Philly update: Widow of man who received artificial heart settles lawsuit

[NRSKarenRN, BSN, RN]

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

http://www.philly.com/mld/inquirer/living/health/6085284.htm

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 [email protected].

[sjoe]

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.

[oramar]

I read about this suit somewhere else and thought it was just a money grab by the widows and lawyers. No one ever completely grasp the implacations of any medical proceedure especially experimental ones. There are always such big time emotion stuff going on that they don't realize the implications. The transplant patients I used to care for always expected to be like there were before they got ill. No matter what you said to them or got them to sign they always had this excectation that they would be getting their old life back. In reality, even now a transplant means you are substituting one set of fatal problems for another set of problems that can be managed. It is positively ludicrous that she would even imagine that there were any quarantees.

[KMSRN]

After working with cancer and palliative patients I have come to realize that, with some patients and families, no matter what they are told, they hear what they want to hear. The patient has advanced cancer and gets palliative chemo or radiation to reduce symptoms and the family thinks we are going for the cure. Or, like Oramar said - they think they will be back to a normal functional status. I am sure this applies to other patients with terminal diagnoses. Sometimes it takes a couple of weeks and several direct, blunt conversations before it sinks in. I would hope that prior to experimental treatment, consents with all the details were signed. In general, people don't understand healthcare or the healthcare system. Combine this with denial, that is a normal initial reaction to devastating news, and there is a lot of room for misunderstanding. I won't even go into the money grubbing, lawsuit issue.

[NRSKarenRN, BSN, RN]

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."

https://allnurses.com/forums/showthread.php?s=&threadid=24531&highlight=James+Quinn