University of Pennsylvania faces gene therapy lawsuit. James M. Wilson
has been named in a new suit charging wrongdoing in a medical study.
By Alexis Gilbert, December
13, 2001
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.
