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

GOLDBERG, Before REAVLEY and Goldberg, Judge, Circuit filed dissent- GARWOOD, Judges. Circuit ing opinion. REAVLEY, Judge: Circuit Plaintiff, Mrs. Dieie Hibley Ellen Swayze, appeals from a directed verdict granted defendant, McNeil Laboratories. son, The plaintiffs Wayne Swayze, Michael years died surgery three after compli- from cations by caused an overdose of nar- cotic fentanyl, anesthetic a prescription drug produced by and marketed the de- During operation, fendant. a nurse anesthetist determined dosage what ad- minister Michael without receiving proper supervision an anesthesiologist or the supervising surgeon. plaintiff brought suit in Mississippi state court doctor, against hospital, anesthetist. suit by That was settled payment of plain- a substantial sum to the tiff, and she then sued the manufac- diversity action, turer this federal claim- ing product liability negligence. According testimony practice failing supervise nurse anesthetists during pervasive surgery Mississippi, perhaps many other plain- states. The argues tiff administering anesthetic prescription by without a medical doctor, law, of Mississippi violation was a practice well known com- anesthesia munity and defendant should be charged knowledge of it. plain- therefore, tiff urges, jury that the should have been allowed determine whether distributing defendant was liable for consumers, fentanyl without or doing compel more to the medical communi- ty properly supervise distribution its Liston, Liston, drug. William Gibson & Lancas- The defendant denies that it had ter, Winona, Miss., George Gillespie, Jr., E. knowledge practice, it should Hattiesburg, Miss., plaintiff-appellant. charged knowledge; with that de- analgesic, monly used narcotic

fendant insists that it had no to warn de- dangers of a general public sufentanyl, morphine sulphate, rivative it did all the law prescription drug, and that (or meperidine) comprising demerol the rest practition- requires it to do to warn medical generally of the class of used narcotics. dangers. Upon completion of ers of those effect, Beyond palliative its is as- evidence, district court plaintiff’s respiratory depression, sociated with granted the defendant’s motion for a di- common side-effect of all narcotics. affirm. rected verdict. We degree respiratory depres- duration and of directly sion is related to the dose adminis- determining dosage, tered. When beside Background Facts & drug the cumulative effect of the on the 13, 1978, Wayne respiratory system, age weight of July Michael and On plaintiff seven-year old son of Swayze, patient also must be taken into consid- Hibley Swayze, sustained an Dicie Ellen eration. Dr. to his knee. accidental bullet wound pharmaceutical parlance, drugs In all at Methodist Hos- Attix removed bullet may generally types, be classified into two Hattiesburg, Mississippi, where Mi-

pital in drugs “prescrip- “over-the-counter” and following an chael had been transferred drugs. Drugs tion” sold over-the-counter attempt unsuccessful at Marion earlier sufficiently are deemed safe to be dis- During County Hospital. both General pensed directly public accompanied received, surgical procedures Michael use, only by proper directions for and rele- among drugs, fentanyl, a narcotic other warnings printed packages. vant on anesthetic, exclusively at this marketed hand, Prescription drugs, on the other due un- time defendant McNeil Laboratories characteristics, potency to their or unusual At Marion der the brand name Sublimaze. dispensed only upon are a doctor’s order. County Hospital, Michael received 4.5 cc’s Prescription carry no fentanyl, Hospital Methodist of and at labels, registered public anesthetist on their other than that certified nurse (CRNA), Collier, Danny administered they may pre- not be distributed without drug. cc’s of the Collier testified that he scription. fentanyl dosage alone determined the of law, Mississippi fentanyl pre- is a Under Hospital, Methodist Michael received at prescribed, scription drug may be ad- though present during Dr. Attix was even ministered, dispensed only under the and drug. of the The 15 cc’s

