Genentech Lawsuit

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<p>1 23</p> <p>Angela M.Alioto,SBN 130328) ( Emily St John Cohen,SBN 239674) (LAW OFFICES OF JOSEPH L. ALIOTOAND ANGELA ALIOTO SAN MATCB COUNTY</p> <p>LED2012</p> <p>700 Montgomery Street4</p> <p>San Francisco, CA 94111 2104 -</p> <p>AUG 0Cie</p> <p>Telephone: 415)4348700 ( 56 7</p> <p>Facsimile:415) 4638 ( 438 Sandra L.Ribero, SBN 236769) (RIBERA.LAW FIRM</p> <p>t</p> <p>parlor court</p> <p>E</p> <p>8 9 10 11 12</p> <p>A Professional Corporation 807 Montgomery StreetSan Francisco,CA 94133 Telephone: ( 415)576 1600 Facsimile: ( 415)842 0321 -</p> <p>Attorneys for Plaintiff Juliet KnileySUPERIOR COURT OF CALIFORNIA</p> <p>13 14 15 1617</p> <p>SAN MATEO COUNTY</p> <p>UNLIMITED JURISDICTION</p> <p>QWJULIET KNILEY, ) Plaintiff, )VS. )</p> <p>Case No.</p> <p>COMPLAINT FOR DAMAGES</p> <p>18</p> <p>1. Whistleblower Retaliation ( al.Lab. CCode 1102. c)) 5( 2. Retaliation in Violation of FEHA</p> <p>19</p> <p>GENENTECH, INC., } and20</p> <p>3. Harassment in Violation of FEHA 4. Failure to Prevent Retaliation and</p> <p>DOES 1 -20, )21</p> <p>Harassment in Violation of FEHA</p> <p>5. Wrongful Termination in Violation</p> <p>2223 24 25</p> <p>Defendant(s).</p> <p>)</p> <p>of Public Policy 6. Wrongful Demotion in Violation of Public Policy7. Intentional Infliction of EmotionalDistress</p> <p>JURY TRIAL DEMANDED26 27</p> <p>28</p> <p>Kniaay v.Gcmnwk inn at al.</p> <p>cam*at hr. i Damum</p> <p>1</p> <p>12</p> <p>PlaintiffJULWT KNILEY or Plaintiffs for her Complaint against Defendant ( "GENENTECH,INC. ( " Genentech"or Defendant'), " hereby alleges as follows:NATURE OF THE ACTION</p> <p>34 5s</p> <p>1.</p> <p>This is an action for damages for Defendant's whistleblower retaliation in violation ofCalifornia Labor Code </p> <p>1102(c), retaliation in violation of FEHA,harassment in violation of</p> <p>89</p> <p>FEHA,failure to prevent retaliation in violation of public policy,wrongful termination in</p> <p>violation ofpublic policy,wron&amp; demotion in violation of public policy,and intentionalinfliction of emotional distress.The action arises out of Plaintiffs employment withDefendant</p> <p>101112</p> <p>JURISDICTION AND VENUE13</p> <p>1415</p> <p>2.</p> <p>Jurisdiction is conferred upon this court</p> <p>1 by California Code of Civil Procedure 410. 0.</p> <p>3.</p> <p>Venue is proper in this Court pursuant to California CodePARTIES</p> <p>ofCivil Procedure </p> <p>395.</p> <p>16</p> <p>174.18</p> <p>At all pertinent times mentioned in this Complaint,Plaintiff was a resident ofthe County ofSan' rancisco, State of California. F</p> <p>1920 21 22</p> <p>5.</p> <p>Defendant Genentech, a corporation incorporated under the laws of the State of Delaware,but has had its headquarters in South San Francisco in the State of California eversince its founding in 1976.</p> <p>23</p> <p>6.24</p> <p>Defendant Genentech, a pharmaceutical company, and employs approximately eleven thousand, five hundred ( 1, 00)employees in the United States. 1 5</p> <p>25</p> <p>2627</p> <p>7.</p> <p>In March of 2009,Defendant Genentech, Inc.and the Roche Group combined their</p> <p>pharmaceutical operations and Defendant became an independent center within the RocheGroup.Kzu* GemnteA al. v. Complaint for Damages2</p> <p>28</p> <p>1</p> <p>8.</p> <p>From approximately December 5,2005 to August 30,2011, Plaintiffwas employed byDefendant.Plaintiffs official job site for Defendant was located at 1 DNA Way, South SanFrancisco, California,94080.</p> <p>2</p> <p>34</p> <p>9.567</p> <p>At all the pertinent times mentioned in this Complaint,Defendant acted with the intent toa tortious effect on the Plaintiff within the State of California.</p> <p>10.</p> <p>Corporate Defendant is directly liable to Plaintiff for the harassing conduct of their</p> <p>8 9 10 11 12 13 14 1516</p> <p>supervisors,managers, division heads, other employees and agents.11.