Court Opinion

ID: 9741773
Source: CourtListenerOpinion
Date Created: 2023-08-26 21:01:53.265986+00
Date Added: 2024-06-11T07:24:26.206488
License: Public Domain

Coleman, C.J.
This product liability case arose from the acute anaphylactic (extreme hypersensitivity) reaction resulting in the death of Shirley Smith which occurred when Renografin-60, a product of defendant E. R. Squibb & Sons, Inc., was injected into her blood stream. Such sensitivity is extremely rare and cannot be discovered prior to injection. It is undisputed and clearly reflected in the record that there was no intrinsic defect in the drug.
Plaintiff named the drug manufacturer, various *85doctors and the hospital as defendants in the action. Upon trial by jury, one doctor received a directed verdict on his behalf. The two other doctors, the hospital and the drug manufacturer were successful in obtaining jury verdicts of no cause of action. Nevertheless, plaintiff received monetary settlements from the two doctors and from the hospital after he filed an appeal of the verdicts. The drug manufacturer, E. R. Squibb & Sons, Inc., is the sole remaining defendant.
In the trial court, plaintiff predicated the drug manufacturer’s liability upon an alleged failure to provide adequate warnings to the medical profession of the dangers indigenous to Renografin-60 and of the proper precautionary procedures. Although counts of breach of implied warranty and negligence were pled, the trial court refused to instruct the jury concerning the implied warranty claim. Furthermore, proffered evidence of subsequent changes in the literature accompanying the product was held inadmissible.
We granted leave to appeal and limited our inquiry to the following issues of law:
1. Whether it was reversible error for the trial judge to refuse to charge the jury regarding breach of implied warranty, and
2. Whether the trial judge improperly excluded evidence of changes in written material made by the defendant subsequent to 1969.
The Court of Appeals answered both questions in the negative and affirmed the jury’s verdict of no cause of action. 69 Mich App 375; 245 NW2d 52 (1976).
The finding of the jury that the warnings were adequate is not at issue. We are here confined to questions of law relating to the adequacy of instructions to the jury and of admissibility of cer*86tain evidence. We affirm the circuit court and the Court of Appeals.
I
On April 14, 1969, Shirley Smith was referred to St. Joseph Mercy Hospital for an intravenous pyelogram (IVP) by her personal physician, Dr. Kozlinski. An IVP is an X-ray of the kidneys which involves the injection of a contrast medium into the veins. The contrast medium serves as a dye by which X-rays can more effectively reveal the operation of the kidneys. The particular contrast medium used was Renografin-60, a 60% iodine solution manufactured by E. R. Squibb & Sons, Inc.
Plaintiff’s decedent arrived at the hospital on April 16, 1969 at approximately 12:30 p.m. After the patient was prepared by a technician, an emergency room physician, Dr. Scerhelmi, administered the drug. Dr. Scerhelmi injected a one-half cc trial amount and then, slowly, the remainder of the drug. Several minutes subsequent to the injection, Mrs. Smith became nauseated — a not uncommon occurrence. After Dr. Scerhelmi departed, however, a delayed reaction set in. Foam started to form on her mouth, she had difficulty in breathing and fainted. The radiologist, Dr. Dolan, was called. The patient underwent acute anaphylactic shock. All efforts to revive her failed and Shirley Smith died at approximately 2:30 p.m. The cause of death was determined to be a hypersensitive reaction to Renografin-60.
Each packing case of Renografin-60 contained 25 vials, each vial containing 30 cc of the drug. Because of the small size of the vials, no warnings appeared on the labels. However, each vial came with a "package insert” wrapped around it. At the hospital, these individual vials were taken to and *87placed in cabinets in the X-ray rooms, while the packing cases and the inserts remained in the pharmacy.
Dr. Scerhelmi testified that she had read the Renografin-60 inserts and had read journals on the subject prior to administering the fatal IVP. Moreover, she was an experienced physician who had previously given hundreds of IVP’s.
The inserts were four pages long and contained information concerning the chemical contents, dosage, functions, precautions and adverse reactions relative to Renografin-60. The possibility of delayed anaphylactic reactions was stated in the text and further specific recommendations for diagnosis and treatment were set forth in an article (17 pages long) cited in a footnote.
As Dr. Dolan said about the Squibb warnings:
"Every single piece of this medicine has it with it. Every intravenous pyelogram has literature with it, contraindications, contraindications and reactions. The company has literature in everything. This is the way it’s packed. Even if you don’t know them, you can read them and know what to expect, what might happen, even without any medical knowledge * * *.”
