Lawsuits target medical research - Patient safeguards, oversight key issues

By Alice Dembner

Boston Globe 8/12/02

For years, medical researchers were largely immune from lawsuits. While other doctors faced a wave of malpractice suits, researchers seeking cures for diseases such as cancer found patients eager to participate in experiments and unlikely to hire a lawyer if something went wrong.

But the death of Jesse Gelsinger in 1999 changed all that. The healthy teenager died of massive organ failure in a gene therapy experiment gone awry. His family won a multimillion-dollar settlement in 2000, opening the door to other suits by focusing national attention on the flawed protections for study participants.

While the total number of suits remains small, involving only a few dozen of the hundreds of thousands of people who participate in medical experiments in the United States each year, their existence is sending shivers through the research community. Together with increased federal prosecution of research fraud, the suits are spurring efforts to improve the safety of experiments - and a scamble for more insurance.

''Lawsuits were unheard of eight to 10 years ago,'' said Janet Richardson, a Los Angeles lawyer who defends drug and medical device manufacturers. ''Now, it's the hot topic.''

Most of the suits target alleged medical malpractice where patients were injured, but some are focusing on alleged ethical violations - such as inadequate oversight or hidden financial conflicts - that are particular to research. Cases filed in the last few months illustrate the range of claims: A Philadelphia woman contends she lost complete control of her bowels as a result of an experiment at Graduate Hospital of Philadelphia. She is suing not only the hospital and a surgeon, but the ethics committee that approved the experiment.

A Peabody woman is seeking damages for the death of her husband during a gene therapy experiment at St. Elizabeth's Medical Center in Brighton. Roger Darke suffered from severe heart disease, and federal officials uncovered no evidence that the experiment killed him. But the lawsuit notes that he died only hours after a gene was injected into his beating heart, and asserts he was tricked into participating by doctors who had a financial interest in the experiment's outcome.

A Bucks County, Pa., woman who participated in the University of Pennsylvania study that subsequently killed Gelsinger charges researchers breached her right to be treated with dignity and caused psychological harm by misrepresenting the study's dangers.

All the doctors and institutions deny the allegations.

The suits have sparked debate about whether they represent legal opportunism or a force for meaningful change. But there is widespread agreement that protections for participants have not kept pace with the rapid growth of experiments required to test new drugs and devices.

Federal officials, too, are taking more action against research wrongdoing. Regulators have shut down research at several major universities in the last few years because of safety lapses and prosecuted individual researchers for fraud in experiments. And in April, the government won a guilty plea and a $1.2 million fine from an Ohio company, Gliatech, accused of falsifying study results to obtain Food and Drug Administration approval of a surgical gel.

''We're walking on eggshells,'' said Susan Cronin, a researcher at Bone Care International, a Wisconsin pharmaceutical company. Many attribute the increase in suits to one lawyer in a New Jersey firm, who now specializes in medical experiments following his success in the Gelsinger case. Alan Milstein has brought nearly a dozen cases, which he posts on the Internet, where other lawyers have easy access to his arguments.

But Milstein points to problems in the experiments themselves as the true source of the suits. ''You've got an explosion of clinical trials in this country, and you've got more injuries, more bypassing of regulations, more violations,'' said Milstein.

''There is also an increased recognition that human subjects harmed in research have rights and remedies. The clients I represent ... have welcomed the approach of trying to make real change through this process,'' he said. While the Gelsinger case involved a wrongful death claim, as malpractice cases have for years, Milstein is seeking to create new case law with suits for ''dignitary harm'' to patients who can prove no physical harm from experiments. The claims, such as those of Dolores Aderman of Pennsylvania, draw on the 14th Amendment to the Constitution, which guarantees life and liberty, as well as international covenants on ethical treatment of research participants. They also focus on requirements that patients in experiments knowingly consent to the risks before agreeing to participate. In the past, in the absence of severe harm to participants, lawyers often considered that consent an obstacle to a suit.

Aderman contends she suffered emotional harm because the University of Pennsylvania gene therapy researchers didn't fully disclose the experiment's risks, including that a similar test made monkeys ill, or the university's investment in marketing gene therapy. School officials have denied the allegations and asserted that Aderman suffered no harm.

Milstein is not the first to bring a claim of dignitary harm. Stephen F. Hanlon, a Florida lawyer, won a $3.8 million settlement from the University of South Florida and Tampa General Hospital in 2000 in a federal class action suit arising from a drug study of poor women with high-risk pregnancies.

None of the women or their babies suffered any physical harm. In fact, the study showed the drugs helped their babies' lungs develop. But the women asserted they weren't told the drugs were experimental or that they could refuse to participate, and they said the consent form was far above their reading level.

In settling, neither the university nor the hospital admitted wrongdoing, and the case did not set legal precedent. But the institutions simplified their consent forms and the case pointed the way for other suits. ''The traditional defense of the biomedical research profession was no harm, no foul,'' said Hanlon. ''I thought that was wrong. When you touch someone without their consent, that is independently compensable because it violates their basic human dignity.''

''I don't think there are many lawyers out there who are going to have the guts to take on a dignitary harm claim,'' he added. ''But if you've got injury, then this whole informed consent process is not going to be a barrier to litigation the way it has been in the past.''

Some of the suits Milstein and other lawyers filed in the last two years break other new ground by targeting the ethics committees that oversee experiments. Federal officials have also cited these committees, called institutional review boards, as a weak link in experiment safety.

So far, no review board member has been held liable by the courts for problems in an experiment, although Milstein and other lawyers have won settlements from hospitals where the panels were included as defendants. The lack of verdicts and small number of cases leads Leonard Glantz, a professor of health law at Boston University, to conclude that concern about the suits is overblown. ''Anyone can sue anyone,'' he said. ''Lawyers sue as many people as possible because it leads to quicker and richer settlements. So far, we have a few cases settled out of court.''

But some hospitals say the suits are making it more difficult to recruit researchers and citizens to take on the voluntary duties of a review board member.

''They are concerned about liability for themselves as well as the institution,'' said Paula Knudson, executive coordinator of the institutional review board at the University of Texas Health Science Center. And she said the suits and government actions have ''focused the attention of IRB members and offices on the problems and caused us to reassess what we're doing.''

Indeed, academic medical centers nationally are spending millions of dollars to improve protection of study participants, according to Jennifer Kulynych, an administrator at the Association of American Medical Colleges. Many hospitals and companies that do medical experiments are also seeking more insurance coverage.

''We've been inundated,'' said Jill Wadlund, a casualty underwriter for the Chubb Group of Insurance Companies.

But insurers are offering coverage at a price, wary of the likelihood of more lawsuits, said Robert Hartwig, chief economist for the Insurance Information Institute. Insurers are requiring higher deductibles or co-insurance and investigating researchers' safety and consent practices before writing policies, he said.

More researchers will probably need those insurance policies in the future, prosecutors indicated, as more whistle-blowers come forward and the FDA increases its referrals to the Department of Justice.

''There are a significant number of cases coming,'' said James Sheehan, an assistant US attorney in Philadelphia who specializes in medical cases. ''We had a training program for experienced health care prosecutors recently, and half the session was on clinical trials. This is an area of significant interest and growth.''