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Preconception Tort Liability: Recognizing a Strict Liability Cause of Action for DES Grandchildren

Published online by Cambridge University Press:  24 February 2021

Marisa L. Mascaro
Marisa L. Mascaro*
Affiliation:
A.B. Princeton University, anticipated May 1992, Boston University School of Law
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Abstract

Over the past decade more than 1,000 "DES daughters" have filed lawsuits against the manufacturers of DES, alleging that their in utero exposure to the drug caused various reproductive tract abnormalities, including cancer. Plaintiffs now allege that their grandmothers' use of DES during pregnancy caused genetic damage leading to cancer in third generations. This Note addresses the validity of preconception tort liability in the context of third-generation DES cases. Plaintiffs in preconception tort liability cases have sought recovery under both negligence and strict liability causes of action. Courts should recognize the validity of preconception tort liability and allow a strict liability cause of action in third-generation cases.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 17 , Issue 4 , 1991 , pp. 435 - 455
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1991

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References

1 STEDMAN's MEDICAL DICTIONARY 434 (25th ed. 1990).

2 Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 502, 539 N.E.2d 1069, 1072, 541 N.Y.S.2d 941, 944 (1989), cert, denied, 110 S. Ct. 350 (1990); DES Suit New Threat to Makers, 237 CHEMICAL MARKETING REP., Mar. 19, 1990, at 7, 9 [hereinafter DES Suit Threat].

3 See infra text accompanying note 84.

4 Hymowitz, 73 N.Y.2d 487 at 503, 539 N.E.2d at 1072, 541 N.Y.S.2d at 944.

5 N.Y. Times, May 17, 1977, at 18, col. 2.

6 Marcotte, DES Legacy: Suit Claims Grandchild of Woman Who Took Drug Was Harmed, A.B.A.J., June 1990, at 14; Okie, Link Alleged in Girl's Cancer, Grandmother's Use of Drug DES, Wash. Post, Mar. 11, 1990, at A4.

7 Mr. Roberts’ mother took DES for the “entire nine months” of her pregnancy. Okie, supra note 6.

8 By 1947, Eli Lilly was aware of studies which indicated that DES posed the threat of cancer to the user, that DES could cross the placental barrier and that DES had caused malformations in the offspring of pregnant mice. In addition, by the early 1950s, studies indicated that DES was ineffective in preventing miscarriages. Bichler v. Eli Lilly & Co., 79 A.D.2d 317, 322-23, 436 N.Y.S.2d 625, 629 (N.Y. App. Div. 1981), aff'd, 55 N.Y.2d 571, 586, 436 N.E.2d 182, 189, 450 N.Y.S.2d 776, 783 (1982).

When DES manufacturers first marketed the drug for the purpose of preventing miscarriages, the FDA only required them to submit proof of the drug's safety. Comment, DES and A Proposed Theory of Enterprise Liability, 46 FORDHAM L. REV. 963, 966 n.12 (1978) [hereinafter Comment, DES and Enterprise Liability] (citing Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, § 505(b), 52 Stat. 1052 (1938)). In 1962, Congress amended the Act to require proof of effectiveness as well. Id. (citing Act of Oct. 10, 1962, Pub. L. No. 87-781, 76 Stat. 781 (codified at 21 U.S.C. § 355 (1970))). In the late 1960s, the FDA sponsored a study to review the effectiveness of all drugs which it approved before the 1962 Amendment. The study rated the drugs as follows: effective, probably effective, possibly effective and ineffective. Id. (citing NATIONAL RESEARCH COUNCIL, NATIONAL ACADEMY OF SCIENCES, DRUG EFFICACY STUDY 7 (1969) [hereinafter DRUG EFFICACY STUDY]). The designation “possibly effective” indicated that “there is little evidence of effectiveness under any of the criteria stated[.]” Id. (citing DRUG EFFICACY STUDY, supra, at 42). In 1971, the study rated DES as “possibly effective” for preventing the accidents of pregnancy. Although at that time the FDA allowed drugs to be sold for their “possibly effective” purposes, the known hazards of DES outweighed these purposes. Id. (citing 36 Fed. Reg. 21,537 (1971)). The FDA now prohibits drugs to be sold for their “possibly effective” indications. Id. (citing 38 Fed. Reg. 26,824 (1973)). See infra text acccompanying notes 81-83.

