GLOUKHOVA v. CSL BEHRING LLC

CourtDistrict Court, E.D. Pennsylvania
DecidedNovember 4, 2022
Docket2:22-cv-02223
StatusUnknown

This text of GLOUKHOVA v. CSL BEHRING LLC (GLOUKHOVA v. CSL BEHRING LLC) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
GLOUKHOVA v. CSL BEHRING LLC, (E.D. Pa. 2022).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

SVETLANA GLOUKHOVA CIVIL ACTION Plaintiff,

v. NO. 22-2223

CSL BEHRING LLC, Defendant.

MEMORANDUM OPINION Plaintiff Svetlana Gloukhova brings a wide range of claims against her former employer, Defendant CSL Behring LLC (“CSL”), a global biotechnology company manufacturing and selling plasma-derived medicinal products in over one hundred countries around the world, for whom she worked for approximately three and a half years before she was terminated. Defendant now moves to dismiss, pursuant to Federal Rule of Civil Procedure 12(b)(6), only her claim brought under the Pennsylvania Whistleblower Law, 43 Pa. Const. Stat. § 1422 (the “PWL”). For the reasons that follow, Defendant’s Motion will be denied. FACTUAL BACKGROUND The following facts are drawn from the Amended Complaint and, for the purposes of the motion to dismiss, will be taken as true. See Kost v. Kozakiewicz, 1 F.3d 176, 183 (3d Cir. 1993). As a pharmaceutical company CSL is required to comply with patient safety laws and regulations in each country and jurisdiction in which it sells its products. As Global Head of Regions, Safety and Pharmacovigilance, Gloukhova’s primary job responsibilities were to enact systems and oversight infrastructure to ensure CSL’s compliance with the safety laws and regulations in each country and jurisdiction in which CSL operates. In serving that role Gloukhova came to believe that CSL’s safety compliance infrastructure was significantly under-resourced because CSL was unwilling to invest adequate financial resources into its global safety operations. As a result, CSL did not comply with and was in violation of its own internal policies and many of the patient safety laws and regulations, including requirements to correctly report patient safety related information to the Food and Drug Administration (FDA) and its international counterparts and archiving/storing source

documents related to adverse events in accordance with laws and regulations. Gloukhova reported to her superiors, including CSL’s Chief Medical Officer William Mezzanotte, that CSL’s critical safety efforts were under-funded and in violation of safety laws and regulations in the United States and other countries around the world and that CSL Safety Officers and what she refers to as Full-Time Equivalents (“FTEs”) were absent and misused. At two separate meetings attended by Gloukhova, Mezzanotte and Frank Mauler (interim Head of Safety) in 2021, Gloukhova reported about the severe degree of CSL’s non-compliance with its legal and regulatory obligations and pleaded for additional resources in an effort to bring CSL into compliance. Specifically, she reported that: (1) CSL’s patient safety organization “is significantly under-resourced for the task to assure PV [Pharmacovigilance] compliance in 107

countries; so, it[’s] unfit [to] assume [the] responsibility of [the] SO [Safety Officer] network in current state;” (2) that CSL’s violation of safety laws and regulations threatened its ability to conduct its business operations in certain countries: “[the] Current SO [Safety Officer] network cannot fulfill the task of establishing and maintaining PV systems in all countries of CSL operations, which may lead to failure to operate and significant fines;” and (3) that the absence of and misuse of Safety Officers and FTEs resulted in waste of CSL’s resources and diversion from patient safety related tasks. While acknowledging that the global safety apparatus within CSL was under-resourced, Mezzanotte refused to address the concerns raised by Gloukhova and instead blamed the lack of resources on others within CSL. Things came to a head at the April 2021 annual meeting of Gloukhova’s work group, which included company executives and Safety Officers. During the meeting, Mezzanotte faced challenging questions from the company’s Safety Officers related to many of the same issues that Gloukhova had reported about previously, including the lack of resources of Safety Officers,

lack of technological tools, non-compliance with regulations, and confusion with respect to responsibility for safety-related studies. At the meeting, when Gloukhova corroborated and supported the concerns and reports raised by the Safety Officers, Mezzannotte interrupted her and, when she tried to speak, he yelled at her: “Lana, not you again!” A few months later, despite a recent glowing performance review, Gloukhova was put on a Performance Improvement Plan (PIP) which criticized her for “repeatedly rais[ing] complaints concerning processes and the organization without taking into account the Company’s situation and previous decisions.” During a meeting about the PIP, Gloukhova was provided with a “Final Written Warning” and was told “we are going to fire you.” And, she was in fact fired a little more than a month later.

LEGAL STANDARDS The Federal Rules of Civil Procedure require complaints to include, among other things, “a short and plain statement of the claim showing that the pleader is entitled to relief[.]” Fed. R. Civ. P. 8(a)(2). “‘[S]tating . . . a claim requires a complaint with enough factual matter (taken as true) to suggest’ the required element. This ‘does not impose a probability requirement at the pleading stage,’ but instead ‘simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element.’” Great Western Mining, 615 F.3d

at 177 (quoting Twombly, 550 U.S. at 556). “In other words, ‘there must be some showing sufficient to justify moving the case beyond the pleadings to the next stage of litigation.’” Id. (quoting Phillips v. Cnty. of Allegheny, 515 F.3d 224, 234-35 (3d Cir. 2008)). “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). At the

motion to dismiss stage “a complaint may not be dismissed merely because it appears unlikely that the plaintiff can prove those facts or will ultimately prevail on those merits.” Phillips, 515 F.3d at 231. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (quoting Twombly, 550 U.S. at 556- 57 (internal quotation marks omitted)). “In other words, ‘there must be some showing sufficient to justify moving the case beyond the pleadings to the next stage of litigation.’” Great W. Mining & Mineral Co. v. Fox Rothschild LLP, 615 F.3d 159, 177 (3d Cir. 2010) (quoting Phillips, 515 F.3d at 234-35). In determining the adequacy of a complaint, the Court must

“accept all factual allegations as true [and] construe the complaint in the light most favorable to plaintiff.” Warren Gen. Hosp. v.

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GLOUKHOVA v. CSL BEHRING LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/gloukhova-v-csl-behring-llc-paed-2022.