637 F.2d 87 (2nd Cir. 1980), 848, Lindsay v. Ortho Pharmaceutical Corp.

Docket Nº:848, Docket 79-7706.
Citation:637 F.2d 87
Party Name:Nancy C. LINDSAY and Bruce H. Lindsay, Plaintiffs-Appellees, v. ORTHO PHARMACEUTICAL CORPORATION, Defendant-Appellant.
Case Date:December 08, 1980
Court:United States Courts of Appeals, Court of Appeals for the Second Circuit

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637 F.2d 87 (2nd Cir. 1980)

Nancy C. LINDSAY and Bruce H. Lindsay, Plaintiffs-Appellees,



No. 848, Docket 79-7706.

United States Court of Appeals, Second Circuit

December 8, 1980

Argued April 2, 1980.

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[Copyrighted Material Omitted]

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David F. Dobbins, New York City (Patterson, Belknap, Webb & Tyler, George S. Frazza, Karl E. Seib, Jr., Theodore B. Van Itallie, Jr., Fred J. Baumann and Robert W. Sparks, New York City, on brief), for defendant-appellant.

Roger P. McTiernan, Bridgett A. Lundy, New York City (Barry, McTiernan & Moore, New York City, on brief), for plaintiffs-appellees.

Before VAN GRAAFEILAND and NEWMAN, Circuit Judges, and GOETTEL, District Judge. [*]


Ortho Pharmaceutical Corporation (Ortho) appeals from a judgment entered against it in the United States District Court for the Eastern District of New York for injuries allegedly resulting to Nancy C. Lindsay (plaintiff) from the use of oral contraceptives manufactured by Ortho. The jury awarded $750,000 to Mrs. Lindsay and $75,000 to her husband on his derivative claim. Because of error in the proceedings below, we reverse and remand for a new trial.

Ortho is a New Jersey corporation which manufactures an oral contraceptive called Ortho-Novum. This drug is used principally for birth control purposes and is obtainable only by prescription. Mrs. Lindsay began to use Ortho-Novum in December 1965, shortly after she gave birth to her second child. While still in the hospital, plaintiff inquired of her obstetrician and gynecologist, Dr. Bruce Harris, about the use of oral contraceptives. After some discussion of potential side effects, Dr. Harris prescribed Ortho-Novum.

At plaintiff's six-week post-delivery checkup, she reported to Dr. Harris that she was experiencing a tingling feeling and some numbness on the right side of her body, and Dr. Harris sent her to a neurologist, Dr. Edward Vastola. On February 19, 1966, Dr. Vastola reported to Dr. Harris that the entire neurological examination was normal except for a questionable impairment of vibratory sense in both lower extremities. He stated that these symptoms indicated a possibility of multiple sclerosis but that the relevant evidence was insufficient to merit serious discussion of this possibility with the plaintiff or to warrant more extensive neurological diagnostic procedures at that time. Neither Dr. Harris

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nor Dr. Vastola recommended discontinuance of Ortho-Novum.

In March 1967, plaintiff returned to Dr. Harris for her annual checkup. Although the numbness and tingling sensations were not then as severe as before, she had developed some brown facial blotches. Because of the blotches, Dr. Harris advised plaintiff to stop using Ortho-Novum and recommended instead the use of a diaphragm. It is unclear from the record whether plaintiff followed her doctor's advice. It does appear, however, that between March and September 1967 there was at least a one-month period during which she took no pills.

In May 1967, plaintiff decided to get a second opinion concerning her neurological problems. She went to her family internist, Dr. Clifford M. Weingarten, who referred her to Dr. Edward P. Ryan, a neurological surgeon. Dr. Ryan reported to Dr. Weingarten that plaintiff's neurological examination was completely normal. He dismissed the possibility of multiple sclerosis and saw no need for a more extensive neurological work-up. A copy of this report was sent to Dr. Harris.

In September 1967, Dr. Harris sent plaintiff a new prescription for Ortho-Novum. Although Dr. Harris testified that this prescription was for only a six-month supply of pills, plaintiff continued to have it refilled at her pharmacy until February 1970. At that time the pharmacy informed her she would need a new prescription if she wanted more pills. Instead of returning to Dr. Harris whom she had not seen since March 1967, plaintiff went, on the recommendation of a neighbor, to a Planned Parenthood clinic. She was examined there by Dr. Robert Van Son, who gave her a prescription for a six-month supply of Ortho-Novum. When plaintiff returned to Planned Parenthood for a checkup on October 9, 1970, her blood pressure was found to be abnormally high. She was told to stop using oral contraceptives for one month and was referred back to Dr. Weingarten for treatment of the blood pressure problem. She did not use Ortho-Novum thereafter.

