Infuse Bone Graft Lawsuit information will cover Off-label usage, fraudulent statements made by Medtronic, and settlements with the medical device manufacturer. It will also explain how these lawsuits are filed. This article will cover Class action lawsuits and settlements with Medtronic. Infuse bone graft lawsuits have been filed since 2012.
Off-label use of Infuse Bone Grafts
Off-label use of infused bone grafts can cause serious complications, including uncontrolled bone growth and pain, sterility in male patients, and nerve damage. Medtronic has not recalled this product, which means that victims of this complication will have to file a lawsuit against the company. However, Medtronic says that it has not endorsed this use.
Although the FDA has approved Infuse for spinal fusion procedures, many doctors are using the device in ways that are not authorized. Infuse grafts are also being used to repair tibial fractures and sinus cavities. Although the FDA has approved the Infuse bone grafts for spinal fusion, they are being used in more than one hundred thousand surgeries. This practice has led to accusations of bridging physicians to use the device for unapproved uses and hiding negative side effects to increase sales.
Although the Infuse bone graft was not approved for use in other locations, it is widely used for tibial shaft fractures in adults and children. The patient must be skeletally mature and have no prior history of bone fracture. The Infuse bone graft consists of two components: the recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold. Both parts must be used together to prevent any infection or misapplication of the graft.
Fraudulent statements made by Medtronic
The recent class action alleges that Medtronic’s representatives made fraudulent statements regarding its flagship Infuse bone graft. The lawsuit says that the company intentionally misrepresented the safety of the device and encouraged doctors to use it off-label, causing stock prices to skyrocket. Infuse procedures were covered by Humana and other medical insurance companies.
As the Infuse device failed to protect patients from dangerous complications, the company sought to block lawsuits by arguing that it was approved by the FDA, a fact that was later proven untrue. Medtronic also denied that its statement was false, and sought to settle for $85 million. However, the settlement was so substantial that Medtronic has refunded more than $1 billion to patients suffering from Infuse complications.
The company also hid information from consumers and paid doctors and researchers to promote the device, resulting in severe injury and pain to patients. Although many cases were settled, there are still thousands of infusing bone graft lawsuits pending. While the company denies any wrongdoing, the lawsuits do reveal that Medtronic misled consumers about its products and their risks. The company should pay damages to patients who suffered traumatic injuries because of their negligence.
Class action lawsuits
As a result of its unapproved use, the Medtronic company was accused of promoting the infuse of bone grafts off-label. These claims were proven when Medtronic paid out millions of dollars in damages to affected patients. The company also set aside $300 million to settle these lawsuits. These settlements came as a result of a lengthy investigation by the U.S. Department of Justice.
In December 2017, Medtronic settled with five states, paying $12.5 million to settle the lawsuits. The lawsuits claimed that the company marketed the grafts deceptively and fraudulently. The company was also investigated by the Justice Department for paying kickbacks to doctors. The company agreed to settle the case, but it is not clear whether it will do so in the future. But if you’ve been injured by this device, you may be eligible to file a mass tort lawsuit against Medtronic. If you were harmed by it, you can get a share of the settlement.
There is now an extensive list of Infuse lawsuits based on a decade of research and controversy. Many people were forced to undergo the off-label procedure because of a complication. Others suffered from paralysis, muscle spasms, and even wrongful death. The lawsuits were so successful that the U.S. Senate Finance Committee began an official investigation into Medtronic’s practices.
Settlements with Medtronic
As of August, a judge in Missouri has set a trial date for the Trisha Keim lawsuit. This has effectively backed Medtronic into a corner, as the company reported setting aside $300 million to pay litigation costs. Despite the recent announcement that it has settled thousands of Infuse bone graft lawsuits, the company has not yet released the exact amount of the settlements.
The deadline to file a Medtronic Infuse Bone Graft lawsuit depends on the unique circumstances of your case. Because the deadline to file a lawsuit is tied to the first time you hear about the side effects of the surgery, you must contact an attorney right away. Depending on your circumstances, you may qualify for a portion of a large Mass Tort settlement for the damages caused by the surgery. The court will use a complex legal matrix to determine your share of the settlement.