Dr. Egan is a pioneering neonatologist whose team began trials of one of just three FDA-approved drugs to aid maturation of the lungs of premature babies at Buffalo Women & Children's Hospital in 1981.
ONY also is suing Cornerstone's paid researchers, study authors, the Journal and its sponsor, the American Academy of Pediatrics, for their involvement in the study's publication.
ONY's lawsuit claims the Journal failed to follow "journalistic standards applicable to peer-reviewed articles." The article was also evaluated by two reviewers, one of whom "found its conclusions to be unreliable and recommended it not be published," according to ONY's court documents. Two of the authors, Drs. Jatinder J. Bhatia and Krisnamurthy C. Sekar, are members of the editorial board of the Journal of Perinatology.
"I personally contacted the editor of the Journal requesting he retract this false and misleading article, and he refused to retract it, leaving us with no choice than to file this lawsuit," Dr. Egan said.
The legal documents also note Cornerstone has publicized the article's conclusions in press releases and promotional materials targeting hospitals and physicians currently using Infasurf® in their neo-natal ICUs and practices.
ONY is seeking a minimum of $10 million in monetary damages, citing the harm to its sales and financial health caused by continued distribution of the article and spin-off publicity by Cornerstone.
In addition to North Carolina-based Cornerstone and its Italian parent company, defendants in the suit also include: Nature America, Inc. (aka Nature Publishing Group); Edward E. Lawson, M.D., editor of the Journal of Perinatology; the American Academy of Pediatrics; Premier Inc. (aka Premier Research Services), and the article's authors Bhatia and Sekar, Rangasamy Ramanathan, M.D. and Frank R. Ernst, PharmD.
The small drug company, whose sole product is Infasurf®, emp
|SOURCE ONY, Inc.|
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