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IN RE AMERICAN HOME PRODS.

December 27, 1994

Re: American Home Products
v.
The Procter & Gamble Company, Syntex USA Inc. and Procter-Syntex Health Products Co.



The opinion of the court was delivered by: NICHOLAS H. POLITAN

 ORIGINAL ON FILE WITH CLERK OF THE COURT

 Dear Counsel:

 This matter is presently before the Court on the application of plaintiff American Home Products Corporation for a preliminary injunction against defendants The Procter & Gamble Company, Syntex USA Inc., and Procter/Syntex Health Products Company seeking to enjoin advertising introducing defendants' new over-the-counter pain reliever known as "ALEVE." The Court conducted a six-day evidentiary hearing on plaintiff's application. For the reasons expressed herein, plaintiff's application is DENIED.

 I. Findings of Fact

 A. Procedural Background

 This case involves a dispute between manufacturers and marketers of competing over-the-counter ("OTC") analgesic drugs. Plaintiff American Home Products Corporation ("AHP"), through its Whitehall-Robins Health Care Division, manufactures and sells for resale to consumers a variety of health care products including ADVIL(R), an OTC analgesic containing 200 mg. of ibuprofen per tablet. Defendants Procter & Gamble Company ("Procter"), a consumer products company, and Syntex USA Inc. ("Syntex"), a pharmaceutical company, formed Procter/Syntex Health Products Company ("Procter/Syntex"), a general partnership which is in the business of manufacturing, advertising, promoting and marketing ALEVE(R), an OTC analgesic containing 220 mg. of naproxen sodium.

 On August 8, 1994, AHP filed this action, together with a motion for expedited discovery and a motion for a preliminary injunction. AHP seeks preliminary and permanent injunctive relief including corrective advertising, compensatory damages as well as an award of profits, damages, costs, and attorneys' fees, in order to redress alleged violations of the Lanham Act in connection with the advertising, marketing and promotion of ALEVE.

 Specifically, the Complaint alleges that, in violation of § 43(a)(2) of the Lanham Act, 15 U.S.C. § 1125 (a)(2), the advertising and promotion of ALEVE convey false and misleading claims including the claims that: (1) ADVIL is ineffective or significantly less effective than ALEVE, either in general or for headaches, muscle aches or arthritis pain; (2) many people who do not get enough pain relief from ADVIL will get better or more complete pain relief from ALEVE, either in general or for headaches, muscle aches or arthritis pain; (3) well-controlled clinical studies establish that ALEVE provides a high level of pain relief for 12 hours following painful dental surgery; (4) well-controlled clinical studies establish that ALEVE is more effective than ADVIL; (5) physicians recommend ALEVE in preference to ADVIL; (6) ALEVE has a longer duration of action than other OTC analgesics, including ADVIL; (7) ALEVE has a duration of action twice as great as ADVIL; (8) EXTRA-STRENGTH TYLENOL(R) has a longer duration of action than ADVIL; (9) well-controlled clinical studies establish that ALEVE has a greater duration of action than ADVIL; (10) ALEVE is the OTC version of NAPROSYN(R); (11) NAPROSYN is "The number 1 selling prescription brand in its class"; (12) physicians prescribe the medicine in ALEVE more than the medicine in ADVIL; (13) persons 65 years of age and older may take ALEVE every 8 to 12 hours; (14) the duration of action of ALEVE, EXTRA-STRENGTH TYLENOL, ADVIL and BAYER(R) aspirin is proportional to the recommended dosage of each drug; (15) ALEVE provides pain relief in as little as 20 minutes; and (16) the efficacy of ALEVE has been confirmed in 32 clinical trials involving 2,857 patients.

