¹ PROSSER AND KEETON ON THE LAW OF TORTS 24, 357, 667 (5th ed. 1984).

² Surrick, , Punitive Damages and Asbestos Litigation in Pennsylvania: Punishment or Annihilation? , 87 DICK. L. REV. 265 (1983)Google Scholar; See In re Northern District of California “Dalkon Shield” IUD Products Liability Litigation, 526 F. Supp. 887 (N.D. Cal. 1981); In re “Agent Orange” Product Liability Litigation, 597 F. Supp. 740 (E.D.N.Y. 1984).

³ Schonberger, , Bregman, , Sullivan-Bolyai, , Keenlyside, , Ziegler, , Retailliau, , Eddins, & Bryan, , Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United States, 1976-1977, 110 AM. J. EPIDEMIOL. 105 (1979)CrossRefGoogle Scholar (hereinafter cited as Schonberger). For a complete history of the Swine Flu Act, see Bean v. United States, 533 F. Supp. 567 (D. Colo. 1980); Unthank v. United States, 533 F. Supp. 703 (D. Utah 1982). See also R. NEUSTADT AND H. FINEBERG, THE SWINE FLU AFFAIR: DECISION-MAKING ON A SLIPPERY DISEASE, UNITED STATES DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, 1978; Baynes, , Liability for Vaccine Related Injuries; Public Health Considerations and Some Reflections on the Swine Flu Experience, 21 ST. LOUIS U.L.J. 44 (1977).Google Scholar

⁴ The Agent Orange litigation is an example of a complex class action suit which could be resolved only in favor of the plaintiffs if the latter were treated as a class. The statistical inferences of causation are only valid when they refer to groups of individuals or when the event under study is catastrophic, as was the defective construction of the Pinto automobile. Agent Orange litigation began as a class action suit in 1979 and was finally resolved, after denial of certiorari by the United States Supreme Court, in 1984. See In re “Agent Orange” Prod. Liab. Litig., 506 F. Supp. 762 (E.D.N.Y. 1980), modified, 100 F.R.D. 718 (1983), mandamus denied, 725 F.2d 858 (2nd Cir. 1984), cert. denied, 465 U.S. 1067 (1984).

⁵ Sindell v. Abbot Laboratories, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132 (1980), cert. denied, 499 U.S. 912 (1980). See Surrick, supra note 2, for a discussion of issues surrounding the difficulty in identifying all defendants when the period of exposure occurred many years in the past. See also Hall v. Dupont, 345 F. Supp. 353 (E.D.N.Y. 1972). Thirteen plaintiffs (all children) sued six corporations, each of whom manufactured blasting caps. The children were injured in separate accidents. The court held that if the plaintiffs could prove, by a preponderance of the evidence, that one of the defendants manufactured the particular blasting cap that caused each injury, the burden would shift to the defendants, who would then be required to prove that their cap was not involved in the particular incident.

⁶ Sindell, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132. A market share case results where the court finds that a given noxious substance is the causative agent, but where the precise manufacturer(s) and distributor(s) cannot be identified. The court may then decide that equity demands that the known manufacturers be assessed a proportionate share of the damages based on their proportionate sales in the marketplace at the time the harm initially occurred. See also Note, Overcoming the Identification Burden in DES Litigation: The Market Share Liability Theory, 65 MARQ. L. REV. 609 (1982).Google Scholar

⁷ See Sindell, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132. A.H. Robins Company (the manufacturer of the Dalkon Shield) and Johns-Mansville, Inc. (a leading manufacturer of asbestos) have both filed for Chapter 11 bankruptcy protection. Therefore, thousands of plaintiffs who have already filed compensatory and punitive damage suits have no access to the corporate assets of these companies. In re Johns-Mansville Corp., 36 Bankr. 743 (Bankr. S.D.N.Y. 1984) provides a projection of Johns-Mansville's potential liability for both compensatory and punitive damages.

