Summary
holding that a doctor's departure from a manufacturer's direction or warnings is prima facie evidence of deviation from the standard of care if there is competent medical testimony that the patient's injury resulted from the doctor's failure to adhere to the recommendations
Summary of this case from Bowman v. Songer, JROpinion
December 31, 1984
Appeal from the Supreme Court, Westchester County, Morrie Slifkin, J.
Hurley, Fox, Selig Robustelli ( Ralph S. Joseph, Harry A. Fox and Anthony Occhipini of counsel), for appellant.
McHenry Gerver ( Elizabeth A. Horan and Robert J. McHenry of counsel), for The Presbyterian Hospital in The City of New York, respondent.
Garbarini, Scher DeCicco, P.C. ( George J. Kehayas of counsel), for Frank Boschenstein, respondent.
Simpson Thacher Bartlett ( Charles E. Koob and George M. Newcombe of counsel), for Winthrop Laboratories, respondent.
This action revolves around the use of the drug Talwin and its effect upon Patricia Paul (hereafter plaintiff). Although the products liability case against the drug manufacturer went to the jury and resulted in a defendant's verdict (which is supported by the record), the complaint as against the doctor and the hospital was dismissed at the conclusion of plaintiff's case. Plaintiff now argues that a prima facie case was made out when the package insert that accompanies each container of Talwin was received in evidence. After describing some of the adverse reactions that may follow ingestion of the drug, the insert recommends that daily dosage not exceed 360 milligrams. It is not disputed that the dosages prescribed in this case exceeded that amount.
It is plaintiff's contention that prescribing and injecting drugs in amounts exceeding their recommended dosages are evidence of departure from accepted standards of medical care sufficient to establish a prima facie case of malpractice without expert testimony. We are able to accept only part of that proposition. We agree that dosages in excess of those recommended by the manufacturer in a package insert are evidence of a deviation, but we do not accept that this evidence, standing alone, makes out a malpractice cause of action. The rule we adopt in disposing of this appeal is now in force in a number of States (see, e.g., Mulder v Parke Davis Co., 288 Minn. 332; Ohligschlager v Proctor Community Hosp., 55 Ill.2d 411; Mueller v Mueller, 88 S.D. 446; see, also, Winkjer v Herr, 277 N.W.2d 579, 585 [ND]). It provides that "[w]here a drug manufacturer recommends to the medical profession (1) the conditions under which its drug should be prescribed; (2) the disorders it is designed to relieve; (3) the precautionary measures which should be observed, and (4) warns of the dangers which are inherent in its use, a doctor's deviation from such recommendations is prima facie evidence of negligence if there is competent medical testimony that his patient's injury or death resulted from the doctor's failure to adhere to the recommendations" ( Mulder v Parke Davis Co., supra, pp. 339-340).
Generally, expert testimony is necessary to prove a deviation from accepted standards of medical care unless the matter is one which is within the experience and observation of the ordinary juror (see, e.g., McDermott v Manhattan Eye, Ear Throat Hosp., 15 N.Y.2d 20, 26; Meiselman v Crown Hgts. Hosp., 285 N.Y. 389). This is so because without expert assistance a jury will often have no understanding of what constitutes reasonable behavior in a complex and technical profession such as medicine. With respect to the proper dosage and usage of drugs, however, it is the manufacturer and not the practitioner, who is in the best position to provide such information (see Mulder v Parke Davis Co., 288 Minn. 332, 339-340, supra). Prior to marketing a drug, the manufacturer is required to subject it to stringent testing to ensure its effectiveness and its safety. It is the manufacturer which conducts the experiments that establish proper dosages and methods of application, not the practitioner who of necessity must rely on the information supplied by the manufacturers (see Mueller v Mueller, 88 S.D. 446, 452-453, supra). For these reasons, the Mulder rule is salutary and we make it our own.
In the instant case, we affirm dismissal of the complaint against the doctor and the hospital for failure to make out a prima facie case because there was no medical testimony adduced to establish that the excessive dosages were a proximate cause of plaintiff's ailments. What exists is evidence of deviation without evidence of its causative effect.
The jury verdict in favor of the defendant drug manufacturer was supported by the evidence while the complaint against the defendants doctor and hospital was properly dismissed at the close of plaintiff's case for failure to make out a prima facie case of negligence (see McDermott v Manhattan Eye, Ear Throat Hosp., 15 N.Y.2d 20, 24; Meiselman v Crown Hgts. Hosp., 285 N.Y. 389, 396).
LAZER, J.P., RUBIN and BOYERS, JJ., concur; O'CONNOR, J., concurs in the result, with an opinion.
Judgment of the Supreme Court, Westchester County, entered September 11, 1981, affirmed insofar as appealed from, with one bill of costs.