Savina v. Sterling Drug, Inc.

• Decision Date: 13 July 1990
• Docket Number: No. 63655,63655
• Citation: 247 Kan. 105,795 P.2d 915
• Parties: , 59 USLW 2088, Prod.Liab.Rep. (CCH) P 12,552 Richard K. SAVINA, Appellant, v. STERLING DRUG, INC., Gust H. Nelson, M.D., and St. Joseph Medical Center, Inc., Appellees.
• Court: Kansas Supreme Court

Page 915

795 P.2d 915

247 Kan. 105, 59 USLW 2088, Prod.Liab.Rep.

(CCH) P 12,552

Richard K. SAVINA, Appellant, v. STERLING DRUG, INC., Gust H. Nelson, M.D., and St. Joseph Medical Center, Inc., Appellees.

No. 63655.

Supreme Court of Kansas.

July 13, 1990.

Syllabus by the Court

In a products liability action against the manufacturer of metrizamide, a dye used in performing a myelogram, and in a medical malpractice action against the physician who performed the myelogram and the hospital where the myelogram was performed, the record is examined and it is held: (1) The district court erred in granting summary judgment in favor of the defendant manufacturer, and (2) the district court did not err in granting summary judgment in favor of the defendants physician and hospital.

Richard D. Cordry, Wichita, argued the cause, and Frances A. Hartman and Sharon A. Werner of the same firm, were with him on the briefs for appellant.

Donald Patterson of Fisher, Patterson, Sayler & Smith, Topeka, argued the cause, and Steve R. Fabert of the same firm, was with him on the brief for appellee Sterling Drug, Inc.

Hal D. Meltzer of Turner & Boisseau, Wichita, argued the cause, and W. John Badke, II of the same firm, was with him on the brief for appellee Gust H. Nelson, M.D.

Amy S. Lemley of Foulston & Siefkin, Wichita, argued the cause, and Jay F. Fowler of the same firm, was with her on the brief for appellee St. Joseph Medical Center.

Dwight A. Corrin of Corrin & Krysl, Chartered, Wichita, was on the brief for amicus curiae Kansas Trial Lawyers Ass'n.

ALLEGRUCCI, Justice:

This is a products liability action against Sterling Drug, Inc., (Sterling Drug) and a medical malpractice action against Gust H. Nelson, M.D., and St. Joseph Medical Center, Inc., in Wichita. Plaintiff alleges that the paralysis he experiences in the lower part of his body was due either to the dye metrizamide, used in his myelogram, or to the negligent performance of the myelogram procedure. Plaintiff appeals from the order of the district court granting summary judgment to each of the defendants.

The district court entered three separate journal entries, one as to each of the defendants. As to Sterling Drug, the court made 34 separate findings of uncontroverted material facts. As to Dr. Nelson, the facts set forth in his memorandum brief were adopted by the court, and summary judgment was granted to appellee St. Joseph Medical Center based "on the uncontroverted and undisputed facts presented by all the parties."

Since the trial court resolved this case by summary judgment, the facts need to be recited in detail. In October 1981, plaintiff first saw Dr. Schnelle and Dr. Miller, who practiced together, for pain in the lumbar region of his back. Plaintiff saw Dr. Schnelle again on April 11, 1983, and was admitted into St. Joseph Medical Center for pain in his lower back. After three days in traction, a myelogram was performed upon Dr. Schnelle's recommendation.

A myelogram is a procedure used to obtain a picture of an individual's spinal column. Although the picture can be done by fluoroscope or x-ray, soft tissues do not photograph unless a contrast medium is used. In April 1983, two radiopaque contrast agents were commonly used in myelograms: Pantopaque and Amipaque, the brand name for metrizamide. The contrast agent is inserted by needle into the thecal sac, which is the sheath of dura mater enclosing the spinal cord. The contrast medium is inserted into the spine below the spinal cord. In plaintiff's case, it was inserted between lumbar 2 and lumbar 3 (L-2 and L-3) discs. The puncture that occurs when the thecal sac is penetrated by the needle, and which remains after the needle is withdrawn, reduces the hydrostatic pressure surrounding the spinal column. If a higher-level obstruction exists above the area of the puncture, such as a hematoma cyst or thoracic-level herniated disc, the drop in hydrostatic pressure in the lower part of the thecal sac can increase pressure on the spinal cord at the higher obstruction, which can cause additional injury.

Pantopaque is an oil-based contrast medium that will not mix with spinal fluid. Pantopaque is neurotoxic and must be removed from the thecal sac after the myelogram is completed. Because removing all of the Pantopaque after the myelogram is mechanically impossible, the patient continues to risk a neurological problem, called arachnoiditis. Dr. Nelson, who performed the myelogram on plaintiff, preferred using Pantopaque in the cervical area but, otherwise, preferred metrizamide.