9 DES Suit Threat, supra note 2, at 7. Second-generation DES cases, those filed by “DES daughters,” differ from third-generation DES cases in that the former involve prenatal tort liability while the latter involve preconception tort liability.

10 See Sorrells v. Eli Lilly & Co., 737 F. Supp. 678 (D.D.C 1990) (dismissing preconception claim); Enright v. Eli Lilly & Co., 77 N.Y.2d 377, 570 N.E.2d 198, 568 N.Y.S.2d 550 (1991) (dismissing preconception claim).

11 See Sorrells, 737 F. Supp. at 678; Enright, 77 N.Y.2d at 381, 570 N.E.2d at 199, 568 N.Y.S.2d at 551.

12 As used in this Note, the phrase “preconception tort liability” refers only to those situations in which the defendant's tortious actions prior to the plaintiff's conception result in harm to the infant plaintiff. This Note does not address the related subject of wrongful birth. For a more complete discussion of that topic, see generally Robertson, Toward Rational Boundaries of Tort Liability for Injury to the Unborn: Prenatal Injuries, Preconception Injuries and Wrongful Life, 1978 DUKE L.J. 1401.

13 A prenatal tort exists when an individual tortiously inflicts physical injury, through the body of the mother, upon a fetus. W. KEETON, PROSSER AND KEETON ON TORTS 367 (5th ed. 1984). See infra text accompanying notes 16-31.

14 Under a negligence cause of action, the plaintiff must show the following: (1) the existence of a duty; (2) a breach of that duty; (3) a causal connection between the conduct breaching the duty and the resulting injury; and (4) actual loss or damage resulting to another. W. KEETON, supra note 13, at 164-65.

15 Under a strict liability cause of action, one can be liable without either committing an intentional wrong or a negligent action. For this reason, commentators often refer to it as liability without fault. Id. at 534. Under a strict liability cause of action,

  • (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property … .

  • (2) [This] rule … applies although

  • (a) the seller has exercised all possible care in the preparation and sale of his product, and

  • (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. RESTATEMENT (SECOND) OF TORTS § 402A (1965).

16 3 E. COKE, THE THIRD PART OF THE INSTITUTES OF THE LAWS OF ENGLAND 50 (1628 & photo reprint 1979); 1 W. BLACKSTONE, COMMENTARIES * 129-30.

17 1 W. BLACKSTONE, supra note 16, at *130.