⁸ A. LILIENFELD & D. LILIENFELD, FOUNDATIONS OF EPIDEMIOLOGY (2nd ed. 1980). Epidemiology is the study of the incidence and prevalence of diseases with a community. (See infra notes 16 and 17 for operational definitions of incidence and prevalence, respectively). The discipline is concerned with the patterns of events affecting the health of human populations and the factors influencing these patterns. Data elements are specific demographic characteristics such as age, race, sex, height, weight, the dose exposure to a given substance, or the presence or absence of a particular medical sign (what is objectively recorded by an observer) or symptom (what is subjectively reported by the individual under study). These data elements are the basic.components of data files which are analyzed to produce probability statements about the likelihood of two or more events not occurring by chance. This correlation of historical and geographic pathology provides a mechanism for the expression of the relationship of disease to its probable etiologic (causative) agent(s). See generally Black, & Lilienfeld, , Epidemiologic Proof in Toxic Tort Litigation, 52 FORDHAM L. REV. 732, 733-34 nn.2 & 3 (1984)Google Scholar; M. ALDERSON, AN INTRODUCTION TO EPIDEMIOLOGY (1976); B. MACMAHON, T. PUGH & J. IPSEN, EPIDEMIOLOGIC METHODS (1960). See also A. EDWARDS, EXPERIMENTAL DESIGN IN PSYCHOLOGICAL RESEARCH, (3rd ed. 1968); D. SACKETT, R. HAYNES & P. TUGWELL, CLINICAL EPIDEMIOLOGY: A BASIC SCIENCE FOR CLINICAL MEDICINE (1985). Textbooks on clinical medicine, in general, and epidemiology, in particular, spend little time on the definition of epidemiology. Rather, entire works are often dedicated to illustrating the potential uses of epidemiologic data.

⁹ Hoffman, , The Use of Epidemiologic Data in the Courts, 120 AMER. J. EPIDEMIOL. 190 (1984).CrossRefGoogle Scholar

¹⁰ A. LILIENFELD & D. LIUENFELD, supra note 8, at 317.

¹¹ The numerator usually represents the number of cases identified as having the study condition in question. Thus, the ratio of numerator/denominator yields the rate of events under study in a given community. The rate per unit time is the incidence of the condition.

¹² The denominator usually represents the total community under study.

¹³ Validity is determined by examining whether what it is being studied is actually being measured. Validity testing requires the comparison of the instrument under consideration with a second, independent procedure which has already been established as an accurate measure of the variables in question. Face validity refers to a judgement that the new instrument makes sense to the investigator, who believes that it is measuring what it should be measuring.

¹⁴ Reliability refers to the ability of the study instrument or questionnaire to give consistent and reproductible results when used by different examiners at different points in time. This is particularly important when implementing a prospective study design or a collaborative study (multiple investigators at multiple sites).

¹⁵ An acute infection is easy to diagnose, especially if accompanied by a high fever. However, a major organ cancer, like cancer of the pancreas or liver, is diagnosed only when the individual, who may be feeling poorly for a period of time, finally seeks medical attention and undergoes the appropriate diagnostic tests, usually including a tissue biopsy. The period between feeling poorly and receiving a clinical diagnosis is the prodromal period.

¹⁶ Incidence refers to the rate of new cases that have occurred in a given time period. See infra note 41.

¹⁷ Prevalence, or point prevalence, refers to the proportion of the population who have a given disorder at a specified point in time. Lifetime prevalence is the number of individuals who have had a given condition, but who may not have it at present. The point prevalence data for pregnancy and lifetime prevalence of ever having been pregnant are illustrations of the distinction between these two types of prevalence.

¹⁸ The conclusions drawn from epidemiologic data are inferential. The data is objectively collected from scientifically drawn samples. The data elements, the individual values obtained from each subject in the study, have no putative behavior. In contrast, Comment b, Section 908 of the Restatement (Second) of Torts states that punitive damages are for “acts done with a bad motive or with a reckless indifference to the interest of others.” Punitive damages deal with intentional acts. See also McSparran v. Pennsylvania R.R. Co., 258 F. Supp. 130 (E.D. Pa. 1966). See M. ALDERSON, AN INTRODUCTION TO EPIDEMIOLOGY (1976); B. MACMAHON, T. PUGH & J. IPSEN, EPIDEMIOLOGIC METHODS (1960); see also A. EDWARDS, EXPERIMENTAL DESIGN IN PSYCHOLOGICAL RESEARCH (3rd ed. 1968); D. SACKETT, R. HAYNES & P. TUGWELL, CLINICAL EPIDEMIOLOGY: A BASIC SCIENCE FOR CLINICAL MEDICINE 3-15 (1985); A. LILIENFELD & D. LILIENFELD, supra note 8.

