Medtronic Inc., Healthcare Kickbacks, Minnesota 2023

Medtronic Inc. of Fridley, Minnesota, has agreed to pay the United States $23.5 million to resolve allegations that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the company’s pacemakers and defibrillators.

Post-market studies are intended to assess the clinical performance of a medical device or drug after that device or drug has been approved by the Food and Drug Administration. Registries are collections of data maintained by a device manufacturer concerning its products that have been sold and implanted in patients.

The United States contends that Medtronic caused false claims to be submitted to Medicare and Medicaid by using two post-market studies and two device registries as vehicles to pay participating physicians illegal kickbacks to induce them to implant Medtronic pacemakers and defibrillators. Although Medtronic collected data and information from participating physicians, each of the studies and registries required a new or previous implant of a Medtronic device in each patient, and in each case Medtronic paid participating physicians a fee ranging from approximately $1,000 to $2,000 per patient.

“Patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,” said Tony West, Assistant Attorney General for the Civil Division. “Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.”

Medtronic Inc. (Fridley, MN): The defendant/respondent is a Minnesota-based medical device manufacturer. Exact criminal charges: violating the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks. City and state: Fridley, Minnesota. EXACT DATE: This settlement was announced on the current date. Sentence or outcome: Medtronic Inc. agreed to pay the United States $23.5 million to resolve the allegations.

The settlement resolves allegations contained in two whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in Minnesota and California, respectively. As part of today’s resolution, the whistleblowers will receive payments totaling more than $3.96 million from the federal share of the recovery.

This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009.

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