Gaston v. Hunter
| Citation | 588 P.2d 326,121 Ariz. 33 |
| Decision Date | 29 August 1978 |
| Docket Number | No. 1,CA-CIV,1 |
| Parties | Katherine GASTON and Paul Gaston, wife and husband, Appellants, v. Willard S. HUNTER, Howard H. Johnston, Arizona Orthopedists, P. C., a corporation, Baxter Laboratories, Inc., a corporation; and Travenol Laboratories, Inc., a corporation, Appellees. 3093. |
| Court | Arizona Court of Appeals |
Herring & Stephan by Norman Herring, Phoenix, and David M. Harney, Los Angeles, Cal., for appellants.
O'Connor, Cavanagh, Anderson, Westover, Killingsworth & Beshears, P. C. by Harry J. Cavanagh and Donald E. Dyekman, Phoenix, and Jennings, Strouss & Salmon by William T. Birmingham, Phoenix, for appellees Hunter, Johnston and Arizona Orthopedists.
Snell & Wilmer by Loren W. Counce, Jr., Phoenix, for appellees Baxter and Travenol.
Many questions are raised in this appeal from a judgment resulting from a jury verdict for the defendants in a medical malpractice and products liability case. The central issues in the trial court related to the liability of the defendant doctors and the defendant drug manufacturers for physical ailments suffered by the plaintiff after the defendant doctors treated plaintiff's back by means of a relatively novel procedure known as "chemonucleolysis", which involved an injection of chymopapain, an investigational drug manufactured by the defendant drug companies.
The appellant Katherine Gaston, plaintiff in the trial court, had a history of intermittent back pain. On October 16, 1970, she experienced severe pain in her low back and legs. She consulted her doctor, an internist, who prescribed some pain medication and recommended that she see an orthopedic specialist. When the recommended orthopedist could not immediately see her, she contacted appellee Dr. Willard Hunter, an orthopedic surgeon, and made an appointment for November 2, 1970.
After examining Mrs. Gaston, Dr. Hunter made a diagnosis of intervertebral disk herniation at two levels. He suggested conservative treatment, and Mrs. Gaston was admitted to St. Luke's Hospital that day for pelvic traction. She remained in the hospital for approximately eight days, and was then told to use traction at home. Unfortunately, her condition did not respond to this conservative treatment, and on December 14, 1970, Dr. Hunter discussed with her the possibility of performing a diskography and chemonucleolysis.
We must digress here to describe the contemplated procedure and identify other parties to this litigation. When an intervertebral disk is bulging outward, it may press against some of the many nerves in the area of the spine and cause pain. If the situation is severe, a normal medical response is surgery: a laminectomy with excision of the offending disk. The drug chymopapain was designed to provide an alternative to back surgery. Chymopapain is an enzyme derived from the papaya. It was manufactured by Travenol Laboratories, a subsidiary of Baxter Laboratories, under the trade name "Discase". Chemonucleolysis is a procedure whereby chymopapain is injected into a bulging disk. The theory was that the drug would dissolve some of the center part of the disk (I. e., the nucleus pulposus), the pressure would be relieved, and the bulging or herniated disk would contract and no longer press upon nerve roots.
When this operation was discussed with the plaintiff, chymopapain had not been approved for general use by the Food and Drug Administration. However, the drug could be distributed to selected physician investigators as an "investigational" drug. Because an investigational drug is still in the clinical testing phase, the investigators using the drug had to operate under close supervision of the drug's sponsor (manufacturer) and had to carefully monitor the results experienced in using the drug. Dr. Howard Johnston, who practiced medicine with Dr. Hunter in the professional corporation Arizona Orthopedists, was an authorized investigator for chymopapain at the time of the plaintiff's injection. Dr. Hunter was not so authorized.
The procedures to be performed on Mrs. Gaston involved placing the patient on her side on the operating table under a general anesthetic. Needles would then be inserted into the nucleus pulposus of each suspected troublesome disk, using a lateral approach (I. e., from the side). The insertion of the needles would be monitored on fluoroscopic equipment to insure proper placement. A radio-opaque dye would then be injected into the disks and X-rays taken. By this procedure (diskography) ruptured disks would be revealed through the leakage of dye. These X-rays would also show the placement of the needles in the disk space. Without moving the needles, chymopapain would then be injected into the affected disks to, hopefully, dissolve some of the nucleus pulposus.
