O'HARE v. Merck & Company

• Decision Date: 29 August 1967
• Docket Number: No. 18581.,18581.
• Citation: 381 F.2d 286
• Parties: Beverly O'HARE, Appellant, v. MERCK & COMPANY, Inc., a New Jersey Corporation, also known as Merck, Sharp & Dohme, Appellee.
• Court: U.S. Court of Appeals — Eighth Circuit

381 F.2d 286 (1967)

Beverly O'HARE, Appellant, v. MERCK & COMPANY, Inc., a New Jersey Corporation, also known as Merck, Sharp & Dohme, Appellee.

No. 18581.

United States Court of Appeals Eighth Circuit.

July 19, 1967.

Rehearing Denied August 29, 1967.

Harvey E. Skaar, Minneapolis, Minn., for appellant.

G. Alan Cunningham, Minneapolis, Minn., for appellee and filed brief with Paul J. McGough, Faegre & Benson, Minneapolis, Minn.

Before VAN OOSTERHOUT, MATTHES and LAY, Circuit Judges.

MATTHES, Circuit Judge.

This products liability case involves a prescription drug manufactured and sold by appellee Merck & Company, Inc. (defendant below). Beverly O'Hare, a Minnesota citizen, filed suit in federal court to recover damages resulting from the development and subsequent surgical removal of a non-specific lesion in the small intestine, also referred to in the record as an ulcer or bowel lesion. She premised her cause of action on the theory that the lesion was caused by her use of HydroDIURIL Ka-50, hereinafter referred to as Ka-50. Between January 17, 1964 and April 15, 1964, appellant had taken about forty of the Ka-50 pills. She was overweight and her legs swelled due to the excess fluids in her body. Her doctor prescribed three medicines, one being Ka-50. In March, 1964, she experienced abdominal pains, was hospitalized and discharged in an improved condition. She reentered the hospital on April 13th when the abdominal pains reoccurred, and surgery followed on April 15th. At the time of its removal the cause of appellant's lesion was unknown.

The case was tried and submitted to the jury solely on the alleged negligence of appellee in failing to engage in more extensive research and testing of the drug before placing it on the market, and in failing to adequately warn doctors who prescribed the drug that it could produce a condition such as that experienced by appellant.

Appellee filed a timely motion for a directed verdict at the close of all the evidence but the Court, Judge Nordbye, although entertaining doubt as to the sufficiency of the evidence to establish negligence, submitted the case to the jury which returned a verdict in favor of the appellant for $5,000.00. Thereafter the Court granted appellee's motion for judgment n. o. v. and entered judgment dismissing the case on the merits.¹ This appeal is from that judgment.

Judge Nordbye found that the evidence was sufficient to support a finding of a causal connection between the use of Ka-50 and the small bowel lesion found in appellant. Appellee does not challenge that finding. We are therefore faced with but one issue, i. e., whether the evidence was sufficient to present a fact question on the issue of the negligence of appellee with respect to testing the drug and giving an adequate warning prior to placing it on the market.

We again take note of the Supreme Court's observation in Dick v. New York Life Insurance Co., 359 U.S. 437, 444-445, 79 S.Ct. 921, 3 L.Ed.2d 935 (1959), that the question whether it is proper to apply a state or federal test of the sufficiency of the evidence to support a jury verdict where federal jurisdiction is rested on diversity of citizenship remains unsettled.² See also Mercer v. Theriot, 377 U.S. 152, 156, 84 S.Ct. 1157, 12 L.Ed.2d 206 (1964). We have similarly left the question open. See Jiffy Markets, Inc. v. Vogel, 340 F.2d 495, 498 (8th Cir. 1965); Hanson v. Ford Motor Company, 278 F.2d 586, 589 (8th Cir. 1960).

Since the test to be applied is not in issue here, we again decline to take a definitive position on the question. In Land O'Lakes Creameries, Inc. v. Hungerholt, 319 F.2d 352 (8th Cir. 1963) and Ford Motor Company v. Zahn, 265 F.2d 729 (8th Cir. 1959), cited by appellant, we reiterated the familiar rule that all disputed fact questions and permissible inferences must be viewed in the light most favorable to the plaintiff, and only where all or substantially all of the evidence is on one side should a directed verdict be entered. Appellee does not contend otherwise, and therefore we will apply that test in ruling on the question presented.³

The pertinent facts are not in dispute. Ka-50 is a coined trademark for appellee's combination of Hydrochlorothiazide and potassium chloride. HydroDIURIL is appellee's trade name for Hydrochlorothiazide, which is the diuretic. The designation "Ka" indicates the presence of potassium chloride. Ka-50 is a combination of 572 mg. of potassium chloride in enteric coated form and 50 mg. of Hydrochlorothiazide. The diuretic increases the urine flow and rids the body of excessive fluids. It is also effective in the treatment of certain heart conditions. Diuretics have been used for many years by the medical profession, but until the discovery of the thiazides by appellee in the mid 1950's, the diuretics then offered were not very effective. HydroDIURIL became available as a prescription drug in 1958 after approval by the Food and Drug Administration. Prior to favorable action by that Agency, appellee had conducted extensive animal and human testing.

