Pharma Fraud

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 28, 2017

Mary Inman appeared as a special guest on RAC Monitor’s “Monitor Monday” radio broadcast “Pharma on Pharma:  Sanofi-Aventis Blows the Whistle on Mylan $465 Million False Claims Settlement.”  Mary’s remarks begin at 22:11 minutes into the program.

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)