416 F.2d 417 (2nd Cir. 1969), 578, Basko v. Sterling Drug, Inc.

Docket Nº:578, 32669.
Citation:416 F.2d 417
Party Name:Lydia BASKO, Plaintiff-Appellant, v. STERLING DRUG, INC., and Winthrop Laboratories, Defendants-Appellees.
Case Date:October 07, 1969
Court:United States Courts of Appeals, Court of Appeals for the Second Circuit
 
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416 F.2d 417 (2nd Cir. 1969)

Lydia BASKO, Plaintiff-Appellant,

v.

STERLING DRUG, INC., and Winthrop Laboratories, Defendants-Appellees.

No. 578, 32669.

United States Court of Appeals, Second Circuit.

October 7, 1969

Argued May 14, 1969.

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Morgan P. Ames, Stamford, Conn. (Helen F. Krause, Bridgeport, Conn., on the brief), for plaintiff-appellant.

Paul V. McNamara, Bridgeport, Conn. (Donald J. Stat. John, Bridgeport, Conn., of counsel), for defendants-appellees.

Before WATERMAN, SMITH and KAUFMAN, Circuit Judges.

J. JOSEPH SMITH, Circuit Judge:

In the field of drug marketing, as Professor Kessler writes in a thoughtful article, 'defining the outer limits of strict liability presents us with most difficult questions of policy.' Kessler, Products Liability, 76 Yale L.J. 887, 930 (1967). This case demands analysis of those 'outer limits.'

The plaintiff, Mrs. Lydia Basko, appeals from a judgment entered for the

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defendant drug manufacturers, Sterling Drug, Inc. and Winthrop Laboratories, after a two-week jury trial in the United States District Court for the District of Connecticut, Edward C. McLean, Judge. 1 Her main argument is that the evidence established a case of strict liability as a matter of law, and that Judge McLean erred in not granting her motion for a directed verdict at the close of the case. In addition, plaintiff argues that the jury was erroneously instructed on the theory of strict liability under § 402A of the Restatement (Second) of Torts. Finally, plaintiff urges that Judge McLean erred in not instructing the jury that there could be recovery on the alternative theories of negligence, express warranty, implied warranty, and fraud upon the Food and Drug Administration. We find error in the charge, and reverse.

I.

From 1953 to 1961 plaintiff was treated with three different drugs for a skin disease called lupus erythematosus. The drugs were sold under the trade names Aralen, Atabrine, and Triquin, and were manufactured by Winthrop Laboratories, a division of Sterling Drug Co., Inc. The drugs had been prescribed for plaintiff by doctors at Yale-New Haven Hospital. In 1956, plaintiff began experiencing a blurring of her vision, although she complained of seeing 'butterflies' as early as 1954. From 1961 to 1965 her vision deteriorated quite badly, and she is now almost totally blind.

At trial plaintiff called a number of medical experts who testified that she was suffering from a form of retinal damage known as chloroquine retinopathy. This is thought to be an idiosyncratic side effect of certain drugs made from chloroquine, although there is some evidence to indicate that the idiosyncratic reaction occurs more frequently when chloroquine is administered in high doses. The condition is quite rare, and as one expert testified, chloroquine retinopathy 'has an incidence of probably less than half a per cent, maybe as low as a tenth of a per cent, perhaps one in a thousand.' According to the prevalent theory, chloroquine has a special affinity for the melanin pigment cells of the eye. Once absorbed by the pigment cells, the chemical inhibits the flow of nutrients to the nervous tissue of the overlaying retina. A second theory, somewhat discredited now, is that chloroquine constricts the blood vessels in the retinal part of the eye.

Plaintiff's first witness was Dr. Marvin Sears, chief ophthalmologist at Yale-New Haven Hospital. He indicated that he had examined plaintiff on December 12, 1962, and stated quite emphatically that she was suffering from an 'irreversible' case of chloroquine retinopathy. He based his conclusion on the fact that plaintiff had taken chloroquine in amounts sufficient to cause this condition, and added, 'I can't think of any other disease or drug that could do it.' When asked how certain he was, Dr. Sears replied, 'I'm about as certain as anyone can be about any condition in medicine.'

Similar testimony was given by Dr. Howard N. Bernstein, who had done extensive research on chloroquine retinopathy at the National Institute of Health in Bethesda, Maryland, and who had examined plaintiff on July 27, 1966. He said that plaintiff's retinal damage was probably due to long-term treatment with chloroquine drugs, and based his conclusion on the facts that (1) the dosage and duration of treatment were sufficient to cause chloroquine retinopathy, (2) the retinal appearance was similar to other cases of chloroquine retinopathy he had observed, and (3) progressive loss of visual acuity is characteristic of this condition.

