Women in Clinical Trials: Are Sponsors Liable for Fetal Injury?

See, e.g., “Toward Healthy Women,” editorial, New York Times, 9/9/91, p.A14; Paul Cotton, “Women's Health Initiative Leads Way as Research Begins to Fill Gender Gaps,” 267 J.A.M.A. 469 (1992).

In the early 1960s, approximately 10,000 children throughout most of the world were born with deformed “seal” limbs or no limbs at all, as well as defective sight and/or hearing. Harvey Teff and Munro Colin R. , Thalidomide: The Legal Aftermath, Great Britain, 1976, p.4. Studies found conclusive evidence that ingestion during early pregnancy of an over-the-counter sleeping pill, Thalidomide, caused these bizarre and hitherto rare malformations. Views of Sens. Kefauver, Carroll, Dodd, Hart and Long on the Drug Amendments of 1962. Sen. Rep. No. 1744, July 19, 1962. Reprinted in U.S. Code and Admin. News 1962, p. 2905.

Discovery of the teratogenicity of thalidomide in 1961 came as a major surprise to the medical community which had previously believed that the fetus was protected from harmful environmental influences by the placenta. Mitchell Allen A. , “Teratogens and the Dermatologist: New Knowledge, Responsibilities, and Opportunities,” 127 Arch. Dermatology 399–401 (1991).

Hilts Philip J. , “N.I.H. Starts Women's Health Office,” New York Times, 9/11/90; p.C9, col.l.; quoting Congresswoman Patricia Schroeder, “What they [officials from the National Institutes of Health] admitted to was that from the time of thalidomide on, researchers were terribly frightened for fear there would be some unexpected effects on fetuses;” and Mason James Dr. , Assistant Secretary for Health and Human Services, “I think there has been timidity in the past, perhaps related to the thalidomide disaster and its effects on women during pregnancy.” See also, Carol Levine, “AIDS Crisis Sparks Quiet Revolution,” L.A. Times, 11/15/90, Pt. B, p.7, col.l.

Shepard Thomas H. , “Human Teratogenicity,” 33 Adv. Pediatrics 225 (1986); Dukes M.N.G. and Swartz B. , Responsibility for Drug-Induced Injury, pp. 261–267 (1988).

The clinical trial…is a systematic experiment in which individuals are randomly allocated to two (or more) groups, one of which is known as the control and the other as the experimental group. The experimental group is administered the new drug being tested and the control (or comparison) group is given the drug in current use; and if no such drug exists, then a placebo, an inert substance such as a sugar pill or a saline injection is used. Lilienfield Abraham M. , “Ceteris Paribus: The Evolution of the Clinical Trial,” 56 Bull. Hist. of Medicine 1–18, 1–2 (1982). “[W]hen the groups are compared they should be similar with respect to the many factors that may influence the disease under consideration.” Id. at 7. “The aim…is to allocate the patients to the ‘treatment’ and ‘control’ groups in such a way that the two groups are initially equivalent in all respects relevant to the inquiry.” Hill Bradford A. “The Clinical Trial,” 7 Brit. Med. Bull. 278, 280 (1951). See also. Feinstein A. , Clinical Epidemiology: The Architecture of Clinical Research, p. 684, (1985).

See note 8, infra.

