American Home Products Corp. v. Johnson & Johnson

Citation: 654 F. Supp. 568Docket: 85 Civ. 4858 (WCC)

Court: District Court, S.D. New York; April 7, 1987; Federal District Court

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A lawsuit was filed by American Home Products Corporation (AHP) against Johnson & Johnson (J.J.) and its subsidiary McNeilab, Inc. over false advertising claims related to their over-the-counter analgesics, Advil (ibuprofen) and Tylenol (acetaminophen). AHP alleges that J.J. and McNeil's advertisements inaccurately linked ibuprofen with aspirin and disparaged it in comparison to acetaminophen regarding side effects. In response, J.J. and McNeil counterclaimed, asserting that AHP's advertisements for Advil and other products misrepresented their efficacy.

Both parties' claims are grounded in Section 43(a) of the Lanham Act, New York General Business Law, and common law unfair competition. The case was tried over four weeks, featuring extensive expert testimony from 22 witnesses and deposition testimony from 37 additional witnesses, all specializing in various medical fields relevant to the claims. Hundreds of exhibits were submitted, consisting mainly of technical medical articles, though the court did not review all evidence due to its volume and complexity.

The court received nearly a thousand pages of post-trial briefs. AHP's attorneys urged the court for a prompt decision after J.J. resumed airing contested commercials. The court opted to summarize its findings without an exhaustive analysis of the evidence to expedite the resolution of the case.

Aspirin, introduced in 1899 as the first OTC analgesic, is classified as a non-steroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin production, effectively reducing pain and inflammation. However, it can cause gastrointestinal irritation, renal dysfunction, and prolong bleeding, leading to a consensus that it would likely not receive FDA approval if presented today. Aspirin is marketed by various companies, including Sterling Drug Co. under the Bayer trademark and AHP with a mixture of aspirin and caffeine branded as Anacin.

Acetaminophen, widely marketed in the 1950s, elevates pain thresholds and acts as an antipyretic without significant effects on prostaglandin synthesis, distinguishing it from NSAIDs. It is safer than aspirin with fewer side effects but can cause severe liver damage in overdoses. It is sold OTC by McNeil under Tylenol, with various formulations, and also marketed by AHP and Bristol-Myers.

Ibuprofen, developed in the 1960s and introduced as a prescription medication in 1974, functions similarly to aspirin by inhibiting prostaglandin synthesis but is less harsh on the gastrointestinal tract. AHP gained FDA approval to market an OTC version as Advil in 1983, while McNeil's attempts to market ibuprofen were unsuccessful, leading to Bristol-Myers obtaining the rights to market it as Nuprin.

McNeil, unable to secure approval for its own ibuprofen product and concerned about competition with AHP's ibuprofen, actively opposed AHP's New Drug Application (NDA) to the FDA starting in September 1983. McNeil attempted to have AHP's application reviewed again by the Arthritis Advisory Committee, citing adverse central nervous system (CNS) side effects linked to high prescription doses of ibuprofen. Despite AHP's request for over-the-counter (OTC) ibuprofen dosages up to 1600 mg per day, the FDA, following FTC guidance, ultimately limited OTC package instructions to a maximum of 1200 mg per day.

McNeil submitted extensive petitions to the FDA, aiming to amend the FDA's Summary Basis of Approval (SBA) for OTC ibuprofen, which noted that side effects from ibuprofen at recommended doses would be comparable to those of other OTC analgesics. McNeil's efforts were unsuccessful, and the FDA issued the SBA in May 1984, affirming that ibuprofen had a lower incidence of gastrointestinal issues compared to aspirin and posed less risk in overdose situations.

Despite failing to impose warnings regarding potential gastric ulcers and renal dysfunction for OTC ibuprofen packaging, McNeil proceeded to market its own ibuprofen product, Medipren, following the expiration of Boots U.S. patent in 1985. McNeil's NDA for Medipren, submitted in September 1984, lauded ibuprofen's safety at higher doses, which contrasted with its prior attempts to restrict AHP's ibuprofen approval. In response to AHP's market encroachment, McNeil launched aggressive marketing strategies, including physician sampling and discount coupon campaigns, which ultimately led to AHP's false advertising complaint. A significant focus of AHP's complaint was a four-page promotional folder distributed by McNeil, particularly a table comparing the safety profiles of non-prescription analgesics, highlighting potential side effects categorized as minor and serious.

