Schenebeck v. Sterling Drug, Inc.

• Decision Date: 29 April 1970
• Docket Number: No. 19576.,19576.
• Parties: Mrs. Jewell SCHENEBECK and Russell Schenebeck, Appellees, v. STERLING DRUG, INC., Appellant.
• Court: U.S. Court of Appeals — Eighth Circuit

423 F.2d 919 (1970)

Mrs. Jewell SCHENEBECK and Russell Schenebeck, Appellees, v. STERLING DRUG, INC., Appellant.

No. 19576.

United States Court of Appeals, Eighth Circuit.

April 1, 1970.

Rehearing Denied April 29, 1970.

Alston Jennings, Wright, Lindsey & Jennings, Little Rock, Ark., for appellant and filed briefs.

Henry Woods, McMath, Leatherman, Woods & Youngdahl, Little Rock, Ark., for appellees, C. A. Walls, Jr., Lonoke, Ark., and Thomas C. Hullverson, Hullverson, Richardson & Hullverson, St. Louis, Mo., were with him on the brief.

Before VOGEL, BLACKMUN and BRIGHT, Circuit Judges.

BRIGHT, Circuit Judge.

Plaintiff Jewell Schenebeck sustained blindness from taking the prescription drug Aralen over a five-year period. She and her husband brought an action for damages against the manufacturer, Sterling Drug, Inc. (Sterling). An Arkansas district court jury awarded her $40,000.00, and her husband an additional $10,000.00 for consequential loss, based on defendant's negligence. Following the verdict, Sterling moved for judgment n. o. v. The trial court denied the motion for reasons stated in a memorandum opinion reported in 291 F.Supp. 368 (E.D.Ark.1968). Sterling appeals from the judgment and urges two contentions upon us:

(1) Defendant's failure to timely warn that Aralen could produce blindness was of no legal consequence and not a proximate cause of the harm sustained by Mrs. Schenebeck (hereinafter plaintiff), since her attending physician otherwise timely acquired equivalent information concerning the drug from an independent source, and

(2) Plaintiff sustained harm from Aralen prior to December 9, 1963, and her failure to bring action within three years thereafter as required by the applicable Arkansas statute of limitations bars her action.

Arkansas substantive law controls this products liability diversity case. On our review of the record, we hold that the trial court properly submitted the issues in question to the jury.

Aralen constitutes Sterling's brand name for the ethical drug chloroquine phosphate, usually referred to as chloroquine, a synthetic anti-malarial drug that has also proved effective in the treatment of rheumatoid arthritis.

Dr. Ralph Patterson, an internist practicing his specialty in Hot Springs, Arkansas, first prescribed Aralen in 1958 for treatment of Mrs. Schenebeck's chronic rheumatoid arthritis. He initially prescribed the usual does of one 250 milligram tablet to be taken each day. He mailed her a second similar prescription in July of 1962. Both were refillable. He did not personally see her between November, 1961 and May, 1963. The plaintiff took Aralen tablets almost daily until May 7, 1963, when she reported to Dr. Patterson that she had experienced blurring of her vision. Dr. Patterson recommended that she stop taking the drug until she had been checked by a qualified ophthalmologist. Thereafter, Mrs. Schenebeck underwent eye examinations by Dr. Raymond Cook (July 22, 1963) and Dr. John G. Watkins (October 11, 1963), both qualified ophthalmologists from Little Rock, Arkansas. Neither doctor discovered any pathology in her eyes. She had also earlier been examined by Dr. W. J. Schwarz, also practicing in Little Rock, who reported negative findings from examinations on October 23, 1962, and on March 5, 1963. Mrs. Schenebeck, however, continued to have difficulties with her vision. On November 16, 1963, she wrote to Dr. G. A. Peters of the Mayo Clinic at Rochester, Minnesota, whom she had consulted in 1958 for her arthritic problem, inquiring whether Aralen could cause her eyes to fail. She complained, "They are failing more and more all the time until I am half blind. Eye specialist find no disease, no cause. I stayed off the tablet Aralen for 3 months with no change." Dr. Peters referred this letter to another Mayo staff specialist, Dr. John G. Mayne, who wrote in reply:

"If you have been taking Chloroquine (Aralen) constantly over this period it is indeed possible that your visual defect is related to the use of the medication. I would advise that you stop the medication completely until this can be definitely settled. I think you should discuss this with your general doctor and with your eye specialist who can answer this question * *."