 At the hearing before this Court, AHP sought preliminary injunctive relief prohibiting pendente lite claims that (a) ALEVE relieves headache or other pain better than ADVIL; (b) ALEVE has a greater duration of action than ADVIL; (c) ALEVE works twice as long as ADVIL; (d) EXTRA-STRENGTH TYLENOL has a longer duration of action than ADVIL; (e) the recommended dosage of over-the-counter analgesic drugs is equivalent to their duration of action; (f) 32 clinical studies established the efficacy of ALEVE; (g) ALEVE is the over-the-counter version of the prescription drug NAPROSYN; and (h) persons over the age of 65 can safely medicate using the dosing schedule permitted by law for persons under the age of 65. *fn1"

 B. Development and Introduction of ALEVE

 OTC internal analgesics are manufactured and sold to the public for temporary relief of minor pain of headache, muscle aches, the minor pain of arthritis, and the pain of menstrual cramps. Prior to June 1994, aspirin, acetaminophen (the active ingredient in TYLENOL) and ibuprofen (the active ingredient in ADVIL) were the principal OTC analgesics available for sale to the U.S. consumer.

 For the past 18 years, Syntex has manufactured and sold a prescription pain reliever under the brand name NAPROSYN. Tr.1.195 (DeArmond). *fn2" The only active ingredient in NAPROSYN is a chemical compound known as naproxex. Tr. 1.195-96 (DeArmond). Like ibuprofen, the active ingredient in ADVIL, naproxex belongs to a class of pain relievers known as nonsteroidal anti-inflammatory drugs, or "NSAIDS."

 Syntex also manufactures and markets another prescription pain reliever called ANAPROX(R), which contains the active ingredient naproxen sodium. The singular purpose of the sodium in naproxen sodium is to accelerate the body's absorption of naproxen. Once in the body, naproxen and naproxen sodium are identical, i.e., they behave the same way and have the same efficacy, except that naproxen sodium has a faster onset of analgesic effect than naproxen. Tr. 1.101-03 (Davis); 1.195-96, 1.199-200 (DeArmond); 4.139-40 (Benet).

 In 1988 defendant Procter/Syntex set out to develop an OTC formulation based on naproxen. The company "[was] hoping to build on the heritage of [NAPROSYN], a drug that is well known, even better known than [Syntex's] ANAPROX brand . . . ." Tr. 1.173 (DeArmond). In April 1992, Procter/Syntex filed a New Drug Application ("NDA") seeking approval from the Food and Drug Administration ("FDA") for OTC naproxen with a 6 to 8 hour dosing regimen. Tr. 1.199-200 (DeArmond); 4.182-84 (Feldman).

 The FDA, however, was concerned that naproxen would have an onset of pain relief that was too slow for an OTC analgesic and requested that a new application be submitted proposing naproxen sodium (200 mg of naproxen and 20 mg of sodium per tablet or caplet) as ALEVE's active ingredient. Tr. 4.221-22 (Feldman). After conducting additional tests on naproxen sodium, Procter/Syntex resubmitted the NDA in December 1992, seeking FDA approval for an OTC version of ANAPROX (i.e., naproxen sodium) with a 6 to 12 hour dosing schedule. Tr. 4.184-85 (Feldman); Pl. Ex. 305.

 In January 1994, the FDA approved this OTC version of ANAPROX, summarizing its basis for so doing in its official "Summary Basis of Approval" or "SBA." Def. Ex. 1. The FDA approved a dosing regimen of either one tablet (220 mg) every 8 to 12 hours, or an initial dose of two tablets (440 mg) followed by one tablet every 12 hours, with no more than three tablets every 24 hours. In explaining the rationale for this dosing regimen, the FDA declared in the SBA that results from tests submitted by Procter/Syntex, known as LAB 982 and LAB 983, indicated that ALEVE had a "longer duration of action [than ibuprofen] supporting a BID-TID [twice a day - three times a day] dosing regimen." Def. Ex. 1, at C0051. Defendants are presently manufacturing and selling this drug under the trade name ALEVE.