21 U.S.C. 355(a). Applications for approval of new drugs must contain, Inter alia, “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” 21 U.S.C. 355(b)(A). The Secretary of the Department of Health and Human Services may refuse to approve the application if there is a “lack of substantial evidence that the drug will have the effect it purports or is represented to have.” 21 U.S.C. 355(d). “‘Substantial evidence’ means evidence consisting of adequate and well-controlled investigations, including investigations by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could be fairly and responsibly concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labelling or proposed labelling thereof.” 21 U.S.C. 355(d). The regulatory definition of “adequate and well-controlled studies, 21 C.F.R. 314.126 (1988), states that the following types of controls are recognized: “placebo concurrent control,” (experimental drug compared with a placebo) (314.126(i); “dose comparison concurrent control,” (at least two doses of the drug are compared) (314.126(ii), “no treatment concurrent control,” (the experimental drug is compared against no treatment) (314.126(iii), “active treatment concurrent control,” (experimental drug tested against a known effective therapy) (314.126(iv), “historical control,” (“The results of treatment with the test drug are compared with experience historically derived from the adequately documented natural history of the disease or condition, or from the results of active treatment, in comparable patients or populations. Because historical control populations usually cannot be as well assessed with respect to pertinent variables as can concurrent control populations, historical control designs are usually reserved for special circumstances. Examples include studies of diseases with high and predictable mortality (for example, certain malignancies) and studies in which the effect of the drug is self-evident (general anesthetics, drug metabolism)).” 21 C.F.R. 314.126(v).

To a large extent, the results of RCTs define how the drugs are used in treatment. The trial will determine if and in what dosage the drug is safe and effective for a particular disease. The drug must then be labelled and marketed in accordance with the test results for the treatment of the disease targeted in the trials. Sidney Shapiro A. , “Limiting Physicians' Freedom to Prescribe a Drug For Any Purpose: The Need for FDA Regulation,” 73 Northwestern L.Rev. 801, 805 (1979). Use of the drug in the treatment of another disease or in doses beyond that recommended by the labelling are considered “off-label” uses. While such use by a single physician will not affect the drug's manufacturer, promotion of such off-label use by the manufacturer is illegal under the federal Food, Drug and Cosmetic Act. See, e.g. Kessler David A. , “Regulation of Investigational New Drugs,” 320 N.Eng.J. of Med. 281, 285 (1989).

Berlin Chester , “The Use of Drugs During Pregnancy and Lactation,” 102 Pub. Health Rep. (Supp.) 53–54 (1987). See also, Joan O'Hamilton C. , “When Medical Research Is For Men Only,” Business Week, 7/16/90, p.33.

Blakeslee Sandra , “Research on Birth Defects Shifts to Flaws in Sperm,” New York Times, 1/1/91; sec. 1, p.1, col. 1.

Id. See also, Khoury Muin J. , “Selected Midline Defects Associations: A Population Study,” 84 Pediatrics 266–272 (1989).

The right of a child to be compensated for injury occurring in utero is well established. For a discussion of the development of the cause of action, See, e.g. Crockett Karen G. and Hyman Miriam , “Live Birth: A Condition Precedent to Recognition of Rights,” 4 Hofstra L. Rev. 805, 823–830 (1976).

See Healy Bernadine M.D., “The Yentl Syndrome,” 325 N.Eng. J. of Med. 274, (1991) citing “sex-exclusive prevention studies, diagnostic methods, and intervention for coronary heart disease: Murphy M.L. Hultgren H.N. Detre K. Thomsen J. Takaro T. , “Participants of the Veterans Administration Cooperative Study, Treatment of Chronic Stable Angina: A Preliminary Report of Survival Data of the Randomized Veterans Administration Cooperative Study,” 297 N. Eng. J. of Med. 621 (1977); Multiple Risk Factor Intervention Trial Research Group, “Multiple Risk Factor Intervention Trial: Risk Factor Changes and Mortality Results,” 248 J.A.M.A. 1465 (1982); Manson J.E. Grobbee D.E. Stampfer M.J. “Aspirin in the Primary Prevention of Angina Pectoris in a Randomized Trial of United States Physicians,” 89 Am. J. of Med. 772 (1990). See also, Eleanor Rosenthal, “High Blood Pressure May Pose Less of a Danger for Women,” New York Times, p.C11, col. 1, 9/4/91, reporting that new research provides evidence that “high blood pressure is less dangerous for women than for men…[and]…treatments that work for men may be ineffective or even harmful for women if not used judiciously.” In a very real sense, the differences in the way that many drugs will affect men and women render the drugs tested in men only “unapproved” for women. Such drugs should be marketed and labelled with the marking “FOR MEN ONLY” rather than the label so ubiquitous it is likely to be ignored: “If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.” (Bayer Aspirin, The Bayer Company, 1990).