Mrs. Gaston signed a consent form for diskography and chemonucleolysis, and a form entitled "The Use of Chymopapain in Disc Disease", which explained the investigational nature of the drug.
The injection was performed on December 18, 1970. Following the operation, Mrs. Gaston experienced some temperature elevation, disorientation, difficulty in urination, pain, restlessness, and diarrhea. Doctors Hunter and Johnston were not worried, however, until December 23, 1970, when her temperature suddenly spiked to over 103 degrees. An immediate blood culture was ordered. When the laboratory report was returned a couple of days later, it revealed the presence of E-coli bacteria.
Because of abdominal pain, a general surgeon was called in. Gallbladder disease was suspected and the surgeon performed an exploratory laparotomy on December 24th. The only finding, however, was "mesentary adenitis", which is inflammation of the lymph nodes in the membranous tissue which holds up the intestines.
While recovering from this surgery, and on the same day, a spinal tap was performed, revealing E-coli infection in the cerebrospinal fluid. She was immediately placed on antibiotics and this bacterial meningitis was eventually controlled.
Mrs. Gaston, however, suffered additional complications, which necessitated several more operations. She was left with an abnormal gait, some numbness in her feet and toes, inability to control her bladder or bowels, and constant pain.
Mrs. Gaston sued Drs. Hunter and Johnston and Arizona Orthopedists (collectively referred to as the defendant doctors), St. Luke's Hospital, Baxter Laboratories and Travenol Laboratories. 1 The plaintiff contended that the defendant doctors were negligent in selecting her as a candidate for chemonucleolysis, in performing the injection, and in rendering post-operative care. She contended the doctors operated on her without first obtaining an informed consent, a claim sounding in both negligence and battery. Also, since the procedure of chemonucleolysis was investigational, she argued that the defendant doctors were engaged in an ultrahazardous activity and that they should be absolutely liable for any adverse results. The plaintiff claimed that St. Luke's Hospital was negligent in failing to supervise the conduct of the investigational procedure of chemonucleolysis, in not providing a sterile operating theater and equipment, and in not keeping adequate records of plaintiff's condition following the injection. She claimed that the defendant drug companies were negligent in the manufacturing and testing of chymopapain, and in failing to warn of its dangers. She also asserted claims against the defendant drug manufacturers based on breach of warranty and strict tort liability. Finally, she contended that the drug companies, as well as the defendant doctors, should be absolutely liable because the distribution and use of investigational drugs is an ultrahazardous activity.
The defendant drug manufacturers contended that none of the adverse physical ailments suffered by plaintiff after the chemonucleolysis procedure could have resulted from that procedure if properly performed by the defendant doctors, and that, in any event, there was no showing that they were negligent in their investigation, manufacturing or supplying of the drug involved.
The trial of this matter lasted in excess of three months. At the close of the plaintiff's case, the trial court directed a verdict for St. Luke's Hospital. The case against the defendant doctors was submitted to the jury on the issues of malpractice (negligence) and battery. The case against the drug companies was submitted on the theory of negligence. The judge did not instruct the jury on plaintiff's strict tort liability and breach of warranty claims against the drug companies, and the court refused to give an instruction on absolute liability against either the defendant doctors or drug companies. The jury returned verdicts in favor of all the defendants. Plaintiff does not appeal the directed verdict for St. Luke's Hospital, but she contends the verdicts in favor of the drug companies and the doctors must be reversed. On this appeal she asserts a multitude of errors involving the exclusion of evidence, judicial misconduct, and improper jury instructions.
We hold that multiple errors were committed which necessitate a new trial against the defendant doctors on the issue of professional negligence. However, these errors did not involve the issue of informed consent, and no new trial is required on either the negligence theory or the battery theory of informed consent. We find no errors on any of the plaintiff's claims against the drug companies which would justify reversal, and the verdicts for Baxter and Travenol may stand. During the course of this opinion, additional facts
will be developed when necessary to resolve the issues raised by appellant. I. CLAIMED ERRORS RELATING TO THE TRIAL COURT'S RULINGS WHICH EXCLUDED EVIDENCE OF CHYMOPAPAIN INJECTIONS OCCURRING AFTER THE DATE OF PLAINTIFF'S...
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