Posted by In a recent settlement, Medtronic has agreed to pay $85 million to settle a lawsuit that claims the company made misleading statements about its Infuse bone graft system. This amount is far less than the $460 million that patients are expected to recover from the lawsuits. Unfortunately, this is not the end of the story. Patients are still suffering from the complication that a defective device can cause.
Medtronic paid $85 million to settle a lawsuit accusing it of making misleading statements about its Infuse bone graft system
After a series of whistleblower lawsuits, the Minnesota-based medical device manufacturer has settled at least four of them, paying $22 million to 950 patients. Despite the settlement, the company has not acknowledged any wrongdoing and said it will not disclose further settlement amounts. The lawsuits allege that Medtronic paid millions of dollars to doctors and promote its products while minimizing their risks. The U.S. Attorney for Massachusetts has subpoenaed documents from Medtronic to learn more about its relationship with the former U.S. Army surgeon. The document requests information about contracts and payments to physicians.
The settlement agreement addresses accusations that Medtronic did not disclose the fact that most Infuse sales were off-label. This was an important factor in the company’s settlement. The lawsuits also claimed that Medtronic failed to disclose that the majority of its bone graft product was sold for uses other than their labeled indication.
The company did not admit wrongdoing
A lawsuit alleges that Medtronic paid doctors to promote its Infuse IV pump. The Army notified the company’s medical journal after a study by Dr. Timothy Kuklo overstated the device’s benefits. The lawsuit alleges that Medtronic used deceptive marketing to influence orthopedic surgeons to downplay risks and hype benefits. The company denied the allegations, saying it paid doctors for their intellectual property rights and reported potential adverse events to regulators.
The lawsuit also points out that Medtronic paid a surgeon $800,000 in connection with the Infuse product, which was used in over 1 million patients. The company had sought to limit reports of Infuse’s complications and safety issues to protect its pending acquisition. The company did not admit wrongdoing but admitted to paying the surgeon because he “guaranteed” favorable results from scientific research.
Patients injured by off-label use
The Medtronic Infuse bone graft product is designed to mimic the body’s own bone morphogenetic protein. Specifically, Medtronic’s bone graft uses genetically engineered cells that produce large amounts of rhBMP-2. These cells are used during spinal fusion procedures. But patients who receive the device have reported serious injuries. Some of these injuries were serious enough to prompt the FDA to issue a warning.
A former Medtronic employee is attempting to block the release of relevant documents that may prove that the company knew about the risks of using the Infuse device and deliberately ignored them to maximize profits. The company has argued that releasing such documents would subject its employees to self-incrimination, but this argument is hardly persuasive. Those documents could prove Medtronic’s negligence in the treatment of Keim’s injury.
Settlements expected to total more than $460 million
The settlement amounts for Medtronic Infuse problems are not set in stone. The exact amounts will depend on your unique circumstances. Medical bills, pain, suffering, and loss of earnings will all contribute to the award you receive. It is estimated that more than $460 million has been paid to patients so far. However, these settlement amounts are likely to increase as more lawsuits come forward.
The lawsuits allege that Medtronic secretly paid marketing employees to influence medical journals. These employees allegedly secretly edited articles in favor of Infuse and paid surgeons millions of dollars to lend their names to the studies. This resulted in a faulty product that caused serious problems and injuries. In addition, it was not tested thoroughly before it was used in the first place.