Antitrust Law Daily Wrap Up, ADVERTISING—S.D.N.Y.: Bayer denied injunction over Johnson & Johnson prostate drug advertising, (Apr 21, 2026)

By Donielle Tigay Stutland, J.D.

J&J’s communications did not misrepresent the methodology or the results of its study.

The federal district court in New York City denied a request for a preliminary injunction made by Bayer Healthcare LLC to prohibit Johnson and Johnson Inc. and its wholly-owned subsidiary Janssen Biotech, Inc. from using a study in its advertising for its drug apalutamide ERLEADA® that Bayer alleged was false and misleading. In denying the injunction, the court concluded that Bayer failed to show any methodological errors in the study cited that would be so substantial as to make J&J's representations regarding the study's findings materially false (or even misleading) in violation of the Lanham Act (Bayer Healthcare LLC v. Johnson & Johnson, No. 1:26-cv-01479-DEH (S.D.N.Y. Apr. 17, 2026)).

Background. Both Bayer and J&J are in the market for a drug used in the treatment of metastatic castrationsensitive prostate cancer. J&J’s marketing, including a presentation as well as a press release, describe the results of a retrospective observational study (the "Study") that purports to show a roughly 50% reduction in the risk of death for patients prescribed ERLEADA®, compared to Bayer's drug, darolutamide (branded as NUBEQUA®). J&J published a press release titled, "Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months.” Within the press release, J&J made several claims regarding the Study.

Bayer filed a motion for preliminary injunction to enjoin J&J from continuing to make these statements in its advertisements. Bayer alleges that various statements made in the challenged communications, including that apalutamide patients had a 51% lower death rate than darolutamide patients, are literally false or false by necessary implication. The parties submitted voluminous briefings, including 22 declarations from medical and statistical experts, and after the court held a two-day hearing at which 13 of those witnesses testified.

Bayer argued that J&J's statements that there was a lower risk of death for patients taking apalutamide are false due to several alleged methodological flaws in the Study. These purported flaws include: (1) possible differences in the treatment cohorts, stemming from the fact that the use of darolutamide in doublet form was "off-label" for much of the Study period; (2) the inadequacy of the statistical controls employed by J&J to account for differences between the treatment cohorts; (3) the low quality of the data sources on which the Study was based; and (4) the inaccuracy of J&J's method of calculating the relative risk of death among the treatment cohorts (the "hazard ratio"). Second, Bayer also claims that the challenged communications misrepresent the Study's methodology and results in various ways, including by: (1) overstating the Study's findings regarding the relative risk of death between the two treatment cohorts, by describing the Study's results as showing a 51% difference in the risk of death; (2) using the word "reduces" to ascribe a causal relationship between the drugs in question and the observed differences in death rates between the two treatment cohorts, when the Study could not provide actual evidence of causation; (3) falsely claiming that the Study involved a period of "24 months" total of follow-up for all patients, when many patients in the Study were actually followed for a shorter time period; and (4) falsely describing the Study as "replicating" the conditions of a clinical trial, when it could not do so.

Likelihood of success. In reviewing the request for an injunction, the court analyzed the likelihood of success based on the merits of Bayer’s Lanham Act claim. The court concluded that Bayer’s evidence did not establish that the study’s methodological choices were so flawed as to render J&J’s representations about its findings materially false or misleading.

The court began with Bayer’s claim that the Study’s methodology was flawed. The court first concluded that found that “at least at this stage, Bayer has failed to show that among mCSPC patients in doublet therapy, those receiving off-label darolutamide were sicker in some unmeasured way than those receiving apalutamide on-label.” The court based this on the testimony that darolutamide was often prescribed throughout the Study period in doublet form despite its off-label status at that time. The court also rejected Bayer’s contention that there was an inadequacy of statistical controls and its challenge to the methodology used by the Study to control for population imbalances, known as Inverse Probability of Treatment Weighting (IPTW). Based on the testimony of J&J's experts, the court preliminarily found that the balancing methods used by researchers in the Study were properly executed and unlikely to have biased results through the failure to capture unmeasured confounders. The court also disagreed with Bayer’s challenge to the underlying data sources used in the Study. The court determined that Bayer failed to demonstrate the inadequacy of the data validation method used in the Study, noting that, “Bayer's assertions of flaws in the Study data associated with using the PPS and Komodo research databases are unsupported by the record.” Finally, the court rejected Bayer’s allegation that the reporting of an overall hazard ratio for the entire Study period was likely to provide an inaccurate picture of the underlying association between drug treatment and mortality. Based on the evidence presented, the court indicated that it could not conclude that the Study's results are unreliable.

Having concluded that the Study was conducted using a reliable and valid methodology, the court next looked at Bayer's arguments that J&J's statements in the challenged communications misrepresent the Study's methodology and results. Here, the court also concluded that the challenged communications, taken as a whole, accurately represent the Study's methods and conclusions. The relevant audience for the communications at issue would be prescribing physicians, and analyzed the statements with a sophisticated audience in mind. As such, the court determined that the challenged communications” adequately disclose the nature of the Study as an observational, retrospective study and therefore convey all the limitations that this fact would entail, such that a prescribing physician would not misunderstand the statements.” The court also found that J&J’s disclaimers included in its press release and presentation adequately disclosed the potential limitations of the Study such that the top line conclusions were not themselves literally false (or even misleading) to a sophisticated population that would understand the meanings and implications of the terms employed.

The Case is No. 1:26-cv-01479-DEH.

Judge: Ho, D.

Attorneys: Nicholas Cunha (Simpson Thacher & Bartlett LLP) for Bayer Healthcare LLC. Steven Alan Zalesin (Webb & Tyler LLP) for Johnson & Johnson.

Companies: Bayer Healthcare LLC; Johnson & Johnson

Cases: Advertising NewYorkNews