Editorial, New York Times, supra, note 1, p.A14; Purvis Andrew , “A Perilous Gap,” Time Special Issue, Fall 1990, p. 66.

Abramson Lawrence , “Uncaring Women's Health Care,” New York Times (Op.ed.), 5/14/90, p. Al 7. See also Rosenthal, supra note 14, “There is currently little good information on treating high blood pressure in women, which is why practicing doctors are divided on how to respond to the growing concern that they may be overtreating women.”

Healy , supra, note 14.

New York Times editorial, supra, note 1.

The most extreme example of the cases providing a cause of action for pre-conception injury is Renslow v. Mennonite Hospital, 367 N.E.2d 1250 (Ill. 1977). There, defendant doctors twice negligently transfused plaintiff's mother, who was Rh negative, with Rh positive blood when she was 13 years old. The resulting sensitization of her blood caused prenatal damage to her hemolytic processes, some eight years later, which required premature induction of her child's (the plaintiff's) birth which injured the plaintiff.

This reasoning has been soundly criticized. The majority opinion in Albala v. City of New York, 429 N.E.2d 786 (N.Y. 1981) and the dissent in Monusko v. Postle, 437 N.W.2d 367 (Mich. 1989) opined that the issue was not whether the existence of the child-plaintiff is foreseeable at the time the defendant treated the mother, but whether it was foreseeable that the defendant's conduct would create a risk of harm to the plaintiff. To hold otherwise, “all persons would be deemed to foresee, and thus owe a duty to, the future children of all other persons.” Monusko, at 370.

As this article went to press, the FDA issued new guidelines pertaining to women and clinical trials. The guidelines reviewed the studies done examining the participation of women in clinical trials, and sponsors' provision of gender-based analyses of pharmacokinetic and pharmacodynamic differences in drug response, and modified the Agency's policies regarding the inclusion of women in clinical trials. While the guidelines do not require routine inclusion of women in particular trials, such as early safety trials, they do recommend that drug approval applications include “careful characterization of drug effects by gender. The guidelines also announce the Agency's conclusion that “(1) the exclusion of women from early trials is not medically necessary because the risk of fetal exposure can be minimized by patient behavior and laboratory testing, and (2) initial determinations about whether that risk is adequately addressed are properly left to patients, physicians, local IRBs, and sponsors, with appropriate review and guidance by FDA, as are all other aspects of the safety of proposed investigations.” 58 F.R. 39406, 39408 (7/22/93).

Even the most onerous of tort theories, strict liability, immunizes defendants from liability if they have met the standard of conduct by warning of the dangers of their socially beneficial pursuits or products. Restatement of Torts 2d., sec. 402, Comment k.

See, Prosser, pp. 189–190, discussing the evolution of informed consent claims from battery to medical malpractice.

Id.

See, e.g., Planned Parenthood of Southeastern Pennsylvania v. Casey, 112 S.Ct. 2791, 1992 WL 142546.

The regulations require that the investigator provide the subject with, Inter alia, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures which will be followed and identification of which are experimental, a description of any reasonably foreseeable risks or discomforts to the subject, a description of any benefits to the subject or to others which may be expected from the research, as well as disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 21 C.F.R. 50.25.

For an explanation of the powers and functions of the Institutional Review Board, hereinafter referred to as IRB, See infra notes 83–87.

21 C.F.R. 56.109(b) (1991) and 45 C.F.R. 46.109(b) (1991).

While federal funds sometimes support F.D.A. required research into the safety and efficacy of potential treatments of diseases (David H. Banta “RCTs and the Federal Government,” 3 Controlled Clinical Trials 173–183, 173–4 (1982), especially those such as AIDS and cancer, and because of the role such trials might play in the lives of the terminally ill, we will assume for the sake of discussion that the research has received federal funding.

