Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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14 Liability Exposure When Offspring Are Injured Because of Their Parents' Participation in Clinical Trials
14 Liability Exposure When Offspring Are Injured Because of Their Parents' Participation in Clinical Trials
Pages 103-112
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From page 103... ...
The argument here is that if there is a threat of liability, efforts to include women in clinical trials will fail because potential parents will not enroll in and third parties will not include potential parents in clinical trials. The majority's dictum on Johnson Controls that the goal of Title VII of ensuring equal access to the work place could preempt tort claims brought by children allegedly injured by their mothers' exposure to lead in the work place would appear to support this line of reasoning.
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From page 104... ...
In recent years, most courts have looked favorably on prenatal injury claims and on occasion have awarded very large amounts of damages, commensurate with the child's special needs over the course of a lifetimes By contrast, children are said to be seeking damages for "wrongful life" when they are bom alive but their parents say that more information would have led them to avoid childbearing. These claims have almost universally been rejected by courts and legislatures.6 Interestingly, one court permitted two children who were born with fetal hydantoin syndrome to recover some damages for wrongful life when their mother alleged that she had expressed concem about taking Dilantin during pregnancy to her providers, who inappropriately reassured her that there was little risk.7 The nature of parents' claims differs depending on whether the child was born alive or not and on whether the parents would have avoided the drug or put off procreation.
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From page 105... ...
Such "wrongful life" claims by children are highly disfavored in general, as was discussed above, but they are particularly unlikely to succeed when made against parents.37
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From page 106... ...
In general, a potential beneficiary may not recover damages if his or her negligence caused the wrongful death, but the negligence of one beneficiary does not preclude recovery by other beneficiaries. One court recently held that the father of a child stillborn because of the mother's negligence could not recover damages because the mother might indirectly benefit.~9 This imputation of the negligence of one parent to the other, however, has been criticized as a "senseless survival of a discarded concept of marital unity."20 Thus, if one parent negligently takes a fetotoxic drug in a jurisdiction that permits wrongful death actions when children are stillborn, the other parent may well be able to recover damages.
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From page 107... ...
The states vary widely in whether they allow physicians who work for governmental institutions and the institutions themselves to be sued. Some states say that provision of health care is not protected because it is not inherently governmental or because the state does not exercise control over the provider,26 while others waive immunity to the extent of available insurance coverage.27 Some states, however, retain immunity for some providers and government institutions.28 Under the Federal Tort Claims Act, physicians who are working within the scope of their employment for the federal government may not be sued in their
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From page 108... ...
Subsequently, a number of cases held that claims on behalf of fetuses harmed by negligent prenatal care of women who were members of the military were barred by the Meres doctnne.3~ These courts reasoned that medical care was incident to service and that if the service member cannot sue, the child cannot sue for any derivative injuries.32 Recent cases, however, have ruled to the Conway, challenging both of these lines of argument. First, some cases have held that the children injured by negligent prenatal care to a service member are suing for their own injuries and not asserting simply derivative claims.33 Second, a recent end potentially more far-reaching case has challenged the notion that all injuries resulting from medical care are "incident to service." A service woman was allowed to pursue a claim for injuries sustained as a result of her voluntary participation in a milita~y-run blood donor drive on the grounds that her donation did not implicate sensitive military matters and was more civilian in nature.34 Thus,while children injured as a result oftheir parents' participation es members of anned services in clinical research are still unlikely to succeed in their claims against the federal government, these recent trends raise Me possibility that their claims soon will be more successful.
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From page 109... ...
It may be that most fetotoxic effects will not be detected in clinical trials. But unless the drug will never be used in fertile individuals, the answer to this dilemma is not to exclude such people from clinical trials but rather to broaden the scope of inquiry to require animal studies of mutagenicity and teratogenicity prior to testing or at least marketing for human use and to implement truly effective methods of long-term surveillance that begin during clinical trials.
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From page 110... ...
Some states have passed statutes limiting this period, but where the traditional rule still applies, children injured prior to birth can bring claims until they are twenty years old. See Renslow v.
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From page 111... ...
22. Vanessa Merton, The Impact of Cu~rent Relevant Federal Regulations on the Inclusion of Female Subjects in Clinical Studies, this volume; 45 C.F.R.
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From page 112... ...
35. Patients, Doctors, and Lawyers: Medical Injury, Malpractice Litigation, and Patient Compensation in New York: The Report of the Harvard Medical Practice Study to the State of New York.
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