Posted by You might have already heard of the Medtronic Infuse Bone Grafting procedure, but do you know if it’s safe? Medtronic admits paying a surgeon $800,000 for his participation in the Infuse study. The payments reportedly helped the company convince the FDA to approve the device. The company’s financial ties with the surgeon also prompted an investigation by the Senate Committee on Finance.
Medtronic Infuse lawsuits
If you suffered from serious injuries or were denied full compensation because of the defective Medtronic Infuse Bone Grafting device, you may be able to file a claim against the company for damages. Depending on the circumstances of your case, you may be able to seek damages for past and future medical expenses, pain and suffering, and more. In some cases, you can file a Mass Tort lawsuit against Medtronic.
There have been numerous claims filed against Medtronic for promoting the off-label use of its Infuse Bone Graft device. The FDA has not approved this product for any use other than a vertebral fusion, which makes it illegal. Patients who had undergone off-label procedures have filed lawsuits against Medtronic to recover damages. In one recent case, a California woman filed a personal injury lawsuit against the company, claiming that the device had caused her severe pain and nerve compression.
Complications
The Medtronic Infuse Bone Grafted is a genetically engineered substance made from human bone and cow collagen, intended to stimulate bone growth. It is approved for use in two dental procedures and one type of spine surgery. However, three-quarters of reported Infuse Bone Graft complications occurred with uses not approved by the FDA. The FDA issued an alert in 2008 citing the risk of rhBMP-2 for cervical spine fusion surgeries.
Because of the risks of this graft, it should not be used in off-label procedures. Medtronic failed to warn the medical community and consumers about heterotopic bone growth, also known as bone overgrowth. It is important to note that patients who received Medtronic Infuse Bone Grafts had lower back pain, but there were no reported cases of spinal fusion. This is a significant medical problem, especially if there are multiple levels.
Financial ties
Infuse is a manufactured version of human bone-growth protein that was approved by the U.S. Food and Drug Administration in 2002 to replace bone grafts in spinal surgeries. Approximately 85 percent of sales have come from off-label uses, however, and the FDA has warned doctors about the risks. Infuse was found to be causing serious complications in patients, and a Senate Finance Committee investigation found that Medtronic had “heavily influenced” published studies on the product. It also paid doctors $210 million for writing those studies. Two Medtronic units have agreed to settle investigations by the attorneys general of five states.
Infuse’s financial ties were also cited as a factor in the lawsuit. Medtronic filed a securities filing in June 2012, disclosing settlements with more than 4,000 Infuse bone graft lawsuits. The company also disclosed that it settled a lawsuit involving a $175 million settlement with one patient, with another 4,000 pending. The lawsuit alleged that the company failed to disclose many “off-label” sales or sales of the product that aren’t the primary function of the graft.
Whistleblowers
The case against Medtronic has been consolidated into a single class action, with the lawyers representing whistleblowers, including Jacqueline Poteet and Bobbie Vaden. While Poteet and Vaden are not part of the original class, their lawsuits were filed in response to alleged misconduct at Medtronic. They allege that the company was misusing government funds to make off-label sales of their grafts, which often lead to negative outcomes and even deaths.
Several whistleblowers alleged that Medtronic improperly marketed products. These cases involve claims of improper marketing and inducements of physicians to use Medtronic spine products. Two of the lawsuits have been settled for $40 million each. While the whistleblowers did not admit wrongdoing, they are still entitled to a share of the federal recovery.
Timeliness of filing
The timeliness of filing a Medtronic Infuse Bone Grafting lawsuit is critical for proving Medtronic was negligent in the design and promotion of this device. While it is true that the FDA did not approve Infuse before its pre-market approval in 2002, the company warned of its restrictions and suggested using a metal cage for this type of procedure.
As the timeframe for filing a suit varies by state, it is important to act quickly. There are specific deadlines for filing a lawsuit. The law firm of Hare, Wynn, Newell & Newton understands the repercussions of an injury, death, or disability, and the thought of taking legal action. That is why we have dedicated ourselves to helping victims of Medtronic products.