Plaintiffs seek relief on theories of negligence, strict liability, breach of warranty, intentional tort, and nuisance.
This court certified a class action against the defendant chemical companies pursuant to Rule 23(b)(3). See In re "Agent Orange" Product Liability Litigation, 506 F. Supp. 762, 787-92 (E.D.N.Y. 1980), modified, 100 F.R.D. 718 (E.D.N.Y. 1983), mandamus denied, 725 F.2d 858 (2d Cir.), cert. denied, U.S. , 104 S. Ct. 1417, 79 L. Ed. 2d 743 (1984). The class was defined as "those persons who were in the United States, New Zealand or Australian Armed Forces at any time from 1961 to 1972 who were injured while in or near Vietnam by exposure to Agent Orange or other phenoxy herbicides, including those composed in whole or in part of 2, 4, 5-trichlorophenoxyacetic acid or containing some amount of 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin." 100 F.R.D. at 729. The class also included spouses, parents, and children of the veterans born before January 1, 1984 directly or derivatively injured as a result of the exposure.
A separate class was certified on the issue of punitive damages under Federal Rule of Civil Procedure 23(b)(1)(B). Potential class members were allowed to opt out of the Rule 23(b)(3) class but not out of the Rule 23(b)(1)(B) class. 100 F.R.D. at 728.
Extensive notice of the class certification was given. See 597 F. Supp. 746, at 756-57. The notice included a Request for Exclusion Form to be completed by anyone wishing to opt-out of the class. Id.
Over 2.6 million veterans from the United States, Australia, and New Zealand served in Vietnam during the relevant period. Letter from Arvin Maskin, Trial Attorney, Torts Branch of the Department of Justice dated March 29, 1985. The number of persons from that group said to have been exposed to Agent Orange has been estimated in the order of 600,000 or more. See 597 F. Supp. 740, at 756. The class size is far larger since it includes family members of the exposed veterans.
As of May 6, 1984, the Eastern District's Clerk's Office had received 2,440 requests to be excluded from the class, but a substantial number of these opted back in. See 597 F. Supp. 740, at 756. The 281 plaintiffs in the captioned cases under consideration at this time, together with the plaintiff in Lilley v. Dow Chemical Co., Civil Action No. 80-2284, appear to comprise all the opt-outs whose claims are now pending in this court. Some of the remaining opt-outs apparently have not yet filed suit; if they do, their cases presumably will be transferred to this court. A considerable number of opt-outs have been dismissed without opposition or for a variety of reasons not germane to the present discussion.
After settling with members of the class on May 7, 1984, defendants moved on July 24, 1984 for summary judgment in the opt-out cases and a number of cases brought by civilians. On December 10, 1984, the court heard oral argument on defendants' motion. Defendants offered overwhelming proof that no causal connection exists between exposure to Agent Orange and development of miscarriages or birth defects. In response, the veterans' wives and children produced no evidence sufficient to create an issue of material fact on causation. See also In re "Agent Orange" Product Liability Litigation, 603 F. Supp. 239 (E.D.N.Y. 1985) (dismissing claims of wives and children against government).
The court denied summary judgment in the case of Lilley v. Dow Chemical Co., Civil Action No. 80-2284. Defendants' motion to reargue was granted, expedited discovery occurred, and oral argument was heard on April 15, 1985. This case is considered in a separate memorandum granting summary judgment for defendants. F. Supp. (E.D.N.Y. 1985) (forthcoming).
The court adjourned consideration of the opt-out veterans' claims against the chemical companies to allow plaintiffs' counsel time to produce evidence of causation. Counsel produced the affidavit of Dr. Barry M. Singer and 189 accompanying affidavits on January 24, 1985. At that time, the court, at the request of plaintiffs' counsel, allowed plaintiffs fifteen days to produce additional affidavits; the court's order stated that "no further extensions [would] be granted." See Order dated January 24, 1985. Nevertheless, on March 12, 1985, without leave for late filing, counsel produced a second affidavit by Dr. Singer with 93 accompanying affidavits. On that day, counsel also produced a general affidavit by Dr. Samuel S. Epstein with 15 accompanying affidavits.
Subsequently, counsel for plaintiffs, by application dated April 23, 1985, sought 60 additional days to file further affidavits on behalf of 21 opt-out plaintiffs on whose behalf nothing has been submitted by plaintiffs' counsel. This motion for additional time was denied on April 29, 1985.
Counsel for defendants moved to strike these additional materials as untimely on March 13, 1985 and again on March 18, 1985. The court reserved decision and granted defendants' request to adjourn oral argument on the summary judgment motion from March 18 until April 15. Oral argument was heard on that date. In view of the importance of the matter, rejection on the ground of lateness of any papers heretofore filed seems inappropriate. The court has in fact considered all of the voluminous papers filed up to April 30, 1985 by both sides, as well as all documents in all the related MDL cases, including those studies and reports filed on the court's own motion as it announced from time to time that it was taking judicial notice. Since no objection to the taking of judicial notice has been made, all of the papers encompassed in the more than 6,000 docket entries in this complex multidistrict litigation are before the court and are relied upon in deciding the motion for summary judgment. See Federal Rules of Evidence, Rule 201.
In support of their contention that Agent Orange did not cause the various ailments that allegedly afflict the veteran plaintiffs, defendants rest upon a number of epidemiological studies. As this court has indicated in extensive and repeated recorded colloquy with counsel and in prior opinions, e.g., In re "Agent Orange" Product Liability Litigation, 597 F. Supp. 740, 777-95 (E.D.N.Y. 1984), all reliable studies of the effect of Agent Orange on members of the class so far published provide no support for plaintiffs' claims of causation. See also In re "Agent Orange" Product Liability Litigation, 603 F. Supp. 239 (E.D.N.Y. 1985) (granting summary judgment against the veterans' wives and children in their case against the government for failure to show causation).
