Archive

September 5, 2017

Novo Nordisk Inc. agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza.  The New Jersey based pharmaceutical manufacturer is a subsidiary of Denmark’s Novo Nordisk A/S.  At the time of Victoza’s FDA approval in 2010, the FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. Under the REMS, Novo Nordisk was required to disclose to physicians the potential risk. If it failed to comply with these disclosure requirements, including requirements to communicate accurate risk information, the drug would be considered misbranded under the law.  According to the government, Novo Nordisk failed to comply with the REMS requirements, providing information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant.  The allegations originated in several whistleblower lawsuits filed under the qui tam provisions of the False Claims Act. The whistleblowers who brought these actions will receive a yet-to-be-determined whistleblower award from the proceeds of the government’s recovery. Whistleblower Insider

August 23, 2017

US Bioservices Corp. agreed to pay $13.4 million to settle charges it violated the False Claims Act and Anti-Kickback Statute by participating in a kickback scheme with Novartis Pharmaceuticals Corp. relating to the Novartis drug Exjade.  Specifically, the government alleges US Bio was promised additional patient referrals and related benefits in return for refilling a higher percentage of Exjade than the two other pharmacies that also dispensed Exjade.  DOJ (SDNY)

August 17, 2017

Pharmaceutical companies Mylan Inc. and Mylan Specialty L.P. agreed to pay $465 million to settle charges they violated the False Claims Act by purposely misclassifying EpiPen as a generic drug to avoid paying higher Medicaid rebates.  Under the Medicaid Drug Rebate Program, state Medicaid programs are entitled to larger rebates for brand-name drugs compared to generics.  According to the government, Mylan circumvented this program and its purpose by erroneously reporting EpiPen as a generic drug to Medicaid so it could demand massive price increases in the private market while avoiding its corresponding rebate obligations to Medicaid.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by competing pharmaceutical manufacturer Sanofi-Aventis US.  Sanofi will receive a whistleblower award of roughly $38.7 million from the proceeds of the government’s recovery. Whistleblower Insider

November 17th, 2017

New York announced the indictment of Hin T. Wong ("Wong"), 49, of Manhattan, Mery Gooden, 58, of the Bronx, and three pharmacies. The indictment charges Wong, the owner of three Manhattan pharmacies – New York Pharmacy Inc. ("NY Pharmacy"), NYC Pharmacy Inc. ("NYC Pharmacy"), and New York Healthfirst Pharmacy Inc. ("NY Healthfirst") – for defrauding several government-funded healthcare programs, including Medicaid and Medicare, by falsely billing prescription refills and stealing over $3 million in reimbursement for medication they did not dispense. Wong was indicted for Grand Larceny in the First Degree, a class "B" felony, and other crimes. In addition, Mery Gooden, a pharmacist at NYC Pharmacy, was indicted for Grand Larceny in the Second Degree and other related crimes. NY

September 5, 2017

Novo Nordisk, Inc. has agreed to $1.1 million to resolve claims that its diabetes drug Victoza was unlawfully promoted for off-label use in violation of the California Insurance Frauds Prevention Act.  The claims were brought in a whistleblower action under that act filed by former Novo Nordisk researcher Peter Dastous, who will receive a share of the settlement.  CA

August 18, 2017

Illinois and other states announced a $465 million settlement between the federal government and states with Mylan Inc. and its wholly-owned subsidiary, Mylan Specialty L.P. (Mylan), to resolve allegations that Mylan knowingly underpaid rebates owed to the Medicaid program for EpiPen® and EpiPen Jr.® (EpiPen) dispensed to Medicaid beneficiaries. The settlement resolves allegations that from July 29, 2010 to March 31, 2017, Mylan submitted false statements to the Centers for Medicare and Medicaid Services (CMS) that incorrectly classified EpiPens under terms defined in the Rebate Statute and Rebate Agreement. Mylan also failed to report a "Best Price" to CMS for EpiPens, as directed by the same statute. As a result, Mylan submitted false statements related to EpiPens to CMS and the states for Medicaid rebate purposes and underpaid EpiPen rebates to the state Medicaid programs. IL, IA

August 18, 2017

Illinois announced a $4.45 million settlement with the pharmaceutical company Insys Therapeutics Inc. (Insys) for deceptively marketing and selling a highly addictive opioid drug for an array of treatments that were not approved by the Food And Drug Administration (FDA). The settlement resolves Madigan’s 2016 lawsuit against Insys for its sale of Subsys, which is significantly more powerful than morphine and intended exclusively for the treatment of breakthrough cancer pain. Madigan alleged Insys deceptively promoted and sold Subsys to treat a wide variety of pain, such as back and neck pain, even though the drug was not approved for those uses. IL

July 11, 2017

Mallinckrodt LLC, a pharmaceutical manufacturer and one of the largest manufacturers of generic oxycodone, agreed to pay $35 million to settle allegations it violated certain provisions of the Controlled Substances Act.  According to DOJ, it is the first settlement of its magnitude with a manufacturer of pharmaceuticals resolving nationwide claims the company did not meet its obligations to detect and notify DEA of suspicious orders of controlled substances such as oxycodone.  DOJ

July 7, 2017

Wal-Mart Stores Inc. agreed to pay $1.65 million to resolve allegations it violated the False Claims Act by submitting pharmacy claims to California’s Medi‑Cal program not supported by applicable diagnosis and documentation requirements.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by a Wal-Mart pharmacist.  The whistleblower will receive a whistleblower award of roughly $264,000 from the proceeds of the government's recovery.  DOJ (EDCA)

July 26, 2017

Washington recovered nearly $750,000 in Medicaid reimbursement this week from pharmaceutical company Celgene Corporation for promoting medications to treat conditions they were not approved for, including certain types of cancer. The company is also accused of paying kickbacks to doctors for prescribing the medications and helping them change billing codes to ensure Medicaid would pay for their use. Off-label marketing, fraudulent billing and providing kickbacks to doctors are all violations of the Medicaid False Claims Act. WA