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False Advertising Litigation
Under the Lanham Act for Pharmaceutical Companies
By Randall K. Miller, Esq.1
Arnold & Porter, LLP
This article examines lessons learned from (website postings, patient brochures, patient • Rhone-Poulenc’s ad for hypertension drug Lanham Act false advertising cases in the testimonials, and verbal statements made by a call center representative). As one court Pharmaceutical companies regularly become held, “even a single promotional
substituted for a competitor’s (Marion involved in lawsuits with competitors over presentation to an individual purchaser may whether promotional claims are “deceptive.” be enough to trigger the protections of the which, unlike Rhone-Poulenc’s drug, had The “Lanham Act”2 provides a private cause Act.”3 been approved for additional indications, of action permitting a company to sue Examples of Pharmaceutical Company
namely the treatment of both hypertension its competitor whenever the competitor Violations. Pharmaceutical companies run
uses a promotional claim that is likely to afoul of the Lanham Act for many types of An area of heightened exposure for mislead customers (here, physicians or claims, including minimizing risks, pharmaceutical advertisers is comparative broadening indications, overstating efficacy, claims. A plaintiff’s burden to obtain Section 43 of the Lanham Act prohibits any and making comparative claims in the emergency injunctive relief is reduced company from making any statement that absence of supporting head-to-head clinical whenever a claim is comparative,8 and “misrepresents the nature, characteristics [or] comparative claims may trigger an obligation qualities” of its own or a competitor’s • Johnson & Johnson was found to violate to disclose related but unfavorable products or services. A successful Lanham Act plaintiff can obtain an injunction (stopping “Night Time Strength” for antacid A Lanham Act defeat may also serve as a the use of a claim and/or requiring corrective product Mylanta implied that the springboard to further litigation. For product was specially formulated for example, after a federal court enjoined (including disgorgement of profits, attorney’s nighttime heartburn, but Johnson & Pfizer’s claim for mouthwash Listerine “as fees, and treble damages). Only competitors Johnson did not have substantiation for effective as” dental floss in reducing the risk of gingivitis,10 consumer class actions were addresses competitive injuries—it is not a • Procter & Gamble’s claim of “24 Hours” filed around the country, targeting the same consumer protection act; therefore, the actual relief for heartburn medication Prilosec advertising under state law. In Zeneca, Inc. targets of promotional claims (patients, was deceptive because it implied 24 v. Eli Lilly & Co.,11 Eli Lil y was found to doctors, formularies, hospitals, and the like) hours of relief after ingestion; in fact, the violate the Lanham Act by promoting its product provided relief only after it osteoporosis therapy Evista off label for the The scope of the Lanham Act is broad.
became “effective,” about 5 hours after prevention of breast cancer. Several years Anything a pharmaceutical company writes or after the Lanham Act defeat, Lilly faced a says potentially is the subject of a Lanham Department of Justice criminal investigation • Pharmacia’s television campaign for Act claim. The Lanham Act is not limited to into the same conduct, and ultimately pled traditional advertising but instead reaches a wide range of “statements,” including misbranding and agreed to pay $36 million in superiority claim over competitive product statements to physicians (detail aids and Nicoderm regarding sleep disturbance, but verbal statements by sales representatives to Pharmacia lacked head-to-head clinical Recent—and huge—penalties paid for doctors) and direct-to-consumer materials data to support this comparative claim.6 improper promotion (such as the $2.3 billion 1 Randy Miller is a Partner at Arnold & Porter, LLP. Mr. Miller represents both plaintiffs and defendants in Lanham Act false advertising cases. 