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Ony, Inc v. Cornerstone Therapeutics

May 17, 2012

ONY, INC., PLAINTIFF,
v.
CORNERSTONE THERAPEUTICS, INC., CHIESI FARMACEUTICI S.P.A., NATURE AMERICA, INC. D/B/A NATURE PUBLISHING GROUP, EDWARD E. LAWSON, M.D., AMERICAN ACADEMY OF PEDIATRICS, PREMIER , INC. D/B/A PREMIER RESEARCH SERVICES, RANGASAMY RAMANATHAN, M.D., JATINDER J. BHATIA, M.D., KRISHNAMURTHY C. SEKAR, M.D. AND FRANK R. ERNST, PHARM.D., DEFENDANTS.



The opinion of the court was delivered by: William M. Skretny Chief Judge United States District Judge

DECISION AND ORDER

I. INTRODUCTION

Plaintiff commenced this action in December 2011 seeking damages and injunctive relief for Defendants' publication and distribution of an academic article containing allegedly false and misleading statements about Plaintiff's product. Presently before this Court are the following motions: Motion of Defendant Frank R. Ernst to Dismiss for Lack of Personal Jurisdiction (Docket No. 34); Motion of Defendants Jatinder J.Bhatia, M.D., Rangasamy Ramanathan, M.D., and Krishnamurthy C. Sekar, M.D., to Dismiss for Lack of Personal Jurisdiction and for Failure to State a Claim (Docket No. 45);*fn1 the Motions to Dismiss for Failure to State a Claim of Defendants Nature America, Inc., and Edward E. Lawson, M.D. (Docket No. 28), Defendant Premier, Inc. (Docket No. 37), Defendant American Academy of Pediatrics (Docket No. 39), and Defendants Chiesi Farmaceutici S.p.A. and Cornerstone Therapeutics, Inc. (Docket No. 43); Plaintiff's Cross-Motion for Leave to File and Amended Complaint (Docket No. 53); Plaintiff's Motion to Expedite Discovery (Docket No. 4);*fn2 and the Motion of Defendants Cornerstone, Chiesi, Ramanathan, Bhatia, Sekar, American Academy of Pediatrics, Premier, and Ernst to Strike the Supplemental Declaration of Edmund Egan, M.D., submitted in support of Plaintiff's Motion to Expedite (Docket No. 84).

These motions are fully briefed and the Court finds oral argument unnecessary. For the reasons that follow, Defendants' motions to dismiss are granted, Plaintiff's motion to amend is denied, and the remaining motions are denied as moot.

II. BACKGROUND

Plaintiff is the manufacturer of an animal derived surfactant, a calfactant known as Infasurf®, which is used in the treatment of Respiratory Distress Syndrome ("RDS") in prematurely born infants. (Complaint, Docket No. 1, ¶¶ 14-20). Infants exhibiting RDS often suffer from inadequate lung development, specifically the lack of naturally produced surfactants which line the surface of the lungs. (Compl. ¶¶ 14-18). Infasurf® is developed from bovine lung surfactant. (Compl. ¶ 20). Defendant Chiesi Farmaceutici S.p.A. ("Chiesi"), an Italian corporation, manufactures poractant alfa, a surfactant known as Curosurf® derived from porcine lung mince. (Compl. ¶¶ 3, 22). Curosurf® is distributed and marketed in the United States by Defendant Cornerstone Therapeutics, Inc. ("Cornerstone")(Compl. ¶ 22). A third surfactant, beractant (Survanta®), is manufactured from bovine lung mince by non-party Abbott Pharmaceuticals. (Compl. ¶ 21).

As alleged in the Complaint, Defendant Chiesi "directly or through an agent . . . commissioned a 'study' to support the claim that Curosurf® was a superior surfactant." (Compl. ¶ 28). Chiesi hired Defendant Premier Inc., d/b/a Premier Research Services ("Premier") to "provide a database to support the desired conclusion." (Compl. ¶ 28). Defendant Frank D. Ernst is the Premier employee who assembled the database. (Comp. ¶ 28). Chiesi then hired Defendants Rangasamy Ramanathan, M.D., Jatinder J. Bhatia, M.D., and Krishnamurthy C. Sekar, M.D., (the "Defendant Authors") to submit the findings to pediatric medical societies in the United States and Europe in 2007. (Compl. ¶¶ 29-33).

In March 2011, the Defendant Authors and Defendant Ernst*fn3 submitted a revised study for publication in the Journal of Perinatology (the "Journal") which included allegedly false claims that preterm infants treated with Chiesi's Curosurf® have a lower mortality rate than those treated with Plaintiff's Infasurf®. (Compl. ¶ 35). As specified in Plaintiff's proposed Amended Complaint (Docket No. 81-1), these statements include:

"Result: Calfactant was associated with a 49.6% greater likelihood of death than poractant alfa;" "Conclusion: Poractant alfa treatment for RDS was associated with a significantly reduced likelihood of death when compared with calfactant;" "Calfactant was found to be associated with a 49.6% greater likelihood of death than poractant alfa;"

"This model found calfactant to be associated with a significantly greater likelihood of death than poractant alfa;"

