Two EpiPen auto-injectors used for treatment of allergic reactions. (Photo: Amy Kerkemeyer/Shutterstock.com) Two EpiPen auto-injectors used for treatment of allergic reactions. (Photo: Amy Kerkemeyer/Shutterstock.com)

 

Already under scrutiny from lawmakers over pricing of its EpiPen epinephrine injector, Mylan faces new lawsuits from consumers and a competitor in New Jersey federal courts accusing it of taking anti-competitive actions to protect its product’s market share.

Sanofi-Aventis U.S. sued Mylan on April 24, seeking reimbursement for lost sales of its competing product. And Mylan was sued on April 7 on behalf of a putative class of consumers who accuse the company of conspiring with others to eliminate competition for the EpiPen. Both suits assert that Mylan paid bonuses to insurance companies, benefit managers and other third-party payors if they refused to reimburse users of competing products, including Auvi-Q, an epinephrine injector introduced by Sanofi in 2013.

The New Jersey suits come on the heels of similar litigation in California, Ohio, Michigan and elsewhere, targeting Mylan’s business practices concerning the EpiPen. Mylan has been mired in controversy over the price of its product, which ranged around $75 to $100 per dose from 2001 to 2008 but reached $600 per dose in 2016.

EpiPen and Auvi-Q both allow users to self-administer an injection of epinephrine to treat anaphylaxis, a potentially fatal condition caused by food allergies, insect bites and other causes. But EpiPen resembles a large felt-tip marker while Auvi-Q is the size of a credit card and the thickness of a smartphone. In addition, Auvi-Q provides users with audio instructions for administering the drug. The more advanced design of the Auvi-Q raised hopes that it would gain market share from EpiPen, according to the Sanofi suit. But Mylan’s anti-competitive actions have caused Auvi-Q’s market share to fall from 13 percent in 2013 to 7 percent in 2014, the Sanofi suit said.

“Quite simply, Mylan used its monopoly power in the U.S. [epinephrine auto-injector] drug device market to exclude Auvi-Q and maintain its monopoly,” the Sanofi suit said.

Mylan, of Canonsburg, Pennsylvania, also gave discounts to schools that kept the EpiPen on hand if they agreed in writing not to use competing devices such as Auvi-Q, the Sanofi suit said. Sanofi sought to offer discounts of its own, but after the Auvi-Q was recalled in 2015 due to manufacturing defects, the company took it off the U.S. market, the suit claims.

Sanofi’s suit brings three counts for violation of the Sherman Act against Mylan, and seeks treble damages from Mylan for the damages caused by its illegal conduct. Sanofi U.S. is headquartered in Bridgewater.

The putative class action on behalf of consumers raises two Sherman Act counts, claims under state laws for monopolization and for consumer protection, and unjust enrichment and disgorgement. In addition to Mylan, the consumer case names as defendants Pfizer and two of its subsidiaries, King Pharmaceuticals and Meridian Medical Technologies, which, the complaint says, manufacture and supply EpiPens to Mylan.

Diane Sullivan of Weil, Gotshal & Manges in Princeton, who represents Sanofi, did not return a call. Nor did James Cecchi of Carella, Byrne, Cecchi, Olstein, Brody & Agnello in Roseland, local counsel in the consumer class action. The consumer class is also represented by Boies Schiller Flexner in New York; Robbins Geller Rudman & Dowd in Boca Raton, Florida; and Goldman, Scarlato & Penny in Conshohocken, Pennsylvania. Mylan and Pfizer did not respond to requests for comment about the suits.