McEwen v. Ortho Pharmaceutical Corp.

• Decision Date: 15 November 1974
• Citation: 270 Or. 375,528 P.2d 522
• Parties: Freda McEWEN, Respondent, v. ORTHO PHARMACEUTICAL CORPORATION and Syntex Laboratories, Inc., Appellants.
• Court: Oregon Supreme Court

Page 522

528 P.2d 522

270 Or. 375

Freda McEWEN, Respondent, v. ORTHO PHARMACEUTICAL CORPORATION and Syntex Laboratories Inc., Appellants.

Supreme Court of Oregon.

Argued and Submitted Jan. 10, 1974.

Decided Nov. 15, 1974.

Edwin J. Peterson, Portland, argued the cause for appellant Ortho Pharmaceutical Corp. With him on the brief were Tooze, Kerr & Peterson, and Souther, Spauding, Kinsey, Williamson & Schwabe, Portland

Sheila L. Birnbaum, New York City, argued the cause for appellant Syntex Laboratories. On the brief were Bruce Spaulding, and Souther, Spaulding, Kinsey, Williamson & Schwabe, Portland.

J. Harold Williams, of Michaud, Cranmer, Syrios & Post, Wichita, Kan., and Roger Tilbury, Portland, argued the cause for respondent. With them on the brief were Bruce J. Rothman, and Martindale, Ruben & Rothman, Portland.

Before O'CONNELL, C.J., and McALLISTER, DENECKE, ^* HOLMAN, HOWELL and BRYSON, JJ.

HOWELL, Justice.

This is a negligence action involving the liability of a manufacturer of ethical drugs ¹ for its alleged failure to make timely, adequate warnings to the medical profession of dangers which the manufacturer knows, or has reason to know, are inherent in the use of its drug.

Freda McEwen brought this action against defendants, Ortho Pharmaceutical Corporation and Syntex Laboratories, Inc. (hereinafter Ortho and Syntex, respectively), to recover damages for blindness in her right eye and injuries to her left eye. In her complaint, Mrs. McEwen alleged that each defendant failed to adequately warn the medical profession concerning the dangerous propensities of its oral contraceptive to cause circulatory and visual damage. She further alleged that her combined use of defendants' drugs resulted in ocular injuries. Both defendants appeal from a jury verdict for plaintiff.

Defendants assign a total of 26 errors to the proceedings below, but their principal assignments of error arise from the trial court's denial of defendants' motions for a judgment of involuntary nonsuit and for a directed verdict. In our consideration of the propriety of the trial court's refusal to grant such motions, the plaintiff is entitled to the benefit of every reasonable inference which may be drawn from the evidence; such inferences may be drawn from defendants' as well as plaintiff's evidence. Scott v. Mercer Steel/Edwards Realty, 263 Or. 464, 466--467, 503 P.2d 1242 (1972); Phillips v. Colfax Co., 195 Or. 285, 302--303, 243 P.2d 276, 245 P.2d 898 (1952). Moreover, all evidence must be interpreted in the light most favorable to the plaintiff, and it is beyond our power to weigh or evaluate conflicting evidence. Schweiger et ux. v. Solbeck et ux., 191 Or. 454, 471, 230 P.2d 195, 29 A.L.R.3d 435 (1951). See also Kraxberger v. Rogers, 231 Or. 440, 449, 373 P.2d 647 (1962); Oregon Constitution, amended Article VII, § 3.

Our sole concern is whether there was sufficient evidence to submit the case to the jury. The validity of the trial court's determinations depends upon whether there was substantial evidence that each defendant failed to adequately warn the medical profession of the pertinent dangerous propensities of its oral contraceptive and, if so, whether there was also substantial evidence that this failure caused plaintiff's injuries. With this perspective, we set forth Defendants' oral contraceptives involved herein are chemically identical. Syntex calls its product 'Norinyl,' while 'Ortho-Novum' is the trade name used by Ortho, Each contraceptive consists of 2 milligrams of the progestogen norethindrone and 0.1 milligram of the estrogen mestranol. Syntex and Ortho have coordinated their efforts to discover the dangerous propensities of this compound by sharing information, undertaking joint animal studies, and exchanging reports of adverse reactions.

the factual chronology which produced this litigation.

Mrs. McEwen began using Norinyl on December 3, 1966. In the following months she experienced severe headaches, nausea, falling hair, swollen ankles and feet, and a constant backache. Beginning in July, 1967, plaintiff discontinued her use of the drug for three months, and during this period these symptoms subsided. She resumed her use of Norinyl in October. Within a short time she began to experience difficulty with her vision. In November, 1967, plaintiff called Kaiser Hospital in Portland and reported that she was losing the sight in her right eye. The following month she began to cough up blood. On December 20, 1967, an examining physician at Kaiser changed plaintiff's prescription from Norinyl to Ortho-Novum oral contraceptives.

