Daum v. SpineCare Medical Group, Inc., A068116

• Decision Date: 21 February 1997
• Docket Number: No. A068116,A068116
• Court: California Court of Appeals Court of Appeals
• Parties: , 97 Cal. Daily Op. Serv. 1262, 97 Daily Journal D.A.R. 1843 Edwin DAUM et al., Plaintiffs and Appellants, v. SPINECARE MEDICAL GROUP, INC. et al., Defendants and Respondents.

Page 260

61 Cal.Rptr.2d 260

52 Cal.App.4th 1285, 97 Cal. Daily Op. Serv. 1262,

97 Daily Journal D.A.R. 1843

Edwin DAUM et al., Plaintiffs and Appellants, v. SPINECARE MEDICAL GROUP, INC. et al., Defendants and Respondents.

No. A068116.

Court of Appeal, First District, Division 3, California.

Feb. 21, 1997.

Review Denied June 11, 1997.

Gerald A. Clausen, San Francisco, for Appellants.

James M. Goodman, Los Angeles, for Respondents.

PARRILLI, Associate Justice.

In Cobbs v. Grant (1972) 8 Cal.3d 229, 104 Cal.Rptr. 505, 502 P.2d 1 (Cobbs ), and Arato v. Avedon (1993) 5 Cal.4th 1172, 23 Cal.Rptr.2d 131, 858 P.2d 598 (Arato ), our Supreme Court established a carefully limited role for expert testimony in determining the scope of a physician's duty to disclose information to a patient before undertaking a medical procedure. In neither of those cases was the court presented with a legislatively prescribed disclosure. Here we hold that when the duty to disclose certain information is imposed by statute or regulation, it is error to require the jury to consider only expert testimony in determining whether communication of that information was necessary for the patient's informed consent. Further, in view of the limitations discussed in Cobbs and Arato, we hold a jury may not be restricted to considering expert opinion in determining whether the timing and method of a physician's disclosure was adequate.

Appellants Edwin and Michele Daum sued SpineCare Medical Group, Inc. and Drs. John Pletz and Noel Goldthwaite (collectively, SpineCare) for medical malpractice. The action arose out of unsuccessful spinal fusion surgery on Mr. Daum; Michele Daum asserted a cause of action for loss of consortium. The Daums' theory of liability at trial was restricted to SpineCare's failure to obtain informed consent for the implantation of a fixation device in Mr. Daum's back. The Daums did not dispute that Mr. Daum agreed to the use of the device, known as the Wiltse II. However, they claimed he was not informed the device was considered investigational or experimental by the Food and Drug Administration (FDA), nor was he told his surgery was part of an FDA-approved clinical investigation of the Wiltse II conducted by SpineCare.

California statutes, and federal regulations incorporated in the manufacturer's protocol for clinical trials of the Wiltse II, require that patients be informed of its investigational status. The patients must consent in writing to participate in the trial, and must be given a copy of their consent form. Mr. Daum did not sign a written consent form disclosing the investigational status of the Wiltse II until shortly before surgery, when he was lying on a gurney. Soon thereafter he received an anesthetic that had a retroactive memory-blocking effect. After surgery he had no memory of signing the form, nor was he given a copy. The surgeon, Dr. Goldthwaite, believed he had orally informed Mr. Daum the device was investigational sometime before the day of surgery. Mr. Daum denied this. The parties' experts disagreed on whether the disclosure to Mr. Daum was within the standard of care. The jury returned a special verdict finding SpineCare had disclosed to Mr. Daum "all relevant information which would enable him to make an informed decision regarding the proposed operation." Judgment for SpineCare followed.

On appeal, the Daums contend the trial court improperly instructed the jury that the standard of care must be determined solely from expert testimony, and erroneously refused the Daums' proposed instructions on negligence per se and battery. They also challenge the nonsuit granted to Dr. Pletz during trial. We conclude the nonsuit was proper, and the battery instruction did not apply in this case. However, it was prejudicial error to require the jury to determine the standard of care governing informed consent exclusively from expert testimony, and to refuse to instruct on negligence per se. Therefore, we affirm the judgment of nonsuit as to Dr. Pletz and otherwise reverse.

I. BACKGROUND

A. Mr. Daum's Earlier Treatment

Mr. Daum worked for IBM as a designer and teacher of training courses for the company's employees from 1962 until his 1989 surgery at SpineCare. He first experienced back problems on a teaching trip in the spring of 1985. In November 1985 he had surgery to partially remove a herniated disc between his fifth and sixth lumbar vertebrae. The operation relieved his discomfort and he was able to return to work until March 1987, when he was struck from behind in an automobile accident. Mr. Daum immediately felt a sensation of paralysis in his legs, which subsided the same day but was followed by persistent pain in his back and right leg. He missed a considerable amount of work. Despite physical therapy, a doctor discovered atrophy of Mr. Daum's right thigh muscle in February 1988. Again, a herniated disc was found between the fifth and sixth lumbar vertebrae. Mr. Daum discussed with Dr. Golden, his surgeon, whether to simply remove additional disc material or fuse the vertebrae. He decided on the simpler procedure, although he knew that removal of more disc material might lead to instability requiring a fusion.

