Gene therapy suit settled out of court

The family of Jesse Gelsinger settled their wrongful death and negligence lawsuit against the University and others involved with Penn's Institute for Human Gene Therapy for an undisclosed amount of money last week. The settlement, announced on Friday, comes just six weeks after Gelsinger's family filed the lawsuit, and more than a year after 18-year-old Jesse died while participating in a Penn gene therapy trial, becoming the first known patient to die as a result of gene therapy. Gelsinger's death prompted the U.S. Food and Drug Administration to suspend all human experiments at the IHGT and brought Penn national scrutiny for its scientific research methods. Last summer, the administration dramatically reduced the IHGT's mandate. "This has been a difficult year for everybody involved, and we are pleased that we have been able to reach an amicable resolution of the lawsuit," University President Judith Rodin said in an e-mail statement. For Paul Gelsinger, Jesse's father, the lawsuit brings closure to his discussions with Penn about the situation surrounding his son's death. "I let Penn off the hook here," Gelsinger said last night. "I could have refused to settle this case." "It's over with Penn as far as I'm concerned," he added. "I don't need to see them embarrassed anymore." As part of the settlement, Gelsinger dropped as defendants Arthur Caplan, the director of Penn's Center for Bioethics, and former Health System CEO William Kelley. The suit alleged that negligence by Penn, IHGT Director James M. Wilson and the two other scientists running the experiment directly resulted in Jesse's death. The suit also claimed that Wilson and Kelley, who both hold several gene therapy patents, stood to gain financially from the success of Penn's gene therapy experiments, and that their judgement was clouded because of it. Paul Gelsinger said he was disappointed that Penn never apologized to his family. "An apology from them would go a long way," he said. "I don't know if they have the heart to do so. That we never got an apology does not help this wound to heal." Gelsinger said that he planned on using the money from the settlement to establish a foundation in Jesse's name to distribute money to different charities. He said he hoped to work with the National Organization for Rare Disorders and Circare, a human rights organization that deals with research subjects. Gelsinger expressed doubt that Penn could really take a national leadership role in changing research conditions. "If they don't have the heart to even apologize, I don't see how they can consider themselves a national leader in bioethics," he said. The Children's Hospital of Philadelphia, the Children's National Medical Center in Washington, D.C., and IHGT investor Genovo, Inc. -- founded by Wilson -- were also named in the original suit. The suit also charged that researchers Mark Batshaw and Steven Raper withheld information regarding the risks of the trial. According to Gelsinger family attorney Alan Milstein, Caplan and Kelley were both dropped from this list "in accordance with the requirements of Penn to settle." Caplan said he was pleased that he had been dropped from the suit, and that this might send a message to the legal community about naming bioethicists in lawsuits. But Caplan said he still wasn't sure why he was named in the first place, though he speculated it may have been because he was actively involved in talking about human trials. "I think that I had a role in talking about this," he explained. "It may have been the visibility of bioethics, media accounts which didn't get the story across." Many were surprised when Caplan was named as a defendant, saying that involving bioethicists in litigation might hamper their ability to give advice. The lawsuit alleged that Caplan was at fault because it was at his prompting that researchers used adults with less severe cases of the liver disease, like Jesse, rather than fatally ill infants. The suit also repeated the violations that the FDA reported after their detailed investigation of the IHGT last year, including that Wilson's team misled the Gelsingers about the risks involved in the study and that they repeatedly violated federal research protocol. Though Penn issued a statement with the announcement of the settlement, none of the other defendants could be reached for further comment over the weekend. "Penn's hope is that the agreement among the parties will enable the Gelsingers to bring a small measure of closure to their loss," the University statement said. Gelsinger was born with a mild form of ornithine transcarbamylase deficiency, or OTC, which affects the liver's ability to break down ammonia. Though many OTC sufferers die as infants, Jesse's form of the disease could be controlled through medication and diet. He joined the trial in the hopes of helping others with fatal forms of the disease.

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