Lawyer sees his role as warning to clinical researchers
Alan Milstein gained acclaim for winning a large settlement in the case of
a young man who died in a Penn experiment on gene therapy. Several of his
pending cases will be much bigger challenges.
By Marie McCullough Inquirer Staff Writer
Alan
Milstein, the Pennsauken- based lawyer who helped win a multimillion settlement
from Penn after Jesse Gelsinger's death, has become known as an expert on
how clinical trials go wrong. He is pursuing several other cases.
On the Web site of his law firm, headquartered in Pennsauken, Alan Milstein
is described as "a nationally recognized litigator" in the areas
of insurance, product liability, computer law, and research on human subjects.
That last specialty is a new one.
Just 29 months ago, Paul Gelsinger approached the firm to discuss the death
of his son Jesse in a gene-therapy experiment at the University of Pennsylvania.
At the time, Milstein candidly says, he knew basically nothing about clinical
trials.
Now, Milstein, 48, is relishing his spot - and the spotlight - as an expert
on what is wrong with the way new medical treatments are tested on humans.
Besides suing major research institutions across the country, Milstein has
become something of a human-research historian, lecturer and gadfly. He
decries "trivial" trials of redundant drugs, researchers with financial
conflicts of interest, and the "myth" that patients give informed
consent.
"I think we have changed the nature of [human] research already,"
Milstein
said recently in his office, a stoplight down the road from the Cherry Hill
Mall. "There are so many problems, so simply getting the issue out there
doesn't solve the problems. But researchers are aware now of what will
happen when they screw up."
Kendra Dimond, a Washington health-care lawyer, said: "Alan is a true
believer in this [issue], and that's what makes him more formidable. He has
done ... his homework. He's all over the place. He's talking to patients,
attorneys, compliance officers."
Milstein, whose longish locks and smart suits give him a GQ air, grew up
outside Baltimore, earned his master's degree in American studies at the
University of Kansas, and went to law school at Temple University.
He calls himself a "Sixties liberal," even though he was only 15
in 1969.
His tidy office is decorated with photos of Bob Dylan and the Kennedy
brothers, as well as shots of his wife and three children.
Milstein's crusade was unforeseen, but, as a believer in "cosmic
connections," he believes it was not accidental.
Milstein got the case of his career because Paul Gelsinger's brother, who
lives in Medford, is a longtime client of Sherman, Silverstein, Kohl, Rose
&
Podolsky, the firm of 29 lawyers in which Milstein is a partner.
Gelsinger, of Tucson, Ariz., called Milstein "a good man. He's a lawyer,
but
he's a human being first."
Although the case was high-profile, it was an easy legal victory, thanks
to
revelations from federal investigators. The University of Pennsylvania
settled, without admitting wrongdoing, a month after Milstein filed suit.
The settlement is undisclosed but is believed to be around $10 million.
Milstein's pending cases, observers say, will be much bigger challenges.
Among them:
A suit against Penn on behalf of Dolores Aderman, who suffered temporary
liver toxicity in the same trial as Jesse.
A class-action lawsuit against Seattle's Fred Hutchinson Cancer Research
Center for allegedly harming subjects in a study aimed at making bone-marrow
transplantation safer.
A suit against Ohio State University on behalf of a patient and her husband
who claim they were harmed by an experimental medication to aid nerve
regeneration.
A suit against four University of Oklahoma scientists that alleges patients
were harmed in a melanoma cancer vaccine trial.
A suit stemming from a University of California-Los Angeles study in which
a
schizophrenic patient committed suicide after researchers deliberately
stopped his medication.
Milstein's tactics and legal theories are controversial.
Typically, he sues not only the researchers who treated subjects, but also
ethics board members who approved the study, university executives and
trustees, even hospitals. His claims include not only traditional
malpractice and negligence, but also product liability; assault and battery;
loss of consortium; and a largely untested human-rights claim - breach of
the "right to be treated with dignity."
Milstein contends the dignity claim is rooted in the 14th Amendment of the
Constitution, a dissenting opinion in a recent U.S. Supreme Court case, and
international legal doctrine spelled out in the Nuremberg Code and the
Declaration of Helsinki.
"What Alan's doing is being as creative as possible, and using as many
different theories as possible to see what sticks," said Dimond, the
Washington health-care lawyer. "And he's going into both state and federal
courts."
Skeptics of Milstein's methods note that in January, a federal judge
dismissed the suit against the University of Oklahoma, saying the dignity
claim was "vague" and had "no support in federal law."
However, Milstein and his co-counsel also had filed suit in Oklahoma state
court, and this month they settled with university officials, leaving claims
only against the lead researcher and three others.
"I think Alan has done good in terms of bringing attention to the harms
people have faced," said Penn bioethicist Art Caplan, who was dropped
as a
defendant from the Gelsinger lawsuit before the settlement. "But he's
using
a very blunt instrument where you need to have more precision."
No matter what happens, experts agree that Milstein has delivered a wake-up
call to a research establishment that had grown far too complacent.
"To me, it's a symbol of our not having taken care of the problems ourselves,"
said Marcia Angell, a faculty member at Harvard Medical School and former
editor of the New England Journal of Medicine. "It's a pity that it takes
someone like Alan Milstein to hold our feet to the fire. It's something we
should have done ourselves."
