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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13 Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies
13 Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies
Pages 91-102
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From page 91... ...
Companies sponsor studies of pharmaceutical or medical device products; physician investigators conduct and monitor studies; institutional review boards JRBs3 review and approve proposed protocols and informed consent; research institutions provide the study site and may provide attendant medical care; and the Food and Drug Administration (FDA) administers federal statutes and regulations that govern the conduct of clinical investigations, the data required to support product approval applications, and the information contained in product labeling.
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From page 92... ...
Even if you are likely to prevail in an action brought against you, the fear of becoming involved in such a legal proceeding is a very strong factor affecting decisions concerning clinical trials. A lawsuit or investigation entails substantial burdens and costs, including the disruption of ongoing work, psychological effects on the individuals who have been accused of causing or contributing to an injury, attorney fees, litigation costs, adverse publicity, and perhaps the costs of settling the plaintiff's claims.
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From page 93... ...
California and Utal1 have expressly ruled that comment k applies to all properly prepared drugs accompanied by adequate warnings.8 Wisconsin and Alaska, on the other hand, have refused to adopt comment k and thus declined to protect drug manufacturers from strict liability.9 The rule in many states is that prescription drugs, prescription medical devices, and vaccines should be accorded the comment k exemption only on a case-by-case basis.~° Those states opting for case-by-case application of comment k typically require a drug manufacturer to carry the burden of proving that a product's benefits outweighed its risks at the time of distribution.' Often the focus will be on whether a safer, equally efficacious alternative was available when the plaintiff took the challenged product.'2 Most courts have held that obtaining FDA approval of a drug does not provide a manufacturer with an absolute shield from state tort liability.'3 Evidence of compliance with FDA warning regulations may be introduced as evidence of the adequacy of such warnings.'4 But manufacturers have been held liable for an inadequate waning even where FDA had expressly refused to approve the addition of the warning owing to a lack of evidence supporting causation.'5 Courts have also held that FDA approval of a vaccine does not preempt state tort claims.'6 Under federal legislation in effect since 1988, however, certain properly prepared childhood vaccines accompanied by adequate warnings to the medical community can be afforded comment k protection, and there is a rebuttable presumption that warnings in compliance with federal regulations are adequate.'7
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From page 94... ...
preempt strict liability claims involving experimental intraocular lenses.'9 In recent months, two federal appellate courts have ruled that state claims are preempted for Class III medical devices that require premarket approval of safety and effectiveness by the FDA under 21 U.S.C.
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From page 95... ...
A vaccine can be found defectively designed if it is not "as safe as the best available testing and research permits."29 Although "unexpected and unknown risks" will not trigger strict liability, sellers are deemed to be experts and are imputed to have all "[knowledge of the product's risks based on reliable and obtainable information."30 To obtain the benefits of comment k, a medical product "must conform to the highest standards of available scientific and technical knowledge."3~ Such standards include stateof-the-art testing of the product.32 Drug manufacturers will likely find it increasingly difficult to prove that allmale studies of many drug products constitute state-of-the-art testing. There is growing recognition that the physiological differences between men and women make it scientifically inadequate in many instances to conduct clinical tests or epidemiological studies using only male subjects.33 For example, in 1990 Dr.
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From page 96... ...
50, 312, and 8123. These include: the submission and approval of a study protocol and informed consent by an IRB; the submission of an application to FDA containing pharmacology and toxicology information from studies in laboratory animals or in vitro showing that it is "reasonably safe" to conduct the proposed clinical investigation, as well as information on previous human experience with the product (e.g., from marketing outside the United States3; preparation of an investigator's brochure contairdng information about the product and its effects, possible risks, and precautions; and prompt reporting by investigators and study sponsors of significant safety information arising during the clinical study.4' Where all of these requirements have been followed, any injury to a subject that does occur is unlikely to result in liability.
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From page 97... ...
Provided that the manufacturer warns that the drug is experimental and warns of known and reasonably knowable risks, comment k should apply to an experimental dnag.42 Of course, should evidence of risks to women develop during clinical trials, manufacturers would be responsible for determining whether to exclude women from further involvement in the trials as well as to warn about the newly discovered risks.43 Investigators testing an experimental drug are likely to be held to the same standards as physicians treating a patient.44 Thus, a subject's probable theories of recovery would be negligence and lack of informed consent.45 Federal regulations regarding informed consent prohibit requiring subjects to waive their legal rights.46 Investigators and institutions conducting clinical trials therefore are potentially liable for negligence in implementing a clinical study. IRB members also may be sued under state tort law.47 Although IRBs are not primarily responsible for the design of clinical studies, they potentially could be liable for failing to assure that adequate warnings were given to women where evidence existed of particular risks to women.48 However, there is apparently no reported case in which IRB members have been successfully sued for breaching their duties to protect research subjects, male or female.
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From page 98... ...
. While declining to adopt comment k itself, the court in Shanks did indicate that drug manufacturers could raise as an affirmative defense to a strict liability design defect claim the type of risktbenefit analysis that many courts use in deciding whether to grant a drug comment k protection.
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From page 99... ...
1992) (declining to find preemption regarding a Class III device that underwent a less rigorous premarket approval process than the devices involved in the Collagen cases because the Larsen device was '` ~substantially equivalent' " to devices already approved for marketing)
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From page 100... ...
L Elizabeth Bowles, The Disfranchisement of Fertile Women in Clinical Trials: The Legal Ramif cations of and Solutions for Rectifying the Knowledge Gap, 45 Vand.
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From page 101... ...
12, 1992) (although related malpractice claims were barred by statute of limitation, hospital at which investigational devices installed is potentially liable for fraud due to physician's alleged failure to obtain informed consent)
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From page 102... ...
('the primary responsibilities of an IRB are to assure that human subjects are adequately protected, are not exposed to unnecessary risks, and are provided with enough information about a study so that they can give effective informed consent. However, the agency believes that it is impossible to divorce completely considerations of science from those of ethical acceptability and of protection of human subjects.
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