The document presents a checklist comparing the side effects of three analgesics: Plain/buffered Aspirin, Ibuprofen, and Extra-Strength Tylenol. Each of the seventeen side effects is marked with a check mark, an asterisk, or left blank in the respective columns. The footnotes clarify that a check mark indicates occurrence, with varying incidence, while an asterisk denotes a relatively rare occurrence. Aspirin has check marks for thirteen side effects and asterisks for four; ibuprofen has check marks for sixteen and a blank for one side effect related to delayed ulcer healing. Extra-Strength Tylenol shows one check mark, six asterisks, and ten blanks.

The fourth page claims Extra-Strength Tylenol has a "superior safety profile" compared to both aspirin and ibuprofen, citing eight technical publications to support these statements. AHP acknowledges that ibuprofen can cause the side effects indicated but contends it is as safe as or safer than acetaminophen and superior to aspirin. Defendants argue that AHP overlooks the footnote's clarification regarding the meaning of check marks and point to the common usage of similar checklists in medical literature, which employ different coding for incidence.

However, the document notes that the way McNeil presents the data may mislead readers, as the smaller font of footnotes is likely to be overlooked. The checklist's central message is a comparative one, suggesting that if ibuprofen has a check mark and aspirin has an asterisk for a side effect, aspirin appears safer. This could be misleading if ibuprofen’s safety is not significantly inferior to aspirin’s. AHP also highlights that the visual separation in the checklist, where a heavier line distinguishes the Tylenol column from the others, reinforces the false impression of equivalency in safety profiles between ibuprofen and aspirin—a tactic believed to be part of McNeil's advertising strategy aimed at healthcare professionals.

Chandler Simonds, McNeil's Vice President, emphasized in an internal memorandum the campaign's goal of highlighting Tylenol's safety advantages compared to aspirin, while John Wernette, the Product Manager, aimed to portray OTC ibuprofen as unsafe by associating its side effects with aspirin's profile. A checklist detailed five central nervous system (CNS) side effects: dizziness, nervousness, tinnitus, headache, and drowsiness. Ibuprofen was marked for all five side effects, while aspirin was marked for only tinnitus, with the remaining four classified as 'relatively rare' for both aspirin and Extra-Strength Tylenol. This presentation suggests ibuprofen has significantly worse CNS side effects than both aspirin and Tylenol. McNeil did not provide trial witness testimony to substantiate claims regarding ibuprofen's side effects, relying instead on references indicating minimal CNS side effects at prescription doses. Dr. Andrei Calin, McNeil's CNS expert, acknowledged he could not distinguish CNS effects between ibuprofen and acetaminophen at OTC levels. AHP introduced thirteen double-blind studies, showing ibuprofen performed better than acetaminophen regarding CNS side effects and was even superior to placebo. McNeil's attempts to undermine these studies were unconvincing, and the Court found no statistically significant difference in CNS side effects between ibuprofen and acetaminophen, deeming McNeil’s checklist representation false.

Regarding gastrointestinal effects, the checklist listed three minor (stomach upset, mucosal irritation/erosion, occult bleeding) and four major side effects (gastric ulcers, duodenal ulcers, delayed healing, massive GI hemorrhage). Aspirin showed check marks for all seven, ibuprofen for six, and Extra-Strength Tylenol for only one (stomach upset). Evidence confirmed ibuprofen causes all gastrointestinal side effects in at least a minor percentage of users, demonstrating that it is notably superior to aspirin and significantly inferior to acetaminophen in this regard.

