Six weeks after filing a lawsuit against the University and other parties over the death of 18-year-old Jesse Gelsinger [“Gazetteer,” November/December], the Gelsinger family agreed to an out-of-court settlement for an undisclosed sum. The family had filed its suit on September 18 for wrongful death, assault, battery, lack of informed consent and fraud; the agreement to settle was announced November 3.
In addition to Penn, the suit had named Dr. James M. Wilson, the John Herr Musser Professor and Chair of Cellular and Molecular Engineering who serves as director of the Institute for Human Gene Therapy (IHGT); Dr. Mark Batshaw C’67 and his employer, the Children’s National Medical Center of Washington; Dr. Steven Raper, associate professor of surgery at Penn; the Children’s Hospital of Philadelphia; Genovo, a genetic-research firm, founded by Wilson, that provided much of the institute’s funding; Dr. William N. Kelley, the former head of the University of Pennsylvania Health System and former dean of the medical school, who recruited Wilson; and Dr. Arthur L. Caplan, director of Penn’s Center for Bioethics and Trustee Professor of Bioethics in Molecular and Cellular Engineering. Caplan and Kelley were dismissed from the suit prior to the settlement.
Gelsinger suffered from a hereditary liver disorder known as ornithine transcarbamylase deficiency (OTCD), which prevents the liver from properly processing ammonia. He died on September 17, 1999, four days after being injected with a modified cold virus designed to carry corrective genes to his liver.
In a statement, the University said it “extends its deepest sympathy to the Gelsinger family,” and that it “appreciates the seriousness and openness with which the family and its representatives entered into the discussions that led to the settlement.” Saying that it hoped that the agreement “will enable the Gelsingers to bring a small measure of closure to their loss,” Penn noted that it can now “concentrate on moving forward with its aggressive efforts to improve its oversight and monitoring of human subject research,” an effort to which it has “already devoted substantial resources of time, energy and money.” The goal, it added, “is to establish—and to continually improve upon —a national model for clinical research, and in this way honor Jesse Gelsinger’s memory.”
The Gelsinger family noted that the purpose of their lawsuit was “always to bring to the public certain critical issues concerning human participation in clinical trials in general, and gene-therapy trials in particular.” Saying that while they “fervently hope gene therapy will one day be the means to cure many of the horrible diseases afflicting so many, they urge that the road toward this or any medical breakthrough is free of conflicts of interest, bioethical missteps and inadequate government insight.
“The Gelsingers appreciate that Penn, whatever its faults in the past, is taking seriously the need for research universities to improve the conditions under which clinical research is conducted,” they added. “Penn has said it is staking out a leadership position on these issues, and that meant a great deal in resolving this case.”
