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Infuse Class Action Lawsuit

by Nathaniel Richardson on

As more evidence mounts against Medtronic and its faulty bone-growth product Infuse Bone Graft, injured patients are taking a more critical look at the medical device company and the risks involving Infuse.With ongoing investigations by the U.S. Senate Finance Committee and the U.S. Food and Drug Administration (FDA), Medtronic is under the microscope more than ever before. While no formal class action or multidistrict litigation (MDL) lawsuits have been filed, it appears to a matter of time before some sort of coordinated action is initiated on behalf of injured consumers.

Already, thousands of patients have been victim to the Infuse system. Approved by the FDA for a singular type of low-back surgery, Infuse has been readily used in scores of off-label surgeries. Some claim that Medtronic itself encourages such off-label uses by paying physicians large sums for positive reviews in educational meetings, peer journals and professional conferences. While it is illegal for Medtronic to promote off-label uses for its device, it is common for pharmaceutical companies to pay huge consulting fees to physicians in conjunction with product sales.

Medtronic Infuse Class Action Lawsuit

Based in suburban Minneapolis, Minnesota, Medtronic grew from a tiny start-up business to the world’s largest medical technology corporation and a Fortune 500 company. In 2002, the FDA approved Infuse for the treatment of degenerative disc diseases in the lower back. By 2008, the FDA issued a warning against using the device for off-label purposes, saying that dozens of patients reported adverse effects from such uses. By 2011, the device was under the spotlight again when a prominent medical journal accused Medtronic of paying spine surgeons to skew medical trial results in the device’s favor. The Senate Finance Committee is currently investigating claims that doctors were paid for positive reviews.

Do to the unique nature of the damages suffered by Infuse patients, a class action lawsuit against Medtronic appears unlikely however as with many cases involving drugs and medical devices that injure patients there is the possibility of a court establishing a multidistrict litigation (MDL) which has some similarities to class actions in that efficiencies are gained through the sharing of information and discovery efforts.

Additionally, common issues of fact and law are often tried only once thereby saving time and money for all parties. Most importantly, the damages sustained by each client are recognized in either a settlement or a judgement as opposed to a class action that treats all members of the class essentially the same.

Amid the political turmoil surrounding the device are patients – thousands of them who were injured because some physicians insisted that the off-label uses were safe. Take, for example, the case of a California woman who died after doctors implanted the device in her neck vertebrae. Her family said that within days of the surgery, her neck swelled, she couldn’t breath and she slipped into a vegetative state. The family went on to say that a Medtronic sales representative was in the operating room during the woman’s surgery and recommended that the Infuse device be placed in her cervical (neck) spine.

Know Your Legal Rights

Across the country, patients are facing similar results. Studies show that the placement of the Infuse in the neck area causes increased swelling and difficulty breathing and speaking. In addition, the device has been linked to nearly a dozen types of cancer, uncontrolled bone growth, inflammatory cysts, chronic nerve injuries and male sterility.

As a patient who has suffered because of the Medtronic device, you have legal rights to compensation for your injuries, mounting medical bills and time off work. Our legal experts have the skill and expertise to ensure your case will receive the professional care it deserves. Call us for a no-cost, no-obligation consultation.

Infuse Lawsuit

by Nathaniel Richardson on

Infuse Bone Graft patients who were promised repairs to their spinal problems instead got host of new complications as a result of this faulty medical device. Today, patients by the thousands are facing cancer, long-term nerve damage and abnormal bone growth after an apparent disregard for patient safety.Welcome to your Infuse Bone resource guide. From medical information to legal assistance, we will help you fight for what you need to lead a healthy lifestyle. We are the online headquarters for Infuse Bone information and strive to provide the most accurate and up-to-date medical and legal resources. Our skilled staff utilizes all of its sources to provide up-to-date information on cutting-edge medical therapies. We have caring professionals who provide emotional support and legal experts to help resolve your financial questions.

We offer a variety of resources so you and your family can make the best decision for your future outcome:

  • Case evaluation – A free consultation with our skilled professionals can provide peace of mind and a plan for the future.
  • Referral to one of the best national Infuse Law Firms.

Infuse Bone Graft

Introduced in 2002 by the Minnesota-based Medtronic, Infuse is a synthetic protein that was developed to grow like normal bone and approved by the U.S. Food and Drug Administration (FDA) to repair very specific lower spine problems. The liquid bone-growth agent is soaked into a tiny sponge, placed into a thimble-sized cage and surgically implanted into the lower back area to fuse spinal sections together for a repair of degenerative disc diseases. Instead of harvesting bone or using cadaver bone to make this repair, Infuse was aimed at making these fixes easier and more efficient. The device is also FDA approved for a limited number of oral surgical procedures.

Despite the FDA restrictions on the device’s applications, scores of surgeons have used it in off-label procedures, including cervical (neck) spine surgeries. Some medical experts charge that Medtronic paid a group of prominent spine surgeons to praise the off-label uses and encourage other doctors to follow suit. Today, federal drug regulators and a congressional committee are evaluating the claims and reviewing the options.

Infuse Off-Label Uses (neck and other areas)

In using the device off-label, patients have been exposed to a number of medical problems that have never been investigated through clinical trials or other means. Inserting the material into the neck area has resulted in numerous injures and deaths, the FDA said. Some patients have suffocated to death because of Infuse throat swelling and airway restrictions.

Infuse Bone Graft Complications

Medtronic is also facing charges that it altered the results of original clinical trials to make the device seem safer than it really is. Studies now show the device, when used as originally approved, is linked to radiating leg pain, nerve damage and retrograde ejaculation. It is also linked to cancer and uncontrolled bone growth.

Infuse Lawsuits

With an estimated 100,000 patients a year undergoing on- and off-label Infuse procedures since it was introduced, the court system has been inundated with patients seeking claims. Learn if you can receive compensation by filling out our free case evaluation.