STATEN ISLAND, N.Y. -- The blend of methadone and an anti-psychotic medication may have contributed to 10 deaths at Staten Island University Hospital clinics, a bombshell whistleblower lawsuit alleges.
The federal suit claims the drug, Seroquel, which is used to treat depression, bi-polar and schizophrenia, and its maker, AstraZeneca, knew for years the cocktail could cause an abnormal heart rhythm but did not warn the public until 2010.
Allison Zayas, a former New York sales representative for the London-based pharmaceutical company who worked in Staten Island and Brooklyn, is suing the company on behalf of the U.S. government and 27 states, including New York and New Jersey.
Staten Island University Hospital is not named as a defendant in the suit.
In 2009, 10 methadone patients unexpectedly died at Staten Island University Hospital (SIUH) clinics, and "the one common denominator for these deaths" was the use of Seroquel, known in its generic form as quetiapine, according to the federal court filing.
The suit claims at least three SIUH physicians believed Seroquel "played a role" in the patient deaths.
The hospital disputed those claims.
"The patient cases referred to by whistleblower date back more than seven years. There were no definitive findings that the deaths mentioned in the whistleblower complaint were caused by a combination of Seroquel and methadone," said Terry Lynam, chief public relations officer for Northwell Health, in a statement to the Advance.
"As for the three clinicians who are mentioned in the complaint, they were never involved in the care of addiction patients," Lynam said. "It's important to keep in mind that the allegations contained in the lawsuit are not based on validated testimony or court evidence."
AstraZeneca sales reps, the filing alleges, targeted physicians treating heroin and pill addicts to push the drug at borough facilities -- including both Staten Island Island University Hospital locations, Richmond University Medical Center MICA (mentally ill/chemically addicted) program at the Bayley Seton campus in Clifton, and Bridge Back to Life in Castleton Corners -- and were given bonuses based on their sales numbers.
Zayas, who claims the company never informed her of the potentially fatal risks, first reported the information from SIUH to the drug maker in December 2009, but there were no warning labels placed on bottles in January 2010.
The U.S. labels on the medication were not amended until June 2010, when the FDA mandated the new labels warn patients and physicians that the use of Seroquel and methadone should be avoided, the filing said.
In 1997, Seroquel was approved in the Unites States for treating schizophrenia, and was cleared in 2004 to treat bipolar disorder and depression. Doctors also used it to treat anxiety and insomnia, said the suit.
Since 1997, AstraZeneca was engaged in illegal marketing for the purpose to drive up its sales, said the suit.
According to court documents, Seroquel sales in the United States reached $5.3 billion in 2010.
On Nov. 14, Zayas and the company reached a settlement in principle, according to court records. Zayas is seeking reimbursement for the cost to government health agencies.
The parties are due back in federal court Monday.
Time Magazine reported that AstraZeneca agreed to pay $520 million in 2010 to settle U.S. Department of Justice allegations that it promoted Seroquel for numerous off-label uses, though it didn't admit wrongdoing.
AstraZeneca aslo paid more than $1 billion in settlements over side effects and marketing of Seroquel, the article said.