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Hatfield v. Sandoz-wander

OPINION FILED MAY 29, 1984.

BEVERLY SUE HATFIELD ET AL., PLAINTIFFS-APPELLANTS,

v.

SANDOZ-WANDER, INC., DEFENDANT-APPELLEE.



Appeal from the Circuit Court of Cook County; the Hon. David Cerda, Judge, presiding.

JUSTICE O'CONNOR DELIVERED THE OPINION OF THE COURT:

Plaintiffs Beverly and Richard Hatfield, filed an action in strict liability against defendant, Sandoz-Wander, Inc., alleging that Beverly Hatfield ingested the prescription drug Mellaril over a period of time, as a result of which she lost most of her eyesight and is now legally blind. Defendant manufactures, distributes and supplies the drug Mellaril. Defendant stipulated at trial that it was aware that a condition known as pigmentary retinopathy could occur from the use of Mellaril, and had warned of this possibility since 1961 in all prescribing information issued with the drug. Defendant also stipulated that in certain cases pigmentary retinopathy can result in blindness.

Plaintiffs' cause of action was based on the alleged inadequacy of the warnings which were supplied by defendant to the medical profession as to the possible side effects of Mellaril. After a jury trial, judgment was entered for defendant and plaintiffs now appeal. We affirm.

The warnings which were furnished by defendant appeared both in the Physician's Desk Reference (hereinafter referred to as P.D.R.), a reference book which is provided by the drug companies to physicians, containing all available information on prescription drugs, and on package inserts which are affixed to each container of Mellaril manufactured by defendant. Each P.D.R. contains a section labeled "Precautions" and one labeled "Warnings" as to each drug. During the years relevant to this lawsuit, the following information appeared under the "Precautions" section of the P.D.R.:

"* * * Pigmentary retinopathy, which has been observed in patients taking larger than recommended doses over long periods of time, is characterized by diminution of visual acuity, brownish coloring of vision, and impairment of night vision; examination of the fundus discloses deposits of pigment. The possibility of this complication may be avoided by remaining within the recommended limits of dosage."

The prescribing information also states that a maximum recommended daily dose for neurotic patients is 200 milligrams per day, and that the maximum daily dose for adult psychotics is 200 to 800 milligrams per day. The material states that "in all cases, the smallest effective dosage should be determined for each patient." Finally, all pharmacy bottles of the 200 milligram tablet size contain the warning that "This strength tablet is for use only in severe neuropsychiatric conditions," and the prescribing information specifically states that: "For severely disturbed hospitalized psychotics, dosages of 100 to 200 milligrams three times a day may be necessary." (Emphasis added.)

At the time of trial, Beverly Sue Hatfield was 47 years old. In the early part of 1960, she had been hospitalized for emotional problems, during which time she underwent 25 electro-shock treatments. Plaintiff's problems were precipitated by the birth of a new baby and the knowledge that her husband Richard, who had been injured as a serviceman in Korea, was to become a cripple and would possibly end up in a wheel chair. Mellaril was first prescribed for plaintiff by her physician, Dr. Hammel, in August of 1969, at which time she took one 50 milligram tablet per day. Plaintiff continued using Mellaril in varying amounts through January of 1974: from August 1971 to December 1971, she took two 200 milligram tablets per day and from January 1972 to August of that year she took three per day; from September 1972 to May 1973 she took three to four tablets per day; and from July 1973 to January 1974, she took from five to as many as eight 200 milligram tablets per day. Plaintiff never took in excess of eight tablets per day. Dr. Hammel retired in February 1972, and Dr. Pillai became the prescribing doctor for the remaining period. Plaintiff obtained all of the prescriptions at either one of two drugstores. She was not sure whether the prescription label said two, or three to four tablets in the latter part of 1973, but she testified that her doctor allowed her three to four, and that when she began to tolerate the effects of Mellaril, Dr. Hammel would double it. She was never able to obtain Mellaril without a prescription. The record shows that the largest prescription plaintiff actually received before she became blind was for two tablets per day of 200 milligrams each. Thus, by plaintiff's own admission, from July 1973 to January 1974, she took up to 1,600 milligrams per day; four times more than her largest prescription allowed. The pharmacy records show that during June and July, she purchased as much as 3,157 milligrams per day, almost eight times the amount allowed under her largest prescription. Plaintiff testified that Dr. Pillai didn't state anything to her with regard to her taking the drug, and that although he never specifically stated that she could take six to eight pills per day, she did not think that she was going against what the doctor allowed when she did so. In January 1974, plaintiff woke up one morning and found that most of her eyesight was gone. She is presently unable to do housework or to take care of her personal needs.

