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Appeals Court Revives Medtronic Infuse Lawsuit

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A special appeals court found Monday that off-label promotion claims related to a Medtronic-related lawsuit are not preempted, thus reviving a man’s lawsuit filed over Medtronic’s Infuse bone growth product.

The man alleges he suffered serious injuries after his surgeon inserted the Infuse device in an off-label manner during 2007 surgery to treat back pain. The U.S. Food and Drug Administration (FDA) approved Infuse to be inserted in an anterior approach, but the patient claims his surgeon inserted the device in a posterior approach at the urging of Medtronic, the product’s manufacturer, Law360 reported.

The court found that Medical Device Amendments to the Federal Food Drug and Cosmetic Act do not preempt state-law claims that a device maker violated federal bans against the marketing of a device for unapproved uses. The court said that claims allegedly made by Medtronic in discussions with doctors and with the public are not preempted, though the claims that target statements by Medtronic in labels approved by the FDA are. “Insofar as Medtronic’s alleged misrepresentations consist of false statements of material fact in the context of off-label promotion, outside the scope of the safe harbor, a state-law misrepresentation claim would parallel the FDCA prohibitions on off-label marketing,” the court said in documents obtained by Law360. “To that extent, therefore, a state-law misrepresentation claim would not impose any requirements different from or in addition to those imposed under federal law.”

According to the suit, the man’s surgeon inserted Infuse in the posterior approach, through his back. The device is only FDA-approved in the anterior approach, through the abdomen. A Medtronic sales representative was allegedly present during the surgery to supervise the off-label implantation of the bone growth device. The man purports that the posterior approach caused him serious injuries including unwanted bone growth and that he had to undergo reparative surgery in 2010. In 2011, the man learned that he had developed two nodules in his lungs that could become cancerous, according to Law360.

The lawsuit states that Infuse was approved by federal regulators under the condition that it only be used in the anterior approach and that Medtronic knew it could cause cancer if it was used in an unapproved manner. Despite this knowledge, the patient asserts, Medtronic marketed Infuse for off-label purposes, to insert it through the back, by providing them with financial incentives and by sending sales representatives to attend surgeries, Law360 reported.

Additionally, the court observed that the U. S. Senate Committee on Finance, which investigated the Medtronic’s practices for more than a year, concluded that Medtronic was “shaping” articles that are published in medical journals by generously paying consultants in the form of royalties and fees. The man claims in the lawsuit that about 85 percent of Medtronic’s $900 million revenue in 2010 was from off-label uses of its products, according to Law360. disclaimer: This article: Appeals Court Revives Medtronic Infuse Lawsuit was posted on Thursday, October 9th, 2014 at 2:52 pm at and is filed under Medical Device Lawsuits, Misleading Information Lawsuits.

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