A. Epidemiological Studies
Epidemiological studies rely on "statistical methods to detect abnormally high incidences of disease in a study population and to associate these incidences with unusual exposures to suspect environmental factors." Dore, "A Commentary on the Use of Epidemiological Evidence in Demonstrating Cause-in-Fact," 7 Harv. Envtl. L. Rev. 429, 431 (1983). In their study of diseases in human populations, epidemiologists use data from surveys, death certificates, and medical and clinical observations. Id.
A number of sound epidemiological studies have been conducted on the health effects of exposure to Agent Orange. These are the only useful studies having any bearing on causation.
All the other data supplied by the parties rests on surmise and inapposite extrapolations from animal studies and industrial accidents. It is hypothesized that, predicated on this experience, adverse effects of Agent Orange on plaintiffs might at some time in the future be shown to some degree of probability.
The available relevant studies have addressed the direct effects of exposure on servicepersons and the indirect effects of exposure on spouses and children of servicepersons. No acceptable study to date of Vietnam veterans and their families concludes that there is a causal connection between exposure to Agent Orange and the serious adverse health effects claimed by plaintiffs. Chloracne and pophyria cutanea tarda are the only two diseases that have been recognized by Congress as having some possible connection to Agent Orange exposure, but no proof has been shown of any relationship of these diseases to these plaintiffs. See In re "Agent Orange" Product Liability Litigation, 597 F. Supp. 740, 856 (E.D.N.Y. 1984) (of all Vietnam veterans, no chloracne and 2 porphyria cutanea tarda cases are recognized as having a connection with Vietnam, but not necessarily with Agent Orange); Veterans Administration, Adjudication of Claims Based on Exposure to Dioxin or Ionizing Radiation, 50 Fed. Reg. 15848, 15849-50 (April 22, 1985). See also, e.g., Tr. at 182 (Hearings March 5, 1985) (comments of David Dean for Plaintiffs' Management Committee) ("chloracne without disability is not compensable" out of Agent Orange funds).
1. Miscarriages and Birth Defects
The claims of the opt-out wives and children were dismissed orally on December 10, 1984 and many of them subsequently rejoined the class. Evidence regarding their claims is, however, still relevant because it suggests that the veterans' concerns about their ability to reproduce healthy children are, like their concerns about their own health problems, unrelated to Agent Orange exposure. It must be recalled that plaintiffs' counsel pressed these claims of children and wives with at least as much vigor as those of the veterans, relying on much the same kind of inadequate proof now reasserted in connection with the veterans' claims.
The studies to date conclude that there is as yet no epidemiological evidence that paternal exposure to Agent Orange causes birth defects and miscarriages. See, e.g., Erickson, Mulinare, et al., "Vietnam Veterans' Risks for Fathering Babies with Birth Defects," 252 J.A.M.A. 903-12 (1984); J.D. Erickson, J. Mulinare, et al., Vietnam Veterans' Risks for Fathering Babies with Birth Defects, published by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control (August, 1984) ("CDC study"); J.W. Donovan, et al., Case-control Study of Congenital Anomalies and Vietnam Service (Birth Defects Study); Report to the Minister for Veterans' Affairs, January 1983, published by Australian Government Publishing Service, Canberra (1983) ("Australian study"); Donovan, MacLennan and Andena, "Vietnam service and the risk of congenital anomalies," 140 Med. J. of Australia, 394 (March 31, 1984). See also e.g. the discussion of lack of proof of causation in In re "Agent Orange" Product Liability Litigation, 597 F. Supp. 740, 749, 775-95 (E.D.N.Y. 1984).
In a comprehensive epidemiological examination of 96 categories of birth defects occurring among subsequently conceived offspring of American servicemen who served in Vietnam, the authors of the CDC study concluded: "This study provides strong evidence that Vietnam veterans, in general, have not been at increased risk of fathering babies with the aggregate of the types of defects studied here." CDC study at 2. The CDC study further concluded: "At present, no adverse human reproductive effects have been shown to be related to exposure to phenoxy herbicides and dioxin." Id. at 67 (emphasis supplied).
The conclusions of the Australian study are similarly negative:
There is no evidence that Army service in Vietnam increases the risk of fathering children with anomalies diagnosed at birth.
Donovan, MacLennan and Andena, "Vietnam service and the risk of congenital anomalies," 140 Med. J. of Australia 394 (March 31, 1984). See also CDC study at 6-7 (number of offspring of Vietnam veterans with serious birth defects no greater than the population at large); cf. House Rep. No. 98-592 on Veterans' Dioxin and Radiation Exposure Compensation Standards Act, reprinted in 1984 U.S. Code Conq. & Admin. News 4449, 4453 ("insufficient credible scientific evidence" that veterans exposed to Agent Orange are experiencing higher incidence of medical problems).
Epidemiological studies addressing the effect of Agent Orange exposure on veterans' health have not furnished support for plaintiffs' claims. They have been negative or inconclusive.
The Air Force study is the most intensive examination to date of Agent Orange effects on exposed veterans. See Air Force Health Study, An Epidemiologic Investigation of Health Effects in Air Force Personnel Following Exposure to Herbicides (February 24, 1984) (Ranch Hand II Study -- 1984 Report). This study utilized 1,024 matched pairs of men for analysis. Id. at v. Essentially all those who had participated in the fixed wing spraying and who could be located were studied. The conclusion was negative. In summary,
This baseline report concludes that there is insufficient evidence to support a cause and effect relationship between herbicide exposure and adverse health in the Ranch Hand group at this time.
