Smith v. E. R. Squibb & Sons, Inc., Docket No. 19119

• Decision Date: 14 June 1976
• Docket Number: Docket No. 19119
• Citation: 245 N.W.2d 52,69 Mich.App. 375
• Parties: Eddie SMITH, Jr., Administrator of the Estate of Shirley Smith, Deceased, Plaintiff-Appellant, v. E. R. SQUIBB AND SONS, INC., a Delaware Corporation, et al., Defendants- Appellees. 69 Mich.App. 375, 245 N.W.2d 52
• Court: Court of Appeal of Michigan — District of US

Page 52

245 N.W.2d 52

Eddie SMITH, Jr., Administrator of the Estate of Shirley Smith, Deceased, Plaintiff-Appellant, v. E. R. SQUIBB AND SONS, INC., a Delaware Corporation, et al Defendants- Appellees.

Docket No. 19119.

69 Mich.App. 375, 245 N.W.2d 52

Court of Appeals of Michigan.

June 14, 1976.

Rehearing Denied Aug. 17, 1976.

Released for Publication Sept. 9, 1976.

[69 MICHAPP 377] Barbara & Wisok, P.C., by Peter R. Barbara, Detroit, for plaintiff-appellant.

Plunkett, Cooney, Rutt, Watters, Stanczyk & [69 MICHAPP 378] Pedersen by W. P. Cooney and John P. Jacobs, Detroit, for Squibb.

Kitch, Suhrheinrich & Getto, P.C., by Gregory G. Drutchas, Detroit, for hospital.

Kerr, Wattles & Russell by Donald C. Morgan, Detroit, for Kozlinski.

Vandeveer, Garzia, Tonkin, Kerr & Heaphy by Edmund M. Brady, Jr., Detroit, for Dolan.

Matheny, Schureman & Frakes by Charles F. Glass, Detroit, for Scerhelmi.

Before BASHARA, P.J., and WALSH and WHITE, JJ.

WALSH, Judge.

This is a wrongful death action in which a Wayne County jury returned a verdict of no cause of action in favor of the defendant E. R. Squibb and Sons, Inc. ¹ Indisputably the decedent's death followed the injection of a drug manufactured by Squibb. There was no question of any defect in the manufacture of the drug itself, nor of its beneficial qualities when administered as prescribed. The plaintiff contends, however, that Squibb failed properly to warn the medical profession of the dangerous propensities of the drug and of precautionary measures which should be taken following its administration.

On April 14, 1969, plaintiff's decedent Shirley Smith visited her physician, Dr. Kozlinski, complaining of pains on her right side. A possible right pyelonephritis (inflammation of the kidney) was diagnosed and the patient was referred to St. Joseph Mercy Hospital for an intravenous pyelogram test (essentially a kidney X-ray).

This particular test involves the injection of an X-ray contrast medium, Renografin-60 into the veins. As a contrast medium, Renografin-60 helps to visualize the operation of the kidneys during the X-ray procedure. Dr. Scerhelmi administered the drug to the decedent. Following the injection Mrs. Smith became nauseous, began foaming at the mouth, [69 MICHAPP 379] slipped into acute anaphylactic shock ² and fainted. Despite efforts taken to revive her Mrs. Smith eventually expired and the cause of death was determined to be acute anaphylactic reaction.

Renografin-60, a 60% Iodine solution manufactured by Squibb, was shipped to St. Joseph Hospital in nested cases of 25 bottles, each bottle or vial containing 30 cc. Warning slips ³ were loosely packed within each case but were not attached to the vials themselves, and no warning of any kind appeared on the vial labels. While the cases of Renografin-60 were stored in the hospital's pharmacy, the individual bottles were placed in the X-ray rooms. Thus no warning at all accompanied the bottles to the X-ray rooms where the drug was customarily administered.

It was developed at trial that, aside from the package inserts, there were at least two other methods of conveying information, warnings and instructions as to the use of Renografin-60 to those who used the drug. The first is by publishing the information in the Physicians' Desk Reference to Pharmaceutical Specialties and Biologicals (PDR). The second is by employing company representatives called 'detail men' to instruct users of the drug.

PDR is an annual publication of all major drug [69 MICHAPP 380] products and it contains information as to their use, warnings and instructions supplied by the manufacturers and descriptions of procedures used to minimize the dangers of adverse reactions. The PDR contained no information regarding the effects of Renografin-60 in its 1969 publication.

'Detail men' are manufacturer's agents who have regular contact with physicians. It was specifically alleged by the plaintiff that Squibb's detail man for St. Joseph Hospital, Harold Statts, had not thoroughly discussed with Dr. Scerhelmi the precautionary measures which ought to be taken when administering Renografin-60, nor was Statts aware that Dr. Scerhelmi, a non-radiologist, was administering the drug.

I.