the administration supervision phy- of a licensed direction and Michael amounted to a Collier administered Ann. sician. Miss.Code 41-29-305 § overdose. severe pre- Under no circumstances a CRNA overdose, Michael As a result of this Mississippi. fentanyl in scribe cardiorespiratory arrest about suffered a According to the evidence CRNAs rou- eight surgery. He was resusci- hours after tinely dosages during surgical determine well, tated, appeared to do until five procedures Mississippi, conducted in days he a second car- later when suffered states, perhaps many other because there diorespiratory Although again re- arrest. enough anesthesiologists super- suscitated, not permanent Michael suffered damage operations being performed. second arrest. from this vise all of the brain Thereafter, holidays, Mi- except for several Although is administered hospital Ap- bed. chael was confined to a oper- presence and under the license proximately years three later Michael died. plaintiff’s expert ating physician, the testi- overwhelming majority” fied that “an extremely potent anes- Fentanyl is an procedure is operations in thetic, a hundred times estimated supervised. The defend- adequately not morphine milligram- on a potent more than expert this conclusion. most com- ant’s concurred with per milligram basis. It is the testified Collier that he advised was well II dangers possible adverse conse- Principles Liability: Liability Strict quences fentanyl, and to Dr. had talked Negligence previous the drug Attix on several about Although plaintiff relies alternatively Indeed, he he occasions. testified that had principles negli- strict previously administered “thou- gence, agree with the we district court that addition, patients. sands” of he had in principles this case these merge into one workshops attended and had read numer- inquiry: adequacy of the defendant’s pamphlets magazines concerning ous warnings. principles Under of strict liabili- Attix, hand, drug. Dr. on the other did ty, the “unreasonably defendant’s testify, but several testified if dangerous” witnesses not accompanied by ade- quate warnings; under negligence princi- that he should have been well aware ples, the reasonableness of the defendant’s potential drug. depends conduct this case also on essentially The defendant relies on three adequacy its warning. of If warnings for the avenues dissemination of informa- provided care practitioners, health through tion the benefits of fen- about PDR, package men, inserts and detail First, tanyl. prints defendant exten- were adequate, drug then the un- was not warnings and sive detailed information dangerous, reasonably and the defendant’s packet packages inserts enclosed in the neg- conduct was neither unreasonable nor addition, containing fentanyl.1 sim- ligent.3 warnings published are Physi- ilar in the governing liability rule of strict (PDR),2 cians Desk a “dictio- Reference as section stated in 402A of the Restate nary” drugs routinely upon by of relied (Second) (1965) ment adopted Torts was of physicians. Finally, the defendant dis- State Stove Manufactur men,” patches “detail sales- part who are Hodges, 113,118 (Miss. ing Co. v. 189So.2d educator, part speak man and anes- with 1966). 402A Section states that who “[o]ne thesiologists anesthetists fenta- about any product in sells a defective condition nyl. dangerous unreasonably to the con- user or pages 1. These inserts consist of of two full fíne print covering medical information a wide ar- ADVERSE REACTIONS ray "warnings," of "indications” "contrain- analgesics, As with narcotic other the most passages Some dications." of the more relevant reported common serious adverse reactions state as follows: respi- (fentanyl) occur SUBLIMAZE are ACTIONS ratory apnea, rigidity, depression, muscular (fentanyl) analgesic SUBLIMAZE is a narcotic untreated, bradycardia; if these remain qualitatively with actions those of similar to arrest, respiratory circulatory depression or morphine meperidine____ As the dose of cardiac could occur. arrest increased, pulmo- narcotic nary exchange the decrease greater. Large doses becomes warnings contained in the PDR virtu- [i.e., may produce apnea stoppage of breath- ally package identical those contained in the ing]. inserts. longer acting analgesics, As with narcotic 3. As stated in Comment a to § 402A of the respiratory depressant duration of SUBLIMAZE effect (Second) (1965), applica- Restatement Torts of longer (fentanyl) may than be principles liability tion of the of strict "does analgesic effect. preclude liability upon based the alternative ground negligence negligence ... where such WARNINGS Here, negligence proved.” principles can be DEPRESSANTS, AS WITH OTHER CNS PA- applicable, fully remain but we consider WHO HAVE SUBLI- TIENTS RECEIVED plaintiffs proof along of them strict her (fentanyl) MAZE SHOULD HAVE APPROPRI- they since claim both raise the same ATE SURVEILLANCE. issue. EQUIPMENT A NAR- RESUSCITATIVE AND COTICANTAGONISTSHOULD BE READILY AVAILABLETO MANAGEAPNEA. However, sig- prepared. properly subject to liabil- thus property is or to his sumer surrounding dispute exists nificant thereby harm caused ity physical plaintiff marketing drug, in that the Fentanyl, as user or consumer.” ultimate given should have been claims “unavoidably un- agree, parties consumers, have been and more should nature, “una- drug. By very safe” physicians supervise distri- done to force ele- drugs present some voidably unsafe” proper drug. The issue bution However, will ment of harm. then, proper that of marketing subsumes se, dangerous per unreasonably deemed be plain- warning; if the defendant owed the liable, only if the producer held its and above tiff a over product effects of the potential harmful fentanyl practitioners, provided health care public interest outweigh legitimate “unreasonably danger- “defective” and Fentanyl, adminis- availability. when its ous” as marketed. supervision, is an indis- proper tered under argument, plaintiff support her To care arsenal. weapon in the health pensable negligence princi- enlists the aid of the also presents an in- present case Although the 302 of the Re- ple announced section supervision, improper stance (1965), (Second) Torts statement dangerous per unreasonably se. is not itself provides follows: determine whether We must then one negligent A act or omission danger as cur- presents an unreasonable risk of an unreasonable which involves rently marketed. (b) through the fore- harm to another ... provides, in k section 402A Comment person____ a third seeable action ... pertinent part: with the principle, From this combined proper- [unavoidably product], unsafe An 402A, k to section in Comment rule stated by proper accompanied and ly prepared, to clothe the plaintiff knits a fabric the defective, warning, is not directions and duty to warn not defendant with a dangerous____ unreasonably nor is it consumers as practitioners but products, again with The seller of such problems with the We have two well. they properly are qualification that the First, operat- it is the plaintiff’s position. marketed, proper prepared and danger than the ing procedure room rather warning given, the situation is where is chal- drug that the defendant of the it, And, not to be held to strict warning. calls for is sec- lenged to add to the consequences at- liability ond, though for unfortunate markets a reason- defendant use, accompanied ably product he has safe when tending merely because danger,4 warning of its we prudent public supply to the undertaken an addi- impose upon defendant asked to product, and desirable apparently useful hospi- intrude itself into the duty tional to apparently attended with a known but doctor-patient the operation tal as well as risk. reasonable no warrant for relationship. We see Therefore, k, an “unavoid- under Comment Mississippi law. position under product unreason- ably unsafe” becomes dangerous, subjecting its manu- ably thus Ill it liability, to whenever is facturer Duty and En- to Warn A Manufacturer’s marketed, or properly prepared, properly Warning Its force warnings. proper Both accompanied by fentanyl argument adminis- in these cases focus- agree that the The usual parties and, warning, tainted, language of the es on the not itself tered to Michael was j is to 4. Comment section 402A also relevant to warning given, may the seller rea- duty provides follows: is Where to warn sonably will be read and heed- assume that it warning. prevent to In order Directions ed; bearing warning, product such a and a being unreasonably danger- product from followed, use if it is is not is safe for ous, give di- the seller condition, unreasonably nor is it container, defective warning, on the as to its rections or dangerous. use. particular, pro consequences whether was circumstances of its dis- sufficient vided information understand tribution. See Mauldin v. While we see no material drug. of the factual issues Co., Upjohn (5th cert. Cir.), F.2d 644 here, though we conclude that the Mis- denied, 848, 104 464 U.S. S.Ct. sissippi imposes upon law drug Co., Upjohn v. Timm (1983); L.Ed.2d beyond manufacturer that discharged by denied, cert. (5th Cir.1980), F.2d 536 defendant, we fully will discuss 1112, 101 U.S. 66 L.Ed.2d 840 S.Ct. plaintiff. contention of the language warning If the of the brief, plaintiff In its eight lists adequate then the manufacturer ordi See, e.g., courses of action that the defendant narily liability. could freed from Timm, (“[P]laintiffs have taken 624 F.2d at 538 con to ensure that its was that, argument and, in oral if the correctly,