Id. at iii. Significantly, "no cases of chloracne were diagnosed clinically or by biopsy." Id. at iii, XV-9.
The small Ranch Hand sample and other factors, particularly the length of time it takes for most cancers to develop, support the conclusion that more work is needed before any firm conclusion can be reached respecting morbidity. Id. at v. The authors suggest a 20-year mortality follow-up study. Id. at v., XVIII-1-3.
The Ranch Hand Study authors state that "[i]n full context, the baseline study results should be viewed as reassuring to the Ranch Handers and their families at this time." Id. at iii; see also id. at XIV-4 to XIX-9. Their study offers no solace to plaintiffs in the instant litigation. It is at best inconclusive. See In re "Agent Orange" Product Liability Litigation, 597 F. Supp. 740, 788 (E.D.N.Y. 1984).
A comprehensive study by the Centers for Disease Control may be available after mid-1989. See Centers for Disease Control, Protocol for EpidemioloqicStudies of the Health of Vietnam Veterans (November 1983). But cf. McIntyre, "End to Dioxin Study Fund Asked," Newsday, May 1, 1985, at 25, col. 1 (White House scientist Alvin L. Young, a toxicologist, recommends that no further research on dioxin should be funded, "because research has failed to show it causes cancer or birth defects in humans.").
No valid state study supports plaintiffs' causality claims. See In re "Agent Orange" Product Liability Litigation, 597 F. Supp. 740, 787 (E.D.N.Y. 1984); see also 3 Agent Orange Review 1 (July 1984) (describing ongoing studies); Agent Orange Advisory Committee to the Texas Department of Health, Guy R. Newell, Chairman, Development and Preliminary Results of Pilot Clinical Studies 13, 15-19 (March 26, 1984) (Texas study).
Two recently-released studies fail to establish any causal connection. A comparison of New York State Vietnam veterans with veterans of that era who did not serve in Vietnam revealed no increased incidence of disease. Lawrence, et al., Mortality Patterns of New York State Vietnam Veterans, 75 AJPH 277 (1985). The authors note that the long induction period involved in some of the diseases suggests the need for further study, but conclude:
Overall, these studies show no remarkable disease differences between Vietnam veterans and other veterans of that era. To the extent that Vietnam service may be indicative of dioxin-contaminated herbicide exposure, we find no suggested association with cause of death.
The comprehensive three-part Australian study is similarly negative. Australian Veterans Health Studies, The Mortality Report (1984). In 1980, the government of Australia commissioned the Commonwealth Institute of Health to conduct a series of scientific studies of the health of Vietnam veterans and their families. The Commission undertook a retrospective cohort study of mortality among former national servicemen of the Vietnam era, which is reported in Part I of the Report. Australian forces that served in Vietnam were exposed at least as heavily as United States forces to Agent Orange. See Tr. at 479 (San Francisco Hearings, August 24, 1984).
This study sought to determine whether death rates among Vietnam veterans were higher than among comparable non-veterans for all causes of death combined. The study included 46,166 subjects: 19,209 veterans who served in Vietnam or Vietnam waters for over 90 days and did not die prior to two years of service, and 26,957 non-veterans. Information about the study subjects was obtained through death registers, medical certificates, and military and nonmilitary records. The follow-up rate was high, and the authors conclude that the data used was of "high quality." "Executive Summary," at vii.
The study found the death rate among study subjects -- both veterans and non-veterans -- "statistically significantly lower than expected for Australian males, taking age and calendar year into account." Id. Mortality among veterans was not higher than that among non-veterans in a statistically significant sense, except among Veterans who were members of The Royal Australian Engineers. Id. at viii. Part III of the Report offers several possible explanations for this discrepancy, none of them attributable to Agent Orange. See Part III, "The Relationship Between Aspects of Vietnam Service and Subsequent Mortality Among Australian National Servicemen of the Vietnam Conflict Era," at 41-46 (1984).
With respect to specific causes of death, the Report found no statistically significant difference in death rates from cancer among veterans and non-veterans. In particular, the study found that:
there was no statistically significant difference in the death rates from soft tissue sarcoma or non-Hodgkin's lymphoma. Other studies have indicated that both cancers are possibly caused by phenoxy acetic acid herbicides * * * sprayed in Vietnam.
Part I, "Executive Summary," at ix.
The study found no statistically significant difference in death rates from a number of other causes of death, including diseases of the skin, of the musculoskeletal system and connective tissue, of the blood, and of the neoplasmic, endocrine, nutritional, metabolic, and circulatory systems. Id. at ix-x; see also id. at 79-90. The study attributed a higher veteran mortality rate from diseases of the digestive system to alcoholism. Id. at x; see also id. at 88.
While cautioninq that diseases such as cancer may take longer to develop, id. at ix, the Australian study found no evidence of an excess of deaths among the veterans studied due to "unusual causes." Id. at x. Such evidence -- had it surfaced --"might have suggested that some deaths of veterans might have been caused by a specific toxin or pathogen." Id. (emphasis supplied).
Congress agrees with this generally negative assessment of the effect of Agent Orange exposure. The House Report accompanying the recent Veterans' Dioxin and Radiation Exposure Compensation Standards Act, Pub. L. No. 98-542, 98 Stat. 2725 (1984), states that "[t]here is no consensus of opinion in the scientific community that exposure to dioxin causes any identifiable disability other than chloracne." House Rept. No. 98-592 (Veterans' Affairs Comm.) at 5, reprinted in 1984 Cong. & Ad. News 4449, 4451. As of May 22, 1984, Senator Cranston noted that:
Although 13 chloracne cases have been granted service connection, the VA reported in a May 17, 1984 letter * * * that it appeared after review that none of the cases, in fact, involved chloracne.
