Hoffman v. Sterling Drug, Inc., 72-1257 to 72-1259.

• Citation: 485 F.2d 132
• Decision Date: 08 August 1973
• Docket Number: No. 72-1257 to 72-1259.,72-1257 to 72-1259.
• Parties: Clifton F. HOFFMAN, Appellant, v. STERLING DRUG, INC., a Corporation and Winthrop Laboratories, Inc., a Corporation and division of Sterling Drug, Inc. Clifton F. HOFFMAN, v. STERLING DRUG, INC., a Corporation and Winthrop Laboratories, Inc., a Corporation and division of Sterling Drug, Inc., Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals (3rd Circuit)

485 F.2d 132 (1973)

Clifton F. HOFFMAN, Appellant, v. STERLING DRUG, INC., a Corporation and Winthrop Laboratories, Inc., a Corporation and division of Sterling Drug, Inc.

Clifton F. HOFFMAN, v. STERLING DRUG, INC., a Corporation and Winthrop Laboratories, Inc., a Corporation and division of Sterling Drug, Inc., Appellants.

Nos. 72-1257 to 72-1259.

United States Court of Appeals, Third Circuit.

Argued January 12, 1973.

Decided August 8, 1973.

As Amended August 24, 1973.

COPYRIGHT MATERIAL OMITTED

Joseph D. Shein, Shein, Mele & Brookman, William B. Anstine, Jr., Anstine & Anstine, Philadelphia, Pa., for appellant in Nos. 72-1257, 72-1258 and appellees in 72-1259.

W. Bradley Ward, Schnader, Harrison, Segal & Lewis, Frank B. Boyle, Philadelphia, Pa., for appellee in Nos. 72-1257, 72-1258 and appellants in No. 72-1259.

Before BIGGS, HASTIE and HUNTER, Circuit Judges.

OPINION OF THE COURT

BIGGS, Circuit Judge.

In this diversity action¹ Hoffman, plaintiff-appellee cross-appellant, sought to recover damages for serious and permanent injuries allegedly sustained as the result of ingesting the drug chloroquine phosphate, which was manufactured by Sterling Drug, Inc. and Winthrop Laboratories, Inc., and marketed under the trade name of Aralen. Count I of the complaint charged that the defendants were negligent insofar as they failed to properly test the drug prior to placing it on the market, failed to adequately warn users or the medical profession of the dangers inherent in their product, and violated Sections 301, 501, and 502 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 331, 351, 352. Count III alleged that the defendants were strictly liable in tort,² and Count IV charged the defendants with fraudulently, falsely and deceitfully misrepresenting and concealing the true state of knowledge about the safety of the drug, or, in the alternative, making such misrepresentations in reckless disregard of reports to them of the harmful nature of the product.³

After a lengthy trial, the jury returned a verdict in the plaintiff's favor in the amount of $437,000, and judgment was entered on the verdict. The defendants' motion for a new trial was denied by the district court,⁴ and the plaintiff's motion for a retrial on the issue of punitive damages was also denied. These appeals followed.

The plaintiff's relevant medical history dates back to the early 1950's, when, while seeing a Dr. Kammer for a gastric condition and arthritic pains, Dr. Kammer recommended that plaintiff see a dermatologist about a rash on his face. The plaintiff was referred to Dr. Ernest Markey, an osteopath specializing in dermatology, who diagnosed the plaintiff's condition as lupus erythematosus and in May of 1957, prescribed Aralen as treatment. Dr. Markey treated the plaintiff for 13 months, from April, 1957 to May, 1958, until Dr. Kammer referred plaintiff to Dr. Milton Cohen, a medical doctor and dermatologist. Dr. Cohen treated the plaintiff from June, 1958 until March, 1964, and he too prescribed Aralen. Dr. Cohen testified⁵ that he was aware of and informed the plaintiff of the possibility of eye damage from the prolonged use of chloroquine, that he questioned the plaintiff about his sight on each visit, and on several occasions suggested to the plaintiff that he see an eye doctor for a slit-lamp examination, but that he did not know that eye damage would be irreversible.⁶ The plaintiff stopped seeing Dr. Cohen in March, 1964, and continued taking Aralen under a refillable prescription from Dr. Cohen until June, 1965, when Dr. Ludwig, another doctor consulted by the plaintiff concerning his arthritic type of pain, advised him to stop taking the drug.

