Smith v. E R Squibb & Sons, Inc

Squibb E Smith v R & Sons 79 1979] SONS, SQUIBB E SMITH v R & INC 11, (Calendar 5). Argued April No. Docket 58894. 1978 No. Decided 10, January 1979. Smith, Jr., Smith, Shirley Eddie administrator of the of estate deceased, brought wrongful against an for action death E. R. Sons, Inc., Squibb Joseph Hospital, Mercy Anthony & St. E. Kozlinski, M.D., and other doctors. The decedent’s death (a by hypersensitive Renografin-60 caused an acute reaction Squibb product) injected which was into her blood stream as a X-ray for contrast medium an al- examination. The leged give adequate that defendant had failed to warn- ings profession dangers of medical precautions using to take in it. This failure was said to consti- implied warranty negligence. tute both a breach The Court, Wayne Kaufman, J., Circuit J. Nathan refused the plaintiffs request charge breach implied warranty. The trial court also excluded evidence of subsequent Squibb. remedial measures taken defendant The gave a directed verdict for defendant Kozlinski which was ^{[12] [10] [9] [11] [7]} [2, ^{[4] [5] [6]} [10, ^{[3] [13] [1]} Products 63 Am Jur Liability 8] 63 Am Jur 63 Am Jur 63 Am Jur 63 Am Jur 63 Am Jur 25 Am Jur ALR2d medicine sold. 79 ALR2d 301. 63 Am Jur 63 Am Jur 25 Am Jur 63 Am Jur 11, Am63 Am Jur liability: Manufacturer’s 9. Jur 2d, 2d, 2d, 2d, 2d, 2d, 2d, 2d, Drugs, Narcotics, manufacturer or 2d, 2d, 2d, 2d, References affecting 2d, Products Products Products Products Products Products Products Products Products Drugs, Products strict Products his Narcotics, Liability Liability Liability Liability Liability Liability Liability or seller’s for Points in Headnotes Liability Liability Liability Liability seller in tort. 13 ALR3d 1049. § 3.§ § § §§ §§ § and Poisons 54. §§ 53. § § 111. 114. 131. duty 98.§ 46, 26, 27, 57. for Poisons 53, 79. injury product-caused injury. 54. 42. give warning §§ §§ caused 49, 50. regarding 405 Mich appealed, other of action for the and a verdict of no cause defendants, Following with the other defendants. a settlement Squibb. Appeals, plaintiff appealed only Court of as to JJ., White, Bashara, P.J., W. S. affirmed D. Walsh and and F. 19119). (Docket judgment. appeals Leave to the No. Plaintiff jury instructions and the appeal issues of the is limited to the question. Held: evidence implied warranty Negligence theories. are distinct product However, the issue is whether the when factual defective, provided the manufacturer has but whether itself warnings, adequate identical facts and the two theories involve elements, proof exactly require of the because the focus same theory warnings regardless adequacy the of of the of on the warning adequacy liability. determining of under the The test theory reasonable exercised either is whether the defendant Therefore, the trial court did not care under the circumstances. refusing jury to instruct the commit reversible error Indeed, warranty. giving the re- of of breach repetitive quested have been and could have instruction would impression plaintiff giving jury by the could that the misled the Squibb implied warranty if were the even defendant recover on negligent. judge properly evidence that defendant 2. The trial excluded Squibb subsequently changed warnings physicians about its subsequent excluding Renografin-60. policy evidence of The of encourage improvement products, of measures is to remedial prejudicing any property, of services and customs without risk consequently delaying implementation proceeding court sought improvements. plaintiff the evidence admit- The have argument warnings were inade- ted to buttress his that the quate. against allowing policy estab- such evidence is well the new rules of evidence lished in case law and is continued in applicable requested trial were if the new which would be granted, point meaningless would be as so that reversal this improper. well as Affirmed. implied warranty Justice Levin dissented. A manufacturer’s produce higher quality require product may it than that care; product

