On appeal from Superior Court of New Jersey, Law Division, Middlesex County, Docket No. L-1011-95.
Before Judges Havey, Braithwaite and Weissbard.
The opinion of the court was delivered by: Havey, P.J.A.D.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
OPINION CORRECTED 03/06/02
In this medical malpractice case, judgment was entered on a no-cause jury verdict in favor of defendant Stephen S. Cook, M.D. The central issue raised on appeal is whether a surgeon must inform a spinal-fusion patient that the internal fixation device he intends to utilize during surgery was not approved by the Federal Food and Drug Administration (FDA) for use on the lumbar spine. Plaintiffs argue that because defendant failed to disclose the absence of FDA approval in this case of "pedicle" screws, Edward T. Blazoski (plaintiff) did not give an informed consent to the surgical procedure as a matter of law. Plaintiffs therefore challenge the denial of partial summary judgment as to liability, their motion for a directed verdict at the close of the case, and their motion for a new trial.
We affirm. We hold that the doctrine of informed consent did not require defendant in this case to advise plaintiff of the FDA regulatory status of the pedicle screws.
Plaintiff was sixty-seven years of age at the time of trial. In 1975, he suffered from spondylolisthesis, and underwent a decompression and spinal fusion at the L-4/5 level performed by Dr. Joseph Zawadsky. In 1980, he underwent a second spinal fusion at the L-3/4 level. In 1990, plaintiff was examined by Dr. Zawadsky on several occasions after he injured his back while at work. A myelogram and CAT scan revealed that plaintiff had a narrowing of the spinal canal and disc herniation at the L-2/3 level. Plaintiff was referred to defendant, part of Dr. Zawadsky's group. Defendant is an orthopedic surgeon specializing in spinal surgeries.
After defendant examined plaintiff and various diagnostic test results, plaintiff signed an "informed consent" form on October 31, 1990, stating that defendant proposed to perform a "revision lumbar laminectomy, fusion, and internal fixation." The form contained a "Physician Certification," which stated that the physician has "specifically discussed the more common risks of this procedure, the nature and purpose of this procedure, and the possible alternative methods of treatment." The certification further provided that the physician has advised the patient "that the potential benefits of this procedure outweigh the potential risks" but that the patient may seek out "second opinions." Finally, it stated that the "possible complications" discussed with the patient are "those which I consider to be the most common ones . . . ." Plaintiff signed the form, acknowledging he had "read the physician's certification . . . and agree[s] that the information referred to in it has been discussed with me, and that I have been given the opportunity to ask further questions about any areas which were not clear to me."
The spinal fusion was performed at Robert Wood Johnson University Hospital on November 20, 1990. During the operation defendant found that there was a nonunion at the L-3/4 level. Defendant decided to utilize an internal fixation device. He performed laminectomies at the L-2/3 level, removed the disc herniation and released the nerve roots. He then grafted bone and after bridging the bone between the L-2/3 level, he placed two screws into the pedicles of L-2 and two screws into the pedicles of L-4 and connected the bridging rods. The screws utilized by defendant are referred to as "pedicle" screws because they are implanted into the pedicle, part of the vertebra, to achieve fusion.*fn1 The apparatus was then secured by locking nuts to hold the bars and vertebrae in place.
After the surgery plaintiff experienced "jabbing pains" and spasms in his back, numbness and weakness in his legs and a pulsating feeling in his buttocks. According to plaintiff he felt metal in his back moving and heard a clicking sound. Eventually, x-rays were taken which revealed that a locking nut had come off one of the pedicle screws and there was motion of the fixation device at the L-3/4 level. When plaintiff's pain worsened, he was examined by Dr. R. Bruce Heppenstall, an orthopedic surgeon who admitted plaintiff to the University of Pennsylvania Hospital where the internal fixation device was removed. Dr. Heppenstall located the free-floating locking screw that was buried in plaintiff's tissue and removed it. However, he left part of a broken screw in plaintiff's back because it was buried in bone near the spinal cord and nerve root.
Prior to trial, defendant admitted that at the time of plaintiff's surgery, the FDA classified pedicle screw systems as Class III devices, "experimental devices of unproven safety and efficacy." Defendant also acknowledged that he was aware in 1990, when plaintiff's surgery was performed, that the FDA had not approved the use of pedicle screws for use in locations other than the sacrum, the location for which the screws were originally designed. Defendant was also aware that the FDA had approved a few hospitals across the country to experiment with the insertion of the screws in patients' pedicles. The institutions involved in this study used a particular informed consent form that described the use of these screws as experimental.
