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Marchese v. Monaco

Decided: November 10, 1958.


Price, Hall and Gaulkin. The opinion of the court was delivered by Gaulkin, J.A.D.


Defendant appeals from a judgment entered upon the verdict of a jury. Plaintiff sues defendant doctor, a general practitioner, alleging that he negligently treated him with injections of a drug called mycifradin sulfate (hereafter called mycifradin) as a result of which he became deaf. The jury returned a verdict of $56,000. Defendant's motion for a new trial was denied.

A principal ground of appeal is that defendant's motions for judgment at the end of the plaintiff's case and after both sides had rested should have been granted. The motion for a new trial on the ground that the verdict was against the weight of the evidence insofar as it determined liability, was based on substantially the same grounds as the motions for judgment. Therefore, we will deal with the appeal from the denial of all these motions at the same time. We will deal with these questions first because their discussion and decision will facilitate the disposition of the remaining grounds of appeal.

In the review of a civil action (even to decide whether the denial of the motion for judgment at the end of the plaintiff's case was error) we consider all of the competent and relevant testimony introduced during the entire trial. Falk v. Unger , 33 N.J. Super. 589, 592 (App. Div. 1955). And here, when we view plaintiff's evidence as true and draw therefrom every legitimate inference of fact favorable to the plaintiff (as we must upon motions for dismissal, Melone v. Jersey Central Power & Light Co. , 18 N.J. 163, 170 (1955)), we find that it shows the following:

Mycifradin is the trade name of a particular brand of neomycin, an antibiotic. The carton in which defendant received it had printed on it the following:

"Warning -- Intramuscular injections of this drug should be given only for treating serious systemic infections caused by gram-positive or gram-negative organisms that are resistant to antibiotics that are less toxic parenterally. To assure constant medical supervision, intramuscular administration should be restricted to hospital patients. To avoid renal damage and loss of auditory function, dosage should not exceed 1 Gm. per day nor be continued longer than 10 days."

The carton was enveloped by a wrapper on which also the very same warning was printed. In addition, both the wrapper and the carton had printed on it "Read insert for uses, warnings and toxicity."

In the carton was the insert (sometimes called "brochure" in the testimony) the pertinent parts of which read as follows:

"Warning: Intramuscular use of neomycin sulfate solution should be restricted to hospitalized patients with (1) serious systemic infections caused by gram-positive or gram-negative organisms -- particularly Staph. aureus, K. pneumoniae, H. influenzae, P. vulgaris, Ps. aeruginosa -- and organisms resistant to other antibiotics, and (2) urinary tract infections caused by strains of Ps. aeruginosa, E. coli, P. vulgaris or A. aerogenes resistant to other antibiotic and chemotherapeutic agents but susceptible to neomycin.

When a total daily dose of neomycin exceeding 15 mg. per Kg. of body weight (more than one gram of neomycin per day) is continued for more than ten days, signs of toxicity referable to renal and auditory function are likely to develop. These nephrotoxic and ototoxic effects appear to be closely related. In the presence of intrinsic renal disease, neomycin excretion is impaired with resulting increases in serum neomycin concentrations and possible subsequent development of eighth nerve toxicity. The toxic effects of neomycin on the eighth nerve are principally auditory, appear to be additive to those produced by streptomycin, and are irreversible. Nephrotoxic manifestations, including mild albuminuria, presence of granular casts and depression of urinary output with elevation of blood urea nitrogen, are reversible, usually disappearing upon discontinuing administration of the drug.

Neomycin given intramuscularly in a total daily dose of 15 mg. or less per Kg. of body weight for less than ten days in patients with unimpaired kidney function has been shown to be usually well-tolerated

and not likely to give rise to clinical signs of toxicity. However, the procedures and precautions outlined in the following section should be strictly followed.

Procedures and Precautions for Intramuscular Use

(1) In the presence of impaired renal function neomycin should be administered parenterally only with extreme caution since, because of the delayed excretion of the drug, such patients may develop manifestations of eighth nerve toxicity at dosages tolerated by patients with normal renal function. Under such conditions the benefits that may be derived from parenteral neomycin therapy should be weighed against the possible development of deafness.

(2) Before starting parenteral neomycin therapy, the urine should be examined for albumin, casts and cellular elements, and blood should be taken for blood urea nitrogen or nonprotein nitrogen determination.

(3) During the course of therapy, the urine should be examined daily and the blood urea nitrogen determinations repeated twice.

(4) Audiometric tests should be made prior to and during the course of therapy, because evidence of impairment of hearing may be detected by the audiometer before clinical signs develop. This is especially important in patients who have received streptomycin or dihydrostreptomycin previously.

(5) Intramuscular injection of neomycin sulfate should not be continued for longer than ten days, and the total daily dose should not exceed 15 mg. per Kg. of body weight or a total of more than 1.0 Gm. The total daily dose should be divided into four equal doses injected intramuscularly every six hours. The parenteral use of neomycin sulfate solutions for systemic effect is limited to intramuscular injection only."

Defendant admitted he had never used the drug before he used it on plaintiff, and that before he used it he read what was printed on the carton, the wrapper, and the insert. He insisted that in all substantial respects he followed the manufacturer's directions.

Plaintiff bases his action against defendant upon grounds which may be grouped under three heads. First, says plaintiff, defendant should not have prescribed mycifradin for him at all. Second, even if defendant were justified in prescribing it for him, he failed to take the precautions and make the studies that should have been taken and made before the drug was administered to him. Third, defendant failed to take the precautions and make the checks that should have been taken and made while the drug was being

administered, for they would have warned defendant to discontinue its use.