would the of reasonable the result from exercise reasonably purpose hold intended. He would must be fit higher quality, for the fitness reasonable applies adequacy purpose, accom- intended to the adequacy panying product structure or well of the as design product itself. adequacy jury 1. In this was instructed to decide case E R Squibb Smith & v Sons warnings by an assessment of the reasonableness of conduct, Squibb’s negligence standard, defendant and was given no instruction consider the reasonableness of the warning itself. The was thus instructed unless blameworthy concluded that was adequate. product may In a case find for the deciding without that the manufacturer was to blame inquiry solely or at fault. The is not whether the manufacturer might all has done that a reasonable manufacturer have done but, rather, reasonably focuses on whether the fit for purpose may dangers Where intended. there be inherent in duty use of the and therefore to warn of known danger, inquiry is not whether the manufacturer acted reasonably warnings actually given but whether the are rea- adequate. sonably Warnings, design like structure of a product, up higher quality must measure standard of implicit requirement in the that the fit purpose. for the intended solely 2. The standard looks to the defendant’s acted, judge conduct and seeks to determine he whether as the charged case, jury conformity the in this in to what the law expects implied warranty looks, rather, of him. The to product question product the a asks different the —whether up may reasonably to measures the standard which a user expect policy of it. The of is to the law enforce the consumer’s expectations though doing product reasonable even so might required product mean that is of more the than reasona- produce. drug ble conduct the manufacturer would A manu- subject anaphylactic facturer is to for reaction or reasonably expected for risks it does not know and cannot be to is, however, subject know. It to if the means of notifica- notify jury actually tion of known risks does not and the adequate concludes that more means of notification can reason- expected. ably be prescription drug may unavoidably 3. A be unsafe even intended, though way impurities, it is made the in contains no planned. product accompa- and is the in condition If such a is adequate warning, nied it is not defective and is not unrea- sonably dangerous. However, accompanied by when not adequate defective, warning, product may the and thus unreasonably dangerous. dangerous The defect is not in the propensities drug, or side of effects but the failure to warn. Although jury 4. concluded that had acted reason- might ably, drug that the nevertheless have concluded warnings fit its more intended use without 405 Mich 79 given. in- complete have been than were should product was not reason- it could conclude that structed ably of the life-threat- fit for its intended use unless a delayed anaphylactic ening and of the treat- reaction risk employed such reaction was attached ment to be in event of physi- to to the vial or in some other manner communicated drug. administering cians (1976) App 375; affirmed. 69 Mich 245 NW2d op the Court Duty Liability — — Drugs — to Warn Products and Narcotics Negligence. drug legal duty prescription a a to warn has manufacturer any profession in risks inherent the use the medical exist; or should know to which the manufacturer knows warnings negligence must be exam- of a claim context under circumstances. ined as to their reasonableness Liability Implied Warranty. — 2. Products warranty product implied is established when Breach of an product plaintiff proves attributable to the defect relationship plaintiff’s inju- has a causal manufacturer ries. Implied Liability Warning — — Inadequate 3. Products War- ranty. Inadequate may defect alone constitute implied plaintiff’s warranty theory or strict whether the liability in tort. Implied Liability Warning — — Inadequate 4. Products War- ranty Negligence. — of an of a is liable because Whether a manufacturer inadequate warning the use of the of the risks inherent care whether the turns the standard of reasonable therefore, warranty; plaintiff’s theory on a it is not reversible error refuse instruct implied warranty the case of breach of and to submit solely negligence issue is the on a of where the factual warnings given. adequacy of Liability Drugs — — — 5. Products Narcotics Evidence Warning — Inadequate Subsequent Measures. changes warnings by drug subsequent issued Evidence of in the product of is of risks in the use its manufacturer inherent E Smith v R & Sons prove given previously admissible that (MRE 407). inadequate were Dissenting Levin, J. Liability Implied — Warranty. Products implied warranty may require produce A manufacturer’s that it product higher quality of than would result from the exercise care; product reasonably of reasonable must be ñt for the purpose intended. Liability Implied — Warning —

7. Products Inadequate War- ranty. quality implied warranty, The standard of of a manufacturer’s purpose, applied reasonable ñtness the intended should be adequacy warnings danger accompanying to the of of a known product adequacy as well as to the or structure design product itself. Liability Implied Warranty. — 8. Products product jury may In a case a find for the deciding without was to mnaufacturer blame at fault; solely inquiry is not whether the manufacturer has but, might done all reasonable manufacturer have done rather, focuses on whether the ñt for the purpose intended. Liability Implied — Warranty Negligence. — 9. Products solely standard looks to the defendant’s conduct conformity seeks to determine whether he acted with expects him; implied warranty what the law standard looks, rather, and asks whether the up may reasonably measures to the standard which a user it, expect though might require even this more produce. the manufacturer than reasonable conduct would Liability — Drugs — Inadequate 10. Products and Narcotics Warning. subject A manufacturer if the means actually notify notiñcation of known risks does and the adequate concludes that more means of notiñcation can reason- ably expected. be Liability Drugs— — Inadequate 11. Products and Narcotics Warning. prescription drug may unavoidably though unsafe even way intended, impurities, made in the contains no and is in Mich op the Court adequate accompanied planned; drug an the condition if risks, warning and is so the it is defective known subject unreasonably manufacturer to dangerous as to liability product. for its Implied Liability Drugs — — War- 12. Narcotics Products Warning. ranty — Inadequate drug unavoidably defective prescription unsafe is which warning; accompanied by adequate defect is an when not drug, dangerous propensities side but or effects not in the to warn. in failure Liability Drugs — — Inadequate and Narcotics Products Warning. in action for should have been instructed prescription drug was not it could conclude that the life- for intended use unless a ñt its drug delayed anaphylactic threatening reaction to the risk of employed of such to be in event and of the treatment containing drug vial in was attached reaction administering physicians other manner communicated some drug. Becker, R. Barbara and Frank G. for Peter plaintiff. Watters,