The FDA determined that ibuprofen poses a lower risk of serious gastrointestinal damage compared to aspirin, although it can still cause gastrointestinal ulceration and hemorrhage. McNeil, in its New Drug Application, indicated that ibuprofen has significantly less gastric irritant capacity than aspirin and results in fewer and less severe gastric mucosal lesions. While it was appropriate to acknowledge the gastrointestinal side effects of ibuprofen, the debate centers on whether using identical marks for ibuprofen and aspirin misled consumers into thinking the two drugs are equivalent in risk. The court concluded that it was misleading for several reasons: McNeil's choice of check marks suggested an equivalence in safety profiles, smaller footnote text risked misunderstanding the meaning of the check marks, and the absence of asterisks for ibuprofen implied that its side effects were not relatively rare when compared to aspirin. The checklist's layout further encouraged readers to perceive ibuprofen and aspirin as similar, despite evidence indicating differing risk levels.

Regarding hemostatic effects, the checklist notes that ibuprofen prolongs bleeding time, a consensus supported by various sources, including the PDR and FDA statements. AHP argued that ibuprofen does not significantly prolong bleeding time more than Extra-Strength Tylenol and claimed both should receive the same markings. However, the court found no error in the checklist regarding bleeding time prolongation, as evidence did not support AHP's claim of comparability between acetaminophen and ibuprofen's antihemostatic effects.

The checklist also includes serious allergic reactions as a side effect, marking both aspirin and ibuprofen with check marks, but only providing an asterisk for Extra-Strength Tylenol.

AHP acknowledges that allergic reactions occur more often with aspirin and ibuprofen than with acetaminophen but argues that the checklist exaggerates this difference, claiming it affects less than 1% of the general population sensitive to aspirin. McNeil counters that at least 4.5 million Americans are at risk, supported by evidence indicating that 10-20% of 9 million asthmatics and 20-30% of individuals with chronic urticaria may be aspirin-allergic. The Court finds McNeil's position more credible and notes the FDA's requirement for Advil to carry a warning against use by individuals with severe allergic reactions to aspirin, while Extra-Strength Tylenol is deemed safe for aspirin-sensitive individuals. AHP’s own product, Anacin-3, also emphasizes its safety for these users, leading the Court to conclude that the checklist regarding allergic reactions is accurate.

Regarding renal dysfunction, the checklist indicates this serious side effect for aspirin and ibuprofen, but only marks an asterisk for Extra-Strength Tylenol. AHP admits that ibuprofen can cause renal failure in individuals with preexisting conditions but claims it is equally likely to cause kidney damage as acetaminophen. The FDA's analysis does not support this equivalence, noting ibuprofen’s potential adverse effects on renal function, especially in at-risk patients. AHP's expert nephrologist, Dr. Dunn, concedes that ibuprofen poses a greater risk of kidney damage compared to acetaminophen, yet questions remain about whether the checklist's distinction is misleading. The Court determines that acetaminophen also carries a risk of serious kidney damage and concludes that the representation of renal risks on the checklist is misleading. The FDA has also indicated that OTC analgesics can lead to significant renal issues, further complicating AHP's claims regarding the safety of its products.

Papillary necrosis and chronic interstitial nephritis, initially linked solely to phenacetin, are now recognized as associated with combination analgesics taken in high doses over extended periods, particularly those containing acetaminophen and aspirin. While ibuprofen has not been directly implicated in this condition, it can cause papillary necrosis in animals. Dr. Dunn indicated that renal issues are more severe with acetaminophen, suggesting comparable overall renal risks for both drugs. However, most reports of acetaminophen-related renal failure involve chronic alcoholics who may have taken large overdoses. The Court found that the checklist should have noted acetaminophen's potential for renal dysfunction, albeit rare, to avoid misleading comparisons with ibuprofen.

Regarding drug-drug interactions, the checklist indicated risks for aspirin and ibuprofen but only acknowledged acetaminophen with an asterisk. AHP claimed this was misleading, asserting that all three drugs pose similar risks when combined with other medications. However, expert testimonies demonstrated that ibuprofen has well-documented adverse interactions with several drugs, while AHP failed to provide sufficient evidence to show acetaminophen’s equivalent susceptibility.

