There's a surprise twist in a long-expected claim for damages filed this week in the death of Jesse Gelsinger, an 18-year-old volunteer in a gene therapy trial. Paul Gelsinger, Jesse's father, seeks unspecified compensation from the University of Pennsylvania (which hosted the trial), the director of Penn's Human Gene Therapy Institute, several clinicians, and a biotech firm. But the suit, filed in Pennsylvania state court, also names a prominent ethicist at Penn, Arthur Caplan, who advised the researchers.
Gelsinger's attorney, Alan Milstein of Camden, New Jersey, says that Caplan was named because he helped to shape the trial and the consent document that Gelsinger signed. Caplan recommended that the researchers recruit adult volunteers, such as Gelsinger, who suffered from a mild form of genetic liver disease, rather than babies at risk of dying from the disease. Caplan advised that it is better to use subjects who have made a decision for themselves than to rely on parents' consent. But Caplan says his involvement was purely informal. "It's standard in such cases to name as many people as possible and let judges and juries sort it out," Caplan notes, adding, "I worry that this may intimidate bioethicists from talking to their colleagues." Penn has already acknowledged "weaknesses" in its oversight of the trial, but says they "did not contribute to Jesse's death." The university is negotiating with Gelsinger on a settlement.