Dr. Sutton, an ophthalmologist with Kaiser Hospital, examined plaintiff on January 2, 1968. He noted that Mrs. McEwen's eyes did not focus properly. He also found her eyeballs to be bulging and diagnosed the condition as nearsightedness. He observed no other abnormalities in her eyes at that time. Plaintiff informed Dr. Sutton that she was taking Ortho-Novum.

About 11 months later, on December 5, 1968, plaintiff noticed two vivid black lines come across the field of vision in her right eye. She blinked, and the lines disappeared. Similar lines appeared a few days later, followed by black dots which seemed to fill her right eye. Dr. Neville, an ophthalmologist, examined Mrs. McEwen on December 9, 1968, and observed a growth of abnormal new blood vessels extending out from the retina ² into the vitreous ³ of her right eye. Dr. Neville further noted a vitreous hemorrhage in plaintiff's right eye. On December 11, 1968, Dr. Sutton again examined plaintiff, finding retinal hemorrhages and essentially confirming Dr. Neville's diagnosis.

Mrs. McEwen noticed a change in the vision in her left eye on December 21, 1968, which she described as 'streaks or looking through gelatin.' Dr. Burns of the University of Oregon Medical School advised the plaintiff to discontinue her use of oral contraceptive and she did not take Ortho-Novum after December 22, 1968. ⁴ To stop the hemorrhaging, Dr. Burns performed photocoagulation operations on plaintiff's right eye. ⁵ Later, Dr. McPherson, a retinal specialist, photocoagulated Mrs. McEwen's left eye.

Plaintiff's right eye is totally and permanently blind. Her left eye now tires more easily than before and bears the scars of photocoagulation.

With these facts in mind, we proceed to the legal issues raised by this appeal. Plaintiff's sole theory of recovery in this negligence action is founded upon the alleged We will first examine the scope of defendants' duty.

                failure of defendants to adequately warn the medical profession of the dangerous propensities of their oral contraceptives.  Therefore, it was for the court to initially determine 'whether the defendant owed any duty whatsoever to the plaintiff with respect to the type of harm suffered by the plaintiff[270 Or. 385]  * * *.'  Dewey v. A. F. Klaveness & Co., 233 Or. 515, 541, 379 P.2d 560, 573 (1963) (O'Connell, J., concurring).  6  Next, it was incumbent upon plaintiff to prove that there had been a breach of duty by each defendant.  Plaintiff finally had to prove that the negligent acts or omissions of each defendant had been a substantial factor in physically causing the damage of which she complained.  7
                

I. DEFENDANTS' DUTY TO WARN PLAINTIFF'S DOCTORS

There is no question here of any defect in the manufacture of defendants' oral contraceptives, nor of their efficacy when taken as prescribed. It is well settled, however, that the manufacturer of ethical drugs bears the additional duty of making timely and adequate warnings to the medical profession of any dangerous side effects produced by its drugs of which it knows, or has reason to know. E.g., Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966); Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390 (8th Cir. 1969); Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653 (1973); Love v. Wolf, 226 Cal.App.2d 378, 38 Cal.Rptr. 183 (1964); Krug v. Sterling Drug, Inc., 416 S.W.2d 143 (Mo.Sup.Ct.1967); See 2 Restatement (Second) of Torts 300, § 388 (1965). ⁸

The duty of the ethical drug manufacturer to warn is limited to those dangers which the manufacturer knows, or has reason to know, are inherent in the use of its drug. However, the drug manufacturer is treated as an expert in its particular field, and is under a 'continuous duty * * * to keep abreast of scientific developments touching upon the manufacturer's product and to notify the medical profession of any additional side effects discovered from its use.' Schenebeck v. Sterling Drug, Inc., 423 F.2d 919, 922 (8th Cir. 1970); Accord O'Hare v. Merck & Co., 381 F.2d 286, 291 (8th Cir. 1967). The drug manufacturer's duty to warn is, therefore, commensurate not only with its actual knowledge gained from research and adverse reaction reports but also with its Although the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, ⁹ the manufacturer is directly liable to the patient for a breach of such duty. See Schenebeck v. Sterling Drug, Inc., supra; Love v. Wolf, supra. The manufacturer's compliance with this duty enables the prescribing physician to balance the risk of possible harm against the benefits to be gained by the patient's use of that drug. Moreover, as observed by the court in Sterling Drug, Inc. v. Cornish, supra 370 F.2d at 85:

constructive knowledge as measured by scientific literature and other available means of communication.

'* * * (T)he purchaser's doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellant chance that injury to the patent can be avoided. This is particularly true if the injury takes place slowly * * *.'

Although the ethical drug manufacturer's duty to warn has been discussed most often with...