State reopens review in toddler's death

Children's accused of holding records

The state has reopened an investigation of two prominent doctors at Children's Hospital Boston after learning the hospital may not have provided complete information about the care they gave a toddler who apparently suffered brain damage during his hospital stay.

The parents of the boy, Jason Fox, allege that the hospital and doctors failed to provide the Board of Registration in Medicine an important medical record suggesting that Jason suffered a brain injury because of too much dye administered during a heart procedure. The dye leaked into his brain.

Unable to walk or speak, 3-year-old Jason died a year and a half later, in December 2004.

The medical board originally decided in September 2006 against disciplining the doctors involved in Jason's case, despite an initial report from a board consultant finding care provided by one of Jason's doctors "substandard in part." After a review by a second consultant that was more favorable, the board wrote three doctors formal Letters of Advice to communicate better with families about the risks of procedures and document all discussions.

The boy's parents, who live in Pennsylvania, objected to the board's decision not to take disciplinary action - which can include a reprimand, fine, or suspension - and have been pressing the board to reopen the case. Last month, they sought help from Senate President Therese Murray's office. They raised their concern about the missing document, and three other documents they allege had been altered, and also asserted in a letter to her that one board member had a financial conflict of interest in the case.

"The only real protection to the public is the Board of Registration doing their job," Jason's father, Brian Fox, said in an interview. "And their job may have been obstructed here."

During Jason's stay at the hospital, doctors also discovered a tiny piece of metal lodged in the child's brain, probably from a medical instrument, although it is uncertain whether it broke off during a procedure at Children's or a prior procedure at another hospital.

Barbara Piselli, the board's director of enforcement, informed Fox last week that the board's complaint committee had reopened the case, though she did not give a reason. Murray's spokesman, David Falcone, would not say whether the senator's staff asked that the case be reopened. "Our office made inquiries on behalf of Mr. Fox and was told that it's possible to reopen the case," he wrote in an e-mail.

Board spokesman Russell Aims said he cannot discuss ongoing investigations. Generally, he said, it is uncommon for the board to reopen a case, but it will if there is new information. Withholding records, either intentionally or accidentally, would be a "very serious matter," he said.

Children's Hospital spokeswoman Michelle Davis said neither the hospital nor the doctors would comment on specifics of the case, which also is the subject of a malpractice lawsuit by the Foxes. She provided a statement saying that the hospital and doctors "cooperated fully" with the board's investigation and that they "extend their sympathy to the Fox family, as we have done in the past."

"We are confident the new proceedings will be resolved in their favor," she said.

Jason Fox was born in July 2001, with Tetralogy of Fallot, a complex but usually treatable birth defect affecting the flow of blood through the heart. In Jason's case, the defect was particularly serious and prevented his blood from carrying enough oxygen to his organs and limbs, among other problems. During the first two years of his life, Jason underwent open heart surgery and had seven cardiac catheterizations at the Children's Hospital of Philadelphia to try to widen the arteries that carry blood to his lungs.

Doctors in Philadelphia referred Jason to Dr. James Lock at Children's Hospital Boston, who pioneered the use of catheterization to repair cardiac birth defects and is the hospital's physician-in-chief. Lock agreed to try to widen more of the toddler's pulmonary arteries. Hours after the child's second catheterization, on April 18, 2003, Jason suffered a seizure. A CAT scan showed that contrast dye, which is injected during the procedure so doctors can better see the patient's anatomy, had leaked into his brain.

Brian Fox said in an interview that Lock gave his son too much dye, and that a one-page "ICU Team Note" was not given to the medical board or to the Department of Public Health, which regulates hospitals and conducted its own investigation. Written by an ICU physician, the document suggested that Jason's brain injury was caused by "contrast toxicity due to high contrast load."

The Foxes obtained the ICU note from the hospital through their legal proceedings and discovered that it was not contained in the case file they obtained from the medical board.

In a recent letter to Fox, the board asked for this document as well as others. The health department did not find any deficiencies but is reviewing the new information, a spokeswoman said.

In a written response to the medical board for its initial investigation, Lock acknowledged that he gave Jason more than twice the maximum dose of dye recommended by the manufacturer and that prescribing information provided by the dye-maker states that care must be taken whenever the maximum dose is exceeded. But Lock said it was necessary to exceed the maximum because of the multiple procedures required and the child's difficult anatomy. Lock said he believed that Jason's only chance of having his heart defect corrected, and avoiding a shortened life-span, was for doctors to enlarge his pulmonary arteries.

The first expert report said that Lock should have considered stopping the procedure or reconsidered the entire approach once Jason's contrast limit had been exceeded, according to a letter from the board's lawyer to Lock's lawyer in June 2005.

Aims said he could not discuss any subsequent expert reports.

The board has reopened the case against Lock and Dr. Peter Laussen, director of the cardiac intensive care unit and chief of the division of cardiovascular critical care.

After his seizure, Jason was transferred to the cardiac ICU and was given two MRIs to determine the extent of his brain damage. During the first MRI, doctors discovered the metal object in Jason's brain and, at one point, his heart rate plummeted and doctors had to resuscitate him. Fox said that Laussen told the board that an anesthesia record indicates Jason was carefully monitored before his heart attack. But Fox alleges that was a misrepresentation and that another doctor wrote up the record after the fact.

When Jason left the hospital, his father said, he was not the same boy, though doctors say in board records that Jason had developmental delays before his hospitalization.

Fox said the board's investigation of the case also may have been biased by conflict-of-interest. Dr. Guy Fish, a board member who served on the complaint committee that decided against disciplining the doctors, is a venture capitalist whose company has a close relationship with Lock and Children's Hospital, Fox said. But Brenda Beaton, the board's acting executive director, told Fox in an Oct. 30 letter that Fish was not biased in the case because he was not aware of the financial relationship between his company and Lock and Children's Hospital.

Liz Kowalczyk can be reached at kowalczyk@globe.com.