Swayze v. McNeil Laboratories, Inc.
| Decision Date | 09 January 1987 |
| Docket Number | No. 85-4894,85-4894 |
| Citation | 807 F.2d 464 |
| Parties | , Prod.Liab.Rep.(CCH)P 11,224 Dicie Ellen Hibley SWAYZE, Legal Guardian and Next Friend of Michael Wayne Swayze, Plaintiff-Appellant, v. McNEIL LABORATORIES, INC., Defendant-Appellee. |
| Court | U.S. Court of Appeals — Fifth Circuit |
William Liston, Liston, Gibson & Lancaster, Winona, Miss., George E. Gillespie, Jr., Hattiesburg, Miss., for plaintiff-appellant.
George Gore, Arter & Hadden, Cleveland, Ohio, Easterling & Varnado, S. Wayne Easterling, Hattiesburg, Miss., for defendant-appellee.
Appeal from the United States District Court for the Southern District of Mississippi.
Before GOLDBERG, REAVLEY and GARWOOD, Circuit Judges.
Plaintiff, Mrs. Dicie Ellen Hibley Swayze, appeals from a directed verdict granted to defendant, McNeil Laboratories. The plaintiff's son, Michael Wayne Swayze, died three years after surgery from complications caused by an overdose of the narcotic anesthetic fentanyl, a prescription drug produced and marketed by the defendant. During the operation, a nurse anesthetist determined what dosage to administer Michael without receiving proper supervision from an anesthesiologist or the supervising surgeon. The plaintiff brought suit in Mississippi state court against the doctor, the hospital, and the anesthetist. That suit was settled by the payment of a substantial sum to the plaintiff, and she then sued the drug manufacturer by this federal diversity action, claiming product liability and negligence.
According to the testimony the practice of failing to supervise nurse anesthetists during surgery is pervasive in Mississippi, and perhaps many other states. The plaintiff argues that administering anesthetic drugs without prescription by a medical doctor, a violation of Mississippi law, was a practice well known in the anesthesia community and that the defendant should be charged with knowledge of it. The plaintiff urges, therefore, that the jury should have been allowed to determine whether the defendant was liable for distributing fentanyl without warning consumers, or doing more to compel the medical community to properly supervise distribution of its drug. The defendant denies that it had knowledge of the practice, or that it should be charged with that knowledge; and defendant insists that it had no duty to warn the general public of the dangers of a prescription drug, and that it did all the law requires it to do to warn medical practitioners of those dangers. Upon completion of the plaintiff's evidence, the district court granted the defendant's motion for a directed verdict. We affirm.
On July 13, 1978, Michael Wayne Swayze, the seven-year old son of plaintiff Dicie Ellen Hibley Swayze, sustained an accidental bullet wound to his knee. Dr. Attix removed the bullet at Methodist Hospital in Hattiesburg, Mississippi, where Michael had been transferred following an earlier unsuccessful attempt at Marion County General Hospital. During both surgical procedures Michael received, among other drugs, fentanyl, a narcotic anesthetic, marketed exclusively at this time by defendant McNeil Laboratories under the brand name Sublimaze. At Marion County Hospital, Michael received 4.5 cc's of fentanyl, and at Methodist Hospital a certified registered nurse anesthetist (CRNA), Danny Collier, administered 15 cc's of the drug. Collier testified that he alone determined the dosage of fentanyl Michael received at Methodist Hospital, even though Dr. Attix was present during the administration of the drug. The 15 cc's Collier administered Michael amounted to a severe overdose.
As a result of this overdose, Michael suffered a cardiorespiratory arrest about eight hours after surgery. He was resuscitated, and appeared to do well, until five days later when he suffered a second cardiorespiratory arrest. Although again resuscitated, Michael suffered permanent brain damage from this second arrest. Thereafter, except for several holidays, Michael was confined to a hospital bed. Approximately three years later Michael died.
