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
the district court granting summary judgment to each of the
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
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needle, and which remains after the needle is withdrawn, reduces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
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
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
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
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
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
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
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
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,
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
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,
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
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
"3. A contrast medium makes a Myelogram possible.
Without a contrast medium, there can be no
"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."
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
"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
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
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 ...