Cong. Rec. Sen. S.6145 (daily ed. May 22, 1984). The House Report concluded that "it is generally agreed that there is insufficient credible scientific evidence that this group of veterans has demonstrated they are experiencing any higher incidence or frequency of medical problems related to their possible exposure to dioxin while in service as to warrant a statutory presumption that such medical problems are related to military service." House Rept. at 7, reprinted in 1984 Cong. & Ad. News 4449, 4453.
Plaintiffs cite a number of studies conducted on animals and industrial workers as evidence of a causal link between exposure to TCDD and the development of various hepatotoxic, hematotoxic, genotoxic, and enzymatic responses. None of these studies do more than show that there may be a causal connection between dioxin and disease. None show such a connection between plaintiffs and Agent Orange.
Plaintiffs also rely on several depositions and affidavits by experts. As indicated below, to the extent that these experts rely on available epidemiological studies, the studies supply no basis for an inference of causation. There is simply no other reliable data on which an expert can furnish reliable testimony. Thus, no expert tendered by plaintiffs would be permitted to testify under Rules 702 and 703 of the Federal Rules of Evidence
Even most of plaintiffs' experts express doubt about causation, except for some ill-defined possible "association" as compared with associations with any specific other products or natural carcinogens; none supports the conclusion that present evidence permits a scientifically acceptable conclusion that Agent Orange did cause a specific plaintiff's specific disease. See e.g., Report of Dr. Hyman J. Zimmerman, Comments on Porphyria Cutanea Tarda & Related Matters ("[t]he relevance of [liver destruction and cancer] to man and the relevance of liver injury and PCT to exposure to DIOXIN remains to be evaluated by proper epidemiologic studies.") (Plaintiffs' Supplemental Memorandum in Support of Plaintiffs' Opposition to Defendants' Motion for Summary Judgment, Ex. 8; emphasis supplied); Deposition of Dr. Ellen Silbergeld, at 321 ("I think there is an association [between exposure to Agent Orange and lymphoma]") (Id., Ex. 2; emphasis supplied); Deposition of Dr. Marvin Schneiderman, at 50 ("rhabdomyosarcoma * * * is more likely, in my opinion, to have been related to that exposure than to some other not known ill-defined set of causes." (Id., Ex. 3; emphasis supplied.); id. at 144 ("Lymphocitic lymphoma * * * could be related to exposure * * * to Agent Orange") (Id., Ex. 3; emphasis supplied); Deposition of Dr. Maureen C. Hatch, at 54 ("there may be a causal association") (Opt-out Plaintiffs' Opposition to Defendants' Motion to Dismiss, or in the Alternative, for Summary Judgment, Ex. 6; emphasis supplied).
It is significant that like Doctors Singer and Epstein, whose affidavits are described in detail below, the various experts referred to in the preceding paragraph apparently had no physical contact with individual plaintiffs. For example, Dr. Silbergeld, whose opinion is relied upon heavily in plaintiffs' briefs, states:
In preparing this affidavit, I have not seen any material related to the plaintiffs in this litigation, no medical records or other descriptions of the medical status of these persons.
Undated Aff. of Dr. Ellen K. Silbergeld, 4 at 2, Ex. 5 to Opt-Out Plaintiffs' Opposition to Defendants' Motion to Dismiss or, in the Alternative, for Summary Judgment.
Plaintiffs' Supplemental Memorandum in Support of Plaintiffs' Opposition to Defendants' Motion for Summary Judgment devotes considerable attention to the specific background of one David Lambiotte, with reference to expert opinions inferring that his illnesses were caused by Agent Oranqe exposure. Id. at 3-6. Much of this discussion is irrelevant to the specific opt-out cases the court. Mr. Lambiotte, for example, is a member of the class and filed a claim form seeking to share in the settlement proceeds. See Claim No. 28397 (on file at Agent Orange Computer Center).
Plaintiffs offer the opinion of two experts who conclude that in the cases of the specific opt-out plaintiffs before the court, exposure to Agent Orange caused adverse health effects. One is Dr. Singer's submission. The other is Dr. Epstein's.
1. Dr. Singer's Affidavit
Plaintiffs submitted two affidavits on causation by Dr. Barry M. Singer. Their wording is virtually identical. Dr. Singer's affidavits were accompanied by 282 "affidavits" by individual veteran plaintiffs. The latter are form statements, signed by either the plaintiff or his attorney, or both. A representative set of statements is attached as Appendix "A" to this opinion.
The forms typically allege that the plaintiff "saw spraying of Agent Orange, entered defoliated areas and consumed local food and water." The forms then describe the plaintiff's diagnosed medical problems and refer to an attached "checklist" for a description of alleged Agent Orange related symptoms.
The checklists allow the individual to identify any or all of a number of symptoms which they attribute to their exposure to Agent Orange in Vietnam. In addition to general symptoms such as fatigue, space is provided in which to indicate specific skin, skeletal-muscular, gastrointestinal visual and behavioral disorders, as well as to identify any tumors as malignant or nonmalignant. Finally, the checklist asks for information about the individual's offspring. A perusal of the checklists reveals that plaintiffs believe they suffer most frequently from "behavioral" disorders: memory loss, increased irritability, anger and anxiety, insomnia, confusion, depression, and tremors.
