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

Published online by Cambridge University Press:  01 January 2021

Extract

Calls for the inclusion of women in clinical trials raise the obvious question: why have sponsors excluded them? The answer most often given is one tragically evocative word: Thalidomide. The tragedies of the children born with seal limbs because their mothers took this over-the-counter sleeping pill and cure for morning sickness showed that, contrary to previous perceptions, the placenta could not be depended upon to filter out toxins before they reached the fetus. The specter of birth defects spawned sponsors’ fears of a variety of catastrophes which contributed to closing the doors of clinical trials for women.

This paper will not argue that the possibility of birth defects arising from the ingestion of an experimental drug does not exist. Sadly, scientists do not yet have the ability to predict which drugs will cause birth defects. Rather, it will argue that case law does not provide a basis for sponsor liability when a woman gives informed consent and the regulations governing clinical trials are followed.

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Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 1993

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References

The author gratefully acknowledges the support of the Silver Program in Law, Science and Technology at Columbia University School of Law, as well as Professor Harold Edgar, Nersa Miller, Barbara Finger, and Peter C. Richter.Google Scholar
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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).Google Scholar
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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.Google Scholar
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).Google Scholar
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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.Google Scholar
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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).Google Scholar
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.Google Scholar
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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.)Google Scholar
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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.Google Scholar
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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.” Kolder, V., Gallagher, J., and Parsons, M.; “Court-Ordered Obstetrical Interventions,” 316 N. Eng. J. of Med. 1192, 1195 (1987).Google ScholarPubMed
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“…[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).Google Scholar
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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).Google Scholar
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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.Google Scholar
45 C.F.R. 107(e).Google Scholar
These regulations refer only to “pregnant women” and do not specifically include women who may become pregnant. 45 C.F.R. 46.207 (1990).Google Scholar
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).Google Scholar
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).Google Scholar
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.24 (1978).Google Scholar
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. Rhoden, Nancy K., “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.Google Scholar
21 C.F.R. 46.111(A)(1).Google Scholar
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.Google Scholar
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.Google Scholar
Conn. P.A. 91349 (1991) (West).Google Scholar
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.Google Scholar
See King, supra note 62.Google Scholar
Blakeslee, , supra, note 11.Google Scholar