18 See Wolfe v. Isbell, 291 Ala. 327, 280 So. 2d 758 (1973); Mace v. Jung, 210 F. Supp. 706 (D. Alaska 1962); Summerfield v. Superior Court, 144 Ariz. 467, 698 P.2d 712 (1985); Norland v. Washington Gen. Hosp., 461 F.2d 694 (8th Cir. 1972) (Arkansas); Wilson v. Kaiser Found. Hosp., 141 Cal. App. 3d, 190 Cal. Rptr. 649 (Cal. Ct. App. 1983); Continental Casualty Co. v. Empire Casualty Co., 713 P.2d 384 (Colo. Ct. App. 1985); Simon v. Mullin, 34 Conn. Supp. 139, 380 A.2d 1353 (Conn. Super. Ct. 1977); Worgan v. Greggo & Ferrara, Inc., 50 Del. 258, 128 A.2d 557 (Del. Super. Ct. 1956); Bonbrest v. Kotz, 65 F. Supp. 138 (D.D.C. 1946); Day v. Nationwide Mut. Ins. Co., 328 So. 2d 560 (Fla. Dist. Ct. App. 1976); OB-GYN Associates v. Littleton, 259 Ga. 663, 386 S.E.2d 146 (1989); Volk v. Baldazo, 103 Idaho 570, 651 P.2d 11 (1982); Stallman v. Youngquist, 152 Ill. App. 3d 683, 504 N.E.2d 920 (Ill. App. Ct. 1987); Cowe v. Forum Group, Inc., 541 N.E.2d 962 (Ind. Ct. App. 1989); Lambert v. Sisters of Mercy Health Corp., 369 N.W.2d 417 (Iowa 1985); Hale v. Manion, 189 Kan. 143, 368 P.2d 1 (1962); Orange v. State Farm Mut. Auto. Ins. Co., 443 S.W.2d 650 (Ky. 1969); Vicknair v. Hibernia Bldg. Corp., 482 So. 2d 95 (La. Ct. App. 1986); Group Health Assoc, v. Blumenthal, 295 Md. 104, 453 A.2d 1198 (1983); Payton v. Abbott Laboratories, 386 Mass. 540, 437 N.E.2d 171 (1982); O'Neal v. Annapolis Hosp., 183 Mich. App. 281, 454 N.W.2d 148 (Mich. Ct. App. 1990); Masden v. Park Nicollet Medical Center, 419 N.W.2d 511 (Minn. Ct. App. 1988); Reynolds v. West, 237 Miss. 613, 115 So. 2d 742 (1959); Bergstreser v. Mitchell, 448 F. Supp. 10 (E.D. Mo. 1977); White v. Yup, 85 Nev. 527, 458 P.2d 617 (1969); Bennett v. Hymers, 101 N.H. 483, 147 A.2d 108 (1958); Gleitman v. Cosgrove, 49 N.J. 22, 227 A.2d 689 (1967); Davila v. Bodelson, 103-N.M. 243, 704 P.2d 1119 (N.M. Ct. App. 1985); Duffey v. Fear, 121 A.D.2d 928, 505 N.Y.S.2d 136 (N.Y. App. Div. 1986); Bridges v. Shelby Women's Clinic, 72 N.C. App. 15, 323 S.E.2d 372 (N.C. Ct. App. 1984); Hopkins v. McGee, 359 N.W.2d 862 (N.D. 1984); Peterson v. Nationwide Mut. Ins. Co., 175 Ohio St. 551, 197 N.E.2d 194 (1964); Evans v. Olson, 550 P.2d 924 (Okla. 1976); Mallisson v. Pomeroy, 205 Or. 690, 291 P.2d 225 (1955); Hudak v. Georgy, 390 Pa. Super. 14, 567 A.2d 1095 (Pa. Super. Ct. 1989); Labree v. Major, Ill R.I. 657, 306 A.2d 808 (1973); Phillips v. United States, 566 F. Supp. 1 (D.S.C. 1981); Wheelden v. Madison, 374 N.W.2d 367 (S.D. 1985); Tate v. Eli Lilly & Co., 522 F. Supp. 1048 (D. Tenn. 1981); Delgado v. Yandell, 468 S.W.2d 475 (Tex. Civ. App. 1971); Reiser v. Lohner, 641 P.2d 93 (Utah 1983); Kalafut v. Gruver, 239 Va. 278, 389 S.E.2d 681 (1990); Vaillancourt v. Medical Center Hosp., 139 Vt. 138, 425 A.2d 92 (1980); Young v. Group Health Coop., 85 Wash. 2d 332, 534 P.2d 1349 (1975); Panagopoulous v. Martin, 295 F. Supp. 220 (D.W. Va. 1969); Kwaterski v. State Farm Mut. Auto. Ins. Co., 34 Wis. 2d 14, 148 N.W.2d 107 (1967).

19 Dietrich v. Inhabitants of Northampton, 138 Mass. 14 (1884).

20 Id. at 15, 16.

21 Id. at 16.

22 Id. at 16-17.

23 Allaire v. St. Luke's Hosp., 184 Ill. 359, 56 N.E. 638 (1900).

24 Id. at 367-68, 56 N.E. at 640.

25 Id. at 374, 56 N.E. at 642 (Boggs, J., dissenting). Viability is the stage of development at which a fetus can survive independently of its mother. See STEDMAN's MEDICAL DICTIONARY 1714 (25th ed. 1990); see also infra text accompanying notes 32-42.

26 Bonbrest v. Kotz, 65 F. Supp. 138 (D.D.C. 1946).

27 Id. at 139.

28 Id. at 142.

29 Allaire, 184 Ill. at 374, 56 N.E. at 642 (Boggs, J., dissenting).

30 See Bonbrest, 65 F. Supp. at 140; see also Note, Preconception Negligence: Reconciling an Emerging Tort, 67 GEO. L.J. 1239, 1246 (1979) [hereinafter Note, Preconception Negligence] (arguing that the Bonbrest court relied upon Justice Boggs’ dissent in Allaire).

31 However, many jurisdictions limit this right by requiring that the fetus be viable at the time of injury. Comment, Legal Duty to the Unborn Plaintiff: Is There a Limit?, 6 FORDHAM URB. L.J. 217, 229-30 (1978) [hereinafter Comment, Duty to Unborn Plaintiff].

