Reprinted from:
St. Petersburg Times
St. Petersburg Times
Risky drug was boy's last chance
St. Petersburg; Aug 22, 1995; STEPHEN HEGARTY;
Full Text:
Copyright Times Publishing Co. Aug 22, 1995
As he did most days, Ralph Leon Pitts lined up to take his medication at about 8 o'clock on a Saturday morning in July.
For the mentally retarded 16-year-old and some of the other residents of the group home in Seffner, taking medication was a routine part of the morning - like eating breakfast and getting dressed.
On this morning, Leon suddenly keeled over backward and dropped to the floor. He hit his head and lay sprawled on the living room carpet with his muscles painfully rigid. He was having another seizure.
As sudden as it was, the seizure was not unexpected. Leon had been having intense and frequent seizures since his medication was eliminated in May. The anti-seizure medication, Felbatol, was suspected of deadly long-term effects, and doctors everywhere were reconsidering its use.
In Leon's case, eliminating the drug might have been just as deadly. Since being taken off Felbatol, Leon had experienced dozens of seizures every day. He often collapsed without warning. One time he fell face-first on a sidewalk and smashed his front teeth. His falls were so frequent he had to wear a helmet all the time.
So it wasn't unusual when Leon hit the living room floor that Saturday morning in the medication line.
For about an hour after the July 8 seizure, no one moved Leon. Intense seizures can be physically draining, and Leon often wanted to nap afterward. He was left to sleep it off.
But as he lay on the floor after the seizure, Leon wasn't sleeping.
He was dying.
The impact of the fall - and perhaps the seizure itself - caused the veins between Leon's skull and brain to tear. As he lay there seemingly asleep, a pool of blood was forming inside his skull. Pressure was building around his brain. Leon was dying right where he fell. `He just fell apart'
Teacher Peggy Ferro was at Dover Elementary School on Monday morning, July 10, when she learned that Leon died. He was one of her students, and she had expected he would stroll into class any minute.
Ferro, a special education teacher, knew firsthand of Leon's problems. For weeks she watched in frustration as the handsome teen who was so popular with the girls got banged up and worn out by the constant seizures.
Still, his death seemed impossibly sudden.
"A few weeks earlier he was a completely healthy kid," Ferro said. "Then his medication was changed, and he just fell apart."
Days after his fall, Leon's death was determined by the medical examiner to be accidental. He fell. He hit his head. He died.
Still, Ferro believes Leon's death could have been prevented. She has a sense that the people who were supposed to look out for Leon failed him - before and after his fall. Ferro questions the decision to change his medication, and the lack of attention after he fell. More than two hours passed before the group home staff called 911.
"I understand that sometimes these things happen," Ferro said. "If I knew in my heart that everything that could be done for him was done, I would be fine. But I feel like a lot of people let him down."
Leon was born to Edna McDonald, who lives up in the Florida Panhandle between Interstate 10 and the Alabama state line. It wasn't long before Leon's seizures started and he became a tough child to care for.
"He started having seizures when he was about 2," said Chris "Manny" Mira, associate director of the Florida Center for the Handicapped, the group home where Leon lived. "His mom loved him. I know that. But I think she had trouble handling him. Leon's a pistol. He didn't listen to his mother."
When Leon was about 10, Mrs. McDonald gave up caring for him. He was a tough case, and he was sent to the group home far away in Seffner. His mother retained custody and remained in telephone contact. A few times a year she made the seven-hour drive to visit him. In fact, just days before his fatal fall, she came down for a visit.
But for the last six of his 16 years, Leon lived with other children who were retarded or had behavioral problems.
"I just about raised him," Mira said.
Leon was considered trainably mentally handicapped, the middle range of retardation. That means he had limited intelligence, yet could learn and possibly hold a job. He wanted to be a country music star. Or a professional wrestler. Perhaps Leon's biggest handicap in life was his seizures.
About a year and a half ago, a new epilepsy drug entered the market, and it proved near-miraculous for Leon. With the new medication, Felbatol, Leon experienced only a few seizures a year.
"Originally it was seen as a panacea - the wonder drug," said Dr. Richard Gunderman, a Tampa neurologist. "It really did a wonderful job controlling seizures for a lot of people."
Then came the bad news about Felbatol. Last year, word spread through the medical community that Felbatol caused aplastic anemia and liver failure. Several deaths were attributed to the drug.
"There was quite a scare all around the country," said Dr. Gregory L. Holmes, director of the epilepsy program at Children's Hospital in Boston and an associate professor of neurology at Harvard Medical School. "There was a great deal of pressure from patients and from doctors, who felt everyone had to be off the drug.
