New York court finds scientific hypotheses are not libelous

A federal court in Buffalo said last week that peer-reviewed journals, not courtrooms, are the proper place to vet scientific disputes. A libel claim brought by ONY, Inc., against the Journal of Perinatology for a negative study of an ONY pharmaceutical product was dismissed.

Under libel law pure opinion is protected; false assertions of fact form the basis of a libel suit. The district court refused to find that any of the study's alleged scientific flaws demonstrated the study made false assertions of fact.

"This decision reaffirmed the notion that issues about scientific debate should be resolved in a scientific community and not in a court room. [It affirmed] science is a discipline that by its very nature that provokes questions and disagreements," the defendant's counsel Robert Balin said in an interview.

The study at issue was paid for by competitor company Chiesi Farmaceutici, which markets a drug that, like ONY's, is used to treat the fatal infant condition respiratory distress syndrome (RDS). The study concluded that ONY's brand carried a "49.6 percent greater likelihood of death" than Chiesi's.

Chiesi, along with the physicians who authored the study, and publisher Nature, Inc., were sued for publishing an "injurious falsehood" — also known as trade libel — about ONY's product.

The lawsuit raised questions about the methodology of the study, such as its failure to cite a contradictory report, and the omission of data which would have produced a less skewed conclusion. It also pointed to several conflicts of interest that affected the study's authors and editors.

ONY characterized the article as a false advertisement in its complaint.

"This was an article promoting a specific commercial product. It was designed to create an impression that was not accurate," said Mitchell Banas, counsel for the plaintiffs.

But the court found the article was not libelous. It said that the study's statements were protected as pure opinion, and that the outcome turned on whether a reasonable reader would conclude that the statements are facts or opinion.

"The average reader would perceive these statements as debatable hypothesis rather than assertions of unassailable fact," the court held.

In its analysis, the court pointed to the fact that the authors' conflict of interest and the study methodology were fully disclosed, which allowed a reader to draw their own conclusion. The court also said that it was not the appropriate venue for the ethical questions raised by plaintiffs.

"Any perceived fault in the method by which the authors reached their conclusions should be subjected to peer review rather than judicial review," the court said.

The decision will have ramifications in the scientific publishing world, and for journalists who republish scientific statements.

"Had [the decision] gone the other way it would have been a great concern to scientific journals and publishers. You shouldn’t have to make decisions looking over your shoulder for a possible lawsuit or complaint," Balin said.