Cooley v. Carter-Wallace Inc., CARTER-WALLACE

• Decision Date: 13 July 1984
• Docket Number: CARTER-WALLACE
• Citation: 478 N.Y.S.2d 375,102 A.D.2d 642
• Parties: Stanley COOLEY and Diane Cooley, Appellants, v.INCORPORATED, Respondent, and John N. Burgess, M.D., P.C., and John N. Burgess, M.D., Individually, Defendants.
• Court: New York Supreme Court — Appellate Division

Page 375

478 N.Y.S.2d 375

102 A.D.2d 642

Stanley COOLEY and Diane Cooley, Appellants, v. CARTER-WALLACE INCORPORATED, Respondent and John N. Burgess, M.D., P.C., and John N. Burgess, M.D. Individually, Defendants.

Supreme Court, Appellate Division,

Fourth Department.

July 13, 1984.

Schepp & D'Addario, Syracuse (Francis D'Addario, Syracuse, of counsel), for appellants.

Mackenzie, Smith, Lewis, Michell & Hughes, Syracuse (Catherine Gale, Syracuse, of counsel), for respondent.

Before HANCOCK, J.P., and DOERR, DENMAN, GREEN and MOULE, JJ.

GREEN, Judge.

The adequacy of the warning in a products liability case based on a failure to warn is, in all but the most unusual circumstances, a question of fact to be determined at trial. Special Term erred in this case finding the warning on the label of the product "Nair" adequate as a matter of law.

Plaintiff Stanley Cooley consulted a physician, defendant John N. Burgess, M.D. (not a party to this appeal), regarding a vasectomy. Dr. Burgess suggested that plaintiff use a depilatory cream such as "Nair" or "Neet" to shave his scrotum in preparation for surgery. Plaintiff then purchased a 6 oz. plastic container of "Nair" and applied the lotion on his scrotal area. The vasectomy was performed as scheduled, but shortly thereafter Mr. Cooley experienced a severe infection which eventually disintegrated his scrotum and caused a prolapse of his testicles. He was hospitalized for over a month and required reconstruction of his scrotum by application of a plastic mesh and a skin graft from his left thigh. Mr. Cooley alleged that as a result of using "Nair" he will have a permanent scar and hormonal deficiency and has suffered much pain, anxiety and embarrassment.

The back of the container of "Nair" included the following:

WARNING: IRRITATION OR ALLERGIC REACTION MAY OCCUR WITH SOME PEOPLE, EVEN AFTER PRIOR USE WITHOUT ADVERSE EFFECT. THEREFORE, TEST BEFORE EACH USE BY APPLYING NAIR ON A SMALL PART OF THE AREA WHERE HAIR IS TO BE REMOVED. FOLLOW DIRECTIONS AND WAIT 24 HOURS. IF SKIN APPEARS NORMAL, PROCEED. DO NOT USE ON IRRITATED, INFLAMED, OR BROKEN SKIN. KEEP AWAY FROM EYES. SHOULD NAIR TOUCH THE EYES, WASH THOROUGHLY WITH LUKEWARM WATER. RINSE WITH BORIC ACID SOLUTION AND IF IRRITATION OCCURS, CONSULT YOUR PHYSICIAN. KEEP OUT OF THE REACH OF CHILDREN. NAIR LOTION CAN BE USED ON LEGS, ARMS, FACE, ANYWHERE EXCEPT ... EYES, NOSE, EARS OR ON BREAST NIPPLES, PERIANAL (sic) OR VAGINAL/GENITAL AREAS.

Mr. Cooley acknowledged at an examination before trial that he read this label and was concerned about the exception for "vaginal/genital areas."

Special Term, in a brief memorandum, found that the warning on the label was adequate as a matter of law because it was "clear, precise and specific" and observed that "to ask anything further would be unreasonable." We disagree.

Whether brought under a negligence or strict tort liability theory, a products liability claim usually alleges a defect in either the manufacture, design or warning of a product. Unlike the often highly technical design or manufacturing defect cases, warning cases usually center on a factual determination of whether an adequate warning was given. These factual determinations are often interwoven with the question of whether the defendant manufacturer has a duty to warn, and if so, to whom that duty is owed.

Theoretically, a consumer buys a product after evaluating the risks in its use. But the consumer is not on an equal footing with the manufacturer who is in a unique position to know the specific risks involved. The imposition of the duty to give a warning of some kind involves a balancing test which weighs the seriousness of potential harm to the consumer against the costs to the manufacturer. Since the cost of providing warnings is often minimal, the balance usually weighs in favor of an obligation to warn. Once a warning is given, the focus shifts to the adequacy of the warning--the precise question before us on this appeal.

