FIRST AMENDMENT--FALSE ADVERTISING--SECOND CIRCUIT AFFIRMS THAT DISSEMINATION OF SCIENTIFIC PUBLICATIONS CANNOT BE FALSE ADVERTISING UNDER THE LANHAM ACT--ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490 (2d Cir. 2013).
Advertising and other forms of commercial speech have long been recognized to be protected by the First Amendment, subject to certain restrictions. (1) The Lanham Act (2) creates a civil cause of action against a commercial speaker who makes a "false or misleading representation of fact" (3) that "misrepresents the nature, characteristics, qualities, or geographic origin of his ... goods, services, or commercial activities." (4) The line between represented fact and protected opinion, however, is often unclear. Recently, in ONY, Inc. v. Cornerstone Therapeutics, Inc., (5) the Second Circuit held that there could be no actionable false advertising claim against a company that had published and disseminated the allegedly flawed conclusions of a peer-reviewed article. (6) The court correctly concluded that publication of a controversial scientific article qualified as protected academic speech, the accuracy of which should not be adjudicated by the courts. However, the court did not recognize that dissemination of the published article for marketing purposes should be considered separately as a secondary act of speech that may provide a basis for liability under the Lanham Act. Given the ongoing debate on the reliability of corporate-funded studies, especially in the pharmaceutical industry, the court may have provided a shield of superficially scientific speech behind which unscrupulous corporations may hide.
ONY, Inc. (ONY) produces Infasurf, a surfactant used to treat prematurely born infants who suffer from respiratory distress syndrome (RDS). (7) Chiesi Farmaceutici, S.p.A. (Chiesi) manufactures a competing surfactant, Curosurf, which is sold in the United States by Cornerstone Therapeutics, Inc. (Cornerstone). (8) In 2006, Chiesi commissioned Premier, Inc. (Premier) to develop a database of hospitals' uses of each surfactant for treating RDS and to conduct a comparative study using the data therein. (9) The study's conclusions included the finding that infants treated with ONY's product had a 49.6% higher mortality rate than those treated with Chiesi's. (10) Chiesi also paid several physicians to present the study's findings. (11) They, along with a Premier employee, submitted a manuscript to the Journal of Perinatology, which was published in 2011 after passing peer review. (12) Chiesi passed out copies and excerpts of the published paper and also touted the paper's conclusions in a press release. (13)
In December 2011, ONY filed false advertising and other claims against Chiesi, Cornerstone, the article's authors, and others in the Western District of New York. (14) ONY argued that the Chiesi article itself, as well as Chiesi's subsequent touting and distribution of the article's findings to neonatal physicians who use ONY's surfactant, violated the Lanham Act's prohibition on the use of false or misleading descriptions of a product. (15) ONY alleged that there were several flaws in the Chiesi article that made the article misleading, including that the source data had been selectively culled to favor Chiesi's surfactant, that the methodology and reporting had failed to include a critical variable (the lengths of hospital stays for the infants in the analysis), and that the paper had failed to acknowledge studies that reached different conclusions. (16) Chiesi responded that the paper had fully disclosed the methods used in the analysis, that the paper included a caveat speculating that the observed difference in effect may have been due to differences in the dosages administered to patients rather than differences in the inherent efficacy of the surfactants, and that objections to study design were subjective issues that could not be considered a dispute over a "representation of fact" as required by the Lanham Act. …