ceded distributed presumably, adequate, prop the action would more liability. plaintiff’s avoid eight sug- The erly against lie prescribing physician”). gestions may roughly be divided into three lan here, agree parties both But first, categories: providing warnings guage warnings, pack printed consumers; second, pressuring the medical PDR, age published inserts and community to heed provided contends, adequate. plaintiff however, The it; third, removing fentanyl because CRNAs administer the market.5 We consider these three al- proper supervision, and the without defend ternatives turn. fact, knew or should ant have known this it just do more warn must than health care Duty a. to Warn Consumers erred, practitioners. court district ac plaintiff places great cording plaintiff, allowing in not reliance on this Reyes Wyeth Labora- jury to determine court’s decision in the defendant’s tories, denied, cert light (5th marketing fentanyl Cir.), of all of 498 F.2d 1264 consumers, regard warning plaintiff 5. 5. McNeil its could send detail men to call suggests, bring prac- the risk of this general physicians. public tice to the McNeil could warn the attention [operating practice mailings this ring was physi- room] occur- direct McNeil could use cians, to public and increase awareness of the in hospital nurse anesthetists or increased risk inherent this unlawful journal advertising trade to focus atten- dangerous practice. danger prac- tion on the inherent in this 2. McNeil could warn the consumer of the tice. increased risk. 7. McNeil could restrict the sale of Subli- suggestions second of The these we consider at hospitals maze to which establish and en- section; length some in the next the first one we appropriate procedures force to assure support Surely find no for in or reason. law prescribed that Sublimaze is and adminis- the defendant cannot to take out compliance tered in with state law. newspaper and television advertisements alert- practice commonplace plain- If this is as as the ing Mississippians negligent practices to the argues, suggestions tiff five and six are not like- Mississippi physicians. ly help, parties the since all of listed in these Arguing pressure could the defendant of, of, guilty prac- two either know are or community properly supervising medical into suggestion requires tice. The third the defend- CRNAs, plaintiff suggests, law, interpret Mississippi although ant to it is problem bring the 3. McNeil could to the possible Conceivably, for defendant do so. a authorities, proper attention of the includ- drug manufacturer undertake could four and ing law administrative and enforcement However, liability imposed only seven. for a agencies, empowered who are to enforce reasonably, act defendant’s failure to not for compliance applicable laws with state failing to do all that be done. drugs could ethical controlled and other sub- plaintiff’s suggestion, The stances. last that if all else drug 4. McNeil down could start back the chain fails the ket, removed from should be the mar- culpability that the and insist considered in final section of this drugs steps sold in which its are take opinion. bring practices conformity into state law. dispensed “without drug to be 688 knew was 42 L.Ed.2d 95 S.Ct. 419 U.S. balancing by a drug a manufactur- an individualized (1974), we found where cases, involved”). a In such failing to warn consumers risks of the er liable receiving pre- its provide inherent in consum- dangers drug manufacturer must polio drug oral vaccine. them scription enough information to allow ers with —an re- polio after plaintiff contracted Reyes’ educated decision. to make an registered nurse ceiving from a the vaccine that, fact, in Mi- maintains plaintiff program at a during mass inoculation a a “learned physician did not act as chael’s physicians clinic where health law, required by and that intermediary” as However, exception is an Reyes present. practice part pervasive of a failure was prescription general rule that where to the was, Mississippi the defendant in which concerned, a manufacturer’s drugs are Indeed, been, have aware. or should physicians only extends to duty to warn manufacturer Reyes we held as fol- laymen. explained not to We field, in- expert in the skill of an lows: “knowledge common in cludes general prop- quarrel We cannot and administra- industry as to distribution drugs prescription that where osition products.” 498 F.2d pharmaceutical tion of concerned, the manufacturer’s are specific duty matter what at 1277. No obligation to to an is limited to warn him, plaintiff Michael’s doctor owed physician of prescribing advise general profession’s argues, the medical result potential of fenta- the distribution failure to oversee use____ expert, drug’s As a medical upon the defendant nyl it incumbent makes into physician can take prescribing warnings to consumers. provide drug, propensities account sig- ease differ present The facts in the pa- his susceptibilities well as tient____ Reyes, however. nificantly from those he makes is an The choice great that “a expert an testified Reyes, In one, individualized medical informed received their vac- majority” of vaccinees knowledge of on a judgment bottomed “assem- administrations cine mass palliative. Pharmaceu- patient and both Addi- F.2d at 1277. bly line” fashion. 498 then, must warn ul- companies who tical there expert testified that tionally, dangers inherent in purchasers of timate counter, personnel or rarely sufficient time drugs patent sold over judgment” required to selling prescription make “an individualized susceptibilities. prescribing physician, who only the needs warn of the vaccinee’s intermediary” Attix, contrast, between Dr. physician, acts as a “learned Id. and consumer. during manufacturer the administra- at all times present As Michael’s drug in this case. tion original). (emphasis 498 F.2d at of the role surgeon, Dr. Attix assumed in Timm v. has been reaffirmed This rule judge intermediary” to what 536, (5th “learned Co., 538 Cir. 624 F.2d Upjohn should receive. patient 1112, 101 treatment his denied, 1980), 449 U.S. S.Ct. cert. must be made while of decisions (1981), v. Thousands 840 and Mauldin 66 L.Ed.2d Cir.), operating (5th on the Co., patient a lies unconscious 697 F.2d 647 Upjohn table, made based denied, 78 most must be 464 U.S. S.Ct. of which cert. Indeed, exigencies of the moment. L.Ed.2d 143 on the to choose plaintiff had had Reyes, the physician not But, a is Reyes, as in when getting polio if not the risk of between for weigh the risks and benefits present to the risks of the vaccination vaccinated and consumer, prescription the the basis for the categorical determination a itself. Such disappears. also Davis drug rule tragic The error was not exist here. 121, did Laboratories, Inc., 399 F.2d Wyeth fentanyl, it was decision to receive not the (9th Cir.1968)(drug manufacturer held little dose inflicted on this drug the excessive marketing with- prescription liable for Michael’s the determination consumers, boy. it This was warning a to because out doctor, mother entrusted with the between and patient, thus formed; one but a doctor could have made it. relationship else this special receives and, protection law, time, at the same plaintiff The directs our attention to Gor- great creates a responsibility every for Works, Niagara & Tool don v. Machine case, physician. In relationship this this (5th Cir.1978), where we F.2d encompassed dosage much more than the imposition the of affirmed district court’s of anesthetic Michael would receive. Al- punch pow- on of a a manufacturer though retrospect decision, this or fail- press failing er to the actual warn decision, others, ure of dwarfed all it was Niagara, the users of machine. the manu- integral part responsibili- an of Dr. Attix’s power of press, facturer the had warned ty to Michael. He the assumed role plaintiff’s employer the intermediary,” “learned and the burdens machine, warning the had not affixed but a thereof. The facts of this case reveal or, the way, label to machine other practice in Mississippi a of physicians al- Niagara’s employees. warned The district lowing CRNAs too much discretion in a court held the manufacturer’s they role play; trained to but it past to employer extended the the users of physicians who have undertaken the machine, rely and that it could not on responsibility supervising CRNAs, intervening employer’s negligence to responsibility onto, cannot be shunted escape liability. F.2d at 1192. with, drug or shared manufacturers. However, again once we must look at the facts, for the reasonableness of the defend- Duty b. A Manufacturer’s to Enforce depends ant’s conduct on situation it Warnings Its Niagara, warning In confronted. at- plaintiff argues to also tached the machine would have alerted operating defendant should have person the machine of the done more to force dangers. physicians hospitals query relevant We must what to its heed warn ings. out, plaintiff points form a similar should this As perti take argument, plaintiff’s danger case. At oral counsel nent simply was not the adverse suggested posters drug; use or consent side-effects it unsu patients to they might forms alert pervised drug. administration But during operation observed, receive anesthesia their in as the trial court practice this unsupervised fashion. But what would every operating does not occur in room patients do this information? It Mississippi. practice appears to abe prompt might patients put would-be depends particular variable one that on the pressure physicians their better su- diligence supervising physician pervise, physicians hardly but need more hospital. the resources of Many physi In likeli- non-negligent. incentive all activities, duly supervise the cians CRNA’s hood, would lead to larger or wealthier hire anes confusion, perhaps phy- undermine perform thesiologists to function. It relationship. sician-patient impractical expect both and unrealistic to police op manufacturers individual physician-patient When the relation erating rooms determine which doctors exist, here, we ship does hesitate to adequately supervise surgical teams. encourage, require, much less man in it. Reyes, ufacturer intervene Removing Fentanyl c. from the Mar- a one-time consumer received inoculation ket polio vaccine in a mass administration. Here, brought though Finally, plaintiff suggests Michael was even the basis, not, cannot, Hospital emergency on an if the defendant or Methodist does responsibility care, change existing practice took Dr. Attix his the which fen administered, during operation tanyl both the and for some is it should remove its A special relationship, fentanyl time afterwards. from the But market. is not (1971) used, 206, (interpreting inadequate analgesic generally the narcotic 402A; only producer of warnings under Restatement nor is the defendant § here lies with problem products. such basis the trial [of evidence] “[o]n th[e] operating in certain physicians, individual jury that if it found court instructed supervis- not Mississippi, rooms in who Parke, was on notice that the Davis very potent of this ing the administration being indiscriminately, used was it. The defend- many others like drug, and try proper its use yet failed to to restrict practices the individual ant cannot control situations, company then the could be if community, it is the even of the medical negligent. charge We think found to im- decline prevailing practice, we warning is re- proper. When a Drug manufacturers duty. a pose such unchanged being face of wide- tained physicians of the adequately must warn supplier knows or ly disregarded, and prescription potential side-effects disregard, reason to know of such wide has thereafter, his physician, with drugs; jury may permitted to find warn- a needs, knowledge patient’s special insufficient.”); Parke, ing Salmon v. presiding over the burden assumes (4th Co., 1359, F.2d Cir. Davis & interests. patient’s best (“when 1975) does not a manufacturer AFFIRMED. widely dis- change a it knows regarded, jury may infer that the warn- GOLDBERG, dissenting: Judge, Circuit insufficient.”) (citing ing Incollingo). My dissent. brethren view respectfully scope duty imposed narrowly the too I. “adequate warnings” provide on McNeil to prescription drugs. inherently unsafe trial, expert Swayze introduced the At McNeil liable for law holds Settled eminent anesthesi- testimony of two proximately drugs actually and harm the Mississippi medical ologists, familiar with intermediary” inter if “learned cause 1978, testimony practices drugs that the if McNeil knows venes or anesthetic to administered the nurse who widespread practice utilized will be testimony more Swayze. This Michael dangerous activity. illegal that McNeil to establish than sufficient immunize itself from liabili McNeil cannot or known—had actual knew or should have “adequately” simply by providing writ ty knowledge widespread constructive —of practical matter will warnings that as a ten many Mississippi practice and common Rather, prophylaxis. effect only were admin- hospitals that nurses not inadequate accompanying but warn il- improperly, also istering fentanyl but unreasonably products ings are defective anesthetic, choosing deter- legally were dangerous public. See Restatement administering dosage, mining the (1965); (Second) Torts, 402A Section surgeons totally failed to drug. Attending Hodges, 189 So.2d Mfg. Co. v. State Stove supervision regarding anesthe- provide any 113, (Miss.1966), sub nom. cert. denied sia, anesthesiologists present. and no 860, 912, 87 S.Ct. Hodges, 386 U.S. Yates v. are abundant- Appendix 1. These facts (1967) (incorporating Re 17 L.Ed.2d 784 juror a reasonable ly sufficient to convince law); Mississippi 402A into statement § known, knew, have or should that McNeil & Tool Niagara Machine Gordon prescribed without would be (5th Cir. Works, F.2d 1186-95 supervision by any doctor. passive active law, intervening 1978) (under Thus, trial court’s obser- majority’s insulate a manufactur negligence does not to direct or to that doctors acted vations ulti liability for failure warn er from and that supervise nurse anesthetists it has reason to know mate users whom supervi- the level of could not know warnings); Incollingo v. receive will not cf. sion, 471; District Rec. Vol. majority 282 A.2d 444 Pa. Ewing, 444 Pa.