As a result of this widespread recognition of prenatal tort liability, manufacturers are now taking precautions to limit their future liability. See International Union, UAW v. Johnson Controls, 886 F.2d 871 (7th Cir. 1989) (en banc), cert, granted, 110 S. Ct. 1522 (1990), rev'd, 111 S. Ct. 1196(1991).

32 Bonbrest, 65 F. Supp. at 142.

33 E.g., Renslow v. Mennonite Hosp., 67 Ill. 2d 348, 367 N.E.2d 1250 (1977) (criticizing the viability standard, stating that viability depends upon many factors, including the health of the mother and fetus, the length of the pregnancy, the weight of the fetus, the race of the fetus and the availability of life-sustaining techniques); Smithy. Brennan, 31 N.J. 353, 157 A.2d 497 (1960) (rejecting the viability standard as having no relevance to the justice of denying recovery for harm which can be proven to have resulted from the wrongful act of another).

34 Renslow, 67 111. 2d at 352-53, 367 N.E.2d at 1252-53.

35 Problems arise when a child seeks to hold its parents, rather than a third-party tortfeasor, liable for prenatal injury. One commentator suggests that courts should recognize a child's claim against its parents for prenatal injury in order to protect fully the fetus’ rights. Note, Preconception Negligence, supra note 30, at 1260-61. This suggestion, however, has dangerous implications for a woman's right to privacy with respect to abortion. See Roe v. Wade, 410 U.S. 113, 163 (1973), in which the Court's trimester analysis relies on the viability standard. The third-party tortfeasor distinction is crucial because it protects the fetus without restricting a woman's right to an abortion.

36 Note, Preconception Negligence, supra note 30, at 1247.

37 Note, The Impact of Medical Knowledge on the Law Relating to Prenatal Injuries, 110 U. PA. L. REV. 554, 563 (1962).

38 4C L. GORDY & R. GRAY, ATTORNEY's TEXTBOOK OF MEDICINE § 311.00 (3d ed. 1991).

39 Allaire v. St. Luke's Hosp., 184 Ill. 359, 370, 56 N.E. 638, 641 (1900) (Boggs, J., dissenting).

40 Note, Preconception Negligence, supra note 30, at 1246-47.

41 Id. at 1247.

42 Comment, Duty to Unborn Plaintiff, supra note 31, at 232. Currently, 16 jurisdictions recognize the fetus’ right to a cause of action in tort only when the fetus is viable: Wolfe v. Isbell, 291 Ala. 327, 280 So. 2d 758 (1973); Mace v. Jung, 210 F. Supp. 706 (D. Alaska 1962); Summerfield v. Superior Court, 144 Ariz. 467, 698 P.2d 712 (1985); Worgan v. Greggo & Ferrara, Inc., 50 Del. 258, 128 A.2d 557 (Del. Super. Ct. 1956); Bonbrest v. Kotz, 65 F. Supp. 138 (D.D.C. 1946); Volk v. Baldazo, 103 Idaho 570, 651 P.2d 11 (1982); Hale v. Manion, 189 Kan. 143, 368 P.2d 1 (1962); Orange v. State Farm Mut. Auto. Ins. Co., 443 S.W.2d 650 (Ky. 1969); Hopkins v. McGee, 359 N.W.2d 862 (N.D. 1984); Peterson v. Nationwide Mut. Ins. Co., 175 Ohio St. 551, 197 N.E.2d 194 (1964); Evans v. Olson, 550 P.2d 924 (Okla. 1976); Mallisson v. Pomeroy, 205 Or. 690, 291 P.2d 225 (1955); Hudak v. Georgy, 390 Pa. Super. 14, 567 A.2d 1095 (Pa. Super. Ct. 1989); Wheelden v. Madison, 374 N.W.2d 367 (S.D. 1985); Vaillancourt v. Medical Center Hosp., 139 Vt. 138, 425 A.2d 92 (1980); Panagopoulous v. Martin, 295 F. Supp. 220 (D.W. Va. 1969); Kwaterski v. State Farm Mut. Auto. Ins. Co., 34 Wis. 2d 14, 148 N.W.2d 107 (1967).