"We learned a great deal during the scare, and we learned it the hard way. A lot of patients took a turn for the worst" after they stopped taking the drug. `Damned if you do . . .'
At the Florida Center for the Handicapped, Manny Mira set out to take Leon off Felbatol.
Mira had received an Aug. 2, 1994, memo from the state Department of Health and Rehabilitative Services, which licenses the group home. The memo referred to a TV news report on Felbatol, which "recommended that the medicine be discontinued on patients now using." The memo also said patients' records should be reviewed by their doctors.
"We were under the impression there was a recall, and nobody could use it anymore," Mira said. "As far as I knew, we had no choice. Our hands were tied."
Leon's case was reviewed. The medication was ended.
Around the same time, experts such as Gregory Holmes were urging doctors to familiarize themselves with the risks of Felbatol, but also to consider the significant risks of taking patients off the medication.
As soon as he stopped taking Felbatol in early May, Leon lost control of his body. The seizures started with a vengeance.
"They said we might see an increase in seizure activity," said Ferro, his teacher. "We saw an increase, all right."
Ferro kept a record of Leon's seizures. He had a seizure at the prom. He fell face-first on a sidewalk and smashed his teeth. He landed on his chin and needed stitches. The seizures came so often and were so unexpected, the school hired a full-time aide to keep an eye on him.
The seizures wreaked havoc in the group home, too. Mira estimated that Leon suffered dozens of seizures each day, and as many as 75 one day.
"This was a medicine that worked pretty well for him," Mira said. "I understand there was a danger if he stayed on the medicine. But the falling and the seizures, they were beating him up. You're damned if you do, damned if you don't."
Leon was given another anti-seizure medication, but it didn't work like Felbatol.
Mira took Leon to the hospital at least twice. Each time Leon was released. Once after leaving the hospital, Mira took Leon to McDonald's. He had three seizures there. They got their food to go.
Even when he wasn't having a seizure, Leon had a constant reminder: the helmet that he hated to wear.
On the morning Leon fell while in line for medication, there was one woman on duty at the group home. Mira described her as perhaps five inches shorter and 20 pounds lighter than Leon, who stood about 5 feet 6 and weighed around 125 pounds. She probably couldn't have moved Leon if she had to, he said.
According to the group home report of the incident, Leon fell at about 8 a.m., his helmet on his head. After the seizure passed, he mumbled and squeezed the woman's hand. She allowed him to doze where he fell. At 9 a.m., two more staff members came on duty, and they moved Leon to a couch. Mira was called and told about the seizure. He agreed to let Leon sleep.
"It might seem tacky, but that was Leon," Mira said later. "He had to go to sleep afterward. You'd check on him later and he'd still be lying there, but he'd be watching TV."
At 10 a.m., two hours after the fall, Mira was called and was told that Leon was not responding to efforts to wake him. He was pale. His breathing was shallow. Mira told them to take Leon to the hospital. When the staff went to move him, they discovered his skin was cold and clammy. His eyes were dilated. At about 10:15, the staff phoned Mira a third time and told him they were going to call for an ambulance.
Leon lost the ability to breathe on his own about 1:30 p.m. Doctors were able to keep him alive for nearly two days. The official time of his death was 4:55 a.m. July 10. The official cause was subdural hematoma resulting from "blunt impact to the head."
The medical examiner did not perform an autopsy, because Leon's mother did not want one done.
"I told her I would strongly recommend a medical exam to clear the air, to find out exactly what happened," Mira said. "She said, `No, I don't want nobody cutting on my baby.' "
The death was ruled accidental. The group home was found to have acted appropriately.
Three days after his death, a memorial service was held for Leon at the First Baptist Church of Brandon. Classmates, teachers, group home staffers and residents attended. In the center of it all was a picture of Leon, taken just a few months earlier when he was handsome, full of energy and mischief. He was buried near Marianna in the Panhandle.
Peggy Ferro has gone over the details of Leon's death more than a few times. She knows that Leon often slept after seizures. He sometimes slept it off in her class. And she knows that there was great risk in keeping him on a medication that might kill him years from now.
"But he went downhill so quick," she said. "I can't believe nobody could help him. I feel like ultimately there was not a soul in the state of Florida who was looking out for him."
Manny Mira has gone over the details a few times himself. He has been interviewed by the Department of Health and Rehabilitative Services and by the medical examiner's office. He has questioned his staff. And he's lost sleep.
"I got angry after he died," Mira said. "I guess he needed that medication. The question is do you leave a child on medication that might hurt him later? I don't want to be the person to have to answer that question."
Reprinted from:
St. Petersburg Times