Lawsuits can be a result of poor communication

Improved consent process can offer protection

The recent lawsuit against Abiomed Inc. of Danvers, MA, and others involved in clinical trials involving the AbioCor Implantable Replacement Heart shows that sometimes the best preparation and informed consent process still cannot prevent litigation.

It also shows that research subjects and their families sometimes fail to understand issues that clinical trial administrators and others think have been clearly communicated.

Irene Quinn, wife of James Quinn, who died about 10 months after receiving an AbioCor heart in November 2001, sued Abiomed, as well as Tenet Healthcare Corp. of Santa Barbara, CA; Drexel University and Hahnemann University Hospital, both of Philadelphia; and David Cassarett, MD.

Cassarett was employed for patient advocacy services during the clinical trial, says Haavi Morreim, PhD, professor in the College of Medicine at the University of Tennessee-Memphis, and chair of the Independent Patient Advocacy Council (IPAC).

IPAC was created by Abiomed to provide patient advocacy services and advise the corporation on the ethical aspects of the trials. IPAC is funded through an irrevocable trust and is self-governing and independent of Abiomed.

The lawsuit, filed by plaintiff’s attorney Alan C. Milstein of Pennsauken, NJ, made a number of claims that highlight how differently a research subject and researchers may look at the same clinical trial and informed consent process.

For example, the lawsuit claimed the following: "The defendants, through their agents, represented to the Quinns that they would work to set up a trust fund for Mrs. Quinn, which would be available to her following the experiment."

This is the type of issue that demonstrates how poorly a subject and a subject’s family might understand the clinical trial process.

Abiomed’s 13-page informed consent for the AbioCor clinical trials makes no mention of any such trust fund. However, the subject and his wife may have heard about another AbioCor clinical trial subject who did benefit from a trust fund established by a bank and local community in order to help the couple defray traveling costs during the man’s surgery and recuperation.

"I can’t say what was in the mind of the plaintiff, but obviously Mr. Milstein did not understand," Morreim says. "He was alleging [Quinn] would receive a trust fund at the end of the trial, and no IRB [institutional review board] is going to approve a surrogate decision maker coming into substantial sums of money after the patient is no longer alive."

The lawsuit was settled out of court, first by all defendants except Abiomed and Cassarett, and then by Abiomed after the corporation’s insurance company ordered the attorneys to settle. Cassarett paid no part of the settlement, which totaled $125,000, and resulted in all claims being dismissed with prejudice, he says.

One of the major problems with any type of litigation against clinical trials sponsors, investigators, and health care organizations is that the plaintiff’s attorney controls the public’s information about the case, Morreim says.

"That makes it difficult for defendants, who are subject to confidentiality requirements," he says. "Even when the plaintiff has waived patient confidentiality by filing a lawsuit, medical ethics expects us to honor privacy and confidentiality."

Therefore, Abiomed and other companies in similar situations may have evidence to rebut the charges, but these never come out unless the case goes to trial.

"This case was settled because the insurer demanded it, and so the evidence that the defendants had to vindicate their name and reputations will never be public," Morreim says.

Communicate more clearly

This underscores the importance of improving the communication and informed consent process with subjects and taking steps that may reduce the risk of exposure to litigation. Here are a few of the steps clinical trial administrators can take to make certain subjects are fully informed about their potential risks, benefits, and other issues:

• Give patients time to absorb information. "In terms of conversations, it would seem that periodic pausing helps," Morreim says. "Pause periodically and ask the enrollee, Tell me what you are thinking; what have you heard?’"

Listen for gaps between what the patient advocate or clinical trial administrator has described and what the enrollee has heard, he advises.

"It can be a good idea to jot down questions to remember them, and it’s especially important to do so because we bring questions to the principal investigators or to whoever is the suitable person to answer them," Morreim says.

If the person discussing the trial with the subject sees that the subject is tired or under stress, then take a break and come back to the conversation later, he says.

"Allow the person to rest between conversations," Morreim says. "There’s no rule that the informed consent has to be done in one sit-down session."

For the AbioCor heart trials, there are numerous conversations held at each site for all prospective enrollees, so it’s never done in one face-to-face conversation, he notes.

• Emphasize what isn’t known about the treatment/device/medication. "Emphasizing uncertainties can be important," Morreim says.

For instance, in the trial of a new drug or device, there are various outcomes that could happen and not all of them are expected, he notes.

One way to broach uncertainty with an enrollee is to say, "Unexpected things can happen sometimes; sometimes they are minor; sometimes they are serious, and sometimes they are very serious," Morreim suggests.

• Talk about the enrollee’s values and goals regarding participation. "We feel it’s very important to talk about a patient’s values and goals for participating in the research," he says. "Because [AbioCor] is a device that involves potentially prolonging or not prolonging life, they need to think about their goals for end-of-life care and what sort of quality of life is OK, and what is not very good quality."

It’s important to let enrollees know that they may want to think about or talk about these issues, but the topic shouldn’t be forced, Morreim says.

"We invite people to talk with each other and to talk with the clinical team and, if they wish, with the patient advocate," he explains.

The idea is to encourage participants to discuss this to the extent that they’re willing to do so.

"Then if things do go badly, at some later point when the family members or whoever has to make a decision, the principal investigator and others can have a clear basis for knowing what the patient would want them to do," Morreim says. "This is important for high-profile, end-of-life research like AbioCor."

One strategy for approaching this type of discussion is to say to the patient and family, "Now I’m going to ask a question; and if you’re uncomfortable and if you’d rather not discuss it at this time, then that’s OK," he says.

"You also can say, Some people feel that life is precious and worth extending no matter what the quality of life; other people think that if life doesn’t have at least a certain minimum quality, like being able to communicate, then it may not be worth going forward with aggressive interventions,’" Morreim says. "Whatever that person’s view is, it’s OK."

The idea simply is to elicit their thoughts on these issues and to help them think about their own values, he adds.

• Discuss the role of informed consent. Patient advocates and clinical trial administrators who discuss the informed consent process with participants need to make sure it’s clear that they are not there to recommend what the participant should do, Morreim says.

"We do emphasize, I’m not here to tell you what to do; instead I’m here as a sounding board to help you think through and reflect on your own values and reflect on what’s important to you as you decide whether or not to enter this trial,’" he explains.

"It’s important to reinforce the information that the principal investigator provides and help them think of questions they might not otherwise have thought of," Morreim says. "Discuss what happened previously in the trial in general terms, protecting the privacy of other patients."

Although clinical trials administrators and investigators are not required to update the informed consent as major developments arise, this probably is a good strategy, anyway, Morreim says.

"In most trials you can’t do this because the trial is blinded," he notes. "But we think it’s a good idea to keep patients and their families reasonably well updated within the constraints of privacy of other patients."