Metrizamide, which is the active ingredient of Amipaque, is a water-soluble contrast medium developed more recently than Pantopaque. Because it is water soluble, Amipaque is metabolized by the surrounding tissues and absorbed into the bloodstream after the procedure is completed, making manual removal unnecessary. Metrizamide is less dense and fills the nerve root sleeves better than Pantopaque, giving a nicer image aesthetically and diagnostically.

Both Pantopaque and Amipaque were used by physicians in Wichita. After plaintiff's myelogram, defendant St. Joseph Medical Center returned to using Pantopaque exclusively until a radiopaque contrast agent known as Omnipaque was introduced. Pantopaque is still available today and is used by some radiologists.

Plaintiff was not told that he risked developing either temporary or permanent paralysis of his lower extremities as a result of a myelogram using Amipaque or metrizamide. Dr. Nelson explained to plaintiff the procedure used in performing a myelogram and the probability of headaches, nausea, and vomiting afterwards. A patient consent was obtained by a student nurse at St. Joseph Medical Center. She stated that the consent was obtained the night before the myelogram, although the date and time on the form indicates it was signed after the procedure was completed.

Dr. Nelson, a board-certified radiologist, performed the myelogram on April 14, 1983. A myelogram tray was prepared by Mr. MacDonald, a radiology technician. He mixed 16 cc's of diluent (a diluting agent) with a full ampule of metrizamide. A syringe and needle is used to draw the diluent from a bottle with a rubber stopper and to then place it into an ampule of metrizamide. The two are mixed for delivery into the spinal column.

Dr. Nelson explained each step to plaintiff as he performed the myelogram. First a local anesthetic, Xylocaine, is injected into the patient's back. The metrizamide dye is then injected into the thecal sac, and the table is lowered to a 40? angle. Plaintiff felt the local anesthetic, needle, and dye going into his spine. He expressed discomfort and then fainted when the local anesthetic was injected. After waiting for the fainting to clear, Dr. Nelson injected the dye and noticed no immediate reaction. Dr. Nelson believed plaintiff had a herniated disc at lumbar 5--sacral 1, pointing to this on the monitor during the myelogram procedure.

The myelogram procedure, which took about 20 minutes, was completed by 9:45 a.m. Plaintiff was placed in the hallway of the x-ray department to await transfer to his room. Approximately two to three minutes after being placed in the hall, plaintiff felt numbness, swelling, and pain from his waist to his toes. His feet felt like they were swelling and on fire until he was placed on pain medication. Plaintiff remained in the hallway approximately 30 minutes before being transported to his room.

Dr. Nelson learned of plaintiff's complaints when the nurse telephoned at approximately 11:30 a.m. Dr. Nelson had never heard of a patient complaining of burning and swelling in the lower legs after a myelogram procedure. Nor had Dr. Nelson ever heard of a case of permanent paralysis following a metrizamide myelogram. Plaintiff had pain in his legs and trouble using his legs and arms. Dr. Nelson instructed the nurse to call Dr. Schnelle. The two doctors met at approximately 1:30 p.m. and decided to consult a neurologist. Dr. Dilawer Abbas, a neurologist, saw plaintiff for the first time at St. Joseph Medical Center on April 14, 1983, at approximately 5:00 p.m. He found a decreased sensation at the L-4/L-5 level and no sensation below the L-3/L-4 level.

The evening of April 14, Dr. Schnelle, Dr. Hered, who was a neurosurgeon brought in for consultation, Dr. Abbas, and Dr. Nelson discussed plaintiff's condition. They decided to attempt a second myelogram to determine whether a mechanical obstruction existed higher in the spinal cord, such as a tumor or hematoma. Dr. Nelson placed a needle between the L-3/L-4 interspace and attempted to place a second needle at the L-2/L-3 interspace, but no fluids were returned in either needle. The contrast medium being used, Pantopaque, was not inserted because the thecal sac had collapsed due to the loss of fluid from the earlier myelogram. Collapse of the thecal sac is not an unusual occurrence after it has been punctured for a spinal tap. When the second myelogram failed, a computerized tomography (CT) scan was completed. The radiologist who read the CT scan did not find evidence of a hematoma or lesion at or above the level of the initial myelogram that would explain plaintiff's condition.

Currently, plaintiff has loss of motor control and sensation in his lower legs, can walk only with the aid of crutches and braces, has some bladder and bowel dysfunction, and has sexual dysfunction. All are considered permanent conditions. Three and a half years after the first myelogram by Dr. Nelson, a diagnostic device, Magnetic Resonance Imaging (MRI), revealed a thoracic-level herniated disc. MRI was not available in Wichita in 1983.

When the Amipaque was purchased, St. Joseph Medical Center had a contrast medium guide from Sterling Drug containing a reprint of the package insert and information available in the Physicians Desk Reference (PDR). This information gave detailed instructions, contraindications, warnings, risk...