2 15 U.S.C. § 1125. 3 Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379, 1384 (5th Cir. 1996) (emphasis added). 4 Novartis Consumer Health v. Johnson & Johnson Merck Pharms., 290 F.3d 578 (3d Cir. 2002) (affirming preliminary injunction). 5 J & J-Merck Consumers Pharms. v. The Proctor & Gamble Co., 285 F. Supp. 2d 389 (S.D.N.Y. 2003). 6 Pharmacia Corp. v. GlaxoSmithKline Consumer Healthcare, 292 F. Supp. 2d 611, 619 (D.N.J. 2003). 7 Rhone-Poulenc Rorer Pharms. v. Marion Merrell Dow, Inc., 93 F.3d 511, 516 (8th Cir. 1996) (affirming corrective advertising order to “explain[] the differences in the two products” where original advertising claimed the products could be “indiscriminately substituted”). 8 McNeil Lab, v. Am. Home Prods., 848 F.2d 34, 38 (2d Cir. 1988). 9 Am. Home Prods. v. Johnson & Johnson, 654 F. Supp. 568, 579-80 (S.D.N.Y. 1987) (rejecting defense argument that “the law does not require that they disclose the disadvantages of the product as well as the advantages”). 10 McNeil-PPC, Inc. v. Pfizer Inc., 351 F. Supp. 2d 226, 256 (S.D.N.Y. 2005) (preliminarily enjoining defendant from using that claim because consumers perceived this claim to be a overall claim of superiority not limited to gingivitis). 11 Zeneca, Inc. v. Eli Lilly & Co., No. 99 Civ. 1452, 1999 WL 509471 (S.D.N.Y. 1999). penalty Pfizer paid for improper promotion12 by a sales representative. If a “not consumers were taking away a much and $1.42 billion Lilly paid for off-label insubstantial”17 portion of doctors surveyed broader “replacement” message; that is, one promotion of Zyprexa13) underscore the (15% or more) are “misled” (i.e., they report a could replace flossing with Listerine and statement that is misleading), that may be receive all of the same benefits. It was the FDA Authority Over Advertising Is enough to show a Lanham Act violation.
truthfulness of this implied claim that Pfizer Not Typically a Successful Defense.
Writing for a panel of the Second Circuit, was forced to defend. Pfizer’s defense was A common misconception within Judge (now Justice) Sonia Sotomayor wrote that it did not make this broader pharmaceutical companies is that that surveys asking for doctors’ “memories” “replacement” claim and, in fact, the compliance with applicable FDA guidelines and “impressions” of detail sessions are advertising specifically encouraged and regulations is suf icient to avoid reliable, including to prove “a pattern of consumers to “floss daily.”22 Notwithstanding advertising challenges. However, FDA implied falsehood.”18 Schering v. Pfizer19 Pfizer’s protests, the court found that the consideration of (or failure to object to) a involved an allegation that antihistamine presence of a “replacement” take-away in a claim is not ordinarily a defense to a Lanham Zyrtec was promoted as “nonsedating.” minority (25-30%) of survey responses was Act false advertising case, and the fact that Zyrtec, a second generation antihistamine sufficient to demonstrate the presence of the FDA has overlapping jurisdiction does not that was relatively low-sedating, did in fact implied claim and therefore, a Lanham Act cause sedation at a rate statistically higher than placebo. In surveys of doctors detailed FDA Advertising Principles Are
determines that a Lanham Act plaintiff’s true on Zyrtec, about 15-20 percent of the doctors Potentially Useful in Lanham Act Cases.
