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March 18, 2002 - FDA Status of a Medical Device Does Not Need To Be Disclosed Under Informed Consent Rules

March 18, 2002 - FDA Status of a Medical Device Does Not Need To Be Disclosed Under Informed Consent Rules

The doctrine of informed consent did not require the defendant surgeon to disclose to the plaintiff spinal-fusion patient that the pedicle screws used by the surgeon were not approved for use in the lumbar spine.

Edward Blazoski, a 67-year-old male suffered from spondylolis-thesis. He underwent spinal fusion surgery at the L-4/5 level in 1975 and at the L-3/4 level in 1980. In 1990, after Blazoski injured his back at work, he was examined by the surgeon who had performed the first spinal fusion. This examination revealed a herniation at the L-2/3 level. Blazoski was referred to Dr. Steven Cook, an orthopedic surgeon who specializes in spinal surgery. Cook recommended "revision lumbar laminectomy, fusion, and internal fixation." Blazoski signed an informed consent form, which contained a physician's certification that stated that Cook had discussed common risks, the nature and purposes of the procedure, and possible alternative treatments. Blazoski's signature acknowledged that he had read the physician's certification, that he and Cook had discussed the topics mentioned in the certification, and that he had been given the opportunity to ask questions.

Cook performed the surgery on November 20, 1990. During surgery, Cook discovered a "nonunion" at the L-3/4 level, and he decided to use an internal fixation device. Therefore, after performing the laminectomies, he inserted pedicle screws at L-2 and L-4, added connecting rods, and secured this apparatus with locking nuts to hold the vertebrae in place. Later, Blazoski experienced pain and spasm in his back after the surgery and "felt metal in his back moving." Examination revealed that one of the locking nuts had come loose from a pedicle screw and that there was movement in the fixation device at the L-3/4 level. Blazoski underwent additional surgery to remove the fixation device.

Blazoski brought a medical malpractice action against Cook and others. Before trial, Cook admitted that the federal Food and Drug Administration classified "pedicle screw systems" as Class III "experimental devices of unproven safety and efficacy" at the time of Blazoski's surgery. Cook also admitted that he knew that the FDA had approved pedicle screws for use only in the sacrum and that the few hospitals that were approved to experiment with pedicle screws in a patient's pedicle were required to use an informed consent form that revealed that the device was experimental.

When the case closed, Blazoski moved for a directed verdict on liability. He argued that he had not given informed consent because Cook had not revealed that the FDA had not approved the use of pedicle screws. Blazoski also argued that he was entitled to a directed verdict because Cook had not revealed the specific risks that the screws or rods might break or that there could be damage to bones, nerves, or blood vessels. The jury returned a no cause verdict in favor of Cook and the Appellate Division affirmed, holding that the doctrine of informed consent did not require Cook to disclose the FDA regulatory status of the pedicle screws to Blazoski.

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