473 14, Opinion, directly at contradict the whether commonly Court is adminis- clear record at trial.1 tered without individualized bal- Parke, But see Stanback v. ancing____”). activity undisputed It is that such vio- Co., Davis & 642, (4th F.2d 657 647 Cir. lates law and sound medical 1981). regardless practice, training C.R.N.A.S. The nurse here and An operating nurses can room become the legal many Mississippi equivalent admin- of a flu clinic when treated as narcotic, by more importantly doctors. The majority thus istered but errs chose, prescribed, and implying monitored anes- supervised the doctors who solely performed thesia The choice of surgery supervised own. or also or agent dosage, and anesthetic and the performed Majority anesthesia. at It 468. actual administration of anesthetic were all knowledge is common that doctors and proximate medical causes of the harm. See medicine have highly specialized become Appendix 2. compartmentalized; surgeons are not

licensed anesthesiologists. McNeil’s de- II. provided men tail information to nurses be- surgeons cause played no role anesthe- clear, major The case makes law chose, sia. The nurses illegally solely concedes, ity duty that a warn consum prescribed, and administered anesthesia as physician adopts ers if no attaches the role much as if doctor never entered the room. intermediary” prescribing of “learned Denial of liability surgeon’s because of a Reyes Wyeth v. Labora the medicine. physical presence mere form exalts over tories, (5th Cir.1974), cert. 498 F.2d 1264 artificially substance and profes- defers to denied, 419 U.S. 95 S.Ct. 42 sionalism that does not exist this case. Lederle, (1974); v. Givens L.Ed.2d 688 556 (5th Cir.1977); Wyeth 1341 Davis v. F.2d III. Laboratories, Inc., (9th 399 F.2d 121 Cir.

1968). Despite majority’s reasoning, disagree I also majority’s impli with the physical presence the mere subjecting cation that ato broader operating way scope duty room not in any way infringe does would in or Givens, Reyes, distinguish Davis. doctor-patient upon intrude relationships. Majority 471; failure of a see Pharmaceutical Mfrs. fiduciary doctor to exercise his Ass’n v. supervise Admin., Food & Drug duty prevent care un 484 F.Supp. 1179,1186-88 qualified persons (D.Del.1980) (legally by training) (upholding F.D.A. prescribing fentanyl regulation con requiring pharma cannot be doctors and performing provide package warning sistent with a “learned interme cists to inserts to States, See Brazzell United diary” role. patients receiving estrogen rejecting (8th (on Cir.1986) regulation 788 F.2d re upon would intrude hearing) (doctor “physician’s right assumed the role of dis professional to exercise tributor, than intermediary, rather learned judgment”). The here facts establish that invoking duty manufacturer’s many surgeons warn ulti are in total breach of their consumer); Reyes, supervision mate regard F.2d at 1277 and care in Hilbun, (drug anesthesia. See Hall v. administered “without the sort of 466 So.2d balancing (Miss.1985) medical (Mississippi individualized standard of Anderson, contemplated care); Pharr v. risks vaccinee that prescription drug exception.”); Giv So.2d 1357, 1361 (Miss.1983) (negligent fail ens, 1345; treat). Williams v. Lederle 556 F.2d at rely ure to Because these (S.D. Laboratories, F.Supp. entirely C.R.N.A.s, upon meaningful 1984) (“The appropriate doctor-patient relationship Ohio test ... or real exists in Heads, Killer, Talking Psycho Making facts.”). Stop up seem to face Cf. (movie (“Can’t 1985) Sense or record version 474 Thus, could to do v. less. See Jackson

