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# Medtronic Settles Infuse Case for $12 Million with States
- URL: https://www.fdaweb.com/medtronic-settles-infuse-case-for-12-million-with-states/
- Published: 2017-12-14T12:00:00.000Z
- Updated: 2026-09-14T23:08:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140342

Medtronic has reached a $12 million settlement with five states to resolve allegations that it unlawfully promoted to doctors its Infuse bone graft device used in spinal fusion procedures. Oregon attorney general **Ellen Rosenblum** [announced](media-home/news-media-releases/attorney-general-rosenblum-announces-12-million-settlement-medtronic-oregon-receive-2-4-million/) the settlement and said her state would receive $2.4 million. The other states participating in the suit were California, Illinois, Massachusetts, and Washington.

The states alleged that Medtronic made deceptive claims about Infuse by using trusted scientific publications to report that Infuse was superior to other therapies and that patients who used it experienced fewer side effects than what research showed.

Under the settlement, Medtronic will be required to ensure its marketing and promotional practices do not unlawfully promote Infuse by: 

- making Infuse clinical trial data available at ClinicalTrials.gov;
- refraining from making false, misleading, or deceptive claims about Infuse;
- using information about Infuse clinical trials for promotional purposes in a manner that is truthful, non-misleading, accurate, fairly balanced, consistent with approved labeling, appropriately substantiated by objective evidence, does not contain overreaching messaging, and compliant with FDA regulations;
- disseminating published medical journal articles reporting on clinical trials relating to Infuse only if they are truthful, scientifically and medically valid, and disclose any Medtronic sponsorship of the clinical trials, if applicable;
- contractually requiring medical journal article authors to comply with authorship standards, acknowledge Medtronic sponsorship, and comply with conflict of interest disclosure standards in medical journal articles reporting on Medtronic-sponsored trials of Infuse where the company approved the release of trial data; and
- complying with applicable federal regulations on disclosure to FDA of Medtronic’s financial relationships with investigators for Medtronic-sponsored Infuse clinical trials.