Wolfgruber v. Upjohn Co.

• Decision Date: 21 December 1979
• Citation: 423 N.Y.S.2d 95,72 A.D.2d 59
• Parties: Dr. Paul WOLFGRUBER, Respondent, v. The UPJOHN COMPANY, Appellant.
• Court: New York Supreme Court — Appellate Division

Page 95

423 N.Y.S.2d 95

72 A.D.2d 59

Dr. Paul WOLFGRUBER, Respondent, v. The UPJOHN COMPANY, Appellant.

Supreme Court, Appellate Division, Fourth Department.

Dec. 21, 1979.

Kernan & Kernan, P.C., Utica, for appellant (Andrea Lynch, Utica, of counsel).

Shults & Shults, Hornell, for respondent (Eric Shults, Hornell, of counsel).

Before CARDAMONE, J. P., and SIMONS, HANCOCK, DOERR and MOULE, JJ.

CARDAMONE, Justice Presiding.

Plaintiff, Dr. Paul Wolfgruber, has been a practicing physician for over 25 years. He prescribed defendant's antibiotic, Cleocin, for an infection he developed in 1974 and followed a course of self-treatment. The defendant, Upjohn Company, distributed free samples of Cleocin to the medical profession which contained package inserts warning of possible diarrhea and/or colitis from ingesting the drug. The Physician's Desk Reference also contained similar warnings respecting the use of Cleocin. This is the precise malady incurred by plaintiff as a result of his course of self-treatment. Plaintiff conceded that he knew of the drug since at least 1974 when defendant's "detail man" gave him free samples with descriptive literature. Prior to taking the drug himself, he prescribed it to 20 of his patients. His strict products liability and breach of warranty of merchantability of fitness suit against defendant withstood a motion for summary judgment to dismiss them. We reverse.

This drug products liability and warranty suit against Upjohn is based not on the failure of its drug to effect a cure, but rather on the conduct of the manufacturer in subjecting the consumer to a risk of side effects. Whether such a claim is legally viable is dependent upon an assessment of the adequacy of the warnings or precautions provided by the manufacturer to the medical community which dispenses prescriptions.

Although New York courts have for a long time consistently held that there is a duty to warn and properly label drugs (Laturen v. Bolton Drug Co., 188 N.Y. 574, 80 N.E. 1112; Thomas v. Winchester, 6 N.Y. 397; 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; Halloran v. Parke, Davis & Co., 245 App.Div. 727, 280 N.Y.S. 58; Wechsler v. Hoffman LaRoche, 198 Misc. 540, 99 N.Y.S.2d 588, mod. 279 App.Div. 654, 108 N.Y.S.2d 990; Marcus v. Specific Pharmaceuticals, 191 Misc. 285, 77 N.Y.S.2d 508; Fagan v. McRae, App.Div., n. o. r., 169 N.Y.S. 577), the extent of the required warnings or how they are to be disseminated has to date not been precisely formulated. Because 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, the federal statute and regulations enumerate specific requirements for drug labeling (21 U.S.C. § 352-353; 21 CFR Parts 201-202; 310). With the exception of oral contraceptives (see 21 CFR § 310.501), the warnings are not found in the packaging of the drug, but are furnished instead to the medical community as the "informed intermediary" between the manufacturer and the patient (see e. g., Magee v. Wyeth Laboratories, 214 Cal.App.2d 340, 29 Cal.Rptr. 322; McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522; Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206). Since non-medical consumers are legally precluded from "self-prescribing" prescription drugs, the physician's function is to evaluate a patient's needs, assess the risks and benefits of available drugs and then prescribe a drug, advising the patient of its risks and possible side effects (Magee v. Wyeth Laboratories, supra; Parke, Davis & Co. v. Mayes, 124 Ga.App. 224, 183 S.E.2d 410; Kasperowitz v. Schering Corp., 70 N.J.Super. 397, 175 A.2d 658).

Thus, the manufacturer's liability, if any, is directly related to the adequacy of the warning provided (see generally, Merrill Compensation for Prescription Drug Injuries, 59 Va.L.Rev. 1; Rheingold, Products Liability The Ethical Drug Manufacturer's Liability, 18 Rutgers L.Rev. 947; Willig, The Comment "K" Character: A Conceptual Barrier to Strict Liability, 29 Mercer L.Rev. 545). The scope of the warning is the key factor in a drug products liability suit because prescription drugs are "unavoidably unsafe products". As explained in Comment "K" of the Restatement (Second) of Torts, § 402A: ". . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it Unreasonably dangerous . . . (M)edical experience . . . justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use . . . ."

Other states have held that the sufficiency of a manufacturer's warning for a prescription drug is generally a question of fact for the jury (see, e. g., Love v. Wolf, 226 Cal.App.2d 378, 38 Cal.Rptr. 183; Smith v. Squibb, 69 Mich.App. 375, 245 N.W.2d 52, affd. 405 Mich. 79, 273 N.W.2d 476). However, where the warning given to the prescribing physician by the manufacturer through the Physician's Desk Reference (PDR), package inserts and other literature gives specific detailed information on the risks of the drug, the manufacturer has been held absolved from liability as a matter of law (Magee v. Wyeth Laboratories, Supra; Carter v. Metropolitan Dade County, (Fla.App.) 253 So.2d 920, cert. den. (Fla.) 263 So.2d 584; Nolan v. Dillon, 261 Md. 516, 276 A.2d 36). Recently the Second Department considered a case similar to the one before us and concluded that there was a question of fact (Baker v. St. Agnes Hospital (Eli Lilly Co.), App.Div., 421...