regard to anesthesia. 506, surgeons’ relation- infringe upon Corp., 727 F.2d not these Sales Johns-Manville the doctors ship patients, Cir.1984), (5th to because rehearing on and 515 aff'd relationship have confined the themselves (5th part, Cir. 750 F.2d 1314 reinstated surgical v. Javu- to matters. See Carlsen (en banc), 1985) questions Mis to certified 202, (8th Cir.1975) rek, 526 F.2d 206-07 (5th Court, sissippi Supreme 757 F.2d 614 (mere at presence of one of two doctors banc), Cir.1985) (en ques certificate for shrugged surgery, when doctor even dismissed, (Miss.1985) 469 99 tions So.2d deci- response his shoulders to nurse’s banc), issues, (en on 781 aff'd certified anesthesia, nurse administer sion to banc), (5th Cir.1986) (en cert. de F.2d partial interpreted approval, was insuffi- — 3339, nied, -, U.S. 106 S.Ct. in anesthe- participatory cient to create role (1986). simply L.Ed.2d 743 McNeil cannot permit negligence claim would sia which duty alterna disclaim when reasonable duty). the doctor against for breach least, very exist. tive actions At the doctor-patient meaningful Even a were to jury opportunity should have had the in- relationship exist, majority to as the pass upon the reasonableness of the manu tones, relationship intrusion on such facturer’s activities. recognized legal principle for not a valid or plaintiff has ac- suggested numerous shielding liability. doctors from On reasonably that McNeil could have tions contrary, constantly the law intrudes Thus, failure taken to avoid risks. through relations of mal- law adequate provide to or to take practice, forcing changes in medical care change any action the circumstances insuring legal provision, compliance with from which constitutes sufficient evidence duties, doctors subjecting and medical and juror a reasonable could infer that McNeil’s inadequate for relations marketing and manufacture patients. Similarly, manufacturers proximate of Michael were cause constantly alter of care medical standards doctor, injuries, Swayze’s and that through generation technolo- both of new nurse, hospital not the sole and/or gies through marketing market and cause as the trial proximate found context, mechanisms. the inter- Opinion, Rec. Vol. District Court court. responsible party of a to force com- vention Jackson, 15; (citing 727 F.2d at 523 see pliance protect law and to Burge, 2 unwitting public from the New Orleans & N.E.R. Co. v. vulnerable (Miss. supposed 1941)); do not doctors who but So.2d Buskirk Van adequate merely accept- provide Mines, Ltd., care is not 760 F.2d Carey Canadian able, absolutely necessary. but (3rd Cir.1985). nurses, doctors, hospitals,

The failure of authorities to insure a IV. meaningful doctor-patient relationship does general products liability law not and should not inure to benefit intermediary from which learned law (im- majority McNeil. The and trial court prescription requires also re- derives however, plicitly), the manufac- find that dangerous deter- unreasonably versal. The the medical pressure turer has no ways; made Mis- myriad mination can be community properly supervise C.R.N.A.S. adopted a sissippi “flexible” standard 471; District Court Majority at Rec. Vol. jury to determine “unreasonableness” however, believe, Opinion, at Anderson, Fixture Hamilton Co. v. require McNeil to morality law both (Miss.1973). products generally it J. So.2d 744 monitor ensure that general- Beasley, Inability Products manufactures and markets are Un- dangerous reasonably Dangerous Requirement fash- unreasonably in an ly used settled, moreover, that no It pressure ion. If this entails avoid some adequate if the prevent, that McNeil McNeil is can be considered deaths can warning foreseeably recognize[d] argument will not be communi of the Plain- cated, prevent the tiff that detail men and thus cannot concom were another method warning of disseminating or Judge succinctly As Wisdom itant harm. information Fentanyl, about stipulated and it Paper is that v. Prod stated Borel Fibreboard they visited with the 1076, 1091, anesthesi- & n. Corp., ucts 493 F.2d 1092 ologists However, and the anesthetists. (5th Cir.1973), denied, 419 U.S. 29 cert. surgeons it’s not fault McNeil’s that the (1974) 869, 127, 95 S.Ct. 42 L.Ed.2d 107 fulfilling are not all of obligations. their original): (emphasis in If McNeil had taken actions to ed- agree the Restatement: We a seller along ucate the anesthetists an- may be liable the ultimate consumer ethesiologists drug, having about this give adequate user for the failure to or knowledge supervision that the by sur- warnings. warning The seller’s must be geons been, was not what it should have per- reasonably calculated to reach such allegation we have an of failure to presence intermediary of an sons adequately get warning person to the party will not itself relieve the seller actually it, who needed that is [to] duty. Sterling Drug this Co. Cor- of person position who would be in the best 82; nish, Cir.1966, 8 370 F.2d Yarrow v. weigh risks, the benefits against the Drug, Cir.1969, 978; Sterling 8 408 F.2d the anesthetists. Noel, Products Defective Because of In- But here, McNeil did both in this adequate Warnings, 23 S.W.L.J. 256 opinion. They Court’s pack- made this (1969)____ product is Where a extreme- age available; they insert made it acces- dangerous, however, ly or seller man- available; sible. The P.D.R. was it was rely upon the ufacturer cannot interme- accessible. And this court does not find party warning. diate to transmit a See that this case falls within rule Prosser, Citadel, (Strict Fall of the [The v. Niag[a]ra Gordon & Tool Machine Consumer), Liability to the 50 Minn.L. Works, (5th Cir.1974), 506 419 F.2d after 791, (1966)].... Rev. 826-828 remand, (5th Cir.1978), 574 F.2d 1182 today needWe not decide whether fenta- denied, (1978), reh. 578 F.2d 871 “inherently nyl, product, “ex- unsafe” they phy- knew on all occasions that the tremely dangerous” presents an or “unrea- knowledgeable sicians were not risk, sonable” because the relevant circum- particular drug of this and knew stances reveal that McNeil’s reliance on an they exercising fully were not imaginary intermediary inadequate supervision. provide warning.2 You generalize cannot area. this context, reasoning In this the dis- Dr. Attix ... had worked with Mr. Col- court plainly trict in error. The lier years. district number Collier had Clinic; Mayo court been trained at he had ad- Williams, 389, F.Supp. implies (criticizing incorporation negligence concepts 2. 591 at regardless Hamilton, McNeil can be held liability); liable of whether into strict 285 So.2d actually constructively McNeil 747-48; knew of the Bridges Specialty at v. Chemrex Coat- cf. intervention, intermediary absence of learned if Inc., (5th ings, Cir.1983). 175 F.2d But see illegal practice. is a administration common Chrysler Corp., Walton v. Motor 229 So.2d (implicitly) (explicitly) Williams other cases (Miss. 1969), overruled, Toliver v. General warning negligent abandon the old view that (Miss.1985) (en Corp., So.2d Motors warning pose inquiry. same defective banc). generally Beasley, See J. Products Liabil- Contrary majority’s and district court’s ity Unreasonably Dangerous Require- and the assertions, 3; majority 467 n. Rec. Vol. at (1981) (“Failure ment 421-43 Ade- Provide Opinion, foreseeability con- District Court cases). (discussion quate Warnings”) citing cepts negligence may inapposite derived from be majority negligent decide should not claims, liability warning to strict because the equivalent defective are issues under underlying rationale of strict focuses otherwise; view, Mississippi law or under either conduct, product, not on in relation to the facts sufficient hold McNeil liable. Jackson, F.2d circumstances. at 512 times; warnings insufficient. But here it this thousands