¹⁹ Relative risk ratios compare two groups, one with the risk factor, and the other without. This type of measurement has been a powerful tool in the Dalkon Shield and toxic shock syndrome cases. In both cases there were other products on the market which were used for a similar purpose. The users of the analogous products became comparison groups. The control groups were composed of those who had neither used the products in question nor the analogous products.

²⁰ An odds ratio portrays the relative risk in case-control (case-comparison) studies. A ease-comparison study involves previously diagnosed individuals, rather than a population of potential cases (case-control study). Comparison groups must be drawn from the same population or universe. For instance, comparing Air Force servicemen not exposed to Agent Orange to those who claimed to have been injured as a result of their exposure to the pesticide is an example of a case-comparison study. The comparison group must be drawn in such a manner as to eliminate the effect of extraneous variables.

²¹ Chan, , Primary Carcinoma of the Liver, 59 MED. CLIN. N. AM. 989 (1975).CrossRefGoogle Scholar

²² Industrial Union Dep't, AFL-CIO v. American Petroleum Inst., 448 U.S. 607 (1980) (the benzene standard case).

²³ Id. at 608.

²⁴ Id. at 607.

²⁵ Id. at 635-36, 656.

²⁶ Id. at 656. See also Davis v. Wyeth, 399 F.2d 121 (9th Cir. 1968), where the court held that a duty to warn existed even where the probability of contracting poliomyelitis was only one in a million.

²⁷ 736 F.2d 1529 (D.C. Cir. 1984).

²⁸ Id. at 1531-32.

²⁹ Id. at 1535.

³⁰ Id. at 1536 (citations omitted).

³¹ Id. at 1535-36.

³² Id.

³³ Id. at 1536.

³⁴ The National Swine Flu Immunization Program of 1976, 42 U.S.C. § 247b(j)-(l). Sections 247b(k)(2)(A) and (3) specifically indicate that the government, and not the manufacturer, will be liable for most claims arising as a result of the swine flu vaccination program. The manufacturer could provide the vaccine to the government knowing its liability did not extend beyond the requirement to follow the Good Manufacturing Practices (GMP) of the Food and Drug Administration (FDA) for the vaccines. See also infra note 41.

³⁵ Schonberger, supra note 3.

³⁶ Id.

³⁷ The original data has been re-analyzed and extensively reviewed. See Langmuir, , Bregman, , Kurland, , Nathanson, & Victor, , An Epidemiologic and Clinical Evaluation of Guillain-Barre Syndrome Reported in Association with the .Administration of Swine Influenza Vaccines, 119 AM. J. EPIDEMIOL. 841 (1984)CrossRefGoogle Scholar. This analysis was a direct result of the individual patient records (redacted to maintain anonymity of identity) made available under a court order issued by Judge Gesell. See Varga v. United States, 566 F. Supp. 987 (N.D. Ohio 1983).

³⁸ Schonberger, supra note 3.

³⁹ Id.

⁴⁰ Alvarez v. United States, 495 F. Supp. 1188 (D. Colo. 1980); Thompson v. United States, 533 F. Supp. 581 (N.D. Okla. 1981); Padgett v. United States, 553 F. Supp. 794 (W.D. Tex. 1982); O'Gara v. United States, 560 F. Supp. 786 (E.D. Pa. 1983).

⁴¹ In each case the plaintiffs sought to recover for personal injuries which they alleged were caused by the swine flu vaccine. Their claims arose under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b) & 2671-2680 (1982), as incorporated by the National Swine Flu Immunization Program of 1976, 42 U.S.C. § 247b(j)-(l) (1976). The United States government assumed liability for most personal injuries or deaths arising from the administration of the swine flu vaccine. In each case the primary issues were whether the plaintiff actually had a diagnosed case of Guillain-Barre Syndrome (GBS), and if so, whether the swine flu vaccine caused the condition.

