Litigation in Clinical Research: Malpractice Doctrines versus Research Realities

Author:

Morreim E. Haavi

Abstract

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference127 articles.

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3. 89. Some states, such as Pennsylvania and Tennessee, still emphasize battery as the cornerstone of the duty to disclose. See Morgan v. MacPhail, 704 A.2d 617, 620 (Pa. 1997); Duttry v. Lewis T. Patterson, M.D., 771 A.2d 1255 (Pa. 2001); Cardwell v. Bechtol, 724 S.W.2d 739 (Tenn. 1987); Shadrick v. Coker, 963 S.W.2d 726 (Tenn. 1998).

4. 115. In Diaz v. Tampa General Hospital , such reasoning led to a high-dollar settlement in a case where no physical injury was ever claimed. Plaintiffs argument was that sophisticated consent forms were tantamount to inadequate research disclosures for pregnant women whose socioeconomic and cultural status impeded their comprehending the information they were given. Plaintiffs were poor, uneducated, mostly Spanish-speaking women who said that they did not understand the three-page, IRB-approved consent form. In addition to conceding there was no injury, the plaintiffs also agreed that they had signed the consent form. When the case was certified as a class action, defendants determined they could not afford to defend the suit. A settlement of $3.8 million closed the case. Diaz v. Tampa General Hospital, 2000 WL1682918 (M.D. Fla. 2000). See also Research “Roundtable Report on Diaz v. Tampa General,” at .

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