The final part of the form affidavits describes the individual's medical history, and asks for a description of tobacco, alcohol, and drug use. This portion also alleges no exposure to any toxic chemical besides Agent Orange.
Dr. Singer, who is board certified in internal medicine, hematology, and oncology, reaches a number of conclusions based on his review of the numerous form affidavits with their attached checklists. He bases his opinion on his medical background, a review of the literature on the biomedical effects of Agent Orange, and an examination of the individual affidavits. He apparently did not examine any medical records nor any plaintiffs. In discussing his conclusions, the numbers from his two separate affidavits will be combined.
Dr. Singer notes at the outset that 2, 4-D, 2, 4, 5-T, and 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin ("dioxin") "are potent and toxic agents capable of inducing a wide variety of adverse effects both in animals and in man." Singer Aff. 5 (emphasis supplied). See also In re "Aqent Orange" Product Liability Litigation, 597 F. Supp. at 778 (dioxin one of most powerful poisons known). Dr. Singer then analyzes the various ailments suffered by the individual affiants.
Fifty-four plaintiffs, Dr. Singer reports, suffer from some form of hepatic (liver) abnormality, either abnormal liver function tests, hepatitis, cirrhosis of the liver, or pericentral steatosis. He notes that liver disorders have been reported to develop in humans after industrial exposure and accidents, and in dogs, rats, mice, and primates after subacute and chronic exposure. For example, "[in both mice and rats, small doses of TCDD predictably produce an increase in liver weight.]" Aff. 6.
Dr. Singer also asserts that 2, 4, 5-T "produces liver enzyme abnormalities * * * liver swelling and centrilobular necrosis" (death of a central liver lobule, or functional unit of the liver), and that one plaintiff suffered from a bile duct microadenoma (small, usually benign tumor in the passage between the liver and gall bladder) and from fatty metamorphosis of the liver. He concludes that "these compounds are capable of producing marked alteration in hepatic architecture and function" and that the liver abnormalities plaintiffs allege are "consistent with" the known effects of polychlorinated herbicides. (Emphasis supplied.) Although Dr. Singer does not reveal the studies that he relies upon to reach this conclusion, it is clear he is not referring to studies that analyze the effects of Agent Orange on exposed veterans. In any event, the liver disorders Dr. Singer finds in the animal and industrial studies substantially from those plaintiffs report they suffered.
Dr. Singer next notes that many affiants suffer from asthenic (exhaustion) symptoms: "[f]atigue was present in  patients, numbness of the extremities in , tremor in  and depression in  [and]  patients complained of increased irritability, increased anger was present in , increased anxiety in , sleep disturbances in , increased aggression in , and confusion in  patients." Aff. 7. He notes that such neurological effects have been reported to result from industrial accidents and testing in animal models, again without naming his sources or specifying what quantity of 2, 4, 5-T was involved. He concludes that many neurological symptoms complained of by the plaintiffs are "clearly compatible with" the known effects of dioxin on the human nervous system. (Emphasis supplied.)
Dr. Singer next discusses the affiants complaining of weight loss (57), decreased appetite (88), and gastrointestinal disturbances (178). He asserts that nausea, vomiting, diarrhea, and abdominal pain have been reported after industrial exposure to polychlorinated herbicides; he adds that TCDD produces weight loss in primates, rodents, and fowl. Dr. Singer thus concludes that the affiants' symptoms are "compatible with known biological effects of polychlorinated herbicides." (Emphasis supplied.)
Dr. Singer again relies on animal and industrial exposure studies in reaching his conclusion that the elevated cholesterol or triglyceride levels alleged by thirteen affiants "are compatible with" exposure to polychlorinated herbicides." Aff. 9 (emphasis supplied).
Similarly, unnamed studies of rats and primates convince him that the decreased reproductive capacity claimed by nine plaintiffs "would be compatible with known effects of polychlorinated herbicides." Aff. 12 (emphasis supplied).
Sixteen of the plaintiffs allege that they suffer from some form of cancer, including Hodgkin's Disease. Dr. Singer cites animal and industrial exposure studies that conclude that exposure to TCDD leads to cancer of the hard palate and the stomach, and increases the incidence of sarcomas and lymphomas. He also refers to a study allegedly conducted in North Vietnam between 1962 and 1968 which found an increased incidence of liver cancer, although he does not mention in which segment of the population. Cf. Frank, 13A Courtroom Medicine, § 24.30 at 24-12 ("[h]ematologic malignancies have been reported with pesticide exposure, but, since there have been no population-based studies, cause-and-effect relationship cannot be proven at this time.") (emphasis supplied). Based on these studies, Dr. Singer asserts that polychlorinated herbicides "would represent potential causative factors in the tumors claimed by the affiants." Aff. 10 (emphasis supplied).
Dr. Singer next turns to what may be broadly described as plaintiffs' dermatological difficulties: hair loss (93), rash (226), acne (105), and other skin problems such as peeling, hypopigmentation, and photosensitivity (211). Only two plaintiffs specifically mention chloracne, but Dr. Singer warns that it may be confused with acne without a careful physical examination. Mammals exposed to TCDD, Dr. Singer notes, have developed alopecia (baldness) and contact dermatitis (inflammation of the skin caused by allergy to a substance). Dr. Singer concludes: "Thus polychlorinated herbicide exposure may well constitute a cause of the dermalogic difficulties complained of by plaintiffs." (Emphasis supplied.)
