Dicie Ellen Hibley Swayze, Legal Guardian and Next Friend of Michael Wayne Swayze v. McNeil Laboratories, Inc.

807 F.2d 464

• Court: Court of Appeals for the Fifth Circuit
• Decided: February 6, 1987
• Docket: 85-4894
• Status: Published

Opinions

REAVLEY, Circuit Judge:

Plaintiff, Mrs. Dieie Ellen Hibley Swayze, appeals from a directed verdict granted to defendant, McNeil Laboratories. The plaintiffs 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.

I

Facts & Background

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 car-diorespiratory 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. § 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 fen-tanyl. 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 fenta-nyl.

II

Principles of Liability: Strict Liability and Negligence

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” product becomes unreasonably dangerous, thus subjecting its manufacturer to liability, whenever it is not properly prepared, properly marketed, or accompanied by proper warnings. Both parties agree that the fentanyl administered to Michael was not itself tainted, and thus was properly prepared. However, significant dispute exists surrounding the marketing of the drug, in that the plaintiff claims a warning should have been given to consumers, and more should have been done to force physicians to supervise distribution of the drug. The issue of proper marketing then, subsumes that of proper warning; if the defendant owed the plaintiff a duty over and above the warnings provided health care practitioners, fentanyl was “defective” and “unreasonably dangerous” as marketed.

To support her argument, the plaintiff also enlists the aid of the negligence principle announced in section 302 of the Restatement (Second) of Torts (1965), which provides as follows:

A negligent act or omission may be one which involves an unreasonable risk of harm to another through ... (b) the foreseeable action of ... a third person____

From this principle, combined with the rule stated in Comment k to section 402A, the plaintiff knits a fabric to clothe the defendant with a duty to warn not only medical practitioners but consumers as well. We have two problems with the plaintiff’s position. First, it is the operating room procedure rather than the danger of the drug that the defendant is challenged to add to the warning. And, second, though defendant markets a reasonably safe product when accompanied by a prudent warning of its danger,⁴ we are asked to impose upon defendant an additional duty to intrude itself into the hospital operation as well as the doctor-patient relationship. We see no warrant for that position under Mississippi law.

Ill

A Manufacturer’s Duty to Warn and Enforce Its Warning

The usual argument in these cases focuses on the language of the warning, and, in particular, whether the physician was provided sufficient information to understand the dangers of the drug. See Mauldin v. Upjohn Co., 697 F.2d 644 (5th Cir.), cert. denied, 464 U.S. 848, 104 S.Ct. 155, 78 L.Ed.2d 143 (1983); Timm v. Upjohn Co., 624 F.2d 536 (5th Cir.1980), cert. denied, 449 U.S. 1112, 101 S.Ct. 921, 66 L.Ed.2d 840 (1981). If the language of the warning is adequate then the drug manufacturer ordinarily is freed from liability. See, e.g., Timm, 624 F.2d at 538 (“[P]laintiffs conceded in oral argument that, if the warning was adequate, the action would more properly lie against the prescribing physician”). But here, both parties agree that the language of the warnings, printed in the package inserts and published in the PDR, was adequate. The plaintiff contends, however, that because CRNAs administer fentanyl without proper supervision, and the defendant knew or should have known this fact, it must do more than just warn health care practitioners. The district court erred, according to the plaintiff, in not allowing the jury to determine the defendant’s liability for marketing fentanyl in light of all of the circumstances and consequences of its distribution.

While we see no material factual issues here, and though we conclude that the Mississippi law imposes no duty upon a drug manufacturer beyond that discharged by the defendant, we will discuss fully the contention of the plaintiff.

In its brief, the plaintiff lists eight courses of action that the defendant could have taken to ensure that its drug was distributed correctly, and, presumably, avoid liability. The plaintiff’s eight suggestions may roughly be divided into three categories: first, providing warnings to consumers; second, pressuring the medical community to heed the warnings provided to it; and third, removing fentanyl from the market.⁵ We consider these three alternatives in turn.

a. Duty to Warn Consumers

The plaintiff places great reliance on this court’s decision in Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.), cert denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974), where we found a drug manufacturer liable for failing to warn consumers of the dangers inherent in receiving its prescription drug — an oral polio vaccine. The Reyes’ plaintiff contracted polio after receiving the vaccine from a registered nurse during a mass inoculation program at a health clinic where no physicians were present. However, Reyes is an exception to the general rule that where prescription drugs are concerned, a manufacturer’s duty to warn only extends to physicians and not to laymen. We explained as follows:

We cannot quarrel with the general proposition that where prescription drugs are concerned, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use____ As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his pa-tient____ The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.

