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In False Ad Dispute Between Inhaler Companies, Court Grants PI Enjoining Unsupportable Clinical Superiority Claims

In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a pharmaceutical company from making certain marketing claims of clinical superiority that the Court found did not match up with the study results purportedly supporting them. In doing so, the Court offered instructive guidance on the proof required to show falsity under the Lanham Act and on the showing necessary to justify preliminary injunctive relief. 

The litigation involved competing manufacturers of prescription inhalers used to treat Chronic Obstructive Pulmonary Disease (“COPD”), a potentially fatal lung disorder. The plaintiff, GlaxoSmithKline (“GSK”), and the defendant, Boehringer Ingelheim (“BI”), each manufacture and market dry powder inhalers (“DPIs”) containing their respective proprietary COPD medications. However, in 2015, BI introduced a second type of inhaler called a slow mist inhaler (“SMI”) and became the only seller of SMIs for COPD in the United States. Id. The core difference between a DPI and an SMI is its method of activation by the user: a DPI is activated by the force of a user’s inhalation, while SMIs are activated by the press of a button on the device.

This point of differentiation between SMIs and DPIs became the centerpiece of BI’s marketing campaign for its new product. After launching its SMI in July 2018, BI began distributing marketing materials, through sales representatives and otherwise, claiming that physicians should be prescribing BI’s SMI for COPD patients who, because of their illnesses, are unable to inhale with sufficient force to optimally activate a DPI. Id. at 3.

GSK—the maker of a leading DPI—soon got wind of the marketing campaign and issued a cease and desist letter. Following several largely unsuccessful months of attempting to negotiate with BI, GSK filed suit against BI in the Eastern District of Pennsylvania in November 2019, seeking a preliminary injunction. According to GSK, BI’s marketing of its SMI had violated the Lanham Act by falsely and misleadingly claiming, in numerous different ways, that BI’s testing had shown SMIs are clinically superior to DPIs for COPD patients with limited ability to inhale. BI, in opposition, contended that its marketing claims regarding its SMI product were supported by scientific evidence.

In considering GSK’s preliminary injunction application, the Court began its analysis by evaluating whether the claims were literally false, rather than misleading. Under well-established Lanham Act case law, a finding of literal falsity obviates the need for the claimant—here GSK—to prove consumer deception through survey evidence. The Court noted that in cases like this one, where the claims at issue “either expressly or impliedly assert[] that the fact is testor study-validated, the fact of the validation becomes an integral and critical part of the claim.” Id. at 6 (quoting C.B. Fleet Co. v. SmithKline Beecham Consumer Healthcare, L.P., 141 F.3d 430, 435 (4th Cir. 1997)). Therefore, GSK could establish literal falsity by demonstrating either (a) that “the tests were not sufficiently reliable to permit [the] conclusion” BI advertised in its marketing materials; or (b) “that the tests did not establish the proposition for which they were cited.” Id. (quoting Castrol Inc. v. Quaker State Corp.., 977 F.2d 57, 63 (2d Cir. 1992)).

The Court thus analyzed the reliability of the studies underlying BI’s marketing claims and whether those claims aligned with the studies’ conclusions. The court concluded that BI had “identified reliable studies that support [aspects of] its marketing campaign,” id. at 9, including studies demonstrating that (a) DPIs require a certain amount of inhalation force for optimal activation, and (b) many COPD patients are unable to inhale with the requisite force, id. at 8.  However, the Court concluded that BI had failed to identify reliable evidence linking suboptimal inhalation from a DPI to an inferior outcome in a COPD patient. Therefore, “any marketing that represents that a correlation between suboptimal [inhalation] and clinical outcomes has been established . . . crosses the line” into literal falsity. Id. at 10. 

Applying this standard, the Court concluded that most of the challenged marketing statements were not literally false because they did not connect inferior inhalation to inferior clinical outcomes. Id. at 11-18. The Court held, however, that GSK had met its burden to show the literal falsity of one claim that certain patients would not receive a clinically sufficient dose of medication from a DPI, since BI had not provided evidence supporting this. Id. at 13.

The court then proceeded to consider whether GSK had, in the alternative, shown that some or all of BI’s claims were misleading, even if not literally false. To show that a claim is misleading, the claimant must come forward with evidence that a significant portion of the relevant consuming population would be confused or deceived by the claim. Id. at 7. GSK presented physician survey evidence showing that a significant number of physicians interpreted one of BI’s advertisements as suggesting that DPIs could not effectively deliver medication for certain COPD patients—exactly the message the Court had concluded was literally false because it was not supported by BI’s clinical evidence. Id. at 18-19. The Court therefore held that GSK had established a likelihood of success on the merits on its claim targeting that advertisement. However, the Court also held that GSK had not established a likelihood of success on the merits on its claims with respect to certain other purportedly misleading claims, because it offered no evidence of deception beyond the ads themselves. Id. at 18 n. 83.

