Author: Jon Merz
Date: 03-26-04 15:01
Source: Philly Inquirer
URL: http://www.philly.com/mld/inquirer/living/health/8273159.htm
Date published: March 26th 2004
From Haavi Morreim:
http://www.philly.com/mld/inquirer/living/health/8273159.htm
Mar. 25, 2004
Hospital accused over use of stent
A baby's parents say the Delaware facility did not tell them that the heart
device was unapproved.
By Karl Stark and Susan FitzGerald
Inquirer Staff Writers
Doctors at a Wilmington hospital used an experimental treatment on a baby
without the parents' knowledge, the parents have told federal investigators.
Judith and Kevin Guinan of Vineland, N.J., said they did not know that a
covered stent used to treat their daughter's heart defect lacked federal
approval when she underwent treatment in October 2002 at Alfred I. du Pont
Hospital for Children.
The couple said they learned the procedure was experimental when a du Pont
doctor called a year later, asking them to sign and backdate a consent form.
The couple refused, and filed a sworn statement, reviewed by The Inquirer,
with the U.S. Food and Drug Administration.
The statement also asserts that key hospital officials were in the dark
about the research in the cardiac center.
The hospital halted the stent procedure amid federal and state
investigations, and the key doctors at its cardiac center, world-renowned
surgeon William I. Norwood and chief cardiologist John D. Murphy, and the
center's administrator, John T. Walsh, left the hospital in a major shake-up
last month.
In response to questions from The Inquirer, Dr. David J. Bailey, vice
president for patient operations for du Pont's parent, Nemours, yesterday
issued an apology to patients and acknowledged "serious problems at the
cardiac center."
"We are in the process of implementing corrective action to deal with those
problems," Bailey said. "We offer our sincere apology to the parents of
patients whose concerns were not addressed in the appropriate manner."
The question of "informed consent" has become a major issue in American
medicine, as innovative, unproven procedures and drugs are pushing the
leading edge of health care.
Other parents are also questioning the stent procedure that du Pont doctors
portrayed as a way to avoid more surgery. Kristen and Chris Conway, of
Wayne, said they were misled about the procedure's experimental nature when
their son Teagh got the stent in December.
"It was presented to us like, 'This is the biggest piece of cake,' " said
Chris Conway. He said Teagh's stent clogged, his health worsened, and the
device had to be removed by surgeons at another hospital.
Some parents said they knew the stent was experimental and trusted in the
procedure, performed by Dr. Murphy.
Tracy Farley, of Hammonton, N.J., whose son Ryan was operated on at du Pont
for a rare heart defect, praised Norwood and his team, saying they "saved my
son's life."
Du Pont officials declined to discuss specific allegations until the
investigations are done. The FDA, which received the Guinans' complaint in
November, declined to comment.
The Guinans also spoke to Delaware's health department, which is looking at
one case, a spokesperson said. She declined to identify the patient.
Victor F. Battaglia Sr., an attorney for Norwood and Murphy, said he does
not know anything about complaints by parents and has not seen the Guinans'
complaint to the FDA.
"Our position is that this matter is still being evaluated, and we're not
going to make any comment until the evaluation is completed," Battaglia
said.
Covered stents, tubes designed to redirect blood flow, are being tried in
the treatment of congenital heart defects, particularly one called
hypoplastic left heart syndrome. In that condition, the heart's main pumping
chamber is underdeveloped. The condition was always fatal until the early
1980s, when Norwood developed a treatment that requires three surgeries to
reroute blood flow; the procedure is now standard.
Some doctors have recently been testing whether the final surgery could be
omitted. Instead of cutting into the chest, doctors open a blood vessel and
use a thin catheter to maneuver a stent into place.
Some families at du Pont were offered this less-invasive procedure. The
Conways said they would not have passed up the proven third stage of surgery
if they had understood that the stent technique was in its infancy.
"It's like going down a road you've never been down," Chris Conway said.
"That's where they took us."
