A review of recent Canadian and American cases demonstrates that in commencing lawsuits over alleged research misconduct, plaintiffs cast a wide net, naming as defendants anyone who had anything to do with the research in question. Named defendants have included the researchers, the research ethics committee/board/institutional review board (REC) that approved the research and its individual members, as well as bioethicists who consulted on the research project.
For example, in Gelsinger v. Trustees of the University of Pennsylvania [2], an eighteen year-old who had volunteered to participate in a corrective gene study died during the course of the study. In that case, the trustees of the university and two hospitals affiliated with the research, the investigators, the company that sponsored the research, the former medical school dean and a bioethicist, were all originally named as defendants on the bases (among others) of wrongful death, assault and battery linked to a lack of informed consent, and common law fraud/misrepresentation linked to the informed consent process. The case settled for an undisclosed amount [3].
In Robertson v. McGee [4], the REC had approved a protocol for a Phase I study of a cancer vaccine. Many of the patients who enrolled in the study had advanced disease, were unresponsive to standard therapies and had very poor prognoses. According to news reports, 94 subjects received the vaccine and 26 died during the study, although the deaths were not attributed to the vaccine itself [5]. On January 29, 2001, a number of subjects and subject representatives filed a lawsuit seeking actual and punitive damages. The Robertson plaintiffs sued the hospital, the principal investigator, the pharmaceutical sponsor, a top university official, the individual members of the REC, and the university bioethicist who consulted with the REC. The issues in this case were never decided by the court because the court held that it did not have jurisdiction over the allegations made in the complaint and dismissed the case.
In the case of Weiss v. Solomon [6], a research subject suffered a cardiac arrest and died after undergoing a fluorescein angiogram as part of a research study. The deceased's family sued the principal investigator, the hospital and a physician who referred one of his patients to the study. The Court hearing the case ultimately found liability against the primary investigator and hospital only. Interestingly, the liability against the hospital was based in part upon the fact that the hospital's REC had approved the research protocol and the consent form which was determined by the Court to be deficient.
All of these cases demonstrate that plaintiffs cast a wide net when deciding whom to name as defendants in cases where research goes wrong. It is possible for almost anyone involved in a research project, no matter how remotely connected, to be named in legal proceedings if something goes wrong. Unfortunately, there are not enough decided cases to predict with any degree of certainty how far the courts in Canada and the United States (U.S.) will be prepared to go in attributing fault in research negligence cases to those that have less than a direct connection to the injuries that have been sustained.