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District Judge Frederic Block

 

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Relator Zayas’s qui tam action under the False Claims Act (FCA) alleged the Astrazeneca defendants marketed Seroquel IR and Seroquel XR as safe to be prescribed with QT/QTc prolonging medications despite knowing the risks of such concomitant prescriptions. She also alleged off-label promotion of Seroquel. The court dismissed Zayas’s off-label promotion claim as barred by the FCA’s “first-to-file” rule, finding her claim based on the same facts as an earlier-filed case in Delaware. Although stayed, the Delaware case was never dismissed. However, Zayas alleged facts establishing a fraudulent scheme in each instance where Seroquel was prescribed with QT/QTc medications without warning from defendants. Thus she appropriately alleged a “complex fraudulent scheme … occurring over a lengthy period of time and involving thousand of billing documents.” Discussing U.S. ex rel. Booker v. Pfizer Inc., 9 F. Supp. 3d 34, the court rejected Zayas’s “reverse false claim” asserting defendants’ violation of Corporate Integrity Agreements with the government. Stipulated penalties were not automatically imposed. Rather, the government must choose to impose such penalties and defendants may appeal their imposition to an administrative law judge.

District Judge Frederic Block

 

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Relator Zayas’s qui tam action under the False Claims Act (FCA) alleged the Astrazeneca defendants marketed Seroquel IR and Seroquel XR as safe to be prescribed with QT/QTc prolonging medications despite knowing the risks of such concomitant prescriptions. She also alleged off-label promotion of Seroquel. The court dismissed Zayas’s off-label promotion claim as barred by the FCA’s “first-to-file” rule, finding her claim based on the same facts as an earlier-filed case in Delaware. Although stayed, the Delaware case was never dismissed. However, Zayas alleged facts establishing a fraudulent scheme in each instance where Seroquel was prescribed with QT/QTc medications without warning from defendants. Thus she appropriately alleged a “complex fraudulent scheme … occurring over a lengthy period of time and involving thousand of billing documents.” Discussing U.S. ex rel. Booker v. Pfizer Inc. , 9 F. Supp. 3d 34 , the court rejected Zayas’s “reverse false claim” asserting defendants’ violation of Corporate Integrity Agreements with the government. Stipulated penalties were not automatically imposed. Rather, the government must choose to impose such penalties and defendants may appeal their imposition to an administrative law judge.