21 C.F.R. 50.26(b)(1) (1990) and 45 C.F.R. 46.116(b)(1) (1991).

If the research is supported by federal funding, the IRB must ensure that extra care has been taken in the recruiting of subjects. 45 C.F.R. 46.205 (a)(2) (1990).

The question must be asked what sort of woman would continue a pregnancy knowing that she required treatment that could injure her fetus. In my opinion, such a woman would have to be gravely ill and refusing to undergo an abortion because she believed this would be her only opportunity to have a child. I submit the number of such women is very few.

See, e.g. N.Y.Pub. L. Health section 2504(2) (McKinney's 1985).

Curran William , “A Problem of Consent: Kidney Transplantation in Minors,” 34 N.Y.U. L. Rev. 891, 892 (1959).

See, e.g. Shack v. Holland, 389 N.Y.S.2d 988 (Sup.Ct. 1976); Hughson v. St. Francis Hospital, 92 A.D.2d 131, 459 N.Y.S.2d 814 (1983).

See, e.g., “New Liability-Limit Law Designed to Boost Research,” 6 AIDS Policy and Law 2 (1991) (discussing enactment of a bill to limit the liability of pharmaceutical manufacturers testing an AIDS vaccine intended to prevent pregnant women from transferring HIV to their fetuses. “There is no way to obtain consent from a fetus to do this type of testing, so without this new law it would be very difficult to go ahead and test,” statement by Franklin Volvovitz, president and chairman of company.)

I acknowledge the debate regarding fetal personhood. However, because the answer to that question is ultimately irrelevant to the conclusion of this article, I decline to add my voice. I will presume, for the sake of simplifying the article's discussion, that the fetus has interests that require recognition, but that his interests are not superior to his mother's. (To simplify the discussion grammatically, the fetus will be presumed to be male, the mother female.)

The article presumes that the treatment was performed by a physician who is either a researcher or an agent of a researcher and that the physician is an agent of the sponsor. Reference to the actions of the physician/researcher are referable to the sponsor.

Roboz , “Does Doxorubicin Cross the Placenta?” 2 Lancet 1382–83 (1979) (discussing the fact that doxorubicin, a toxic chemotherapeutic agent used in the treatment of cancer appears not to cross the placenta. The physicians/authors opine that “Experience with chemotherapeutic agents during human pregnancy is limited.” It is not, however, non-existent. Sadly, “most of the reliable knowledge which currently exists as to the effects of drugs on the unborn child has been acquired because drugs were given recklessly or unknowingly to pregnant women.” Dukes and Swartz, supra, note 5, at 264; Ginsberg J. , “Heparin Therapy Risks during Pregnancy: Risks to the Fetus and the Mother,” 149 Arch. Internal Med. 223–2236 (October 1989) (discussing the use of two common anticoagulants, heparin and Coumadin, during pregnancy); Ziaya Paul R. , “Intravenous Penicillin Desensitization and Treatment During Pregnancy,” 256 J.A.M.A. 2561–1562 (11/14/1986) (reporting that Erythromycin does not readily cross the placenta.) For a general discussion, see Shepard, supra, note 5.

The paucity of “on point” cases is revealing. One can presume that the lack of reported opinions reflects a lack of litigation and that that in turn reflects a lack of injury caused by a pregnant woman's ingestion of a drug beneficial to her but harmful to her fetus. These presumptions are supported by the findings of the American College of Obstetricians and Gynecologists Ethics Committee: “[t]he welfare of the fetus is of the utmost importance to the majority of women; thus only rarely will a conflict arise.” (American College of Obstetricians and Gynecologists Ethics Committee Opinion No. 55: Patients Choice: Maternal-Fetal Conflict, October, 1987), cited in In re: A.C. at footnote 20. The majority of women will not knowingly put their fetuses at risk.

See infra, notes 45 and 47–52 and accompanying text.