"A lot of parents have said they were unaware of the experimental nature of
this procedure," said attorney James E. Beasley Jr., who along with Andrew
J. Stern represents the Guinan and Conway families.
The covered stent, made by NuMED Inc., in Hopkinton, N.Y., has been approved
in Europe, and the firm has been seeking approval for the device in the
United States for about five years, president Allen J. Tower said.
The device has been used in about 20 children at duPont, Tower said. He did
not acknowledge that their use constituted a clinical trial.
"We send out all the [consent and disclosure] paperwork with the product,"
Tower said. "As far as I know, everyone signed all the agreements and was
aware there was potential danger in this procedure and [it] hasn't been done
before."
Tower said the NuMED stent, designed by John P. Cheatham, a cardiologist at
Columbus Children's Hospital in Ohio, is continuing to be used at that
institution. Cheatham did not respond to requests for an interview.
The question of whether the stents were used in a clinical study is
potentially a crucial one. Under FDA rules, patients must be informed if
they are given an unapproved device. They also must be told if they are part
of a clinical trial.
The potential penalties are much greater if patients are not told they are
involved in a research study. Doctors could lose the right to conduct
studies and even lose their medical license, according to state and federal
officials. Hospitals can also be sanctioned.
The Guinans' daughter, Molly, 3, was born with Down syndrome and a serious
heart defect.
Norwood operated twice on their daughter, the Guinans said. Then, instead of
a third surgery, she underwent a stent procedure on Oct. 14, 2002, in the
catheterization lab, the parents say.
The next summer, the Guinans had a chance encounter with another du Pont
family, who mentioned that the stent procedure was experimental. The Guinans
said they didn't think much about the information until Judith Guinan
received a call on Oct. 1, 2003, from another du Pont cardiologist. The
doctor said that while records were being compiled for a study, their
consent form for the stent procedure could not be located.
When a fax of the consent form arrived, Judith Guinan said, she and her
husband could not recall having seen it before. The two-page form, detailing
possible complications, had stent-maker NuMED's name and address at the top.
"You can't get past the first two lines without reading this is clearly
FDA-not-approved, experimental," Judith Guinan said. "It had information on
there that we had no knowledge of."
Another surprise came, she said, when she called the hospital on Oct. 22 and
was told by a research administrator that du Pont's Institutional Review
Board was unaware of any covered-stent study at the cardiac center. Such
boards must approve a hospital's research studies and help ensure that
procedures are followed.
Guinan, who was trained as a pharmacist, filed all these allegations - and
the fax from the cardiologist - with the FDA on Nov. 24. A copy of the fax
was reviewed by The Inquirer.
The family also said the du Pont cardiac center did a poor job handling
their daughter's complications and was slow to call in specialists from
other departments. Molly now receives care elsewhere, but her parents still
worry about the stent.
"The biggest fear we have is 'What if something happens, and another doctor
has to treat our daughter?' " asked Kevin Guinan, an assistant prosecutor in
Cumberland County, N.J.
Weeks after the Guinans talked to the FDA, the Conways agreed to the stent
procedure for their son Teagh, who has hypoplastic left heart syndrome.
Teagh had the procedure on Dec. 4, about 10 days after the hospital sent out
requests for parents to release medical records to investigators.
Chris Conway said he and his wife did not know the stent was experimental or
that a federal probe had been launched. "They knew they were being
investigated, and they still did it," he said.
Teagh, 3, developed a dangerous buildup of fluid around his lungs, the
Conways said. Then, when a clot was found blocking the stent, he had to be
taken to nearby Christiana Hospital, which had equipment to remove the
blockage.
After the Conways heard that Norwood and Murphy had left du Pont under
unexplained circumstances, they moved their still-ailing son to Children's
Hospital of Philadelphia, where they were told their son was suffering from
congestive heart failure. Doctors found the stent had clogged a second time
and removed it. The Conways say their son now needs another major surgery.
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Contact staff writer Karl Stark at 215-854-5363 or kstark@phillynews.com or
staff writer Susan FitzGerald at 215-854-2780 or sfitzgerald@phillynews.com.
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