Private Sector Florida Whistleblower Act Amended Complaint.

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Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 12 of 25 PageID 164 stopping of production lines. He explained that Defendant’s failure to properly respond to nonconformities had mandated his actions. He further suggested that the Defendant was in effect ratifying the wrongful and/or illegal conduct of its employees in its inadequate responses to the nonconformities. 40. From June 16 -30, 2008, the scheduled manufacturing operations were shut down. During this time, the Plaintiff attended a meeting conducted by the new Quality Assurance Direction WENDY GOULD. During said meeting, the Plaintiff raised many of his above stated concerns, in the presence of all attendees, and urged review of the apparent shortcomings in business ethics within the Quality Department. 41. On July 14, 2008, the Plaintiff observed defects in the product similar to those referenced above and reported these to the maintenance mechanic and operator. Plaintiff requested that operator GUDALUPE stop the line, but GORDON overruled the Plaintiff. Later that day, the Plaintiff was called to a meeting with THOMAS, GUADALUPE, and GORDON in which he was subjected to hostile questions as to his justifications in stopping the production line being operated by GUADALUPE. The Plaintiff informed the attendees of his reasons, and offered proof in the form of a defect sample bottle he had secured. 42. On July 15, 2008, the Plaintiff reported to MQA Manager MONICA BRIGGS, Team Leader Quality ANITA MUJAGIC, and HR Representative JAVIER CALLEJAS of many of the anomalies referenced above and the ongoing resistance and hostility he was facing for stopping the line in order to adhere to production and safety standards. The Plaintiff expressed his view that the Defendant was committing and ratifying violations of the CFRs and SOPs. The Plaintiff produced the secured sample referenced above to BRIGGS, CALLEJAS, and First Amended Complaint, page 12
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 13 of 25 PageID 165 MUJAGIC and requested review of security camera media to verify that he had taken the prescribed actions to prevent shipping of defective product into the market. 43. On July 16, 2008, the Plaintiff requested copies of certain Transaction History Inquiry reports to document the appropriate of his remedial responses to the above anomalous events. 44. On July 17, 2008, the Plaintiff informed GORDON that he lacked the prescribed training to perform the inspection duties assigned to him on the Ocucoat® Viscoelastic production line, an ophthalmic surgical aid. Despite this, he was not given the prescribed training. 45. On July 18, 2008, the Plaintiff informed QA Manager BRIGGS that, as to one or more of the anomalous events described above, Defendant was acting in violation of the CFRs. MQA section manager BONEWHITT admonished Plaintiff about the retaliation another whistleblower had suffered from complaining about violations when he previously mentioned the CFR violations. 46. On July 22, 2008, Plaintiff’s prior legal counsel informed Defendant’s CALLEJAS that the Plaintiff had retained a law firm to protect himself from violations of his legal rights in employment. 47. On July 25, 2008, the Plaintiff reported to Environmental Associate WANDA ROSARIO that it appeared that one of the production lines had been unmonitored during the second shift on July 24, 2008. Required documentation demonstrating mandated monitoring was absent from official records in violation of SOPs. First Amended Complaint, page 13
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Private Sector Florida Whistleblower Act Amended Complaint.

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