Ferretti v. Pfizer Inc.

855 F. Supp. 2d 1017, 2012 WL 694513, 2012 U.S. Dist. LEXIS 27214
CourtDistrict Court, N.D. California
DecidedFebruary 29, 2012
DocketCase No. 11-CV-04486
StatusPublished
Cited by19 cases

This text of 855 F. Supp. 2d 1017 (Ferretti v. Pfizer Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ferretti v. Pfizer Inc., 855 F. Supp. 2d 1017, 2012 WL 694513, 2012 U.S. Dist. LEXIS 27214 (N.D. Cal. 2012).

Opinion

ORDER GRANTING IN PART AND DENYING IN PART MOTION TO DISMISS; DENYING MOTION TO STRIKE

LUCY H. KOH, District Judge.

Before the Court is Defendant Pfizer Inc.’s Motion to Dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) and Motion to Strike pursuant to Federal Rule of Civil Procedure 12(f) (“Mot.”). ECF No. 14. Pursuant to Civil Local Rule 7-1(b), the Court finds these motions appropriate for determination without oral argument. Accordingly, the hearing on the motions set for March 1, 2012, is hereby VACATED. The case management conference set for March 1, 2012, at 1:30 p.m. remains as set. Having considered the parties’ submissions and the relevant case law, the Court GRANTS IN PART and DENIES IN PART Defendant’s motion to dismiss and DENIES Defendant’s motion to strike.

I. Factual Background

The following facts are taken from the original complaint and are assumed to be true for purposes of the instant motions. From April 2008 to September 16, 2010, Plaintiff Delina Ferretti (“Plaintiff’) was employed as Director — Oncology for Pfizer Inc. (“Defendant”), a global research-based pharmaceutical company. Compl. [1020]*1020¶¶4, 8. In this role, she served as “the Lead Clinical Protocol Manager, and was responsible for handling clinical operations for particular molecules.” Id. ¶ 4. Her duties at Pfizer included, among other things, “overseeing data review performed by study managers and other team members for quality and training.” Id. ¶ 6.

During her first year at Pfizer, Plaintiff worked primarily on the PanHER program, which was directed toward the clinical testing of PF-0299804, a molecule with promise as a cancer inhibitor drug. Id. ¶ 22.

In November 2008, Plaintiff noticed problems with the data related to the Pan-HER Phase I studies. Id. ¶ 25. Plaintiff, along with other Clinical Project Managers and study managers, reviewed the Phase 1 A5481001 study data. Id. Plaintiff “collated and reviewed all out-of-range clinical data, including electrocardiogram changes, prohibited medications, [and] all clinical changes from baseline.” Id. Plaintiff alleges that “[i]n particular, there were over 200 incidences of Phase I study participants using prohibited medications, which can interfere with the test results and put the participants at risk. In addition, there were many instances of adverse events and changes from baseline that went unreported in the Investigator’s Brochure and to the FDA, in violation of 21 C.F.R. sections 312.23(a)(5), 312.32, and 312.55.” Id. Two of the Clinical Project Managers who investigated the data with Plaintiff agreed that the data was “dirty” and questionable. Id. ¶ 26.

Plaintiff immediately reported the abnormal Phase I study results to her supervisor, Bridget Rohmiller. Id. ¶ 27. “Plaintiff advised her superiors that the Phase I results should be thrown out because, inter alia, a majority of the individuals upon whom the drug was being tested were using medications prohibited under the study protocol. Because the prohibited medications could affect the test results, Plaintiff reported that she believed the study needed to be redone and that she could not in good conscience conduct Phase III testing on the product. Plaintiff, therefore, urged her supervisor, colleagues, and the Medical Monitor to redo the Phase I studies.” Id. ¶ 1.

Plaintiff alleges that after the conclusion of Phase I trials, a Clinical Study Report (“CSR”) is mandated to be written and provided to the FDA. Id. ¶ 29. To date, Defendant has not written a CSR for the Phase I PanHER trials. Id. In addition, the annual update of the Investigator’s Brochure mandated by the FDA to document new findings did not contain the issues of concern identified by Plaintiff and the other reviewers and colleagues. Id.

In or about February 2009, Plaintiff prepared a list of prohibited medications, which she provided to Dr. Louis Denis, the Director of Clinical Research for Pfizer Oncology. Id. ¶ 30. However, Dr. Denis refused to disseminate this information to the investigators and study sites, and issued a directive to Plaintiff to rescind any information previously sent. Id.

Plaintiff alleges that Pfizer “refused to do anything about the ‘dirty’ study results.” Id. ¶ 31. Plaintiff claims that after reporting the defects in the Phase I trials, she was subjected to a hostile work environment which included being “vilified and disregarded,” being “shut out” of certain meetings and being forced to run other meetings “without having time to prepare for them.” Id.

In response to what Plaintiff perceived as a hostile working environment, and because of Defendant’s unwillingness to remedy the defects in the study, Plaintiff asked to be transferred from the PanHER program in April 2009. Compl. ¶32, 34. This request was granted, and Plaintiff [1021]*1021was placed under a new supervisor, Ms. Rashmi Gandhi. Id. ¶ 32.

Plaintiff alleges that under the supervision of Ms. Gandhi, Plaintiff was further subjected to “overt bias and unprofessional behavior.” Id. ¶ 33. Specifically, Plaintiffs workload increased dramatically, and Ms. Gandhi refused to provide to Plaintiff the following: travel authorization for Plaintiff to meet with her team in person; a new, properly functioning computer; and reimbursement for job-related expenses, as previously authorized by Ms. Rohmiller. Id.

In or about December 2009, Plaintiff received a Performance Cycle Manager Review, which Plaintiff found to be “subjective, unsupported, and containing] false and misleading information.” Id. ¶ 34. In response to the review, Plaintiff noted that “she had asked to be transferred from the PanHER team because of her ‘concerns about [good clinical practice], questionable data, clinical team inexperience, the takeover of Clinical Operation by the [Project Manager, Carole Klingerman,] and clinician, combined with retaliation by these team members when presented with serious issues.’ ” Id.

In or about March 2010, Plaintiff reported her concerns about study safety, unreported adverse events, and lack of a Clinical Study Report to the Pfizer Compliance Hotline. Id. ¶ 35. Plaintiff also complained about the alleged retaliatory actions that had been taken against her and the alleged hostile work environment to which she was being subjected. Id. She also filed a complaint against Ms. Gandhi. Id. In response, Pfizer assigned Plaintiff to another supervisor, Ms. StuarL-Smith. Id.

In Plaintiffs April 28, 2010 Performance Improvement Plan (“PIP”), Ms. StuartrSmith noted that Plaintiff needed to improve her “follow through/accountability and communication.” Id. ¶ 36. Plaintiff responded to and refuted each of these charges. Id. Plaintiffs July 7, 2010 PIP reiterated the need for Plaintiff to improve in these areas. Id. ¶ 37. Plaintiff again responded and refuted each charge. Id. Finally, on or about August 19, 2010, Defendant sent Plaintiff notice of her termination. Id. ¶ 38. Plaintiffs date of termination was September 16, 2010. Id.

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Cite This Page — Counsel Stack

Bluebook (online)
855 F. Supp. 2d 1017, 2012 WL 694513, 2012 U.S. Dist. LEXIS 27214, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ferretti-v-pfizer-inc-cand-2012.