ministered surgeons any serious does not matter whether the ever had never been and there from the use of received or understood the P.D.R. warn- consequences or results during surgical procedures. ings, arguably knew that because routinely supervise pre- surgeons did not Opinion, at 12- District Court Rec. Vol. surgeons supervise scription. If did not prescription, to them could First, gener- testimony established a passed patient anyone on to the or to who commonly prac- pattern and known alized warning; if could use the would surgeons, many hospitals that tice in anesthesia, warning play any not role no su- present, routinely did not only doctors any them could ever have effect. to pattern If the pervise anesthesia. Thus, incompetent prescrip- majority improperly the relies illegal and practice of known, j upon presumption the harm was foreseea- the of Comment to tion were Further, Restatement, Niagara does not stand for 402A of the ble. Section cited; only holds proposition Niagara warnings the heeded. McNeil’s would be Cf. negligence intervening (Second) Torts, 388, foreseeable Restatement of Com- § (1965) manufacturers from liabili- g (presumption proper does not shield ment of use Thus, ty. if the manner of harm were circumstances, “[sjave exceptional as foreseeable, it does not matter whether person supplied the it is where ... to whom specifically of Dr. Attix and McNeil knew it”); obviously likely is to misuse Doss v. Collier, or of “all occasions.” Mr. Co., 1317, 430 F.2d 1321 Apache Powder (5th Cir.1970) (applying Restatement Second, precisely it is because C.R.N.A.s 388). recently We have reiterated that § prescribe, regardless of qualified are not to through the to can satisfied warn be training or the level of their under- “ only ‘by proving that intermediaries [the] standing, warnings the that no to nurses intermediary capable passing of on was ... adequate. undis- can be considered It was warning warning.’ a ... was thus [The] puted any are not in at trial C.R.N.A.s solely the of whether or evaluated basis position “consequences” the to to assess consumer; the not it would reach ultimate drug. patients the from the adequacy of there was no mention of legally technically unqualified They are warnings training to or of inter- risks, [the] [the weigh against to the benefits mediary].” Aluminum Leonard v. Co. regardless they fully under- of whether of (5th Cir.1986) America, (quot- 800 F.2d 523 respiratory complication of stand the risks America, ing Aim v. Aluminum Co. Mississippi un- fentanyl. from law and the (Tex.1986)). 588 If the interme- S.W.2d currently disputed testimony medical re- diary his actions that he makes clear from agent quire that the choice of an anesthetic effectively pass not use not on will will prescription appropriate and the of an dos- warning, rely cannot the manufacturer age performed by a medical doctor. (Sec- upon him to do so. Restatement See Hence, educating nurses about the risks Torts, (1965) ond) Comment f provide remedy any § cannot failure to ade- (“Again, if the seller has reason to antic- Re- quate doctors. Cf. possibility warning ipate the (Second) Torts, statement § conveys he to an intermediate dealer will Third, given only warning to the sur- the seller is not reach ultimate user ... only present, geons, often the doctors when the user does relieved through publication Physician’s in the Desk warning.”). not receive the (P.D.R.). stipulated parties Reference only to anesthetists that sales were made V. testimony anesthesiologists, and estab- subject question likely It is also whether lished that did not see fully warning patients A could be “ade- warnings accompanying itself. may quate.” Surgery patients not be able juror could conclude that P.D.R. reasonable illegal to evaluate or to consent to an would have revert to old “the ether” or prescribing dangerous manner of ad “a whiskey.” shot of Rec. Vol. District anesthesia, ministering the majority rec Opinion, Court plaintiff sug- at 14. As the Even ognizes, majority gested, McNeil prevented could have liabili- death, that, explicitly stating pa at risk of ty by removing, selectively, from tients not consent to administra should hospitals that could not quali- ensure that tion of under these conditions fied prescribe. doctors would might adequately comprehensible. not be police would not have had evaluating Patients have means operating by room engaging in selective danger illegal pre the likelihood of withdrawal or conducting other activi- weighing against scription danger nor of suggested by plaintiff. ties Enforcing benefits; precisely why a learned compliance would have remained the task intermediary prescription hospitals, doctors, drugs. Spence, Canterbury authorities. McNeil’s task would have (D.C.Cir.1972), denied, F.2d cert. adequate been obtain assurances of com- 560, 34 409 U.S. 93 S.Ct. L.Ed.2d pliance on which reasonably rely. it could (1972)(“The average patient has little or no Moreover, competitive pressures or media arts, understanding and or resulting from selective withdrawal would dinarily only has his to whom he likely have forced to themselves enlightenment can look for with to illegal practice abandon the and to insist decision.”). intelligent Similarly, reach an anesthesiologists that were hired or that patients may unlikely be to that believe surgeons were required meaningfully to willingly subject would doctors them to supervise anesthesia. At that point, risks, foreseeably thus and would not might McNeil have its boosted market warnings. Brazzell, heed the 788 F.2d Cf. through share publicity beneficial of (listing three factors the validi responsible precedent action. The of tem- relating ty presumptions of to causation: porarily Tylenol and entirely removing (af- public without the advice cyanide) ter some lots were laced with from of helpful; public a doctor would not be example the market one of how effective policy placing favors the risks of loss on pre- withdrawal restoration be to can consumers; manufacturers not and the harm and to vent maintain or boost market publicity surrounding pro the “swine flu share. gram the impact minimized of warn ing.”); Salmon, (overpro 520 F.2d at 1363 I Finally, holding do not believe that warnings). motion nullifies effect of valid McNeil accountable for the foreseeable say But to could ade be “preposterous” harm would be even were quate requires neither absolution from lia anesthetic, fentanyl were McNeil bility, prohibition product. nor This provider fentanyl, the sole and were regulatory question, case does not raise a (to McNeil liability) avoid to re- appropriate legislature for the or adminis fentanyl move all from the market. agencies, the judicial trative but rather event, requires Restatement 402A § question of who should bear the costs of balancing social benefits and careful avoidable risks. risks, equal regard with for the successes the failures of modern medicine in the