 C. The Advertising Claims Challenged by AHP

 1. Defendants' Print Advertising

 It is useful at the outset to review plaintiff's objections to the ALEVE promotional campaign and defendants' responses thereto. Much of AHP's consternation regarding the ALEVE advertising centers on a colored bar graph that accompanies most if not all of defendants' print and display advertising for the product. See, e.g., Pl. Exs. 206, 207, 214. The bar chart displays on its face the recommended dosing schedules for the OTC analgesics ALEVE, EXTRA-STRENGTH TYLENOL, ADVIL and BAYER aspirin; indeed, the dosing rather than duration nature of this chart is confirmed by the caption "Recommended Dosing" that accompanies the graph in nearly every setting in which it is presented.

 The bar charts featured in these materials are comprised of colored bars that extend horizontally from left to right along an axis broken up by hourly time intervals. Each bar represents a separate product. The bar graph for ALEVE stretches out horizontally to the 12-hour point, EXTRA-STRENGTH TYLENOL extends to approximately the 8-hour point, ADVIL to the 6-hour point and BAYER aspirin to the 4-hour point. Pl. Exs. 206, 207, 211, 212, 213, 214. There is a color change or fading out of color toward the end of each of the bars in the bar chart. Id. In some presentations, to the left of the bar graph is the statement in large type "All day strong." Underneath the bar graph is the statement "That means you could work all day or sleep all night without being interrupted by pain." See, e.g., Pl. Ex. 206. *fn3"

 AHP does not profess that the ALEVE print advertising contains explicit words claiming superior duration of action over competing analgesic drugs. Nevertheless, it is AHP's contention that the intended message of the bar chart is that ALEVE has a longer duration of action -- twice as long in fact -- than does ADVIL and that EXTRA-STRENGTH TYLENOL has a longer duration of action than does ADVIL. These messages, according to AHP, are communicated mainly by the comparative length of the bars. AHP also claims that these purported duration messages are fortified by the proximity of the dosing chart to duration claims (e.g., "all day long, all day strong" and "longer than EXTRA-STRENGTH TYLENOL") and the graphics chosen for the color bars.

 AHP also takes issue with the free-standing insert ("FSI"), a full page color advertisement promoting ALEVE and containing a coupon, that was distributed in Sunday newspapers nationwide, initially in August 1994 and again in September 1994 after this action was filed. Malkoski Dep. at 188:10-188:20, 190:6-190:10. In the case of a national product launch, the FSI is one of the first advertisements a consumer is likely to see for the new product. Tr. 1.42 (Davis). Makers of OTC analgesics typically use FSIs in their advertising because it is an effective way to communicate with a large number of consumers at one time. Toomey Dep. at 25:23-26:10.

 AHP asserts that the ALEVE FSI explicitly seeks to link ALEVE's dosing and duration of action. A paragraph in the FSI under the heading "All day long" states as follows:

 
ALEVE is the only non-prescription pain reliever with 8 to 12 hour dosing. Just one ALEVE tablet or caplet gives you long-lasting relief that can last up to 12 hours.

 Procter/Syntex began mass media print advertising to consumers in June 1994. An ALEVE consumer print advertisement appeared in the New York Times and numerous magazines of widespread circulation in July 1994. Pl. Ex. 207; Toomey Dep. at 39:5-39:15. The New York Times print advertisement reads in full:

 
Before you take Tylenol or Advil again, get a second opinion. Introducing the only non-prescription pain reliever with 8-12 hour dosing. New Aleve. The first pain reliever with the non-prescription strength of Anaprox, a fast-acting form of the medicine in Naprosyn. The #1 selling brand in its class for 10 years. The brand doctors have prescribed over 150 million times, outselling Motrin and all other prescription ibuprofen brands combined. Aleve is longer-lasting than Extra-Strength Tylenol. Advil isn't stronger. Yet Aleve is gentler to you stomach lining than aspirin. And because the maximum daily dose for Aleve is only 3 pills, compared to 12 aspirin, Aleve won't upset your budget. In fact, Aleve costs half as much as Tylenol or Advil per maximum daily dose. Try new Aleve. To take pain away and keep pain away all day.

 Pl. Ex. 207. In addition, this printed ad contains the bar chart as well as the slogan "All day strong all day long." AHP claims that the New York Times print advertisement implies the same purportedly false messages as the FSI and the ALEVE television commercials. Tr. 1.65-66, 1.72-73 (Davis).