Since the Court found that GSK had established a likelihood of success on the merits, it moved onto the irreparable harm element of the preliminary injunction analysis. BI disputed GSK’s claim of irreparable harm on the grounds that GSK had waited over a year after learning of the allegedly false statements before moving for a preliminary injunction. Id. at 22. The Court rejected this argument, however, noting that GSK had attempted to resolve the dispute through negotiation with BI during that period, and the Third Circuit has allowed a party to delay in seeking a preliminary injunction when it “delays only in the reasonable belief that negotiations may resolve the dispute.” Id. at 22-23 (quoting Lanin v. Borough of Tenafly, 515 Fed. App’x 114, 118 (3d Cir. 2013)). BI further argued that GSK had not suffered irreparable harm because its market share in the COPD inhaler market had not declined during the course of BI marketing campaign. Id. at 23. But the Court noted that market share data alone is insufficient to refute the existence of irreparable harm. According to the Court, “GSK need not wait until its market share begins to suffer and it is too late to obtain injunctive relief;” instead, it was enough that GSK had shown the marketing campaign was “likely to fundamentally alter the existing paradigm for treating COPD in ways that irreparably harm GSK’s reputation and goodwill.” Id. at 25. This was especially relevant in the instant litigation, because BI’s SMI products were novel and physician-consumers were therefore likely to form their initial impressions of those products based on BI’s false marketing. Id. at 24.

Finally, the Court then found that the public interest weighed in favor of a preliminary injunction since “enjoin[ing] BI from making false and misleading statements not supported by scientific studies” would protect the health and safety of COPD patients, and BI would not be precluded from making truthful claims about its SMI. Balancing these factors, the court granted GSK’s requested injunction with respect to the marketing claims found to be false or misleading. Id. at 25-26.

GlaxoSmithKline v. Boehringer Ingelheim presents several important insights for false advertising litigators. First, the case is a reminder that scientific evidence is not always sufficient to defeat a finding of literal falsity under the Lanham Act, since courts typically require a close fit between the scientific evidence and the marketing claim. Here, there were several scientific studies that tended to support some of BI’s marketing claims, but BI also made an additional claim that drew a link not directly supported by the underlying studies. While it was perhaps possible to draw an inference from the existing studies to BI’s marketing claims, the Court held that this was not sufficient to overcome a finding of literal falsity. This holding should remind companies and their counsel to ensure congruity between study-based claims and the findings of the studies on which they are based.

Second, the case illustrates the importance, in certain jurisdictions (like the Third Circuit) of providing specific evidence of consumer confusion when alleging that a marketing claim is misleading. In those jurisdictions, some extrinsic evidence of deception—typically in the form of a survey—is deemed essential, even at the preliminary injunction stage. By contrast, false advertising claims premised on a finding of literal falsity do not require such extrinsic evidence, thus underscoring the advantage to claimants who can cast the challenged message as one that is false on its face.

Third, the case indicates that a delay in initiating litigation need not defeat a finding of irreparable harm. GSK was able to secure a finding of irreparable harm, and a preliminary injunction, despite the passage of over a year between learning of the marketing at issue and initiating litigation. This reflects that in some circumstances, courts will approach the irreparable harm analysis more holistically, rather that limit their analysis to a simple computation of the time between advertisement and suit. However, potential plaintiffs cannot simply sit on their rights: in this case, GSK expeditiously sought to address its dispute with BI outside of court, and as the Court observed, plaintiffs who wait too long to seek relief may forfeit their entitlement to a preliminary injunction. To preserve their remedies, potential false advertising plaintiffs should act swiftly to protect their rights as soon as possible, even if the first step is not litigation.

Finally, the case reflects a broad understanding of irreparable harm under the Lanham Act. Even if a defendant can point to hard data, such as sales or market share data, suggesting a lack of business injury resulting from the purportedly false advertising, a court may nonetheless rest an irreparable harm finding on more qualitative assessments. This is particularly important in the context of false advertising litigation involving new products, such as the BI inhalers at issue in this litigation, where there may not be sufficient data to adequately quantify the harm. In such circumstances, some courts have concluded, consumers are particularly susceptible to false advertising when the false advertising involves a new product, because the “buying public is particularly attentive and educable” and subsequent “correct[ion of] the false impressions made on consumers” can be “difficult.” Johnson & Johnson-Merck Consumer Pharmaceuticals Co. v. Procter & Gamble Co., 285 F.Supp.2d 389, 393 (S.D.N.Y. 2003). As these courts have reasoned, a contrary rule that unduly focuses on market share changes would effectively grant a free pass to manufacturers of new products in their launch advertising, given that most of the market impact has yet to materialize.