On hepatic effects, AHP argued it was misleading not to include liver damage as a potential side effect, asserting that acetaminophen poses greater risks, especially in overdose situations or among chronic alcoholics. Evidence confirmed acetaminophen's risk for liver damage, while no similar risks were established for ibuprofen. McNeil did not contest that including hepatic effects would show ibuprofen as safer than acetaminophen, but claimed the checklist aimed to promote Extra-Strength Tylenol without requiring a balanced disclosure of its disadvantages.

The Lanham Act does not mandate full disclosure like securities laws. In typical consumer advertising, such as automobile ads comparing standard features, omissions of rival products' details are generally not viewed as unethical. However, in advertisements claiming to present a 'Comparison of Non-Rx Analgesic Safety Profiles,' there is a risk that consumers may assume the information is complete, especially when accompanied by claims of superior safety for Extra-Strength Tylenol. The omission of critical side effects related to acetaminophen creates potential for misleading information, particularly concerning consumer health.

Regarding the claim that Extra-Strength Tylenol has a 'Safety profile superior to both aspirin and ibuprofen,' evidence suggests that while acetaminophen may indeed be superior in certain adverse effects, it lacks significant differences in others, with ibuprofen outperforming acetaminophen in some aspects not mentioned in the advertisement. Thus, the Court finds that McNeil's claim is either true or falls within acceptable promotional exaggeration, as consumers and medical professionals are generally skeptical of such comparisons.

AHP raises concerns about the 'rotten apple ad,' which depicted an attractive apple with a wormhole, captioned 'Aspirin and Ibuprofen—The Closer You Look,' suggesting that these drugs may be inferior to Extra-Strength Tylenol. The ad claims that aspirin and ibuprofen can cause gastrointestinal irritation and allergic reactions, which is accurate but may mislead viewers into thinking both drugs are equally harmful and inferior to acetaminophen, reinforcing the notion of them being the 'rotten apples' among OTC analgesics.

AHP conducted a physician survey to evaluate perceptions of an advertisement regarding the likelihood of gastric ulcers caused by aspirin and ibuprofen. During the trial, the validity of the survey questions was contested, with AHP's expert acknowledging some questions were unsuitable. AHP focused on responses to a specific multiple-choice question (No. 14), which aimed to determine how the ad was interpreted. The results indicated that 46% of physicians believed the ad suggested aspirin and ibuprofen had similar gastric ulcer risks.

McNeil criticized the survey's reliability, arguing that the closed-ended nature of Question 14 led to suggestive responses and potential guessing from participants unclear on the ad's message. AHP contended that a preliminary question filtered out respondents who did not perceive any message about similarity or dissimilarity, with 47% indicating they received no such message. However, AHP's expert noted that any response below a 20% threshold is statistically insignificant. 

The primary flaw identified in Question 14 was its incomplete answer choices, failing to include an option that accurately reflected the ad's message. Instead, the provided choices were misleadingly slanted, as they did not represent the literal meaning of the advertisement and included clearly false statements. A more balanced response option should have been included to accurately capture the nuances of the ad's claims regarding gastric irritation from both medications.

Giving respondents a choice between the statements that aspirin and ibuprofen have a "somewhat different" or "very different" likelihood of causing stomach ulcers creates an illusion of choice, as only 4% selected these options, indicating that the majority were directed to the first two choices. The percentage that would have chosen a more accurate statement, had it been an option, is uncertain but likely higher than the 6% who selected the less relevant choices. Question 14 suggests that the "rotten apple ad" implies ibuprofen can cause gastric ulcers, despite the ad not making any explicit claim about ibuprofen causing this condition. It states only that both drugs can cause "unpredictable gastrointestinal irritation," with the first two bullet points focusing on gastric ulcers, the first mentioning only aspirin, and the second making a general statement about gastric ulcers without naming either drug. A doctor reviewing Question 14 without the advertisement might mistakenly believe it indicates ibuprofen's specific risks related to gastric ulcers. McNeil's survey of physicians yielded similarly misleading results, as the options provided were clearly false, steering respondents towards the least inaccurate choice. A more appropriate option would have been to state that aspirin and ibuprofen have "similar" side effects, rather than presenting only extreme choices. The stark difference in response bias is evident, with only 2% of AHP survey respondents indicating that the advertisement did not communicate any specified degrees of similarity, compared to 52% in the McNeil survey.