 In addition, the ALEVE promotion extended to medical journals. The language "Introducing ALEVE the only OTC analgesic with" appears as a preface to "The endurance of 8-12 hour dosing" in the health professional advertising. Pl. Exs. 213, 214. The ALEVE bar in that chart is labeled "ALEVE offers the convenience of 8-12 hour dosing," whereas the bars in the chart for the other drugs state that the referenced drug "recommends" its dosing regimen. Moreover, the following introductory language also appears in the ALEVE professional advertising:

 
The activity of naproxen sodium The efficacy of ALEVE has been confirmed in 32 clinical trials involving 2,857 patients.

 Pl. Ex. 214 (footnote omitted). AHP's chief complaint with respect to the advertising addressed to medical professionals concerns the claim that 32 clinical studies has proven the efficacy of ALEVE.

 2. Defendants' Television Advertising

 Defendants commenced television advertising for ALEVE in early July 1994 with four commercials that are virtually identical. See Pl. Ex. 208 (entitled "Talking About His Wife"); Pl. Ex. 208a (entitled "Her Brother Needs Aleve"); Pl. Ex. 208b (entitled "Talking About Her Husband"); Pl. Ex. 208c (entitled "Mom Needs Strong Medicine"). Each commercial contains two references to ADVIL. The initial reference to ADVIL is sandwiched between statements about TYLENOL and aspirin: "when the pain lasts longer than the TYLENOL, when you've tried the ADVIL, and aspirin upsets your stomach, . . . " The latter mention of ADVIL ("ADVIL isn't stronger") is made between claims of ALEVE'S superiority over EXTRA-STRENGTH TYLENOL and ALEVE's superiority over aspirin. Each commercial states:

 
Only ALEVE has 8 to 12 hour dosing. It lasts longer than EXTRA-STRENGTH TYLENOL. ADVIL isn't stronger, yet ALEVE is gentler to your stomach lining than aspirin.

 Pl. Exs. 208, 208a, 208b, 208c. During the commercials, a visual of a medicine cabinet with the three competing drugs is shown. Each of the drugs is discarded from the medicine cabinet as the narrator refers to it. Id.

 AHP contends that by their language and presentation, the ALEVE commercials falsely imply that ALEVE is more effective than ADVIL and has a longer duration of action than ADVIL, as well as conveying false messages concerning the prescription heritage of ALEVE. In addition, AHP claims that the commercial "Mom Needs Strong Medicine" (which uses an actress who plaintiff contends appears to be over the age of 65) also communicates false messages with respect to the ability of those over 65 years of age to take ALEVE using the 8 to 12 hour dosage regimen applicable only to those under 65.

 In contravention to the claims of false or misleading advertising, Procter/Syntex asserts, with respect to both its print and television promotions, that the ads make no explicit superiority claims against ADVIL. Defendants direct the Court's attention to a July 1994 memorandum authored by AHP and addressed to the Vice President for Commercial Standards at the American Broadcasting Company. Def. Ex. 31. While the document is intended to justify AHP's slogan that "Nothing has been proven to last longer than ADVIL," AHP also acknowledged therein that:

 
Whatever the recent P&G/Syntex Aleve newspaper ads and TV commercials might imply, they have been careful to avoid any explicit claim of greater duration or efficacy than Advil. For example, in the full page ad introducing Aleve that appeared in many newspapers on June 24, P&G said: "Aleve is longer-lasting than Extra-Strength Tylenol. Advil isn't stronger . . ." The recent set of Aleve TV commercials said the same thing. In both cases, P&G/Syntex do make an explicit claim of greater duration than Tylenol but claim no more than equality with Advil.

 Memorandum of AHP to Harvey Dzodin, Vice President -- Commercial Standards, Capitol Cities ABC (July 7, 1994) (footnotes omitted). In addition, defendants also point to the testimony of AHP's Andrew Davis, Senior Vice President of Marketing for the Whitehall-Robins division of AHP, which they claim concedes that ALEVE's advertisements make only a parity claim against ADVIL and that none of the challenged claims are literally false. Tr. 1.87, 91-93 (Davis). Indeed, Mr. Davis testified that "in terms of explicit claims, there is not an explicit claim that goes beyond equality with ADVIL." Tr. 1.93 (Davis).

