Medical misstep

[Editor’s note: At the request of the family described in this article, Mountain Xpress agreed not to identify them.]

A lawsuit resulting from the failure to administer a critical test to a newborn child has led to one of the biggest known settlements ever awarded in Buncombe County — and improved security for local infants.

The suit, filed in Buncombe County Superior Court in April 1998, claimed the child had suffered significant, irreversible brain damage due to the delay in diagnosing and treating his disease. In a pretrial settlement approved last December, the defendants and their insurers agreed to pay at least $8.5 million.

Memorial Mission Hospital; Dr. Harald H. Kowa (the child’s pediatrician) and his practice, Asheville Children’s Medical Center; and Dr. Terry C. Childers (the on-call pediatrician) and his practice, Mountain Area Pediatric Associates and their insurers agreed to pay $2.73 million up front and at least $5.78 million in periodic payments throughout the child’s lifetime.

Apparently healthy at birth in 1995, the child developed slowly, and his parents grew increasingly concerned. After 20 months, a neurologist delivered terrible news: Their son suffered from phenylketonuria, commonly called PKU.

Untreated, the disease prevents the brain from developing normally. Babies born with PKU — about one in 12,000 — can’t metabolize a protein component called phenylalanine, causing severe mental retardation.

But starting infants on a special formula shortly after birth can prevent retardation, physical disabilities and even death, experts say. PKU can be identified by a routine blood test that’s usually done when babies are between one and three days old.

In this case, however, health-care providers never took the critical blood sample that could have identified the baby’s condition early on.

“We at Mission St. Joseph’s are deeply saddened that a child has been harmed by a condition that can be treated when it is detected in time,” said Lou Hammond, a vice president at the hospital system, in a written statement. “Our staff members who helped care for this family were devastated when they learned about their baby’s condition, and we can only imagine the grief the family has experienced. We continue to offer them our deepest condolences.”

Both the child’s parents and their Asheville lawyer, George Ward Hendon, declined to comment for this article. The doctors involved did not return Xpress’ phone calls.

The missed test

The tragic chain of events began the day the baby was born.

PKU tests are most accurate when a baby is between one and three days old, explained Hammond. Testing a newborn less than 24 hours old could yield a false-positive result.

In this case, the parents received permission from Kowa to take their newborn home from the hospital when he was less than 24 hours old — and before the time the hospital had scheduled to draw blood for the test, according to court documents.

Kowa had also ordered that the baby get his PKU test on either the third day or the day of discharge — whichever came first. But the legal complaint claims his orders were overridden by Childers, the on-call physician. The complaint also blames Childers and Memorial Mission Hospital (now part of Missiont St. Joseph’s) for failing to notify Kowa that the baby hadn’t been tested.

When the mother and baby were discharged, hospital personnel told the parents that, because they were leaving early, the hospital hadn’t been able to administer certain tests — and that they needed to make an appointment with their pediatrician in four days to have those tests performed, the lawsuit maintains.

One of the main reasons for testing a newborn before discharge is to make sure the test is recorded with the N.C. State Laboratory for Public Health, which alerts the attending doctor if there’s a need for retesting, court documents assert.

But when the parents took the baby to Asheville Children’s Medical Center for his first doctor’s appointment, four days later, no blood sample was taken either, according to court documents. The lawsuit faulted Kowa for not reviewing the baby’s hospital and office records to confirm whether the PKU test had been done.

The lawsuit also blamed the hospital for not requiring every infant to have a blood test before discharge, and for failing to establish a screening program that followed state guidelines.

The parents continued to take their son to Asheville Children’s Medical Center for his pediatric care. At 13 months, ACMC personnel noted that the child didn’t pull himself up and wasn’t crawling, the complaint states.

The parents were referred to Dr. Olson Huff, a specialist in developmental pediatrics, who examined the child in November 1996 and “expressed immediate concern” about the child’s development, according to the complaint. Huff advised the parents to arrange for a neurological evaluation.

The neurologist, Dr. Joseph Huffstutter, diagnosed the baby with PKU in December 1996. The child, then 20 months old, was immediately started on a special diet of low-protein formula — the only way to treat the condition, court documents say.

The child requires speech, developmental and occupational therapy, along with assisted routine daily care — which he’ll need for life, according to the lawsuit. The complaint also cites the child’s suffering, physical and mental pain, many medical procedures, seizures, permanent injuries, and the loss of “normal use of his body and mind,” as well as future income.

Like most legal settlements, this one prohibits those involved from discussing details of the case, explained Hammond.

“We can say that our own internal investigation convinces us that everybody involved cared deeply for the well-being of the baby and his family, and acted conscientiously,” she added.

No one involved in the case is admitting liability or wrongdoing, according to the settlement agreement.

Although the settlement is a matter of public record, the document takes pains to protect the defendants’ identities, barring the plaintiffs and their attorneys from mentioning the names of the defendants and their insurance companies — Medical Mutual Insurance Co. of North Carolina and The Virginia Insurance Reciprocal — in any statement to the media about the lawsuit (none did).

All the defendants contributed to the court-approved settlement, though not equally. The hospital agreed to pay $1.5 million; the two pediatricians and their insurers are contributing $1.23 million up front, and are responsible for a series of payments through an annuity — totaling at least $5.78 million — to be put into a trust fund set up for the boy.

Hendon, the family’s lawyer, will receive $1.66 million from the settlement, which also was approved by a judge.

A new policy

Besides its financial contribution to the settlement, Memorial Mission Hospital agreed to change its policy and procedure for screening newborns to follow N.C. Department of Health and Human Services recommendations.

The hospital’s previous policy was at odds with the state’s administrative code, according to documents filed in the case. State rules say that infants should be screened for PKU unless the parents or guardian object to the test.

But the hospital’s policy, starting in 1992, was to have infants tested for PKU unless the parents objected, or “unless otherwise ordered by the physician,” the complaint maintains.

“The hospital initially contended that they were free to establish their own policy, since the state health-department provisions were just recommendations,” Hendon, the family’s lawyer, told North Carolina Lawyers Weekly. “They took the position that the system is doctor-driven, and doctors always have the authority to direct treatment.”

But Hendon produced pediatrics and genetics experts who said the hospital’s practices didn’t meet standards for proper care, according to Lawyers Weekly.

“Our experts said that, notwithstanding the fact they were recommendations, the state guidelines established the standard of care,” Hendon told Lawyers Weekly. “That meant the test should have been done before the child left the hospital. The only time not to test before discharge is if the child is in trouble and needs to be transferred to a different hospital. In that case, you can rely on the other hospital to take care of it.”

Hendon told the legal publication that he had reviewed discharge policies from a dozen other hospitals, most of which followed state health-department recommendations.

In the past year, Memorial Mission revised its policy to remove the doctor’s option of ordering that the test not be done, Hammond revealed. The hospital delivers 3,500 babies a year; all of them are now screened unless the parents refuse to allow it, she added.

Because PKU can lead to brain damage, the importance of the screening can’t be overlooked, says Lib Moore, unit head for genetic health care and the newborn screening program for the state Division of Public Health.

“That’s why it’s so important to identify [any problems] as soon as possible,” Moore observes. “Once the brain is damaged, you can’t go back and repair it.”

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