ISTA Pharmaceuticals to pay $15 million in multi-state settlement

By Bryan Cohen | Jul 22, 2013

MADISON, Wis. (Legal Newsline) - Wisconsin Attorney General J.B. Van Hollen announced Friday that Wisconsin joined a multi-state and federal settlement with ISTA Pharmaceuticals Inc. to resolve allegations of off-label marketing.

Between January 2006 and March 2011, ISTA allegedly marketed its ophthalmic drug Xibrom for uses that were not approved by the U.S. Food and Drug Administration and paid inducements to doctors to write prescriptions for Xibrom. Xibrom was approved for use after cataract surgery. ISTA allegedly marketed the drug for a wider range of uses, including the treatment of glaucoma, inflammation other than postoperative inflammation, pain and inflammation related to non-cataract eye surgery and cystoid macular edema.

Under the terms of the settlement, ISTA paid the states and the federal government $15,000,000 in civil damages to compensate Medicare, Medicaid and other federal healthcare programs. State Medicaid programs received more than $740,000 with the federal government receiving most of the damages because the majority of Xibrom prescriptions written were for conditions suffered primarily by older Medicare patients.

Wisconsin received $8,202.54 as the state share of the $20,814.43 provided to Wisconsin Medicaid. Medicaid is a health insurance program for the disabled and needy that is funded jointly by the federal and state governments.

ISTA also resolved concurrent criminal charges by entering into a plea agreement with the federal government. ISTA pleaded guilty to conspiracy to introduce a misbranded drug into interstate commerce and conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute. ISTA paid criminal forfeitures and fines of approximately $18.5 million in addition to the civil settlement.


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