43 This Note does not discuss cases involving wrongful birth.

44 Jorgensen v. Meade Johnson Laboratories, 483 F.2d 237 (10th Cir. 1973).

45 Id. at 238.

46 Jorgensen v. Meade Johnson Laboratories, 336 F. Supp. 961 (W.D. Okla. 1972).

47 Jorgensen, 483 F.2d at 240.

48 Renslow v. Mennonite Hosp., 67 Ill. 2d 348, 367 N.E.2d 1250 (1977).

49 Id. at 350, 367 N.E.2d at 1251. The negligence resulted from the transfusion of an incompatible blood type. Id.

50 Id. at 359, 367 N.E.2d at 1256.

51 Id. at 357, 367 N.E.2d at 1255.

52 See id. at 357, 367 N.E.2d at 1254-55. Courts have recognized transferred negligence in analogous situations. Plaintiffs use the theory in derivative actions for the loss of services of a spouse or child. The theory suggests that a wrong to one person may invade the protected rights of another. Prosser, Pakgraf Revisited, 52 MICH. L. REV. 1, 20-22 (1953).

53 Renslow, 67 Ill. 2d at 356, 367 N.E.2d at 1255.

54 Id. at 365, 367 N.E.2d at 1258-59 (Dooley, J., concurring).

55 Id. at 371, 367 N.E.2d at 1261 (Ward, C.J., dissenting); id. at 372, 367 N.E.2d at 1262 (Underwood, J., dissenting); id. at 378, 367 N.E.2d at 1265 (Ryan, J., dissenting).

56 Id. at 376-77, 367 N.E.2d at 1264 (Ryan, J., dissenting).

57 Bergstreser v. Mitchell, 577 F.2d 22 (8th Cir. 1978).

58 Id. at 25. See Bergstreser v. Mitchell, 448 F. Supp. 10 (E.D. Mo. 1977).

59 Bergstreser, 577 F.2d at 25.

60 Although the court cited Jorgensen, that case was decided on a strict liability, rather than a negligence, cause of action. The court also cited a third case, Park v. Chessin, 88 Misc. 2d 222, 387 N.Y.S.2d 204 (N.Y. Sup. Ct. 1976), in which the court refused to recognize a cause of action based on wrongful life.

61 Albala v. City of New York, 54 N.Y.2d 269, 429 N.E.2d 786, 445 N.Y.S.2d 108 (1981).

62 Id. at 271, 429 N.E.2d at 787, 445 N.Y.S.2d at 108-09.

63 Id. at 271-72, 429 N.E.2d at 787, 445 N.Y.S.2d at 109.

64 Id. at 273, 429 N.E.2d at 788, 445 N.Y.S.2d at 110.

65 Id.

66 Id. at 274 n.*, 429 N.E.2d at 788 n.*, 445 N.Y.S.2d at 110 n.*.

67 Id.

68 Id. at 275, 429 N.E.2d at 789, 445 N.Y.S.2d at 111 (Fuchsberg, J., dissenting).

69 Catherwood v. American Sterilizer Co., 130 Misc. 2d 872, 498 N.Y.S.2d 703 (N.Y. Sup. Ct. 1986).

70 Id. at 873, 498 N.Y.S.2d at 704.

71 Id. at 875, 498 N.Y.S.2d at 706.

72 See id. at 875, 498 N.Y.S.2d at 706.

73 Id.

74 Catherwood v. American Sterilizer Co., 126 A.D.2d 978, 511 N.Y.S.2d 805 (N.Y. App. Div. 1987).

75 Albala, 54 N.Y.2d at 269, 429 N.E.2d at 786, 445 N.Y.S.2d at 108. The New York Court of Appeals, that state's highest court, decided Albala. The decisions from this court have precedential influence over all lower court cases in New York, including Catherwood.

76 Id. at 271, 429 N.E.2d at 787, 445 N.Y.S.2d at 108-09. See supra text accompanying notes 61-67.

77 Catherwood, 130 Misc. 2d at 874, 498 N.Y.S.2d at 705.

78 Id.

79 See supra text accompanying notes 66-67.

80 Catherwood, 126 A.D.2d at 979-80, 511 N.Y.S.2d at 806 (Callahan, Green, J.J., dissenting).

81 Comment, DES and Enterprise Liability, supra note 8, at 976.

82 Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 502, 539 N.E.2d 1069, 1072, 541 N.Y.S.2d 941, 944 (1989), cert, denied, 110 S. Ct. 350 (1990). Estimates of the number of women who took the drug during pregnancy range from 1 ½ million to 3 million. Comment, DES and Enterprise Liability, supra note 8, at 964-67.