498 F.2d at 1276 (emphasis in original). This rule has been reaffirmed in Timm v. Upjohn Co., 624 F.2d 536, 538 (5th Cir. 1980), cert. denied, 449 U.S. 1112, 101 S.Ct. 921, 66 L.Ed.2d 840 (1981), and Mauldin v. Upjohn Co., 697 F.2d 644, 647 (5th Cir.), cert. denied, 464 U.S. 848, 104 S.Ct. 155, 78 L.Ed.2d 143 (1983).

But, as in Reyes, when a physician is not present to weigh the risks and benefits for the consumer, the basis for the prescription drug rule disappears. See also Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 131 (9th Cir.1968) (drug manufacturer held liable for marketing prescription drug without a warning to consumers, because it knew drug was to be dispensed “without an individualized balancing by a physician of the risks involved”). In such cases, a drug manufacturer must provide consumers with enough information to allow them to make an educated decision.

The plaintiff maintains that, in fact, Michael’s physician did not act as a “learned intermediary” as required by law, and that this failure was part of a pervasive practice in Mississippi of which the defendant was, or should have been, aware. Indeed, in Reyes we held a drug manufacturer to the skill of an expert in the field, which includes “knowledge common in the drug industry as to distribution and administration of pharmaceutical products.” 498 F.2d at 1277. No matter what specific duty Michael’s doctor owed him, the plaintiff argues, the medical profession’s general failure to oversee the distribution of fenta-nyl makes it incumbent upon the defendant to provide warnings to consumers.

The facts in the present ease differ significantly from those in Reyes, however. In Reyes, an expert testified that “a great majority” of vaccinees received their vaccine in mass administrations and in “assembly line” fashion. 498 F.2d at 1277. Additionally, the expert testified that there rarely was sufficient time or personnel to make “an individualized medical judgment” of the vaccinee’s needs or susceptibilities. Id. In contrast, a physician, Dr. Attix, was present at all times during the administration of the drug in this case. As Michael’s surgeon, Dr. Attix assumed the role of “learned intermediary” to judge what treatment his patient should receive. Thousands of decisions must be made while a patient lies unconscious on the operating table, most of which must be made based on the exigencies of the moment. Indeed, in Reyes, the plaintiff had had to choose between the risk of getting polio if not vaccinated and the risks of the vaccination itself. Such a categorical determination did not exist here. The tragic error was not the decision to receive fentanyl, it was the excessive dose inflicted on this little boy. This was the determination Michael’s mother entrusted with the doctor, and no one else but a doctor could have made it.

The plaintiff directs our attention to Gordon v. Niagara Machine & Tool Works, 574 F.2d 1182 (5th Cir.1978), where we affirmed the district court’s imposition of liability on a manufacturer of a punch power press for failing to warn the actual users of the machine. Niagara, the manufacturer of the power press, had warned the plaintiff’s employer of the dangers of the machine, but had not affixed a warning label to the machine or, in any other way, warned Niagara’s employees. The district court held that the manufacturer’s duty extended past the employer to the users of the machine, and that it could not rely on the employer’s intervening negligence to escape from liability. 574 F.2d at 1192.

However, once again we must look at the facts, for the reasonableness of the defendant’s conduct depends on the situation it confronted. In Niagara, a warning attached to the machine would have alerted the person operating the machine of the relevant dangers. We must query what form a similar warning should take in this case. At oral argument, plaintiff’s counsel suggested the use of posters or consent forms to alert patients that they might receive anesthesia during their operation in an unsupervised fashion. But what would patients do with this information? It might prompt would-be patients to put pressure on their physicians to better supervise, but physicians hardly need more incentive to be non-negligent. In all likelihood, such warnings would only lead to confusion, and perhaps undermine the physician-patient relationship.

When the physician-patient relationship does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it. In Reyes, the consumer received a one-time inoculation of polio vaccine in a mass administration. Here, even though Michael was brought to Methodist Hospital on an emergency basis, Dr. Attix took responsibility for his care, both during the operation and for some time afterwards. A special relationship, between physician and patient, thus formed; this relationship receives special protection in law, and, at the same time, creates a great responsibility for every physician. In this case, this relationship encompassed much more than the dosage of anesthetic Michael would receive. Although in retrospect this decision, or failure of decision, dwarfed all others, it was an integral part of Dr. Attix’s responsibility to Michael. He assumed the role of “learned intermediary,” and the burdens thereof. The facts of this case may reveal a practice in Mississippi of physicians allowing CRNAs too much discretion in a role they are not trained to play; but it is the physicians who have undertaken the responsibility of supervising CRNAs, and that responsibility cannot be shunted onto, or shared with, drug manufacturers.