This study "show[ed] a significant greater likelihood of death with calfactant than poractant alfa;" and "[T]his large retrospective study of preterm infants with RDS found lower mortality among infants who received poractant alfa, compared with infants who received either calfactant or beractant, even after adjusting for patient characteristics such as gestational age and BW, and after accounting for hospital characteristics and center effects." (Prop. Amend. Compl. ¶ 35; see Docket Nos. 6-2, 30-1 (the study is entitled "Mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant: a retrospective study," hereinafter referred to as "the Article")). The Journal is the official journal of Defendant American Academy of Pediatrics ("AAP"), the "preeminent organization for physicians who practice in general pediatrics and its sub-specialties, including neonatology," and is published by Defendant Nature America (Compl. ¶¶ 38, 59). According to the Complaint, "[a]rticles in AAP-sanctioned journals are perceived to present reliable information for patient care by neonatologists." (Compl. ¶ 60).

Plaintiff alleges that: "the data which served as the basis for the Article was not based upon an actual clinical study. Rather, the data was culled from a database of information which Defendant Premier collected from various reporting hospitals and physicians. As a result, the data was retrospective and was subject to selective distortion. Specifically, the reliability of any reported mortality data is a function of the similarity of the characteristics of the group of infants examined, including [length of stay, or] LOS data. Deliberate omission of the LOS data allows the Defendants to postulate, promote and disseminate false conclusions regarding any differences in the mortality of infants treated with one product versus another." (Compl. ¶ 37). 'LOS data' refers to the length of the hospital stay, and is therefore inversely proportionate to premature infant mortality. (Compl. ¶ 26). "Without the LOS data, the conclusions of the Article are unreliable, and therefore misleading. Had the Article presented the Curosurf® patients as having both a lower mortality and a shorter length of stay, it would be obvious that the differences in the results were a result of differences in the groups of patients treated, not of any differences in the effect of the particular lung surfactant administered." (Compl. ¶ 67 (emphasis altered)). "The Defendant Authors had access to and were aware of the pertinent LOS data, yet chose to omit it from the Article." (Compl. 41). Plaintiff further alleges that the Defendant Authors neglected to cite at least one journal article contradicting the findings in the Article, despite knowing of its existence, and that these Defendants also submitted the Article for publication knowing that it was deficient. (Compl. ¶¶ 44-45). "Indeed, upon information and belief, the Defendant Authors did not actually write the Article, or conduct the research or reach the conclusions set forth therein. Rather, it was other, undisclosed agents of Defendants Chiesi and Cornerstone who did." (Compl. ¶ 46).

It is further asserted that Defendant Premier benefitted economically from its employee Ernst "submit[ting] the Article for publication." (Compl. 48). "[T]he publication of the Article reporting 'findings' to the benefit of its customers Defendants Chiesi and Cornerstone served as advertising for Premier's database and related services, and announced to pharmaceutical companies and other providers of medical products and services . . . that the engagement of Premier in connection with similar self-serving 'studies' would be to their economic benefit as well." (Compl. ¶ 48).

Defendant Edward E. Lawson, M.D. is the Editor-in-Chief of the Journal. (Compl. ¶ 51). Prior to being accepted for publication, the Article was sent to two peer reviewers. (Compl. ¶ 49). Lawson accepted the Article for publication despite the fact that one of the two reviewers found the Article's conclusions therein unreliable. (Compl. ¶¶ 49-51, 54). Plaintiff alleges that this acceptance was based in part on the fact that Defendant Bhatia is an Associate Editor for the Journal and Defendant Sekar is on the Journal's Editorial Board. (Compl. ¶¶ 52-53). Defendants "Chiesi and/or Cornerstone" then paid Defendant Nature America to publish the Article in an 'open access' format, which allows non-subscribers to access the Article (Compl. ¶¶ 56-57). After the Article was published, "Defendant Cornerstone, on behalf of itself and Defendant Chiesi, issued a press release touting the Article and, upon information and belief, began distributing the Article, either in part or in whole, to current and potential customers, including hospitals and physicians nationwide which currently use [Plaintiff's] Infasurf®." (Compl. 61).

Plaintiff's president, Edmund Egan, M.D., wrote to the Journal and Defendant AAP requesting that the Article be retracted due to its deficiencies, a request that was denied. (Compl. ¶¶ 64-65, 68, 70). Plaintiff alleges that, as such, the Journal and AAP are sanctioning and condoning scientifically unreliable information which influences purchasing decisions by hospitals and prescribing decisions by neonatologists. (Compl. ¶¶ 69-71).

In light of these alleged facts, Plaintiff asserts that publication and distribution of the Article constitutes false advertising in violation of 15 U.S.C. § 1125 (a) (first cause of action against Defendants Chiesi and Cornerstone); an injurious falsehood (second cause of action against Chiesi and Cornerstone, third cause of action against Nature America and Lawson; fourth cause of action against AAP, fifth cause of action against the Defendant Authors and Ernst); tortious interference with contract (sixth cause of action against Chiesi and Cornerstone); and a violation of New York General Business Law § 349 "and Similar Statutes of Other States"*fn4 (seventh cause of action against ...


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