As a method of sales promotion primarily, drug manufacturers also commonly inform physicians concerning prescription drugs by two other methods. The information is published in the Physicians Desk Reference to Pharmaceuticals and Biologicals (PDR). This annual volume contains information supplied by drug manufacturers relevant to each product. The 1969 publication of the PDR did not mention the possible adverse effects of Renografin-60.
The other method of conveying information to the medical profession is through "detail men”. *88Detail men are sales representatives of the drug companies who extol the virtues of the product while presumably instructing doctors in the proper method of administering the drugs. Squibb’s detail man had briefed all radiologists at the hospital prior to Shirley Smith’s injection. Dr. Scerhelmi was an emergency room physician and not a radiologist so she was not present on these occasions.
The essence of plaintiffs allegations against Squibb is that adequate warnings relative to inherent dangers and necessary precautions were not conveyed to doctors prescribing and using Renografin-60. Such failure is alleged to constitute both a defect in the drug and negligence on the part of the manufacturer.
II
,The Court of Appeals held that in the context of an alleged failure to provide adequate warnings, breach of implied warranty and negligence involve identical evidence and require proof of exactly the same elements. Although facially contradictory, upon thorough analysis this position becomes both compelling and irrefutable.
A manufacturer of a prescription drug has a legal duty to warn the medical profession, not the patient, of any risks inherent in the use of the drug which the manufacturer knows or should know to exist. McEwen v Ortho Pharmaceutical Corp, 270 Or 375; 528 P2d 522 (1974), Sterling Drug, Inc v Yarrow, 408 F2d 978, 993 (CA 8, 1969), Love v Wolf, 226 Cal App 2d 378, 395; 38 Cal Rptr 183, 192-193 (1964). However, this duty has been held to require warnings to the patient when the prescription drug is administered in a mass immunization program. E.g, Davis v Wyeth Laboratories, Inc, 399 F2d 121 (CA 9, 1968). Determination *89of whether this duty has been breached in the context of a negligence claim necessitates that the warnings given be examined as to their reasonableness under the circumstances.
Breach of implied warranty, on the other hand, is established when plaintiff proves that a product defect attributable to the manufacturer has a causal relationship to plaintiff’s injuries. Heckel v American Coupling Corp, 384 Mich 19, 22; 179 NW2d 381 (1970), Piercefield v Remington Arms Co, 375 Mich 85, 96-99; 133 NW2d 129 (1965). It is commonly accepted that inadequate warnings alone can constitute a product defect, whether the theory be implied warranty or strict liability in tort. E.g., Gutowski v M & R Plastics & Coating, Inc, 60 Mich App 499; 231 NW2d 456 (1975), Berkebile v Brantly Helicopter Corp, 225 Pa Super 349; 311 A2d 140 (1973), 2 Restatement Torts, 2d, § 402A, Comments h-k, Noel, Products Defective Because of Inadequate Directions or Warnings, 23 SW L J 256 (1969). As noted by the Court below, it is also generally recognized "that implied warranty and negligence are separate and distinct theories of recovery and that under the implied warranty theory it is not necessary to prove negligence”. 69 Mich App 375, 381 (citation omitted).
The distinction between the elements of negligence and breach of implied warranty is that in the former plaintiff must prove that the defect was caused by the manufacturer’s negligence, whereas under the warranty theory, plaintiff need only establish that the defect was attributable to the manufacturer, regardless of the amount of care utilized by the manufacturer.
However, when the factual issue is not whether the product itself is defective, but is whether the manufacturer has provided adequate warnings, the *90existence of a product defect and a breach of duty is determined by the same standard — reasonable care under the circumstances. In the context of a product liability case, it has been said that "[t]he standard by which a jury determines adequacy is the general negligence standard that liability is created by 'conduct which falls below the standard established by law for the protection of others against unreasonably great risks of harm’ ”. Gutowski, supra, pp 507-508, quoting from Prosser, Law of Torts, (4th ed), p 145. On the facts, therefore, the two theories involve identical facts and require proof of exactly the same elements. This is true because the focus is upon the adequacy of the warnings, regardless of the theory of liability.
Although plaintiff is correct when he argues that negligence and implied warranty are separate and distinct theories, it is clear that Renografin-60 could not be defective unless Squibb was negligent. The test for determining whether a legal duty has been breached is whether defendant exercised reasonable care under the circumstances. Determination of whether a product defect exists because of an inadequate warning requires the use of an identical standard. Consequently, when liability turns on the adequacy of a warning, the issue is one of reasonable care, regardless of whether the theory pled is negligence, implied warranty or strict liability in tort. See, e.g., Gutowski, supra, Basko v Sterling Drug, Inc, 416 F2d 417, 427 (CA 2, 1969), Kidwell, The Duty to Warn: A Description of the Model of Decision, 53 Texas L Rev 1375 (1975), Merrill, Compensation for Prescription Drug Injuries, 59 Va L Rev 1, 31 (1973).
