How many children must die before the world wakes up?
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.
BY NIRVI SHAH
May 1, 2010
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.