Bine v. Sterling Drug, Inc.

• Decision Date: 08 January 1968
• Docket Number: No. 52863,No. 1,52863,1
• Citation: 422 S.W.2d 623
• Parties: Joseph BINE, Respondent, v. STERLING DRUG, INC., Appellant
• Court: Missouri Supreme Court

Page 623

422 S.W.2d 623

Joseph BINE, Respondent, v. STERLING DRUG, INC., Appellant.

No. 52863.

Supreme Court of Missouri, Division No. 1.

Jan. 8, 1968.

Thomas C. Hullverson, Hullverson, Richardson & Hullverson, St. Louis, for respondent.

Wilton D. Chapman, Arthur Litz, St. Louis, for defendant-appellant, Sterling Drug, Inc.

HIGGINS, Commissioner.

Appeal from $125,000 remitted judgment on $175,000 jury verdict to plaintiff for permanent eye damage resulting from drug manufacturer's failure to warn his doctors of the dangers of a prescribed drug.

Chloroquine phosphate, sold under trade names Aralen, Triquin, and Plaquenil, is a drug invented by Sterling in 1946 for the prevention and treatment of malaria. In 1955 Sterling introduced the drug to druggists and the medical profession for treatment of arthritis and lupus erythematosus. The drug has certain side effects, one of which is its affinity for melanin pigment in the eyes resulting in a condition now known as chloroquine retinopathy, a degeneration of cells in the retina of the eye, causing blindness. Joseph Bine, 54 years of age at trial, was first treated in Detroit, Michigan, in 1952 for disseminated or systemic lupus erythematosus. In 1954 he went to St. Louis, Missouri, and came under the care of Dr. Ernest T. Rouse, an internist, and Dr. Henry Conrad, Jr., a dermatologist, for his condition. Under prescription from his doctors he began taking Aralen in late 1954, one to three pills per day, until November 1960. In February 1961 he was put on Plaquenil which he took until September 1961. He had worn glasses for 18 to 20 years but had no eye trouble before taking Aralen. He first noted occasional blurring when reading after starting on Aralen in 1954. In June 1959 he saw Dr. Lawrence T. Post, complaining of difficulty with near vision and 'bizarre visual sensations.' By October 25, 1960, his right eye was bothering him but he could see 'quite well' with his left eye. Dr. Post made tests and charted his findings. At this time the blind spot in plaintiff's right eye was slightly larger than normal, but there was a very definite change in the visual field next to the center of fixation of vision. Dr. Post wrote Dr. Rouse recommending discontinuance of Aralen since less toxic drugs were now in existence. Plaintiff was then taken off Aralen and took nothing until he began with Plaquenil in February 1961. Dr. Post's examination of January 15, 1962, showed that vision in plaintiff's right eye had begun to fail and vision in the left eye was worse. These conditions progressed until in November 1965 plaintiff was virtually blind in his right eye and the left eye had developed 'a real ring blind spot.' By January 1966 the central vision in plaintiff's right eye was 1/200 and there was an island of complete blindness. The central vision of the left eye was 20/25 and, on visual field testing, there was a spot with 'a seeing area right in the center, something like the shape of a doughnut.' Ophthalmoscopic examination showed retinal changes around the macula 'and right in the center of the eye where the seeing part is the retina did look somewhat degenerated.' Plaintiff was forced to quit his job in December 1961, at which time he was earning $100 per week. By trial time the same job paid $225 per week. Drs. Post, Sanders, and Bernstein were of the opinion that plaintiff's eye condition was permanent and due to chloroquine, and Drs. Post and Sanders said the condition was not caused by plaintiff's lupus. Additional evidence will be stated as necessary in connection with appellant's points.

Appellant charges: 'The Court erred in not sustaining appellant's motion for a directed verdict at the close of all the evidence on the ground that there was no evidence adduced of any reliance by plaintiff's doctors of a lack of warning and thus no causal connection was shown between plaintiff's injury and appellant's alleged negligence.' Stated in reverse, this point is limited to a contention that plaintiff's case on proximate cause fails because there was no evidence of reliance by plaintiff's doctors on a lack of warning. In argument appellant refers to evidence on what it did by way of warnings and to testimony of plaintiff's doctors that they read literature on the drug and used their skill in setting the dosage, all of which is beside the point.

