Senior Trial Partner, Sean F.X. Dugan, assisted by Partner Gregory Radomisli, obtained a defense verdict in the United States District Court for the Southern District of New York, tried before Judge Lorna Schofield. The case involved a claim that bony overgrowth resulting from a two-level lumbar fusion resulted in impingement of the spinal nerves. Plaintiff was a 37-year-old married, working father of three young children who underwent fusion of the lumbar spine in fall of 2009 performed by our client orthopedic surgeon. Bone Morphogenic Protein (BMP) was utilized intraoperatively to stimulate bony healing. Plaintiff alleged that he was not informed preoperatively that the Food and Drug Administration (FDA) had NOT approved BMP to be used in this fashion; that the compound was used improperly; and in any event, it should not have been used. At mediation, he demanded $6 million to settle his claim at which point the decision was made to try the case.
At a pre-trial deposition, the plaintiff’s expert orthopedist (who ‘specialized’ in spinal surgery) conceded that many surgeons use BMP in the very same way as the defendant used it on plaintiff and that it was not contraindicated. However, the expert maintained that the standard of care required that physicians include the FDA status of products to be used intraoperatively with the patient during the preoperative informed consent discussion. At trial, the defendant surgeon testified that the standard of care required that the patient be informed of the potential risks of surgery, i.e. bony overgrowth, benefits and alternatives to surgery. However, the FDA status of the material used intraoperatively does not have to be specifically discussed.
Our expert neurosurgeon agreed. We argued that the FDA does not regulate a physician’s practice of medicine. Although the plaintiff alleged that the resulting bony overgrowth that resulted impinged on his nerves resulting in disabling right leg pain, a subsequent treating neurosurgeon called by plaintiff conceded on cross-examination that this bony overgrowth was on the left side of the spine (away from the right leg) and that the patient’s postoperative complaints were of the same intensity as before the surgery. In rendering a defense verdict following a lengthy trial, the jury agreed that the patient was properly advised of the known risk of bony overgrowth, that the surgery was performed properly, and that the patient’s right leg pain was unrelated to the bony overgrowth.