In a survey of court-ordered obstetrical procedures, the authors found that “hospital administrators and lawyers often have little forewarning of impending conflicts.” The survey also found that in 88 percent of the 21 cases in which the order was granted, the orders were obtained within six hours; in 19 percent, the orders were obtained in an hour or less, at times by telephone. The authors conclude that “the time required to weigh complex relative medical risks and benefits for both mother and fetus and then to balance these against the woman's rights is rarely, if ever available … [and] … the court is unlikely to provide a meaningful review of the medical facts.” V. Kolder, J. Gallagher, and M. Parsons; “Court-Ordered Obstetrical Interventions,” 316 N. Eng. J. of Med. 1192, 1195 (1987).

410 U.S. 113 (1973).

Roe at 164.

Some states distinguish between abortions that are permitted in the third trimester for the sake of the mother's life and those that are permitted for the sake of her health. See, e.g, N.Y.P.L. 125.05(3) (life); Arkansas Code of 1987 sec.20-16-705 (life or health).

In the Matter of Nancy Klein, 145 A.D.2d 145 (2d Dept. 1989); In the Matter of D.K, 497 A.2d 1298 (N.J. 1985); Rothenberger v. Roe, 149 N.J. Super. 478 (1977).

“Developments—Medical Technology and the Law,” 103 Harv. L.R. 1519, 1565; Thomas Shepard, supra, note 5.

For example, see Raleigh Fitkin-Paul Morgan Memorial Hospital v. Anderson, 201 A.2d 537 (cert. denied 377 U.S. 985 (1964) (court ordered blood transfusion of pregnant Jehovah's Witness whose severe hemorrhaging threatened her life and that of her eight month old fetus); Jefferson v. Griffin Spaulding County Hospital, 274 S.E.2d 457 Ga. 1981) (court ordered cesarean section ordered on a full-term woman who refused it on religious grounds despite diagnosis of placenta previa, a condition almost certain to cause her death and the death of her fetus. Order not carried out because woman left hospital. She later vaginally delivered a healthy baby with no complications). See Annas George J. , “Forced Caesareans: The Most Unkindest Cut of All,” The Hastings Center Report, (6/82), p.16. But see, contra, In re: A.C., 573 A.2d 1235 (D.C.App. 1990) and text infra accompanying notes 55–60.

Robertson John A. , “Procreative Liberty and the Control of Conception, Pregnancy and Childbirth,” 69 Va. L. Rev. 405, 446–7.

In the two reported cases addressing the issue of judicial intervention for the sake of a pre-viable fetus, the courts split, one court granting the request for treatment over the mother's objections, while the other court refused to do so. However, the court which refused to override the mother's objections limited its holding to the facts of the case before it.

In Taft v. Taft, 446 N.E.2d 395 (Mass. 1983), the husband of a 16 week pregnant woman sought a court order requiring his wife to undergo a “purse string sutures” operation to “hold the fetus” in order to save its life. The wife objected on religious grounds. The trial court granted the request, but the appellate court reversed on the ground that no evidence was provided to support the necessity of this invasion of the mother's bodily integrity. The decision, while protecting the mother's rights, was clearly fact-based and left room for the granting of such a request under different, better substantiated and compelling circumstances. Taft, at 397.

In the second case, In re: Jamaica Hospital, 491 N.Y.S. 2d 898 (S.Ct. Queens Co. 1985), the court ordered a blood transfusion for a woman 18 weeks pregnant in order to save both her life and that of her fetus. The woman objected on religious grounds. The court, relying on Roe's determination that the state has a “significant interest in protecting the potential of human life represented by an unborn fetus, which increases throughout the course of pregnancy” determined that, although the fetus was not yet viable and the state's interest not yet “compelling,” that interest was “highly significant” and outweighed the mother's right to refuse the transfusion on religious grounds. The court relied on other states' judicial decisions which supported interventions for the benefit of viable fetuses.

