On August 17, 2017, Mylan Inc. and Mylan Specialty L.P. resolved claims brought under the whistleblower provisions of the False Claims Act (“FCA”), agreeing to pay $465 million in a civil settlement with government regulators.  The government alleged that Mylan erroneously and knowingly reported EpiPen to Medicaid as a generic medication, despite the unavailability of any equivalent pharmaceutical, allowing them to charge high prices on the private market while evading corresponding obligations to Medicaid under the Medicaid Drug Rebate Program.  Under the program, which was designed to prevent price gouging of the Medicaid program, drugs available from a single source are subject to a higher rebate payment to Medicaid, while generic drug rebate payments are lower.  From 2010 to 2016, the price of Mylan’s EpiPen increased by approximately 400%, while the company paid a fixed rebate of 13% during that time.  Mylan entered into a settlement agreement with the DOJ, Office of the Inspector General, and the Department of Health and Human Services, under which it agreed to pay $465 million to the U.S. government, the affected Medicaid Participating States, and the entities participating in the 340B Drug Pricing Program that were overcharged for EpiPens.  Additionally, the whistleblower in this case, pharmaceutical manufacturer Sanofi-Aventis US LLC, will receive approximately $38.7 million of the federal recovery for reporting the conduct.  United States ex rel. Sanofi-Aventis US LLC v. Mylan Inc. et al.,No 16-C-11572 (D. Mass.).

DOJ Press Release