Two sources in the 1940s promoted the belief that DES would significantly reduce the incidence of spontaneous abortion. Karnaky, The Use of Stilbestrol for the Treatment of Threatened and Habitual Abortion and Premature Labor: A Preliminary Report, 35 S. MED. J. 838 (1942); Smith, Diethylslilbestrol in the Prevention and Treatment of Complications of Pregnancy, 56 AM. J. OBSTETRICS & GYNECOLOGY 821 (1948).

Researchers soon criticized these studies for their lack of adequate controls. Subsequent controlled studies failed to substantiate earlier claims of effectiveness. See Comment, DES and Enterprise Liability, supra note 8, at 966 n.12 (citing Davis & Fugo, Steroids in the Treatment of Early Pregnancy Complications, 142 J.A.M.A. 778 (1950); Dieckmann, Davis, Rynkiewicz & Pottinger, Does the Administration of Diethylslilbestrol During Pregnancy Have Therapeutic Value?, 66 AM. J. OBSTETRICS & GYNECOLOGY 1062 (1953); Robinson & Shettles, The Use of Diethylslilbestrol in Therapeutic Abortion, 63 AM. J. OBSTETRICS & GYNECOLOGY 1330 (1952)). But see Bichler v. Eli Lilly & Co., 55 N.Y.2d 571, 585 n.8, 436 N.E.2d 182, 189 n.8, 450 N.Y.S.2d 776, 783 n.8 (1982) (listing additional studies relied upon by the DES manufacturers in filing their NDAs).

83 Hymowitz, 73 N.Y.2d at 502, 539 N.E.2d at 1072, 541 N.Y.S.2d at 944.

84 Adenosis growths may spread to other parts of the body. Treatment requires cauterization, surgery or cryosurgery. Women who suffer from this condition must be monitored by biopsy or colposcopic examination twice a year. Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 594, 607 P.2d 924, 925, 163 Cal. Rptr. 132, 133, cert denied, 449 U.S. 912 (1980).

85 Adenocarcinoma is a fast-spreading deadly disease which requires radical surgery to prevent it from spreading. The disease manifests itself after a minimum latency period of 10 to 12 years. Id. at 594, 607 P.2d at 925, 163 Cal. Rptr. at 135. The National Institute for Cancer estimates that one in every 1,000 DES daughters will develop clear-cell adenocarcinoma. Sherman, New DES Front, Nat'l. L.J., Mar. 12, 1990, at 1.

86 Ulfelder, Herbst & Poskanzer, , Adenocarcinoma of the Vagina: Association of Maternal Stilbestrol Therapy with Tumor Appearance in Young Women, 284 NEW ENG. J. MED. 878, 878 (1971)Google Scholar. This landmark study observed that vaginal cancer is rare and usually occurs as epidermoid cancer in women over 50 years old. Id. at 878. The study, conducted between 1966 and 1969, examined the unusual occurrence of clear-cell adenocarcinoma of the vagina in eight girls from 15 to 22 years of age. Since 7 of the 8 mothers of the patients with carcinoma took DES during their first trimester of pregnancy, the authors concluded that DES creates a highly significant risk of adenocarcinoma of the vagina in the daughters of those who took the drug. Id. at 879.

87 N.Y. Times, May 17, 1977, at 8. Currently, approximately 1,000 DES cases are pending. Finz Justice for DES Victims Now, N.Y.L.J. Mar. 5, 1990, at 2. Identification of the defendant manufacturer has been the significant issue in most of the DES daughter cases. Approximately 300 manufacturers produced the drug over the 24 years during which they sold DES for use during pregnancy. Hymowitz, 73 N.Y.2d at 503, 539 N.E.2d at 1072, 541 N.Y.S.2d at 944. As a result, courts have adopted several theories to allow recovery for the thousands of women harmed by DES. See McElhaney v. Eli Lilly & Co., 564 F. Supp. 265 (D.S.D. 1983) (market share liability theory); Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert, denied, 449 U.S. 912 (1980) (market share liability theory); Abel v. Eli Lilly & Co., 418 Mich. 311, 343 N.W.2d 164, cert, denied, 469 U.S. 833 (1984) (concerted action liability theory); Bichler v. Eli Lilly & Co., 55 N.Y.2d 571, 436 N.E.2d 182, 450 N.Y.S.2d 776 (1982) (modified concerted action liability theory); Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 539 N.E.2d 1069, 541 N.Y.S.2d 941 (1989) (national market share liability theory), cert, denied, 110 S. Ct. 350 (1990); Martin v. Abbott Laboratories, 102 Wash. 2d 581, 689 P.2d 368 (1984) (market share alternative liability theory).

