A spate of recent multimillion-dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act if they misstate the country of origin of their products in violation of the Trade Agreements Act.

The TAA requires that certain products sold to the U.S. government originate either in the United States or in one of the designated countries with which the United States has special trade agreements. Government contractors, therefore, are required to determine the proper country of origin of their products and certify that they are providing the government with TAA-compliant products. If this certification proves to be false, however, the contractor may be subject to substantial civil and criminal penalties under the FCA, including debarment and suspension or exclusion from Medicare.

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