IN RE CELGENE CORPORATION, INC. SECURITIES LITIGATION

CourtDistrict Court, D. New Jersey
DecidedJuly 23, 2024
Docket2:18-cv-04772
StatusUnknown

This text of IN RE CELGENE CORPORATION, INC. SECURITIES LITIGATION (IN RE CELGENE CORPORATION, INC. SECURITIES LITIGATION) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
IN RE CELGENE CORPORATION, INC. SECURITIES LITIGATION, (D.N.J. 2024).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

Civil Action No. 18-4772 In Re CELGENE CORPORATION, INC. (MEF)(JBC) SECURITIES LITIGATION OPINION and ORDER

* * * I. Background A. The Facts B. The Lawsuit C. Procedural History D. The Motion E. The Court’s Approach II. Legal Standards A. The Securities Exchange Act of 1934 B. Summary Judgment III. The Defendants’ Argument IV. The Chief Operating Officer V. The Other Individual Defendants VI. Conclusion

* * * Investors in a pharmaceutical company sued the company and some of its executives. Their claim: certain public statements indicated the company was close to submitting a new drug application to regulators, even though the application was not well-enough developed; the application was submitted and rejected, and that caused the stock price to fall. The company and certain executives now move for summary judgment. The motion as to the company will be taken up in a separate opinion. Here, the motion as to one of the executives is granted. As to the remaining executives, the investors appear to have abandoned any objection they may have to the entry of summary judgment. I. Background A. The Facts The evidence as relevant for now is as follows. A drug company (“the Company”1) spent a number of years developing a particular drug (the “Drug”2). See Defendants’ Statement of Material Facts Not in Dispute Pursuant to Local Civil Rule 56.1 (“Defendants’ Rule 56 Statement”) ¶¶ 3-4. As part of doing so, the Company assessed the metabolites, if any, that use of the Drug might generate. See id. at ¶ 13. Metabolites are “the chemical byproducts of the body breaking down a drug.” Id. at ¶ 12. They can sometimes impact the safety or efficacy of a drug, so the Food and Drug Administration (“FDA”) considers metabolites when it decides whether to approve a new drug. See id. at ¶ 22. * * * During 2017, two sets of things happened. First, during the initial months of the year certain Company employees began to zero in on the possibility that the Drug potentially produced a particular metabolite.3 And by June, the

1 The Company is Celgene Corporation, Inc. See Third Amended Consolidated Class Action Complaint (the “Complaint”) at 1, ¶ 41. 2 The Drug is Ozanimod. See Complaint ¶ 10. 3 See Declaration of James E. Cecchi in Support of Lead Plaintiff’s Response Pursuant to Local Civil Rule 56.1 to Defendants’ Statement of Material Facts Not in Dispute and Lead Plaintiff’s Supplemental Statement of Disputed Material Facts Pursuant to Local Civil Rule 56.1 (the “Cecchi Decl.”), Ex. 18 at CELG-AMF 00967643 (January 2017 meeting minutes from the “[Drug] Team”); Cecchi Decl., Ex. 21 at CELG-AMF 01229071 metabolite’s existence was said to have been “definitively confirmed.”4 Second, the Company put out a series of public statements, describing the Drug application it was gearing up to submit to the FDA. See Complaint ¶¶ 397-399, 403, 405-408, 411; cf. id. at ¶¶ 420, 422, 424; see also Defendants’ Rule 56 Statement ¶¶ 37-38, 41, 43-44, 56. The gist of the statements: the Company would soon apply for FDA approval to market the Drug. See id. * * * The Company filed the FDA application at the end of 2017,5 but it was bounced a couple of months later, in February of 2018. See id. at ¶¶ 62, 66-69.6 Per the FDA: the application was too sparse. It did not lay out enough information as to the metabolite testing and what it had shown. See Cecchi Decl., Ex. 78 at CELG-AMF_01420920-23. After the FDA’s decision, the Company’s stock price fell, by around 8.5%. See Lead Plaintiff’s Supplemental Statement of Disputed Material Facts Pursuant to Local Civil Rule 56.1 (the “Plaintiffs’ Rule 56 Statement”) ¶ 117; Memorandum of Law in Support of Defendants’ Motion for Partial Summary Judgment (the “Motion for Summary Judgment”) at 13.

