The number of lawsuits filed against Medtronic Inc. over its Infuse Spinal Fusion Device has grown to 1000, with many more cases expected in the coming weeks and months. The Infuse Bone Graft elutes bone morphogenetic protein-2 (BMP-2) to heal fractures and repair musculoskeletal tissues. Unfortunately, this device has been widely used “off-label” during spine fusion surgery, and has been reported to cause a high rate of severe, potentially life-threatening complications including cancer, retrograde ejaculation, and swelling of neck and throat tissue.
Spinal Fusion Device Moves From Operating Room to Courtroom
Three years after having back surgery, Grace Nestler-Bramm found out that a product used to repair her spine had caused new bone growth which was wrapping around her spine and compressing nerves. At that point it was already too late. The bony overgrowth caused by the Infuse spinal fusion device already had done irreparable harm. Nestler-Bramm now suffers from severe pain and has difficulty walking, often requiring a cane or wheel chair to get around. Her doctor has informed her that revision surgery to fix the problem would be too dangerous. In March of 2014, the Cedar Grove, Wis. resident joined nearly 1,000 other people who are suing Medtronic Inc., the company that manufactures the Infuse Bone Graft. It is expected that the number of plaintiffs will likely grow significantly in the near future.
Why Did the FDA Approve Infuse?
A recent analysis of FDA data identified over 6,500 reports of Infuse-related complications submitted to the administration’s medical device reporting system since 2002, the year the device first hit the market. Approximately half of those — some 3,300 — were filed in 2013 alone.
In May 2014, Medtronic informed investors that it will pay out $22 million to settle about 950 Infuse Bone Graft Lawsuits, and is setting aside an additional $140 million to settle an anticipated 3,800 more complaints.
FDA approved Infuse as a combination product, one that includes both a medication and a device. Surgeons implant a collagen sponge carrier, a threaded metal cage, and bone morphogenetic protein-2. A recent investigation determined that the agency approved the spinal fusion device after far less testing than other similar products, despite serious concerns being raised about its safety before it was even approved.
“It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product,” said Bradley Weiner, MD, chief of spinal surgery at the Methodist Hospital in Houston. “We only learned of the harms as they emerged over time.”
In June 2013, over 10 years after Infuse entered the U.S. market, a study in the Annals of Internal Medicine determined that the bone graft offered little benefit over conventional spine surgery, and that it may expose patients to serious health risks. Unfortunately, by then it had been implanted in over 1 million patients worldwide.
That study came on the heels of an investigation by the Journal Sentinel and MedPage Today which found that a group of spine surgeons who were paid millions in royalties from Medtronic had co-authored papers that failed to note the link between the bone graft and severe health risks. In some cases, the medical journals publishing the papers failed to disclose Medtronic’s relationship with the doctors.
Medtronic Falsified Spinal Fusion Safety Data: Senate Report
The problems with the Infuse Graft were further highlighted by a 2013 report issued by the Senate Committee on Finance, which accused Medtronic of editing health journal articles and giving kickbacks to doctors who conducted company-sponsored studies on bone morphogenetic protein-2. According to the committee, Medtronic’s role in editing the articles was not disclosed by the company, and that by law, “Medical journals should ensure industry role contributions be fully disclosed.” The senate kicked off the investigation in June of 2011, after information came to light about surgeons being paid by Medtronic to omit complications associated with Infuse.