Artificial Heart Implant Leads to Suit Over Consent Process


Artificial Heart Implant Leads to Suit Over Consent Process

Recipient’s Widow Says She and Her Husband Were Misinformed and Misled on Risks, Benefits
By Debbie Goldberg
Special to The Washington Post
Saturday, November 30, 2002; Page A03

http://www.washingtonpost.com/ac2/wp-dyn/A54921-2002Nov29?language=printerwashingtonpost.com

PHILADELPHIA, Nov. 25 — When James Quinn, a 51-year-old Vietnam veteran dying of heart failure, agreed to become the fifth patient to test the first fully implanted artificial heart last November, he and his wife, Irene, thought he was getting a new chance at life.

“I figured it was like a regular heart,” Irene Quinn said last week. “You get it, and we come home and do the things we normally do.”

Instead, she said, after a remarkably promising recovery in the weeks after the surgery, her husband suffered complications and setbacks over the next nine months before suffering a massive stroke Aug. 23. Three days later, after Quinn had been declared brain dead, Louis E. Samuels, the surgeon who implanted the heart in Quinn, was at his side when the heart was turned off.

“He would have been better off dead,” Irene Quinn said of her husband and her experience with the artificial heart. “There was no quality of life. It was too painful. He said he wished he’d never done it.”

Now, Irene Quinn is suing Abiomed Inc., the maker of the AbioCor artificial heart; Hahnemann University Hospital, its parent company and affiliated medical school; and the patient advocate assigned to help the Quinns understand the consent process. She claims they were misinformed and misled about the risks and benefits of the procedure and the potential for pain and suffering.

“The informed-consent process failed,” said Alan Milstein, Quinn’s attorney, who has represented plaintiffs in other cases involving clinical trials. “They didn’t understand what it meant to volunteer for a human subject experiment. They thought this was his only chance, that it was a therapeutic option, and not that he was a human guinea pig.”

To some extent, this is human nature, according to Thomas H. Murray, president of the Hastings Center in Garrison, N.Y., which researches health and medical ethical issues. “People are desperate, there is no good alternative, and they may develop unreasonable hopes,” Murray said.

But Quinn’s lawsuit, filed last month in Philadelphia’s Common Pleas Court, puts the spotlight on the informed-consent process in clinical trials, and raises questions about whether patients who are near death and perhaps in extreme emotional states can make good choices about taking chances with a new medical procedure or treatment.

Vera Hassner Sharav, president of the New York-based Alliance for Human Research Protection, said the informed-consent process for many trials is a sham. Clinical trials are “set up in such a way that patients are misinformed and misled,” she said. “Patients and families are not told what the actual and foreseeable risks are, and what they may expect in the way of pain and suffering.”

Yet, the Quinns signed a 13-page informed-consent document that details such “significant risks” as stroke leading to brain and organ damage, loss of mental function, device failure, liver and kidney failure, impaired breathing and discomfort and pain. The form states that as a “new and experimental surgical operation, complications could occur which were previously unknown or currently unforeseeable.” . In addition, it reads, the potential benefits of implanting the AbioCor heart are “uncertain and have not been proven to exist.”

“I think it’s not right to say someone who’s dying can’t make an informed consent,” said Laman A. Gray Jr., a surgeon at Jewish Hospital in Louisville. Gray implanted the first AbioCor heart July 2001 in Robert L. Tools, who lived almost five months with the device. “People can understand the options,” he said.

Thomas L. Adams, chief executive officer for the Association of Clinical Research Professionals, said there are hundreds of thousands of clinical trials underway in the United States at any given time, and very few lawsuits result from them. That, he said, is an “amazing record.”

In setting up the trial, Abiomed, the Danvers, Mass., firm that makes the AbioCor heart, took steps beyond those required to help families make informed choices about participating. The company set up a trust establishing an independent patient advocacy council to provide advocates not affiliated with any of the trial sponsors to help patients understand the informed-consent process. The advocates typically have medical training and are experienced in end-of-life issues and medical ethics.

“What’s new here is that a commercial organization has hired a person experienced in patient care and ethics to serve as an advocate for each patient,” said Robert A. Levine, Yale University professor of medicine and bioethics.

“We believe it’s the most progressive practical model yet devised to protect patients in high-stakes clinical trials,” said Abiomed Vice President Edward E. Berger. “We’re very proud of the effort that was made by the clinical staff at Hahnemann Hospital and by the original patient advocate to assure well-informed decision making. We do intend to defend against this lawsuit very vigorously.”

The Quinns’ advocate, David Casarett, a bioethicist and geriatrics specialist at the University of Pennsylvania, is being sued by Irene Quinn. But notably absent from the lawsuit is Samuels, with whom the Quinns had grown close and who, ultimately, was the person responsible for ensuring they were fully informed and getting them to sign the consent document. Neither Casarett nor Samuels would comment on the case.

Without suing Samuels, the lawsuit “doesn’t have a prayer,” said George J. Annas, chair of the health law department at Boston University’s School of Public Health. “It’s his obligation to get informed consent, and it looks like he did.”

Regardless of whether Quinn prevails in court, some worry that a lawsuit such as this may scare away potential trial volunteers and hinder research efforts.

“It’s kind of a negative thing that our legal system will allow for such [lawsuits] to happen,” said Robert Dowling, a heart surgeon who, with Gray, implanted the AbioCor heart in Tools and Tom Christerson, the second recipient and the only one of seven still living. “If we want to advance medicine in general, this is how we do it.”

In the 14 months since Christerson, 71, received the AbioCor heart, he celebrated his 55th wedding anniversary and held his first great-grandchild, Ellen. He was doing well enough to return to his Central City, Ky., home in April. “I enjoy going to the coffee shop in the morning and hanging out with all my buddies,” Christerson said in a statement voicing no regrets over his decision to participate in the trial. “I’m looking forward to doing great things in life.”

The AbioCor heart, the first artificial heart that is fully implanted in the chest and runs on an external battery pack, has potential to help the 100,000 or so people who die annually in this country from heart failure, Berger said. Although the current AbioCor is too large for most women and some men and has limited portable battery life, which restricts mobility, Berger said the company is “extraordinarily happy” with its performance so far.

The most serious problem has been strokes, and the company has slightly altered the heart to reduce its potential to cause strokes. With the new device ready to use, the company expects to recruit eight more patients in the next nine months. The Food and Drug Administration has approved a total of 15 implants for the trial.

For those considering participating in the trial, Irene Quinn has this advice: “Do research on it, and know what you’re getting into,” she said. “It never clicked about being a pioneer; the only thing I thought about was my husband getting well.”

© 2002 The Washington Post Company

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