Plaintiff's husband, Richard, was 50 years old at the time of the trial. He testified that he had had disagreements with his wife over her use of Mellaril, and that she often became sleepy and groggy from the pills. He threw the pills away three to four times in the middle of 1973.

Dr. Gerald Fishman, an opthamologist, testified as plaintiffs' first expert witness. Based upon his examination of Beverly Hatfield, he determined that she was legally blind, that her condition was permanent, and was consistent with the use of Mellaril. Dr. Fishman stated his opinion that defendant's warnings concerning Mellaril failed to cover the spectrum of the potential seriousness of the complication that could occur with the use of the drug. He also stated his belief that in order to make the warnings adequate regarding irreversible eye complications from Mellaril, they should include some statement about the potential severity of the complications; that they may be irreparable and that they may progress even if the patient goes off the drug. In Dr. Fishman's opinion, it was foreseeable to the defendant prior to 1974 that some patients were taking in excess of 1,600 milligrams of Mellaril a day, as evidenced by a statement in the 1968 P.D.R. that the specified retinal problems may well occur if the dosage exceeds 1,600 milligrams.

Dr. William Barnhart, an internist, testified that, with reference to the material contained in the P.D.R.'s concerning Mellaril, his opinion was that the difference between "precautions" and "warnings" was that warnings implied a much more severe risk to patients than precautions. He did not believe that the relevant information as set forth in the P.D.R. was adequate to warn physicians of the possible complications of going over any particular dose of Mellaril; nor did he think that Dr. Pillai had been adequately warned that the drug could cause irreversible eye damage to plaintiff, based on the fact that plaintiff was able to obtain and take through the doctor's prescription from 1,000 to 1,600 milligrams of Mellaril per day over a seven month period.

The deposition of Dr. John Reuter, another of plaintiffs' experts in opthamology, was introduced. Dr. Reuter treated Beverly Hatfield in January 1974 and again in May of that year. His diagnosis of plaintiff's condition was Mellaril intoxication with pigmentary retinopathy. Dr. Reuter's only criticism of the materials issued by defendant was the failure to state the possibility that the eye complications resulting from the use of Mellaril could be irreversible. Both Dr. Reuter and Dr. Barnhart admitted, however, that if the prescribing doctor knew that pigmentary retinopathy could result in a complete loss of vision, then he or she would have been adequately warned.

Dr. Pillai testified, stating that he consulted the P.D.R. when he first authorized the pharmacy to refill Dr. Hammel's prescription of Mellaril for Beverly Hatfield. When he viewed the statement that pigmentary retinopathy had occurred in patients taking larger than recommended doses of Mellaril over a long period of time, he was aware of the fact that pigmentary retinopathy could result in a complete loss of vision in some patients. He presumed that he reviewed the P.D.R. in November 1973. Dr. Pillai had no formal training concerning eye problems other than what he had received in basic medical school, and his only knowledge of the drug Mellaril was that which he had derived from the P.D.R. Dr. Pillai's deposition was also introduced, in which he stated that on July 7, 1972, plaintiff had asked him to authorize the pharmacist to continue dispensing Mellaril, which had been earlier prescribed for her by Dr. Hammel. His notes indicated that he ordered 50 milligram tablets to be taken three times a day, which was a lesser dosage than that which Dr. Hammel had prescribed. He again ordered the same prescription pursuant to a subsequent request by plaintiff on November 15, 1973. His notes also indicated that he advised plaintiff at that time to taper off gradually, with the eventual goal of stopping the medication.

Defendant presented the testimony of three expert witnesses, Drs. Lubin, Drill and Westlin, each of whom stated his opinion that the warnings about Mellaril in the material supplied by defendant were adequate, and that the absence of the words "permanent," "irreversible," "blindness" and "complete loss of vision" did not make Mellaril unreasonably dangerous. In addition, the evidence depositions of two pharmacists were introduced regarding plaintiff's prescription records. One of them also ...


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