McNeil in case to supply chose circumstances, particular to determine effort. If without further particular product’s whether the risks are preferred had not to run foreseeable Reyes, 498 F.2d at 1274. changed “reasonable.” liability, risk of McNeil could have foregone, conclusion the dis- provided the circumstances under which it drug. imply; would health compelled disagree feel trict court benefits thus elective, surgery necessary with the district court’s determination —both socially regard life expectancy to remove a useful anesthetic from and with “preposterous” quality the market is or that we of life have valuations—would weighed against empirical likelihood of harms. I thus believe that both the law respiratory and death cir- failure under the require and common sense the directed ver- cumstances. dict to be reversed and the case remanded for a new trial. found,

If McNeil could still anesthetic, provide spread a useful through pricing risk of loss its mecha- APPENDIX I comport public

nisms. This would Collier, Danny pre- the C.R.N.A. who law, equi- policy and settled tort and would Swayze, scribed for Michael testi- tably efficiently expand segment fied as follows: per- public that shoulders costs of risks, missible, regulated from those who Q. Isn’t it a fair statement that Dr. Ed- (includ- directly purchasers harmed [(the surgeon ward Attix Swayze harmed), shareholders, ing those and the operation)] usually relied upon you, the industry’s gen- insurance customers. See working him, C.R.N.A. that was Calabresi, erally G. The Costs Acci- aspects handle all par- anesthesia for a Legal Analysis dents: A and Economic ticular case? (1970); Abraham, Internalization, Cost yes. A. On most cases Insurance, Compensation and Toxic Tort Funds, 2 Va.J.Nat.Res.L. 123

Conclusion majority permit problem would Q. say Is it fair you worked with illegal prescription of anesthesia C.R. Hattiesburg most in the area solely N.A.s to rest with the individual hospital? there at the physician, pre- who “assumes the burden of A. Correct. siding patient’s over the best interests.” Q. above, Is it also a fair Majority at 472. As stated this statement to make that presides surgeons get situation where no doctor over the the other did actively patients’ majority’s interests. The incanta- questions involved with anesthesia in the phrase tion talismanic “learned inter- surgeries you in which and the other sur- mediary” transfigure reality cannot of geons worked with? tragedy. A. Yes. Moreover, merely this is not a doctor’s Q. So, basically, the other left

problem, doctors, problem; but a social questions all up you, anesthesia Dan- nurses, clearly at fault Collier, ny is that correct? enforcing state authorities are not A. Yes. compliance case, with law. In such a simply

McNeil cannot continue to sell its

product, knowingly provide an ineffective warning, public and let the confront sub- Q. your years In you seven while were stantial, illegal, potentially unreason- practicing your trade of C.R.N.A. in Hat- able risks. tiesburg, you do ever a recollection of have others, drug companies Like must bear having pulled package insert such as compensating the burden of the avoidable fentanyl warning] Exhibit A from the [the caused; others, they harms that have like ampules directly box anesthetic mailed [of drug companies praised still will for the Collier, surgeons, nurse not to they convey. social benefits that We must bring nurse Collier operat- would into the always permit questions two to be asked ing hospital room from the pharmacy at his meaningfully analyzed: Whether the discussing own it with a sur- initiative] harms, benefits fact exceed the geon? Here, whether the harms can be avoided. reasonably my could have avoided the A. Not to recollection.

APPENDIX I—Continued A. No. Q. Did Dr. Attix you know what were Q. kept you understand box with [the administering and in what increments and warning] in the drawer cart so it you amounts administering during theater, operating was available in the but surgical procedure? surgeon would the as a matter of course A. my Not to knowledge. ever come across A Exhibit in a standard operation? Q. words, you other didn’t call it out to him, Doctor, fixing X, I’m Y, to do Z? A. my knowledge. Not to

A. That’s correct.

Q. Now, following surgery or close to surgery, the end of Q. you perform Did you administered to induction on Mi- Swayze Michael 1 cc. of Narcan Swayze? chael anta- [an gonist to combat respiratory Yes, A. I did. depression], is that correct? Q. you When and how did do that? A. Correct. A. When Dr. Attix inwas the theater and Q. And that’s all of the Narcan that Mr. ready go, was he told me he ready Swayze received that day? to start. That’s performed when I induction. A. As far as I know.

Q. you How did do the Q. induction? Whose decision was it to administer 1 cc. of Narcan? IA. did a crash induction. A. It my decision.

Q. Who made the determination to utilize Q. a crash induction? you Did exercise judgment Michael Swayze needed cc. of Nar- A. I did. can? Q. Did Dr. Attix make that decision? A. Yes. A. No. Q. Did Dr. Attix any have discussion with Q. you Did and Dr. Attix have discus- you about that administration of 1 cc. of sion of making Sublimaze before that in- Narcan? duction? A. No. A. No. Q. you Did ever inform Dr. Attix either you

before or after administered that cc. of Narcan you as what did? Now, Q. did you Dr. Attix instruct when A. No. [incrementally] administer another cc. of Sublimaze? Q. your knowledge, To did Dr. Attix know that the man any ever received Narcan A. No. during surgical procedure and immedi- Q. entirely in your judgment Was it when ately thereafter? you administer and if needed to adminis- A. I Not that know of. ter cc. another of Sublimaze? A. Yes. Q. Is that true for the entire 15 cc. of Q. interchange you between and Dr. you

Sublimaze that administered? prior Attix surgery, during surgery, and A. Yes. immediately surgery after the of Michael Swayze, interchange was it similar to the Q. Did Dr. Attix have discussion with you between and Dr. Attix and other sur- you during surgical procedure about geons during surgery in surgeries? other your anesthesia or you method used or the amount? A. Yes.