 Moreover, Procter/Syntex states that no ALEVE promotional material claims that the product has a longer duration or greater efficacy than ADVIL. Rather, defendants affirm that nearly all their advertising contains explicit superiority claims against EXTRA-STRENGTH TYLENOL and aspirin with only a so-called "parity" claim with ADVIL. As to the bar chart mentioned above, defendants claim that the chart accurately reports the recommended dosing schedules for ALEVE, EXTRA-STRENGTH TYLENOL, ADVIL and BAYER.

 Thus, having set forth the basic claims and defenses presented in this case, the Court commences its review of the rather extensive survey and clinical evidence before it.

 D. Survey Evidence

 As part of its efforts to demonstrate that the ALEVE advertising is misleading, AHP relied on two consumer surveys conducted by the research firm of Audits and Surveys. Dr. Donald Pace, Senior Vice President of Audits & Surveys, testified as plaintiff's survey expert. He conducted separate surveys of the ALEVE FSI (Pl. Ex. 206) and one of the ALEVE television commercials. Pl. Ex. 208c; Tr. 4.3-6; 4.12; 4.50 (Pace).

 1. The FSI Survey

 Audits & Surveys was retained by plaintiff's counsel in May 1994 to do a survey on the FSI. The firm recommended that the full national survey consist of about 500 mall intercept interviews in geographically dispersed markets throughout the country and that a pilot test be conducted first to assure that the questionnaire would be easily understood by consumers and easy to administer. Plaintiff's counsel accepted this recommendation. Tr. 4.7-10 (Pace).

 Dr. Pace was present on the first day of the pilot study and observed approximately 15 interviews. He concluded that the questionnaire was workable and recommended that the draft questionnaire be used, without any changes, in the national study. This recommendation was accepted, and the national survey on the ALEVE FSI was conducted in late June 1994 in malls in 10 cities across the country. Tr. 4.12-13 (Pace). The parties' experts both testified that the use of malls is an acceptable way of obtaining a survey sample and is a method frequently used in the market research industry. Tr. 4.15 (Pace); Tr. 6.107 (Rappeport).

 The national survey conducted by Audits & Surveys on the ALEVE FSI included 522 consumers who had purchased or used an over-the-counter analgesic in the past year. All 522 interviews were "validated" by contacting each participant by telephone after the survey was completed to confirm that the interviews had been conducted. Tr. 4.15-19 (Pace).

 During the course of the actual survey, defendants' FSI remained available to each survey respondent if she or he desired to look at it in responding to the survey questions. AHP claims that this practice was intended to simulate reality because a consumer has the opportunity to read or examine an FSI as long as she or he wishes. According to AHP, allowing respondents in the survey to refer to the FSI was an appropriate procedure and enhanced the survey's ability to ascertain the messages conveyed to consumers by the FSI. Tr. 4.21 (Pace).

 The questionnaire in the FSI survey consisted of nine questions, some of which had several subparts. See Pl. Ex. 801. For example, questions 1 through 4 of the FSI survey were open-ended questions that did not direct the respondents to any particular subject in the FSI. Each of questions 5 through 8 was a directed open-ended question, asking what the FSI communicated about a comparison between ALEVE and another drug. In three of these questions, the other drug was one shown in the bar chart -- EXTRA-STRENGTH TYLENOL, ADVIL, and BAYER. In the fourth, the other drug was EXCEDRIN, which is one of the drugs shown on the shelf in the FSI but is not included in the bar chart. The EXCEDRIN question was designed to serve as a control question designed to measure whether consumers were paying attention to the survey questions and the FSI and responding to the survey questions only on the basis of what the FSI was communicating to them. Questions 5 through 8 also included subparts (asking "Why do you say that?") that were intended to probe the precise source in the FSI of ...


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