Dr. Singer's final analysis focuses on 324 complaints of chronic sore throat, lymphadenopathy (simple enlargement of the lymph nodes), sinus congestion and inflammation. Dr. Singer attributes these problems to Agent Orange exposure. Animal studies have shown, he states, that polychlorinated herbicides may induce "thymic atrophy" in animals. Cf. J.E. Schmidt, 1-2 Attorneys' Dictionary of Medicine, at A-298 & T-52 (atrophy, a wasting away, is usually due to defective nutrition; the thymus may be a gland of internal secretion but its function is not understood). He also relies on animal studies finding a number of alterations in the immune system after exposure to TCDD: phytohemagghetining transformation of spleen cells, decline in serum globulin concentrations, increased sensitivity to bacterial endotoxins, depressed T-cell rosette formation, and delayed hypersensitivity. Although he does not reveal the dosage of TCDD involved in creating these aberrations in the functioning of the immune system, he concludes that they "could be contributing factor in the infectious symptoms experienced by some of the plaintiffs." (Emphasis supplied.)
As a review of Dr. Singer's affidavit reveals, he attributes some 37 separate diseases, disorders, and symptoms -- including baldness and diarrhea -- to exposure to Agent Orange. He mentions only two doubtful examples of chloracne and none of porphyria cutanea tarda, the two afflictions Conqress considered worthy of a statutory presumption of service connection, although not without reservations. See House Report, supra, reprinted in 1984 U.S. Code Cong. & Admin News 4447, at 4453 ("insufficient credible scientific evidence" that veterans exposed to Agent Orange suffer increased adverse health effects).
Stripped of its verbiage, Dr. Singer summarizes his overall conclusion by stating that if the affiants are telling the truth and if there is no cause for their complaints other than Agent Orange, then Agent Orange must have caused their problems. Dr. Singer states:
Assuming the truth of the affidavits submitted, and absent any evidence of preexisting, intervening, or superseding causes for the symptoms and diseases complained of in these affidavits, it is my opinion to a reasonable degree of medical probability (that is, more likely than not) that the medical difficulties described by the affiants were proximately caused by exposure to Agent Orange.
Put differently, Dr. Singer's analysis amounts to this: the affiants complain of various medical problems; animals and workers exposed to extensive dosages of TCDD have suffered from related difficulties; therefore, assuming nothing else caused the affiants' afflictions, Agent Orange caused them. One need hardly be a doctor of medicine to make the statement that if X is a possible cause of Y, and if there is no other cause of Y, X must have caused Y. Dr. Singer's formulation avoids the problem before us: which of myriad possible causes of Y created a particular veteran's problems. To take just one of the diseases reported by plaintiffs in an undifferentiated form, and relied upon by Dr. Singer, hepatitis: this is a disease common in the civilian population and there is not the slightest evidence that its incidence is greater among those exposed to Agent Orange than those not exposed. See e.g., J.E. Schmidt, 1 Attorney's Dictionary of Medicine H36-37 (1977) (listing various forms).
As section IV.A.3 will show, Dr. Singer's conclusory allegations lack any foundation in fact. His analysis, in addition to being speculative, is so guarded as to be worthless.
2. Dr. Epstein's Affidavits
Plaintiffs belatedly submitted affidavits by Dr. Samuel S. Epstein. He has been specially trained in the fields of pathology, bacteriology, and public health. He is currently Professor of Occupational and Environmental Medicine at University of Illinois Medical Center in Chicago. Among his 239 publications are a number of articles on the effects of exposure to 2, 3, 7, 8-tetrachlorodibenzo-paradioxin ("TCDD"). His credentials clearly suffice to qualify him as an expert pursuant to Rule 702 of the Federal Rules of Evidence.
Dr. Epstein submitted a general or master affidavit on the scientific literature on causation. This 65-page affidavit is substantially identical to an earlier brief submitted by plaintiffs dated September 18, 1984 in opposition to the motion for summary judgment -- some time before Dr. Epstein was retained on February 27, 1985. Dep. of Dr. Epstein at 14 (April 11, 1985). An extensive deposition of Dr. Epstein dated April 11, 1985 adds nothing of a substantive nature to the affidavit, but consists of a devastatingly successful showing of his lack of knowledge of the medical and other background of those on whose behalf he submitted affidavits.
Just as n plaintiffs' brief, Dr. Epstein reviews over one hundred epidemiological studies of the effects of TCDD on animals and on humans as a result of industrial accidents. These studies were submitted to the court and have been made a part of the record in the multidistrict litigation. They were discussed orally on the record during argument of the motion and rejected as virtually useless in establishing causation.
Dr. Epstein also relies on affidavits by Doctors Carnow, Silbergeld, and Singer which were separately submitted in the "opt-out" cases. None of these affidavits are helpful in supporting causation. The Carnow affidavit is discussed in the opinion granting summary judgment in Lilley v. Dow Chemical Co., F. Supp. (E.D.N.Y. 1985) (forthcoming). Dr. Epstein concludes that "a causal relationship exists between exposure to Agent Orange and a wide range of toxic multi-system and multi-organ effects." Aff. at 63.
The court has reviewed these and other like studies dealing with animal laboratory studies, industrial accidents, and other products. They suggest that dioxin may cause diseases in animals, including man. They are not correlated to those exposed to Agent Orange in Vietnam. At most, they collectively have the probative force of a scintilla of evidence.
Dr. Epstein also submitted fifteen individual affidavits of causation. In reaching conclusions with respect to the individual plaintiffs, he says that he generally relied upon their military service records, Veterans Administration medical records, and interview questionnaires, symptomology checklists, and affidavits completed by plaintiffs. See Attachments to Dr. Epstein's Deposition submitted as Appendix A to Defendants' Supplemental Memorandum in Opposition to Plaintiffs' Motion for Partial Summary Judgment and Reply Memorandum in Further Support of Defendants' Motion to Dismiss and/or for Summary Judgment, Dep. at 474 ff. Each affiant-plaintiff states in general terms that he was exposed to Agent Orange.
