November 05, 2016 – By
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.
Medtronic recently settled a suit making many of the same charges in a California state court. The company admitted no wrongdoing. The settlement amount was undisclosed.
Like the state case, the federal suit raises questions about the FDA approval process, which lets device makers sell products if the FDA deems them “substantially equivalent” to devices the government has already approved for sale. The suit also raises questions about the ability of device makers to market products for non-FDA approved uses, a practice known as off-label promotion.
Doctors are allowed to use medical devices in any way they think will help patients, but federal law prohibits misbranding and some kinds of off-label promotion. Balancing patient safety with free speech has grown so contentious that the FDA will conduct two days of hearings this week to consider “manufacturer communications” about “unapproved uses” of products.
Brian Shapiro, a former Medtronic salesman, brought the federal suit as a whistleblower on behalf of himself and the United States, 31 states, including Minnesota, and the District of Columbia. The federal False Claims Act lets private citizens who believe they have proof of fraud against the government sue and collect a portion of any settlement, even if they have not been injured.
The U.S. government has “declined to intervene in the case at present,” but “remains a party for service, must be notified of all filings and discovery in the case, and reserves the right to intervene at any point in the future,” John Parker, one of Shapiro’s lawyers, said.
Seems like Mr. Shapiro has a significantly valid and worth while argument and case considering you can’t use these products for their intended use. Very interesting…