The attorneys of the Infinity Law Center are currently evaluating potential lawsuits for patients who have experienced negative side effects from an Infuse Bone Graft.
Hundreds of lawsuits have been filed against Medtronic, the maker of Infuse Bone Graft, after patients suffered severe health complications. Patients who have suffered health complications should seek legal advice to determine whether or not financial compensation can be obtained.
Several hundred complaints have been submitted to the FDA involving health complications as a result of off-label use of Infuse Bone Graft. The FDA has only approved Infuse Bone Graft for a specific type of spinal surgery, tibia repairs, and dental procedures. Reports indicate that up to 80% of surgical procedures involving Infuse Bone Graft were off-label procedures.
When used in off-label procedures, Infuse Bone Graft has been linked to serious side effects. According to the FDA, the most common side effects include swelling in the neck, difficulty breathing, and difficulty swallowing. However, the following severe side effects have also been reported:
The growing number of complaints from patients injured by Infuse Bone Graft forced the FDA to release a warning to alert customers that off-label use of Infuse Bone Graft could cause serious complications, especially when used for off-label purposes.
The FDA announced that swelling in the neck and throat was the most common complication but there were several other reported complications that required patients to undergo emergency surgery.
After the FDA released a statement, the U.S. Justice Department launched an official investigation. The investigation found that up to 80% of surgical procedures using Infuse Bone Graft were for off-label purposes. In addition, the investigation released a previous settlement in which Medtronic paid $10 million dollars in a whistleblower suit that alleged that Medtronic gave inappropriate payments and referrals fees to doctors and surgeons for recommending Medtronic for off-label purposes.
Despite the evidence the Justice Department uncovered, no criminal or civil charges were filed and the case was closed. However, it still exposed Medtronic’s unethical business practices.
After further complaints, the U.S. Senate Finance Committee launched their own investigation into Medtronic. Their investigation uncovered a $200 million dollar payout in consulting fees to Medtronic-paid study authors when the authors were supposed to be objectively examining the effectiveness and safety of Infuse Bone Graft.
Due to the lack of warning given to patients and the promotion of Infuse Bone Graft for off-label purposes by Medtronic, several lawsuits have been filed against the company. These lawsuits claim that:
If you or a loved one has been injured as a result of an Infuse Bone Graft surgery, then take a moment to fill out our no-obligation case evaluation form. The experienced and dedicated attorneys of Infinity Law Center will review the details of your case and determine whether or not you have a claim.
You or a loved one did not deserve to be injured as a result of Infuse Bone Graft surgery. Our experienced attorneys of the Infinity Law Center will fight to get you the compensation you rightfully deserve for your injuries.