The Medtronic Infuse Bone Grafting lawsuit involves claims of serious complications and a lack of safety testing. The device was used in off-label procedures without proper testing or approval. Thousands of patients have suffered severe complications as a result of this dangerous device. As a result, the device was prone to faulty design and inadequate manufacturing. In addition, the medical device did not meet the highest standards of safety.
Medtronic Infuse lawsuits
The use of Medtronic Infuses bone grafts has been the subject of controversy for years. A recent stockholder lawsuit settled for $85 million alleged that Medtronic concealed off-label sales of the device and did not disclose these to its shareholders. The company was also sued by the Minneapolis Firefighters’ Relief Association for selling the device for reasons other than its intended function. In June 2013, a similar shareholder lawsuit was filed.
At the end of 2016, there were thousands of lawsuits filed against Medtronic for the defective Infuse bone graft. The company initially tried to settle these cases individually, but eventually agreed to pay compensation to thousands of claimants and set aside $300 million to settle future cases. Thousands of people had filed lawsuits over the defective product, claiming that Medtronic forced doctors to use the device off-label. The device was designed to be used for surgical purposes but could cause complications, including infection.
Class action lawsuits
Infusing bone grafts have been a source of controversy for many years. One class action lawsuit brought by the Minneapolis Firefighters’ Relief Association sought over $85 million in damages for failing to disclose bone graft off-label sales. Another shareholder lawsuit filed against Medtronic in June 2013 sought the same amount of money but was unsuccessful. Regardless, the latest settlement will put the rest of the Infuse lawsuits on hold, as the company has already settled with the surviving 950 plaintiffs.
According to the lawsuits, Medtronic is responsible for the development of the Infuse. However, patients may have suffered severe injuries due to this device. Some of the lawsuits claim that Medtronic improperly promoted the bone graft off-label, even though the FDA did not approve it. Also, Medtronic misrepresented the safety of the device and omitted critical information about the risks of the product.
In 2010, Patricia Caplinger underwent a surgical procedure involving an Infuse Bone Graft, a procedure that involves implanting a bone graft through the abdomen or back. This procedure results in problematic bone growth around the spinal cord, putting pressure on nerves. Caplinger sued Medtronic for the off-label use of the device. She alleged that Medtronic failed to warn doctors of the potential risks of this surgery and that the company was buying off doctors to use its product.
While Infuse Bone Graft is approved for use in bone fusion procedures, doctors have been using it for off-label applications, including cervical spine fusions. Because of this, Medtronic may have illegally marketed this device and improperly promoted it for use in these procedures. Several lawsuits filed by patients accuse the company of improperly marketing the device to doctors and may have contributed to the rising number of off-label usages of Infuse Bone Graft.
A health insurer has filed a lawsuit against Medtronic over their aggressive marketing strategy for the Infuse bone graft. Humana accuses the company of deceiving doctors by marketing the graft for uses off-label. The company allegedly violated the federal antitrust laws by hiding adverse effects, altering complication rates, and lying to the public. The case is the first to prove that Medtronic manipulated studies for off-label uses to maximize sales.
The company’s marketing tactics have failed to sway medical professionals away from the product. While the device may have been approved for off-label use, thousands of people have filed lawsuits against the company. As a result, Medtronic has agreed to pay approximately $22 million to settle Infuse Bone Graft lawsuits. The settlement is a compromise of disputed claims and does not constitute an admission of liability or validity of any defense. The product has been used by more than one million patients since it was approved.