Amherst-Based Pharmaceutical Company Files Federal Lawsuit Accusing Competitor of False Claims Regarding the Efficacy of Infasurf®, its Life-Saving Respiratory Drug for Premature Infants ONY, Inc. Seeks $10 Million in Damages and Injunction Tied to a Study Published in the September issue of the Journal of Perinatology. The Lawsuit targets an Italian drug company and its U.S. subsidiary, as well as the publication, editor, authors and institutional sponsor.
AMHERST, N.Y., Dec. 2, 2011 /PRNewswire/ -- ONY, Inc., the maker of Infasurf®, a locally developed, FDA-approved drug administered to premature infants to combat Respiratory Distress Syndrome, filed suit in U.S. District Court in Buffalo today, accusing Cornerstone Therapeutics and its parent firm, Chiesi Farmaceutici S.p.A., of "cherry-picking" data to claim its competing drug, Curosurf®, produces significantly lower mortality rates.
"They purposely fudged the data and engaged in selective distortion to produce bogus conclusions to promote their product," said Dr. Edmund "Ted" Egan, President, ONY, Inc.
ONY asserts that the authors failed to include all the data in their study. The paper reports a lower mortality for Curosurf®-treated patients, but omits the critical fact that Curosurf®-treated babies also had shorter hospital stays.
"A premature baby with a reported short hospital stay either died early or was healthier because close to full-term," Dr. Egan pointed out. "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."
"There have been multiple clinical trials comparing lung surfactants, yet in no completed trial has one surfactant been identified as being superior with respect to the outcome of death," Dr. Egan said.
The data which served as the basis for the article was not based upon an actual clinical study; instead, it was culled from various hospital and physician databases, and the suit says, was purposely manipulated to produce the desired outcome.
In the article, the authors compared statistical outcomes of 14,173 preterm infants from 236 hospitals across the U.S. who received one of three FDA-approved surfactant medications to aid maturation of their underdeveloped lungs. Data was culled from hospital discharge information.
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®, employs 26 staffers at its headquarters and labs located at 1576 Sweet Home Road, in Amherst, N.Y.
Dr. Egan and the late Dr. Bruce Holm have received numerous awards and accolades over the past 30 years for their research in the area of Respiratory Distress Syndrome in preterm babies, as well as their translation of medical research into a successful biotech company.
SOURCE ONY, Inc.