Breaking news and expert analysis on legal and compliance issues
From Health Law Daily, April 18, 2017
A whistleblower adequately alleged that between 1997 and 2009, AstraZeneca Biopharmaceuticals, Inc. submitted false claims to Medicare for Seroquel® prescriptions that were prescribed concomitantly with QT/QTc prolonging medications, despite AstraZeneca’s misrepresentation of the risk of drug interaction. Although the court permitted the False Claims Act (FCA) (31 U.S.C. § 3729 et seq. ) misrepresentation claims to proceed, it dismissed the relator’s claims that off-label promotion of the drugs led to false claims. The court held the off-label promotion claims were barred by the FCA’s first-to-file rule, as a result of similar litigation pending in Delaware (U.S. ex rel. Zayas v. Astrazeneca Biopharmaceuticals, Inc., April 17, 2017, Block, F.).
Drug interaction. The relator alleged that AstraZeneca misrepresented the risk of drug interaction between Seroquel and QT/QTc prolonging medications in the requisite drug utilization review in order to fill Seroquel prescriptions, and, in turn, promote government payment for the claims. As a result of the misrepresentation, the relator alleged the claims were factually false. The relator asserted that AstraZeneca’s claims were also legally false because despite the fact that AstraZeneca was party to two corporate integrity agreements (CIAs), the manufacturer failed to disclose its knowledge about the interaction between Seroquel and QT/QTc prolonging medications.
Off-label. AstraZeneca asserted that the relator’s off-label promotion claims were barred by the first-to-file rule because they were premised upon the same facts as an earlier action in Delaware. The relator countered that: (1) she was alleging off-label promotion to treat different diseases than those alleged in the Delaware action; (2) she alleged off-label promotion of Seroquel IR, whereas the Delaware action only related to off-label promotion of Seroquel XR; and (3) the Delaware action was no longer pending. The court rejected the first argument on the grounds that the bar is a restriction on related actions, not "identical actions." The court noted that the relator’s second argument was factually inaccurate because the Delaware action concerned both drugs. Finally, because the Delaware action was stayed but not dismissed, for FCA, purposes, the court held that it remained "pending." Accordingly, the court dismissed the off-label promotion claims.
The case is No. 1:14-cv-01718-FB-SMG.
Attorneys: Kenneth M. Abell, U.S. Attorney's Office, for the United States. Bruce W. Kauffman (Elliott Greenleaf) and Perry M. Amsellem (Pryor Cashman LLP) for States of California, Delaware, Connecticut, Maryland, Colorado, Florida, Georgia, Illinois, Indiana, Hawaii, Louisiana, Michigan, Montana, New Hampshire, New Mexico, New York, Nevada, Tennessee, Texas, New Jersey, Rhode Island, Oklahoma, Wisconsin, North Carolina, Minnesota, Washington, and The Commonwealths of Massachusetts and Virginia. John C. Dodds (Morgan, Lewis & Bockius LLP) for AstraZeneca, LP.
Companies: AstraZeneca Biopharmaceuticals, Inc.; AstraZeneca PLC; AstraZeneca, LP; United States of America; State of California; State of Delaware; State of Connecticut; State of Maryland; State of Colorado; State of Florida; State of Georgia; State of Illinois; State of Indiana; State of Hawaii; State of Louisiana; State of Michigan, State of Montana, State of New Hampshire; State of New Mexico; State of New York; State of Nevada; State of Tennessee; State of Texas; State of New Jersey; State of Rhode Island; State of Oklahoma; State of Wisconsin; State of North Carolina; State of Minnesota; State of Washington; Commonwealth of Massachusetts; Commonwealth of Virginia
MainStory: TopStory CMSNews AuditNews DrugBiologicNews FCANews PrescriptionDrugNews SafetyNews NewYorkNews
Introducing Wolters Kluwer Health Law Daily a daily reporting service created by attorneys, for attorneys providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.