goal is to circumvent the bar on private reported that the sales representative said or FDA advertising principles, such as “fair enforcement of the Federal Food, Drug and implied that Zyrtec was essentially balance,”24 can be useful in Lanham Act Cosmetic Act (“FDCA”); however, as long as “nonsedating.” the case turns on whether a claim is false or Judge Sotomayor ruled that this level of principles are used to shed light on the issue misleading, the fact that FDA may have survey response was sufficient to trigger the of falsity. However, over-reliance on these authority to consider the same issue is not a Lanham Act. Likewise, in Zeneca v. Eli Lilly, defense.15 Companies should be prepared which involved the off-label promotion of jurisdiction arguments. For example, in a to litigate these issues: FDA’s broad authority osteoporosis therapy Evista for the case involving competing proton pump particularly over prescription pharmaceutical prevention of breast cancer, survey evidence inhibitors Nexium and Prevacid, the parties as well as other sales representative data debated the FDA concept that an advertiser jurisdiction issues more plausible than in such as call notes, demonstrated that the should not disseminate a claim that has only sales representatives were making the statistical significance without clinical Surveys of Patients and Doctors Are Core
significance. The court commented that this Evidence in Lanham Act False
Surveys of patients likewise are powerful Advertising Cases. Lanham Act false
Lanham Act inquiry, which is focused on the evidence in lawsuits over direct-to-consumer advertising cases are typical y proven by truth or falsity of the advertising message: advertising and for over-the-counter products surveys. With regard to verbal statements of “[I]t is not sufficient for a Lanham Act sales representatives to physicians, surveys reveal the presence of unanticipated implied of doctors are used and accepted as reliable claims. For example, in the Listerine case,21 and trustworthy evidence of what a sales Pfizer had clinical data to support its claim representative said. A survey of a doctor that Listerine was as effective as floss, but recently detailed on a pharmaceutical only with respect to reducing the risk of guidelines; the plaintiff must also show product allows the doctor to report to the gingivitis. The survey data showed that surveyor the content and impression given misleading to the public.” Thus, citation 12 News Release, U.S. District Attorney’s Of ice for the District of Massachusetts, Justice Department Announces Largest Health Care Fraud Settlement in Its History, (Sept. 2, 2009), available at www.usdoj.gov/usao/ma/press.html; see also Gardiner Harris, “Pfizer Pays $2.3 Billion to Set le Marketing Case,” N.Y. Times (Sept. 3, 2009). 13 Press Release, U.S. Dep’t of Justice, Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa, (Jan. 15, 2009), available at http://www.usdoj.gov/opa/pr/2009/January/09-civ-038.html. 14 See, e.g., Ethex Corp. v. First Horizon Pharm., 228 F. Supp. 2d 1048, 1055 (E.D. Mo. 2002) (“false statements . . . are actionable under the Lanham Act even if they involve 15 On the question of whether a plaintiff seeks to circumvent the bar on private rights of action under the FDCA, or whether a case encroaches on FDA’s primary authority to such an extent as to warrant dismissal, see generally Alpharma, Inc. v. Pennfield Oil, 411 F.3d 934 (8th Cir. 2005); Mylan Labs. v. Matkari, 7 F.3d 1130 (4th Cir. 1993); Axcan Scandipharm Inc. v. Ethex Corp., 2007 WL 3095367 (D. Minn. 2007); Solvay Pharms. v. Global Pharms., 298 F. Supp. 2d 880 (D. Minn. 2004); Summit Tech. v. High-Line Med. Instruments, 933 F. Supp. 918 (C.D. Cal. 1996); Grove Fresh Distrib. v. Flavor Fresh Foods, 720 F. Supp. 714 (N.D. Ill. 1989). 16 Cf. Sanderson Farms v. Tyson Foods, 547 F. Supp. 2d 491 (D. Md. 2008) (preliminary injunction ordering Tyson to halt its national advertising campaign that its chicken was “raised without antibiotics,” when evidence showed that the chickens were fed a product proven to function as an antibiotic, despite prior approval for the claim by the 17 Sanderson Farms v. Tyson Foods, 547 F. Supp. 2d 491, 504 (D. Md. 2008) (quoting Johnson & Johnson * Merck Consumer Pharms. v. Smithkline Beecham Corp., 960 18 Schering v. Pfizer, 189 F.3d 218 (2d Cir. 1999). 19 Id. 20 No. 99 Civ. 1452, 1999 WL 509471 (S.D.N.Y. 1999). 