Each of the fifteen plaintiffs described by Dr. Epstein reports that he suffers from a number of diseases and has varying family histories and personal habits as follows: cancer of the ileum (family history of cancer; 1-1/2 packs of cigarettes per day); Hodgkin's Disease, coronary artery disease, cavernous angioma of the brain, bile duct microadenoma (no family history; infrequent smoker); chloracne, infertility (no family history; nonsmoker); brain cancer (family history of lung cancer; nonsmoker (now deceased)); malignant astrocytoma of the brain (no family history; smokes two packs of cigarettes per day); chronic hepatitis (no family history; nonsmoker; nondrinker; subsequent exposure to chlorinated hydrocarbon solvents); basil cell carcinoma of the skin (no family history; one pack of cigarettes per day); chronic hepatitis (no family history; one pack of cigarettes per day; moderate drinker); chloracne (no family history; two packs of cigarettes per day; moderate drinker; possible exposure to toxic substances at a sewage plant); squamous and basal cell carcinomas of the lip (no family history; cigarette smoker; alcohol consumption unknown); chronic hepatitis and child with multiple birth defects (no family history; current nondrinker with history of alcohol abuse); chloracne (no family history); chloracne (no family history; nonsmoker); carcinoma of the bladder (no family history; nonsmoker); cancer of the colon (nonsmoker).
In sum, Dr. Epstein attributes some fourteen different diseases and afflictions to exposure to Agent Orange of fifteen plaintiffs. Dr. Epstein's affidavits, even if considered timely, are insufficient to oppose the motion for summary judgment. All the diseases in the cases he relies upon are found in the general population of those who were never exposed to Agent Orange. There is no showing that the incidence of the diseases relied upon are greater in the Agent Orange-exposed population than in the population generally. It must be borne in mind that these are fifteen cases not taken at random but deliberately summitted because of their claims from a population of 2,400,000 who served in Vietnam.
A. Legal Standards Governing Expert Opinion
In determining whether an expert opinion is sufficient to withstand a summary judgment motion, courts undertake a detailed inquiry into the admissibility of the proffered testimony. In a case such as the one before us, Rules 102, 104(a), 401-403, 702-703 and 803(18) of the Federal Rules of Evidence control the inquiry. See Fed. R. Ev. 101; Weit v. Continental Illinois National Bank and Trust Co., 641 F.2d 457, 467 n.38 (7th Cir. 1981) (Rules of evidence apply to summary judgment motions), cert. denied, 455 U.S. 988, 102 S. Ct. 1610, 71 L. Ed. 2d 847 (1982). Rule 104(a) of the Federal Rules of Evidence requires a court to make a preliminary inquiry into the admissibility of expert testimony. See In re Japanese Electronic Products Antitrust Litigation, 723 F.2d 238, 260 (3d Cir. 1983) (In limine rulings on admissibility appropriate even when not required by Rule 104), cert. granted, 105 S. Ct. 1863 (1985). The preponderance of the evidence standard generally governs in such a determination. Cf. Lego v. Twomey, 404 U.S. 477, 484, 489, 92 S. Ct. 619, 624, 626, 30 L. Ed. 2d 618 (1972).
1. Admissibility of Epidemiological Studies
In a mass tort case such as Agent Orange, epidemiologic studies on causation assume a role of critical importance. Cf. In re Swine Flu Immunization Products Liability Litigation, 508 F. Supp. 897, 907 (D. Colo. 1981) ("[w]here * * * the exact organic cause of a disease cannot be scientifically isolated, epidemiologic data becomes highly persuasive."), aff'd sub nom. Lima v. United States, 708 F.2d 502 (10th Cir. 1983). Confronted with the reality of mass tort litigation, courts have been forced to abandon their traditional reluctance to rely upon epidemiological studies. Dore, "A Commentary on the Use of Epidemiological Evidence in Demonstrating Cause-in-Fact," 7 Harv. Envtl. L. Rev. 429 (1983).
Commentators have approved the growing judicial reliance on such scientific evidence. See, e.g., Black & Lilienfeld, "Epidemiologic Proof in Toxic Tort Litigation," 52 Ford. L. Rev. 732 (1984); Symposium on Science and the Rules of Evidence, 99 F.R.D. 187 (1983); Gianelli, "The Admissibility of Novel Scientific Evidence: Frye v. United States, a Half-Century Later," 80 Colum. L. Rev. 1197 (1980); Korn, "Law, Fact, and Science in the Courts," 66 Colum. L. Rev. 1080 (1966).
One vehicle for the admissibility of such studies has been Federal Rule of Evidence 803(8), the public records and reports exception to the hearsay rule. This exception is based upon our experience that public officials who are scientists generally perform their duties accurately and faithfully. Grant, "The Trustworthiness Standard for the Public Records and Reports Hearsay Exception," 12 W. State U. L. Rev. 53, 56 (1984); see also In re Japanese Electronic Products Antitrust Litigation, 723 F.2d 238, 265 (3d Cir. 1983) ("reports of investigations are presumed to be reliable."), cert. granted, 105 S. Ct. 1863 (1985). Subsection (8)(C) of the rule allows as evidence "factual findings resulting from an investigation made pursuant to authority granted by law, unless the sources of information or other circumstances indicate lack of trustworthiness." See City of New York v. Pullman, Inc., 662 F.2d 910, 914 (2d Cir. 1981) (discretion of trial court emphasized), cert. denied, 454 U.S. 1164, 102 S. Ct. 1038, 71 L. Ed. 2d 320 (1982).
