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Court rejects Medtronic's plea to throw out lawsuit.

In March 2009, Cristina Ramirez, M.D., went under the surgeon's knife for a lumbar fusion procedure to alleviate back pain. Her surgeon used Infuse, a bio-engineered bone graft substitute made by Minneapolis, Minn.-based Medtronic Inc. Following her surgery, she began experiencing severe and ongoing pain. She had developed uncontrolled bone growth, causing nerve impingement, in the area where her surgeon implanted Infuse.

Though the U.S. Food and Drag Administration (FDA) approved Infuse in 2002, the device was not approved for use for posterior lumbar interbody fusion. It was only approved for an anterior approach. The FDA was concerned about potential adverse effects, such as abnormal bone growth of the kind that Ramirez experienced. However, thousands of U.S. patients nationwide have been implanted with Infuse during procedures involving off-label use, including posterior lumbar interbody fusion. Off-label use of Infuse by physicians constituted nearly 90 percent of the $800 million in revenue that Infuse generated for Medtronic in 2011.

Ramirez sued Medtronic. The complaint charged that Medtronic failed to warn the FDA of severe side effects associated with use of its spinal fusion product when used for surgeries other than that originally presented to the FDA. The complaint further alleged that Medtronic aggressively promoted off-label uses of its device utilizing journal articles, advertising media, sales representatives and consultants and paid leading physicians to urge the use and purchase of Infuse. Off-label promotion of prescription drugs and medical devices violates federal law.

The medical device giant fought back, attempting to get the lawsuit thrown out of court. However, on Aug. 21, U.S. District Court Judge G. Murray Snow of the District of Arizona denied in large part Medtronic's motion to dismiss the personal injury lawsuit on grounds that the claims are preempted by federal law.

"We are gratified that the court rejected Medtronic's effort to close the doors to the courthouse on Dr. Ramirez and the many other patients that were implanted with the Infuse bone growth protein," said Kent L. Klaudt, lawyer at the plaintiffs' law firm, Lieff Cabraser Heimann & Bernstein LLP, which represents Ramirez. "The court's carefully-reasoned ruling reaffirms that manufacturers who violate federal safety laws cannot then evade state tort liability to injured patients."

Medtronic asserted that the complaint should be dismissed because the Infuse device was approved by the FDA. As such, Medtronic argued, any claims against a medical device manufacturer under state law for fraud, negligence, design defect, and failure to warn of dangers were preempted because they conflict with the FDA's approval of the design and label of the device.

The court created a bright-line rule distinguishing cases in which the medical device manufacturer in question, although aware of the off-label use, complies with federal regulations applicable to the device from cases where the core of the claim is that the plaintiff was injured due to an off-label use tied to the manufacturer's promotion of such uses. As the court explained, the rationale for the pre-emption of state law claims regarding an FDA-approved medical device "vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not be reviewed by the FDA but has been promoted by the manufacturer."

"Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device," added Klaudt. "That is basic fairness and creates a powerful incentive for manufacturers to properly design, test, and market their products."
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Title Annotation:News Front
Publication:Orthopedic Design & Technology
Date:Sep 1, 2013
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