If you or a loved one have been injured after undergoing spine surgery with a Medtronic Infuse Bone Graft, you may be eligible for compensation. For a free legal consultation, please fill out the form to the right or contact us directly at 1-800-305-6000.
The Medtronic Infuse lawyers at Arentz Law Group, P.C. are currently investigating cases where patients suffered serious injury or death after receiving Medtronic Infuse. Though the FDA published a warning against off-label use of Infuse in 2008, thousands of trusting patients suffered severe pain, injury, or even wrongful death after undergoing off-label cervical surgery with this product. If you or a loved one has been injured after surgery with Medtronic Infuse, you may be eligible to collect substantial compensation for your physical, emotional, and financial damages in a dangerous or defective products lawsuit. To learn about how we can protect your rights in a free legal consultation, contact Arentz Law Group, P.C. today to speak with an experienced Medtronic Infuse attorney.
Medtronic Infuse Bone Graft is a laboratory-created form of recombinant human bone morphogenic protein (rhBMP), a substance that occurs naturally in the body. During Infuse surgery, a surgeon mixes the rhBMP powder with sterile water and applies this mixture to collagen sponges. These sponges can then be inserted into small metal cages which are placed in between the vertebrae, where they act as a sort of scaffolding to support the spine as new bone grows. Medtronic infuse is approved by the FDA for the treatment of degenerative disc disease in the lower (lumbar) region of the back and open fractures of the tibia, and it is also approved for use in two dental bone grafting procedures. However, FDA is not approved for use in the part of the spine that supports the neck (cervical surgery), where it may cause unwanted bone growth and inflammation that could prove injurious or even fatal to the patient.
When a medical product is used “off-label”, it means that it is used for a purpose for which it is not approved by the FDA. The FDA issued a formal warning about off-label use of Medtronic Infuse in cervical surgery in 2008, and again in 2011. To date, the FDA has received hundreds of Adverse Event Reports concerning patient injury or death after use of Infuse, and up to 75% of these reports specifically refer to off-label use of Infuse in cervical surgery. According to the FDA warning, the long list of potential injuries that may occur after use of Medtronic Infuse in neck surgery include:
Infuse complications that result after cervical surgery are especially dangerous because this part of the spine is in such close proximity to airway structures. Patients who experience negative side effects after cervical surgery with Infuse often require tracheotomies, intubation, and anti-inflammatory medications.
It is not illegal for physicians to use medical products for off-label purposes. It is, however, illegal to advertise off-label use of medical products. The Medtronic Infuse lawyers at our firm have undisputed evidence that Medtronic exercised gross negligence in promoting Infuse for off-label cervical procedures. Moreover, it is now public knowledge that the medical device manufacturer paid a surgeon $800,000 to lie about study results related to off-label use of Infuse, and that they willfully downplayed the risk of serious injury or death when Infuse is used in this capacity. In fact, the rate of complication for off-label cervical surgery with Infuse reported by the FDA is significantly higher than the rate disclosed by Medtronic and Medtronic-sponsored doctors in published studies.
Many patients who have undergone cervical surgery with Infuse were not told that this use of the product was not approved by the FDA, nor were they made explicitly aware of the risks associated with off-label use of Infuse. As a result of Medtronic’s negligence, patients who suffered injury, or family members who lost a loved one after cervical surgery with Infuse, are eligible to collect compensation for their damages. If you suffered after off-label use of Infuse, you may wish to learn more about your rights. Contact a Medtronic Infuse lawyer at Arentz Law Group, P.C. today for more information.
If you or a person you love suffered injury or death after off-label cervical use of Medtronic Infuse, you may be able to recover compensation for medical bills, pharmaceutical and therapeutic costs, pain and suffering, and other damages. The respected Medtronic Infuse lawyers at Arentz Law Group, P.C. have the resources and experience victims need to level the playing field against this large corporation, and we are prepared to fight on your behalf until you recover the full compensation to which you are entitled. To schedule a free case evaluation, contact a Medtronic Infuse attorney today.