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Two additional lawsuits against Medicare negotiation dismissed in federal courts

Two additional lawsuits against Medicare negotiation dismissed in federal courts

This week, federal judges in Texas and Connecticut dealt another blow to the pharmaceutical industry by rejecting challenges to the constitutionality of the Medicare drug price negotiation program, while also upholding a related appeal.

In Connecticut, the U.S. Court of Appeals for the Second Circuit backed a prior ruling by U.S. District Judge Michael P. Shea regarding the pharmaceutical company Boehringer Ingelheim. This company had its diabetes medication included among the initial ten drugs selected for Medicare negotiations, with two additional products also entering the latest round.

Judge Shea ruled in 2024 that Boehringer Ingelheim failed to prove it would suffer irreparable harm due to the Medicare negotiations, siding with the federal government that the program did not breach laws like the Medicare Act or the Administrative Procedure Act.

Boehringer Ingelheim claimed that the negotiations infringed upon its First and Fifth Amendment rights.

On Thursday, the Second Circuit upheld Shea’s ruling, indicating the company’s constitutional arguments had not been substantiated.

The ruling noted, “Participation in the negotiation program is voluntary and does not involve illegal disenfranchising.” It further stated that the program aims to manage Medicare spending effectively and does not interfere with company operations in private markets, hence it does not impose unconstitutional conditions on Boehringer’s participation in Medicare and Medicaid.

Inquiry was made to Boehringer Ingelheim for comments.

Meanwhile, in Texas, U.S. District Judge David Alan Ezra dismissed a bias complaint brought by the trade group PhRMA. Echoing sentiments from the Connecticut ruling, Ezra emphasized that drug manufacturers’ involvement in Medicare is entirely voluntary. He argued that, given this voluntary nature, they lack a protected interest in selling drugs to Medicare at a self-determined “fair market value.”

Likewise, the plaintiff could not demonstrate irreparable harm from the negotiation of drug prices, nor did the judge find compelling evidence that the program infringed the plaintiff’s Fifth and Eighth Amendment rights.

The judge summarized, “In essence, the plaintiff cannot show that the program will deprive them of protected benefits.”

The Hill reached out to PhRMA for a response.

These recent decisions arrived a day after a federal ruling dismissed another challenge to Medicare negotiations put forward by the U.S. Chamber of Commerce, citing that some plaintiffs did not possess standing in the case.

Merith Basey, executive director of Patients, a group advocating for affordable drugs, expressed approval of the rulings in a statement. She remarked, “Once again, a pharmaceutical company brought in costly lawyers to contest Medicare negotiations, only to lose again. The ruling against Boehringer Ingelheim marks the fifth consecutive legal victory for patients awaiting relief from major Pharma’s control.”

“It’s truly a battle of us versus Big Pharma. Patients for affordable drugs remain committed to advocating for our diligent Medicare negotiation program against Big Pharma’s ongoing efforts to sabotage it at patients’ expense,” she added.

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