University of California to Pay $8.5 Million Settlement in InFuse Spinal Device Surgery Lawsuits
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.