For a fuller discussion of both In re: Jamaica and Taft v. Taft, see Shannon Such, “Lifesaving Medical Treatment for the Nonviable Fetus: Limitations on State Authority under Roe v. Wade,” 54 Fordham L. Rev. 962 (1986).

Robertson , Id. at 410. Another commentator would go further and impose an affirmative obligation on the woman to prevent birth defects by adhering to a vitamin regimen before she could know that she was pregnant. Margery W. Shaw, “Conditional Prospective Rights of the Fetus,” 5 J. Legal Med. 63 (1984).

Jefferson v. Griffin Spaulding County Hospital, supra, note 47.

Annas , supra, note 47 discussing an unreported case from Colorado.

In an unreported case, a Baltimore Circuit Court, responding to a request by a physician, ordered a drug addicted woman who was seven months pregnant to enroll in a drug rehabilitation program and submit to weekly urinalysis until the baby was born. Shaw, supra, note 44 at 103–104, citing an article in The Boston Globe, 4/27/83.

Roe at 732.

In Re: A.C. supra, at 1244. See also, Lawrence Nelson; Buggy; Brian P. Weil Carol J. ; “Forced Medical Treatment of Pregnant Women: ‘Compelling Each to Live as Seems Good to the Rest,’” 37 Hastings L. J. 703 (1986).

Id. at 1244.

Id. at 1237.

533 A.2d 611 (1987).

In re: A.C., 573 A.2d at 1247 and 1252.

Id. at 1252 (“…in virtually all cases the decisions of the patient, albeit discerned through the mechanism of substituted judgment, will control. We do not quite foreclose the possibility that a conflicting state interest may be so compelling that the patient's wishes must yield, but we anticipate that such cases will be extremely rare and truly exceptional.” The court footnoted, “Absolutes like ‘never’ should generally be avoided because the future may bring scenarios which prudence counsels our not resolving anticipatorily.” In Re: A.C., ftnote 22., Florida Star v. B.J.T. 109 S.Ct. 2603 (1989).

McFall v. Skimp, 10 Pa.D. & C.3d 90 (Allegheny County Ct. 1978) (court refused to order one cousin to donate bone marrow necessary to save another cousin's life) Quoted in In Re: A.C. at 1244.

While several law enforcement agencies have sought to use child neglect statutes to require judicial monitoring of pregnant women who abuse drugs, no court, to date, has expanded those statutes drafted to protect ex utero children to those in utero. Cox v. Court of Common Pleas, 537 N.E. 2d 721 (Ohio 1988); or required a mother to forgo a procedure medically beneficial to her for the sake of her fetus.

“…[S]ociety should not coerce women to act in the best interests of their fetuses even if they have a moral obligation to act. Equity and privacy concerns deserve consideration and perhaps greater priority than the fact that, in a particular case, the pregnant woman seems to be doing the morally wrong thing.” [emphasis supplied]. Patricia King “Should Mom be Constrained in the Best Interests of the Fetus?” 13 Nova L. Rev. 395 (1989). See, also Stahlman v. Youngquist, 531 N.E.2d 355 (Ill. 1988) (women are not guarantors of fetal health and well-being). But see, Grodin v. Grodin., 301 N.W. 2d 869 (Mich. 1980) (pregnant woman bears same liability for negligent condition which results in pre-natal injury as would a stranger).

If a case arose where, despite due care by the medical profession in transmitting the necessary warnings, parents made a conscious choice to proceed with a pregnancy, with full knowledge that a seriously impaired infant would be born, that conscious choice would provide an intervening act of proximate cause to preclude liability insofar as defendants other than the parents were concerned. Under such circumstances, we see no sound public policy which should protect those parents from being answerable for the pain, suffering and misery which they have wrought upon their offspring. (Curlander at 488.)

Because the claim in Curlander was based on negligence, the court limited its discussion to that theory, holding that the parents' “conscious choice” was an intervening cause relieving the physicians of liability. Curlander would immunize the pharmaceutical company from liability in negligence. The issue of parental liability is beyond the scope of this article.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research., p.4. (1978).

