American Home Products Corp. v. Johnson & Johnson

• Decision Date: 07 April 1987
• Docket Number: No. 85 Civ. 4858 (WCC).,85 Civ. 4858 (WCC).
• Citation: 654 F. Supp. 568
• Parties: AMERICAN HOME PRODUCTS CORPORATION, Plaintiff, v. JOHNSON & JOHNSON, McNeilab, Inc., Saatchi & Saatchi Compton, Inc., and Kallir Philips Ross, Inc.
• Court: U.S. District Court — Southern District of New York

654 F. Supp. 568

AMERICAN HOME PRODUCTS CORPORATION, Plaintiff, v.JOHNSON & JOHNSON, McNeilab, Inc., Saatchi & Saatchi Compton, Inc., and Kallir Philips Ross, Inc.

No. 85 Civ. 4858 (WCC).

United States District Court, S.D. New York.

February 25, 1987.

As Amended April 1, April 6 and April 7, 1987.

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Arnold & Porter, Washington, D.C., Parker Auspitz Neesemann & Delehanty P.C., New York City, for plaintiff; Stuart J. Land, Steven P. Lockman, Washington, D.C., Jack C. Auspitz, New York City, of counsel.

Patterson, Belknap, Webb & Tyler, New York City, for defendants; David F. Dobbins, Gregory L. Diskant, of counsel.

OPINION AND ORDER

WILLIAM C. CONNER, District Judge:

This lawsuit represents a major battle in an endless war between two titans of the over-the-counter ("OTC") drug industry, in which each accuses the other of falsity in its advertising claims of efficacy and safety.Small nations have fought for their very survival with less resources and resourcefulness than these antagonists have brought to their epic struggle for commercial primacy in the OTC analgesic field.

American Home Products Corporation("AHP") which, through its Whitehall Laboratories, Inc.("Whitehall") subsidiary, markets the OTC analgesic ibuprofen under its trademark Advil, brought this action against Johnson & Johnson ("J & J") and its wholly-owned subsidiary McNeilab, Inc.("McNeil") which markets the competitive OTC analgesic acetaminophen under the trademark Tylenol, as well as McNeil's advertising agencies, claiming falsity in widely published printed materials and television commercials linking ibuprofen with aspirin and unfavorably comparing both to acetaminophen in the respect of causing adverse side effects.J & J and McNeil have counterclaimed against AHP for alleged falsity in its comparative advertising of Advil and two of its other OTC analgesic products, Anacin, which is a mixture of aspirin and caffeine, and Anacin-3, which, like Tylenol, is acetaminophen.

The claims of both sides are based upon Section 43(a) of the Lanham Act,15 U.S.C. § 1125(a),sections 349(h)and350-d(3) of the New York General Business Law, and the common law of unfair competition.Federal subject matter jurisdiction is based upon 15 U.S.C. § 1121,28 U.S.C. §§ 1331and1338(a) and pendent jurisdiction.

The trial lasted four weeks, and involved the in-court testimony of 22 witnesses, many of them world-renowned physicians and medical researchers specializing in pharmacology, nephrology, hepatology, gastroenterology, hematology, epidemiology, and more particularly in the systemic effects of analgesics.The testimony of 37 additional witnesses was presented by deposition.

Many hundreds of exhibits, filling eight file drawers, were received in evidence, most of them copies of technical articles, couched in the arcane language of medical science, packed with numerical data and embellished with graphs and tables.Because many of these exhibits were merely "dumped" into evidence with only the briefest discussion by a witness, or none at all, the Court has not undertaken the mountainous task of reading all of them, but has confined its review to those which the parties deemed sufficiently important to cite in their briefs or proposed findings.

Almost a thousand pages of post-trial briefs and proposed findings were filed.But before the reply briefs had even been received by the Court, the attorneys for one of the parties sent a letter to the Court urging a prompt decision because the opposing party had recently resumed the broadcasting of certain challenged television commercials which it had voluntarily suspended in order to obtain a continuance of the trial.

Even the briefest discussion of all of the evidence considered would require an opinion thousands of pages in length which would never be read by anyone other than the parties, and which would make it impossible to satisfy counsel's expressed desire for expedited resolution of the controversy.The Court therefore will merely state in summary fashion its findings of fact pursuant to Rule 52, Fed.R.Civ.P., without a detailed analysis of the supporting evidence.