Retention of independent survey organizations by both parties resulted in survey questions designed to elicit desired outcomes, indicating potential manipulation by those drafting the questions. This raises concerns about the objectivity of the surveys, suggesting that litigants should seek court approval for survey questions before incurring costs. The court finds the survey results unreliable, relying instead on the advertisement to determine its message. 

The advertisement in question, referred to as the "rotten apple ad," accurately states that ibuprofen and aspirin can cause gastrointestinal and allergic reactions, but misleadingly implies they are equally harmful. The headline connects both drugs to a negative image, and the supporting text generalizes the side effects without adequately distinguishing between the two. AHP claims the technical publications cited support solely aspirin's side effects, which is confirmed, yet the bulleted items do not clarify the distinct effects of ibuprofen. 

AHP also contests Tylenol ads claiming ibuprofen causes more stomach upset than Tylenol and asserts Tylenol's superiority and hospital preference. AHP argues that "stomach irritation" is synonymous with subjective symptoms of discomfort, necessitating clinical trials for accurate measurement, but the reliance on such trials is flawed. The FDA's reported clinical results do not separate stomach irritation from other side effects, which include various CNS effects.

AHP acknowledges the FDA's report on gastrointestinal reactions associated with nonsteroidal anti-inflammatory drugs, noting that while ibuprofen presents a lower risk of serious gastrointestinal damage compared to aspirin, it can still cause ulceration and hemorrhage. The FDA recommends that individuals with a history of ulcers or bleeding only use ibuprofen under medical supervision. AHP references clinical trials showing a slightly lower incidence of stomach upset in ibuprofen users compared to acetaminophen, though the difference was not statistically significant. Overall, ibuprofen is deemed as safe as acetaminophen for subjective gastrointestinal symptoms, but acetaminophen carries a significantly lower risk of serious objective side effects. The term "stomach irritation" in McNeil's advertisements encompasses both subjective and objective effects, and the Court finds AHP's attempt to equate it solely with "stomach upset" unpersuasive. The Court concludes that McNeil's advertisements accurately state that Tylenol causes less stomach irritation than aspirin or ibuprofen, with the exception of one advertisement that may mislead consumers into believing ibuprofen causes the same level of stomach irritation as aspirin. Other advertisements do not share this misleading implication.

Earlier McNeil commercials claimed that Tylenol provides "effective relief without the stomach irritation possible with aspirin or any other pain reliever," without specifying ibuprofen, potentially misleading consumers about the irritation levels of other pain relievers. Recent ads have differentiated between aspirin and ibuprofen, implying that ibuprofen causes less stomach irritation than aspirin. AHP argues that Advil is a more effective pain reliever than Extra-Strength Tylenol, which McNeil acknowledges is not more effective than OTC ibuprofen but claims is equally effective. AHP cites seven clinical studies comparing acetaminophen, ibuprofen, and placebo, while McNeil contests these studies and presents its own research involving a larger headache patient group. The court reviewed the reliability of these studies, including various statistical methods and pain models but ultimately concluded that there is no significant difference in effectiveness between Extra-Strength Tylenol and Advil for mild to moderate pain. However, Advil is found to be substantially more effective for severe pain and inflammation. Consequently, McNeil's assertion that "you can't buy a more potent pain reliever without a prescription" is deemed false. The court suggests a more accurate statement would be that for mild to moderate pain, one cannot find a more effective pain reliever without a prescription, noting that Advil's additional potency does not justify the increased risk of side effects. The court was unconvinced by McNeil's argument regarding dosage comparisons between the two medications.