Plunkett, Rutt, & Stanczyk Cooney, Jacobs) P. Cooney and John Pedersen W. P. (by defendant. arose C.J. This case Coleman, (extreme hypersensi- anaphylactic

from acute resulting Shirley in the death of tivity) reaction prod- Renografin-60, Smith which occurred when Sons, Inc., was uct R. & Squibb of defendant E. sensitivity is injected into her blood stream. Such prior extremely rare and be discovered cannot injection. It is reflected undisputed clearly in the the record that was no intrinsic defect there drug. manufacturer, various

Plaintiff named the drug E R Smith v & Sons Opinion of the Court doctors hospital defendants in the action. trial Upon by jury, one doctor received a directed verdict his behalf. The two other doc- tors, hospital and manufacturer were successful no obtaining jury verdicts of cause of Nevertheless, action. received monetary from settlements the two doctors and from the hospital appeal after he filed an of the verdicts. manufacturer, Sons, The E. R. drug Squibb Inc., & remaining is the sole defendant. court,

In the trial plaintiff predicated upon manufacturer’s an alleged failure to provide adequate warnings to profes- the medical sion of dangers indigenous Renografin-60 to proper of the procedures. precautionary Al- though counts of breach of warranty pled, were the trial court refused to instruct jury concerning the implied warranty Furthermore, claim. proffered evidence of subse- quent changes in the literature accompanying the held was inadmissible. granted

We appeal leave to and limited our inquiry to the following issues of law:

1. Whether was reversible error for the trial judge to refuse to charge jury regarding breach of implied warranty,

2. Whether the trial judge improperly excluded evidence of changes in written material made by the defendant subsequent

The Court of Appeals questions answered both negative and affirmed the verdict of jury’s no cause of action. 69 Mich 245 NW2d 52 (1976). finding

The were adequate is not at We are issue. here confined questions of law relating of in- adequacy structions and of cer- admissibility 405 Mich Opinion op the Court court and the the circuit tain evidence. We affirm Appeals. Court of

I 1969, referred to 14, Smith was Shirley April On pyel- an intravenous Hospital Joseph Mercy St. (IVP) Dr. Kozlin- personal physician, her ogram kidneys which X-ray An IVP is an ski. into medium of a contrast injection involves the a dye by medium serves as The contrast the veins. oper- reveal effectively can more X-rays which contrast me- particular kidneys. ation of the iodine solu- Renografin-60, was dium used 60% Sons, E. R. & Inc. tion manufactured hospital arrived at decedent Plaintiff’s p.m. 12:30 After approximately 1969 at April technician, prepared by a patient Scerhelmi, Dr. admin- physician, room emergency one-half Dr. Scerhelmi drug. injected istered then, the remainder slowly, cc trial amount and subsequent injec- minutes drug. Several tion, not uncom- Smith became nauseated —a Mrs. departed, After Dr. Scerhelmi mon occurrence. however, in. Foam started reaction set delayed mouth, in difficulty her she had breath- to form on Dolan, Dr. was ing radiologist, and fainted. The anaphylactic underwent acute patient called. The Shirley shock. All efforts to revive her failed p.m. 2:30 The cause approximately Smith died at to be a hypersensitive of death was determined reaction to Renografin-60. Renografin-60

Each contained packing case drug. vials, 30 cc of the containing each vial vials, no Because small size However, came each vial appeared on the labels. it. At the around "package wrapped with a insert” to and taken these individual vials were hospital, E R v Smith & Sons Court placed X-ray in rooms, cabinets in the while packing cases and the inserts remained in the pharmacy.

Dr. Scerhelmi testified that she had read Renografin-60 journals inserts and had read subject prior administering the fatal IVP. More- experienced physician over, she an who had previously given hundreds of IVP’s. pages long

The inserts were four and contained concerning contents, information age, the chemical dos- precautions functions, and adverse reactions Renografin-60. possibility relative to of de- layed anaphylactic in reactions was stated text specific diagnosis and further recommendations for (17 and treatment were forth set in article pages long) in cited a footnote. Squibb warnings:

Dr.As said Dolan about "Every piece single of this has it it. it, medicine with Every contraindications, pyelogram intravenous has literature with contraindications and reactions. The company everything. has literature way This is the them, packed. if you you it’s Even don’t know can read expect, might them and happen, know what what ** even without any knowledge medical *.” promotion primarily, drug aAs method of sales commonly physicians also manufacturers inform concerning prescription drugs by other meth- two published Physi- ods. The information cians Desk Reference to Bio- Pharmaceuticals and (PDR). logicals This annual volume contains infor- supplied by drug mation manufacturers relevant product. publication to each The 1969 of the PDR possible did not mention the adverse of effects Renografin-60. conveying

The other method of information to profession through the medical "detail men”. 88 405 Mich 79 op the Court representatives drug men are sales Detail extol companies who virtues in the instructing proper doctors presumably while Squibb’s administering drugs. method of detail at radiologists hospital man had all briefed Dr. prior Smith’s Scerhelmi Shirley injection. room and a radi- physician was an not emergency ologist present so on these occasions. she was allegations plaintiffs against

The essence of adequate warnings relative to inher- dangers precautions ent and were necessary prescribing using to doctors and Reno- conveyed alleged failure is to constitute both grafin-60. Such drug part negligence a defect in the the manufacturer.

