Experts speculate about potential effects of Gelsinger lawsuit

The lawsuit filed Monday against the University and members of its Institute for Human Gene Therapy has left many in the fields of health law and medical ethics speculating about its possible outcome. Many experts predicted the process would be drawn out and that the University would continue to maintain that Jesse Gelsinger's death was not a direct result of their researchers' error. Boston University Professor of Health Law and Medicine George Annas went even further, forecasting that "the University will be happy to settle on reasonable terms." The lawsuit is "not anything anyone's proud of," he added. Former Penn Communications Director Ken Wildes -- who is still working with the University on the Gelsinger case -- said that it is not likely any of the defendants will be saying much about the suit any time soon. He added that the time it will take for the matter to be resolved is complicated by the fact that there are so many defendants. The University will be defending itself, its Institute for Human Gene Therapy, former Health System Chief Executive Officer and Medical School Dean William Kelley, bioethicist Arthur Caplan and the researchers who conducted the trials who have remained members of Penn's faculty -- IHGT Director James M. Wilson and Steven Raper. Also named in the suit are the Children's Hospital of Philadelphia, the Children's National Medical Center in Washington, D.C., and former Penn researcher Mark Batshaw -- none of whom are commenting on the lawsuit at this time. According to the lawsuit, CHOP was named because its Institutional Review Board "reviewed and approved protocol for the OTC gene transfer experiment" in which Jesse Gelsinger took part. Alan Milstein, the Gelsingers' attorney, said it is for this reason that CHOP and its IRB are being named in the suit, and the U.S. Food and Drug Administration -- which admitted to not properly monitoring the gene therapy trials -- is not. The absence of the FDA's name on the lawsuit was a surprise for many because Jesse Gelsinger's father Paul was an outspoken critic of the FDA from the outset, and had often said he placed the blame for Jesse's death "up and down the line." Milstein said that CHOP's IRB had a greater responsibility to oversee the research than the federal government, and added that CHOP, unlike the FDA, played "some role in the development of the clinical trial." Also a surprise in the suit was the inclusion of Caplan, the director of Penn's Center for Bioethics, among the list of defendants. Caplan's alleged role in Gelsinger's death was that he advised the IHGT to experiment on healthy individuals with only a mild form of OTC -- such as Gelsinger -- as opposed to infants with the more fatal form of the disease. Caplan felt informed consent could not be obtained for the infants, citing clouded judgement on the part of their parents.