German pharmaceutical giant Boehringer Ingelheim is the latest company to sue the U.S. government over Medicare price negotiations under the Inflation Reduction Act. The lawsuit, filed late last week in federal court in Connecticut, contends that the act violates the First, Fifth and Eighth Amendments by taking the company's property without due process and fair compensation, imposing excessive fines and compelling its speech.
Merck, Bristol Myers Squibb, Johnson & Johnson's Janssen, Astellas and PhRMA have filed similar lawsuits. In July, the U.S. Chamber of Commerce filed a motion for a preliminary injunction against the program, claiming it would inflict "irreparable harm" on U.S. businesses and patients.
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The Centers for Medicare & Medicaid Services is set to announce the first 10 drugs eligible for negotiation by September 1. After that, the manufacturers of these drugs will have one month to sign agreements to participate in the negotiations. The Boehringer Ingelheim diabetes drug Jardiance, developed in partnership with Eli Lily, is likely to make the list, the company said in court documents. Boehringer Ingelheim argued the negotiations would cause "serious, irreparable harm" to both the company and patients.
Anna Kaltenboeck, head of prescription drug reimbursement practice for consulting firm ATI Advisor, said the industry lawsuits all "take some flavor of the same argument."
"They have reason to believe that there's a shot here and they should take it, and that also sends a signal to everybody in the market, including CMS, also their shareholders, that they're going to put up a fight," she said. "At some point, someone is going to find a judge somewhere that creates a situation that will eventually elevate this claim or another claim, right?"
The U.S. Department of Justice recently pointed out that companies won't feel the impact of negotiated prices until at least 2026, saying this case could be "fully litigated" by that point.
"The public's interests would be gravely disserved by acceding to plaintiffs' premature efforts to take down the entirety of the negotiation program — which achieves a longstanding goal of controlling skyrocketing Medicare spending and making drugs more affordable for seniors — before that program even begins," it said.
Related: DOJ blasts Chamber of Commerce's lawsuit over Medicare drug price negotiations
Merck said it "intends to litigate this matter all the way to the U.S. Supreme Court if necessary," and many legal analysts agree.
"These cases are undoubtedly headed for the Supreme Court," Robin Feldman, a professor at the University of California College of Law in San Francisco, told Endpoints News. "Industry is likely filing the cases in different locations hoping that a split in the decisions will encourage the Supreme Court to take the cases and resolve the differences."
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Alan Goforth
Alan Goforth is a freelance writer in suburban Kansas City. In addition to freelancing for several publications, he has written a dozen books about sports and other topics.
