Devices

Court Rejects Medtronic Fraud on FDA Case

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 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.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome