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.