II , in the Appeals The Court context held alleged provide adequate warnings, failure breach of involve warranty require proof exactly identical evidence Although facially contradictory, same elements. both upon thorough analysis position this becomes compelling and irrefutable.

A manufacturer of a has prescription legal not the duty profession, to warn medical patient, of risks use of any inherent drug which the knows or should manufacturer McEwen v Ortho Pharmaceutical know to exist. (1974), Sterling Corp, P2d 522 Or (CA Yarrow, Drug, Inc 978, 8, 1969), v F2d Wolf, Love v 378, 395; 38 Rptr 226 Cal Cal 2d (1964). 183, However, been duty 192-193 this has held to when require patient in a immu prescription drug is administered mass E.g, Wyeth Laborator Davis v program. nization 1968). (CA ies, Inc, Determination 399 F2d 121 Smith vER 89 & Sons op Opinion the Court duty of whether this has in been breached negligence of context claim necessitates that the warnings given be examined to their reasona- bleness under the circumstances. implied warranty, hand,

Breach of on the other proves plaintiff is established when that a defect attributable to the manufacturer has a relationship plaintiff’s injuries. causal Heckel v Corp, Coupling 19, American 384 Mich 22; 179 (1970), Remington NW2d 381 Co, Piercefield v Arms (1965). 85, 96-99; 375 Mich 133 NW2d 129 It is commonly accepted inadequate warnings that product defect, alone can constitute a whether the implied warranty or strict E.g., Coating, tort. Gutowski v M & R Plastics & App (1975), Inc, 60 Mich 231 NW2d 456 Brantly Helicopter Corp, Super Berkebile v 225 Pa (1973), 349; 311 A2d 140 2 Torts, 2d, Restatement § 402A, h-k, Noel, Comments Products Defective Inadequate Warnings, Because Directions or (1969). by LSW J 256 below, As noted the Court generally recognized implied is also "that war ranty separate are and distinct recovery theories warranty theory and that under the prove necessary negli

it is not (citation omitted). gence”. Mich negli- The distinction between the elements of gence implied warranty and breach of that is plaintiff prove the former must that the defect was by negligence, caused the manufacturer’s whereas warranty theory, only under need establish that the defect was attributable to the regardless manufacturer, of the amount of care by utilized the manufacturer.

However, when the factual is issue not whether defective, itself is but is whether the provided adequate warnings, manufacturer has 405 Mich 79 Court duty of a defect and breach existence by determined the same standard —reasonable In the context of a care under the circumstances. product liability "[t]he case, it has said been adequacy by determines which standard general negligence the standard which falls below 'conduct created protection of others law for established against unreasonably great of ”. Gu risks harm’ pp quoting supra, Prosser, 507-508, towski, from (4th ed), p Torts, facts, there 145. On the of Law identical and fore, two theories involve facts require exactly proof This elements. is of same upon adequacy of is true because the focus warnings, regardless theory liability. of of argues Although plaintiff he when is correct separate implied warranty are that Renografin-60 theories, it is clear that and distinct negligent. Squibb be defective unless could not legal determining duty has The for whether test rea- exercised is whether defendant been breached Determina- care under the circumstances. sonable of because tion of whether a defect exists inadequate requires an the use of an Consequently, identical standard. when warning, adequacy turns on the issue regardless care, of whether the one theory pled reasonable implied warranty negligence, supra, e.g., Gutowski, See, strict tort. (CA Sterling Drug, Inc, 417, 427 Basko 416 F2d v 1969), Descrip- Duty 2, Kidwell, to Warn: L 1375 Decision, 53 Rev tion the Model Texas (1975), Prescription Compensation Merrill, (1973). Drug Injuries, 59 Va L Rev 31 therefore, not hold, trial court did We that when it refused instruct commit reversible error plaintiffs implied warranty jury Smith Ev R & Sons Opinion op the Court submitted the case solely negligence claim. Indeed, such instruction would repe- have been titive and unnecessary could possibly have misled the into believing plaintiff could , on the warranty recover count even if Squibb were law, negligent. Such not given this Clairol, Skaggs Inc, v setting. factual See Cal (1970) 1; Rptr 3d 85 Cal (hearing granted, 17, 1970, stipulation), June dismissed by Rainbow Co, v Bldg Albert Elia 49 AD 2d 373 NYS2d (1975). Duplicative instructions could have created confusion and prejudicial error. We believe the trial judge properly exercised his dis- cretion this matter.