Dr. Golden performed the second disc operation in March 1988. It provided some relief, but Mr. Daum's back problems recurred. He returned to work in July 1988, but only part-time. Dr. Golden ultimately concluded a fusion operation was necessary, and sent Mr. Daum to another neurosurgeon, Dr. Prolo, for a second opinion in June 1989. Dr. Prolo examined Mr. Daum and recommended a posterior lumbar interbody fusion to stabilize the joint between the fifth and sixth lumbar vertebrae. This procedure would involve implanting blocks of bone obtained from cadavers. No metallic fixation device would be used, but a cast or brace would be needed to immobilize the spine. Mr. Daum took some time to consider this option. In the fall of 1989, he decided to have the surgery and scheduled an appointment with Dr. Golden. However, Dr. Golden had retired and Mr. Daum lacked confidence in the doctor who had taken over the practice. Mr. Daum went to his family doctor for a referral to another surgeon, and his doctor scheduled an appointment for him at SpineCare.

B. Treatment at SpineCare

SpineCare is a multidisciplinary practice founded by Dr. Arthur White to specialize in the treatment of spinal problems. Its staff includes internists, surgeons, anesthesiologists, psychiatrists, a chiropractor, and rehabilitation experts. The great majority of its patients have previously undergone unsuccessful spine surgery. Mr. Daum met with Drs. Pletz and Goldthwaite at SpineCare on October 11, 1989. Dr. Pletz, an internist, was responsible for initially evaluating Mr. Daum's condition, for managing any nonsurgical, conservative aspects of his treatment, and for some aspects of postoperative treatment. Dr. Goldthwaite was the orthopedic surgeon who eventually operated on Mr. Daum's spine.

At the meeting on October 11, the doctors took Mr. Daum's history, performed a physical examination, and concluded that further diagnostic tests were needed. Mr. Daum remembered discussing fusion surgery, and being told a metal fixation device would be used. Dr. Pletz testified no decision on the necessity of surgery was made at the first meeting, and there was no need to have discussed instrumentation with Mr. Daum. Dr. Pletz did not believe they discussed the Wiltse II. Dr. Goldthwaite testified he had contemplated using the Wiltse II at the first meeting "because ... we were just coming on line with that, and it would be the ideal instrumentation to use in a case like that." He did not remember if he discussed the Wiltse II with Mr. Daum on October 11, but believed they had discussed surgery in a general way.

The Wiltse II consists of metal screws and rods implanted in the spine to stabilize the patient's vertebrae and facilitate fusion. The screws are placed in a part of the vertebra called the pedicles, which project on either side from the body of the vertebra. The Wiltse II was an improvement over earlier fixation devices that used screws and plates because its rods could be bent to conform to the curvature of the patient's spine. In 1989 the Wiltse II was considered an experimental or investigational device by the Food and Drug Administration (FDA). ¹ SpineCare became an approved investigator for clinical trials of the Wiltse II on October 27, 1989. In doing so, SpineCare agreed to follow the manufacturer's protocol which had been approved by the FDA. Included in the protocol was a written consent form telling the patient that surgery using the Wiltse II device was part of an investigational study. Mr. Daum was the third or fourth SpineCare patient to receive a Wiltse II implant.

Mr. Daum met with Drs. Pletz and Goldthwaite again on November 2, 1989, after undergoing the tests prescribed at their first meeting. At trial, he had difficulty remembering what happened at the second meeting; he was unsure whether he saw Dr. Pletz, Dr. Goldthwaite, or both. Mr. Daum's testimony from an earlier trial in 1991 arising from his car accident was read to the jury. There, he said he went back to Dr. Goldthwaite after his tests were done, and Dr. Goldthwaite explained he would place steel rods and screws in Mr. Daum's back "and that was [a] rather heavy and involved procedure because they had to operate from the front and back." Dr. Pletz's progress note on the November 2 meeting showed that he and Dr. Goldthwaite saw Mr. Daum together. Dr. Pletz noted Mr. Daum needed a multilevel fusion with hardware and wanted to proceed with the surgery as soon as it was practical. Dr. Pletz said no decision had yet been made to use the Wiltse II; he did not think they had discussed the Wiltse II at that meeting. Dr. Goldthwaite testified that on November 2 he told Mr. Daum he was going to have a Wiltse II surgery; he thought they had...