⁴² In re “Agent Orange” Prod. Liab. Litig., 597 F. Supp. 740, 752, 759 (E.D.N.Y. 1984).

⁴³ Id. at 746-47.

⁴⁴ In re “Agent Orange” Prod. Liab. Litig., 100 F.R.O. 718, 723 (E.D.N.Y. 1983).

⁴⁵ Id.

⁴⁶ 597 F. Supp. at 755-57.

⁴⁷ Id. at 854.

⁴⁸ Id.

⁴⁹ Adenosis and clear cell adenocarcinoma of the vagina and uterus have been associated with DES. These tumors are almost unknown among women whose mothers had never consumed DES. Ulfelder, , The Stilbestrol Adenosis Carcinoma Syndrome, 38 CANCER 426 (1976)3.0.CO;2-I>CrossRefGoogle Scholar; see also Comment, DES and a Proposed Theory of Enterprise Liability, 46 FORDHAM L. REV. 963, 965 (1978)Google Scholar. Asbestosis is allegedly found only in individuals exposed to dust containing asbestos. See Borel v. Fibreboard Paper Prods. Corp., 493 F.2d 1076, 1083 (5th Cir. 1973), cert. denied, 419 U.S. 869 (1974).

⁵⁰ Id. at 817.

⁵¹ 597 F. Supp. at 834.

⁵² Id.

⁵³ Rosenberg, , The Causal Connection in Mass Exposure Cases: A “Public Law” Vision of the Tort System, 97 HARV. L. REV. 849, 856-57 (1984).CrossRefGoogle Scholar

⁵⁴ 597 F. Supp. at 752, 759.

⁵⁵ See supra note 42-45 and accompanying text.

⁵⁶ 597 F. Supp. at 835.

⁵⁷ See Jackson v. Johns-Mansville Sales Corp., 727 F.2d 506, 516 (5th Cir. 1984).

⁵⁸ C. MCCORMICK, MCCORMICK ON EVIDENCE § 339 (2nd ed. 1972).

⁵⁹ E. MORGAN, BASIC PROBLEMS OF EVIDENCE 24 (4th ed. 1963).

⁶⁰ 597 F. Supp. at 785. See M.P. ANDERSON, AN INTRODUCTION TO EPIDEMIOLOGY 128-31 (1976); see also A. LILIENFIELD & D. LILIENFIELD, supra note 8.

⁶¹ Rosenberg, supra note 53, at 851; see alsoSantosky v. Kramer, 455 U.S. 745, 755 (1982).

⁶² 597 F. Supp. at 783. Also, if the toxic substance caused the incidence of the injury to rise more than 100% above background, that is double, the plaintiffs could recover. A Lesser increase would indicate that the probability of specific causation was not more than 50%.

⁶³ 597 F. Supp. at 740 (the final settlement and creation of a plaintiffs’ fund resulted from this case). The Agent Orange litigation was settled in favor of the plaintiffs. Two epidemiologic studies, one completed and one in progress at the time of the Agent Orange products liability settlement, were the basis for the resolution. They are briefly reviewed to reveal the limited usefulness of epidemiologic data in the courtroom. The completed study, Air Force Health Study, An Epidemiologic Investigation of Health Effects in Air Force Personnel Following Exposure to Herbicides (February 24, 1984), is known as “Ranch Hand.” The Ranch Hand Study involved a pairing of 1,024 “ranch hands” (operators of U.S. Air Force fixed wing aircraft used to spray herbicides over the jungles of Viet Nam) with demographically similar individuals not known to be exposed to Agent Orange. The summary of the study stated, “[t]his baseline report concludes that there is insufficient evidence to support a cause and effect relationship between herbicide exposure and adverse health consequences in the Ranch Hand group, at this point in time.” 597 F. Supp. at 788 (quoting Ranch Hand Study at iii). There is a fundamental weakness in the study, however. The data from the Ranch Hand Study may not be generalizable to Army or Marine Corps troops serving as ground forces while Agent Orange was being sprayed into the environment around them. Air Force personnel operating in fixed wing aircraft had access to showers and clean clothes subsequent to each air mission. It is unlikely that ground troops operationally deployed enjoyed these amenities. Primarily due to this critical difference in potential continuous exposure, the report indicated in its summary that the results of the Ranch Hand Study will reassure Air Force personnel, but will offer “no solace to either defendants or plaintiffs in the instant litigation. It simply seems inconclusive.” 597 F. Supp. at 788.

