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Shezad Malik MD JD
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Medtronic Infuse Lawsuits Hits Federal Pre-emption Roadblock

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Medtronic Infuse product liability lawsuits involving Medtronic Infuse bone graft surgery, have hit a federal preemption roadblock. Federal preemption law, for medical devices, is based on a 2008 Supreme Court ruling that has been used as an impregnable defense wall by medical device manufacturers.

Dallas Defective Medical Device attorneyMedtronic has argued that they can not be held liable for injuries, since the device was approved by the FDA. The medical device maker’s argument was upheld in the Supreme Court decision of Riegel v. Medtronic, involving allegedly defective pacemaker leads and injuries.

What is Medtronic Infuse?

Medtronic Infuse is a synthetic bone graft product, which has been promoted as being superior to bone harvesting or bone chips used from a cadaver. The artificial material is place on a collagen sponge and implanted into the spinal bones using a metal LT cage.

The FDA approved Infuse recombinant human bone morphogenetic protein (rhBMP-2) for use in lumbar or low back spinal fusion procedures only.

But, Medtronic Infuse has been used “off-label”, at the discretion of the surgeon for non-FDA approved uses. Here, examples include, the use of the device in multiple level spine fusions, use in cervical spine surgery, also in non-anterior approach to the lumbar spine or without the metal LT-Cage.

According to experts, off-label use may increase the risk of side effects from Medtronic Infuse surgery. The major problem is that the device causes excessive bone growth around the spine, causing nerve damage, paralysis, airway compression, and cancer.

Allegations: Medtronic Promoting Off Label Infuse Use

A congressional investigation found that Medtronic paid $210 million to research authors to downplay Infuse complications in their reports. Furthermore, the investigation revealed that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published.

Medtronic Infuse Lawsuits

Plaintiffs allege that Medtronic illegally promoted Infuse for off label uses by influencing journal articles, making payments to opinion leaders in the medical industry and having sales representatives encourage such use. Plaintiffs assert that their Medtronic Infuse cases should not be pre-empted because of the manufacturer’s illegal off-label marketing.

Recently, an Illinois state court Judge Brewer rejected Medtronic’s motion to dismiss a lawsuit pending in Cook County Circuit Court, based on federal preemption. The court found that the FDA did not apply device-specific requirements on Medtronic for the off-label use, and determined that state court claims are not prevented from providing damages for claims based on a violation of FDA regulations.

In an opposing decision, a Minnesota state court judge recently granted Medtronic’s motion to dismiss many cases, ruling that the plaintiffs could not sue the device maker over injuries caused by Medtronic Infuse because the FDA had approved the product. The Minnesota court found that Medtronic was not under legal obligation to warn of adverse effects involving off-label usage.

Many legal experts, believe that this matter will go up the the U.S. Supreme Court for final adjudication.

New Medical Studies

Recently, two independent studies were published in the Annals of Internal Medicine, which found that the Infuse product provides no benefits over traditional spine surgery and may expose users to unwanted side effects.