A number of courts have found epidemiological studies conducted by the government sufficiently trustworthy. The Fourth Circuit recently held admissible under Rule 803(8)(C) epidemiological studies of toxic shock syndrome conducted by the Federal Centers for Disease Control and three state health departments. Ellis v. International Playtex, Inc., 745 F.2d 292 (4th Cir. 1984). The court noted that CDC and the state health departments used "uniform procedures and methods that are widely accepted by their peers" and carried out the studies in a timely and impartial manner. Id. at 301.
Plaintiffs have failed to show, under Rule 803(8)(C), that the various state and national studies averted to above were flawed. See also Kehm v. Procter & Gamble Mfg. Co., 724 F.2d 613, 617-20 (8th Cir. 1983) (affirming admissibility of CDC and state studies showing link between use of tampons and incidence of toxic shock syndrome; studies were timely, conducted in skillful manner and no motive probative of untrustworthiness present).
CDC epidemioloqical studies have been heavily relied upon in the swine flu cases. See e.q. In re Swine Flu Immunization Products Liability Litigation, 508 F. Supp. 897, 907 (D. Colo. 1981), aff'd sub nom. Lima v. United States, 708 F.2d 502 (10th Cir. 1983); see also Cook v. United States, 545 F. Supp. 306 (N.D. Cal. 1982); Migliorini v. United States, 521 F. Supp. 1210, 1218 (M.D. Fla. 1981); Heyman v. United States, 506 F. Supp. 1145 (S.D. Fla. 1981); cf. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1270 n.1 (5th Cir.) (CDC studies admitted to show incidence of polio), cert. denied, 419 U.S. 1096, 95 S. Ct. 687, 42 L. Ed. 2d 688 (1974).
In the Agent Orange litigation, the federal, state, and Australian government studies discussed above are on file having been subject to the court's judicial notice. In re "Agent Orange" Product Liability Litigation 603 F. Supp. 239, 246 (E.D.N.Y. 1985). These studies are reliable, and would be admitted under Rule 803(8)(C). Ellis v. International Playtex, Inc., 745 F.2d 292 (4th Cir. 1984). See also Black & Lilienfeld, "Epidemiologic Proof in Toxic Tort Litigation," 52 Ford. L. Rev. 732 (1984). Plaintiffs have made no objections to their admissibility and in fact rely specifically on the Ranch Hand Study in supporting their case for causation. See Tr. at 44 (Hearings on April 15, 1985).
The fact that the federal government was a defendant in related Agent Orange cases does not suggest a motive for untrustworthiness by the independent government scientists who conducted the studies. The Swine Flu cases cited supra found no such motive even though there the government was the defendant. Compare United States v. Esle, 743 F.2d 1465, 1474 (llth Cir. 1984) (affirming exclusion of market surveys where radio stations conducting them had motive to exaggerate number of Hispanic listeners). These epidemiological studies alone demonstrate that on the basis of present knowledge, there is no question of fact: Agent Orange cannot now be shown to have caused plaintiffs' numerous illnesses.
The parties, and especially plaintiffs, rely on over one hundred epidemiological studies not conducted by government officials and as such not subject to the 803(8)(C) exception. Such privately conducted studies may be admissible as learned articles under Rule 803(17) and some of them would qualify under Rule 803(6) and other exceptions to the hearsay rule. At trials, they are commonly analyzed under Rule 703 as a basis for expert opinion rather than as independently admissible. Cf. In re Japanese Electronic Products Antitrust Litigation , 723 F.2d 238, 275-84 (3d Cir. 1983) (discussing admissibility of privately conducted economic reports under Rules 702-703), cert. granted, 105 S. Ct. 1863 (1985).
Were they relevant, almost all of these privately conducted studies would be admitted as evidence-in-chief under a variety of the above hearsay exceptions, including Rules 803(24) and 804(5) (catchall exceptions based on need and general reliability). There is no need at this point to analyze them individually. Most of the studies rely on inapposite data and would be excluded under Rules 401 to 403. Some of them on industrial exposure have been recognized as flawed. See, e.g., Palmer v. Stora Kopparberqs Bergslags Aktiebolac (S. Ct. Nova Scotia, Sept. 23, 1983) (Nunn, J.), slip op. at 174-81 (refusing to enter injunction against spraying of 2-4-D, 2, 4, 5-T-phenoxy herbicides in part because expert studies, such as Hardell's, showing alleged adverse health effects were widely recognized as flawed).
The many studies on animal exposure to Agent Orange, even plaintiffs' expert concedes, are not persuasive in this lawsuit. In a jointly-authored article, Dr. Ellen K. Silbergeld writes that "laboratory animal studies * * * are generally viewed with more suspicion than epidemiological studies, because they require making the assumption that chemicals behave similarly in different species." Hall & Silbergeld, "Reappraising Epidemiology: A Reponse to Mr. Dore," 7 Harv. Envtl. L. Rev. 441, 442-43 (1983). Dr. Silbergeld further notes that "[a]nimal studies are aimed at discovering a dose-response relationship, while epidemiological studies show an association between exposure and disease." Id. at 443 n.18.
There is no evidence that plaintiffs were exposed to the far higher concentrations involved in both the animal and industrial exposure studies. Cf. In re "Aqent Orange" Product Liability Litigation, 597 F. Supp. 740, 782 (E.D.N.Y. 1984). The animal studies are not helpful in the instant case because they involve different biological species. They are of so little probative force and are so potentially misleading as to be inadmissible. See Fed. R. Ev. 401-403. They cannot be an acceptable ...