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."