Id. at 5.

Such questions arise, for instance, over the propriety of an incompetent's participation in nontherapeutic treatment such as when her organ, i.e. a kidney, is sought to be transplanted into another, most often a sibling. Because the incompetent's incapacity precludes her giving informed consent to the medical procedure, and because her parents are precluded from consenting on her behalf because of their relationship to the recipient, a guardian is appointed to represent the incompetent and the parents or hospital then seek a court order granting the operation. The issues surrounding the evaluation of risk and benefit that are raised in these proceedings are analogous to those raised when pregnant women seek to participate in clinical research.

A court order granting a request to provide or refuse to provide treatment will afford the physician immunity from liability for injuries occurring as a result of compliance with the order, but not for injuries caused by negligent compliance. Matter of Spring, 405 N.E.2d 115, 122 (Mass. 1980).

Ethicists are also in conflict. Some argue that when the incompetent has never been in a position to express his wishes, the court may not base its decision on substituted judgment because there is no basis to know what the wishes of the incompetent would have been. Ruth Macklin, Mortal Choices (1987), p.104. But see, infra, discussion of substituted judgment, text accompanying notes 77–81 and John A. Robertson, “Organ Donations by Incompetents and the Substituted Judgment Doctrine,” 76 Columb. L. R. 48, 57–78 (1976). (Hereinafter cited as Organs.)

Under the benefits rule, the court determines, from a neutral perspective, if the treatment is in the objective best interests of the incompetent. See, e.g. Curran v. Bosze, 566 N.E.2d 1319 (Ill. 1990); In re Guardianship of Pescinski, 226 N.W. 2d 180 (Wis. 1975); Little v. Little, 576 S.W. 2d 493 (Tex. 1979).

Under the doctrine of substituted judgment, the court decides “in accordance with the interests of the incompetent, as a reasonable person with the incompetent's characteristics, preferences and prospects would.” Robertson, Organs, p. 66; Strunk v. Strunk, 445 S.W.2d 145 (Ky. 1969); Hart v. Brown, 289 A.2d 386 (Conn. 1972).

Robertson , Organs, p.63.

Indeed, if injured during treatment, the incompetent would benefit emotionally from knowing that his injury was not for nothing, that it was caused in an effort to help a loved one, that that effort was of critical importance to that loved one, and that without that effort, that loved one might have died.

39 Ant. Jur. 2d, Guardian and Ward sec. 68.

Robertson , Organs, p. 56.

Strunk v. Strunk, supra note 70.

Hart v. Brown, supra note 70.

Hart, supra note 70; Little, supra note 69, Curran supra note 69.

Strunk, supra, note 70.

Little, supra note 69 at 499; Hart supra note 70 at 389; Strunk supra note 70 at 149; Matter of Doe, 481 N.Y.S.2d 932 (4th Dept. 1984).

24 A.L.R.2d 863, 875 (1969).

Strunk, supra note 70; but see In re Richardson, 284 So.2d 185 (La. 1973).

Robertson , Organs, p.70.

In addition to review by the Institutional Review Board, if the research is federally funded, the Ethical Advisory Review Board, whose membership is appointed by the Secretary of Health and Human Services, may also require submission of the protocol for its review. The funding regulations require that the Secretary establish such a Board and that it determine, with the approval of the Secretary, which categories of research involving pregnant women, fetuses and/or in vitro fertilization require its review. 45 C.F.R. 46.204 (1990).

The IRB must have at least five members. No IRB may consist entirely of men or of women or entirely of members of one profession. The members must have varying backgrounds and must be sufficiently qualified through “the experience and expertise of its members' backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.” Each IRB shall include at least one member whose primary concerns are in a nonscientific area, such as lawyers, ethicists, or members of the clergy. 45 C.F.R. 46.107 and 21 C.F.R. 107.

Kessler , supra note 9, at 283.