It was in 1965 or 1966 that the plaintiff began to experience problems with his eyesight. Plaintiff's optometrist, Dr. Cruse, testified that prior to 1966, plaintiff's vision was correctable to normal or what is termed 20/20 vision. Dr. Cruse stated that in June, 1966, plaintiff's vision had deteriorated to approximately 20/30 in each eye, and plaintiff's eyesight continually worsened.⁷ Dr. McHenry, an ophthalmologist, examined the plaintiff in December, 1965, at which time he found that plaintiff's vision was 20/30 in each eye and could not be corrected to 20/20. In 1970, Dr. McHenry concluded that the plaintiff suffered from chloroquine retinopathy, and in 1971, he found his vision to be 10/200 in each eye, which rendered him legally blind under Pennsylvania law.⁸

Chloroquine retinopathy is a damaged condition of the retina which can result from the long continuous use of chloroquine drugs. That permanent retinal damage might result from the use of such drugs was not suspected when the defendants first started marketing Aralen in 1946. Aralen had been approved by the Food and Drug Administration for the treatment of malaria. Commonly observed side effects noted in the 1940's and early 1950's included nausea, abdominal cramps, and some instances of blurring of vision. Visual disturbances disappeared when chloroquine treatment was discontinued, leading investigators to conclude that the condition was transitory. By 1953, reports of the successful use of Aralen in the treatment of rheumatoid arthritis and lupus erythematosus, the skin disease which the plaintiff suffered from, began to appear. In 1955, defendant Winthrop Laboratories, Inc., published and distributed a pamphlet which discussed Aralen treatment for lupus erythematosus.⁹ In the same year, Winthrop submitted for publication in the Physician's Desk Reference¹⁰ information concerning Aralen's use in the treatment of lupus erythematosus. Finally, on July 25, 1957, defendants filed a supplemental new drug application with the FDA seeking approval to advertise and sell Aralen for use in the treatment of rheumatoid arthritis and purportedly for lupus erythematosus as well.¹¹ Conditional FDA approval was obtained three weeks later, with final approval following on October 2, 1957.

Suspicion that chloroquine use might permanently damage the retina began to arise circa 1957. An article by Dr. Goldman and Dr. Preston, entitled "Reactions to Chloroquine Observed During Treatment of Various Dermatologic Disorders,"¹² stated that chloroquine was suspected of severe fundal (retinal) changes but this could not be proved. In 1959, the suspicion was strengthened by an article entitled "Retinopathy Following Chloroquine Therapy" by Hobbs, Sorsby, and Freedman.¹³ This report explained that "in the doses used to suppress or treat malaria, the toxic effects of chloroquine and its derivatives are only minor. . . . Since in both lupus erythematosus and rheumatoid arthritis the effective dose commonly exceeds that used for malaria, and the drug is administered for much longer periods, it is not surprising that toxic effects have been reported. . . .

"Recently we have seen changes of a much graver character, with visual damage which, in some cases at least, is evidently irreversible. These patients . . . were under treatment with chloroquine compounds for lupus erythematosus and rheumatoid arthritis."¹⁴

The article concluded, after a discussion of certain case reports, "On present evidence, the retinopathy here described results from treatment with chloroquine compounds. . . ."¹⁵ Defendants' witness, Dr. Rice, testified that this article made "it very likely, or quite likely, that chloroquine might be involved in the production of retinopathy. This I say `likely' because the drug that they used was not Chloroquine Phosphate as sold by Winthrop but was Chloroquine Sulfate and which might have an entirely different toxity than Chloroquine Phosphate."¹⁶ Numerous letters were also received by defendants from physicians during this period (1956-1960) reporting loss of vision, field changes, and fundus changes in patients being treated with Aralen and inquiring into the possibility that Aralen might be the cause. Defendants made reference to the Hobbs, Sorsby, and Freedman article in their 1960 product literature, and, after numerous reports in medical literature of irreversible retinal damage following chloroquine treatment, defendants included in their 1962 product literature a warning that retinal changes "have been reported as rarely occurring within several months to several years of chloroquine therapy" and pointed out "the necessity of periodic visual field examinations in order to detect early changes during prolonged treatment with the drug."¹⁷ In February, 1963, defendants sent out letters to physicians, 248,000 in all, warning of occular complications from the use of the drug and of the need for initial and periodic ophthalmologic examinations of the patient.¹⁸

Defendants have appealed the judgment of the district court at our No. 72-1259, asserting that the trial court committed reversible error (1) in submitting to the jury the issue of whether the defendants violated the Federal Food, Drug and Cosmetic Act, (2) in admitting certain evidence relevant to alleged withholding from the FDA of letters of inquiry and reports from physicians, (3) in submitting to the jury the issue of whether the defendants sold Aralen without adequately testing it to discover harmful side effects, and (4) in charging the jury that the defendants were under a duty to warn treating as well as prescribing physicians about the danger of retinal damage. The defendants also contend that (5) the jury's award in the amount of $437,000 is excessive. Plaintiff has appealed at our Nos. 72-1257 and 72-1258 insofar as the district judge refused to permit the jury to consider the issue of punitive damages and refused to tax as costs certain of the plaintiff's expenses.

I.

Defendants maintain that there was no evidence of a violation of the Federal Food, Drug and Cosmetic Act or the regulations thereunder and that, even if there was such evidence, any violation was not the proximate cause of the plaintiff's injuries. Therefore they assert error in the...