Widow of artificial-heart
patient sues maker of implant
Woman says husband wasn't fully informed about strains he'd face
By Gideon Gil -
Louisville Courier Journal, KY - 10/17/02
The widow of
a Philadelphia man who lived 10 months with the AbioCor artificial heart sued
the maker of the experimental device yesterday, saying her husband wasn't
adequately informed of the difficulties he would endure.
The manufacturer,
Abiomed Inc. of Danvers, Mass., had arranged for James Quinn -- and the six
other patients in the AbioCor clinical trial -- to have an independent patient
advocate at their side as they went over the consent form with surgeons and
to help them decide whether to volunteer for the implant.
But Quinn, who
died Aug. 26 after suffering his second stroke, had come to regret taking
part in the testing of the self-contained artificial heart, said Alan Milstein,
the attorney for his wife, Irene. Milstein said Quinn talked to him as early
as four months before his death about filing a lawsuit.
Milstein said
Quinn told him, ''No human being should have to go through what I'm going
through.''
Rather than
physical pain, Milstein said, ''I think he was referring more to just the
act of being an experimental subject, the prodding and the probing and the
feeling that you were just an object being studied.''
Of the seven
recipients of the plastic and titanium AbioCor, Quinn lived the second longest.
Only Tom Christerson, whose Sept. 13, 2001, implant was done at Jewish Hospital
in Louisville, has lived longer, and he is the only surviving recipient.
But unlike Christerson,
who was able to move home to Central City, Ky., in April, Quinn spent most
of his time at Hahnemann University Hospital in Philadelphia, where his implant
was performed. Shortly before his death at age 52, Quinn told The New York
Times in an interview: ''This is nothing, nothing like I thought it would
be. If I had to do it over again, I wouldn't do it. . . . I would take my
chances on life.''
The lawsuit
-- filed against Abiomed, Hahnemann Hospital, a physician who served as Quinn's
patient advocate, and others -- seeks damages in excess of $100,000.
Hahnemann Hospital
had no comment, and an Abiomed spokeswoman could not be reached.
Dr. Laman Gray,
the University of Louisville surgeon who implanted the AbioCor in Christerson
and two others, said last night: ''I'm sorry the Quinns were unhappy. . .
. But it's a little hard for me to believe that they weren't fully informed
of what the risks of the experimental procedure is. I think everybody knows
that this is a highly experimental procedure.''
Gray said he
knows Quinn's surgeon, Louis Samuels. ''Lou's an honest guy, and he told them
the truth,'' he said. ''I don't think there's any deception here.'' Samuels
was not named as a defendant.
Gray said that
in the conversations he and his colleague Dr. Rob Dowling had with their AbioCor
patients before the implants, ''we tried to be honest about what the potential
problems are, what the hardship on the family would be.''
But he acknowledged
that many patients who are near death downplay the risks of experimental treatments
and focus only on the potential benefit of extending their lives.
''You try to
be honest with them,'' Gray said. ''One of the reasons Abiomed had a patient
advocate here was to try to bring reality into the situation.''
Dr. Art Caplan,
a University of Pennsylvania medical ethicist, said the prospect of imminent
death makes it difficult for many patients to reason clearly.
''You grab at
the things that are thrown at you,'' Caplan said. ''You want to hear that
there's hope, and hope colors everything that is presented in those consent
forms. . . . You're not listening to the risks and the long-term consequences.''
In the lawsuit,
Quinn's widow alleged that the defendants should have known that patients
such as her husband were ''extremely vulnerable'' and ''would believe that
enrolling in such a trial was in their best therapeutic interest.''
But contrary
to what Quinn was told before the implant, the AbioCor heart at that time
was not a therapeutic alternative, the suit says. ''The only reason Mr. Quinn
or any subject should volunteer for such an experiment would be to serve as
a martyr for the greater good.''
Many risks were
outlined in the 13-page consent form. Posted on the Web site of Milstein's
law firm, it warns of the risk of strokes and longterm use of a respirator
-- situations that Quinn experienced.
''I understand
that because this is a new and experimental surgical operation, complications
could occur which were previously unknown or currently unforeseeable. These
complications could result in death, or in permanent physical or mental disability,''
the consent form says. It adds that ''potential benefits are uncertain and
have not been proven to exist.''
Quinn received
his AbioCor implant on Nov. 5. Despite a small stroke Dec. 31, he had gained
enough strength by mid-January to be moved from the hospital to a hotel suite,
where his wife could stay with him and caregivers could monitor his condition
from an adjoining room.
He returned
to the hospital three weeks later after developing breathing difficulties,
which turned into pneumonia.
The lawsuit
alleges that after returning to the hospital, Quinn ''could barely breathe
and was in constant, unbearable pain with extreme burning sensations in his
back and chest.'' By June, it says, the Quinns ''had become extremely dissatisfied
with the experiment.''
Quinn suffered
a stroke on Aug. 23 and was withdrawn from life support three days later.
No implant has
been done since April because Abiomed was making changes to prevent strokes,
which have caused the deaths of three of the patients.
But last night
Gray said, ''We have been looking at candidates very actively for the past
month.''
The Associated
Press contributed to this story.