Background

Aspirin

The first OTC analgesic was aspirin (acetylsalicylic acid), which was introduced in 1899 and which, either in pure form or in various mixtures, monopolized the OTC analgesic market for over half a century.Aspirin is classified as a non-steroidal anti-inflammatory drug ("NSAID").Like all NSAIDs, its primary mechanism of action is to inhibit the body's normal production of prostaglandins, a family of substances synthesized by enzyme action in cells throughout the body and having various systemic functions or effects.One of the prostaglandin effects is sensitization of nerve endings to pain and another is inflammation of the joints.Thus prostaglandin inhibition quite effectively reduces pain and inflammation.However, since prostaglandins perform a number of beneficial functions, such as protection of the mucous lining of the gastrointestinal tract, vasodilation — which enhances blood circulation, particularly to the kidneys — and platelet aggregation (blood clotting), NSAIDs tend to cause gastrointestinal irritation and ulceration, renal dysfunction and anti-hemostasis (prolongation of bleeding).

These adverse side effects of aspirin, although not discovered for many years after its introduction, are now well known and undisputed.Indeed, many scientists have expressed the view that if a new drug application ("NDA") for OTC aspirin were now presented to the Food & Drug Administration ("FDA"), it would not be approved.

Aspirin is marketed OTC by many companies.For example, it is sold in pure form under the well-known trademark Bayer by Sterling Drug Co.Plaintiff AHP markets a mixture of 80% aspirin and 20% caffeine under the trademark Anacin.

Acetaminophen

The second OTC analgesic, acetaminophen (N-acetyl-para-aminophenol), was first widely marketed in the United States in the 1950's, although its properties had been discovered many years earlier.It reduces pain by elevating the pain threshold, although its mechanism of action is not fully understood.It also functions as an antipyretic by action on the hypothalamic heat-regulating center.However, unlike aspirin, it has no significant inhibitory effect on prostaglandin synthesis outside the central nervous system, nor any significant anti-inflammatory effect.Thus it is not an NSAID.

It is markedly superior to aspirin in its relative freedom from the adverse side effects of gastrointestinal irritation or ulceration and prolongation of bleeding.At massive overdoses, it can cause serious or even fatal hepatotoxicity, especially in chronic alcoholics or others with pre-existing liver damage.

It is marketed OTC by defendant McNeil in 325 mg. tablets under its trademark Tylenol and in 500 mg. capsules or "caplets" under the trademark Extra-Strength Tylenol.The FDA-approved package instructions for the latter product recommend the taking of two capsules (1,000 mg. or 1 g.) three or four times a day but no more than eight tablets (4 g.) in any 24-hour period.

It is also marketed OTC by plaintiff AHP under its trademark Anacin-3 and by Bristol-Myers under its trademark Datril.However, aggressive marketing and massive advertising by McNeil have given Tylenol a dominant position among the non-aspirin OTC analgesics.

Ibuprofen

Ibuprofen is an NSAID which was developed by Boots Pharmaceutical ("Boots") in Great Britan in the 1960's.Upjohn Company obtained from Boots a license to market ibuprofen in the United States, and in 1974 introduced a prescription ibuprofen product under its trademark Motrin.

Ibuprofen functions, like other NSAIDS, by inhibiting prostaglandin synthesis.Thus like aspirin, it is very effective in relieving pain and inflammation, and has the same types of side effects, although it is significantly more benign than aspirin in the respect of gastrointestinal irritation and anti-hemostasis.

AHP, McNeil and others sought licenses to market an OTC ibuprofen product in the United States.AHP succeeded in obtaining a license directly from Boots and, after lengthy FDA proceedings, obtained approval to market an OTC product which it began distributing under the trademark Advil in 1983.

McNeil sought a license from Upjohn but these negotiations failed and Upjohn instead licensed Bristol-Myers, which now markets an OTC ibuprofen product under the trademark Nuprin.Having initially failed to obtain the right to market its own ibuprofen product and fearing that competition from ibuprofen would seriously erode its market for Tylenol, beginning in September 1983 McNeil repeatedly intervened before the FDA in opposition to AHP's NDA for ibuprofen.McNeil unsuccessfully sought to persuade the FDA to send AHP's application back to the FDA's Arthritis Advisory Committee, pointing to adverse reports on the side effects on the central nervous system ("CNS") of prescription-level use of ibuprofen (up to 800 mg. per dose and 3200 mg. per day).

AHP sought to obtain FDA approval for OTC dosages of ibuprofen up to 1600 mg. per day (one-half the prescription daily maximum), but the FTC finally ruled that the OTC package instructions should specify a dosage of one or, if necessary, two 200 mg. tablets, with no more than six tablets, or 1200 mg., in any 24-hour period.

McNeil repeatedly filed with the FDA lengthy petitions and met with FDA officials in an effort to persuade the FDA to eliminate the statement in the FDA's Summary Basis of Approval ("SBA") of OTC ibuprofen that

consumers taking ibuprofen at recommended doses will experience comparable `common side effects' to those they experience with available OTC analgesics, i.e., acetaminophen and aspirin if the latter 2 drugs are taken at regular strength doses 325-650 mg..At `extra strength' doses 1000 mg. the incidence of adverse side

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