This $465 million EpiPen® settlement among the United States, the States, and pharmaceutical companies Mylan Inc. and Mylan Specialty L.P. was the largest False Claims Act settlement of 2017. This case was one of the reasons attorneys Bob Thomas and Suzanne Durrell were named Lawyers of the Year (2017) by the Taxpayers Against Fraud Education Fund. The settlement resolved allegations that Mylan violated the federal and state False Claims Acts by knowingly misclassifying EpiPen®, a branded epinephrine auto-injector drug, as a generic drug, to avoid paying rebates owed to Medicaid.
Our client worked with the government, and in August 2017, just over a year after we filed the qui tam complaint, Mylan entered into the settlement with the United States and the States. The company agreed to pay $465 million to resolve allegations that it violated the False Claims Act. The government contended that it improperly misclassified EpiPen as a generic drug to avoid paying state Medicaid programs the higher rebates for branded drugs, even though EpiPen had no FDA approved therapeutic equivalents and was marketed and priced as a brand name drug. Mylan raised the price of EpiPen by approximately 400% between 2010 and 2016.
Mylan also entered into a five-year Corporate Integrity Agreement with HHS-OIG that requires, among other things, an independent review organization to annually review multiple aspects of the company’s practices relating to the Medicaid drug rebate program. Mylan further agreed that going forward it would properly classify EpiPen®, meaning that the Medicaid program will receive much higher rebates in the future.
The United States Attorney was especially grateful that our client, another pharmaceutical company, chose to be a relator, stating:
“We will continue to root out fraud and abuse to protect the integrity of Medicaid and ensure a level playing field for pharmaceutical companies. We commend Sanofi for bringing this matter to our attention.”