Defendant is a global healthcare company. Defendant provides pharmaceutical products to hospitals and pharmacies. Defendant has provided laboratory analysis for more than seventy years. Defendants Associate Director of QA was Plaintiffs Direct Supervisor.
In 2011, Defendant hired Plaintiff to work in in Defendants Quality Assurance Department (QA), as Defendants QA Project Manager. Plaintiff reported to the Associate Director of QA and to the Director of QA. As a pharmaceutical industry veteran, Plaintiff was hired based on his Chemical Engineering degree, and his ability to work with difficult people. Plaintiff did not provide rubber-stamp approval to the work performed by validation engineers and technicians. Defendants Validation Department was responsible for creating a documented evidence trail (through rigorously checking and testing) to show that a system, procedure or process used in the production and testing of the pharmaceutical product: maintains compliance at all stages and leads to a consistent and reproducible results. Plaintiff required that the validation work was compliant with Defendants Standard Operating Procedures (SOPs) and federal regulations. To ensure compliance, the work often had to be redone. Even though Plaintiff worked in an unpopular role, Plaintiff had the support of Defendants management.
In 2013, Defendants management sent a note to Plaintiff instructing: Dont change.
In 2014, Defendants QA Vice President sent a note to Plaintiff referring to Plaintiff as the toughest guy in QA.
In early January 2014, Plaintiff was reviewing an Installation Qualification (IQ) final report for one of the new Special Systems used for cleaning equipment in Defendants new Intravenous Immunoglobulin (IVIG) manufacturing facility in California. During his review, Plaintiff noticed a discrepancy in the Component Test Results regarding a valve. The valve was specified as plastic but the actual result was plastic with a stainless steel material of contact. The valve had to be plastic or stainless steel but not both. Plaintiff personally inspected the equipment and discovered that the valve was plastic with a plastic material of contact.
Plaintiff suspected that the IQ Report may not have been field-verified. Plaintiff informed his supervisor, Associate Director of QA of Plaintiffs suspicions. Associate Director of QA instructed Plaintiff to further investigate the Special System in question. Plaintiffs further investigation determined that there were 19 entries in the new Special System IQ Report that did not agree with the actual equipment. Plaintiff informed Associate Director of QA and she instructed Plaintiff to investigate the other twelve Special Systems.
A couple of weeks later, in mid-January 2014, Plaintiff completed his field review of all the Special Systems. The discrepant results were the work of four experienced Validation employees. The results differed from the actual equipment in 111 instances. The results were wrong because the Validation engineer did not do his job and go look at the equipment. The equipment was not what it was supposed to be. This is critical because pharmaceutical manufacturing equipment is specifically designed for a validated manufacturing purpose. Using the wrong equipment may lead to impure, unsafe or contaminated product. Plaintiffs investigation indicated that the IQ Report had been falsified. The validation engineer did not field verify the actual installed system, but simply copied the expected results. Thus, the documentation of the actual equipment is incorrect. Future validation and maintenance of the subject equipment will be based on incorrect information.
By the end of January 2014, Plaintiff sent an email with a summary of his findings to his supervisor, Associate Director of QA, who told Plaintiff that she would discuss this serious matter with Defendants Director of QA.
In March 2014, Associate Director of QA informed Plaintiff that she had met with Director of QA and that they subsequently met with the QA Vice President. Associate Director of QA told Plaintiff that the QA Vice President told Associate Director of QA and Director of QA that QA Vice President did not want these findings to be documented by a Quality Deviation or a Corrective and Preventative Action and that Associate Director of QA and Director of QA were not to talk to Human Resources about this issue. Per Associate Director of QA, QA Vice President said he would talk to the Director of Validation and let her deal with it.
Associate Director of QA told Plaintiff that, after her meeting with QA Vice President, she and Director of QA met and sat there in silence for 5 minutes. Associate Director of QA told Plaintiff that it would not surprise her if the Director of Validation condoned falsification, because (in an different/unrelated matter) behind closed doors with Director of Validation, they have been discussing the data that the Vice-President of Manufacturing wants them to delete from Laboratory Information Management System, the results for the rabbit tests on the IVIG conformance lots that are so damaging.
Nobody at Defendant questioned Plaintiffs findings or asked to be shown the equipment. Nobody asked Plaintiff if he had inspected the equipment firsthand. Initially, Plaintiff took this silence as confirmation that Defendants did not doubt the validity of Plaintiffs investigation.
