When Clinical Trials Fail
Medical research has yielded a brave new world of scientific marvels over the last 20 years.
But along with those developments comes a brave new world of legal issues.
This spring, a Washington state jury delivered the first major verdict in a case on human experimentation, a resounding win for a renowned Seattle cancer institution.
In the case, brought by families of five deceased patients against the Fred Hutchinson Cancer Research Center, a jury found in April that the patients gave informed consent to participate in an unsuccessful clinical trial and that the experiment was not carried out negligently. Wright v. Fred Hutchinson Cancer Research Center, No. 03-2-16586-7SEA.
For the defense, the stakes were high—nothing less than the future of medical research, its lawyers argued.
In closing arguments, attorney George Mernick III told the jury that a verdict for the plaintiffs would send doctors the message: “Don’t be innovative. Don’t think about new solutions to problems. When they come to mind, go real slowly with them.”
But the plaintiffs argued that the patients, who had leukemia and needed bone marrow transplants, weren’t given enough information about the experiment. Specifically, they alleged that the patients weren’t told that the experiment carried an increased risk of graft failure death over conventional treatment.
“They make you assume your care will be at least as good as standard,” says Thomas Dreiling, one of the plaintiffs’ lawyers. They also argued that the informed consent didn’t pass muster because the patients weren’t given the option of taking part in another Hutch experiment that turned out to be successful.
The 12-year experiment, called Protocol 126, tested whether a new drug could prevent graft-versus-host disease, a complication of bone marrow transplants. The drug caused graft failure and almost all participants died.
Had the patients undergone conventional treatment, their chances of cure would have ranged from 15 percent to greater than 50 percent, depending on their age and how sick they were, according to Dreiling.
In fact, the level of illness may have weighed heavily with the jury. Not only the patients’ families but also the doctors on trial broke down weeping on the witness stand, says Mernick. By the end of the emotional 10-week trial the issues for the jury were whittled down to whether the patients gave informed consent and whether Protocol 126 met the standards of the research community.
IT’S UP TO THE PATIENT
But the jury found that the plaintiffs didn’t prove that any missing information would have changed the patients’ decisions. Dreiling says that several jurors told him after the trial that they believed the patients would have been willing to take on extra risks in exchange for a better chance at a cure.
Such reasoning could be a factor in future clinical trial litigation where patients start out very sick. Boston attorney J. Mark Waxman says the verdict may have come partly because the patients had poor prospects before they came to the Hutch.
“You’re dealing with people who have terminal disease, or clients with potential to be terminal,” says Waxman, chair of the ABA Health Law Section’s Committee on Medical Research Technology and Clinical Ethical Issues. In such a situation, he says, jurors can believe that signing up for a risky treatment isn’t as irrational as it sounds.
The Seattle case is one of a handful of recent suits stemming from clinical research trials including, most famously, the Jesse Gelsinger case. The 18-year-old Gelsinger died in 1999 after receiving experimental gene therapy at the University of Pennsylvania. His family filed a lawsuit, which later settled; so far, the suit against the Hutch is the only high-profile case to go to the jury.
Dreiling says the plaintiffs will probably appeal.