## Facts

- ONY sold Infasurf, an FDA-approved bovine-lung-derived surfactant for neonatal respiratory distress syndrome (RDS); a competitor marketed Curosurf, a porcine-lung-derived surfactant.
- A manufacturer of Curosurf sponsored a retrospective observational study comparing mortality outcomes among infants treated with three FDA-approved surfactants.
- The study was published as a peer-reviewed journal article and reported that Curosurf was associated with significantly lower mortality than Infasurf and the third product.
- ONY alleged the article conveyed a false and misleading superiority message because the study’s methodology was flawed (including failure to control for population differences and selective discussion of literature).
- ONY did not allege the study’s underlying data were fabricated or falsified.
- After publication, the Curosurf marketer and manufacturer issued press releases and marketing materials quoting or summarizing the article’s conclusions to physicians and hospitals.
- ONY sued for Lanham Act false advertising, New York consumer deception, and related common-law torts, claiming the article and promotional use diverted sales and harmed goodwill.
- The district court dismissed for failure to state a claim, and ONY appealed.

## Issues

1. Whether conclusions in a peer-reviewed scientific article addressing an unsettled scientific question can be treated as actionable “false” or “misleading” statements under the Lanham Act, New York deceptive-practices law, or common-law commercial tort theories.
2. Whether press releases and marketing materials that accurately quote or summarize such an article’s conclusions can create liability absent allegations that the excerpts materially distort the article or add independent falsehoods.

## Decision

- The Second Circuit affirmed dismissal of all claims.
- The court held that scientific conclusions published in a peer-reviewed journal on unsettled scientific matters are nonactionable opinion for purposes of damages claims premised on falsity.
- Because ONY challenged methodology and inference rather than alleging fabricated data, the complaint did not plead an actionable false statement.
- Secondary distribution of excerpts from such an article is not actionable if the excerpts do not mislead readers about the article’s conclusions.
- ONY failed to plausibly allege that the promotional materials misquoted, distorted, or independently misstated the article’s reported conclusions.

## Legal Principles

- Statements of scientific conclusions about unsettled matters, presented in peer-reviewed scientific literature with disclosed methodology and limitations, are generally treated as nonactionable opinion rather than verifiable false statements in damages-based claims.
- Courts distinguish allegedly fabricated or objectively false underlying data (potentially actionable) from disputes about methodology, interpretation, and scientific judgment (generally for the scientific community to evaluate).
- The Lanham Act and analogous state-law theories cannot be used to recast disputes over contested scientific conclusions in peer-reviewed publications into false-advertising or commercial-tort liability.
- Accurate quotation or fair summary of a protected scientific article’s conclusions in promotional materials does not create liability unless the promotion materially misleads about what the article concluded or adds independent false representations.

## Conclusion

The court held that a competitor could not impose false-advertising or tort liability based on a peer-reviewed article’s contested scientific conclusions on an unsettled question, and could not proceed against promotional materials that accurately repeated the article’s conclusions without distortion or additional false statements.


ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490 (2d Cir. 2013)