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.''