21 McNeil-PPC, Inc. v. Pfizer Inc., 351 F. Supp. 2d 226 (S.D.N.Y. 2005). 22 Id. at 254. 23 Id. at 252-57. 24 See 21 C.F.R. § 202.1(e)(5) (pharmaceutical promotional materials must present a “fair balance” of information between the effectiveness and risks). to the FDA guidelines, in the absence internal company documents or emails can (3) vigilantly monitor competitors’ claims of proof of literal falsity or misleading of the public, is insufficient to show that vulnerabilities. If a competitor brings a the claims in the [advertising] campaign litigants will discover marketing materials, The core question in Lanham Act cases drafted by enthusiastic and creative remains whether a claim is deceptive, not marketers. So-called “rah rah” emails (i.e., whether FDA regulations have been “we are killing them”) may be influential in court, and such evidence can overshadow (4) regularly update training for sales and scientific data. In addition, documents related The FDA and courts take a similar approach to the sales process will affect adjudication of in evaluating promotional statements, but a physician claim. For example, call notes, articulate the standard differently. For sales “scripts,” and other sales training (5) if Lanham Act litigation is threatened, example, an FDA misbranding violation is materials have been used in Lanham Act shown where a efficacy or safety claim has cases 29 to prove that an advertising claim was not been demonstrated by substantial actually conveyed to doctors. (a) science; (b) survey; (c) fraud litiga- tion; (d) marketing; and (e) regulatory. controlled clinical trials).26 Analogously, a Planning For Lanham Act Risk. The
Lanham Act court will enjoin an potential for Lanham Act litigation and coordinate in order to field an effective “establishment” or “tests prove” claim—even significance of such litigation is something without affirmative proof of falsity—where that pharmaceutical companies should Lanham Act cases often proceed at a rapid plaintiff proves that the supporting tests consider when planning and deploying conducted (the clinical trials) do not reliably support the claim.27 Some courts have held Pharmaceutical companies should: preparation, but the impact can be significant that that FDA’s gold standard of two (1) consider lessons learned from Lanham and last for years. Pharmaceutical “imposes a more stringent standard that that on the Lanham Act with key legal and litigation risk, consider offensive strategies for competitors who are breaking the rules, and Discovery and Evidence in Lanham Act (2) carefully substantiate their claims with make sure all claims (express and implied)
Cases. One difference between the FDA
Lanham Act cases in mind, and keep are adequately substantiated, with both FDA process and Lanham Act litigation is the well-developed records on such guidance—and Lanham Act decisions—in availability of discovery and the potential that Randy Miller is a Member of the Antitrust Section's newest committee: the Private Advertising Litigation Committee. Section members can join this new committee at no cost and will be entitled to receive timely and relevant announcements of developments in this area. For more information, please visit the PAL Committee's web site at http://www.abanet.org/dch/committee.cfm?com=AT311570 or contact Amy Mudge at amy.mudge@aporter.com. 25 AstraZeneca LP v. Tap Pharm. Prods., 444 F. Supp. 2d 278, 295 (D. Del. 2006) (evaluating the so-called “Better is Better” campaign, where the advertiser claimed superiority based on clinical data showing efficacy advantages only as to a subset of patients for a subset of conditions; however, consumers interpreted the ad as 26 Constr. Laborers Pension Trust v. Neurocrine Biosciences, Inc., 2008 WL 2053733, at *7 n.8 (S.D. Cal. 2008); accord Warner-Lambert Co. v. Heckler, 787 F.2d 147, 151 27 Zeneca, 1999 WL 509471, at *31, 34 (enjoining therapeutic claims “on the ground that the underlying tests are irrelevant and/or unreliable to support them.”); McNeil v. Pfizer, 35 F. Supp. 2d 226, 248 (S.D.N.Y. 2005); Pfizer, Inc. v. Miles, Inc., 868 F. Supp. 437, 452 (D. Conn. 1994) 28 Bracco v. Amersham Health, 627 F. Supp. 2d 384, 471 (D. N.J. 2009). 29 Id. at 460 (collecting authority including Zeneca, Pfizer v. Miles, and Abbott Labs. v. Mead Johnson & Co., 971 F.2d 6 (7th Cir. 1992)).

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