Bioethicist Caplan puzzled by status in IHGT lawsuit

When the Gelsinger family filed a lawsuit on Monday against Penn for the wrongful death of Jesse Gelsinger, no one was surprised -- until they saw the list of defendants. Arthur Caplan, world-renowned director of Penn's Center for Bioethics and a pioneer in the field, is included in the blame for allegedly misadvising the study's designers. That move, some say, will hurt bioethicists' ability to give scientists moral advice. "I worry that when litigation reaches out as far as people giving opinion, it could have a chilling effect," Caplan said in an interview yesterday. The complaint, filed in Philadelphia Common Pleas Court a year and a day after Gelsinger's death, claims the death was a direct result of negligence and conflict of interest by Penn and the three scientists who ran the gene therapy experiment in which Gelsinger was enrolled. And according to the lawsuit, Caplan gave advice to IHGT researchers that led to Gelsinger's inclusion in the trial. The lawsuit alleges that Caplan told researchers to use healthy adults as subjects instead of terminally ill infants, which was the original plan, for ethical reasons. "Parents faced with hard choices -- that's a hard place to get [informed] consent, study after study shows," Caplan said. Gelsinger's father has said over the past year that researchers misled his son -- who thought by enrolling in the study that he would help fellow OTC sufferers -- about the trials' benefits. A surprised Caplan said he does not think the suit against him has much basis. He explained that the first trial run in any clinical treatment experiment must be a "safety study" -- to test the side effects on humans -- and are by law never allowed to be conducted on infants, or the mentally ill or disabled who cannot give informed consent. "That is the law, not something I made up," he said. Boston University Professor of Health Law and Medicine George Annas said he is not surprised by the lawsuit's inclusion of Caplan -- the first of a bioethicist to Annas' knowledge -- given his well-known name. "There are a lot of strategic reasons why they [Gelsinger's] would have," Annas said. "That's a little bothersome." Annas agreed with Caplan's claim that there are no grounds for including him in the suit. "I can understand why the Gelsinger family is upset," Annas said. "But it is not the ethicist's job to design the study." "Any way you look at it, Dr. Caplan is not in any legal trouble here," he added. "But no one likes to be sued." Still, many of the country's bioethicists now fear that by giving what might be considered bad advice, they might wind up with their own day in court. "[The lawsuit] is going to have an inhibiting effect on the advice that is going to be given," Princeton University Bioethics Professor Peter Singer said. "I don't think the courts are really the best place to sort out whether the advice we give is good or bad," Singer said, adding that he thinks the suit will have "a very damaging effect on freedom of speech and opinion." "It scares me. I don't think it's fair to hold people responsible for decisions they made with their best judgment," Director of the Center for Bioethics at the University of Minnesota Jeffrey Kahn said. "I think he [Caplan] was doing the best he could."

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