The FDA-approved instructions for Advil specify taking 1 tablet every 4 to 6 hours as needed, with a maximum of 6 tablets in 24 hours unless directed otherwise by a doctor. McNeil acknowledges that 400 mg of Advil is an authorized, non-prescription dose. The document refutes McNeil's assertion that "you can't buy a more potent pain reliever without a prescription," emphasizing that 1000 mg of Tylenol is not as effective as 400 mg of Advil for severe pain. 

AHP criticizes McNeil's advertising campaign, which claims hospitals trust Tylenol, suggesting this implies Tylenol's greater safety or efficacy. AHP contends that hospitals dispense more Tylenol primarily due to McNeil's low pricing rather than its effectiveness. The court finds that the implication of safety and efficacy in McNeil's advertisements is not false, although it is a half-truth, as it omits the pricing factor. The court concludes that AHP is free to match McNeil's prices to hospitals and notes that AHP employs similar marketing tactics with its product, Anacin-3, which is also acetaminophen and comparable to Tylenol.

Sterling Drug’s advertising focuses on the popularity of Bayer among doctors without disclosing that Bayer is one of many chemically identical aspirins. AHP is responsible for consumer confusion regarding Anacin-3, an acetaminophen product, due to its similar branding to Anacin, an aspirin-caffeine product. AHP's attempts to associate Anacin-3 with Tylenol's hospital acceptance highlight industry competition, as AHP simultaneously accuses McNeil of exploiting discount popularity. McNeil counters AHP's claims, asserting that AHP's advertisements for Anacin mislead consumers regarding its stomach upset profile. Although AHP displays active ingredients on its packaging, it downplays the mention of aspirin in advertisements to distance itself from aspirin's negative reputation. McNeil contends that AHP’s commercials imply Anacin causes less stomach upset than other pain relievers, which the court finds unsubstantiated. The court concludes that the commercials only suggest that one user experienced relief without stomach upset, a claim that does not necessarily compare Anacin unfavorably to non-aspirin products. McNeil’s consumer surveys aimed at supporting its claims were deemed unconvincing, as they did not accurately reflect the message of AHP's advertisements.

Anacin is associated with a higher likelihood of causing stomach upset compared to aspirin-free pain relievers. AHP's claim about Anacin's "no stomach upset" advertising is deemed acceptable commercial puffery, as evidenced by survey results indicating that only a small percentage of respondents believed otherwise. Regarding AHP's advertisements claiming that Advil was recommended by doctors "over one million times" and later "five million," McNeil asserts this is misleading, particularly since only 2.4% of recommendations were for headaches. The Court finds these claims neither false nor misleading.

AHP's campaign to promote Anacin-3 involved distributing free samples to 250,000 doctors and dentists, leading to 65% of respondents in a survey claiming they recommended Anacin-3. This extrapolated to over 70,000 recommendations. Although McNeil argues that this creates a misleading impression that most doctors support Anacin-3, the Court accepts the extrapolation as valid. AHP is permitted to state that 70,000 doctors recommended Anacin-3, despite the figure representing only about 10% of the total doctors in the country. A concern arises that many doctors simply passed out the free samples rather than offering a genuine preference for Anacin-3 over other pain relievers. Nonetheless, it is acknowledged that these 70,000 doctors at least impliedly recommended the product, paralleling McNeil's own marketing strategies.

AHP's actions have led to a drastic price reduction of Anacin-3, effectively to zero for doctors, which the Court finds does not constitute false or misleading advertising. AHP's campaign states that hospitals, doctors, and pharmacists recommend acetaminophen, the active ingredient in Anacin-3, over other pain relievers. However, the Court agrees with McNeil's assertion that consumers are misled into believing that Anacin-3 is preferred over Tylenol since most do not recognize Tylenol as acetaminophen. The Court notes that hospitals specifically recommend Tylenol, not the generic acetaminophen. The misleading nature of AHP’s advertisements is amplified by the absence of acknowledgment regarding other available OTC acetaminophen products, leading many readers to mistakenly believe that Anacin-3 is favored.

