Billhofer v. Flamel Technologies, SA

663 F. Supp. 2d 288, 2009 U.S. Dist. LEXIS 97287, 2009 WL 3241399
CourtDistrict Court, S.D. New York
DecidedOctober 5, 2009
Docket1:07-cv-9920
StatusPublished
Cited by7 cases

This text of 663 F. Supp. 2d 288 (Billhofer v. Flamel Technologies, SA) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Billhofer v. Flamel Technologies, SA, 663 F. Supp. 2d 288, 2009 U.S. Dist. LEXIS 97287, 2009 WL 3241399 (S.D.N.Y. 2009).

Opinion

MEMORANDUM OF DECISION AND ORDER

HAIGHT, Senior District Judge.

Plaintiff Christel Billhofer (“Billhofer”) filed this putative class action alleging claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder, alleging that both the individual defendants and the defendant corporation, Flamel Technologies, SA (“Flamel”), disseminated statements that were false, either by direct misrepresentation or by omission, and that she relied on those false statements to her detriment. Defendant Stephen H. Willard (“Willard”) was at all relevant times the Chief Executive Officer of Flamel, and Defendant Rafael Jorda was at all relevant times the Chief Operating Officer, Executive Vice President and Director of Manufacturing and Development of Flamel. See Am. Compl. ¶¶ 5-6. 1

Flamel has moved to dismiss this action under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted. Def.’s Mot. To Dismiss [doc. # 11] at 2. Flamel contends that the relevant statement upon which Billhofer allegedly relied was not misleading, did not give rise to a duty of disclosure, and was immaterial as a matter of law as a vague expression of corporate optimism. Flamel also contends that Billhofer has not adequately pled “scienter” as required by relevant case law and the Private Securities Litigation Reform Act (PSLRA). Flamel argues that Billhofer cannot establish scienter because the complaint fails to specify benefits to the defendants, and the proposed fraudulent scheme was doomed to failure from its conception, depriving defendants of any “motive” to commit fraud. Flamel argues that, alternatively, Billhofer cannot establish scienter through “strong circumstantial evidence of conscious misbehavior or recklessness” because facts pled in the complaint do not rise to such a level.

For the reasons stated below, defendant Flamel’s Motion To Dismiss is DENIED.

I. Plaintiffs Allegations

The following factual allegations in plaintiffs Amended Complaint [doc. # 10] are accepted as true for the purposes of this motion to dismiss:

Flamel Technologies develops “polymer-based delivery technologies.” These products allow Flamel’s partners—other pharmaceutical companies—to create “extended release” versions of their own drugs. Am. Compl. ¶ 13. The Amended Complaint alleges:

14. Flamel’s lead product is COREG CR (controlled release) which is used in the treatment of moderate to severe congestive heart failure, left ventricular dysfunction following myocardial infarction and hypertension. COREG CR was introduced by Flamel and its marketing partner GlaxoSmithKline (“GSK”) in March 2007.
15. Prior to the introduction of CO-REG CR, GSK marketed and sold CO- *293 REG IR, which required users to take one pill twiee-a-day while COREG CR is only required to be taken once-a-day. The successful introduction of COREG CR was critical to GSK and Flamel as the companies needed to transition users to COREG CR from COREG IR before generic competition entered the market, which was expected to occur in late 2007.

Id. ¶¶ 14-15.

According to press reports quoted in the Amended Complaint, the success of the new version of COREG would depend on convincing doctors to prescribe it and convincing insurance companies to pay for it. Both of those things, in turn, would require a clinical study to demonstrate that the new version produced better health outcomes than the original, twice-a-day formulation. Id. ¶ 31.

The Amended Complaint also contains several allegations about one such clinical trial that was conducted “by Flamel and GSK,” with the strong suggestion that the study was conducted by those entities together. Am. Compl. ¶ 17.

18. In order to prove the benefits of COREG CR, GSK and Flamel commenced a clinical trial to measure the differential compliance, quality of life and satisfaction with medication in chronic heart failure patients taking CO-REG IR vs. COREG CR (the “CASPER Trial”). The primary outcome of the CASPER Trial was pill-taking compliance.
19. By no later than the start of the Class Period, the CASPER Trial was complete and the results were made known to GSK and Flamel. An abstract of the CASPER Trial was required to be submitted to the Journal of Cardiac Failure by no later than April 9, 2007. To meet this deadline, GSK and Flamel were required to complete the CASPER Trial, analyze the associated data, and draw conclusions therefrom—all sufficiently in advance of the submission date.
20. The abstract of the CASPER Trial, which was submitted to the Journal of Cardiac Failure, concluded that switching from COREG IR to COREG CR “was not associated with better drug taking compliance.... ” Thus, the primary selling point for COREG CR was not supported by the CASPER Trial.

Am. Compl. ¶¶ 18-20 (ellipsis and emphasis in original). Later, when the results of this Trial were made public, the price of Flamel’s stock plummeted, allegedly causing Billhofer and those similarly situated to suffer damages. Id. ¶¶ 21, 33.

Plaintiff Christel Billhofer purchased 900 shares 2 of Flamel on April 24, 2007. Am. Compl. ¶ 3; Certification, Am. Compl. app. [doc. # 1 at 16-17], By that particular date, Flamel had issued only one public statement relevant to this action. Specifically, on March 23, 2007, Flamel issued a press release announcing the nationwide availability of COREG CR. According to Billhofer, defendant Willard made the following comment in the press release:

We are pleased that COREG CR” will now be available to patients in the U.S. for the treatment of these three serious conditions. COREG CR” is the first marketed product incorporating Flamel’s MICROPUMP® technology. The success of the COREG CR” program *294 has generated considerable interest in our MICROPUMP® technology as well as in our MEDUSA® technology platform for the delivery of proteins and peptides. Interest in both technologies has never been higher.

Am. Compl. ¶ 22 (emphasis added).

In later statements, the company and other individual defendants make far more specific statements about COREG CR, all of which were positive. 3 However, for reasons described infra, those statements are not relevant to determining the loss that Billhofer suffered, since her stock ownership position never changed after the initial statement on March 23, 2007—she neither bought nor sold any Flamel shares between her initial purchase and the filing date for this action.

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Bluebook (online)
663 F. Supp. 2d 288, 2009 U.S. Dist. LEXIS 97287, 2009 WL 3241399, Counsel Stack Legal Research, https://law.counselstack.com/opinion/billhofer-v-flamel-technologies-sa-nysd-2009.