88 In a 1982 study examining the reproductive capability and labor complications of 98 women exposed to DES in utero, doctors concluded that spontaneous abortion, ectopic pregnancy, incompetent cervix and premature labor occurred significantly more in the DES-exposed population than in the controls. The study cautioned, however, that doctors must examine any relationship between DES exposure and fertility in light of the fact that many fertility factors are determined genetically, and the mothers who took DES did so to prevent fetal wastage. Mangan, Borow, Burtnett-Rubin, Egan, Giuntoli & Mikuta, Pregnancy Outcome in 98 Women Exposed to Diethylslilbeslrol In Utero, Their Mothers, and Unexposed Siblings, 59 OBSTETRICS & GYNECOLOGY 315 (1982). Plaintiffs claim that as many as two-thirds of all DES daughters suffer from these complications from malformed reproductive organs. Sherman, supra note 85, at 1.

89 Sherman, supra note 85, at 1.

90 Loerch v. Abbott Laboratories, 445 N.W.2d 560 (Minn. 1989) (en banc) (upholding the trial court's grant of summary judgment for the manufacturer, but not deciding the issue of third-generation exposure to DES because the justices were evenly split).

91 Enright v. Eli Lilly & Co., 77 N.Y.2d 377, 570 N.E.2d 198, 568 N.Y.S.2d 550 (1991).

92 Id. at 381, 570 N.E.2d at 199, 568 N.Y.S.2d at 551.

93 id. at 383, 570 N.E.2d at 201, 568 N.Y.S.2d at 553.

94 Albala v. City of New York, 54 N.Y.2d 269, 429 N.E.2d 786, 445 N.Y.S.2d 108 (1981).

95 Enright, 77 N.Y.2d at 388, 570 N.E.2d at 204, 568 N.Y.S.2d at 556.

96 Id. See Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 539 N.E.2d 1069,541 N.Y.S.2d941 (1989), cert, denied, 110 S. Ct. 350 (1990), in which the court adopted market share liability, allowing plaintiffs to recover against multiple, indeterminate defendants. Also, in 1986, the New York Legislature modified the statute of limitations for exposure to toxic substances, ruling that the limitations period accrues upon the plaintiff's discovery of the injury. N.Y. Civ. PRAC. L. 8C R. 214-C (Consol. 1990).

97 Enright, 77 N.Y.2d at 386, 570 N.E.2d at 203, 568 N.Y.S.2d at 554. The majority stated that although the recent developments demonstrate solicitude for DES victims, “they do not establish DES plaintiffs as a favored class for whose benefit all traditional limitations on tort liability must give way.” Id. at 384, 570 N.E.2d at 201, 568 N.Y.S.2d at 553.

98 Id. at 386, 570 N.E.2d at 203, 5 6 8 N.Y.S.2d at 555. After addressing the policy considerations underlying a strict liability cause of action, the majority concluded that the facts of the two cases were indistinguishable, and that it had to confine tort liability. Id.

99 Id. at 387, 570 N.E.2d at 203, 568 N.Y.S.2d at 555.

100 Id.

101 Id.

102 Id. at 389, 570 N.E.2d at 204, 568 N.Y.S.2d at 556 (Hancock, Jr., J., dissenting).

103 Id. at 397, 570 N.E.2d at 209, 568 N.Y.S.2d at 561 (Hancock, Jr., J., dissenting).

104 Sorrells v. Eli Lilly & Co., 737 F. Supp. 678 (1990).

105 id. at 678.

106 Id.

107 Id. at 679.

108 Id. This case is pending. The court subsequently granted the plaintiff's motion to dismiss the case without prejudice so that she could refile the case in Maryland for the Court of Appeals to consider the preconception issue. Sorrells v. Eli Lilly & Co., No. 89-2073, 1990 U.S. Dist. LEXIS 8646 (June 12, 1990).