A survey indicated that 43.9% of respondents identified Anacin-3 as the recommended pain reliever, and 39.3% associated the term "any other aspirin-free pain reliever" with Tylenol, further demonstrating the confusion created by AHP's messaging. AHP's critique of the survey methodology is seen as unfounded, as alternative questioning formats could similarly be deemed suggestive.

Regarding pediatric overdose claims, AHP's press releases highlight the dangers of household chemicals and accidental overdoses, framing acetaminophen as a significant threat to children. McNeil argues that these releases imply that acetaminophen is the primary danger, positioning Advil as a safer alternative. However, the Court finds that AHP's claims merely suggest that acetaminophen overdoses pose more risk than ibuprofen, a statement the Court deems accurate in general terms.

The press releases highlighted the dangers of accidental ingestion of drugs and household chemicals by children, but did not specifically mention analgesics or suggest that one analgesic is riskier than another. The court found no issues with these press releases. AHP claimed in advertisements that Advil interacts with fewer drugs than acetaminophen, citing "Data on file, Medical Department, Whitehall Laboratories," which was not produced during the trial. Dr. Edward Henry, Whitehall's Medical Director, indicated that the data was accessible in their medical library but did not clarify why the supporting textbook was not mentioned in the advertisement. AHP's own expert, Dr. Lasagna, acknowledged a lack of credible support for AHP's superiority claims regarding drug-drug interactions, with evidence suggesting the opposite. 

The applicable law under Section 43(a) of the Lanham Act prohibits false advertising and misleading representations. This section has broad applications aimed at consumer protection. A violation can be established by showing that an advertisement is literally false or has a tendency to mislead. The court evaluates both the literal meaning and any implied messages of the advertisement for its target audience. It is sufficient to demonstrate that a "not insubstantial number" of the audience could be misled, rather than a majority. If an advertisement includes disclaimers that are inconspicuously placed, they may not alleviate the misleading nature of the claims.

Surveys can effectively establish how advertisements are perceived by their target audience, provided they are designed and conducted fairly and objectively. Key factors influencing a survey's probative value include filtering out individuals who did not receive the advertisement's message, addressing relevant issues, and avoiding leading questions. In legal actions under section 43(a) of the Lanham Act, the burden is on the plaintiff to prove that the advertisement is false and misleading, rather than merely unsubstantiated. An advertisement violates section 43(a) if it cites authorities that do not support its claims. There is a significant public interest in preventing misleading advertisements, especially concerning over-the-counter (OTC) drugs, which can outweigh an advertiser's rights to commercial speech. The defense of unclean hands requires "clear, unequivocal and convincing" evidence, and the application of the defense of laches should be limited. The court concluded that McNeil violated section 43(a) through various misleading advertisements, including: 1) falsely implying greater CNS side effects for ibuprofen compared to aspirin; 2) misleadingly suggesting equal gastrointestinal side effects for both drugs; 3) exaggerating acetaminophen's superiority over ibuprofen regarding renal dysfunction; 4) omitting significant side effects in safety profiles; and 5) inappropriately linking ibuprofen and aspirin in adverse comparisons to acetaminophen.

AHP has been found to violate section 43(a) of the Lanham Act through misleading advertising practices, including: 1) suggesting that ibuprofen and aspirin cause stomach upset at similar rates; 2) falsely asserting that Extra-Strength Tylenol is the most potent pain reliever available without a prescription; 3) misleadingly stating that hospitals recommend acetaminophen in Anacin-3 more than any other pain reliever, despite the claim being partially accurate; 4) incorrectly claiming Advil is less susceptible to adverse drug interactions than acetaminophen; and 5) citing generic data in support of claims regarding efficacy or safety without precise identification. An injunction will be issued to prevent these advertising practices. The parties are instructed to work together on a proposed judgment, or submit separate proposals if they cannot agree. While the Court found no violations of the New York General Business Law or common law, it emphasized the public interest involved and deemed injunctive relief appropriate despite both parties having engaged in false advertising. The Court expressed skepticism about the feasibility of reliably proving damages, suggesting the expected net damages would not warrant the costs of a trial. Any party wishing to pursue further action regarding damages may request a conference with the Court.