Author: Jon Merz
Date: 04-01-04 17:11
Source: Philly Inquirer
URL: http://www.philly.com/mld/inquirer/living/health/8288627.htm
Date published: March 27th 2004
from Haavi Morreim:
Sat, Mar. 27, 2004
Lawyer: Couple agreed to heart procedure
An attorney for two Del. cardiologists said the parents signed consent forms for their daughter's experimental treatment.
By Susan FitzGerald and Karl Stark
Inquirer Staff Writers
The lawyer for two heart doctors who used to work at a Wilmington hospital yesterday disputed a couple's claim that their baby was given an experimental treatment without their knowledge.
A consent form explaining the experimental procedure was signed by the girl's father before she was treated in October 2002 but was misplaced until about two or three weeks ago, said lawyer Victor F. Battaglia Sr., who represents cardiac surgeon William I. Norwood and cardiologist John D. Murphy. The doctors worked at Alfred I. duPont Hospital for Children until last month.
"Consent forms are signed and in the file at A.I.," Battaglia said yesterday. He said the family signed two forms - a standard hospital release and one from the company that makes the experimental stent that was implanted in the child. He said the second form, from NuMED Inc., explained that the stent had not been approved by the U.S. Food and Drug Administration.
In a sworn statement to the FDA in November, Judith Guinan of Vineland, N.J., said she and her husband, Kevin, did not know the covered stent used to treat their daughter Molly's heart defect was experimental when she underwent the procedure. They said they learned that when they received a call from a hospital doctor a year later asking them to sign and backdate a consent form.
The couple told the FDA that when a fax of the consent form arrived, they did not recall having seen it before. The Guinans also told the FDA that key hospital administrators were unaware of any covered-stent study going on in the cardiac center.
The Guinans were one of three families whose consent forms were missing, apparently when information was being collected as part of NuMED's efforts to get FDA approval for the stent, Battaglia said yesterday.
"Three of the forms were temporarily not in the file, so the three families were written to and said, 'Please sign these again,'" he said.
Battaglia said that the other two families agreed and that the Guinans did not.
He said the NuMED consent forms were kept in an administrative file separate from patients' medical charts.
"The fact of the matter is there are indeed consent forms," he said. He said the hospital had them.
Anne Wright, a hospital spokeswoman, declined to comment.
Earlier this week, Battaglia said he had not seen the Guinans' complaints to the FDA and would not comment while the matter was being evaluated.
He said yesterday that he "was so disturbed" by an article about the Guinans' allegations published by The Inquirer Thursday, that he decided to speak out about the consent forms.
Last month, duPont hospital said that it had halted a cardiac procedure involving the use of a covered stent amid an investigation by the FDA and Delaware regulators into whether policies were violated.
Norwood, who was chief cardiac surgeon, and Murphy, chief cardiologist, were no longer working at duPont's cardiac center as of Feb. 19. The hospital has declined to say why the two doctors left.
Asked yesterday whether Norwood and Murphy had been dismissed, Battaglia said: "I'm not going to comment on that because I don't have the full information on that." Battaglia also represents John T. Walsh, the cardiac center's administrator, who left the cardiac center with the two doctors.
Battaglia said he would not make his clients available for an interview "because this matter is currently being evaluated and investigated, and that process will not be interfered with."
When asked to respond to Battaglia's contention that the Guinans had given signed consent to the experimental stent procedure, the couple's attorney, James E. Beasley Jr., said, "The Guinans never signed any of these NuMED forms." He said they did sign a standard hospital consent.
Beasley said: "If everything Battaglia says is true, then why did these guys get fired and get thrown out of there so quickly? Not only were they fired, why did the hospital make an apology, if everything Battaglia said is true?"
In response to questions from The Inquirer, duPont's parent organization, Nemours, issued a statement Wednesday acknowledging "serious problems at the cardiac center."
"We are in the process of implementing corrective action to deal with those problems," said David J. Bailey, vice president for patient operations for Nemours. "We offer our sincere apology to the parents of patients whose concerns were not addressed in the appropriate manner."
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Contact staff writer Susan FitzGerald at 215-854-2780 or sfitzgerald@phillynews.com.
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