b. A Manufacturer’s Duty to Enforce Its Warnings

The plaintiff also argues that the defendant should have done more to force physicians and hospitals to heed its warnings. As the plaintiff points out, the pertinent danger was not simply the adverse side-effects of the drug; it was the unsupervised administration of the drug. But as the trial court observed, this practice does not occur in every operating room in Mississippi. The practice appears to be a variable one that depends on the particular diligence of the supervising physician and the resources of the hospital. Many physicians duly supervise the CRNA’s activities, and larger or wealthier hospitals hire anesthesiologists to perform this function. It is both impractical and unrealistic to expect drug manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams.

c. Removing Fentanyl from the Market

Finally, the plaintiff suggests that if the defendant does not, or cannot, change the existing practice by which fentanyl is administered, it should remove its drug from the market. But fentanyl is not the only narcotic analgesic generally used, nor is the defendant the only producer of such products. The problem here lies with individual physicians, in certain operating rooms in Mississippi, who are not supervising the administration of this very potent drug, and many others like it. The defendant cannot control the individual practices of the medical community, even if it is the prevailing practice, and we decline to impose such a duty. Drug manufacturers must adequately warn physicians of the potential side-effects of their prescription drugs; thereafter, the physician, with his special knowledge of the patient’s needs, assumes the burden of presiding over the patient’s best interests.

AFFIRMED.

1 . These inserts consist of two full pages of fíne print medical information covering a wide array of "warnings," "indications” and "contraindications." Some of the more relevant passages state as follows:

ACTIONS

SUBLIMAZE (fentanyl) is a narcotic analgesic with actions qualitatively similar to those of morphine and meperidine____ As the dose of narcotic is increased, the decrease in pulmonary exchange becomes greater. Large doses may produce apnea [i.e., stoppage of breathing].

As with longer acting narcotic analgesics, the duration of the respiratory depressant effect of SUBLIMAZE (fentanyl) may be longer than the analgesic effect.

WARNINGS

AS WITH OTHER CNS DEPRESSANTS, PATIENTS WHO HAVE RECEIVED SUBLI-MAZE (fentanyl) SHOULD HAVE APPROPRIATE SURVEILLANCE.

RESUSCITATIVE EQUIPMENT AND A NARCOTIC ANTAGONIST SHOULD BE READILY AVAILABLE TO MANAGE APNEA.

ADVERSE REACTIONS As with other narcotic analgesics, the most common serious adverse reactions reported to occur with SUBLIMAZE (fentanyl) are respiratory depression, apnea, muscular rigidity, and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur.

2 . The warnings contained in the PDR are virtually identical to those contained in the package inserts.

3 . As stated in Comment a to § 402A of the Restatement (Second) of Torts (1965), application of the principles of strict liability "does not preclude liability based upon the alternative ground of negligence ... where such negligence can be proved.” Here, negligence principles remain fully applicable, but we consider the plaintiffs proof of them along with her strict liability claim since they both raise the same issue.

4 . Comment j to section 402A also is relevant to the duty to warn and provides as follows:

Directions or warning. In order to prevent the product from being unreasonably dangerous, the seller may be required to give directions or warning, on the container, as to its use.

Where warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.

5 . In regard to warning consumers, the plaintiff suggests,

1. McNeil could warn the general public that this [operating room] practice was occurring and increase public awareness of the increased risk inherent in this unlawful and dangerous practice.

2. McNeil could warn the consumer of the increased risk.

The second of these suggestions we consider at some length in the next section; the first one we find no support for in law or reason. Surely the defendant cannot be required to take out newspaper and television advertisements alerting Mississippians to the negligent practices of Mississippi physicians.

Arguing that the defendant could pressure the medical community into properly supervising CRNAs, the plaintiff suggests,

3. McNeil could bring the problem to the attention of the proper authorities, including administrative and law enforcement agencies, who are empowered to enforce compliance with state laws applicable to ethical drugs and other controlled substances.

4. McNeil could start back down the chain of culpability and insist that the hospitals in which its drugs are sold take steps to bring their practices into conformity with state law.

5. McNeil could send its detail men to call on surgeons to bring the risk of this practice to the attention of the physicians.

6. McNeil could use direct mailings to physicians, nurse anesthetists and hospital or trade journal advertising to focus attention on the danger inherent in this practice.

7. McNeil could restrict the sale of Subli-maze to hospitals which establish and enforce appropriate procedures to assure that Sublimaze is prescribed and administered in compliance with state law.

If this practice is as commonplace as the plaintiff argues, suggestions five and six are not likely to help, since all of the parties listed in these two either know of, or are guilty of, the practice. The third suggestion requires the defendant to interpret Mississippi law, although it is possible for defendant to do so. Conceivably, a drug manufacturer could undertake four and seven. However, liability is imposed only for a defendant’s failure to act reasonably, not for failing to do all that could be done.

The plaintiff’s last suggestion, that if all else fails the drug should be removed from the market, is considered in the final section of this opinion.