This opinion is limited its facts. We solely do not suggest implied warranty and negligence independent are not causes of action. When the factual issue is the adequacy given, legal under either theory is one of reasonable care under the circumstances. made, however, that on different Note should be facts error could be prejudicial to give the See, e.g., v instruction. Midgley warranty Co, S Kresge S 67; 55 Cal App 3d 127 Cal Rptr 217 (1976) (issue of requires contributory negligence instruction,on negligence both liability). strict

Ill Plaintiff contends that the trial court erred when it held that changes evidence of subsequent in the Renografin-60 package inserts and PDR references was inadmissible. record indicates that Squibb made its and instructions even more in explicit later The trial court years. relied on against Michigan’s strong policy admit- ting evidence of subsequent remedial measures v the purpose of proving negligence. Crews Gen- 405 79 Mich 92 op the Court 208; 617 253 NW2d Corp, eral Motors 400 Mich Borg-War Judis v also, See, (1977), and MRE (1954), 647 ner 313; 63 Corp, 339 Mich NW2d Co, 395 Mich Frank L Jursik Denolf v (1976). NW2d properly trial excluded judge that

We hold MRE reads: evidence. proffered which, event, "When, are if taken after an measures likely less have made event previously, taken would occur, subsequent measures is not evidence of culpable negligence or conduct prove admissible connection with require rule the event. This does subsequent when measures evidence exclusion proving ownership, purpose, such offered for another control, controverted, measures, if feasibility precautionary or impeachment.” Also committee see comments. the rule restates a basic tenet under

Exclusion Michigan. It accepted long has been which products, persons improve their encourages risk of and customs without services property, proceeding consequently prejudicing any court improvements. See implementation delaying Judis, Denolf, supra, Grawey supra, supra, Crews, Commission, v Road 48 Mich County Genesee (1973). contention 742; 211 Plaintiffs NW2d within rule. does fall any exceptions It is irrelevant this is argument should case. Plaintiffs evidence warranty have been admitted under his legal position of his ignores count the essence Appeals As the Court of stated: these facts. plaintiffs was built "Inasmuch as the entire case inadequate warning, proof around of an * * * negli- concept, the theoretical distinction between gence exploited implied warranty may Smith E & v R Sons Opinion op the Court policy exclusionary obviate the reasons for the rule.” Mich sought Plaintiff have evidence admitted to argument buttress his were In inadequate. light adoption of the recent of MRE continuing and the Court’s policy, trial entirely proper. court’s action was

IV upon The case is decided the instructional evidentiary by plaintiff issues raised limited to its prejudicial legal facts. We find no error on or part of trial court.

It is pure, conceded that was but is contended that possible, of its if rare, upon effect extremely hypersensitive per- son inadequate. This is a negligence concept. approached Whether legal im- plied warranty negligence, proofs and the jury instructions would be the same essential part. duplication of instructions could be not only confusing but possibly misleading. The jury did not find the negligence urged and essential to both theories. We find no legal error committed trial judge. Therefore, we affirm.

We affirm also the decision as to the issue of whether the court precluding erred in evidence of a subsequent change in the warning. policy against allowing such evidence is well established in Michigan and continued in new rules of evidence, in MRE specifically 407 which would be applicable trial, in the requested new so reversal on this point would be meaningless well as improper. We find that the court did not err.

Affirmed. Mich Dissenting by Opinion Levin, J. Fitzgerald, Ryan, Jr., Moody, JJ., and Blair Coleman, concurred with C.J.

Kavanagh Williams, JJ., concurred in the result.

Levin, (dissenting). J. manufactured by Squibb was administered Smith Shirley during a hospital routine procedure. atypical She had an reaction, delayed anaphylactic went into shock complaint and died. The alleged Squibb that did warn adequately of such possibility reaction, sought under recovery two theories— implied warranty and negligence. judge

The trial that the plaintiff concluded could on recover the implied warranty theory, and instructed the jury solely negligence on theory. The Court of Appeals found it unnecessary affirmed, decide whether that error stat- ing that on the case”, facts of "this failure to warn "the standard and the proofs necessary to recovery are Court, identical under both theories”. This adopting reasoning, same also affirms. agree

We all that a product is defective unless the "manufacturer provided has warn- adequate ings”. Court that in concludes a failure warn case the adequacy deter- mined by whether the defendant exercised "rea- sonable care under circumstances”, the negli- gence standard. Since plaintiff cannot "un- recover Squibb less was negligent”, to have instructed the jury plaintiffs warranty "could possibly have misled believing into plaintiff could recover on the warranty count even if Squibb were not negligent”.

The Court thus in holds that action for failure to warn the inquiry focus is on the manufacturer’s conduct although in all E v R Smith & Sons n Dissenting Levin, J.

other cases the focus is on the ñtness of the product. sure,

To be which a should to determine instructed whether a is fit evokes the same concept "reasonableness” instructed to apply determining whether a de- fendant’s conduct was It negligent. does not follow failure the inquiry to warn case is the same whether the theory or implied or, it, as the Court of warranty Appeals put it is "a distinction without a difference”.

A manufacturer’s implied warranty may require it of produce higher than quality would from the of care; result exercise reasonable be must fit for the purpose I intended. would higher hold that standard of quality, reasonable fitness for the pur- intended pose, applies to the adequacy accompa- of nying the as well as to the adequacy of the design structure or of the product itself.

