Pharma Fraud

June 18, 2015

47 states and the District of Columbia reached a settlement with Inspire Pharmaceuticals, resolving allegations that Inspire violated state and federal False Claims Act laws by illegally marketing the drug Azasite for off-label uses not approved by the U.S. Food and Drug Administration. Approved only for the treatment of bacterial conjunctivitis (“pink eye”), Inspire marketed Azasite for the treatment of blepharitis, an inflammation of the eyelash follicles. While physicians are permitted to prescribe drugs for conditions other than those for which the drugs have been approved by the FDA, pharmaceutical companies are prohibited from marketing drugs to physicians for such off label conditions. It is contended that, as a result of Inspire’s illegal off label promotion, Inspire caused the submission of false and fraudulent claims for Azasite to the Medicaid program and other federal programs. NY

June 11, 2015

Louisiana announced that its Medicaid program will receive over $5 million as a result of a settlement between specialty pharmacy company Accredo Health Group, Inc. and 40 states and the federal government, resolving allegations that Accredo engaged in a scheme with drugmaker Novartis to boost sales of the drug Exjade, which is used to treat chronic iron overload due to blood transfusions. Accredo is accused of improperly directing nurses to contact Medicaid beneficiaries to encourage continued use of Exjade. Accredo’s goal in the scheme was to earn higher sales revenue, additional dispensing fees and more rebates from Novartis. The nurses were directed to discuss Exjade’s common side effects, but not its less common but more severe possible side effects such as kidney or liver problems. LA

May 28, 2015

The FTC has reached a settlement resolving the Commission’s antitrust suit charging Cephalon, Inc. with illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil. The settlement ensures that Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total of $1.2 billion available to compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct. FTC Chairwoman Edith Ramirez said, “today’s landmark settlement is an important step in the FTC’s ongoing effort to protect consumers from anticompetitive pay for delay settlements, which burden patients, American businesses, and taxpayers with billions of dollars in higher prescription drug costs.”

May 8, 2015

New York Attorney General Eric T. Schneiderman announced an agreement in principle to settle kickback claims against Medco Health Solutions subsidiary Accredo Health Group, Inc. to resolve allegations that Accredo recommended the drug Exjade to Medicaid patients in exchange for kickbacks from Novartis Pharmaceuticals Corporation which markets the drug. Under the settlement, Accredo will pay $60 million to the federal government, New York, and several other states. About $3.4 million of the settlement will resolve claims relating to New York’s Medicaid program. In January 2014, another pharmacy, BioScrip, Inc., agreed to pay $15 million to resolve similar claims. The case against Novartis is ongoing. NY

March 16, 2015

New York Attorney General Eric T. Schneiderman announced that New York along with 49 other states and the District of Columbia have reached a settlement with global pharmaceutical company Daiichi Sankyo, Inc. to resolves allegations that Daiichi violated the False Claims Act by using lavish meals and speaker programs to improperly induce physicians to prescribe the drugs Azor, Benicar, Tribenzor and Welchol. Under the agreement, Daiichi agreed to pay the US and state Medicaid programs $39 million. The allegations originated in a whistleblower lawsuit filed by former Daiichi sales representative Kathy Fragoules under the qui tam provisions of the federal and New York State False Claims Acts. She will receive $6.1 million of the federal recovery and an undisclosed portion of the state recoveries. NY

March 6, 2015

Florida Attorney General Pam Bondi announced the arrest of three men for their alleged involvement in an $11 million multi-state drug diversion ring which involved the purchase of millions of dollars of medications on the black market, primarily from Medicaid recipients in Miami and Newark, and their resale to pharmacies in the Northeast, including North Philly Pharmacy in Philadelphia and Lu Puja Pharmacy in Chicago. FL

January 30, 2015

Massachusetts Attorney General Maura Healey announced Neighborhood Diabetes, Inc. will pay more than $1.5M to settle allegations it improperly billed and received payments from the state’s Medicaid program when it automatically refilled prescription medications that were not specifically requested by MassHealth patients or caregivers. The settlement is the second case in the Commonwealth to address a pharmacy’s operation of an improper automatic refill program with MassHealth members. In September 2013, AllCare Pharmacy agreed to pay $1.6M to settle similar allegations. MA

October 16, 2014

Texas Attorney General Greg Abbott entered into a settlement with generic drug maker Ranbaxy Pharmaceuticals, Inc., Ranbaxy Laboratories, Inc., Ranbaxy USA, Inc. and Ranbaxy, Inc. to resolve allegations they violated the Texas Medicaid Fraud Prevention Act by fraudulently reporting inflated drug prices to the Medicaid program. Under the settlement, Ranbaxy must pay the State of Texas about $18M. TXAG