The Art of the Decision on the Opinions of Science.

In a wholly unsexy but nonetheless instructive decision in ONY, Inc.  v. Cornerstone  Therapeutics, Inc. dated June 26, 2013, the Second Circuit upheld the dismissal of a plaintiff’s false advertising complaint.  The reason:  Opinions expressed in a scientific article do not constitute false advertising under the Lanham Act if the data analyzed is not fraudulent and the conclusions of the authors of the article can be considered by the relevant sophisticated community — which is free to reject the conclusions in question with or without reproducing the study that led to them.

mdbheadshotfinalThe plaintiff in ONY, Inc. v. Cornerstone Therapeutics, Inc. is a producer of surfactants—“biological substances that line the surface of human lungs”—as is one of the defendants, Chiesi Farmaceutici, S.p.A. (an Italian concern that contracts with Cornerstone to market a competing product). Chiesi and Cornerstone commissioned a study of the efficacy of surfactants, with an eye toward being able to publicize that their product is the best of those in use. To no one’s surprise, the conclusions of the study reached (by physicians hired by the drug manufacturer duo to reach a conclusion) put the Chiesi/Cornerstone surfactant in a more positive light than the ONY surfactant. The physicians submitted their results in the form of an article to a leading journal, where it appeared in print—with notices of the authors’ connections to the recommended drug’s manufacturers—after anonymous peer review.

ONY sued, complaining that the article and distribution of selections from it violates the Lanham act and New York General Business Law § 349 (a consumer protection statute) and constitutes tortious injurious falsehood and interference with prospective economic advantage. The Second Circuit wrote:

In this case, plaintiff claims that the article made statements about scientific findings that were intentionally deceptive and misleading, and that it therefore constitutes false advertising. Plaintiff’s theory is that scientific claims made in print purport to be statements of fact that are falsifiable, and such statements can be defamatory or represent false advertising if known to be false when made. Plaintiff argues that the [United States District Court for the Western District of New York] based its conclusion that the article’s statements were non-actionable solely on its determination that the assertions were statements of opinion, without conducting the more fine-grained analysis required by Milkovich [v. Lorain Journal Co., 497 U.S. 1 (1990), which held that, generally, statements of pure opinion—that is, statements incapable of being proven false—are protected under the First Amendment]. According to plaintiff, dismissal prior to discovery under such circumstances was error.

The Second Circuit was not persuaded. “Where, as here, a statement is made as part of an ongoing scientific discourse about which there is considerable disagreement,” the appellate panel opined, “the traditional dividing line between fact and opinion is not entirely helpful.” The court summarized, anticipatory to upholding the dismissal: “Here, ONY has alleged false advertising not because any of the data presented were incorrect but because the way they were presented and the conclusions drawn from them were allegedly misleading. Even if the conclusions authors draw from the results of their data could be actionable, such claims would be weakest when, as here, the authors readily disclose the potential shortcomings of their methodology and their potential conflicts of interest.”

The Court’s conclusion that the medical journal article’s contents are not actionable under the Lanham Act led to the conclusion that the statements are not actionable under New York statutory or common law, being that New York follows the approach laid out in Milkovich. The separate tort claims also failed and were felled.

Originally posted 2013-07-08 12:42:11. Republished by Blog Post Promoter