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Mylan to Pay $465M Over EpiPen Fraud

This is a settlement for the lawsuit.

Santa Clara, CA: Mylan has agreed to pay $465 million to settle fraud claims that it underpaid rebates for the EpiPen, which amounts to stealing from the government federal authorities claimed. The lawsuit, alleging violations of the False Claims Act, was possible due to Sanofi acting as a whistleblower by alerting the federal government to the scam.

According to the terms of the now finalized agreement, Sanofi will receive $38.7 million for its role in alerting the government, together with a share of monies the states will receive as part of the financial recovery by state and federal health programs.

The lawsuit stemmed from Mylan’s deliberate misclassification of the EpiPen as being generic, which meant it paid lower rebates to the government than it should have. According to government regulations, drugmakers must pay Medicaid in the form of rebates to avoid price gouging. Further, drugmakers must pay a higher rebate to the government for drugs that are only available through a single source, which would be the difference between the current price and the price the drug would have cost if it had only increased by the rate of inflation. In 2009, an EpiPen two pack, which contains live saving medication used to treat people who are going into anaphylactic shock, a potentially fatal allergic reaction, rose in price by $500, from $100 to $600.

Sanofi became aware of Mylan’s alleged The False Claims Act rebate violations when it was allegedly developing its own version of an epinephrine injector, Auvi-Q. Sanofi claimed Mylan tried to block its Auvi-Q by forcing insurance companies to not cover it or to put it at a disadvantage on drug formularies.

Mylan did not admit liability in the settlement.

The case is United States ex rel Sanofi-Aventis US v. Mylan Inc. et al, case number 16-cv-11572, in the U.S. District Court for the District of Massachusetts.

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Published on Aug-17-17


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