HydroDIURIL had the known effect of reducing the body's content of potassium. In order to overcome the potassium deficiency, it was a generally accepted practice for doctors to prescribe potassium chloride. It stands undisputed that the latter has a long history of accepted and safe use by the medical profession. The evidence also shows, however, that potassium chloride was a known irritant when taken in a nonenteric form. It caused nausea, gastric irritation, had "a bitter taste and patients just wouldn't stay on it." Since about 1950, however, enteric coated potassium chloride in a single pill form has been in common use.⁴

The enteric coating permitted the pill to pass through the stomach into the small intestine where the potassium chloride gradually dissolved. By preventing dissemination in the stomach the side effects of nausea and bitter taste were eliminated.

It is also uncontroverted that Ka-50 is a combination of the two previously used and accepted pills and was designed primarily to provide all of the needed medication in a single pill. In this form, the core of the pill is the potassium chloride, surrounded first, by an enteric coating and then 50 mg. of Hydrochlorothiazide. As in the two-pill process the Hydrochlorothiazide, or diuretic, is dissolved in the stomach, but the potassium chloride, because of the enteric coating, does not dissolve until it reaches the small intestine.

Prior to the distribution of Ka-50 on the market appellee conducted several premarketing tests which consisted of chemical studies begun in March, 1959 and continued until the filing of appellee's application with the Food and Drug Administration. Tests were conducted by a number of clinical investigators on humans. The product was administered to patients with various cardiovascular disorders. These tests established the safety and efficacy of the drug under normal conditions of use, subject to the warning and precautions appearing in appellee's literature. Of 136 humans tested there was no indication that Ka-50 did or would produce lesions in the small bowel. A few of the patients experienced an upset stomach or gastrointestinal complaints. These side effects were recognized and incorporated in appellee's basic information booklet to physicians. The results were submitted to the Food and Drug Administration and on June 9, 1960 that Agency approved appellee's application and authorized sale of Ka-50. Since July 1, 1960 the combination pill has been used extensively as have similar thiazide and hydrochlorothiazide enteric coated pills of at least three other drug manufacturers.⁵

Prior to September, 1964 the medical profession was wholly unaware of a causal relationship between potassium chloride and lesions in the small bowel. On September 28, 1964 a Swedish publication appeared, followed in November of 1964 by an American article, which indicated that there was a causal relation between potassium chloride and non-specific lesions in the small intestine, a number of which had been discovered prior to the publication of the two articles. Appellee acted promptly after the articles appeared. Between mid-October and mid-December, 1964 it conducted a study covering a period which varied from five to ten years prior to December 18, 1964. That study revealed 395 cases of small bowel lesions. Approximately half of the individuals tested had a history of using potassium chloride. Small monkeys weighing five to ten pounds were administered heavy doses of Ka-50 and lesions developed in a high proportion of the animals tested. The results of the studies and tests were reported to the Food and Drug Administration, which requested all manufacturers to supplement the warning previously given to doctors by including therein the information that small bowel lesions may occur with enteric coated potassium tablets alone or when they are used with nonenteric coated thiazides or certain other oral diuretics. Pursuant to this request appellee mailed an appropriate statement to all physicians.

In urging that the court erred in vacating the judgment, appellant argues in part that the irritating qualities of potassium chloride were well known for many years prior to the advent of Ka-50; that in assuming the safety of potassium chloride in the combination form appellee improperly relied on the fact that that drug had been used in the medical field since 1951; that in view of the known irritating quality of potassium chloride appellee was negligent in testing only 136 patients prior to marketing Ka-50 and in not making more extensive studies and tests on animals as it did subsequent to the published reports.

We turn now to the standard of care imposed upon a manufacturer of drugs. The increase in products liability litigation has brought forth a body of law dealing with the duty of manufacturers of drugs. See Rheingold, Products Liability — The Ethical...