Here are five key points on the settlement:
1. Three relators sued Medtronic in the U.S. District Court for the District of Minnesota under the whistleblower provisions of the False Claims Act for allegedly violating the Trade Agreements Act. The whistleblowers allege Medtronic sold devices that originated in China to government contractors, violating obligations under the TAA; the TAA requires government contractors to certify they’ll only sell products that originated in the United States or a country with a trade agreement in the United States to the U.S. government.
2. Medtronic has contracts with the Department of Veteran Affairs, Department of Defense and other federal agencies. Devices allegedly sold that originated in China were surgical instruments and devices used in spine surgery as well as certain models of anchoring sleeves packaged with cardiac leads.
3. Medtronic agreed to pay the United States government $4.4 million to settle the qui tam suit.
4. The suit accuses Medtronic of bringing in spine surgery devices from China and relabeling them “Manufactured in Memphis, TN,” where the spine business is based, according to a Star-Tribune report.
5. Medtronic did not admit its activities were improper or unlawful and maintained the majority of the company’s products are manufactured in the United States or in trading partner countries.
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