The second study is being conducted by the Centers of Disease Control (CDC), Atlanta, Georgia rather than the Veteran's Administration (VA). If Agent Orange were found to have caused significant morbidity among servicepersons stationed in Southeast Asia, the resulting injuries would be considered service-connected disabilities. Therefore, the servicepersons would be entitled to free medical care in VA facilities. This would cost the VA system additional funds, and more importantly, the use of limited beds and professional personnel.

The proposed length of the CDC study is approximately 69 months. Due to the fact that almost six years were required for the adequate collection of data from a stratified sample of servicepersons, the court felt inclined to complete the litigation before the definitive epidemiologic data was available. Although the decision to complete the litigation was based on many humane considerations, the court did not address an important pragmatic issue when it insisted that the settlement of this mass tort litigation occur now, rather than in the 1990s. The court appears to have feared that the prospective study would result in inconclusive data. Neither side could have tolerated such a result. Thus, despite careful planning and implementation, the very nature of the critical prospective study precluded its utility in the resolution of the Agent Orange litigation. See 597 F. Supp. at 788-89.

Large scale epidemiologic studies have proved useful in delimiting liability, where the populations under study have been well defined and the clinical endpoints better established. This is not the case with the Agent Orange studies.

⁶⁴ 597 F. Supp. at 835.

⁶⁵ Id.

⁶⁶ Id.

⁶⁷ 597 F. Supp. at 835. Anecdotal or particularistic evidence involves the testimony of an expert witness who indicates that the specific plaintiff was injured by a product manufactured by a specific defendant. This occurred in Reves v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974).

⁶⁸ Rosenberg, supra note 53, at 870.

⁶⁹ 597 F. Supp. at 836.

⁷⁰ 498 F.2d 1264 (5th Cir. 1974), cert. denied, 419 U.S. 1096.

⁷¹ Id.

⁷² There are two types of poliomyelitis vaccine. The Salk vaccine used dead viral material to stimulate the immune system. The trivalent Sabin vaccine used viruses which were still alive, but minimally potent. Therefore, it is possible to argue that the viruses were more active than they should have been, and the child was actually being exposed to an illness-causing virus.

⁷³ 498 F.2d at 1284.

⁷⁴ 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert. denied, 449 U.S. 912 (1980).

⁷⁵ Gray v. United States, 445 F. Supp. 337 (S.D. Tex. 1978); McCreery v. Eli Lilly & Co., 87 Cal. App. 3d 77, 150 Cal. Rptr. 730 (1978).

⁷⁶ 33 Cal. 2d 80, 199 P.2d 1 (1948).

⁷⁷ Id. at 86, 199 P.2d at 4.

⁷⁸ Id. at 85, 199 P.2d at 3.

⁷⁹ 25 Cal. 2d 486, 154 P.2d 687 (1944).

⁸⁰ Id. at 492, 154 P.2d at 690.

⁸¹ Id.

⁸² 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132 (1980), cert. denied, 499 U.S. 912 (1980).

⁸³ Id. at 610-11, 607 P.2d at 936, 163 Cal. Rptr. at 144.

⁸⁴ Id. at 600-01, 607 P.2d at 929-30, 163 Cal. Rptr. at 137-38. The damage is not to the patient who ingests the drug but rather to her daughter at the time she reaches early child-bearing age, at approximately age 18.

⁸⁵ Id. at 598, 607 P.2d 928, 163 Cal. Rptr. at 136.

⁸⁶ Schaffer v. Honeywell, 249 N.W.2d 251, 256 (S.D. 1976).

⁸⁷ Note, supra note 6, at 610.

