Smith v. E. R. Squibb & Sons, Inc.

• Decision Date: 10 January 1979
• Docket Number: No. 5,Docket No. 58894,5
• Citation: 26 UCC Rep.Serv. 330,405 Mich. 79,273 N.W.2d 476
• Parties: Eddie SMITH, Jr., Administrator of the Estate of Shirley Smith, Deceased, Plaintiff-Appellant, v. E. R. SQUIBB & SONS, INC., a Delaware Corporation, Defendant-Appellee, and St. Joseph Mercy Hospital, Anthony F. Kozlinski, M.D., Edward Dolan, M.D., and Maria Scerhelmi, M.D., Jointly and Severally, Defendants. Calendar405 Mich. 79, 273 N.W.2d 476, 26 UCC Rep.Serv. 330
• Court: Michigan Supreme Court

Page 476

273 N.W.2d 476

Eddie SMITH, Jr., Administrator of the Estate of Shirley Smith, Deceased, Plaintiff-Appellant, v. E. R. SQUIBB & SONS, INC., a Delaware Corporation Defendant-Appellee and St. Joseph Mercy Hospital, Anthony F. Kozlinski, M.D Edward Dolan, M.D., and Maria Scerhelmi, M.D. Jointly and Severally, Defendants.

Docket No. 58894.

Calendar No. 5.

405 Mich. 79, 273 N.W.2d 476, 26 UCC Rep.Serv. 330

Supreme Court of Michigan.

Argued April 11, 1978.

Decided Jan. 10, 1979.

Peter R. Barbara and Frank G. Becker, Detroit, for plaintiff-appellant.

Plunkett, Cooney, Rutt, Watters, Stanczyk & Pedersen by W. P. Cooney, John P. Jacobs, Detroit, for defendant Squibb.

COLEMAN, Chief Justice.

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 doctors 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 was 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 N.W.2d 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 certain 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 placed 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". Detail 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 plaintiff's 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 P.2d 522 (1974); Sterling Drug, Inc. v. Yarrow, 408 F.2d 978, 993 (C.A. 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 F.2d 121 (C.A. 9, 1968). Determination of 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 N.W.2d 381 (1970); Piercefield v. Remington Arms Co., 375 Mich. 85, 96-99, 133 N.W.2d 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 N.W.2d 456 (1975); Berkebile v. Brantly Helicopter Corp., 225 Pa.Super. 349, 311 A.2d 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, 245 N.W.2d 52, 55 (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 existence 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...