(CN) - Medtronic pays doctors to promote a medical device for off-label uses, and the InfuseBone Graft is "unreasonably dangerous" because its active ingredient can travel from the implant site to the esophagus or trachea, turning soft tissue into bone, a married couple claims in Los Angeles Superior Court.
John and Robin Webb say the U.S. Food and Drug Administration approved Medtronic's InfuseBone Graft only for lumbar, dental and tibial surgeries, but that Medtronic recommends it for cervical spine fusions.
The product allegedly netted $815 million for Minnesota-based Medtronic in fiscal year ending April 2008.
The Webbs say using the bone graft in cervical spine surgeries is "unreasonably dangerous for the patient" because the active ingredient can travel to the esophagus or trachea, causing calcification, and making it difficult to swallow, breathe or eat.
John Webb claims the bone graft was implanted in his cervical spine after Medtronic encouraged his doctor for the off-label use.
Webb says he needed two more surgeries because the device caused painful and severe complications, including throat swelling, edema and hematomas.
"While physicians may use FDA-approved medical devices in any way they see fit, companies are not permitted to ... pay doctors inducements or kickbacks to promote off-label uses," according to the complaint.
The Webbs say it becomes difficult to distinguish between off-label uses and FDA-approved uses when a company such as Medtronic is "driven by greed" to improperly promote its products.
If "influential physicians are willing to promote the use of a certain device, then other surgeons are likely to follow suit and use that device," the complaint states.
The Webbs sued Medtronic and the Tennessee-based Medtronic Sofamor Danek for fraudulent concealment, negligence, product liability and breach of warranty. They are represented by James Vititoe with Masry & Vititoe of Westlake Village.
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