I shipped in cases 25 of vials. "Warning slips were loosely packed within each case but were not attached to the vials themselves and no warning kind vial any appeared labels.”1 1 (1976). Squibb, 375, Smith v 69 Mich 52 NW2d " 'package The Court states the vial with insert came wrapped’ inserts, slips package they around it”. The or described, not, however, variously shipped wrapped have been around each vial in accompany were they such manner as to insure that would shipping the vial when was removed from the con-

tainer: Statts, clear, "The Court: Mr. I’m not sure whether it’s it isn’t clear Renografin jury. to me. I’m not sure it’s clear to 25 bottles? These bottles package containing come in a Statts): Yes, (By your "A. Mr. Honor. package photo- "The Court: And the has 25 of these inserts right? stat Exhibit is that Mich Dissenting Opinion Levin, J. Yes, this, supplied supplying "A. when we we were 25. I don’t they’re putting today. believe 25 in them bottle, they "The Court: Where do the inserts come? Are are they bottle, box, they question, you on the they are if know? How were making myself on or about the date in 1969? Am I clear? '69, every "A. Yes. In I’m sure we had one around bottle in the nested carton. right, bottle, every "The Court: All and if it was around what held it? there, just loosely packed "A. It would as I recall it. "The Court: A rubber band? No, just put "A. I think the bottle was in and the label was enclosed around it. something It "The Court: would have to have to hold it to the bottle, very pasted, you’d wouldn’t it? It couldn’t be well otherwise you think would tear it. labeled, there, "A. The bottle was and then the insert would be in loosely packed. Cooney (interposing): case, you "Mr. your Did ever see a beer Honor? asking got enough problems "The Court: I’m the witness. I’ve with lawyers. six Statts): (By eggs "A. packed, Mr. you This is like in a carton are know— me, dense, "The Maybe Court: It’s not sorry; clear to sir. I’m I’m and, by asking, opening myself up questions I’m Cooney like Mr. just put me; boxes, Now, but I’ve seen I’ve seen bottles. where is say loosely packed? this insert? Is it in the bottle? You it’s What is it packed with? What holds it to the bottles? my knowledge, "A. It’s not—to it’s not even stuck on the bottle with tape anything, except put Now, a put compartment. today, in that we four, just three or and we include them in with the box. words, you picked "The Court: up, In other if the bottle the label might fall off? off, "A. right The label wouldn’t come but the insert is in there. pull You can the insert out. "The Court: The insert would not fall off? Well, "A. the insert wasn’t attached to the bottle. "The Court: The insert was not attached to the bottle. Where was the insert? right in, understand, "A. It just down as I down in that compartment, just surrounding stuck down in there the bottle. Now, "The magnet. piece paper Court: the bottle is not a is not piece of steel. What holds it to the bottle? Nothing. "A. Cooney (interposing): "Mr. Get a beer case— "The Court: I don’t have a beer case. Cooney: right, you case, "Mr. you All if have this have 24 little compartments you like would have for a bottle of beer. Your bottle E R Smith & v Sons Dissenting by Levin, J. warning It was claimed that the was inadequate i) was not attached warning slip because ii) vial, rubber band or some other means to did not describe delayed anaphy- warning slip drug lactic reaction to the or the treatment iii) reaction, administered for such a drug had Reference, not been listed in the Physician’s Desk iv) and, Squibb’s representative had not discussed measures with precautionary the doctor who ad- (who ministered the instant case room) worked in the emergency as he had with (the staff). other doctors radiology The judge instructed decide the adequacy assessment of the conduct, reasonableness of Squibb’s the negligence standard, gave no instruction to consider reasonableness itself: "Now, getting defendant, back to Squibb, at this time, I it easy you know that is not anybody or else chief, to determine from the case in is from the stand, witnesses on the witness they whether or not gave proper warning profession to the medical proximate was a cause. But consider all of the testi- mony, consider all of the your circumstances and use common sense in determining: did they act way prudent drug manufacturer would have acted under the knowledge they had and the circumstances that existed goes there, you put it, down in top you lay the insert over the it, top depending upon is, packager making who the who’s up. them "The Court: I’d like him to be more exact. Well, Cooney: "Mr. he can’t be because his was back in 1969 that talking about, we’re and this is to the best of his recollection what he carton, knows about it. your We don’t have a 1968 Honor. There’s no way get one. "The Court: I would like him to be more exact. Well, Cooney: "Mr. my knowledge, he can’t. To are little there cardboard sections for each one of these bottles. This was stuck down it, top. other, recall, in around or laid on the One or the he he doesn’t said. right, Brady.” "The Court: All Mr. 405 Mich 79 Dissenting Opinion Levin, J. prudent, acted 16, they way 1969. If April by putting acted drug manufacturer would have careful referring to and the inserts the box the inserts profession, they then to the medical articles various (Emphasis supplied.)2 anything wrong.” didn’t do that unless it was thus instructed blameworthy Squibb the warn- concluded that adequate. ing was

