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From Health Law Daily, August 22, 2013

Most state claims against manufacturer of spinal fusion device survive preemption

By Paul Clark

The majority of a patient’s state law claims, tracing her doctor’s off-label use of Infuse®, a spinal fusion device, to Medtronic’s active promotion of this off-label use, were not preempted by federal law. (Ramirez v Medtronic, Inc., August 21, 2013, Snow, G). The patient’s breach of warranty claim was dismissed without prejudice, with leave to amend; her negligence claim was dismissed with prejudice.

Background. Medtronic, Inc. (Medtronic) manufactures Infuse, a Class III medical device used in spinal fusion surgeries to treat degenerative disc disease. The “intended use” of Infuse, according to Medtronic under the Premarket Approval Application (PMA) for Infuse approved by the FDA, is for a “single-level anterior lumbar interbody fusion.” The Infuse device consists of three components: (1) a metallic spinal fusion cage (the LT-Cage®), (2) a bone graft substitute, which consists of liquid rhBMP-2, and (3) a spongy carrier or scaffold for the protein that resides in the fusion cage. Under FDA regulations, physicians may use FDA-approved medical devices either “on-label” (in accordance with FDA approval) or “off-label” (for other uses). In 2011, off-label use of Infuse by physicians generated more than 90 percent of the $800 million in revenue that Medtronic gained by the use of Infuse that year.

In 2009, Cristina Ramirez underwent a lumbar fusion procedure to alleviate her back pain. Her surgeon, Dr. Wang, who also is a paid Medtronic consultant, used Infuse, but only used the bone-graft substitute rhBMP-2 component, and not the other two components. He also employed a posterior approach, considered an off-label use of the device. Ramirez began experiencing severe pain after surgery and then discovered she had developed uncontrolled bone growth in the area where the surgeon had implanted Infuse. The subsequent pain has “significantly disrupted her life.”

Ramirez filed suit against Medtronic, asserting six state law causes of action: fraudulent misrepresentation/fraud in the inducement, failure to warn, defective design, misrepresentation, negligence, and breach of express warranty. The complaint “alleges that Medtronic’s aggressive promotion of Infuse’s off-label use and obfuscation of the true risks has led to widespread acceptance among spinal surgeons of such uses.” Ramirez alleges that “Medtronic committed fraud by concealing and/or making fraudulent representations during its promotional practices concerning the off-label use of Infuse and concealing its practice of off-label promotion.” Medtronic moved to dismiss and to strike the complaint.

Preemption. Medtronic alleged that every one of Ramirez’s state law claims was “preempted by the pervasive federal regulations that resulted from the FDA’s approval of Infuse.” Under 21 U.S.C. sec. 360k, state law claims are expressly preempted when state laws impose requirements that (1) differ from or are in addition to federal requirements and (2) relate to the safety and effectiveness of the device. The court concluded that Ramirez’s allegations regarding Medtronic’s off-label promotion “suffice to allow the majority of her claims to escape preemption.” The court reasoned, “when the device is not being used in the manner the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to pre-empt the application of state law designed to provide that protection.”

Court’s other conclusions. The court determined that none of Ramirez’s claims relating to fraud, failure to warn, design defect, and misrepresentation were preempted by federal law. Her negligence claim, however, since it was premised wholly on violations of the Food, Drug, and Cosmetic Act and the Medical Device Amendments of 1976, was preempted. While her breach of express warranty claim survived preemption, the court concluded she failed to state a claim under Arizona law. The court provided Ramirez with option of amending this part of her complaint.

The case number is CV-13-00512-PHX-GMS.

Attorneys: Michael Kevin Brown (Reed Smith LLP) for Medtronic, Inc., Medtronic Sofamor Danek USA, Inc.

Companies: Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc.

MainStory: TopStory PreemptionNews MDeviceNews AdvertisingNews FDCActNews ArizonaNews

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