APPENDIX I—Continued

Q. And young man, Danny Collier, had, had if I remember Q. your knowledge, correctly, But ten or [Dr. Attix] years eleven experience when, at using, day-to-day you didn’t know what were practicing (sic) anesthesiology ], so I using particu- don’t you [ much were at that how think we could find fault with experi- his time, is lar that correct? ence, could we? my knowledge. A. Not to A. I haven’t cases, reviewed his but in Q. Is that last statement that I made and generic terms, no. you affirmatively most answered true of surgeries you performed at Methodist So, you that lets come to Q. what think that’s Hospital, physician Danny just would not ac- had that that Collier your conlusion understanding product that tively you by direct verbal comments lack of utilizing; that correct? you and that the unfa- he was would be during performing he miliar the time Yes, understanding of the lack of A. surgery you using, of what were when consequences. it, you using and how much? Is that were true? Well, surgeon

A. has confidence in me says, law but is Q. I understand what anesthesia; surgeon to do the and the at surgeons in fact, Doctor, generally that it a particular including that time has his hands full with these Mississippi, and operation. trade without practice To take time out to discuss their CRNA’s where (sic), anestheologist particulars away him of an supervision would take generally were unfamiliar surgery, these his what he is there for. agents, propensities with anesthesia Q. My generally statement is true? effects, to Dr. Attix’s side similar and their A. Yes. you testified to—is unfamiliarity that fair statement? Q. say large Is it fair to that a number hospitals Mississippi approximate A. That’s a fair statement. Hospital size of Methodist utilized C.R.N. Q. So, my question actually is: Who was in the

A.’s same manner that Methodist exercising independant judg- Hospital your utilized services for the sev- ment in these communities where CRNA’s years you en there? were practicing were their trade without the su- my knowledge, yes. A. To pervision anesthesiologist of an if the sur- 95, 97-100, 106-10, Rec. Vol. 113-14. geons generally unfamiliar with the similarly Dr. James Arens testified as to agents, propensities and the side ef- pattern practice: fects? A. No one. Q. particular hospitals And these about, talking we’ve been there were practicing

CRNA’s there that were their (sic) anesthesiology day-to- trade of on a [ ] Q. saying pretty So what I am is: It was day supervision basis without the of an knowledge common in the anesthesia com- anesthesiologist? munity there certain were practicing that CRNA’s were trade A. Yes. supervision the without and [in] Q. your depositions From in review of basically were unfamiliar with the anesthe- described, you’ve this case that that’s basi- agents, propensities sia and the side cally happended what in the Michael and, effects; therefore, nobody really was Swayze surgery? exercising independant judgment medical patient regard A. That’s correct. for the with to anesthesia? supervision direction physician APPENDIX of a I—Continued limit, all, if at a nurse in anesthetist his or A. That’s correct. independent, one, her number selection of Q. pretty And was knowl- common agent, the anesthesia the dosage to be ad- community? edge in anesthesia ministered, and the administration itself of I A. It for that reason that had the drug? University surgery residents from the A. This can probably only be by answered anesthesia, through Mississippi rotate be- saying that there is a dichotomy care, agree it, I I think cause don’t it’s practice because there is propriety: wrong. currently But it is no different in Practice being way that it commonly Mississippi than it is in other state in done; propriety being way that it is the union in 1985. And this is one of the legally constituted and ethically constituted problems have in at we which CRNA’s drugs. administer these time, present in as matter of a fact prac- are—in some states have a license to Q. Doctor, Under propriety, medical how unsupervised. tice anesthesia would that limit nurse anesthetist Record, 146, 150, Vol. 152-54. Final- category? You mentioned the dichoto- ly, as Roy Dr. Wilson testified follows: my of the situation? Q. Doctor, you you familiar and are A. nurse, This would limit the because the commonly recognized now familiar nurse has no nor license is able obtain Mississippi medical standards license to administer narcotics. qualifications per- that a and ’78 as to prescribe possess son must order to and Q. practice Were these standards of administer a narcotic anesthesia discussed, just recog- we’ve known and fentanyl? nized in the community medical in Missis- Yes, A. sir. sippi among manufacturers and sellers [prescription] drugs ethical in that state Q. What were those standards? in 1977 and ’78? person physician, A. A must be a licensed knowledge, my yes. A. To the best veterinarian, dentist, por- or in the case of (sic) drugs of tions of the a veterinarian [ ]

in order or to to administer these drugs. dispense the Q. you’ve Can the dis- instances which being per- cussed where anesthesia was Q. recognized commonly Under these by formed nurse anesthetists referring that we’re standards talking period in this time that we’re about here, possess did nurse anesthetists supervision of an anesthesi- without professional prescribe qualifications to ologist, who, anyone, supplied actually if fentanyl? administer the, quote, physician supervi- direction and administer, prescribe. A. To but not to sion, requirement quote, end of the stan- Q. right, All sir. Under the standards you previously dard which mentioned? about, Doctor, talking that we’re what does InA. the circumstances where there was term, quote, the direction under supervision any type, oper- it quote, supervision, end ating surgeon. mean? Q. In actuality, as a matter of routine drug, A. that the This means whatever practice, these those who made decisions individual, anesthetizing if it method of situations? being agent, were an inhalation adminis- circumstances, anes- A. most the nurse essentially physi- of a tered the license decision. thetist made this cian. in

Q. Q. commonly right, require- All sir. Was that fact known How does community Mississippi just about medical ment that talked under we’ve prescription and under ’78? and administration of additional doses of the fentanyl APPENDIX to the I—Continued A. child were done with no documentation It was. necessity part on the Q. generally, a matter of Who and as nurse anesthetist. situations, practice in selected routine these dosage drugs and determined Rec. Vol. at 282. administered? circumstances, the nurse

A. Under most

anesthetist.

Q. part, prac- as matter of routine What Wilson,

tice, know, you oper- Dr. did the if

ating surgeon assisting physi- room or his play selecting particu- generally

cian used in

lar anesthesia to be dosage to be administered

case and/or patient?

to the Unfortunately, very little. GARRETT, A. Petitioner-Appellant, Curtis Q. To what extent —what was the extent knowledge within the medical com- McCOTTER, Director, O.L. Texas munity Mississippi within and the Corrections, Department of community 1978 that this Respondent-Appellee. practice just which we’ve discussed was prevalent being done? No. 86-1233.

A. It was absolute. Appeals, United States Court

Fifth Circuit. Q. you opinion you have an can [D]o Jan. state, probabili- on based reasonble 20,1987. Feb. Rehearing Denied ty, as to whether or not a nurse anesthetist Collier, general or Mr. the nurse anes- 13th, July thetist in Michael’s on case had expertise drug,

the medical to select the dosage

determine its it to administer

without the of an anesthesi- intervention

ologist he read from Plain- based what warning]?

tiff's Exhibit 8 [the

A. Mr. Collier has no medical license or so, therefore,

qualifications, an- be, no,

swer on that basis alone would he

did not have.

Rec. at 268-72. Yol.

APPENDIX II

Dr. Wilson also testified: the selection of the anesthetic feel that type

fentanyl for a child with this

surgery totally inappropriate at the selected; second,

time it was the amount given the child ex-

of anesthesia

tremely large point being dan- itself; third,

gerous in the administration

Case Details

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

Court Name: Court of Appeals for the Fifth Circuit

Date Published: Feb 6, 1987

Citation: 807 F.2d 464

Docket Number: 85-4894

Court Abbreviation: 5th Cir.