Ex-Medtronic Sales Rep Accuses Firm of Misrepresenting How the Device Would be Used
Medtronic faces a federal false claims and misbranding lawsuit that accuses the company of designing products for one purpose but tricking the U.S. Food and Drug Administration (FDA) into approving them for another to avoid expensive and time-consuming safety testing.
The suit, by a former Medtronic sales representative, alleges that the company designed a family of spinal devices for the neck but told the FDA they were to be used only in the chest and lower spine, where they were almost always too small to work.
In court documents, Medtronic denied the allegations, saying it developed the product in different sizes to accommodate patients’ anatomical differences. The company has asked a federal judge to dismiss the suit.
The suit, by a former Medtronic sales representative, alleges that the company designed a family of spinal devices for the neck but told the FDA they were to be used only in the chest and lower spine, where they were almost always too small to work.
In court documents, Medtronic denied the allegations, saying it developed the product in different sizes to accommodate patients’ anatomical differences. The company has asked a federal judge to dismiss the suit.