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Friday, May 8, 2026

United States Settles False Claims Act Allegations Involving Medical Product Manufacturer For $14.5 Million - Department of Justice

Company Self-Reported Violations of Contractual Provisions

WASHINBGTON – The United States Attorney’s Office for the District of Columbia reached an agreement with Coloplast, a medical product manufacturer, in the amount of $14,547,347 to settle claims that the company violated the Trade Agreements Act and the Price Reduction Clause in its business dealings with the Department of Veteran’s Affairs. The settlement was announced today by U.S. Attorney Matthew M. Graves and VA Inspector General Michael J. Missal.

Coloplast self-disclosed that it misapplied the Trade Agreements Act substantial transformation standard, which resulted in (a) Coloplast reporting incorrect countries of origin for several Coloplast-manufactured products and (b) some products remaining on the contract after switching manufacturing locations to nondesignated countries. Coloplast also self-reported that it misapplied the Price Reductions Clause by failing to provide the Government with discounts pursuant to the terms of the contract. This failure led to overbilling the United States for certain medical and pharmaceutical products sold to the United States.

“The United States government expects its business partners to act in good faith and follow the rules they agreed to follow,” said United States Attorney Matthew M. Graves. “We cannot overlook the great potential for harm when a company provides products from non-compliant countries.”

“This settlement is significant in both its monetary value and in...



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