Finn v. G. D. Searle & Co.

Decision Date29 March 1984
CourtCalifornia Supreme Court
Parties, 677 P.2d 1147 Michael FINN, a Minor, etc., Plaintiff and Appellant, v. G.D. SEARLE & COMPANY et al., Defendants and Respondents. L.A. 31388.

Heily, Blase & Ellison, David Ellison, Ventura, Richard Gilman, Oxnard, for plaintiff and appellant.

Winchester Cooley, McCutchen, Black, Verleger & Shea, Los Angeles, Donald L. Benton, Benton, Orr, Duval & Cuckingham, Ventura, for defendants and respondents.

RICHARDSON, Justice Pro Tem. *

Plaintiff Michael Finn, a minor, appeals from a judgment for defendants in a civil action for personal injury. The claimed prejudicial error arises from the trial court's modification of certain jury instructions offered by plaintiff. Although we granted hearing in this case to consider the application of strict liability principles to injurious side effects allegedly produced by prescription drugs, our review of the record has convinced us that in light of the basis upon which plaintiff tried his case, this broader issue is not properly before us. Rather, we shall conclude that plaintiff has not demonstrated that it is reasonably probable that the trial court's modifications of his proposed instructions affected the judgment. Accordingly, we will affirm the judgment.

Shortly after his birth on June 6, 1969, plaintiff developed serious diarrhea and a diaper rash. When the rash spread, his pediatrician referred him to a dermatologist, Dr. Romaine, who diagnosed plaintiff's condition as acrodermatitis enteropathica (AE). AE has been described as commencing "as a skin eruption on an extremity or around one of the orifices of the body, followed by loss of hair, diarrhea, and other gastrointestinal disturbances; it is intermittently progressive and frequently ends fatally." (Stedman's Medical Dict. (4th unabridged ed. 1976).)

Dr. Romaine prescribed high doses of a drug, Diodoquin, which had been approved by the United States Food and Drug Administration and manufactured by defendant G.D. Searle & Company (Searle). This drug is a member of a pharmacological group known as hydroxyquinolines. When plaintiff's illness was first diagnosed, the use of these drugs constituted the only known treatment for AE and, of the group, Diodoquin was the most commonly used.

After moving with his parents to California in 1970, plaintiff became the patient of defendant Dr. McGillis, a dermatologist, who again prescribed massive dosages of Diodoquin for the treatment of plaintiff's condition. Plaintiff's health improved dramatically with use of the drug, but periodic attempts to reduce the dosage resulted in reappearance of his AE symptoms.

In September 1971, plaintiff's mother noticed for the first time that plaintiff seemed to have difficulty with his vision. On October 22, he was examined by Dr. Lambert, an ophthalmologist, who diagnosed his condition as possible optic nerve atrophy. Upon learning that plaintiff had been taking large quantities of Diodoquin for an extended period, Dr. Lambert called Searle's headquarters to inquire as to the effects of the drug. After investigation, a physician employed by Searle informed Lambert that there had been a report of possible relationships between optic nerve atrophy and the prolonged use of large quantities of Diodoquin in children with AE. This information of a possible link was given by Dr. Lambert to Dr. McGillis who in turn advised plaintiff's mother to discontinue plaintiff's use of the drug. She did so, but when plaintiff's symptoms promptly reappeared, she again administered Diodoquin, ultimately resuming the higher dosage when a lower amount proved less effective in curbing the AE symptoms.

In December 1971, plaintiff was examined by various physicians on the staff of the University of California at Los Angeles Medical Center. Dr. Hepler, a neuro-ophthalmologist, finding severe visual problems, suspected that Diodoquin was the cause and advised plaintiff's mother to discontinue its use. Following examination, a gastroenterologist who saw plaintiff on December 28 concluded that plaintiff was actually suffering from irritable colon syndrome rather than AE and prescribed a different drug. Plaintiff's rash and diarrhea thereupon subsided, and there was some temporary improvement in his vision. However, he now suffers permanent and almost total blindness.