Of the three drugs involved in this case, only Aralen and Triquin contain chloroquine ingredients. Atabrine is concededly not made from chloroquine, and there is no evidence in this record to indicate that Atabrine produces damage

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to the retinal part of the eye. 2 Certainly Atabrine cannot cause chloroquine retinopathy, and plaintiff apparently concedes this much. Under these circumstances, we think that plaintiff failed to make out a prima facie case implicating Atabrine and so hold.

Aralen is the trade name for chloroquine phosphate. By its chemical structure Aralen is known as a 7-chloroderivative of 4-aminoquinoline. It was developed as a substitute for quinine during World War II, and was extensively tested on both animals and humans before being placed on the market. The tests were conducted by both Winthrop Laboratories and a wartime Board for the Coordination of Malarial Studies, and involved the administration of chloroquine to over 5000 human patients under close clinical observation. The tests showed that chloroquine was highly effective in the treatment of malaria, and further showed that chloroquine produced no serious side effects when taken in the normally prescribed quantity.

The most commonly observed side effects of chloroquine were nausea, abdominal cramps, diarrhea, and occasional vomiting. There were also some instances of temporary blurring of vision. Similar blurring had been observed in patients receiving treatment with quinine and other anti-malarial drugs, and the available evidence strongly suggested that the condition was due to a side effect associated with the eye muscles. Upon further investigation it was found that the blurring disappeared when treatment with chloroquine was discontinued, and investigators thus concluded that the condition was reversible and 'transitory.' Several instances of corneal opacities were also reported, but these were found to clear up when chloroquine was discontinued. 3

In 1946, Aralen was approved by the Food and Drug Administration for the treatment of malaria. By 1953 a considerable number of investigators had used Aralen with good results in the treatment of lupus erythematosus and rheumatoid arthritis, and in 1957 the drug was approved for these additional uses. Defendant subsequently prepared an 'Epitome' promotional booklet entitled 'Chemotherapy of Rheumatoid Arthritis and Other Collagen Diseases with Plaquenil and Aralen,' and made the booklet available to physicians through its field representatives or 'detail men.' The booklet listed 'temporary blurring of vision due to weakness of accommodation' as a side effect, and indicated that 'untoward effects are limited in type and, with rare exceptions, are insignificant.' For prolonged treatment the booklet recommended a 'maintenance dose' of 250 milligrams daily.

Triquin is made from a combination of Aralen, Atabrine, and Plaquenil, and is thus composed of chloroquine phosphate, quinacrine, and hydroxychloroquine sulfate. It was approved by the Food and Drug Administration in 1958, and was placed on the market shortly thereafter.

From the beginning defendant knew of reports of blurring of vision and corneal opacities in patients treated with chloroquine, and this much was conceded by Dr. Edwin J. Foley, vice-president and medical director of Winthrop Laboratories. Indeed, the early literature on Aralen stated that some visual blurring sometimes accompanied the use of chloroquine. Dr. Foley insisted, however, that

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the early investigators failed to disclose any instances of damage to the retina, and testified quite emphatically that there was not even the slightest evidence of retinal damage produced by chloroquine at least until 1957. His testimony was substantially corroborated by Dr. Sears, who testified that clinical ophthalmologists did not begin to suspect some connection between chloroquine and retinal complications until around 1957. 4

In his testimony Dr. Sears made reference to a 1957 article by Dr. Amerigo Cambiaggi entitled 'Unusual Ocular Lesions in a Case of Systemic Lupus Erythematosus,' and said that this was the first article to attribute retinal damage to chloroquine therapy. We have undertaken an independent review of the early literature, and prior to the Cambiaggi article we are unable to find a single mention of retinal damage in cases where blurring of vision had been reported. It also appears from even the latest literature that no investigator has been able to induce chloroquine retinopathy in rats, rabbits, or monkeys. 5

While the use of special interrogatories undoubtedly would have made our reviewing task easier, we think that it is highly unlikely from the evidence in this case that a jury would have concluded that the risk of idiosyncratic retinal damage should have been known prior to 1957. Indeed, practically all of the reviewing courts in similar Aralen cases have strongly suggested that the risk of chloroquine retinopathy was not foreseeable until at least 1959. 6

At this point it is necessary for us to describe the post-1957 medical literature in some detail. The Cambiaggi article described the case of a patient who was treated with chloroquine phosphate and developed unusual fundus lesions. 7'This case is reported,' he wrote, 'because I found no report in the literature of fundus lesions caused by lupus...

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