In August 2017, the U.S. Attorney’s Office of the Federal Justice Department announced that Mylan Inc., a large pharmaceutical company, and Mylan Specialty L.P. settled a federal liability case by paying $465 million. The federal government had alleged that both companies violated the U.S. False Claims Act when they misclassified their brand-name EpiPen ‘epinephrine delivering device’ as a generic product, which allowed them to underpay Medicaid on earned rebates.
This financial settlement agreement followed the March 2017 announcement by Pennsylvania-based Mylan N.V. that their manufacturing partner Pfizer-owned Meridian Medical Technologies would expand a voluntary recall of their defective EpiPen auto injectors. This involved selected lots of the brand-name delivery device that included the EpiPen and EpiPen Junior. The generic forms of the epinephrine delivery device were not included in the voluntary recall.