We hold, therefore, that the trial court did not commit reversible error when it refused to instruct the jury on plaintiffs implied warranty theory and *91submitted the case solely on the negligence claim. Indeed, such an instruction would have been repetitive and unnecessary and could possibly have misled the jury into believing that plaintiff could recover on the warranty count even if Squibb , were not negligent. Such is not the law, given this factual setting. See Skaggs v Clairol, Inc, 6 Cal App 3d 1; 85 Cal Rptr 584 (1970) (hearing granted, June 17, 1970, dismissed by stipulation), Rainbow v Albert Elia Bldg Co, 49 AD 2d 250; 373 NYS2d 928 (1975). Duplicative instructions could have created jury confusion and prejudicial error. We believe the trial judge properly exercised his discretion in this matter.
This opinion is limited solely to its facts. We do not suggest that implied warranty and negligence are not independent causes of action. When the factual issue is the adequacy of the warnings given, the legal standard under either theory is one of reasonable care under the circumstances. Note should be made, however, that on different facts it could be prejudicial error not to give the implied warranty instruction. See, e.g., Midgley v S S Kresge Co, 55 Cal App 3d 67; 127 Cal Rptr 217 (1976) (issue of contributory negligence requires instruction,on both negligence and strict liability).
Ill
Plaintiff contends that the trial court erred when it held that evidence of subsequent changes in the Renografin-60 package inserts and PDR references was inadmissible. The record indicates that Squibb made its warnings and instructions even more explicit in later years. The trial court relied on Michigan’s strong policy against admitting evidence of subsequent remedial measures for the purpose of proving negligence. Crews v Gen*92eral Motors Corp, 400 Mich 208; 253 NW2d 617 (1977), and MRE 407. See, also, Judis v Borg-Warner Corp, 339 Mich 313; 63 NW2d 647 (1954), and Denolf v Frank L Jursik Co, 395 Mich 661; 238 NW2d 1 (1976).
We hold that the trial judge properly excluded the proffered evidence. MRE 407 reads:
"When, after an event, measures are taken which, if taken previously, would have made the event less likely to occur, evidence of the subsequent measures is not admissible to prove negligence or culpable conduct in connection with the event. This rule does not require the exclusion of evidence of subsequent measures when offered for another purpose, such as proving ownership, control, or feasibility of precautionary measures, if controverted, or impeachment.” Also see committee comments.
Exclusion under the rule restates a basic tenet which has long been accepted in Michigan. It encourages persons to improve their products, property, services and customs without risk of prejudicing any court proceeding and consequently delaying implementation of improvements. See Crews, supra, Denolf, supra, Judis, supra, Grawey v Genesee County Road Commission, 48 Mich App 742; 211 NW2d 68 (1973). Plaintiffs contention does not fall within any exceptions to the rule.
It is irrelevant that this is a product liability case. Plaintiffs argument that the evidence should have been admitted under his implied warranty count ignores the essence of his legal position on these facts. As the Court of Appeals stated:
"Inasmuch as the plaintiffs entire case was built around proof of an inadequate warning, a negligence concept, * * * the theoretical distinction between negligence and implied warranty may not be exploited to *93obviate the policy reasons for the exclusionary rule.” 69 Mich App 375, 387.
Plaintiff sought to have the evidence admitted to buttress his argument that the warnings were inadequate. In light of the recent adoption of MRE 407 and the Court’s continuing policy, the trial court’s action was entirely proper.
IV
The case is decided upon the instructional and evidentiary issues raised by plaintiff and is limited to its facts. We find no prejudicial or legal error on the part of the trial court.
It is conceded that the product was pure, but it is contended that the warning of its possible, if extremely rare, effect upon a hypersensitive person was inadequate. This is a negligence concept. Whether approached on the legal theory of implied warranty or of negligence, the proofs and the jury instructions would be the same in essential part. A duplication of instructions could be not only confusing but possibly misleading. The jury did not find the negligence urged by the plaintiff and essential to both theories. We find no legal error committed by the trial judge. Therefore, we affirm.
We also affirm the decision as to the issue of whether the court erred in precluding evidence of a subsequent change in the warning. The policy against allowing such evidence is well established in Michigan and continued in the new rules of evidence, specifically in MRE 407 which would be applicable in the requested new trial, so reversal on this point would be meaningless as well as improper. We find that the court did not err.
Affirmed.
*94Fitzgerald, Ryan, and Blair Moody, Jr., JJ., concurred with Coleman, C.J.
Kavanagh and Williams, JJ., concurred in the result.