Judge Rules Disputes Over Medical Studies Should Be Resolved by Researchers and Scientists not Courts

 

A U.S. federal appeals court ruled that disputes over medical studies should be resolved by researchers and scientists themselves, not in the courts, which it said are ill-equipped to adjudicate issues based on highly technical data. The case involved allegations by the company ONY, which claimed that its treatment for neonatal respiratory distress, Infasurf, was unfairly disparaged by a study linked to Chiesi Farmaceutici, which makes a rival medication, Curosurf.

As noted by Ed Silverman, writing an article in Forbes: “In a decision that should intrigue free speech advocates, researchers and, of course, pharmaceutical advertisers, a federal appeals court has ruled that scientific debate should be resolved among scientists.”

Background

Silverman outlines the background of the case. We are quoting his piece directly: Two years ago, a study in the Journal of Perinatology concluded that Curasurf, a drug used to treat neonatal Respiratory Distress Syndrome and sold by Cornerstone Therapeutics and its parent, Chiesi Farmaceutici, significantly reduced the likelihood of death when compared with Infasurf, which is sold by ONY (here is the study).

However, ONY charged the study was methodologically unsound because the authors failed to include all of the pertinent data. For instance, ONY claimed the study reported a lower mortality for infants treated with Curosurf, but omitted data indicating these babies also had shorter hospital stays, which ONY maintained is a critical distinction that would have accounted for an outcome favorable to its rival.

“They purposely fudged the data and engaged in selective distortion to produce bogus conclusions to promote their product,” ONY president Ted Egan said in a statement at the time the lawsuit was filed. “A premature baby with a reported short hospital stay either died early or was healthier because (it was) close to full-term. The only way the Curosurf infants could have both a lower mortality and a shorter hospital stay is if those infants were more mature and less ill than Infasurf-treated babies.”

Moreover, ONY charged that the circumstances surrounding the publication of the journal article were unusual. The parent company sponsored the study, three of the four authors served as Chieisi consultants and the fourth worked for Premier Research Services, which was a Chiesi contractor hired to build a database for the study. Also, two of the four authors served on the journal editorial board.

Second Circuit Rejects Claim

The Second Circuit upheld the district court ruling, concluding the lower court correctly found that the plaintiff has failed to state a claim based on publication of the article itself, because the challenged statements are protected scientific opinion. The court further concluded there is not sufficient evidence to prove that Chiesi and Cornerstone distributed misleading excerpts of the article.

The court states:

“We conclude that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate cannot give rise to liability for damages sounding in defamation. We further conclude that the secondary distribution of excerpts of such an article cannot give rise to liability, so long as the excerpts do not mislead a reader about the conclusions of the article.”

Furthermore:

“It is clear to us that, while statements about contested and contestable scientific hypotheses constitute assertions that about the world that are in principle matters of verifiable ‘fact,’ for purposes of the First Amendment and the laws relating to fair competition and defamation, they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities,” the court wrote.

The court further stated that ONY did not assert that there was fraudulent data, only a contention that a fuller set of data was not published in the study. As a result, the validity of the methods used to prepare the study can later be questioned by the scientific community as part of an ongoing analysis or debate.

The court concludes: “to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is a legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising.”

Going forward

Silverman writes: “So what might this mean for drugmakers as they go about promoting their medicines? For one, false advertising claims can still be made. If a drugmaker misstates a conclusion or omits material data from promotional materials, a court could rule that false advertising took place, notes Paul Llewellyn, an attorney at KayeScholer, who is co-head of the trademark, copyright and false advertising group.

‘The court is saying that it’s not going to second guess and get behind the scientific process and look at other variables,’ he says. ‘I don’t think it provides a precise road map for what’s okay (for a pharmaceutical manufacturer) to do in the future, but I do think it does provide some useful background for future litigation.’ ”