Ferretti v. Pfizer Inc.

• Decision Date: 29 February 2012
• Docket Number: Case No. 11–CV–04486.
• Citation: 855 F.Supp.2d 1017
• Court: U.S. District Court — Eastern District of California
• Parties: Delina FERRETTI, Plaintiff, v. PFIZER INC., Defendant.

855 F.Supp.2d 1017

Delina FERRETTI, Plaintiff,

v.PFIZER INC., Defendant.

Case No. 11–CV–04486.

United States District Court,

N.D. California,

San Jose Division.

Feb. 29, 2012.

J. Gary Gwilliam, Gwilliam Ivary Chiosso Cavali & Brewer, Oakland, CA, for Plaintiff.

Samantha Newland Hoffman, Jackson Lewis LLP, Newport Beach, CA, for Defendant.

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. ¶¶ 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 PanHER 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 was 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, Plaintiff's 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 contain[ing] 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. Stuart–Smith. Id.

In Plaintiff's April 28, 2010 Performance Improvement Plan (“PIP”), Ms. Stuart–Smith noted that Plaintiff needed to improve her “follow through/accountability and communication.” Id. ¶ 36. Plaintiff responded to and refuted each of these charges. Id. Plaintiff's 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. Plaintiff's date of termination was September 16, 2010. Id.

On September 9, 2011, Plaintiff filed a complaint alleging: (1) violation of California Labor Code section 1102.5; (2) wrongful termination in violation of public policy; (3) intentional infliction of emotional distress (“IIED”); (4) breach of express or implied contract; and (5) breach of implied covenant of good faith and fair dealing. The case was reassigned to the undersigned judge on October 25, 2011. ECF No. 12. Defendant filed the instant motions on November 9, 2011. ECF No. 14. Plaintiff filed her opposition on December 7, 2011. ECF No. 18. Defendant filed its reply on December 28, 2011. ECF No. 20.

II. Legal StandardsA. Motion to Dismiss Under Rule 12(b)(6)

A motion to dismiss pursuant to Rule 12(b)(6) for failure to state a claim upon which relief can be granted “tests the legal sufficiency of a claim.” Navarro v. Block, 250 F.3d 729, 732 (9th Cir.2001). Dismissal under Rule 12(b)(6) may be based on either (1) the “lack of a cognizable legal theory,” or (2) “the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir.1988). While “ ‘detailed factual allegations' ” are not required, a complaint must include sufficient facts to “ ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). “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.” Id.

For purposes of ruling on a Rule 12(b)(6) motion to dismiss, the Court accepts all allegations of material fact as true and construes the pleadings in the light most favorable to Plaintiff. Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir.2008). The Court need not, however, accept as true pleadings that are no more than legal conclusions or the “ ‘formulaic recitation of the elements' of a cause of action.” Iqbal, 129 S.Ct. at 1951 (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955). Mere “conclusory allegations of law and unwarranted inferences are insufficient to defeat a motion to dismiss for failure to state a claim.” Epstein v. Wash. Energy Co., 83 F.3d 1136, 1140 (9th Cir.1996); accord Iqbal, 129 S.Ct. at 1949–50.

B. Leave to Amend Under Rule 15(a)

Under Rule 15(a) of the Federal Rules of Civil Procedure, leave to amend “shall be freely given when justice so requires,” bearing in mind “the underlying purpose of Rule 15 to facilitate decision on the merits,...