</p> <p>Corporate Defendant is directly liable for the conduct of its division heads,managers,</p> <p>supervisors, employees and agents as described herein.At all times pertinent in this Complaint</p> <p>the employees ofDefendant were acting as agents ofDefendant and also were within the scopeof their employment.12.</p> <p>Plaintiff is ignorant ofthe true names or capacities of the Defendants sued here under thefictitious names DOES 1 through DOES 50.Plaintiff is informed and believes that each DOE</p> <p>17 1819 20</p> <p>Defendant was responsible in some manner for the occurrences and injuries alleged in thisComplaint.13.</p> <p>At all times mentioned in the causes ofaction into which this paragraph is incorporated by</p> <p>reference,each and every individual Defendant was the agent or employee of each and every</p> <p>21 22</p> <p>other Defendant. In doing the things alleged in the causes of action into which this paragraph is</p> <p>incorporated by reference, each and every Defendant was acting within the course and scope of23 24</p> <p>this agency or employment and was acting with the consent, permission,and authorization of</p> <p>2526</p> <p>each remaining Defendant. All actions of each Defendant alleged in the causes of action intowhich this paragraph is incorporated by reference were ratified and approved by the officers orthe managing agents of every other Defendant.</p> <p>27 28</p> <p>Knft v.C4meawA aL</p> <p>C= far Damages PWM</p> <p>3</p> <p>1</p> <p>23</p> <p>EXHAUSTION OF ADPAMSTRATM REMEDIES14.</p> <p>Plaintiffhas fully exhausted all applicable administrative remedies. Plaintiff has received a</p> <p>45</p> <p>Right- Sue Notice from the California Department ofFair Employment and Housing on toOctober 5,2011.STATEMENT OF FACTS</p> <p>6</p> <p>169</p> <p>15. Plaintiff Juliet Kniley is a female.16. Plaintiff lives in San Francisco, California.</p> <p>10</p> <p>11 12</p> <p>17. On December 5,2005,Plaintiffwas hired by Defendant as an Associate [Clinical]OperationsTeam Leader with an annual base salary of 115, 00. 00. $ 0</p> <p>1314</p> <p>18. From December 2005 to August 2009,Plaintiff received only excellent performance reviews,as is evidenced by her multiple promotions.</p> <p>15 16</p> <p>19. In July of2007,Plaintiff was promoted to hold the Operational Leadership role in the Pi3 Kinase Program due to her excellent performance reviews.According to Defendant's senior executives and All Hands Meetings," Pi3 Kinase Program was the most important " theprogram at the company.</p> <p>171s</p> <p>1920</p> <p>20. In and around August of2008, Plaintiffwas promoted to the role ofSenior Clinical ProgramManager with an annual base salary of 133, 75. 00. $ 3</p> <p>21.</p> <p>2223 24</p> <p>21. Plaintif'' s status and her work environment began to change, however,in October of2008after Plaintiff,carrying out her duties as listed in her position description,informed</p> <p>25 2' 627</p> <p>Defendant's Development Sub Team Leader DSTL), Deryack,M. ., the first- n( Wla D that i</p> <p>human clinical trial must be followed as written. Plaintiff complained to Defendant'smanagement that instead of following written protocol,Defendant's Pi3 Kinase Program TeamKnft V.GCWVWb, al. Complaint ft Damages</p> <p>28</p> <p>4</p> <p>1</p> <p>was engaging in illegal and unethical conduct in relation to the clinical trials. The laws and</p> <p>2 3</p> <p>regulations that Defendant violated included,but were not limited to: 1) Code of Federal ( 21 Regulations (CF. 30,which requires that a sponsor submit a protocol amendment R.) ' . 312. "</p> <p>4</p> <p>56</p> <p>describing any change in a Phase I protocol that significantly affects the safety of subjects "; 2; (1</p> <p>21 CRR_ 312. 5 which indicates that</p> <p>sponsors (Defendant)are responsible for ensuring that</p> <p>78 9</p> <p>investigations are conducted in accordance with the protocol; 3) ( International Conference ofHarmonisation ( H.) I.. C E6</p> <p>2, indicates that the investigator should not implement 4. . 