Many patients have brought claims against Medtronic, the maker of spinal fusion device InFuse, alleging that they suffered serious injuries as a direct result of the device and that Medtronic failed to warn them about the potential side effects. The lawsuits also state that Medtronic encouraged surgeons and other medical professionals to use the device in unapproved, off-label procedures.
The FDA approved InFuse in 2002 to be used in limited spinal procedures. The device consists of a so-called bone paste containing a synthetic protein known as recombinant human bone morphogenetic protein, or rhBMP-2. The paste is designed to promote bone growth and encourage spinal injuries to fuse together. In 2004, the device was approved for use in tibia repairs, and in 2007, it was approved for dental surgeries.
Now, the University of California is agreeing to pay $8.5 million in settlements for two lawsuits that claim a surgeon formerly employed by the University of California, Los Angeles used Medtronic’s InFuse without disclosing that he has financial ties to Medtronic. Reports also indicate that in one of the surgeries, the physician used InFuse in an off-label procedure. The FDA did not approve InFuse for use in cervical spinal operations. After the procedure, the patient alleged that he suffered from serious bone overgrowth, which resulted in chronic nerve damage and other devastating and debilitating injuries.
Although he underwent corrective procedures, his symptoms persisted. The complaint also states that the UCLA surgeon was aware that the FDA issued a warning in 2008 regarding the potential for bone overgrowth to occur in cervical procedures.
Additionally, the plaintiff contends that the physician assisted Medtronic with developing a device called SeaSpine, which he used in one of the plaintiff’s procedures. He also claims that the assisting physician operated on the wrong disc during the procedure and that the UCLA physician allowed his assistant to perform complex and critical aspects of the procedure that were above his skill level.
Medical device claims can involve a number of theories of recovery. For example, under a strict product liability theory, the plaintiff may prevail if he or she shows that the device was designed in an unreasonably unsafe manner. Each state has different rules regarding how the plaintiff must prove that the design was unsafe, with some requiring the plaintiff to show that there are reasonable alternative designs or that the risks posed by the design of the device outweigh its usefulness.
At Moll Law Group, our defective medical device attorneys have handled many cases throughout the United States and are familiar with the nuances and unique aspects of each locality. We serve clients nationwide, including in Illinois, California, Texas, and New York. We can assist you with the entire judicial process, including pre-filing investigation, gathering evidence, and working with insurance companies, while ensuring that your rights are asserted fully. We offer a free consultation to help you learn about the remedies that may be available to you. Call us now at 312-462-1700 or contact us online to schedule your appointment.