Medical Device Manufacturers Can Not Hide Behind FDA Approval When Promoting Off Label

In an extremely important case a Federal Court has ruled that Big Phrma companies can not hide behind FDA approval for injuries occurring as a result of off label promotion of medical devices. A common defense in medical device cases is that the FDA approved the product so we cant be held responsible. In this case, the Court said not so if you promoted the device for something other than it was specifically approved for.



A Los Angeles judge has refused to dismiss on federal preemption ground a product-liability case against Medtronic Inc. over the use of its Infuse bone graft device during spinal surgeries. Medtronic and its subsidiary, Medtronic Sofamor Danek USA Inc., had argued the claims that it marketed the device for uses not approved by the U.S. Food and Drug Administration were pre-empted under the U.S. Supreme Court’s 2008 decision in Riegel v. Medtronic Inc. and the U.S. Food, Drug and Cosmetic Act. Los Angeles County, Calif., Superior Court Judge Michael Linfield disagreed and sided with the plaintiff, April Cabana, who argued that the federal pre-emption did not cover claims associated with “off label” uses. Pre-emption doesn’t apply to off-label use of medical device