Phila: Widow sues artificial-heart maker; not informed of the ordeal pt faced

[NRSKarenRN, BSN, RN]

Posted on Thu, Oct. 17, 2002

The suit alleges negligence and fraud, saying James Quinn was not well informed of the ordeal he faced.

By Stacey Burling

Inquirer Staff Writer

http://www.philly.com/mld/inquirer/4301284.htm

The widow of artificial-heart recipient James Quinn yesterday sued the maker of the device, the hospital where it was implanted, and the patient advocate who helped Quinn decide to have the surgery. The suit contends the informed-consent process was flawed and alleges fraud, negligence, and "intentional assault and battery."

Quinn, who was 51 when he received the heart Nov. 5, came to regret his decision after an initially remarkable recovery was followed by months in the hospital. He died Aug. 25 after suffering a stroke.

After receiving the mechanical heart, the suit says, Quinn had "no quality of life and his essential human dignity had been taken from him."

Irene Quinn said yesterday that she and her husband did not know what they were getting into when they joined the clinical trial. They thought the machine would save his life, she said. She said they should have been told more about what earlier patients had experienced and that it should have been made more clear just how experimental the device was.

Louis Samuels, the Hahnemann University Hospital surgeon who implanted the artificial heart in Quinn and who was in charge of the trial in Philadelphia, was not named in the suit.

"We believed that Dr. Samuels is a good man with a good heart," said Alan Milstein, the Pennsauken attorney who is representing Irene Quinn and her husband's estate. "The problems that occurred here had more to do with the design of the trial and the flaws in the consent process... that controlled whether the Quinns would agree to participate in this trial."

Irene Quinn said her husband and Samuels became friends. "Butch liked Dr. Samuels," she said. "He loved him."

Quinn was the fifth patient to receive the device, which differed from its predecessors because it could be implanted totally into the chest. Of the seven men who have received the artificial heart, only one - Tom Christerson of Kentucky, is still alive. He has lived with the heart more than a year and has been home since April.

The suit filed yesterday in Philadelphia Common Pleas Court named as defendants Abiomed Inc., the Danvers, Mass., company that made the heart; Tenet Healthcare Corp., which owns Hahnemann; Hahnemann; Drexel University, which supplies physicians who work at the hospital; and David Casarett, an assistant professor in the University of Pennsylvania's geriatrics division and a member of the Center for Bioethics. Casarett was assigned to help the Quinns understand the consent process. In a novel step designed to improve the consent process, Abiomed helped set up an independent panel of advocates to advise patients. Casarett was part of that group until the Quinns fired him in June.

Milstein said he believes he is the first lawyer to sue a patient advocate. The lawsuit accuses Casarett of "patient advocate malpractice." It contends Casarett failed to "protect the interests" of the Quinns and that during meetings to discuss the clinical trial "advocated no position for the Quinns and asked them only whether they had any questions."

The suit calls for damages "in excess of $100,000," but Milstein said that number is meaningless because juries determine the amount of awards.

Most defendants in the lawsuit, who had not seen the complaint, declined to comment yesterday.

Drexel University College of Medicine issued a statement: "We reviewed the decisions that were made and the steps taken in caring for Mr. Quinn and are confident that everyone here did an outstanding job... . In these days when physicians are being driven out of their practices by this type of lawsuit, organizations like ours will find it difficult to participate in providing cutting-edge care to critically ill patients like Mr. Quinn.

"We donated thousands of hours to Mr. Quinn's care, and we did so with pride."

The statement noted that Quinn was willing to "face the unknown" and got extra months of life because of the surgery.

Milstein, who also represented the family of Jesse Gelsinger in a much-publicized suit involving a fatal gene-therapy experiment at the University of Pennsylvania, maintains that the Quinns agreed to test the artificial heart because of "therapeutic misconception" - the idea that, as a man who would soon die of heart failure, James Quinn had no other medical options open to him.

It should have been made clear to Quinn, Milstein said, that the device, which had never been tested in humans before this trial, was not a "therapeutic option." The only reason to participate at that stage of the heart's development, Milstein said, was to be willing to be a "martyr for science."

Because of the lack of informed consent, the suit claims, "Quinn was caused to sustain serious, disabling and permanent physical and emotional injuries." These constituted intentional assault and battery, the suit said.

In addition to problems with the informed-consent process, Milstein said clinical-trial organizers did not prepare well for Quinn to go home and subjected Irene Quinn to a "terrible financial hardship" by sending her bills for her husband's care. The hospital and university have both said that the bills were a mistake and that Irene Quinn does not have to pay them.

George Annas, a lawyer and bioethicist who chairs the health law department at Boston University School of Public Health, said leaving Samuels out of the suit makes it unlikely to succeed.

"The only person who has an obligation to get informed consent is the doctor who does the procedure," he said.

Milstein said that is not true in this type of experiment.

Lawsuits over clinical trials have become more common in the last three or four years, with Milstein being the lawyer most visible in their proliferation, said Dennis DeRosia, a physician assistant who is chairman of the board of the Association of Clinical Research Professionals.

"More lawsuits will definitely have a chilling effect, and we are concerned about that," he said.

He said he does not buy the argument that dying people are unable to make good decisions. They are expected to make important personal and legal decisions, and many decline to enter trials even when no other treatment is available.

Robert Levine, a physician and ethicist at Yale University, said researchers have struggled for years with the problems inherent in offering experimental treatments to extremely sick people. "I think that when people are faced with death, it puts limits on their ability to understand, to appreciate," he said. "It has a tendency to make them somewhat, with rare exceptions, desperate to try whatever they can try."

Although he believes researchers are doing their best to inform people of risks, he said, many patients forget what they are told or fail to realize that making a good decision about whether to participate has nothing to do with how things turn out later.

Milstein hopes the suit makes researchers more careful when seeking consent. "The point is not to stop these trials, but to make them ethical," he said.

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Contact Stacey Burling at 215-854-4944 or [email protected].

[oramar]

Based on everything I have heard I think the people were properly informed. I think it was a mistake to cave into them. Only weakness seems to be advocate. That was the first time they used advocate, not surprised it was a little shaky. Should of used the nurses they had. Give them all two less patients and let them advocate.