The evidence shows that plaintiff had indications of "intrinsic renal disease" or "impaired renal function." The brochure warns that "under such conditions the benefits that may be derived * * * should be weighed against the possible development of deafness." Plaintiff's expert testified that in such a case the drug should be used only in cases of extreme urgency, when the patient is deathly sick and other drugs and less drastic remedies are not available or have not helped. Defendant conceded at the trial that "it was not an emergency."

Plaintiff's expert testified that plaintiff was not sick enough to experiment with such a dangerous drug, but that even if plaintiff had been a great deal sicker than he was, no doctor exercising reasonable care would have prescribed it without first finding out (1) what organism was making him sick, and (2) whether that organism was vulnerable to mycifradin. This, plaintiff contended, defendant did not do.

Defendant admitted he found none of the organisms named in the brochure against which the use of the drug was recommended, but he argues that he was justified in using the drug because he had found staphylococcus albus , which he and his experts called a first cousin to the " staphylococcus aureus " mentioned in the brochure. However his own witness, Dr. Fernicola, testified "aureus is far more pathogenic."

Therefore, the jury had the right to find that the organism that affected plaintiff was not serious enough and did not make him sick enough to risk deafness.

Plaintiff points out further that even if it were, the defendant made no test to determine whether the particular organism was vulnerable to mycifradin. The laboratory report was "nonhemolytic staphyloccocus, probably the albus group." A simple laboratory test was described by Dr. Goldner with which the effect of an antibiotic on an organism can be determined. Defendant admitted he ordered no such test. He and his expert, Dr. Ritota, claimed that such

tests were not available at that time, but the testimony on that point was such that the jury did not have to believe it. Therefore, the jury had the right to conclude not only that defendant did not know precisely what organism was ailing plaintiff but in addition that he failed to exercise reasonable care to find out whether the drug would do any good.

Plaintiff first consulted Dr. Monaco on March 6, 1955. At that time he had fever, purple blotches (purpura) under the skin of his legs, and swollen ankles. The defendant ordered plaintiff to the hospital immediately and wrote the admitting diagnosis in the hospital record as "Nephritis, Diverticulitis of the large bowel." Nephritis was defined by defendant as "an infection of the kidney." Later on the day of his admission plaintiff was examined by a resident physician of the hospital who noted on plaintiff's chart, "working diagnosis, after physical examination, kidney disease." Defendant examined the chart daily when he visited the plaintiff.

Various examinations and tests were made in the hospital which revealed casts, albumin and blood in the plaintiff's urine. These things and other symptoms and findings noted in the hospital record were admitted by defendant and his witnesses to be signs that kidney disease or impaired kidney function might be present. Defendant's expert, Dr. Ritota, testified that casts are impressions of the small tubules in the kidneys, and "therefore if the tubule doesn't work well some sediment gets stuck there and they form sort of a mold * * *."

Dr. Ritota, an internist connected with the hospital, had been called in for consultation by defendant. Dr. Ritota's preliminary impression was that there was a possibility of kidney disorder and he recommended that further tests be conducted and that Dr. Fernicola, a urologist connected with the hospital, be called in. On March 23 Dr. Fernicola made an intravenous pyleogram. The report of this was "films following the day show normal functioning kidneys. No urinary tract pathology demonstrated." On the other hand a "Fishberg concentration test" showed a glomerular function

of only 25% to 50% of normal -- in other words, a loss of function possibly as great as 75%. The glomeruli were defined by Dr. Ritota as "little groups or tufts of capillaries in the kidneys which is the center of the filtration plant of the kidney."

The defendant and his consultants could not determine precisely what was wrong with plaintiff so on March 27, 1955 he was discharged from the hospital. The discharge diagnosis written into the hospital record by defendant was "nephritis acute * * *."

Two or three days later plaintiff came to defendant's office and told him that he had passed blood. Defendant ordered him back to the hospital, which he reentered on April 4. This time defendant wrote into the hospital record an admitting diagnosis of "right ureteral calculus," or kidney stone. The night nurse on duty April 4-5 noted on plaintiff's chart "abdomen and legs distended. Says he drinks more than his output * * *."

The plaintiff remained in the hospital from April 4 until May 6. Again there were swelling, purpura, and albumin and blood in the urine. There was a burning sensation upon urination. Dr. Ritota and Dr. Fernicola were again called in. On April 5 Dr. Fernicola did a cystoscopy which revealed bleeding from the right kidney. An intravenous pyleogram of the right kidney, done at the same time, was reported "suggestive of compression of calyces." Another pyleogram on April 11 revealed "deflection of calyces in mid portion of right kidney * * * possible result of space occupying lesion or normal variation." The calyces were described by Dr. Ritota as "* * * branches which come from the glomeruli or the factors of filtration. They are the collecting channels where urine is collected * * *" Dr. Ritota described the compression or deflection of the calyces as a "deformity in the canal * * * you assume there must be some pressure from without." Dr. Ritota said that did not necessarily impair the function of the kidney, but it was something that would have to be "investigated." Plaintiff's expert testified "the laboratory evidence was rather

conclusive that the man did have a kidney disease with impaired function."

Up to April 14 the only antibiotic that defendant had tried on plaintiff was terramycin, although it was testified that at that time there were more than 50 antibiotics on the market, of which ...

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