5 which</p> <p>any deviation from,or changes of the protocol without approval of the Institutional Ethics1011</p> <p>H Committee,and ( I..E8 3. . 4) C 3, 2 which indicates that adherence to the protocol is</p> <p>12 13</p> <p>essential. The International Conference ofHarmonisation Guidelines,which is advocated bythe FDA,sets an international standard ofthe highest scientific and ethical quality for clinicalstudies that are conducted in human subjects; and other FDA Standards regarding good clinicalpractices in FDAregulated clinical trials.</p> <p>14</p> <p>15 16</p> <p>1718</p> <p>22. Throughout October and November of 2008,Plaintiff complained ton multiple occasions to</p> <p>Defendant's DSTL Mika Derynck,M. ., Defendant's Clinical SubTeam Leader CSTL) D and (Scott Holden,M. .that Defendant's premature and inappropriate safety testing in humans for Dcertain clinical studies-in Defendant's Pi3 Kinase Program violated several laws and</p> <p>1920</p> <p>21</p> <p>regulations that were designed to protect the safety of the patients on whom the tests werebeing conducted.</p> <p>222324</p> <p>23. On or about December 17,2008,Plaintiff complained to Defendant's management about thebehavior of Dr.Holder being inconsistent with Defendant's corporate values and of his</p> <p>25 26</p> <p>insistence on violating federal regulations and international directives. After this meeting,Dr. IHolden began to verbally abuse, harass, and retaliate against Plaintiff.. Holden confronted Dr.</p> <p>27 28</p> <p>Complaint fir Damages</p> <p>5</p> <p>1 2 3</p> <p>Plaintiffmultiple times,in which he yelled,pounded his fists on a table,angrily pointed his finger at her,and belittled her. Additionally,Dr.Holden began to exclude Plaintiff frommeetings that were held to discuss topics under Plaintiff's direct area of accountability. As a</p> <p>4</p> <p>5</p> <p>result,Plaintiff was prevented from obtaining all information necessary for her to fully</p> <p>67e</p> <p>function in her role as Senior Clinical Program Manager of the Pi3 Kinase Program.24. Plainhfftold Defendant's management about Dr.Holden's harassment and retaliation, and</p> <p>specifically sought assistance from her manager, Mark Bradley,and Mr.Bradley's supervisor,Tricia Moore.Plaintiff objected to proceeding with these clinical trials and tests on humans</p> <p>9to</p> <p>11</p> <p>due to the absence ofDefendant's adherence to the rules and regulations promulgated to protect the subjects. Despite Plaintiffs objections, Plaintiffs supervisors consistentlyPlaintiffs objections and permitted the clinical trial violations.Defendant's conduct was</p> <p>1213 14</p> <p>unethical and illegal, and was in violation of 1) ( Federal Regulations; 2) ( Defendant's Good</p> <p>15</p> <p>Operating Procedures; 3) ( Defendant's Standard Operating Procedures (SOPS); (4) and theInternational Conference of Harmonisation Guidelines. Such violations put the lives ofthesubjects of Defendant's Pia Kinase Program clinical trials at unnecessary risk of death andinjury.25.</p> <p>161718</p> <p>19 20 21 22</p> <p>On January 7,2009, Plaintiff complained to Defendant's Vice President Stuart Lutzker,MDvia Defendant's multi-ater feedback foam that Dr.Derynck was making clinical trial r</p> <p>in the area ofprotocol compliance that were putting the relationship with the clinical23</p> <p>24 25 2627 28</p> <p>investigator above the best interests of the human trial subjects.26.</p> <p>On April 28,2009,Plaintiff further complained that she would not be a party to presentingunrealistic clinical trial timelines to Defendant's Senior Management,which could have a</p> <p>significant negative impact on Defendant's business and could put trial subjects' fives inKaft V.amxn ak BL Complain kr Deungw</p> <p>6</p> <p>1 2</p> <p>jeopardy as a result of shortcuts taken to achieve such unrealistic timelines. Despite theaccuracy of the timelines Plaintiff did present to Drs.Derynck and Holden,Plaintiff was</p> <p>3</p> <p>continuously ridiculed and disparaged by them in public forums. Plaintiffwas told by Dr.4</p> <p>567</p> <p>Derynck during two separate team meetings # at " oche will take this molecule away from us h Rif they see these timelines."