(“[Drug] Stakeholders” “NDA Submission Dashboard for the week of Mar 27th [2017]”). 4 See Declaration of Nidhi Yadava in Support of Defendants’ Motion for Partial Summary Judgment (the “Yadava Decl.”), Ex. 21 at CELG-AMF 01303197 (June 22, 2017 email to key members of the Company’s Drug development team: “We have definitively confirmed [a metabolite] as the peak in human plasma.”). 5 The application was a New Drug Application. See generally In re Suboxone (Buprenorphine Hydrochlorine & Naloxone) Antitrust Litig., 967 F.3d 264, 267 (3d Cir. 2020) (describing the New Drug Application process). 6 The FDA issued a Refusal to File. See Defendants’ Rule 56 Statement ¶ 66. A Refusal to File cuts things off at the pass. It is “a regulatory decision from the FDA denying the complete review of a[] [New Drug Application].” Defendants’ Rule 56 Statement ¶ 15. B. The Lawsuit Emphasizing alleged daylight between external statements (the application is coming) and internal information (it might not be far enough along), some investors sued in 2018 on behalf of a putative class of Company stockholders. See Complaint ¶¶ 22-35, 473. From here, these investors are referred to as “the Plaintiffs.” The Plaintiffs sued under the Securities Exchange Act of 1934 (the “Act”). See Complaint ¶¶ 36, 488-492. The lawsuit was in one count, based on Section 10(b) of the Act and Rule 10b-5.7 See id. at ¶¶ 488-489. C. Procedural History The suit moved forward. A class was certified, see Order (November 29, 2020), discovery got underway and wrapped up, and during the fall of 2023, the Court, per Judge Vazquez, ruled on the defendants’ summary judgment motion, granting it in part and denying it in part. See Order (September 8, 2023). Judge Vazquez indicated that part of the denial was without prejudice --- that is, a part of the summary judgment motion could be later renewed. See id. at 2. Judge Vazquez retired, and the case was definitively reassigned to the undersigned, during January of 2024. D. The Motion The Company8 and certain Company employees9 have now renewed their summary judgment motion. (The Company and the Company employees are referred to here, collectively, as “the Defendants.”)

7 “Rule 10b–5 implements section 10(b) of the Securities Exchange Act.” Riley v. Simmons, 45 F.3d 764, 773 n.9 (3d Cir. 1995); see also Globis Cap. Partners, L.P. v. Stonepath Grp., Inc., 241 F. App’x 832, 835 (3d Cir. 2007) (the Act’s “[S]ection 10(b) . . . is enforced through Rule 10b–5”). 8 Recall: Celgene Corporation, Inc. See footnote 1. 9 Scott Smith, Terrie Curran, and Philippe Martin. Each is a named defendant. See Complaint ¶¶ 43-45. Oral argument was held, and the summary judgment motion became fully submitted around 8 weeks ago. E. The Court’s Approach To analyze the summary judgment motion, the Court starts by laying down the general legal standards that apply here. See Part II. The Court then describes the Defendants’ motion, concluding that the Plaintiffs resist the entry of summary judgment as to one individual defendant (the Company’s former Chief Operating Officer) but seemingly not as to the other individual defendants. See Part III. Accordingly, the Court does two things. First, it assesses the Defendants’ summary judgment motion as to the former Chief Operating Officer --- and concludes it should be granted. See Part IV. Second, the Court assesses the Defendants’ summary judgment motion as to the remaining individual Defendants, and concludes that, as to them, the motion should likely be granted --- subject to further submissions the parties will be permitted to make. See Part V. II. Legal Standards Take up, first, the general legal standards that are in play here. These focus on two questions. First, what must the Plaintiffs’ evidence prove? See Part II.A. And second, how should the Court assess an argument like the Defendants’ --- namely, an argument that the Plaintiffs’ evidence does not measure up, that it does not prove what it must.

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IN RE CELGENE CORPORATION, INC. SECURITIES LITIGATION, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-celgene-corporation-inc-securities-litigation-njd-2024.