WHETHER THE TRIAL COURT ERRED IN DIRECTING A VERDICT IN DEFENDANT'S FAVOR ON THE ISSUE OF BREACH OF AN IMPLIED WARRANTY.

The plaintiff's case was presented under the traditional products liability theories of negligence and implied warranty. The theory of the plaintiff's warranty claim against Squibb was that Squibb failed to warn the medical profession effectively as to the dangers inherent in the use of the drug and as to precautions to be taken in its administration, that this failure constituted a defect in the drug, and that this defect was the proximate cause of the death. These latter two elements of proof--a defect attributable to the manufacturer and an injury resulting therefrom--are, of course, essential to a cause of action based on breach of an implied warranty. Piercefield v. Remington Arms Company, Inc., 375 Mich. 85, 96, 133 N.W.2d 129 (1965); Cova v. Harley-Davidson Motor Co., 26 Mich.App. 602, 612, 182 N.W.2d 800 (1970).

[69 MICHAPP 381] At the close of the plaintiff's proofs the trial judge directed a verdict for Squibb on the warranty claim on the ground that there was no evidence that Renografin-60 was unfit for the purposes it was intended to serve. ⁴ The court permitted the case to go to the jury on the negligence theory alone based on an alleged failure to give adequate warning to the medical profession.

This court has held that a product which is otherwise free from defect, can be defective because of the manufacturer's failure to warn of dangers associated with its use. Gutowski v. M & R Plastics & Coating, Inc.,60 Mich.App. 499, 231 N.W.2d 456 (1975). Further it has long been 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. Manzoni v. Detroit Coca-Cola Bottling Co., 363 Mich. 235, 109 N.W.2d 918 (1961).

Under both the implied warranty theory and the negligence theory, however, there must be (1) a standard by which the negligent; and (2) proofs evidencing the product is defective or the manufacturer negligent; and (2) proof evidencing the fact that the condition of a particular product (implied warranty) or the conduct of a particular manufacturer (negligence) failed to meet the standard.

Our review of the record in this case leads us to the conclusion that the standard and the proofs under plaintiff's implied warranty theory are coextensive with and identical to the standard and proofs under plaintiff's negligence theory.

It is the duty of the ethical drug manufacturer ⁵ to warn the medical profession of any dangerous propensities of a drug which are known or should be known to the manufacturer. ⁶ The sufficiency of the warning is a matter of reasonableness and as such, it is generally a question for the trier of fact. Nolan v. Dillon, 261 Md. 516, 523, 276 A.2d 36, 40 (1971); Sterling Drug Inc. v. Cornish, 370 F.2d 82, 84 (CA 8, 1967); Love v. Wolf, 226 Cal.App.2d 378, 395, 38 Cal.Rptr. 183, 192--193 (1964). 'The 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 v. M & R Plastics & Coating, Inc., supra, 60 Mich.App. at pp. 507--508, 231 N.W.2d at p. 461, quoting from Prosser, Torts (4th ed.), § 31, p. 145. The type of evidence considered in determining whether the duty has been discharged will include the degree of risk posed by the drug's dangerous propensities and the difficulties inherent in bringing the warning home to the medical profession. McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 390, 528 P.2d 522, 530 (1974).

We recognize that normally the concept of warranty is not based on the failure to exercise reasonable care. But in this case the alleged defect in the product is really a failure to provide a warning 'reasonable under the circumstances'. Sterling Drug, Inc. v. Yarrow, 408 F.2d 978, 993 (CA 8, 1969). [69 MICHAPP 383] Hence, we are back to the tort concept of reasonable care.

Thus plaintiff's argument runs full circle. He correctly contends that under the implied warranty theory all that need be proven is a defect attributable to the manufacturer and an injury resulting from the defect. It is not necessary to prove negligence. In this case, however, there is no defect unless the defendant was negligent, that is unless the defendant failed to meet that standard of care which was reasonable under the circumstances in providing adequate warnings to users of the drug.

Stated in another way, it is obvious that a drug will be dangerous if used by someone who has no knowledge either of its propensities to cause unusual reactions or of the precautionary measures to be taken to avoid such reactions. However, even if Squibb had used every means of communication suggested by the plaintiff, it might still have happened that a particular technician failed to receive the necessary information. Therefore Renografin-60 was not a defective product because Dr. Scerhelmi did not receive the warnings. The drug was defective only if Squibb did not use reasonable means to communicate the warnings to those who, in the normal course of events, would use the drug. Reasonable means of communication are those means which reasonable prudence would require under the same or similar circumstances. See Hill v. Husky Briquetting, Inc., 54 Mich.App. 17, 220 N.W.2d 137 (1974). Hence under the facts of this case the standard for determining whether the product was defective is the same as the standard for determining whether the drug company was negligent and the proofs required are identical.

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