Author: Jon Merz
Date: 04-08-04 14:20
Source:
URL: http://www.philly.com/mld/inquirer/living/health/8384502.htm?1c
from Haavi Morreim:
Wed, Apr. 07, 2004
Babies' doctors broke rules in use of stent, Del. says
By Karl Stark and Susan FitzGerald
Inquirer Staff Writers
Heart doctors at Alfred I. du Pont Hospital for Children implanted an
experimental device in 14 babies without obtaining full consent from their
parents, a report by Delaware health officials said yesterday.
Doctors also did not get the necessary approval from the U.S. Food and Drug
Administration and from a hospital committee charged with protecting
patients from unproven treatments, investigators said.
The report, which the Wilmington hospital acknowledged yesterday as
accurate, said 14 babies with a congenital heart defect had received an
experimental stent at du Pont. State investigators initially were unable to
find four signed parental consent forms, the state report said, and no
parents knew that the doctors were performing procedures without hospital
approval. The device has not yet received FDA approval.
"It's an obvious violation of the regulations," said Mary Peterson, director
of the state Office of Health Facilities, Licensing and Certification.
"Unfortunately, you can't have full, informed consent if the parents were
not aware that the hospital had not approved this study."
For the first time, the hospital placed clear blame on its cardiac center's
director, surgeon William I. Norwood, and chief cardiologist, John D.
Murphy. The doctors "were involved in the decisions to place unapproved
medical devices in patients without prior notification to, and approved by
our" Institutional Review Board, the hospital said in a response included in
the report.
Kevin E. Charles, chief of Health Systems Protection in Delaware, said the
venerable hospital could lose its license. But he acknowledged that was
unlikely because du Pont was cooperating and making changes.
Norwood and Murphy left Feb. 19 as part of an "administrative overhaul," the
hospital said yesterday. And the hospital said it would form a new
department for Human Subject Protection to help its staff adhere to research
regulations.
The doctors' lawyer did not return phone calls yesterday.
Misfiled consent forms
Neither the state nor the hospital would say whether any babies had been
injured because of the experimental care.
One couple have said their son suffered complications after getting the
stent, which had to be surgically removed at another hospital.
The state's report also noted that the Institutional Review Board's leader
said he did not learn of the experimental procedure until early December
when FDA inspectors showed up unannounced at du Pont in response to a
family's complaint.
The FDA declined yesterday to comment on its probe.
In addition, the report said four parental consent forms were not found
during the inspection. Then, state inspectors said, they received a call
Feb. 26 from a hospital attorney, saying three of the documents had been
found in a drawer in the cardiac catheterization lab. Two were not properly
executed, Peterson said. The fourth has not been found.
The state cited du Pont for failing to properly file those records.
The experimental care at du Pont became public in February when hospital
officials said they had halted a cardiac procedure involving the use of a
covered stent amid an investigation by the FDA and Delaware regulators.
Treating heart defects
Covered stents, tubes designed to redirect blood flow, are being tried to
treat congenital heart defects, particularly one called hypoplastic left
heart syndrome, in which 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.
Murphy was among a small group of doctors that had recently been testing
whether the final surgery could be replaced by opening a blood vessel and
using a thin catheter to maneuver a stent into place.
Some families at du Pont were offered this less-invasive procedure - but
without a full explanation, Delaware officials said.
Last month, The Inquirer reported on a sworn statement that Judith Guinan of
Vineland, N.J., gave to the FDA. Guinan said she and her husband, Kevin, did
not know beforehand that the covered stent used on their daughter Molly's
heart defect was experimental. They said they learned that when a hospital
doctor called a year later in late 2003, asking them to sign and backdate a
consent form.
Judith Guinan said she could not recall seeing the consent form.
The state report indicated that the Guinans' consent form, one of those
found in the drawer, was signed by a parent. Lawyers for the Guinans have
disputed that.
Philadelphia lawyer Andrew J. Stern, whose firm represents the Guinans,
would not comment again yesterday on the forms.
"At least A.I. du Pont has admitted that its doctors were involved in
inexcusable behavior," Stern said.
The state said yesterday that the unapproved stent was used for 11 months,
from June 20, 2002, to May 5, 2003, without the hospital's permission.
Peterson said her state agency did not learn of the situation until Jan. 20
when a parent alerted her. State investigators went to du Pont on Jan. 22
and investigated there until Feb. 11.
In the next 60 days, state inspectors will visit du Pont unannounced and
conduct a full survey. If it is in compliance, the hospital will be
monitored for at least three months, Peterson said.
The hospital said yesterday that it had already begun making changes.
Du Pont cardiologists have personally notified the parents of children who
got the covered stents. Doctors will create a registry for the babies to
monitor their health.
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Contact staff writer Karl Stark at 215-854-5363 or kstark@phillynews.com.
------------------------------------------------------------------------
© 2004 Philadelphia Inquirer and wire service sources. All Rights Reserved.
http://www.philly.com
Thu, Apr. 08, 2004
Cardiologist cleared of consent complaint
A Del. board said he did inform a S. Jersey couple about an experimental
stent for their baby.
By Susan FitzGerald and Karl Stark
Inquirer Staff Writers
The Delaware Board of Medical Practice yesterday cleared cardiologist John
D. Murphy of one complaint of unprofessional conduct arising from his work
at the Alfred I. du Pont Hospital for Children.
The board reviewed a complaint by Kevin and Judith Guinan of Vineland, N.J.,
and concluded that Murphy had obtained a consent form, informing the couple
that their daughter Molly's stent procedure was not approved by the U.S.
Food and Drug Administration, Murphy's lawyer Victor F. Battaglia Sr. said
yesterday.
The Guinans also filed a complaint with the FDA, which has been
investigating du Pont's cardiac center in Wilmington.
The board's action came a day after the Delaware health department issued a
critical report on du Pont's cardiac center. It said Murphy had used an
unapproved stent in 14 babies with a congenital heart defect. The stents
were put in without the required approval of the FDA and the hospital's
Investigational Review Board, which oversees research, the report said.
Murphy and cardiac surgeon William I. Norwood were removed Feb. 19 as part
of an "administrative overhaul" of the cardiac center. The hospital said
both "were involved in the decisions to place unapproved medical devices in
patients."
Kevin E. Charles, chief of health systems protection for the Delaware
Division of Public Health, which oversaw the report, said his agency could
forward its findings to the state medical board.
"We have done it before," he said. "But we haven't made a decision whether
to go forward with any complaint to the medical board."
------------------------------------------------------------------------
Contact staff writer Susan FitzGerald at 215-854-2780 or
sfitzgerald@phillynews.com.
------------------------------------------------------------------------
© 2004 Philadelphia Inquirer and wire service sources. All Rights Reserved.
http://www.philly.com
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