PIERRE v. OTSUKA AMERICA PHARMACEUTICALS

District Court, D. New Jersey·Decided December 23, 2024·No. 3:23-cv-21848·Unknown

Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

MIRRIAM PIERRE, Plaintiff, Civil Action No. 23-21848 (MAS) (JTQ) v. MEMORANDUM OPINION OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC., Defendant.

SHIPP, District Judge This matter comes before the Court on Defendant Otsuka Pharmaceutical Development & Commercialization Inc.’s (“Otsuka” or “Defendant”) Motion to Dismiss Plaintiff Mirriam Pierre’ (“Plaintiff”) Second Amended Complaint (“SAC”)! under Federal Rule of Civil Procedure? 12(b)(6). (ECF No. 34.) Plaintiff opposed (ECF No. 36), and Defendant replied (ECF No. 37). The Court has carefully considered the parties’ submissions and decides the matter without oral argument under Local Civil Rule 78.1(b). For the reasons below, Defendant’s Motion to Dismiss is granted.

' Plaintiff amends the named Defendant in the SAC to “Otsuka America Pharmaceuticals” but keeps the case caption as “Otsuka Pharmaceutical Development & Commercialization, Inc.” on both the SAC and Opposition Brief. In its Moving Brief, Otsuka likewise refers to itselfas “Otsuka Pharmaceutical Development & Commercialization, Inc.” Neither party has moved to amend the caption to date. 2 Unless otherwise noted, all references to “Rule” or “Rules” hereinafter refer to the Federal Rules of Civil Procedure.

I. BACKGROUND A. Factual Background? Plaintiff was employed with Otsuka as a Senior Director and Head of Data Management from December 2020 until January 2023. (SAC 6-7, ECF No. 30.) Otsuka is a pharmaceutical company that develops health products and pharmaceutical drugs to treat various diseases and health conditions. Ud. 9] 52-53.) While employed with Otsuka, Plaintiff was assigned to a department responsible for handling data of pre-market drugs to ensure the integrity of Otsuka’s database in preparation for clinical trials. Ud. {J 54-56.) In other words, Plaintiffs employment at Otsuka involved clinical data from clinical investigations of products called Investigational New Drug Applications (“INDs”). Ud. Jf 20, 22.) Clinical trials are generally divided into three phases. Ud. 4] 24-28.) Plaintiff's department was responsible for Phases 2 and 3 of clinical trials. Ud. § 27.) INDs in Phases 2 and 3 focus on “the assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.” Ud. { 26.) Plaintiff's group “collected, cleaned[,] and locked data” for all of Otsuka’s clinical trials from December 2020 to January 2023. Ud. 4 54.) At the start of Plaintiff's employment, her group was comprised of fifteen members and tasked with handling fourteen clinical trials. J 61.) By January 2023, Plaintiff was responsible for thirty-seven clinical trials, but her group dwindled to nine members. Ud. { 62.) This reduction in headcount is alleged to have “affected the quality of data being collected, cleaned[,] and locked.” Ud. { 63.)

> The Court, as it must, accepts as true all of Plaintiff's well-pleaded factual allegations and “construe[s] the [amended] complaint in the light most favorable to [P]laintiff.” Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009) (citation omitted).

Beginning in the summer of 2022, Plaintiff made monthly presentations to Otsuka’s Research and Development Leadership Team (the “RDLT”) to address certain issues that were affecting the group. (See id. 9-15.) These issues included, among other things: (1) “Otsuka’s decision to refuse approval for [an] adequate headcount” which compromised “[Plaintiff’s] department’s ability to ensure data integrity” (id. § 10); (2) “Otsuka’s database lock period was unreasonably short and objectively shorter than industry standard” (id. § 11); (3) Otsuka’s “site lock process” jeopardized “patient safety and data integrity” (id. |] 12); and (4) Otsuka’s failure to disclose adverse events risked presenting misleading data to regulatory authorities such as the Food and Drug Administration (“FDA”) (id. J§ 13-15). Plaintiff states that, as these issues surfaced, members of the RDLT became “increasingly upset” and Plaintiff was “aggressively questioned” on the information she was presenting during the RDLT meetings. Ud. Jf 123-24.) Plaintiff alleges that she was told by two individuals outside of the RDLT “not to continue to raise these issues.” Ud. 4] 125.) Based on Plaintiff's ongoing concerns regarding the “implications on patient health and safety that could arise from improperly cleaned and locked data[,]” Plaintiff “continued to raise these concerns” with the RDLT—all of which went unanswered. (/d. 132, 134-35.) According to Plaintiff, this caused Otsuka’s leadership team to become “increasingly hostile and aggressive towards [Plaintiff] with the hopes that they could push her to quit her job.” Ud. § 136.) Specifically, Plaintiff alleges that two members of the leadership team, Carol Augustine (“Augustine”) and Debbie Profit (“Profit”) retaliated against Plaintiff by engaging in conduct that included, but was not limited to: stating that Plaintiff was “not capable of performing the role of [Senior] Director” (id. 158), isolating Plaintiff from her peers by stating she was a “‘bad’ employee” (id. 4 159), making disparaging comments about Plaintiff, and “repeatedly

humiliat[ing|] Plaintiff in meetings by minimizing the evidence [Plaintiff] provided on the data issues found” (id. 160). Because Plaintiffs group remained “understaffed” and in light of ongoing concerns over the “risky professional position that Otsuka had put her in,” Plaintiff states that she had no option but to resign from her position with Otsuka in January 2023. Ud. 7 137.) B. Procedural History Several months after Plaintiff's resignation, in October 2023, this action was filed in the Superior Court of New Jersey, Somerset County, alleging a single claim against Defendant under the Conscientious Employee Protection Act (“CEPA”). (See State Court Complaint, annexed to Notice of Removal, Ex. A, ECF No. 1-1.) Defendant timely removed this action in November 2023.4 (See Notice of Removal, ECF No. 1.) On April 19, 2024, this Court dismissed Plaintiff's First Amended Complaint (“FAC”) without prejudice after Defendant initially moved to dismiss. (ECF No, 29.) Plaintiff timely filed a SAC on April 24, 2024. (ECF No. 30.) Defendant again moved to dismiss (ECF No. 34), Plaintiff opposed (ECF No. 36), and Defendant replied (ECF No. 37). Il. LEGAL STANDARD Rule 8(a)(2) “requires only ‘a short and plain statement of the claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant fair notice of what the ... claim is and the grounds upon which it rests.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (alteration in original) (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)). A district court conducts a three-part analysis when considering a motion to dismiss pursuant to Rule 12(b)(6). Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011). “First, the court

* Plaintiff's First Amended Complaint followed the Notice of Removal and was filed on December 15, 2023. (See FAC, ECF No. 17.)

must ‘tak[e] note of the elements a plaintiff must plead to state a claim.’” /d. (alteration in original) (quoting Ashcroft v.

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