II question to a is the answer determined Often thing way It to instruct a it is asked. is one manufacturer is whether to determine negligent blameworthy failed to or because he care; it of reasonable conform to a standard quite did, if manufacturer another to ask adequately fact, warn. jury, the manufacturer acted convinced "guilty” good might faith, it

in negligence. decline to find question If asked were whether the purpose reasonably fit for the intended (whether expect it to be the user can

2The instruction continued: hand, ordinary drug they way if did act the "On other acted, that existed manufacturer and the cause of the medical have under the conditions would 16, knowledge April proximate known on 1969 and it was a death, injury warning to the because of the lack of profession, negligent. they then would be "Negligence ordinary prudent ordinarily defined as what person would under Or the have done like similar circumstances. ordinarily prudent person have done failure under like or similar circumstances. do what the would person; already you corporation "I have told that a is the same as a therefore, way applies corporation, they act to a did ordinarily prudent remember, acted; you must manufacturer would have extent; this this is no claim at case is odd to this there 60, purpose drug, Renografin time that which it was not fit for drug, as far as the was used. There is no claim at this time exception Renografin the failure to warn the medical anything else with the is concerned for profession.” E R Smith v & Sons Dissenting Opinion by Levin, J. defect), alleged jury might free of the same product reasonably that the conclude was not fit— warnings in the instant case that were not adequate. product liability jury may

In a case the find for deciding without the manufac- inquiry turer was to blame or at fault. The is not solely whether the manufacturer has done all that might but, manufacturer reasonable have done product rather, focuses on whether the is reason- purpose ably fit for the intended. dangers may

Where, here, there be inherent product duty in use of the and therefore there is a danger, inquiry to warn of known is not reasonably whether the manufacturer acted but warnings given actually whether the are reason- adequate. Warnings, ably like structure and de- sign, up higher must measure standard of implicit quality requirement prod- in the reasonably purpose. uct be fit for the intended solely The standard looks to the de- fendant’s conduct and seeks to determine whether judge charged acted, he as the this conformity expects case, in to what the law of him. implied warranty looks, rather, product question— and asks a different up whether the measures to the standard may reasonably expect which a user of it. The policy is to law enforce the consumer’s expectations reasonable even though doing might required so mean that more is than reasonable conduct produce. manufacturer would subject manufacturer is not anaphylactic reaction or for risks it does not reasonably expected know and cannot It be to know. subject is, however, if the means Mich 79 Dissenting Opinion Levin, J. actually notify known risks does notification of adequate means that more concludes expected. be reasonably notification can Ill of the Court opinion to in The cases referred can the issue —whether do not address (not notwith- adequate) inadequate the manufac- the reasonable standing conduct turer.3 Hardy, in Hamilton v addressed

The issue is (1976). Plaintiff suf- 549 P2d Colo she claimed was caused fered a stroke which in prescribing her malpractice physician the manufacturer’s drug and the contraceptive oral implied war- express and breach of negligence adverse reactions warning possible ranties. inadequate claimed was given which diseases occur- reports the of thrombotic light in contraceptives. such ring taking in women negli- plaintiff’s on jury case was submitted to instruct judge the "refused gence theory, but Id., p liability”. strict the jury 375; Corp, 528 P2d 522 v Pharmaceutical 270 Or 3 McEwen Ortho (1974), grounded negligence, in in. war was an action ranty. (CA Inc, 2, 1969), Drug, judge Sterling the In v 416 F2d 417 Basko proper gave hybrid the a instruction that the must be duty reasonable efforts to warn. and that Plaintiff did not on the had not been there was to make here, complain, jury was not instructed that the but, rather, higher adequacy warning of the lower, properly negligence, standard. instructed on the (CA 8, 1969), Yarrow, Sterling Drug, the In Inc v 408 F2d 978 higher complained being manufacturer than that it was held to a standard responded judge in had and the court reasonableness reasona- It did not decide that fact used the reasonableness standard. warnings actually given adequate. ble efforts to warn made (1964), Wolf, Rptr In Love v 226 Cal 2d Cal warning adequacy the manufac- issue was not the but whether warning. adequate negate turer’s conduct an otherwise tended to E Smith v R & Sons Dissenting Opinion by Levin, J. The verdict was favor of the manufacturer. Appeals The Court of reversed. here, perceived trial court apparently

As "[t]he on no difference between a claim based claim a failure to warn and a strict based warn, instructing on a failure to and felt both duplicitous theories would be and confuse Id., p 382. jury”. Appeals

The Colorado Court of stated that al- drug of a though scope manu- (which that unavoida- produces facturer people) effects in some is deter- bly causes adverse reasonableness, plain- mined a standard of although tiff could recover found that negligent failing manufacturer had not been if it give adequate warnings more concluded that was not fit without more adequate warnings: "Although agree proves we the evidence which theories,

failure to warn is the same under both we * * * disagree that the theories identical. are

