Equipment manufacturer Medtronic has agreed to pay the federal government $4.4 million to settle claims that it made false statements about the country of origin of its products, according to a statement by the Department of Justice. This agreement marks the company's third settlement of more than $1 million in the last two months and its fourth within the last year.
The settlement resolves allegations by the U.S. government that Medtronic lied about equipment the company sold to the Department of Veterans Affairs and the Department of Defense, claiming it was from the United States when it had been manufactured in China and Malaysia. The Trade Agreements Act of 1979 requires that equipment sold to government agencies be manufactured in the United States. Some of the products in question included anchoring sleeves used to secure cardiac leads, spine surgery instruments and devices, and wireless cardiac devices.
In February, Medtronic settled two separate lawsuits totaling $4 million to settle allegations of overbilling and off-label promotion. In one suit, the company paid $2.8 million for allegedly submitted claims for spinal cord surgical devices used in a procedure that had not yet received Food and Drug Administration approval. On the same day, the company paid $1.2 million to resolve claims linked to unnecessary inpatient admissions for minimally invasive artherectomy procedures.
In May 2014, Medtronic agreed to pay a $9.9 million settlement to the government to resolve allegations that the manufacturer offered kickbacks to physicians that used pacemakers and defibrillators sold by the company. All told, the equipment manufacturer has paid more than $18 million in settlements in the last year.
- here's the DOJ statement