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# Court Rejects Medtronic Fraud on FDA Case
- URL: https://www.fdaweb.com/court-rejects-medtronic-fraud-on-fda-case/
- Published: 2017-09-27T12:00:00.000Z
- Updated: 2026-09-14T22:53:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139720

A California federal court has dismissed a whistleblower’s complaint charging that Medtronic obtained marketing approval for some of its spinal implant products by deceiving FDA as to the products’ intended use and that the company promoted the products for off-label use. Attorneys **Anne Walsh** and **Andrew Hull** (Hyman, Phelps & McNamara) say the federal government had declined to intervene in the whistleblower’s case.

[Writing](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/09/court-deals-blow-to-mysteriously-named-whistleblower-and-blows-off-precedent.html?ref=fdaweb.com) in their firm’s *FDA Law Blog*, the attorneys say the court’s discussion on the lack of grounds for the whistleblower’s complaint is significant for medical device manufacturers facing fraud-on-FDA or off-label promotion claims under the False Claims Act.

The post says the whistleblower claimed that certain devices were designed for cervical use rather than for the thoracolumbar use for which the company sought clearance. But the court held that FDA may grant 510(k) clearance with labeling limitations if it is concerned that a product may be used off-label. “The relator’s claim that a cleared device was actually intended for an off-label use was not itself sufficient to support a claim of improper clearance,” the attorneys say.

The court also dismissed the whistleblower’s off-label promotion theory on the ground that the Centers for Medicare and Medicaid Services may cover a device used off label if the use is “medically necessary” or “reasonable and necessary” to treat a specific patient. It said the allegations “must be sufficient to support the claim that the devices were unsafe, untested, or otherwise unfit for the purposes for which they were used, and that defendants nevertheless knowingly promoted them.”