RAMIREZ_Appendix_Writ_Certiorari_2_6_2017

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Case 8:10-cv-02003-MSS-TGW Document 189 Filed 04/02/15 Page 5 of 12 PageID 2956 Callejas and Mujagic that his issues included: “Downgrading my defects findings, not following SOP’s, GMP’s . . . .” (Dkt. 86-3 at P. 16) The FWA states that “[a]n employer may not take any retaliatory personnel action against an employee because the employee has: . . . [o]bjected to, or refused to participate in, any activity, policy, or practice of the employer which is in violation of a law, rule, or regulation.” Fla. Stat. § 448.102(3). The comments made by Ramirez during the November 3, 2008 meeting indicate that he was objecting to what he perceived to be a violation of law committed by B&L. However, in order to prevail on his claim, Ramirez “must prove that the activity, policy or practice objected to is, in fact, in violation of a law, rule or regulation.” White v. Purdue Pharma, Inc., 369 F. Supp. 2d 1335, 1337 (M.D. Fla. 2005); see also In re Standard Jury Instructions in Civil Cases--Report No. 2011-01 (Unlawful Retaliation), 95 So. 3d 106, 107-10 (Fla. 2012). It is not enough that Ramirez reasonably believed that the actions he objected to were in violation of a law, rule, or regulation. Id. A “[l]aw, rule, or regulation” is defined to include “any statute or ordinance or any rule or regulation adopted pursuant to any federal, state, or local statute or ordinance applicable to the employer and pertaining to the business.” Fla. Stat. § 448.101(4). Generally, violations of a company’s own internal rules and policies are not considered violations of law under the FWA. See Lawson v. Dollar General Corp., No. 8:04-cv-2366-T-17TBM, 2006 WL 1980277, at *3 (M.D. Fla. July 12, 2006). However, violations of a federal rule or regulation are considered violations of law under the FWA because federal regulations are adopted pursuant to federal statutes, and thus, fall within 2012). A. 9 5
Case 8:10-cv-02003-MSS-TGW Document 189 Filed 04/02/15 Page 6 of 12 PageID 2957 the definition of a “[l]aw, rule, or regulation” under the FWA. See Diaz v. Impex of Doral, Inc., 7 So. 3d 591, 594-95 (Fla. 3d DCA 2009). In the context of this case, federal regulations, referred to as GMP’s, require manufacturers such as B&L to establish written procedures, referred to as SOP’s, for production and process control and to maintain detailed batch production and control records. See 21 C.F.R. §§ 211.100, 211.122, 211.188. Any deviation from the written procedures must be recorded and justified. Id. Additionally, manufacturers such as B&L are required to have a quality control unit that is responsible for ensuring that the written procedures are followed. 21 C.F.R. § 211.22. Ramirez worked as a Quality Control Coordinator (“QCC”) in B&L’s quality control unit. (Dkt. 77 at 1; Dkt. 77-1 at P. 13) Many of Ramirez’s alleged “protected actions” are instances of Ramirez detecting and reporting potential nonconformities and defects in the manufacturing process which were then recorded and corrected in accordance with B&L’s SOP’s. These allegations represent Ramirez performing his job as part of the quality control unit. (Dkt. 77-1 at P. 13-14) A violation of law does not occur simply because a potential issue is identified by a QCC and corrective action is taken. (Id.) On the contrary, such actions are actually consistent with, rather than in violation of, the federal manufacturing regulations applicable to B&L. See 21 C.F.R. §§ 211.100, 211.122, 211.188, 211.22. However, Ramirez also made allegations regarding incidents during which he or other employees were instructed to record incorrect information regarding nonconformance issues and anomalies in the batch records. (See Dkt. 88 at 6) For example, on March 19, 2008, Ramirez contends that he was ordered by his supervisor, Valerie Gordon (“Gordon”), to record only two defective units in the batch records when A. 10 6
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