USA –Viatris, formerly known as Mylan, announced that it had agreed to pay US$264 million to settle a class-action lawsuit alleging that the company was involved in an illegal scheme to monopolize the market for epinephrine auto-injector devices known as EpiPens, which are used to treat severe allergic reactions.

According to court documents, plaintiffs filed the lawsuit in 2017, accusing Mylan of using anti-competitive tactics to build and maintain its EpiPen empire.

Consequently, the petitioners sought US$1 billion in damages on behalf of consumers and third-party payers.

In one case, the plaintiffs claimed Mylan made a “hard switch” by only selling EpiPens in packs of two, forcing buyers to pay more for no medical reason.

Plaintiffs claimed that Mylan also paid excessive rebates to pharmacy benefit managers, commercial payers, and state Medicaid programs as long as they did not reimburse competing products.

They also mentioned Mylan’s well-known and dramatic price increases over the years. During the hard switch in 2008, the price of an EpiPen increased from US$100 to US$600, representing a 600% increase from 2007.

Plaintiffs claimed that the price increase was caused by “unaccountable executives and companies who sought to profit off of human misery and fear,” rather than external factors such as market conditions or supply shortages.

They further alleged that by drastically raising the price of EpiPens, the drugmaker was “unlawfully exercising its monopoly power.”

Viatris on the other hand stated has maintained that “it acted lawfully and pro-competitively, and the settlement contains no admission of liability.”

Last year, Pfizer and its subsidiaries agreed to pay US$345 million to settle a lawsuit over EpiPen pricing, but denied any wrongdoing and stated that its “actions were appropriate” as part of its settlement.

The lawsuit accused Mylan and Pfizer, which manufactured the EpiPen of engaging in widespread anticompetitive behavior that allowed them to maintain a monopoly over the device market.

The plaintiffs claimed that in 2012, Teva, Mylan, and Pfizer agreed to a pay-for-delay settlement that extended EpiPen exclusivity.

However, U.S. District Judge Daniel Crabtree in Kansas City dismissed much of Mylan’s case last year, leaving only a claim relating to a 2012 patent litigation settlement with generic drugmaker Teva Pharmaceutical Industries Ltd.

EpiPens are manufactured by two Pfizer subsidiaries, King Pharmaceuticals and Meridian Medical Technologies, and are distributed by Viatris.

Separately, India’s Biocon Ltd announced a US$3.34 billion deal for Viatris’ biosimilars business.

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