"* * * Under strict liability, the test is whether failure of Searle adequately potentially warn of the dangerous propensities of its rendered that product unreasonably dangerous. import It is of no warning whether with this comported manufacturer’s prudent drug a reasonably manufac- given. turer would have liability tort shifts the '[S]trict from focus the conduct of the manufacturer to the product.’ Friedman, nature of the Liability, 2 Frumer & Products Id., p 383. § 16A[4][e].” The court drug stated the of a manufac- duty turer thus: general, "In recovery for there to be under Restate- (Second) Torts, 402A,

ment plaintiff must demon- § 405 Mich 79 Dissenting Opinion Levin, J. product strate that the defective condition of a makes product dangerous. the prescription drugs, In unreasonably the case of Ovulen, may such as which be 'una- voidably unsafe’ as that term is in comment k used 402A, requirements Section and of 'defective condition’ 'unreasonably dangerous’ meaning a different have than in the the in the 402A usual sense. Such a is made in intended, way impurities, contains no and is planned, proves dangerous condition but it to be 'incapable being because it made safe for [its (Second) ordinary intended and Restatement use].’ Torts, 402A, products, comment k. toAs such if the § accompanied by adequate warning, it is not However, unreasonably dangerous. defective and is not accompanied by adequate when not warning, defective, may and thus unreasonably be dangerous. The dangerous propensities defect is not the or the strict ure to drug, side effects of the but the failure to warn. Thus question posed regard to be to the with liability issue is whether the manufacturer’s fail- adequately warn rendered the unreason- ably dangerous the failure to warn remand, regard without to the reasonableness of

judged by negligence standards. On Id., pp should be so instructed.” 384- omitted.) (Emphasis original; citations The Oregon Supreme recognized Court has also although the scope of the manufacturer’s liability may circumscribed aby reasonableness, re- may nevertheless although cover negli- manufacturer was not gent if the trier of fact warning decides that was not reasonably adequate: "In a talking strict case we are about the (dangerousness) condition of an article is sold which without any warning, while in we are talk- ing about the reasonableness of the manufacturer’s actions article lack of selling warning. the article without degree can dangerousness have a because of a which the law of strict will not tolerate though even the actions of the seller were Squibb & 103 E R Sons Smith v Opinion by Dissenting Levin, J. selling the article without a in entirely reasonable knew or should have warning considering what he Phillips it.” v Kimwood time he sold known at (1974). 485, 498; Co, 525 P2d

Machine Or sum, drug unavoidably be may In prescription in the in- way it is made though unsafe even in the tended, and is condi- impurities, contains no accompanied by If is planned. tion such it not defective and is not warning, adequate However, when not ac- unreasonably dangerous. warning, adequate companied by defective, unreasonably danger- may and thus dangerous propensi- not in the ous. The defect drug, but the failure to or side effects of the ties warn.

IV Squibb unless was was instructed that jury The subject liability. it was not negligent had Although concluded attaching warning in not reasonably acted vial, warn- providing complete in not a more listed in drug to it that was ing, seeing PDR, having representative its and in not members hospital discuss adverse effects with staff nevertheless have radiologists, might other than fit for reasonably was not concluded complete more its intended use without given. than were it could should been instructed have fit

conclude that life- for its intended use unless reaction threatening delayed anaphylactic risk in the event employed to be treatment attached vial oT such reaction was to physicians some other manner communicated administering drug. 405 Mich Dissenting Opinion Levin, J.

I reverse and remand for a trial.4 would new Legislature recently public policy stated the has this state conformity industry to be that in a standards is admissible as evidence products liability applies action. The act to failures to warn as manufacturing well as to other defects. The bill as introduced would conformity complete Legislature have made such defense. The has thereby not a parallel by made conduct other manufacturers relevant but complete product liability defense in a case. provides: The act products liability "It evidence in shall be admissible as action manufacture, construction, formula, design, development that the standards, preparation, processing, assembly, inspection, testing, list- ing, ing, warning, instructing, marketing, advertising, packag- certifying, or labeling pursuant generally recognized to the was done prevailing nongovernmental standards in existence at the time the pur- sold or delivered the defendant to the initial 600.2946; (ap- 1978 PA MCL chaser or user.” proved MSA 27A.2946 1978). by the Governor December provided: The bill products liability against "It shall be defense to a action manufacture, manufacturer or a seller of a that the construc- tion, formula, standards, design, development preparation, process- ing, inspection, testing, assembly, listing, certifying, warning, instruct- ing, marketing, advertising, packaging, labeling pursuant was done generally recognized prevailing nongovernmental stan- dards existence at the time the was sold or delivered purchaser the manufacturer or seller to its initial or user. The provided defense for in this subsection shall not be available if the alleged liability is founded on the defendant’s failure to conform to a governmental governmental higher standard if standard is than nongovernmental standard described in this subsection.” House Bill 5689.

Case Details

Case Name: Smith v. E R Squibb & Sons, Inc

Court Name: Michigan Supreme Court

Date Published: Jan 10, 1979

Citation: 273 N.W.2d 476

Docket Number: 58894, (Calendar No. 5)

Court Abbreviation: Mich.