⁸⁸ Id. at 611 n.16.

⁸⁹ Id. at 609.

⁹⁰ Id.

⁹¹ Id.

⁹² 167 Cal. App. 3d 878, 213 Cal. Rptr. 547 (1985) (as modified May 17, 1985).

⁹³ Fleet v. Hollenkemp, 52 Ky. (13 B. Mon.) 219 (1852) (punitive damages were awarded where the case involved the sale of an adulterated drug).

⁹⁴ Owen, , Problems in Assessing Punitive Damages Against Manufacturers of Defective Products, 49 U. CHI. L. REV. 1, 21 (1982)CrossRefGoogle Scholar. Professor Owen argues for establishment of a standard of liability based upon the defendant's “flagrant indifference to the public safety.” Owen, , Punitive Damages in Products Liability Litigation, 74 MICH. L. REV. 1257, 1367 (1976).CrossRefGoogle Scholar

⁹⁵ Note, supra note 6, at 610.

⁹⁶ Id. Comment b, Section 908, Restatement (Second) of Torts states that punitive damages are for “acts done with a bad motive or with a reckless indifference to the interest of others.”

⁹⁷ 167 Cal. App. 3d 878, 213 Cal. Rptr. 547.

⁹⁸ Id. at 889-90, 213 Cal. Rptr. at 554.

⁹⁹ CAL. CIV. CODE § 3294 (West 1970) provides in part:

• (a) In an action for the breach of an obligation not arising from contract, where the defendant has been guilty of oppression, fraud, or malice, the plaintiff, in addition to the actual damages, may recover damages for the sake of example and by way of punishing the defendant.

• (c)(1) ‘Malice’ means conduct which is intended by the defendant to cause injury to the plaintiff or conduct which is carried on by the defendant with a conscious disregard of the rights or safety of others.

• (2) ‘Oppression’ means subjecting a person to cruel and unjust hardship in conscious disregard of that person's rights.

¹⁰⁰ 167 Cal. App. 3d at 890, 213 Cal. Rptr. at 554.

¹⁰¹ Id. at 887, 213 Cal. Rptr. at 552-53.

¹⁰² Supra note 18.

¹⁰³ Magallanes, 167 Cal. App. 3d at 878, 213 Cal. Rptr. at 547.

¹⁰⁴ Gyre v. Dayton-Hudson Corp., 297 N.W.2d. 727 (Minn. 1980), cert. denied, 449 U.S. 921 (1980). Gyre involved a strict liability claim against a manufacturer of cotton flannel used in the production of children's sleepwear. The court held that punitive damages could be awarded in cases of strict liability. In Gyre, the defendant failed to object to the trial court's instruction to the jury on the issue of punitive damages. The instruction, therefore, became the law of the case and was not subject to review on appeal. The court awarded punitive damages based on the finding that the Dayton-Hudson Corp. manufactured a defective product and that the parents of the injured child were unaware of the defect: flammability. The court cited Professor Owen as authority that punitive damages are an appropriate remedy in such cases. See also Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (3rd Cir. 1973); Gillham v. Admiral Corp., 523 F.2d 102 (6th Cir. 1975), cert. denied, 424 U.S. 913 (1976); Boehm v. Fox, 473 F.2d 445 (10th Cir. 1973); Maxey v. Freightliner Corp., 450 F. Supp. 955 (N.D.Tex. 1978); Moore v. Jewel Tea Co., 116 Ill. App. 2d 109, 253 N.E.2d 636 (1969), aff'd, 46 Ill. 2d 288, 263 N.E.2d 103 (1970). But see Roginsky v. Richardson-Merrell, Inc., 378 F.2d 832 (2nd Cir. 1967).

¹⁰⁵ Sindell, 26 Cal. 3d at 588, 607 P.2d 924, 163 Cal. Rptr. 132; Hall v. Dupont, 345 F. Supp. 353 (E.D.N.Y. 1972); Surrick, supra note 2, at 265.

¹⁰⁶ Sindell, 26 Cal. 3d at 610-11, 607 P.2d at 936, 163 Cal. Rptr. at 144.