A Florida couple has filed an Infuse bone graft lawsuit against Medtronic, Inc. for complications the wife suffered after the device was used in her spinal procedure.

Developed, designed and manufactured by Medtronic, the Infuse Bone Graft system is a medical device designed to aid fusion between the vertebrae without needing to harvest the patient’s own bone for use between the spinal vertebrae.

Its usage is limited to spinal fusion procedures where the lumbar spine is approached through the front — any other usage is considered “off-label.” This off-label usage is behind the latest Infuse bone graft lawsuit being filed by plaintiffs Lori and Mark Byrnes.

The labeling approved by the U.S. Food and Drug Administration (FDA) for the Infuse Bone Graft System indicates in bold text that its components must be used “as a system.” This system includes an absorbable collagen sponge that is treated with rhBMP-2 and its LT-Cage. Any missing pieces, or posterior use, constitutes off-label usage.

It’s estimated that up to 90 percent of Infuse bone graft surgeries implanted were off-label. This explains most of the Infuse lawsuits facing Medtronic.

The Byrnes said in her Medtronic lawsuit that she “would not have consented to be treated with the off-label use had he been informed by Medtronic or his spine surgeon of the true Infuse risks,” but she wasn’t informed. Moreover, Medtronic “did not adequately inform her implanting surgeon, John Small, M.D., of the true incidence of ectopic or uncontrolled or unusual bone growth resulting from the use of Infuse in off-label procedures, or of other risks.”

Lacking this knowledge, Mrs. Byrnes “underwent a posterior-approach lumbar fusion at levels L4-5 and L5-S1” without the requisite LT-Cage in October 2006, according to her Infuse bone graft lawsuit.

From post-surgery through 2012,Mrs. Byrnes suffered severe and continuous pain. She reported the issue to her doctor and to the Florida Orthopaedic Institute where she was undergoing rehabilitative treatment for many years.

X-rays finally showed that the Florida woman had developed a “bone overgrowth” where the Infuse bone graft was implanted that was compressing her nerves, the Infuse lawsuit states.

But it wasn’t until the spring or summer of 2013 that Mrs. Byrnes “had reason to suspect that her chronic pain was caused by Infuse-induced bone overgrowth. In fact, it was not until approximately the spring/summer of 2013 that Plaintiff even learned that Infuse was used in her 2006 lumbar fusion surgery and that it was causing her multiple complications and injuries.”

Mrs. Byrnes claims in her Infuse bone graft lawsuit that Medtronic’s ”fraudulent concealment of the relevant facts tolled any relevant statutes of limitation.”

They are suing Medtronic for fraudulent misrepresentation and fraud in the inducement, failure to warn, design defects, misrepresentation, negligence, and breach of express warranty. She is also suing Dr. Small and the Florida Orthopaedic Institute for negligence. All three defendants are being charged with loss of consortium.

The Medtronic Infuse Lawsuit is Lori Byrnes and Matthew Byrnes v. Medtronic Inc., et al., Case No. 14-CA-005936 in the Circuit Court of the Thirteenth Judicial Circuit in and for the County of Hillsborough, State of Florida Circuit Civil Division.

Infuse Bone Graft Issues

Medtronic is currently being sued for marketing this device for off-label purposes, despite knowing the risks. Many Infuse lawsuits claim that specialists were allegedly paid by Medtronic to promote the Infuse Bone Graft for off-label purposes, such as posterior surgical approaches to lower lumbar bone fusions.

From around 2002 until summer 2011, Medtronic allegedly engaged ghostwriters to write articles and reports on clinical studies in order to suppress information about the real risks and dangers of off-label use.

In June 2011, a series of articles in The Spine Journal were published describing Medtronic’s failure to accurately report the side effects from its clinical trials. The articles told of their downplaying Infuse risks, over-emphasizing problems from non-Infuse bone grafts, and Medtronic’s failure to report that “many of the authors who studied and promoted Infuse had significant financial ties to Medtronic with a median range of $12 to $16 million per study.”

More scientific research studies were also published over that time span. In May 2006, an issue of Spine reported that “rhBMP-2 may stimulate bone growth in areas in which bone is not desired.”

Spine published another piece in November 2006 about the risk of swelling from off-label use of Infuse in cervical spine fusions compared to traditional fusion surgeries. And in 2007, The Spine Journal followed up with more of the same.

On July 1, 2008, in light of these reports of serious complications with BMP, the FDA issued a Public Health Notification to the healthcare community warning medical professionals of the grave complications that had occurred from the off-label use of Infuse and other BMP products in the cervical spine. The notice stated that “the agency had received numerous reports of complications from BMP use in the cervical spine that “were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking.”

Byrnes joins the more than 1,100 adverse events reported regarding Infuse, and the number of spinal surgery victims who say that they suffered serious Infuse Bone Graft problems, including bone and nerve damage, urinary problems, and even an increased risk of cancer.

All say the Medtronic knew, or should have known, that they were concealing the risks, and now need to make amends.

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

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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