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Emilio Villamar,
(above) died of a heart attack at 16. His mother
said she was shocked
when she heard the
same psychiatrist was treating 7-year old Gabriel
Myers.
She claims her son
was given a cocktail of drugs, some that were not
approved
for children. “He was
like a zombie, my son was like a zombie all the
time.”
Drug's use again in spotlight
The mother of a Broward
teen who died in 2003 believes it was because of an
anti-psychotic drug he should not have been
prescribed.
A Broward doctor reprimanded by the Food
and Drug Administration for his drug-prescribing
practices is facing accusations in a civil suit
that he caused the death of a Weston teen after
prescribing an anti-psychotic drug not approved
for use in adolescents.
Norma Tringali of Tamarac believes the
drug Seroquel, which Dr. Sohail Punjwani
prescribed to her son Emilio, played a role in
his death seven years ago. Punjwani is the same
physician who was treating 7-year-old foster
child Gabriel Myers before he committed suicide
last year.
Earlier this week, pharmaceutical giant
AstraZeneca agreed to pay state and federal
government agencies $520 million to settle an
investigation into the company’s marketing
practices, which the Department of Justice said
encouraged doctors to use Seroquel for young and
elderly people for indications not approved by
the FDA.
The settlement will yield about $8.5
million for Florida, split between the state’s
Medicaid program, general revenue fund and a
reward program for reporting Medicaid fraud.
Tringali’s case against Punjwani is
expected to go to trial later this year.
All the other doctors and institutions
named in the suit have settled with Emilio’s
family, said her lawyer, Michael Freedland.
In the meantime, for Tringali, the civil
penalty AstraZeneca has said it will pay
provides some resolution.
“That is the thing — that is the answer,”
Tringali said, through tears. “Emilio was taking
something recommended for adults, not kids.”
Punjwani and his attorneys did not return
several phone calls seeking comment.
After a year in Punjwani’s care, Emilio,
who played water polo, had a heart attack and
died. He was a junior at Piper High School in
Sunrise. The lawsuit alleges that Punjwani’s
care “deviated and departed from the prevailing
professional standard of care exercised” by most
doctors.
It goes on to say that Punjwani failed to
monitor the effects of a combination of
anti-psychotic drugs on Emilio’s heart, failed
to perform regular cardiac testing and failed to
consult with a cardiologist or other doctor with
more experience with the heart-related side
effects of anti-psychotic drugs, among other
things.
But it is not certain whether the
settlement will have a direct effect on the suit
against Punjwani, said Tringali’s lawyer, Weston
attorney Michael Freedland.
“She was always convinced that these drugs
caused his death,” Freedland said of Emilio’s
mother.
“For her this settlement was some kind of
vindication in a sense. It doesn’t necessarily
relate to the exact same issue.”
Freedland’s office was simultaneously
working on Tringali’s case and the whistleblower
case that led to this week’s settlement with
AstraZeneca. But rules about whistleblower suits
meant they could not share anything about that
case with Tringali until the settlement became
public this week.
Punjwani was reprimanded by the FDA
because he failed “to protect the rights, safety
and welfare” of children enrolled in clinical
drug trials.
“Your failure to conduct the requisite
safety measures contributed to the unnecessary
exposure of pediatric subjects to significant
overdoses, which jeopardized the subjects’
rights, safety and welfare,” the FDA wrote.
Early last year, drugmaker Eli Lilly
pleaded guilty to illegally marketing the
anti-psychotic drug Zyprexa for unapproved uses.
Freedland’s firm also worked on that case, which
netted a $1.42 billion settlement.
“The issue relates to these drugs,”
Freedland said. “The way Dr. Punjwani treated
Emilio Villamar and the manner in which these
drugs were prescribed is a picture of everything
that’s wrong with this industry and the
relationship between doctors and pharmaceutical
companies.”
The settlement says that AstraZeneca
targeted its illegal marketing of Seroquel at
doctors who do not typically treat schizophrenia
or bipolar disorder, including physicians who
treat older patients, young patients and primary
care doctors and to psychiatrists and other
physicians for uses that were not approved by
the FDA as safe and effective.
The civil penalty will repay Medicaid,
Medicare and other programs that were billed for
the drug, although it was being prescribed
incorrectly.
In a statement, AstraZeneca said under the
agreement, it still denies the allegations.
However, the international company, with
U.S. headquarters in Delaware, entered into a
corporate integrity agreement with the Office of
Inspector General of the United States
Department of Health and Human Services that
will last for five years.
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