Parties Settle Suit Against Penn Over Gene Therapy

Jesse Gelsinger would want his legacy to be about advancing the protection of individuals undergoing gene therapy, a lawyer for his family said last week.

Six weeks after filing suit in the Philadelphia Common Pleas Court over the 18-year-old’s death, the Gelsinger family reached a confidential settlement with parties affiliated with the University of Pennsylvania’s Institute for Human Gene Therapy.

Gelsinger died in September 1999 while undergoing gene therapy as part of a study of Ornithine Transcarbamylase Deficiency.

Gelsinger was diagnosed with the rare disorder, which prevents the body from processing ammonia, at age 2.

According to counsel for the family – Robert J. Mongeluzzi and Larry Bendesky of Saltz Mongeluzzi Bendesky and Alan C. Milstein and Harris L. Pogust of Haddonfield’s Sherman Silverstein Kohl Rose & Podolsky – the parties had been seeking a resolution on to the emotionally charged issue since August.

In a joint statement released Friday, the university said the agreement will “enable Penn to concentrate on moving forward with its aggressive efforts to improve its oversight and monitoring of human subject research, an effort to which the university has already devoted substantial resources of time, energy and money. Our goal is to establish – and to continually improve upon – a national model for clinical research and in this way honor Jesse Gelsinger’s memory.”

Although a complaint was filed in September, conversations continued, Mongeluzzi said. The complaint was filed against the university; Genovo, a bio-tech company; the Children’s Hospital of Philadelphia and the Children ‘s National Medical Center in Washington, D.C.; and several doctors and professors affiliated with the project. Pepper Hamilton’s Nina M. Gussack represented the university in the suit.

The complaint charged those affiliated with the experiment with wrongful death, strict products liability, lack of informed consent, infliction of emotional distress, and fraud and misrepresentation to the patient and the Food and Drug Administration.

“I think everybody realized that the issues were very serious. It was emotionally charged for everybody involved. We were looking down the road and saw where we might go in the future. We wanted to reach an amicable conclusion now rather than later,” Bendesky said.

Counsel for the plaintiff submitted an undisclosed monetary demand and a fall deadline to the defense early in negotiations, Mongeluzzi said. The deadline was extended to late October to address defense concern s about insurance coverage. The final settlement figure was close to the original request, Mongeluzzi said.

“The number and magnitude of local jury verdicts in the last two months certainly was a factor” in the settlement, Mongeluzzi said. “Our number was going to go up.” In late October, Philadelphia Common Pleas Court juries awarded $55 million in one case and $ 100 million in another.

The settlement, which was finalized Wednesday, also released two plaintiffs – Penn trustee professor of bioethics Dr. Arthur L. Caplan and former medical school dean Dr. William Kelly – from the suit.

According to the Gelsinger family’s statement, “the purpose of this 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. While the Gelsingers 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 oversight.”

It was closure the family most wanted, Bendesky said.

According to Mongeluzzi, “The family paid the ultimate sacrifice. One of the things they wanted to accomplish was to have an impact on how clinical trials are run. But they paid a hell of a price.”