Robert J. Boumis  |  October 1, 2014

Category: Legal News

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Medtronic_Infuse

A Medtronic Infuse bone graft complications lawsuit was filed by a Minnesota woman who alleges the device implanted into her was defective and illegally marketed for purposes it had not been approved for.

Plaintiff Rosezena Brown had the Infuse bone graft implanted in her lower back during a spinal fusion surgery. Spinal fusion is a type of back surgery in which two or more individual backbones are joined together to strengthen this part of the back, usually to overcome a damaged spinal disc. However, during her recovery period, she suffered serious pain, which ultimately turned out to be related to nerve problems related to bone overgrowth. In 2011, her physicians read medical journal articles indicating that these problems could have been caused by the Infuse bone graft, the Infuse complications lawsuit said.

Medtronic lawsuits like Brown’s allege that Infuse causes serious spinal problems. Many of these stem from issues related to bone overgrowth. While traditional spinal fusions use redundant bone from elsewhere in the body to encourage the bones to fuse together, Infuse uses a bioengineered gel to promote bone growth. Allegedly, this can cause the bones to grow uncontrollably. Since the spine is rich in important nerves, uncontrolled bone growth in this area could cause pain, as well as paralysis, sexual problems, and nerve damage. Medtronic lawsuits have also alleged the device can promote cancer, sterility, and trouble swallowing.

The Medtronic lawsuit alleges that Medtronic was aware of this risk, but actively downplayed these risks through an elaborate clandestine marketing campaign for the Infuse Bone Graft System. The Medtronic lawsuit states that early trials of the surgical implant were halted due to bone-overgrowth, but that these results were suppressed. Other allegations against Medtronic include that the company illegally promoted the device for off-label usage.

Medical companies must seek separate FDA approval for each potential use of their devices. However, the law recognizes that sometime, medical research may move faster than FDA approval, and allows doctors to use drugs or medical devices for purposes other than their FDA-approved uses if research supports this application. This is called “off-label usage.” However, medical companies like Medtronic are forbidden from promoting drugs off-label. And Medtronic lawsuits like Brown’s hold that the company has engaged in a complex campaign to covertly promote the Infuse Bone Graft System.

According to this Infuse lawsuit, Medtronic Inc. paid influential physicians to promote Infuse without disclosing it. Some doctors were allegedly paid tens of millions of dollars for writing medical articles that promoted off-label uses of Infuse, or recommending the device to colleagues. This included renowned spinal surgeons working at prestigious hospitals like Walter Reed and UCLA.

The Medtronic Lawsuit is Rosezena Brown v. Medtronic Inc., et al., Case No. CV14-4895-BRO-JPRX, in the U.S. District Court for the Central District of California.

In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.

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An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

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