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 20 of 25 PageID 172 F. Impairment of working ability and earning capacity; G. Loss of dignity; and H. Future pay. 85. WHEREFORE, the Plaintiff respectfully prays that this Honorable Court take jurisdiction of the subject matter and parties hereto, grant his request for trial by jury, enter judgment against Defendant and award compensatory damages, consequential damages, costs, interest and such other relief as deemed appropriate by this Court. SECOND CLAIM FOR RELIEF: VIOLATION OF FLORIDA’S PRIVATE WHISTLE BLOWER ACT 86. Plaintiff realleges and incorporates by reference Paragraphs 1 through 85, as though set forth herein verbatim. 87. This is an action for violation of Florida’s Private Whistleblower Act §§448.1010- 448.105, Florida Statutes (Whistleblower Act) with damages in excess of $15,000. 88. Plaintiff is within the protected class of individuals as defined under Florida Statutes §448.01. 89. Defendant is, and at all material times, was an “employer” within the meaning of Florida Statutes §448.101. 90. During his employment with B&L, the Plaintiff objected to, or refused to participate in an activity, policy or practice in violation of a law, rule, or regulation. The Defendant as a manufacturer of medical devices and drugs was required to conduct its business in compliance with federal and state law and regulations, including the following regulations governing training, cleaning, appropriate attire, quality control, process and procedure control, and investigations of complaints, the violations of which Plaintiff objected to: First Amended Complaint, page 20
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 21 of 25 PageID 173 1. Training (medical devices and drugs): 21 C.F.R. §820.25 (a) and (b) requires Defendant, as a manufacturer of medical devices, to proactively identify training needs and provide training for personnel to correctly perform the work activities. 21 C.F.R. § 211.22 requires the Defendant, as a manufacturer of drugs, to train its employees in cGMPs and SOPs with sufficient frequency and consistency to ensure continuing familiarity and to assure drug product safety and quality. 2. Processes (medical devices): 21 C.F.R. §820.70 requires that the Defendant control production processes to ensure that a device conforms to its specifications, standards and codes, including developing SOPs to define and control the manner of production. 3. Hygiene and Dress (medical devices): 21 C.F.R. § 820.70 (d) requires Defendant to maintain requirements for personnel clothing and cleanliness to prevent contamination or adulteration of product. 4. Hygiene and Dress (drugs): 21 C.F.R § 211.28 requires the Defendant to maintain requirements for personnel clothing and cleanliness to prevent contamination or adulteration of any product or equipment. 5. Corrective action (medical devices): 21 C.F.R. §820.100 requires the Defendant maintain procedures for implementing corrective and preventive action, including procedures for analyzing all existing data to identify and remedy any existing or potential quality problems, as well as to detect recurring quality problems and causes. 6. Quality Control (drugs): 21 C.F.R. § 211.22 requires the Defendant have a quality control unit invested with responsibility and authority to approve or reject all components, drug product containers, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred. First Amended Complaint, page 21
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Private Sector Florida Whistleblower Act Amended Complaint.

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