109 In this case, a male plaintiff alleges that his mother's ingestion of DES caused genetic injury. While the effects of DES on women are well documented, scientists also have conducted studies to determine the effects of DES on male offspring. One such study concluded that a variety of genital tract abnormalities occurred with increased incidence in men exposed to DES in utero. Conley, Sant, Ucci & Mitcheson, Seminoma and Epididymal Cysts in a Young Man with Known Diethylstilbestrol Exposure in Utero, 249 J.A.M.A. 1325, 1325 (1983).

110 Marcotte, supra note 6, at 14.

111 Id.

112 Id.

113 Id. Dr. Bruce Walker, a professor of anatomy at Michigan State University, conducted this study. In the study, 13 of the 40 “granddaughter mice” developed cancers of the reproductive tract. In the breed of mice that was used for the research, such tumors are extremely rare, and scientists did not find any tumors in the third-generation mice that were not exposed to DES. N.Y. Times, June 9, 1987, § C, at 3, col. 3.

114 Brown v. Superior Court, 44 Cal. 3d 1049, 751 P.2d 470, 245 Cal. Rptr. 412 (1988).

115 See supra note 15.

116 Comment k states, in relevant part, as follows:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs… . The seller of [prescription drugs], again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held strictly liable for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

RESTATEMENT (SECOND) OF TORTS § 402A comment k (1965) [hereinafter Comment k]. ‘

117 AMERICAN LAW INST., PROCEEDINGS OF THE 38TH ANNUAL MEETING 91-92 (1961) [hereinafter ALI PROCEEDINGS]. See Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991) (comment k provides blanket protection for all prescription drugs); Brown v. Superior Court, 44 Cal. 3d 1049, 751 P.2d 470, 245 Cal. Rptr. 412 (1988) (comment k provides blanket protection for all prescription drugs).

118 See McClellan, Strict Liability for Drug Induced Injuries: An Excursion Through the Maze of Products Liability, Negligence, and Absolute Liability, 25 WAYNE L. REV. 1, 2 (1978); Schwartz, Unavoidably Unsafe Products: Clarifying the Meaning and Policy Behind Comment K, 42 WASH. & LEE L. REV. 1139, 1141 (1985).

119 For this reason, the DES cases often include a cause of action for breach of duty to warn.

120 McClellan, supra note 118, at 5.

121 ALI PROCEEDINGS, supra note 117, at 95-97.

122 See Comment, DES and Enterprise Liability, supra note 8, at 966.

123 Comment k states, in relevant part, as follows: “An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified … .” Comment k, supra note 116.

124 Codling v. Paglia, 32 N.Y.2d 330, 298 N.E.2d 622, 345 N.Y.S.2d 461 (1973).

125 Enright v. Eli Lilly & Co, 77 N.Y.2d 377, 387, 570 N.E.2d 198, 203, 568 N.Y.S.2d 550, 555 (1991).

126 See O'Reilly, Drugmakers Under Attack, FORTUNE, July 29, 1991, at 48 (“While drugmakers funnel hundreds of millions into [research and development] … they spend up to twice as much on sales and marketing.“).

127 Id. (“Pharmaceuticals tied with tobacco as the profitability champs of the 1980s, measured by their returns on stockholders’ equity … .The drug industry ranked second in its ability to increase its returns during the decade … .“).

128 FORTUNE, Apr. 24, 1989, at 389.

129 Comment, DES and Enterprise Liability, supra note 8, at 1006 n.251 (citing SENATE SUBCOMM. ON MONOPOLY, SELECT COMM. ON SMALL BUSINESS, 92ND CONG., 2D SESS., COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY 38 (Comm. Print 1974)). The following are some of these justifications:

Producing a successful new drug probably costs around $200 million, if the cost of drugs that never make it is lumped in. The process usually takes 12 years, from the time a chemical is spotted as having a useful effect on cells in a test tube to the time of Food and Drug Administration approval… . Most [of the budget] is spent on three phases of testing over six to eight years, usually involving thousands of patients and hundreds of physicians and statisticians.

O'Reilly, supra note 126, at 50.

130 Albala v. City of New York, 54 N.Y.2d 269, 429 N.E.2d 786, 445 N.Y.S.2d 108 (1981). But see Note, Preconception Negligence, supra note 30, at 1259.

131 RESTATEMENT (SECOND) OF TORTS § 281 (1965).

132 See supra text accompanying note 31.

133 See supra note 15.

134 See generally McClellan, supra note 118, at 6.

135 See supra text accompanying notes 109-111.