In 1973, plaintiff's mother acting as his guardian ad litem filed suit against Searle and Dr. McGillis, alleging that plaintiff's blindness was caused by Diodoquin. The complaint contained three causes of action. The first alleged that the Diodoquin was defective because Searle failed "to give adequate warning" of the risks of optic nerve atrophy; the second asserted that Searle negligently developed, tested, manufactured and distributed the drug; and the third charged that Dr. McGillis negligently examined, diagnosed and treated plaintiff, and negligently prescribed Diodoquin in excessive amounts and for prolonged periods.

At trial, plaintiff presented a variety of evidence to support his contention that Searle had notice of a possible link between Diodoquin and optic atrophy which required a warning at the time plaintiff took the drug from 1969 through the end of 1971. First, plaintiff presented evidence that in 1966, two physicians, Drs. Etheridge and Stewart, published an article in the British medical journal Lancet reporting the development of optic atrophy in a child suffering from AE who had undergone prolonged high-dosage Diodoquin treatment. Plaintiff also presented a published report in 1968 which linked Vioform, a different drug which was a member of the same chemical family (hydroxyquinolines) as Diodoquin, with the development of optic atrophy in a patient with AE. Finally, in April 1971, another physician reported that Vioform was implicated in the development of a disease called subacute myelo-optic neuropathy (SMON) and in a few cases patients had developed optic neuritis or atrophy. Plaintiff asserted that the chemical similarities between Diodoquin and Vioform were so significant that the Vioform reports in conjunction with the 1966 study provided a basis upon which Searle was required to warn about possible optic atrophy and the use of Diodoquin.

In response, Searle's medical director stated that the 1966 report had been considered, but that because it was unclear whether the patient's eye problems had been caused by the drug or the disease, no labeling change was necessary. This conclusion was reiterated by three experts presented by Searle, including the physician who had served as director of the Federal Food and Drug Administration's Division of Medical Epidemiology in the mid-1960's, who stated that the report did not establish a causal link between the drug and the effect. As to the Vioform reports, Searle's experts testified that (1) the 1968 report failed to demonstrate that the Vioform rather than the AE had affected the optic system, (2) it was probable that SMON was caused by a viral agent or a pollutant and not Vioform, and (3) in any event, because of the chemical differences between Vioform and Diodoquin, the reports of possible side effects associated with the use of Vioform provided no basis for a determination that there was a need to warn about possible side effects from the therapeutic use of Diodoquin. In this connection, the experts noted that Diodoquin had never been linked to the development of SMON.

On the basis of the foregoing evidence, Searle contended that at the time that plaintiff was using the drug there was no basis upon which it could have been required to issue a warning. A warning was later affixed to Diodoquin which recited that "prolonged high-dosage therapy with hydroxyquinolines" should be avoided because optic difficulties had been reported in conjunction with such therapy. Searle explained that this language was included based on consideration of the 1966 report, the SMON report, which was then being reviewed by the FDA, and after it had learned of plaintiff's case and of a similar case which was reported two months later.

Finally, in response to plaintiff's evidence in support of his contention that his condition was negligently diagnosed and that his blindness was caused solely by the Diodoquin, Searle offered testimony supporting the diagnosis and in addition demonstrated that a zinc deficiency has since been identified as a cause of AE. Searle introduced evidence to establish that such a deficiency alone may have caused plaintiff's optic nerve atrophy. In summary, every issue, from the question of whether plaintiff had initially been misdiagnosed, through the possible causes of his blindness, and the propriety of issuing a warning based on the information available at the time, was contested at trial.

The trial court altered two jury instructions proposed by plaintiff which related to the nature and extent of a manufacturer's "duty to warn." One instruction read: "The manufacturer of a prescription drug is strictly liable to a plaintiff if it fails to warn the medical profession within a reasonable time after it knew or should have known that possible harmful side effects could be produced in persons such as plaintiff by long continued use of the drug known as Diodoquin."

The trial court redrafted this instruction, which as given to the jury then read: "The manufacturer of a prescription drug is liable to a plaintiff if it fails to warn the medical profession within a reasonable time after it knew or should have known that harmful side effects could be produced in users of its drug." Plaintiff's counsel withdrew any objection to the deletion of the adverb "strictly" and as the dissent concedes, the word "strictly" in the context of this instruction added nothing of substance. (Dis. opn., post, at p. 883, fn. 8 of 200 Cal.Rptr., p. 1160, fn. 8 of 677 P.2d.) As to deletion of the modifier "possible" before "harmful side effects," cou...

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