Plaintiff's case was submitted by Instruction 2:

'Your verdict must be for the plaintiff if you believe:

'FIRST, defendant sold Aralen for use in the treatment of lupus erythematosus, and

'SECOND, Aralen would cause serious damage to the retina of the eyes of some individuals using such drug on long term therapy in the manner and for the purpose intended, and

'THIRD, defendant knew or by using ordinary care could have known of the danger of such eye damage, and

'FOURTH: plaintiff and his doctors did not know and by using ordinary care could not have known of such danger, and

'FIFTH, plaintiff used Aralen on long term therapy under prescription from his doctors and in the manner and for the purposes intended, and

'SIXTH, defendant failed to give a timely and adequate warning to those members of the medical profession whom the defendant, in the exercise of ordinary care on its part, might reasonably expect to prescribe the drug and, by ordinary care on their part, to note and heed such a warning if one were given, and

'SEVENTH, defendant was thereby negligent, and

'EIGHTH, plaintiff was damaged as a direct result thereof.'

Defendant makes no charge of error in connection with plaintiff's submission and its converse theory was submitted by Instruction No. 3:

'Your verdict must be for defendant if you do not believe: defendant knew or should have known of the danger that the drugs in question could cause a serious disorder to the retina of the eyes in some individuals on long term therapy using the same, at the time plaintiff used the drugs.'

Under this submission it is obvious and may be said, as in Sterling Drug, Inc. v. Cornish, 8 Cir., 370 F.2d 82, 85(5), where it was argued that a failure to show reliance was an intervening proximate cause: 'The sole issue was whether appellant negligently failed to make reasonable efforts to warn appellee's doctors. If appellant did so fail, it is liable regardless of anything the doctors may or may not have done. If it did not so fail, then it is not liable for appellee's injury. The issue was to be resolved by the jury * * *.' See also Yarrow v. Sterling Drug, Inc., D.C.S.D., 263 F.Supp. 159, 163(6), and see Krug v. Sterling Drug, Inc., Mo., 416 S.W.2d 143, 150--151(5), resolving virtually this same point against Sterling and distinguishing the citation, Oppenheimer v. Sterling Drug, Inc., 7 Ohio App.2d 103, 219 N.E.2d 54, upon which Sterling relies.

Appellant's next point is also related to causation: 'There was no evidence in the case showing that the state of scientific knowledge was such that the medical profession knew of any alleged connection between chloroquine retinopathy and Aralen prior to 1959.' The argument clarifies this point to state it as a contention that 'Plaintiff produced no evidence * * * that the state of medical knowledge at the time plaintiff consumed the chloroquine was such that the defendant in the exercise of ordinary care could have anticipated that the drug would cause retinal eye damage.' However, under Instruction No. 2 the question, if one be stated at all by this point and argument, is whether there was evidence to show that defendant, Sterling Drug, knew or by using ordinary care should have known that Aralen would cause 'serious damage to the retina of the eyes' of some users of the drug.

As previously stated, Mr. Bine took chloroquine phosphate under the trade name Aralen, as prescribed by his doctors for his lupus condition from 1954 until November 1960 when his doctors took him off the drug. He resumed the drug as prescribed by his doctors under the trade name Plaquenil February 1961 and remained on it until September 1961. As early as 1953 or 1954, according to Dr. Justus B. Rice, director of medical research for Sterling, Sterling became aware that doctors were prescribing Aralen for lupus in dosages of one, two, or three pills per day as compared to the one or two pills per week dosage for malaria. In addition to its director of research, Sterling employed a medical staff, had a medical library and research institute, and received reports and letters from doctors in the field as well as reports from their own 'detail men' who were field representatives for Sterling in contact with doctors in the prescribing and treating field. From these, Sterling knew that visual disturbances had been experienced with Aralen even in the malarial dosage. It knew of an article by Alving, et al., in 1948, describing visual disturbance side effects resulting from higher dosages, and it knew of Aralen's toxic effects where used in higher dosages than those recommended for malaria. The letters, one of which was from Dr. Weiss, Dr. Conrad's associate, and reports from doctors prescribing Aralen, reporting to and questioning Sterling about connections between Aralen and eye damage, began as early as 1954 and were received by Sterling frequently during the time Mr. Bine was on the drug. Corneal opacities were reported to Sterling in 1957 and 1958; retinal damage possibilities were suggested in March 1957, January 1959, and definitely in an English article by Hobbs, et al., in October 1959. Defendant conducted tests with chloroquine at its research institute from 1944 to August 1959. At trial, the director of research stated they had 'never been able to reproduce the so-called chloroquine retinopathy' but the description of the animal tests performed disclosed that defendant performed only a few tests for chronic toxicity and none for eye damage. Dr. Foley, defendant's medical director, was aware that testing by Sterling had shown that some of the animals...