Cypress Pharmaceuticals, Inc. v. CRS Management, Inc.

827 F. Supp. 2d 710, 2011 U.S. Dist. LEXIS 129495, 2011 WL 6107759
CourtDistrict Court, S.D. Mississippi
DecidedJuly 28, 2011
DocketCivil Action 3:10CV691TSL-MTP
StatusPublished
Cited by9 cases

This text of 827 F. Supp. 2d 710 (Cypress Pharmaceuticals, Inc. v. CRS Management, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Mississippi primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cypress Pharmaceuticals, Inc. v. CRS Management, Inc., 827 F. Supp. 2d 710, 2011 U.S. Dist. LEXIS 129495, 2011 WL 6107759 (S.D. Miss. 2011).

Opinion

MEMORANDUM OPINION AND ORDER

TOM S. LEE, District Judge.

This cause is before the court on the motion of defendants CRS Management, Inc. (CRS), PRACS Institute, Ltd. (PRACS), Gateway Medical Research, Inc. (Gateway) and BA Research International L.P. (BA Research) to dismiss for lack of personal jurisdiction and for failure to state a claim upon which relief may be granted pursuant to Rule 12(b)(2) and (6), respectively. Plaintiffs Cypress Pharmaceuticals, Inc. (Cypress) and Hawthorne Pharmaceuticals, Inc. (Hawthorne) have responded to the motion, and the court, having considered the memoranda of authorities, together with attachments, submitted by the parties, concludes the motion to dismiss on jurisdiction grounds should be denied as to CRS but granted as to PRACS, Gateway and BA Research; that the Rule 12(b)(6) motion should be denied; and that the motion to dismiss any claims by Hawthorne should be granted.

Plaintiff Cypress, a Mississippi corporation with its principal place of business in Madison, Mississippi, is a specialty pharmaceutical company engaged in the business of developing, marketing and distributing prescription drugs, a major focus of which is respiratory therapeutics. On April 30, 2008, Cypress, acting on behalf of Hawthorne, its wholly owned subsidiary, contracted with defendant CRS to conduct bioequivalence testing for two prescription drugs that Cypress had developed to treat cough and cold symptoms, 1 one containing *713 two active ingredients, “A” and “B”, and the other containing three active ingredients, “A”, “B” and “C”.

The agreement provided that Cetero, using the services of one or more of its affiliates (PRACS, Gateway and/or BA Research), would conduct the bioequivalence study according to the protocol set out in the agreement and would perform the services with “due care, generally prevailing industry standards and in compliance with (i) the Protocol and (ii) all Applicable Laws and with accepted standards of Good Clinical Practice and Good Laboratory Practice, as may be applicable to the subject Study and/or as defined in the Protocol.” The agreement required Cypress to provide all drugs and test articles to be studied unless the agreement provided otherwise. Notably, the agreement recites that the “Agreement shall be construed according to and governed by the laws of the State of New Jersey, without regard to principles of conflicts of law.”

As provided for in the agreement, Cypress sent test products for the study from its facility in Madison to Cetero in Missouri. From May to July 2008, Gateway administered the test products to study participants, from whom pre and post-does blood samples were drawn. The samples were then analyzed by BA Research at its facility in Texas. BA Research issued a report of its sample analysis, which was then incorporated into the full Clinical Study Report which was prepared by PRACS.

On September 3, 2008, Cetero mailed the first version of the report to Cypress in Madison and later on October 10, 2008, it provided an updated report. The study conducted by Cetero revealed that two of the active ingredients, “B” and “C”, were within the FDA’s guideline ranges for demonstrating bioequivalence, while ingredient “A” was satisfactory with respect to two parameters and just outside the range with respect to a third parameter. On November 7, 2008, in reliance on the Clinical Study Report, Cypress submitted two New Drug Applications (NDA) to the FDA. The first, for the “ABC” product, was designated NDA No. 022439 and the second, for the “AB” product, was designated NDA No. 022442.

In mid-January 2009, the FDA notified Cypress that while both NDA No. 0022439 and NDA No. 022442 were sufficiently complete to permit substantive review, it had identified “potential review issues” with both applications, stating, “A preliminary assessment of the data indicates that [Ingredient A] for your product is out of the 8-125% goal post of BE [bioequivalence].” On the basis of the FDA’s notice, Cypress engaged another research company to conduct a second study to evaluate and establish the bioequivalence of Ingredient “A”. Based on Cetero’s test results, Cypress believed that Ingredients “B” and “C” would withstand FDA review and thus, did not seek to re-perform the bioequivalence trials for these ingredients.

On September 18, 2009, before the second research company had completed its bioequivalence study, the FDA informed Cypress that neither of its applications would be approved because Ingredient “A” fell outside the approved guideline range of bioequivalence. The FDA did not identify any deficiencies with regard to Ingredients “B” and “C”. In December 2009, Cypress submitted an amended NDA which included the results from the second trial of Ingredient “A” showing that the ingredient met the FDA’s bioequivalence guidelines.

*714 On May 3, 2010, while Cypress’ applications remained pending, and unbeknownst to Cypress, the FDA began an inspection of Cetero’s Houston bioanalytieal testing facility. The next day, by email, Dr. Chinna Pamidai, President of BA Research, advised Cypress of the inspection but did not disclose any issues which might have risen or which could have been expected to arise. The inspection closed on May 7, 2010 with the inspector issuing a Form 483, which under FDA regulations must be issued to top-level management when an inspector finds minor and major issues in during an inspection.

Over the next few days, Cypress made repeated requests for information regarding the inspection. On May 11, 2010, Cetero did advise Cypress that a Form 483 had been issued, but refused to provide either Cypress a copy of the form or any details about the inspection. During the next few weeks, Cetero continued to refuse to provide a copy of the Form 483, intimating that it would do so when it provided the FDA a response. On June 4, 2010, Cypress filed a Freedom of Information Act request with the FDA, seeking to obtain the May 7th Form 483. Finally, on October 27, 2010, Cypress received a redacted copy of the Form 483 from the FDA.

From the Form 483, Cypress learned that the FDA’s investigation had been prompted by receipt from Cetero of a June 2009 report detailing an internal investigation by Cetero. According to the Form 483, the FDA concluded that “[rjecords for the extraction of subject samples in numerous studies were falsified ... in at least 1900 instances over the period April 15, 2005 to June 30,1990. The falsification involve[d] data from multiple studies from multiple sponsors.” According to the complaint, on information and belief, data in Cypress’ Clinical Study Report was found to be falsified.

On June 11, 2010, the FDA rejected Cypress’ NDAs. The FDA concluded that the “[Clinical Study Report] and the study conducted by the third-party CRO, designed to establish the bioequivalence of the active ingredients ‘A,’ ‘B,’ and ‘C’ in Cypress’s drug products to the reference products contained deficiencies both in the conduct of the study and the methods used at the analytical sites.”

Plaintiffs Cypress and Hawthorne filed this suit, premised on diversity jurisdiction, on November 29, 2010, asserting claims against all the defendants for fraudulent concealment, fraudulent misrepresentation, negligent misrepresentation and breach of fiduciary duty.

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827 F. Supp. 2d 710, 2011 U.S. Dist. LEXIS 129495, 2011 WL 6107759, Counsel Stack Legal Research, https://law.counselstack.com/opinion/cypress-pharmaceuticals-inc-v-crs-management-inc-mssd-2011.