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SAVINA v. STERLING DRUG

July 13, 1990.

RICHARD K. SAVINA, Appellant,
v.
STERLING DRUG, INC., GUST H. NELSON, M.D., and ST. JOSEPH MEDICAL CENTER, INC., Appellees.



The opinion of the court was delivered by

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

[247 Kan. 106]

      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 The puncture that occurs when the thecal sac is penetrated by the needle, and which remains after the needle is withdrawn, reduces the hydrostatic pressure surrounding the spinal column.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

[247 Kan. 107]

      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

[247 Kan. 108]

      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 plaintiffs 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 plaintiffs 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

[247 Kan. 109]

      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 plaintiffs 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 of use, recommendations as to patient selection, and possible side effects then known. This was information concerning metrizamide contained in the PDR in 1982.

  The record before the district court indicated that defendant Sterling Drug prepared drug experience reports (DER) during the development and marketing of metrizamide that indicated patients had suffered from temporary or transient paralysis after myelography with metrizamide. Plaintiffs three experts reviewed the DER prepared by Sterling Drug prior to April 1983, the package insert distributed with metrizamide, and plaintiff's medical records. Plaintiffs experts concluded that the DER compiled by Sterling Drug prior to April 1983 indicated that both transient and permanent paralysis could be caused by metrizamide. Therefore, in their opinion, the warnings contained in the package inserts were insufficient to adequately advise a physician using metrizamide of either the potential for an adverse reaction resulting in paralysis or the proper treatment to be employed in the event of paralysis.

  One of plaintiff's experts, Dr. Berger, who is a neurologist and professor at Albert Einstein University, found at least 12 cases where patients suffered adverse reactions similar to plaintiff's after a myelogram using metrizamide. Because Sterling Drug did not

[247 Kan. 110]

      check back with any doctor who reported an adverse reaction, it was impossible to ascertain whether the reported paralysis was in fact transient. According to Dr. Berger, Sterling Drug should have prepared a stronger, more explicit warning that severe transient or permanent paralyses were possible side effects of the use of metrizamide. Dr. Schaumburg, a neurologist and toxicologist as well as a professor at Albert Einstein University, agreed that Sterling Drug was not aggressive or emphatic enough in warning about the possible damage to nerve roots in using metrizamide. He indicated the package insert did not contain sufficient warning or discussion of appropriate subsequent treatment should a problem arise.

  Dr. Heinz, who is a neuroradiologist and professor of radiology at Duke University, criticized the package inserts for referring to the complaints reported in the DER as "transitory." He noted that, for most physicians, the term "transitory" means a few seconds or minutes instead of three weeks as was reported in one DER. At the pretrial conference, plaintiff indicated that he would rely primarily upon the testimony of Dr. Heinz to establish the liability of the defendants. All parties used Dr. Heinz's deposition to support their respective positions regarding the claims raised in their motions for summary judgment and the response thereto.

  At the deposition conducted on October 15, 1987, plaintiff's counsel asked Dr. Heinz if he had an opinion based upon a reasonable degree of medical probability of whether one would expect the results of a lumbar myelography with metrizamide as experienced by plaintiff to occur "but for the negligence of either the manufacturer of the drug or the negligence of the administrator of the drug, i.e., Dr. Nelson, or the negligence of the hospital through its personnel in mixing or preparing the drug for injection." Dr. Heinz indicated he did have an opinion. First, he found no question of negligence regarding the hospital. Second, he saw no direct evidence of negligence by Dr. Nelson. Third, he considered the drug itself. Knowledge about the drug dated from a 1947 paper which recognized that the concentration and duration of contrast material in contact with neighboring tissue are two factors indicating the constituency of neurotoxicity. Based upon cases where transient, persistent, or even chronic changes occurred in relation temporally to the placement of metrizamide,

[247 Kan. 111]

      the doctor's opinion was that plaintiffs injury was probably caused by metrizamide and, perhaps, its persistence in his neural sac for a longer-than-average period of time. Elsewhere during his testimony, Dr. Heinz also noted that, when a therapeutic procedure such as opening the skull, the chest, or abdomen is performed, complications might be expected, but when the procedure is merely diagnostic, a significant complication is not anticipated. Dr. Heinz recognized that plaintiff had a more severe reaction than had been previously reported from the use of metrizamide, but neurologically his symptoms were quite similar, just more severe, than other patients who had experienced, but recovered from, some degree of disability following a myelogram using metrizamide.

  Defendant Sterling Drug denied that metrizamide caused the injury plaintiff experienced following the myelogram. Plaintiff claimed that metrizamide caused his injuries and that Sterling Drug was aware that permanent paralysis was a potential adverse effect but did not discuss it in the package inserts.

  Dr. Nelson denied he was negligent, but plaintiff pointed out that he used an 18-gauge needle to inject metrizamide instead of the 22-gauge needle recommended. Plaintiff does not offer evidence indicating that using a different size needle would cause an injury resulting in the symptoms plaintiff experienced. Nor can plaintiff identify any evidence to support his claim that Dr. Nelson was negligent, except for the fact that plaintiff was injured following the myelogram.

