E.R. Squibb & Sons, Inc. v. Cox

Decision Date04 October 1985
Docket NumberNo. 84-476,84-476
Citation477 So.2d 963
PartiesProd.Liab.Rep. (CCH) P 10,787 E.R. SQUIBB & SONS, INC. v. Royce Y. COX.
CourtAlabama Supreme Court

J. Patrick Logan and F.A. Flowers III of Thomas, Taliaferro, Forman, Burr & Murray, Birmingham, and W. Beatty Pearson of Powell, Powell & Pearson, Andalusia, for appellant.

Michael Jazwinski of Prestwood, Prestwood & Jazwinski, Andalusia, for appellee.

PER CURIAM.

This is a products liability/negligence case. Plaintiff brought suit in the Covington County Circuit Court against: (1) defendant E.R. Squibb & Sons, Inc., a drug manufacturer, alleging negligent and wanton mispackaging of R-U-100 insulin and negligent and wanton failure to adequately warn against confusing R-U-100 insulin with N-U-100 insulin; and (2) defendant Ewin Moody, a pharmacist, alleging negligence and wantonness in failing to detect the insulin mispackaging and in failing to detect that clear insulin is not the kind of insulin plaintiff requires. After a trial on the merits, and after the trial judge directed a verdict for defendant Squibb on the wantonness counts, the case went to the jury, which returned a verdict for plaintiff and against both defendants in the sum of $300,000.00. The trial court entered judgment thereon, and it is from this judgment that defendant Squibb appeals. 1

FACTS

Defendant Squibb manufactures and sells insulin preparations. In 1981, Squibb's line of insulin preparations included: (1) an undiluted, unmodified insulin, clear in appearance, known as R-U-100 insulin, and (2) a diluted, modified insulin, cloudy in appearance, known as N-U-100 insulin. R-U-100 insulin's clear appearance The two kinds of insulin are packaged in boxes of the same size and color. The boxes, however, are labeled differently:

is due to its unmodified state, and it is the only unmodified, clear insulin that Squibb manufactures and markets.

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Likewise, the insulin bottles are identical, except for their labels:

NOTE: OPINION CONTAINS TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Each box of Squibb insulin contains an insert which provides instructions and warnings. The inserts are substantially identical, but the letter in the top righthand corner indicates the kind of insulin contained in the box (e.g., "N" or "R"). Relevant portions of the warning provided in an "R" insulin (R-U-100 insulin) insert in 1981 are as follows:

[symbol]

SQUIBB

J2-705

-------------------------------------------------------------------------------

Revised May 1980

Instructions for the Patient who uses U-100 Insulin Injection USP

[R]

IMPORTANT: See your doctor before using U-100 insulin for the first time.

Warnings: Any change of insulin should be made cautiously and only under

medical supervision. Changes in purity, strength (U-40, U-100), brand

(Manufacturer), type (Lente, NPH, Regular, etc.) and/or source (beef, pork or

beef-pork) may result in the need for a change in dosage. Be aware of the

possibility of symptoms of either hypoglycemia or hyperglycomia (see section

entitled DANGERS YOU MUST GUARD AGAINST).

WHAT IS U-100 INSULIN?

Basically, U-100 insulin is the same as the type you have been accustomed to

using. The only difference is that now you have 100 units of insulin in each

cubic centimeter (cc) instead of 40 or 80 units per cc as are in U-40 and

U-60 insulin. However, your unit dosage remains the same. DO NOT ATTEMPT TO

CHANGE OR ADJUST THE NUMBER OF UNITS OF INSULIN YOU INJECT. Forty units of

U-100 insulin does the same job as 40 units of U-40 or U-60 insulin.

HOW TO RECOGNIZE U-100 INSULINS

Recognition is easier, too. All U-100 insulins have a simplified labeling

system designed for quick, accurate identification. The large capital letter

on every bottle and box stands for the specific type of insulin, and the

orange cap on each bottle designates it as U-100 insulin. The symbols for the

various U-100 insulin preparations are as follows:

[S] - Semilente (R) Insulin (Prompt Insulin Zinc Suspension USP)

[U] -Ultralente (R) Insulin (Extended Insulin Zinc Suspension USP)

[R] -Insulin injection USP (sometimes also called regular, unmodified,

ordinary or plain insulin)

[N] -Isophane Insulin Suspension USP (NPH Insulin)

[P] -Protamine Zinc Insulin Suspension USP (PZI Insulin)

[G] -Globin Zinc Insulin Injection USP (Globin Insulin with Zinc)

[L] -Lente (R) Insulin (Insulin Zinc Suspension USP)

Note: Do not confuse one of these insulin preparations with any of the

others. There is a great difference in the way some of them act, particularly

as to how quickly and for how long they act. Never use any insulin

preparation unless your doctor tells you to and only use the kind he tells

you to use.

