The Medtronic Infuse is a bone-growth protein that is used in spinal fusion surgery. Unfortunately, it has been linked to severe, life-threatening side effects, including sterility, nerve damage, and cancer. One of the most common complications is excessive bone growth, which can cause severe nerve damage and other side effects — especially in children.
UPDATE: FDA Warning for Infuse Bone Graft Safety Risks in Kids
January 23, 2015 — New warnings from the FDA highlight the increased safety risks children face when they undergo spinal surgery with Infuse and other bone-graft substitutes. Click here to read more.
October 15, 2014 — The outcome of a class action lawsuit involving Medtronic’s Infuse bone graft could lead to thousands of personal injury claims. Click here to read more.
May 6, 2014 — Medtronic Inc. announced today that they will settle about 950 Infuse bone graft lawsuits for $22 million, and an additional $120-140 million will be set aside to resolve over 3,000 additional claims. Click here to read more.
March 5, 2014 — In a securities filing, Medtronic Inc. stated that about 1,000 people have filed 700 Infuse Bone Graft lawsuits in state and federal courts, and the litigation is expected to grow considerably in the next few years. Click here to read more.
June 19, 2013 — Medtronic has paid $2.5 million to produce two studies conducted by independent researchers. Both studies have found that Infuse is no better than traditional bone graft surgeries, but may have higher risks (such as cancer). Click here to read more.
December 20, 2012 — A Medtronic Infuse Bone Graft lawsuit has been filed in Virginia by a man who suffered disabling nerve damage in his spine after being implanted with the Infuse in 2003 for an “off-label” use. Click here to read more.
What is the Infuse Bone Graft?
The Medtronic Infuse Bone Graft is a medical device that is intended to be implanted after lower-back (lumbar) spinal surgery. It works by stimulating bone-growth in this area. It was developed as an alternative to traditional bone grafting, which involves painful bone-harvesting from other areas of the body. The device itself consists of two parts — a sponge-like substance, which is soaked in a biological agent. The biological agent is a synthetic liquid form of bone morphogenetic protein, or BMP. The device is implanted between vertebrae, and the BMP stimulates the bones to grow. The sponge dissolves and is absorbed into the body.
What’s the problem?
Medtronic is facing intense pressure regarding its Infuse Bone Graft. The FDA has issued safety warnings and the U.S. Department of Justice (DOJ) opened a criminal investigation in 2008. Recently, Medtronic admitted to paying a surgeon nearly $800,000. The surgeon is accused of falsifying the results of a study, which produced a favorable review of the Infuse Bone Graft, all while downplaying the risks of severe side effects.
Medtronic is also accused of engaging in illegal “off-label” promotion of the Medtronic Infuse Bone Graft. When the FDA approved the device in 2002, they only approved it for use in the lower-spine (lumbar) region. However, there is evidence that the company marketed the device “off-label” for use in upper-spinal or cervical surgeries. The problem is that when the Infuse Bone Graft is used in these upper-spinal areas, there is a risk that the product can cause massive tissue swelling in the neck and throat area, leading to suffocation and death.
Medtronic is facing three whistleblower lawsuits seeking damages on behalf of the U.S. Government. The lawsuits were filed by former Medtronic employees, who allege that the company engaged in illegal marketing. This marketing allegedly involved paying 15 doctors more than $60 million to promote the Infuse and other Medtronic spine products, all while downplaying the risks of severe side effects. Although doctors are allowed to use medical devices for off-label purposes, the manufacturers of such devices are not allowed to engage in off-label promotion.
FDA Warns of Life-Threatening Complications
On July 1, 2008, the FDA published a Public Health Notification to warn of life-threatening complications when the Infuse Bone Graft is used in the neck. The agency received 38 reports of complications during the last 4 years, which included swelling of the throat and neck. Some patients suffered suffocation, compression of the airway, and/or nerve damage in the neck. The patients who suffered this side effect had difficulty breathing, swallowing, and speaking. Most of these complications occurred between 2 and 14 days after the operation.
Off-Label Use & Promotion
The Wall Street Journal reports:
“A number of patients say they have been harmed in off-label uses of Infuse, which is approved by the FDA only for a small section of the spine in the lower, lumbar region. At least 280 reports of side effects involving Infuse have been made to the FDA. About three-quarters of those reports involve off-label use. In July, the agency issued a safety alert about complications from the off-label use of Infuse in the neck, or cervical, area of the spine.”
Medtronic Infuse Complications
- Angioedema (swelling of the neck and throat, which can cause fatal suffocation)
- Male sterility
- Chronic pain that radiates into the arms and legs
- Respiratory depression
- Nerve damage
- Emergency surgery
Infuse Bone Graft Class Action Lawsuit
Medtronic is facing over 3,000 lawsuits involving complications of the Infuse bone graft. These have not been consolidated into a class action lawsuit. Instead, they are individual lawsuits filed by plaintiffs with severe injuries. In May 2014, Medtronic agreed to settle 950 lawsuits for $22 million. They have set aside $120-140 million to settle thousands of additional claims. If you need information about joining this litigation, contact our lawyers today.