Clinical Trial Lawsuits Are on the Rise


Clinical Trial Lawsuits Are On The Rise

Lawyers Weekly

By Nora Lockwood Tooher

September 2, 2005

Jesse Gelsinger was 18 years old and suffering from a rare liver disorder when he entered a gene transfer clinical trial at the University of Pennsylvania in 1999. He died on his fourth day in the study, following a gene therapy injection.

Gelsinger's father testified that his son's condition was under control, but that he agreed to participate in the clinical trial to help others suffering from the disease. His family claimed that the teen had been misled about the experiment's risks.

The Food and Drug Administration concluded that the injection killed Gelsinger. A confidential settlement in the case was reached in November 2000.

For attorney Alan C. Milstein, who represented the Gelsinger family, the case - Gelsinger v. University of Pennsylvania - was his first foray into the burgeoning area of clinical trials litigation. Milstein, a partner in Sherman, Silverstein, Kohl, Rose & Podolsky, in Pennsauken, N.J., has since filed more than 20 similar claims, and currently has about six human research cases pending.

Fueling the litigation is the massive number of clinical trials under way, public distrust of pharmaceutical companies, and concerns about the possible lax ethics of clinical investigators and research institutions.

"There have been lapses," acknowledged Greg Koski, director of Boston-based Partners HealthCare System's human research affairs. "Increased public - and lawyer - awareness of these lapses in professionalism and responsible conduct provide fuel for lawsuits, and the numerous accounts of such lapses in the media have undoubtedly fueled the flames."

There are about 50,000 clinical trials currently under way throughout the world, increasing at the rate of 8 to 10 percent a year, according to CenterWatch in Boston, which lists clinical trials. In 2003, there were 3.6 million individuals enrolled in clinical trials in the United States, according to the center.

Milstein contends that there hasn't actually been a dramatic increase in the number of clinical trial-related suits - only more publicity about them. But most experts agree that this litigation is definitely on the rise.

J. Mark Waxman, a partner at Foley & Lardner in Boston and a member of the Firm's health law and litigation departments, believes that the increasing number of clinical trials, coupled with the fact that outcomes are not always positive, is pushing up the number of suits.

"When you have a negative outcome, questions are always raised whether [patients] understood the potential for a negative outcome and whether people properly administered the processes of the trial," he said.

Spate Of Suits

A number of high-profile clinical trial cases have recently made their way through the courts. They include:

In 2001, Maryland's highest court ruled that researchers at an affiliate of Johns Hopkins School of Medicine could be sued for exposing children to hazardous levels of lead paint during a research project aimed at determining the effectiveness of varying lead abatement procedures. (Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. Ct. App.).)

Families of 13 patients in a melanoma study sued the Oklahoma University School of Medicine at Tulsa, the university's institutional review board and the company that supplied the drug used in a vaccine for fraud in 2001. The suit alleged that the defendants failed to follow federal human subject regulations. A federal court held that it did not have jurisdiction over the allegations, and dismissed the case. A similar claim filed in Oklahoma state court was settled in February for an undisclosed amount. (Robertson v. McGee, No. 4:01CV60 (D. Okla.).) In April 2004 a Seattle jury cleared the Fred Hutchinson Cancer Center of negligence in the death of four patients who died in a medical experiment 20 years ago. The jury did find the center negligent in the death of a fifth patient whose bone marrow was lost in a laboratory mishap, and awarded more than $1 million to his family. Plaintiffs' attorney David E. Breskin, of Short, Cressman & Burgess in Seattle, said he is appealing the four defense verdicts; the Hutchinson Center is appealing the $1 million plaintiff's verdict. (Dagosto v. Fred Hutchinson Cancer Research Center, No. 02-2-0603-9SEA (King County, Washington Superior Court).)

The defendants in these suits range from pharmaceutical and biotech companies to hospitals and institutional review boards. Most of the allegations center on the issue of informed consent - claims that the research participants weren't given enough information before agreeing to participate.

In the Oklahoma case, for example, the plaintiffs alleged "therapeutic misconception," claiming that the study's principal investigator, Dr. J. Michael McGee, "was actually convincing these people it was a therapy, as opposed to an experimental process," said plaintiffs' attorney Robert V. Seacat.

"All these people were terminally ill," said Seacat, of Okmulgee, Okla. "The doctor didn't tell them the state of his vaccine trial was in the toxicity stage - to see if it made them sick, not if it worked."

