Courts defer ruling on science

A lawsuit between rival companies over false advertising has ended with the US Court of Appeals concluding that the courts are not the appropriate forum to resolve scientific disputes. The US Court of Appeals, Second Circuit (Court) in June ruled that a scientific study to evaluate a pharmaceutical product then cited in marketing material could not be attacked as “false advertising” because such studies are protected as free speech under the First Amendment. The lawsuit was brought by ONY of Amherst, New York, against Chiesi Farmaceutici, of Parma, Italy. Both companies make surfactants for lining the surfaces of lungs of premature infants or other patients with respiratory distress syndrome. In 2006, Chiesi hired physicians and other specialists to develop data to show the effectiveness of its product, and they later presented their findings online at several conferences and published those findings on September 1, 2011 in the peer-reviewed Journal of Perinatology (10.1038/jp.2011.125). With qualifications, the authors, who disclosed their relation with Chiesi, concluded that the Chiesi product is superior to the competing ONY product, and the company later touted those conclusions in a press release. ONY objected to the study and its presentations, and then in December of that year brought a lawsuit, claiming false advertising and selective mention of some of the data among other alleged damages and harm, but not claiming that the data were fraudulent or fabricated. Instead, ONY claimed that the “inferences drawn from those data were the wrong ones.” However, the Court states that such scientific matters are best left to “other members of the relevant discipline or specialty,” noting that if conclusions are drawn from nonfraudulent data, and if there is legitimate ongoing scientific disagreement, there are no grounds for a claim of false advertising. The Court also concluded that Chiesi's press release was okay because, even though laudatory of the company's product, it did not distort or misstate the conclusions of the study it cites. In sum, ONY's disagreement with that study and its conclusions is not a matter to be settled by lawsuit, but a matter of scientific dispute that is better settled by more research and debate among scientific experts.

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Fox, J. Courts defer ruling on science. Nat Biotechnol 31, 860 (2013). https://doi.org/10.1038/nbt1013-860

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