Dr. Weingarten treated plaintiff until early January 1971, when he again referred her to Dr. Ryan because of a recurrence of neurological symptoms. On January 16, 1971, plaintiff was hospitalized by Dr. Ryan after apparently suffering a stroke. Dr. Arthur Rosen, then Assistant Professor of Neurology at the State University of New York, Stonybrook, examined her at Dr. Ryan's request and concluded that she had suffered an ischemic cerebral vascular accident.

This action was commenced by Mrs. Lindsay and her husband on October 3, 1972. Although the complaint named both Ortho and Dr. Harris as defendants, plaintiffs agreed just prior to trial to discontinue as against Dr. Harris. The case against Ortho went to the jury under the doctrine of strict products liability. Following the verdict, Ortho's motion for judgment n. o. v., or alternatively for a new trial, was denied by the district judge in a lengthy opinion. See Lindsay v. Ortho Pharmaceutical Corp., 481 F.Supp. 314 (E.D.N.Y.1979). This appeal followed.

Under the substantive law of New York, which is controlling herein, Wright v. Carter Products, 244 F.2d 53, 56-57 (2d Cir. 1957), a drug manufacturer, like any other manufacturer, can be held liable for a defective product under the theory of strict products liability. Baker v. St. Agnes Hospital, 70 App.Div.2d 400, 404, 421 N.Y.S.2d 81 (1979). Unlike most other products, however, ethical or prescription drugs may cause untoward side effects despite the fact that they have been carefully and properly manufactured. For purposes of strict products liability, these drugs, aptly described as "(u)navoidably unsafe products", are not deemed defective or unreasonably dangerous so long as they are accompanied by proper directions for use and adequate warnings as to potential side effects. Wolfgruber v. Upjohn Co., 72 App.Div.2d 59, 61, 423 N.Y.S.2d 95 (1979) (citing Restatement (Second) of Torts § 402A, Comment k (1965)). A plaintiff who seeks recovery for an injurious side effect from a properly manufactured prescription drug must prove

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that the drug caused her injury and that the manufacturer breached a duty to warn of the possibility that the injurious reaction might occur.

Although the issue of causation was hotly disputed, the causal connection between plaintiff's use of Ortho-Novum and her stroke was for the jury. Assuming that all the evidence on this issue was properly admitted, it was sufficient to support the verdict. 1 The issue of adequate warning presents a different picture.

The manufacturer's duty is to warn of all potential dangers which it knew, or in the exercise of reasonable care should have known, to exist. Baker v. St. Agnes Hospital, supra, 70 App.Div.2d at 405, 421 N.Y.S.2d 81; Tinnerholm v. Parke Davis & Co., 285 F.Supp. 432, 451 (S.D.N.Y.1968), aff'd on other grounds, 411 F.2d 48 (2d Cir. 1969). The duty is a continuous one, requiring the manufacturer to keep abreast of the current state of knowledge of its products as gained through research, adverse reaction reports, scientific literature, and other available methods. Baker v. St. Agnes Hospital, supra, 70 App.Div.2d at 406, 421 N.Y.S.2d 81. Except where FDA regulations otherwise provide, the manufacturer's duty is to warn the doctor, not the patient. The doctor acts as an "informed intermediary" between the manufacturer and the patient, evaluating the patient's needs, assessing the risks and benefits of available drugs, prescribing one, and supervising its use. Wolfgruber v. Upjohn Co., supra, 72 App.Div.2d at 61, 423 N.Y.S.2d 95.

Plaintiff was seen by five doctors prior to her stroke, two prescribing physicians and three treating physicians. Any of them could have instructed her to stop using Ortho-Novum. However, the jury heard testimony from the prescribing doctors only. We are persuaded from our review of the record that, before and during the trial, neither party was concerned about what warning, if any, should have been given the treating physicians. The theory that liability could be premised on the inadequacy of warnings to those doctors does not appear to have crystallized until the time of the court's charge.

The district judge commenced his charge on this issue by instructing the jury that the defendant was under a duty to give timely and adequate warnings to the medical profession of dangerous side effects which, in the exercise of reasonable care, it knew or should have known to exist. He then charged that this duty applied to both the prescribing physicians and to those who might reasonably be expected to be treating physicians. He stated that the defendant was required to give each doctor such information as he might reasonably be foreseen to need in order to prescribe for, warn, and treat his patient. In determining this need, the jury was instructed to take into account "what education the doctors to whom these notices come may reasonably be expected to have had, how specialized the area of knowledge is concerning which they are being advised, and the consequences or risks of a failure adequately to warn the doctors."

It is somewhat misleading to say that defendant owed a duty to warn the "medical profession". We are not concerned here with whether adequate warnings were given to chiropodists in...

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