Recently, however, a new legal twist has developed in these cases. A group of clinical trial participants is suing Amgen for denying them continued access to an experimental drug. The company had stopped the trial because of the drug's potentially harmful side effects.

A federal judge in Kentucky in July denied the plaintiffs' motion for a preliminary injunction to force the Thousand Oaks, Calif. company to re-supply them with the drug. (Abney v. Amgen, No. 5:05-CV-254 (E.D. Ky.).)

A similar case filed against the company by two trial participants enrolled at a New York University clinical trial site also failed in June. That case is now on appeal to the 2nd Circuit. (Suthers v. Amgen, 372 F.Supp.2d 416 (S.D.N.Y.).)

Right To Dignity

Lawyers who handle these cases credit Milstein with developing a novel legal argument based on a breach of the right of individuals in human experimentation to be treated with dignity.

Previously, most clinical trials suits alleged medical malpractice. Since the Gelsinger case, however, most suits have cited the Nuremberg Code, a set of ethical rules established after the Nazi's horrific experiments on concentration camp inmates. Plaintiffs also cite the Belmont Report - a 1979 report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that is considered the major ethical statement guiding human research in the United States. Federal regulations governing investigational drugs and the protection of human research subjects, as well as a growing body of case law in this area, may also be noted.

Federal guidelines for clinical trials require that studies must be ethical, financial conflicts of interest that could affect patient care must be disclosed and the rights of participants must be protected. This means that volunteers have to be informed about the purpose of the study, as well as the benefits and risks of participating.

Despite these guidelines, several attorneys believe that more reform is needed.

"The government itself needs to be more concerned with what goes on in human subject research," Milstein told Lawyers Weekly USA. "There needs to be more education among the sponsors, researchers and clinicians as to the rights of human subjects, and there needs to be some real changes in the system so that the money does not taint and corrupt the system."

In Milstein's view, one major area where reform is needed is the consent forms used in clinical trials.

"I don't think the consent forms are worth the paper they're printed on," he said. "There's a real disconnect between what the subjects understand to be going on and what the consent form says."

Nancy Sher Cohen, co-chair of Heller Ehrman's insurance coverage practice group in Los Angeles, agreed.

"The consent form ... needs to be written both thoroughly and in language that people can understand," she said.

Waxman opined that the industry also needs to address concerns about financial conflicts of interest among doctors as research becomes increasingly commercialized.

"I think the public is very interested in research going forward, but the public is also getting more nervous about those involved in the research process having conflicts of interests," he said.

In the Gelsinger case, for example, Milstein alleged that investigators committed fraud by not revealing that previous subjects had died, and that the principal investigator had a financial relationship with the sponsoring biotech company.

In the Hutchinson Center cases, the plaintiffs alleged that doctors misled patients about the risks and had a hidden financial conflict of interest because they owned stock in a biotech company that had licenses for the antibodies being used in the experiments.

"There was no disclosure at all of the potential financial interest the researchers had in conducting the experiment," said Breskin, who represented the plaintiffs.

Impact On Research?

Breskin predicted the increased litigation would help spur needed reforms in clinical trials.

"Undoubtedly, because of cases like these, there's going to be more focus on what human subjects are actually being told, and how they're being courted to participate in these experiments," he said.

But several experts said they worry that mounting litigation may have a chilling effect on research into new drugs and medical procedures.

"There can be a very negative impact in terms of making investigators and institutions less willing to expose themselves to risk of lawsuits, a phenomenon I have called 'reactive hyper-protectionism,'" Koski explained. "Whether the fear is of lawsuits or regulatory scrutiny, the research process suffers. Fear also affects the willingness of individuals to volunteer to participate in clinical research."

Jay Mayesh, a New York pharmaceutical defense attorney, agreed.

"In our current legal climate, one must err on the side of being very conservative in warnings, but on the other hand, the problem is the FDA doesn't want you to be overly negative about a drug because then you're scaring away patients who need the drug, could benefit from the drug and shouldn't be scared away," said Mayesh, a partner at Kaye Scholer.

Koski said that research organizations can best protect themselves from suit by "doing things right in the first place."

This would include having "well-trained, preferably certified individuals working at every level of the research process, and relying solely upon accredited human research protection programs," he said.

Requiring certification and accreditation would "likely reduce the concerns over liability and the negative impact they have on clinical research," Koski added.