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Home/Legal & Regulatory and Reimbursement/Contested Scientific “Speech” Protected Against Defamation Suits
Legal & Regulatory and Reimbursement

Contested Scientific “Speech” Protected Against Defamation Suits

June 27, 2013 1 min read Premium comments

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Contested Scientific “Speech” Protected Against Defamation Suits
Image created by RRY Publications, LLC. Source: Wikimedia Commons
Secondary

Contested scientific hypotheses are a matter of opinion and are entitled to free speech protection.

That’s the June 26, 2013 ruling of the 2nd U.S. Circuit Court of Appeals in ONY Inc. v. Cornerstone Therapeutics Inc. et al. Writing for a unanimous three-judge panel, Circuit Judge Gerard Lynch wrote: “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.”

While statements about contested scientific hypotheses are in principle “matters of verifiable fact, ” for purposes of the First Amendment they are closer to matters of opinion, added Judge Lynch.

ONY sued Cornerstone Therapeutics, Italy’s Chiesi Farmaceutici SpA, several doctors and the American Academy of Pediatrics (AAP) over a 2001 article publishing the findings of the effectiveness of ONY’s Infasurf, a drug meant to help infants with respiratory failure. Chiesi paid for the study which compared their own drug with others, including ONY’s Infasurf.

The findings were used by doctors in the AAP’s Journal of Perinatology and eventually in promotional materials by Chiesi and Cornerstone.

ONY claims the article contained incorrect statements of fact and included selective data. ONY sought damages of $10 million, accusing the defendants of false advertising in violation of the federal Lanham Act, and a New York state law against deceptive business activity.

According to a June 26 Reuters report, Judge Lynch said, “academic freedom is a special concern of the First Amendment, ” and warned against extending the Lanham Act to intrude on the amendment’s values.

Author

WE
Walter Eisner
React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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