This $465 million EpiPen® settlement among the United States, the States, and pharmaceutical companies Mylan Inc. and Mylan Specialty L.P. (Mylan), was the largest False Claims Act settlement of 2017, and was part of the reason 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, agreeing to pay $465 million to resolve the allegations that it violated the False Claims Act by underpaying Medicaid rebates. The government contended that Mylan improperly avoided paying state Medicaid programs the higher rebates for branded drugs by misclassifying EpiPen as a generic drug, even though EpiPen had no FDA approved therapeutic equivalents and even though Mylan marketed and priced EpiPen 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 Mylan’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 going forward.
The United States Attorney was especially grateful that our client, another pharmaceutical company, chose to be a relator against Mylan, 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.”