Later, Plaintiff came to believe that Defendants did not want to bring more attention to the falsification. Defendant had submitted the falsified validation report to the Food and Drug Administration (FDA) to secure FDA approval of its new multi-million dollar IVIG facility. Acknowledging the falsification would delay the schedule for timely FDA approval of the new facility. Associate Director of QA was the Project Manager for approval of the new facility and she would personally benefit if the new facility were approved. In fact, after the FDA approval was achieved (after Plaintiffs termination), Associate Director of QA was promoted to Director of Distribution and Planning.
FDA regulations require that a discovery such as the discovery made by Plaintiff should require a full investigation into the depth and breadth of the falsification. The consequence would have been a complete revalidation of all the Special System equipment. In addition, all the completed Cleaning Validations results should have been voided. An investigation should also have been undertaken to determine what other documents may have been falsified. This is an FDA requirement, but the process would have taken a tremendous amount of time and resources, thereby delaying new facility FDA approval by as much as a year, which would have caused substantial economic harm to Defendant.
To properly execute an IQ Report takes many hours. Each critical component must be inspected for manufacturer, model, size, material, part #, etc. This can be very difficult to do once the equipment is assembled in a maze of piping in a 100 degree room. Then, if the component differs from what was specified, a deviation is noted, a correction must be made, and this adds time. The procedure for handling deviations is mandated by FDA regulations. Rather than execute the IQ Report properly, the Defendants Validation employees simply copied in the actual results from what was expected. The pressure to complete validation of the new facility for FDA approval was tremendous.
In March 2014, Plaintiff was asked to meet with a Validation Manager to discuss the falsified reports. Prior to the meeting, Plaintiff informed QA Vice President that he feared retaliation and was worried about his personal safety because the falsifiers had been informed of Plaintiffs discovery of their transgressions and were told that Plaintiff was responsible for complaining about their discrepancies.
In March 2014, Plaintiff complained again about the falsification, directly to Defendants QA Vice President. QA Vice President acknowledged the complaint. Associate Director of QA told Plaintiff that the falsified IQs were to be redone. However, Plaintiff later reviewed a redone IQ and saw that the discrepant results were simply changed and a note was added that the correction was made because of inadvertent error. Plaintiff informed Associate Director of QA that he would not approve that IQ. In response, Associate Director of QA said that she would personally review the remaining redone IQs.
In mid-March 2014, Plaintiff contacted an attorney to express his fear of retaliation for complaining about the falsification.
In October 2014, Associate Director of QA issued Plaintiff 90-day Performance Improvement Program (PIP) to Plaintiff. The PIP stated and implied that Plaintiff was a poor performer. The tasks that were assigned as part of the PIP were several low priority items that had no pressing deadlines. Plaintiff had achieved above-average reviews prior to his discovery of the falsification. Plaintiff immediately applied himself 100% to completing the six tasks set forth in the PIP. To document completion, Plaintiff emailed Associate Director of QA with constant updates. Associate Director of QA asked Plaintiff to stop updating status through the emails. Plaintiff also met with Associate Director of QA frequently to update his progress. Plaintiff was confident that he would complete all the tasks within the 90 days. By mid-November 2014, Plaintiff had substantially completed the assigned tasks and was 95% done with the remaining work that was set forth in the PIP.
At the end of November 2014, Plaintiff was suddenly called to attend a meeting with Associate Director of QA and the Director of QA and a Human Resources Business Partner. During the meeting, Defendant terminated Plaintiff. Plaintiff was shocked. When Plaintiff asked why he was being fired; Associate Director of QA uttered a vague remark, that, its just not working out. Plaintiff was terminated halfway into the 90-day PIP. Plaintiff was escorted off the premises and was not given an opportunity to gather his personal belongings, which were sent to him months later.
Analyze the following: (1) whether Plaintiff has engaged in protected activity under California Labor Code Section 1102.5; and if so, (2) whether the adverse employment action (i.e., Plaintiffs termination) would have occurred for legitimate, independent reasons even if the Plaintiff had not engaged in protected whistleblowing activities.
Lawson v. PPG Architectural Finishes, Inc., 12 Cal. 5th 703, 713, 503 P.3d 659, 663-664 (2022)
First, it must be demonstrated by a preponderance of the evidence that the employees protected whistleblowing was a contributing factor to an adverse employment action. (§ 1102.6.) Then, once the employee has made that necessary threshold showing, the employer bears the burden of proof to demonstrate by clear and convincing evidence that the alleged adverse employment action would have occurred for legitimate, independent reasons even if the employee had not engaged in protected whistleblowing activities.
Please note: Much of the information provided was for background only and does not need to be cited in the analysis.
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