Many warning cases have involved prescription drugs (see e.g., Baker v. St. Agnes Hosp., 70 A.D.2d 400, 421 N.Y.S.2d 81 and cases cited therein; see also, Reyes v. Wyeth Laboratories, 5th Cir., 498 F.2d 1264, 1275, cert. den. 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688; Laturen v. Bolten Drug Co., Limited, 188 N.Y. 574, 80 N.E. 1112; Donigi v. American Cyanamid Co., 57 A.D.2d 760, 394 N.Y.S.2d 422, affd. 43 N.Y.2d 935, 403 N.Y.S.2d 894, 374 N.E.2d 1245). In fact, Special Term relied heavily on such a case from this court (Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, affd. 52 N.Y.2d 768, 436 N.Y.S.2d 614, 417 N.E.2d 1002). The drug cases are distinguishable, however, because the drug manufacturer's duty to warn is significantly different from that of other manufacturers' duty to warn. Unlike the ordinary consumer shopping in the marketplace, the patient does not freely choose his or her own medication. Often the patient will know very little about the drug prescribed by the doctor. Therefore, the manner of furnishing a warning for a drug to be marketed to the public differs from that which is feasible for ordinary consumer products (see Wolfgruber v. Upjohn Co., supra, pp. 60-61, 423 N.Y.S.2d 95). The drug manufacturer has a duty to warn the prescribing physician, not the consumer-patient. Indeed, this is an exception to the general rule that a manufacturer must warn users of the foreseeable dangers in its product (see Restatement of Torts § 402A ).

The peculiar facts involved in Wolfgruber v. Upjohn Co., supra, render that case particularly inapt here. There, plaintiff was a practicing physician for over 25 years. He prescribed the antibiotic Cleocin for himself. The defendant distributed the drug with package inserts warning of possible diarrhea and colitis, the precise malady plaintiff suffered after ingesting the drug during the course of self-treatment. Plaintiff conceded that he knew of the drug and in fact had prescribed it to 20 of his patients. Recognizing that "the extent of the required (drug) warnings or how they are to be disseminated has to date not been precisely formulated" and that "summary judgment or dismissal is uncommon in a negligence suit," this court held that "the warning given was adequate by any standard and the plaintiff as a doctor knew the risks of taking this particular drug whose side effects were those specifically warned against as fully as defendant was able" ( Wolfgruber v. Upjohn Co., supra, pp. 60, 62-63, 423 N.Y.S.2d 95).

In sharp contrast, defendant in the instant case did not warn of the specific risks involved if "Nair" is applied to the genital area. The label stated only that "irritation or allergic reaction may occur with some people." There is no evidence in the record to ascertain whether defendant in fact, knew, or should have known, of such dangers (see e.g., Baker v. St. Agnes Hosp., supra). Moreover, this court has been careful to confine the result in Wolfgruber to the unusual facts of that case (see McFadden v. Haritatos, 86 A.D.2d 761, 448 N.Y.S.2d 79).

The courts of this state have not yet formulated specific guidelines respecting the adequacy of a manufacturer's warning (see Cover v. Cohen, 61 N.Y.2d 261, 275-276, 473 N.Y.S.2d 378, 461 N.E.2d 864). Rather, our courts have required only in the most general terms that "warnings must clearly alert the user to avoid certain (unsafe) uses of the product which would appear to be normal and reasonable" (Lancaster Silo & Block Co. v. Northern Propane Gas Co., 75 A.D.2d 55, 65, 427 N.Y.S.2d 1009), noting that "the degree of danger is a crucial factor in determining the specificity required in a warning" (Lancaster Silo & Block Co. v. Northern Propane Gas Co., supra, p. 64, 427 N.Y.S.2d 1009) and that to be adequate, the warnings must be commensurate with the risk involved in the ordinary use of the product (see McLaughlin v. Mine Safety Appliance Co., 11 N.Y.2d 62, 69, 226 N.Y.S.2d 407, 181 N.E.2d 430).

Other jurisdictions, however, have specifically addressed the issue of what constitutes an adequate warning. The adequacy of a warning depends on the nature of the product and the context in which it is used (see Tuscon Industries, Inc. v. Schwartz, 15 Ariz.App. 166, 172, 487 P.2d 12, vacated on other grds., 108 Ariz. 464, 501 P.2d 936). An adequate warning or instruction is one that is understandable in content and conveys a fair indication of the nature and extent of the danger to a reasonably prudent person (see Bituminous Cas. Corp. v. Black & Decker Mfg. Co., Tex.Civ.App., 518 S.W.2d 868). The sufficiency of a warning is dependent upon both the language used and the impression that the language is calculated to make upon the mind of the average user of the product (see Harless v. Boyle-Midway Division, American Home Products, 5th Cir., 594 F.2d 1051, 1054).

There are several important considerations that directly affect the adequacy of a warning, including the location and conspiciousness of the warning and the method in which the warning is communicated to the ultimate user (see Cover v. Cohen, supra, 61 N.Y.2d p. 276, 473 N.Y.S.2d 378, 461 N.E.2d 864). Of critical importance is whether the warning sufficiently conveys the risk of danger associated with the product and is qualitatively sufficient to impart the particular risk of harm (see Berg v. Underwood's Hair Adaption Process, Inc., Fiorentino v. A.E. Staley Mfg. Co., 11 Mass.App. 428, 416 N.E.2d 998).

Likewise, a warning may be inadequate when the magnitude of the potential harm requires more. For example, in Johnson v. Husky Industries, Inc., 6th Cir., 536 F.2d 645, a caution to use charcoal only in ventilated areas was inadequate to warn of the risk of burning charcoal indoors. In Eddlemen v. Scalco, Tex.Civ.App. (484 S.W.2d 122), the word "flammable" affixed to a product was deemed inadequate when the real danger of the product was its explosive characteristics. In Chappuis v. Sears, Roebuck &...