U. faces gene therapy lawsuit

A woman who participated in the same gene therapy trial that resulted in the death of 18-year-old Jesse Gelsinger is suing the University for misleading her about the nature of the trial and causing her physical duress.

Dolores Aderman is suing the University, the Hospital of the University of Pennsylvania, Institute for Human Gene Therapy Director James M. Wilson and two other doctors -- Steven Raper and Mark Batshaw -- who worked on the trial.

Aderman has alleged that the University did not treat her with the dignity she, as a research subject, deserved during the gene therapy trial.

Although Aderman filed a writ of summons -- a precursor for the lawsuit -- in June of 2000, she did not specify her allegations against the defendants until last week.

According to Aderman's attorney Alan Milstein, she "is claiming that the clinical trial was below the standards of the ethical guidelines, which are supposed to govern such research, that the informed consent process was flawed, and that they didn't treat her with the dignity all human subjects are entitled to be treated with."

Aderman is asking for a sum in excess of $50,000 in compensatory and punitive damages.

"The University intends to mount a vigorous defense to this complaint, which we believe to be wholly without merit," University spokeswoman Lori Doyle said. "We are confident that a careful review of the record will demonstrate that."

Research trials involving human subjects have not been allowed to resume at Penn since the Gelsinger trials, and the U.S. Food and Drug Administration is still considering whether Wilson should be permitted to perform clinical trials again.

Although Raper remains at Penn, Batshaw has since moved to the Children's National Medical Center in Washington, D.C.

The University provides legal assistance to all of the defendants, but Wilson, Raper and Batshaw also have their own attorneys, who could not be reached for comment last night.

The 1999 gene therapy trial in which Aderman took part was designed to test an experimental treatment for a disease, called ornithine transcarbamylase, or OTC deficiency, which inhibits the liver's ability to process proteins.

Only women are carriers of the disease, passing it on to their sons. Newborn males exhibit symptoms after their first meal, and, in most cases, go into comas shortly thereafter and die.

IHGT researchers sought out adult subjects for the study because they determined it was bioethically wrong to offer an experimental treatment to parents whose babies were about to die. Adult subjects could also provide informed consent to participate in the trial.

The researchers chose relatively healthy adults who were carriers of the disease, like Aderman, or exhibited milder forms, like Gelsinger. Aderman and Gelsinger were given the largest doses of treatment out of any of the participants in the study.

Milstein said Aderman was interested in the study because she had two children who died from OTC.

The University disputes three main points of Aderman' lawsuit. First of all, while Aderman claims she was not properly enrolled in the trial, Penn claims that she was.

Aderman also claims that she was misled about the nature of the study by the consent forms she was asked to sign. She said the forms made no mention of the University's or Wilson's intention to profit from the results of the experiments.

Wilson had a substantial financial stake in the private company Genovo, Inc., which held the patents for the new therapies Wilson was testing.

Doyle, however, said that the University still holds copies of the consent forms and added that they clearly state the therapies could be used for Wilson's and the University's profit.

Finally, Milstein said Alderman "certainly believes she has permanent liver damage as a result of [the trial]. It's difficult to assess at this point what, if any, permanent physical injuries she has suffered."

"But," Milstein added, "she certainly has emotional damages."

Penn counters that it can be proved that Aderman was in no way physically harmed by the therapies.

"We're going to really fight this one," Doyle said. "It's very unlikely that we would settle [out of court] as a matter of principle on this one."

The family of Gelsinger filed a lawsuit on Sept. 18, 2000 -- one year and a day after his death -- against Penn, Wilson, Genovo, Raper, Batshaw, the Children's Hospital of Philadelphia, the Children's National Medical Center, Director of Penn's Center for Bioethics Arthur Caplan, and former CEO of Penn's health system William Kelley.

Milstein was also the Gelsinger family's attorney.

The Gelsinger lawsuit made similar allegations to the ones Aderman has made, but Penn settled the lawsuit out of court in the end. Milstein said the cases are quite different, though.

"The difference is obviously that she didn't die, and I think that's less important than many people like to believe. I've said all along that when such experiments are flawed, all the subjects are injured, and while it's certainly tragic for Jesse Gelsinger's father, the kinds of wrongs committed here were committed against all the participants," he said.

There is also a separate component of the Aderman lawsuit classified as dignity damages.

"In this field of law there has developed a concept known as the right to be treated with essential human dignity. It's a right all research subjects have," Milstein said.

"Those damages are separate and apart from any damages from serious illness or death or the kinds of things that certainly were part of the Jesse Gelsinger case," he explained.

Please note All comments are eligible for publication in The Daily Pennsylvanian.