</p> <p>27. Following a presentation on July 9,2009, Plaintiff again indicated to Dr. Derynck that -</p> <p>8</p> <p>the timelines for certain clinical trials were unrealistic.and not supported by ClinicalOperations.</p> <p>9'10 1112</p> <p>28. On July 29 and August 3,2009,Plaintiff was repeatedly instructed by Drs.Derynck andHolden to allow a clinical trial to go forward without the necessary approvals required under</p> <p>13 14 15</p> <p>the law. Because it was the responsibility of Clinical Operations to ensure the adequacy of theregulatory documentation, Plaintiff complained to her supervisors, including her currentmanager Lenny Kimball,that she was not willing to initiate the clinical trial without sufficient</p> <p>16 17 18 1920</p> <p>information to identify the protocol. Lenny Kimball failed to alleviate or even respond toPlaintiff's complaints about Defendant's illegal conduct Ms.Kimball,as well as other</p> <p>members of Defendant's management, failed to investigate the merits ofPlaintiffs reports ofillegal and unethical conduct, and instead retaliated against Plaintiff for raising concems tomanagement about the lack of adherence to safety laws and regulations by demoting Plaintiff</p> <p>2122</p> <p>2324</p> <p>and removing her from the Pi3 Kinase Program even though she had held her position with theprogram since July 9,2007 and received a promotion from Clinical Program Manager to Sr.Clinical Program Manager in August of2008.</p> <p>2526</p> <p>27 28</p> <p>Way v.Gmanwk I= at aL</p> <p>OMPIRW iar DawAga</p> <p>7</p> <p>12</p> <p>29. In August of 2009,following her complaints about illegal and unethical conduct,Plaintiff was removed from the Pi3 Kinase Program,a demotion, something that was done only when a</p> <p>3</p> <p>Clinical Program Manager demonstrated consistently poor performance or improper behavior.4</p> <p>M</p> <p>30. As Senior Clinical Program Leader,Plaintiffwas exclusively charged with ensuring that all "programs under her oversight were instituted according to ethical,regulatory and legal</p> <p>6 7 89</p> <p>requirements"Plaintiffwas demoted for performing the functions ofher job,a job with dutiesthat she was uniquely qualified to carry out. This was pure retaliation,and such blatant, .wrongful,and baseless conduct by management tended to and did in fact defame Plaintiff's</p> <p>10 11</p> <p>reputation with others at the company as a top notch Senior Clinical Program Leader.</p> <p>12 13 14 15</p> <p>31. Team members ofthe Pi3 Kinase Program,including the Development Sub team Leader andthe Vice President of Development Oncology, repeatedly told Plaintiffthat she was a needed</p> <p>and valued participant on the investigational product Pi3 Kinase Program Other teammembers from another Program for which Plaintiff simultaneously worked as a Senior Clinic</p> <p>16</p> <p>Program Manager provided the same positive feedback about Plaintiff.17 18</p> <p>32. Being removed from the Pi3 Kinase Program caused severe damage to Plaintiffs reputationamongst her coworkers and around the community. The Pi3 Kinase Program was a highlyvalued Program at the company.</p> <p>1920</p> <p>2122</p> <p>33. Plaintiff set up and implemented the Pi3 Kinase Program based on her operational strategiesand expertise.This required a workload ofbetween 5 10 fold higher than Plaintiffs -</p> <p>23 24</p> <p>colleagues. The Manager who replaced Plaintiffin the P13 Kinase Program reaped the benefi</p> <p>2526 27</p> <p>from the success ofPlaintiffs work. Defendant's management then promoted Plaintiffsreplacement to be a Clinical Program Group Leader, a higher position than Plaintiffhad</p> <p>previously had as Senior Clinical Program Leader. Both Defendant's Development Sub teamUft V.Gmewnk Ina.ct aL...</p>