During trial, plaintiff testified that defendant told him he was "going to put a fusion and rods" in his back. Plaintiff acknowledged that he fully understood the meaning and purpose of a fusion and how fusion surgery is accomplished because he had undergone two such prior procedures in the past, and his wife had undergone spinal fusions as well. Plaintiff testified that he assumed that fusion was always successful. He stated that when he asked defendant to explain about the "rods," defendant stated "I've got to put rods in your back, they'll be in there forever, you'll never know they're there, and you'll feel like a new man." Plaintiff claimed that defendant did not tell him anything about the risks of the surgery or that he planned to put screws in plaintiff's back. He also stated that defendant did not offer him any alternatives to surgery. Nevertheless, plaintiff admitted that he knew from his prior conversations with Dr. Zawadsky that he could refuse to have surgery and continue with conservative treatment. Plaintiff agreed to the spinal fusion surgery because he trusted defendant's judgment in view of defendant's association with Dr. Zawadsky. Plaintiff Maureen Blazoski, Edward's wife, verified plaintiff's testimony that the only information defendant gave him about the proposed surgery was that he planned to fuse plaintiff's spine and insert rods.
Plaintiff testified that he would not have allowed defendant to place the pedicle screw fixation device into his back if he had known that the FDA had classified the use of pedicle screws as "experimental" and that the screws could break or that the locking nuts could loosen. He added that if he had known that pedicle screws were to be utilized he would not have undergone the surgery because he was aware that screws can break from his thirty years of experience in working with hardware.
Lawerence I. Barr, D.O., plaintiffs' liability expert, testified that the risks associated with the use of pedicle screws during spinal fusion include the increased risk of infection, fracture of the pedicle bones, damage to the nerve root and failure of the internal fixation device, that is, the screws, bolts, nuts and rods. Dr. Barr explained that if the patient fails to develop a solid fusion, or if the screws or rods loosen, the internal fixation device can be painful because of the abnormal motion occurring at the fusion site.
Defendant's version of plaintiff's preoperative visits to his office differed markedly from plaintiff's account. He testified that he obtained plaintiff's history and performed a physical examination on plaintiff's first visit on October 1, 1990. He reviewed with plaintiff the results of his myelogram and CAT scan, advised plaintiff that he was suffering from a compression of the nerve probably related to a disc problem and that his condition was worsening. He also explained that any surgical procedure in removing the disc would be complicated because defendant did not know the exact origin of plaintiff's pain; it could have been from disc impingement, arachnoiditis changes or "from the mechanical problems of his back . . . ."
Defendant discussed with plaintiff the nature, purpose and benefits of the surgery he proposed and its alternatives. He explained the possible need to decompress all of the nerves in the L-2/3 level, the possibility of risk of injury to the nerve, and that the process of decompressing the nerve might cause instability to the joint and thus, plaintiff would most likely need a fusion. He specifically advised plaintiff that he could continue conservative treatment with medication and physical therapy. However, he explained that physical therapy would not work well because it will tend to aggravate the condition.
Defendant explained to plaintiff that one of the available alternatives was to have a fusion without the insertion of an internal fixation device. Defendant stated that he would like the option of using an internal fixation device if he felt during the operation that it was necessary to help achieve a full fusion. He explained the device to plaintiff as consisting of two screws and connecting rods that would act as an internal splint to stabilize the vertebrae while fusion takes place. He stated that using internal fixation for stabilization was a "new approach" when plaintiff questioned him about it because plaintiff's two prior fusions had not utilized internal fixation.
Defendant also testified that he told plaintiff about the "general risks" of the technical aspects of inserting an internal fixation device, but did not mention specific risks such as spearing a nerve or a blood vessel with a screw because defendant had never had this happen in any of his surgeries. He acknowledged that he did not give plaintiff the percentage rate of success of the surgery he was proposing because there was no reliable literature that gave concise figures on the success/failure rate of a fusion using an internal fixation device with screws in a patient who had had multiple prior back surgeries. However, defendant claimed that he gave plaintiff information as to the relative risk factors of the recommended surgery, limited to the risks defendant thought were important, that is, the major ones and those that were common.
Finally, defendant admitted he did not tell plaintiff that the use of pedicle screws in lumbar fusion surgery had not been approved by the FDA, or that there was any controversy surrounding the FDA's position. He did not do so because it was his view that FDA status was not germane to the medical decision that plaintiff had to make because the FDA regulates manufacturers' labeling, distribution and promotion of medical devices, not the practice of medicine. Defendant had been using pedicle screws since 1987, after learning about their benefits from surgeons participating in spinal surgery at Johns Hopkins Hospital and attending meetings of the North American Spine Society, and other medical groups. He testified that based upon his discussions with colleagues and his attendance at seminars, it was his opinion that ...