Fentanyl is an extremely potent anesthetic, estimated to be a hundred times more potent than morphine on a milligram-per milligram basis. It is the most commonly used narcotic analgesic, with the derivative sufentanyl, morphine sulphate, and demerol (or meperidine) comprising the rest of the class of generally used narcotics. Beyond its palliative effect, fentanyl is associated with respiratory depression, a common side-effect of all narcotics. The duration and degree of respiratory depression is directly related to the dose administered. When determining dosage, beside the cumulative effect of the drug on the respiratory system, the age and weight of the patient also must be taken into consideration.
In pharmaceutical parlance, all drugs may be classified generally into two types, "over-the-counter" drugs and "prescription" drugs. Drugs sold over-the-counter are deemed sufficiently safe to be dispensed directly to the public accompanied only by directions for proper use, and relevant warnings printed on the packages. Prescription drugs, on the other hand, due to their potency or unusual characteristics, are dispensed only upon a doctor's order. Prescription drugs carry no warnings to the public on their labels, other than that they may not be distributed without a prescription.
Under Mississippi law, fentanyl is a prescription drug that may be prescribed, administered, and dispensed only under the direction and supervision of a licensed physician. Miss.Code Ann. Sec. 41-29-305 (1972). Under no circumstances may a CRNA prescribe fentanyl in Mississippi.
According to the evidence CRNAs routinely determine dosages during surgical procedures conducted in Mississippi, and perhaps many other states, because there are not enough anesthesiologists to supervise all of the operations being performed. Although the drug is administered in the presence and under the license of the operating physician, the plaintiff's expert testified that in "an overwhelming majority" of operations in Mississippi this procedure is not adequately supervised. The defendant's expert concurred with this conclusion.
Collier testified that he was well advised of the dangers and possible adverse consequences of fentanyl, and had talked to Dr. Attix about the drug on several previous occasions. Indeed, he testified that he had previously administered fentanyl to "thousands" of patients. In addition, he had attended workshops and had read numerous pamphlets and magazines concerning the drug. Dr. Attix, on the other hand, did not testify, but several witnesses testified that he should have been well aware of the potential dangers of the drug.
The defendant relies on essentially three avenues for the dissemination of information about the benefits and dangers of fentanyl. First, the defendant prints extensive warnings and detailed information on packet inserts enclosed in the packages containing the fentanyl. 1 In addition, similar warnings are published in the Physicians Desk Reference (PDR), 2 a "dictionary" of drugs routinely relied upon by physicians. Finally, the defendant dispatches "detail men," who are part salesman and part educator, to speak with anesthesiologists and anesthetists about fentanyl.
Although the plaintiff relies alternatively on principles of strict liability and negligence, we agree with the district court that in this case these principles merge into one inquiry: the adequacy of the defendant's warnings. Under principles of strict liability, the defendant's drug is "unreasonably dangerous" if not accompanied by adequate warnings; under negligence principles, the reasonableness of the defendant's conduct in this case also depends on the adequacy of its warning. If the warnings provided health care practitioners, through the PDR, package inserts and detail men, were adequate, then the drug was not unreasonably dangerous, and the defendant's conduct was neither unreasonable nor negligent. 3
The governing rule of strict liability as stated in section 402A of the Restatement (Second) of Torts (1965) was adopted in Mississippi in State Stove Manufacturing Co. v. Hodges, 189 So.2d 113, 118 (Miss.1966). Section 402A states that "[o]ne who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer." Fentanyl, as the parties agree, is an "unavoidably unsafe" drug. By their very nature, "unavoidably unsafe" drugs present some element of harm. However, such a drug will be deemed unreasonably dangerous per se, and its producer held liable, only if the potential harmful effects of the product outweigh the legitimate public interest in its availability. Fentanyl, when administered under proper supervision, is an indispensable weapon in the health care arsenal. Although the present case presents an instance of improper supervision, fentanyl itself is not unreasonably dangerous per se. We must then determine whether the drug presents an unreasonable danger as currently marketed.
Comment k to section 402A provides, in pertinent part:
An [unavoidably unsafe product], properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.... The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
Therefore, under Comment k, an "unavoidably unsafe"...
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