Mylan Reaches $465M EpiPen Settlement with DOJ

Last week, Mylan Inc. reportedly reached a $465 million settlement with the U.S. Department of Justice over the classification of its EpiPen Auto-Injectors for the Medicaid Drug Rebate Program.

The DOJ and other federal agencies took issue with the classification of the EpiPen Auto-Injector as a non-innovator (or generic) drug under the Medical Rebate Statute.

The EpiPen Auto-Injector was reportedly classified with the Centers for Medicaid and Medicare Services (CMS) as a generic drug before Mylan acquired the EpiPen in 2007.

The proposed EpiPen settlement will resolve claims that the EpiPen Auto-Injector possibly should have been classified as an innovator drug that was subject to higher rebates.

Mylan denies any wrongdoing. However, it has agreed to the EpiPen settlement in attempt to address some of the controversy surrounding the pricing of its EpiPens.

Mylan states that the settlement terms “provide for resolution of all potential rebate liability claims by federal and state governments as to whether the product should have been classified as an innovator drug for CMS purposes and subject to a higher rebate formula.”

The company says it plans to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

Mylan has also stated that it will continue to cooperate with the government agencies in order to finalize the terms of the EpiPen settlement.

“This agreement is another important step in Mylan’s efforts to move forward and bring resolution to all EpiPen Auto-Injector related matters,” Mylan CEO Heather Bresch said. “The agreement is in addition to the significant steps Mylan has taken in relation to EpiPen Auto-Injector over the past several weeks, including the unprecedented, pending launch of a generic version of EpiPen Auto-Injector and expansion of our patient programs for this product.”

Mylan has been under intense scrutiny for the pricing and marketing of its EpiPen Auto-Injector products, a first-line treatment for people suffering from severe and potentially life-threatening allergic reactions.

In August, Mylan was hit with a class action lawsuit accusing it of violating consumer protection laws with regard to the marketing of EpiPens in two-injector packs instead of single injectors.

The plaintiffs assert that Mylan overstated the medical justification for the two-pack of EpiPens because only a small proportion of users require a second dose, and when a second dose is required, it is typically provided by a health care professional.

Last month, an Ohio mother hit Mylan with another class action lawsuit over the massive price increase of the EpiPen since it acquired the product in 2007.

She asserts that the nearly 550 percent price increase is “unconscionable” and amounts to price-gouging for a medical device that saves the lives of people who are suffering from anaphalaxis.

More information about the proposed Mylan settlement was not immediately available. For the latest updates, keep checking TopClassActions.com or sign up for our free newsletter. You can also receive notifications when this article is updated by using your free Top Class Actions account and clicking the green “Follow Article” button at the top of the post.

UPDATE August 18, 2017: Mylan has finalized a whistleblower settlement resolving claims that it short-changed the government on rebates for EpiPen.