If the Board regularly reviews research involving pregnant women, the Board must consider including one or more individuals who are “knowledgeable about and experienced in working with those subjects.” 21 C.F.R 56.107(1991). If the Board does not regularly review such research, but finds that it must do so, it may turn to outside consultants for assistance in evaluating the protocol. While neither of these options is required, they do provide a means for the community representatives reviewing the protocols to obtain assistance in assessing whether the research protocol and informed consent procedures adequately protect pregnant women and their fetuses.

45 C.F.R. 107(e).

These regulations refer only to “pregnant women” and do not specifically include women who may become pregnant. 45 C.F.R. 46.207 (1990).

The risk/benefit standard to be applied vis à vis the mother is that applicable to any adult human subject: the risk to the subject must be reasonable in relation to the anticipated benefits. 45 C.F.R. 46.111(a)(2).

If the research activity does not target the mother's health needs then the regulations prohibit placing the fetus at any risk more than “minimal risk” which is defined as the risks ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 45 C.F.R. 46.102(i) (1991). Research activity involving women who are not pregnant must balance the risks and benefits to ensure that the risks are reasonable in relation to the anticipated benefits to the subject, if any. 45 C.F.R. 46.111(a)(2).

Levine Robert , “The Role of Risk Assessment of Risk Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects,” Belmont Report, App.I, p.2–4 (1978).

These regulations do not specifically denominate the fetus as a human subject. 45 C.F.R. 46.102(f)(1991)(“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.”) However, the development of new techniques that allow doctors to visualize and assess the fetus' status create the possibility of their taking various actions solely for the fetus' benefit. Because of this, doctors who treat pregnant women perceive themselves as treating two patients with sometimes separate and conflicting needs. Nancy K. Rhoden, “Informed Consent in Obstetrics: Some Special Problems,” 9 N. Eng. L. Rev. 67, 76 (1987). The fact that the woman is involved in research rather than private treatment does not change this duality. That conflict may influence the outcome of treatment decisions, whether or not the fetus is judicially or regulatorily entitled to have its needs factored into the evaluation of risks and benefits of the proposed procedure or research. Those needs are in fact part of the medical evaluation of what should be done. Thus, both the maternal and fetal interests are examined under the same standard applicable to research subjects. 21 C.F.R. 56.111.

21 C.F.R. 46.111(A)(1).

Requiring judicial approval in order to permit the participation of pregnant women flies in the face of the growing recognition that courts are inappropriate forums for bioethical decisions. “Courts are an inappropriate forum for resolving ethical issues. We recognize there may be legal motivations to seeking judicial intervention in such situations. Resort to court should rarely occur.” Settlement Agreement of Nettie Stoner and Daniel Stoner and George Washington University Medical Center, 11/21/90, settling the civil suit brought by the parents of A.C. against her physicians and hospital.

Blum Andrew , “AIDS Research Faces Hurdle: Who's Liable? One State Passes Law,” National Law Journal, 7/29/91, p.3. (referring to belief of Franklin Volvovitz, chairman and president of MicroGeneSys, See, note 35, supra.

Conn. P.A. 91–349 (1991) (West).

A claim in battery (an intentional, unauthorized harmful touching (Prosser, p. 39, citing Rest. Torts 2d, sec. 13) as well as a claim in medical malpractice based on lack of informed consent are defeated because her valid consent was obtained. The consent also defeats an action based on negligence because it acts as an intervening cause, preventing the researcher's provisions of treatment from being the proximate cause of the fetal injury. Id. sec. 44. A claim in products liability would rest on failure to provide proper warnings. Here, the consent precludes such a claim because inherent in both the IRB's approval process and the woman's provision of informed consent is the full disclosure of risks of the drug. A claim sounding in strict liability will similarly fail when full disclosure of the risks is made. Rest. Torts 2d, sec. 402, Comment k. Hence, sponsors are immunized from claims of lack of fetal informed consent by the informed consent of the mother given in conjunction with the IRB review process.

See King, supra note 62.

Blakeslee , supra, note 11.

Ibid.