October 26

Artificial Heart experiment without informed consent?

Artificial Heart experiment without informed consent?

Wed, 30 Apr 2003

The manufacturer of an artificial heart, Abiomed, are seeking to use incapacitated patients who suffered a massive heart attack as human subjects without their informed consent. Does anyone have the moral or legal right to subject a human being to a high risk medical experiment without their voluntary, informed consent?

According to the company, the device (Abiocor) has been implanted in 10 people since July 2001. Nine have died, one remains stable in the hospital.

The first patient to have had the device implanted was James Quinn. His ordeal was the subject of an in-depth New York Times article. Last Journey of Artificial Heart Recipient,, Oct 8, 2002 excerpt at: https://ahrp.org/infomail/1002/08.php

James Quinn suffered far more than he (or his wife) had expected before he died. He told the New York Times reporter: “This is nothing, nothing like I thought it would be, he said. “If I had to do it over again, I wouldn’t do it….I would take my chances on life.”

A lawsuit has been filed on Mrs. Quinn’s behalf. See: https://ahrp.org/SuitsDecisions/heartsuit1102.php


Artificial Heart Plan Raises Questions
Artificial Heart Company’s Proposal to Implant Device Raises Ethics Questions

The Associated Press

BOSTON April 29 — Officials at Abiomed Inc. said Tuesday they were considering implanting their artificial heart into patients who have suffered major heart attacks and whose relatives would have to give consent.

Company officials have discussed the proposal with ethics experts and believe it could be done “without compromising patients’ rights or patient integrity,” said Edward E. Berger, the company’s vice president for strategic planning and policy.

But other experts raised questions.

“It’s such an extraordinary experiment that informed consent is absolutely essential,” said George Annas, a professor of health law and bioethics at Boston University. “I really see no way you could justify this without the individual’s consent.”

Abiomed has gained worldwide attention for its trial of the Abiocor, a self-contained, implantable replacement heart. The Abiocor has been implanted in 10 people since July 2001. Nine have died. The 10th is in stable condition at the Texas Heart Institute in Houston, more than two months after the operation.

So far, the clinical trial has used patients with end-stage heart failure who have a 70 percent chance of dying within a month and no hope of other treatment.

The company’s proposal concerns people who have suffered massive heart attacks, who still have little chance of surviving, but who are otherwise healthier because they haven’t been debilitated by a long-term progressive condition.

These patients are frequently heavily sedated or being kept alive by life support.

Berger said the company hopes it will suffice to have a previously authorized health care proxy usually a relative consent to the implant.

Proxies allow a relative to make a decision about treatment for a patient unable to express his or her wishes. But it’s not clear if laws on medical proxies would allow a relative to put a patient in a medical experiment.

“I guess the question is: Is society comfortable with the notion that somebody can give their body to science while they’re still alive, but are no longer conscious and aren’t able to give their consent?” asked Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia.

Copyright 2003 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed. Copyright © 2002 ABC News Internet Ventures. Click here for Press Information, Terms of Use & Privacy Policy & Internet Safety Information applicable to the site.

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.

Subscribe To Our Newsletter!

Sign up and be the first to find out the latest news and articles about what's going on in the medical field.

You may also like

November 21, 2023

Vera Sharav is joining Christine Anderson as special guest for the Make It Your Business event in

Read More
Vera Sharav Joins Christine Anderson for Make It Your Business – Dec 4, 2023 in New Jersey

November 21, 2023

Vera Sharav is premiering the movie Never Again is Now Global in New York City, December 1.

Read More
Never Again is Now Global – Premiere Screening – Dec 1, 2023 in New York City