Mrs. Schenebeck showed this letter to her attending physician, Dr. Patterson. Dr. Patterson thereafter wrote Dr. Mayne on December 6: "Her vision has not improved and I fear it is permanently impaired. If you have any suggestions concerning her condition, I would appreciate hearing from you." Dr. Mayne responded that he knew of no effective remedy for retinopathy related to antimalarials and he recommended that she take no more of this type of medication. Dr. Patterson then wrote the plaintiff advising that she cease using chloroquine. Mrs. Schenebeck has taken no additional chloroquine-type drugs since receiving Dr. Patterson's letter on December 21, 1963. Though Dr. Patterson and Dr. Mayne suspected that Mrs. Schenebeck suffered from chloroquine retinopathy, no actual pathology was discovered in her eyes until September 2, 1964, when she was again examined by Dr. Watkins. The negative pathology findings of the previous October were replaced with observations of fine clumps of pigment in the macula of both eyes. Her vision, which Dr. Watkins characterized as good the prior October, had deteriorated to a condition he described as "industrial blindness". The patient was again referred to the Mayo Clinic, and Dr. Thomas Kearns on its ophthalmological staff diagnosed her condition as chloroquine retinopathy.

This diagnosis serves as a statement of both disease and medical causation, since the description denotes an abnormal condition of the retina produced by chloroquine.

Sterling's literature on Aralen available generally to the medical profession between 1958 and February of 1963 stressed the relative safety of its use. Among other things, defendant's literature recited that doctors need not concern themselves with "precautions or preventive measures * * * before, during or after the use of * * * Aralen" nor "frequent patient checkups". In the Physicians Desk Reference, a publication generally available to all doctors and utilized by drug companies to inform the medical profession of the characteristics, uses and side effects of drugs, Sterling advertised between 1958 and 1961 (omitting Aralen advertisement in 1962) that Aralen's side effects included "headache, visual disturbances * * *. Often transient, or subsides on withdrawal or reduction of dosage". Sterling's Aralen "product card" distributed to doctors by its detailmen mentioned retinal vascular response in the context of an idiosyncracy.

Information circulated in the scientific and medical community before and during 1961 reported serious ocular side effects in patients utilizing chloroquine therapy. For example, a 1961 American Medical Association publication on drugs called attention to permanent eye damage incurred by a "few" patients as a result of the use of Aralen.

A medical information letter dated December 21, 1962, published by Drug and Therapeutic Information Inc. of New York City, which analyzed antimalarial drugs, including chloroquine (Aralen), noted that frequent toxic effects had been reported from the use of such drugs and suggested caution in their dispensation. It advised that ophthalmological examinations which include plotting of the visual fields should be considered mandatory when the drug "is to be given over a period of months". The letter further indicated that usual doses of chloroquine "* * * can be given with reasonable safety for at least a year — longer on an intermittent schedule". Dr. Patterson received and read this latter drug information letter.

Thereafter, in February of 1963, Sterling radically changed its medical literature concerning side effects attributable to chloroquine and by a special letter mailed to almost every doctor in the United States specifically warned of the risk of chloroquine retinopathy and cautioned that prolonged therapy must be accompanied by initial and frequent ophthalmological examinations.

PROXIMATE CAUSE

Appellant urges that the Drug and Therapeutic Information letter of December 21, 1962, adequately warned Dr. Patterson of the dangers incident to long-term Aralen therapy; that this warning was timely since Mrs. Schenebeck then had reported no ill effects from the use of Aralen and that Dr. Patterson, nevertheless, continued her on Aralen therapy. Appellant concludes that any failure to timely warn played no part in producing the plaintiff's injury.

We disagree. We examine the appellant's contentions in the light of the continuous duty cast upon the manufacturer of an ethical drug to warn physicians of the dangers incident to prescribing the drug, 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. See generally Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 130 (9th Cir. 1968); O'Hare v. Merck & Co., 381 F.2d 286, 290-291 (8th Cir. 1967); Johnston v. Upjohn Co., 442 S.W.2d 93, 95 (Mo.1969); Krug v. Sterling Drug, Inc., 416 S.W.2d 143 (Mo. 1967). A drug manufacturer's compliance with such rule enables physicians to balance the risk of possible harm against benefits to be derived by their patients' use of such drugs. In considering the alternatives of treatment, the prescribing physician is entitled to make an informed choice.

The record in this case, although perhaps not as clear concerning background information on the development, testing, and initial use of the drug as in other reported Aralen products liability cases,¹ established that Sterling ought to have recognized and generally warned the medical profession that permanent eye damage could result from the use of this product in 1961 or,...