Special U-100 disposable and reusable syringes are available at your

pharmacy. Always use a U-100 syringe with U-100 insulin. All U-100 syringes

are distinctively orange color-coded and state "FOR USE WITH U-100 INSULIN

ONLY."

WHAT IS INSULIN INJECTION?

Insulin injection contains insulin, the active substance made by the

pancreas. It us a clear, colorless liquid made from zinc-insulin crystals

obtained from beef and pork pancreas. This preparation is a short acting form

of insulin; its effect is evident in approximately one-half to one hour,

reaches its peak in approximately two to three hours, and persists for

approximately six hours.

HOW MUCH SHOULD YOU USE

Doses of insulin preparations are prescribed in units. U-100 means 100 units

of insulin per cubic centimeter (cc). The strength and kind of any insulin

preparation is clearly stated on the bottle and carton. In addition, U-100

insulins have a large letter on each box and bottle which signifies the type

of insulin it is. The volume of the dose you use will depend on the strength

of the preparation the doctor tells you to use. The dose should not be

altered except by direction of your physician.

Your doctor will tell you what kind and strength of insulin to use, the

number and size of daily doses, and how and when to inject it. Follow the

instructions of your physician.

These considerations, as well as general health, diet, and exercise, are

problems that require direct and continuous medical supervision. See your

doctor regularly and follow his directions.

Diabetics have many rules to follow. Do not worry. Everything will become

familiar and easy very soon.

* * *

DANGERS YOU MUST GUARD AGAINST

* * *

Too much insulin in the blood

When too much of any insulin preparation is taken, the extra insulin acts on

so much sugar that the body develops a sugar shortage. This is called

hypoglycemia. At times, hypoglycemia may be so severe as to cause

unconsciousness. Hypoglycemia may occur:

1. If you take too large a dose of insulin.

2. If you eat less than the diet calls for or if you postpone a meal for too

long after taking an insulin preparation.

3. If food is not being absorbed in usual manner such as when a meal is

omitted, or an illness with vomiting, diarrhea, or delayed digestion.

4. If you exercise or walk more than usual.

5. If your insulin requirement declines or if large doses of insulin are

taken at irregular intervals.

The warning signs are: fatigue, faintness, drowsiness, tremulousness,

dizziness, nervousness, weakness, sweating, double vision, headache, and

nausea. Sometimes headache is the only sign and sometimes the feeling of

being very, very tired for no particular reason is the only warning signal.

When one of these signs is first noticed, eat some kind of sugar at once. A

piece of candy or lump of sugar will do. Always carry lump sugar or candy

with you. If the warning signals persist, contact your physician at once.

Your family and other constant associates should be told that in the event

you become delirious or mentally confused, they should give you diluted corn

syrup or orange juice with sugar. You may follow this with soda crackers and

milk an hour or two later.

Mixing different insulins

Different insulin preparations should never be mixed with one another unless

you are directed to do so by your physician. Patients who have been directed

by their physician to mix two types of insulin (in their hypodermic syringe) should be aware that insulin hypodermic syringes may vary in the amount of

space between the bottom line and the needle. Because of this, do not change:

1. The order of mixture the physician has prescribed or,

2. The model and brand of the syringe or needle, without first consulting

your physician.

Failure to heed this warning can result in a dosage error.

In case of any trouble, always call your doctor at once.

LENTE [R], SEMILENTE [R], and ULTRALENTE [R] are licensed TM of Novo Industry

A/S.

J2-705

J2-705

Plaintiff Cox, a retired civil engineer, was diagnosed as a diabetic in 1972. Pursuant to his doctor's directions, he has always taken N-U-100 insulin.

On or about August 20, 1981, plaintiff went to defendant Moody's drugstore and purchased insulin. Plaintiff testified that on this date he requested N-U-100 insulin, 2 as he always did. Although he did not carefully look at the box, he assumed that he had been given N-U-100 insulin. He took the insulin home and put it in the refrigerator. He never read the insulin box.

On August 24, 1981, plaintiff took the insulin out of the refrigerator, opened the box, and threw it away. He also threw away the insert that comes inside the box. He did not read either the box or the insert. Prior to using the insulin, however, plaintiff noticed that it was clear, rather than cloudy, in appearance. Because plaintiff The evidence is conflicting as to what happened next. According to plaintiff's testimony, he took the insulin back to Moody's drugstore and explained his concern to Moody. Moody then personally looked at the bottle and told plaintiff that the insulin was okay....

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