Posted on Sat, Jun. 14, 2003
James Quinn received a fully implantable heart. He died last summer. The suit alleged fraud.
By Stacey Burling
Inquirer Staff Writer
The widow of the artificial-heart recipient who died last year in Philadelphia has reached a settlement in a lawsuit she filed against the maker of the device, the hospital where it was implanted, and the patient advocate who helped her and her husband, James Quinn, decide to have the surgery.
The lawsuit argued that the informed-consent process used in the clinical trial was flawed, and it alleged fraud, negligence, and "patient advocate malpractice."
A petition filed this week in Philadelphia Common Pleas Court by Irene Quinn's lawyer, Alan Milstein, said she had agreed to a settlement of $125,000 from all of the defendants. A third of that amount would go to Milstein's law firm. The rest would go to Irene Quinn and three other family members.
The settlement has not yet been approved by a judge. Last month, a motion by Milstein to seal the settlement petition was denied.
Quinn was 51 and suffering from heart failure when he agreed to become the fifth person to try the fully implantable artificial heart made by Abiomed Inc. He had surgery at Hahnemann University Hospital on Nov. 5, 2001, and initially recovered remarkably quickly. But he came to regret his decision to test the device after medical setbacks left him hospitalized for the last months of his life. He died Aug. 25 after suffering a stroke.
His wife has said that she and her husband thought the artificial heart would save James Quinn's life and that they did not realize just how experimental the device was.
The lawsuit named as defendants Abiomed, of Danvers, Mass.; Hahnemann; Tenet Healthcare Corp., which owns 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 Penn's Center for Bioethics. He was assigned to help the Quinns understand the consent process. Abiomed had helped set up an independent panel of advocates to advise patients.
Drexel University has filed an answer to the settlement petition, saying it has no objections because Irene Quinn had already dismissed claims against Drexel, without payment.
Gerald McHugh, Drexel's lawyer, said the university would not have changed the way it treated Quinn. "Drexel was proud of the care it rendered to Mr. Quinn and also had great admiration for his courage and willingness to pave the way for future artificial-heart patients," he said.
A spokeswoman said Hahnemann and Tenet were pleased the case had been "resolved amicably" but declined to discuss specifics of the settlement.
Irene Quinn, Milstein, and lawyers for the other defendants did not return phone calls yesterday.
Edward Berger, Abiomed's vice president for strategic planning and policy, said the suit had no effect on the company's informed-consent process because it was already "extraordinarily mindful" of patients' needs.
The Abiomed artificial heart has been implanted in 11 patients, two of whom are still alive, according to Berger. Tom Christerson of Central City, Ky., lived the longest of the group. He died Feb. 7, 17 months after receiving the device.
Although Hahnemann has not officially been removed from the group of hospitals testing the heart, the surgeon who ran the trial there, Louis Samuels, now works at Lankenau Hospital. Berger said there was no longer a trained team in place at Hahnemann.
Contact staff writer Stacey Burling at 215-854-4944 or firstname.lastname@example.org
Jun 14, '03
One more instance where "informed" consent means anything but being fully informed. Perhaps after several hundred more such lawsuits, hospitals will take this issue more seriously.
Or perhaps not.
See the thread "surgical consents" on the general discussion page.
Last edit by sjoe on Jun 14, '03
Jun 15, '03
Consent with details was signed here--- part of suit involved "informed consent" AND the need for an unbiased advocate.
See prior article:
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." ....
"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."
Last edit by NRSKarenRN on Jun 15, '03