  St. Joseph Medical Center also denied negligence by any of its staff and employees. Plaintiff claims that St. Joseph Medical Center's radiology technician, MacDonald, may have been negligent in the preparation of the metrizamide solution. Plaintiff notes that a phenomenon called "coring" can occur when a solution is contaminated during preparation by a part of the rubber stopper entering into the needle when the needle is placed in the rubber stopper to withdraw medication. If coring does occur, the foreign material may not be identified in a myelogram or a CT scan. Defendant Sterling Drug's expert, Dr. Sackett, a neuroradiologist, admitted that if coring occurred, an injection of the contaminated solution into the patient's spinal cord could cause injury. Here, MacDonald, following standard procedures, discarded

[247 Kan. 112]

      the metrizamide and unused diluent from the first myelogram.

  Dr. Nelson admitted that a patient undergoing a myelographic procedure has no control over performance of the procedure. The patient does not choose or control the equipment or the contrast medium.

  Plaintiff's medical history gave no indication that he would suffer an unusual reaction to the use of metrizamide.

  The package insert accompanying the Amipaque used for plaintiff's myelogram contained references to possible paralytic adverse reactions. The injuries suffered by plaintiff are commonly referred to as a "cauda equina" syndrome. The package insert referred to "persistent" cauda equina syndrome as a possible adverse reaction to use of the product but made no reference to a permanent reaction. The disabilities suffered by plaintiff are similar to those present in Guillain-Barre syndrome, which the package insert describes as a potential allergy or idiosyncrasy that can result in permanent impairment.

  At the hearing on the summary judgment motion, Sterling Drug relied upon the discovery record to support its motion to determine the product to be a Comment k product, i.e., an "unavoidably unsafe" product, and thus within an exception to strict liability in tort. In lieu of the live testimony of Dr. Nelson, the parties stipulated as follows:
"1. A Myelogram as a diagnostic tool is beneficial and necessary for medical personnel to treat patients who have suspected spinal lesions.
"2. Any Myelogram itself is a form of photograph. It can be visualized by X-Ray, CT Scan or Fluoroscope.
"3. A contrast medium makes a Myelogram possible. Without a contrast medium, there can be no Myelogram.
"4. The alleged neurotoxic effects of Metrizamide were not avoidable by any means other than a decision not to use the product."
The parties had previously stipulated in the pretrial order as follows: "The Metrizamide manufactured by Sterling Drug, Inc. and used by Dr. Nelson in the myelogram procedure performed upon the plaintiff was not contaminated in any way and was in the form and content intended by its manufacture at the time of purchase by St. Joseph Medical Center."

[247 Kan. 113]

     

  Following a hearing on the motions for summary judgment on February 16, 1989, the next day the court sustained all of the defendants' motions for summary judgment. At that time, the court explained its decision from the bench as follows:
"I find there is no active negligence alleged or capable of proof based on the affidavit and deposition and so on that are on file, the statements, technical title that you file with your motions for summary judgment slips me right now. Based on those, I find that there are no issues of fact; and, of course, if it is controverted, it is controverted so it doesn't become a part of — so it is only the uncontroverted, undisputed facts that I am relying on and also with respect to the claim of res ipsa loquitur, I am saying that res ipsa loquitur could not be used in a malpractice case; but there is really no suggestion as to what the negligence was or what could have happened that would give rise to an inference of negligence.
"As I mentioned yesterday, the problem of the cascading cask of the traditional res ipsa loquitur case sort of goes by the wayside once you have discovery that allows you to inspect the premises; but still I am recognizing that in the proper case, res ipsa loquitur can be proper; but there still has to be some way that you are saying what went wrong; and based upon the entire file, I can't say what went wrong.
"I also find that the drug is a Comment k drug; and, of course, any time you are — based on the Funke case, any time you are dealing with the spinal column it is not so recognized that Mr. Savina went into the hospital with what he thought was to be a relatively minor procedure and came out paralyzed. Indeed a tragedy; but, nevertheless, I think the rulings I have to make require me to make the rulings I have made."
  All issues raised in the appeal concern whether the trial court erred in granting summary judgment in favor of the appellees. In reviewing a motion for summary judgment that has been granted by the district court, this court must read the record in the light most favorable to the party who defended against the motion for summary judgment. Danes v. St. David's Episcopal Church, 242 Kan. 822, 830, 752 P.2d 653 (1988). In so doing, if "`the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law,'" summary judgment is proper. 242 Kan. at 830 (quoting Hollingsworth v. Fehrs Equip. Co., 240 Kan. 398, 400, 729 P.2d 1214 [1986]).

  We first consider whether the trial court erred in finding that metrizamide qualified as a product described in Comment k of § 402A of the Restatement (Second) of Torts (1986). Plaintiff seeks

[247 Kan. 114]

      to impose liability upon Sterling Drug under the doctrine of strict liability in tort. This doctrine had its genesis in a concurring opinion by Justice Roger Traynor of the California Supreme Court, where he suggested that a manufacturer should be absolutely liable if it placed a product in the market that it knew would be used without inspection and which had a defect that caused injury. Escola v. Coca Cola Bottling Co., 24 Cal.2d 453, 461, 150 P.2d 436 (1944). The public policy considerations underlying the doctrine of strict liability are that the manufacturer can anticipate and guard against the recurrence of hazards, that the cost of injury, which may be overwhelming to an injured individual, can be distributed by the ...


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