RAMIREZ_Appendix_Writ_Certiorari_2_6_2017
- TAGS
- pharmaceutical
- plsrtmyqcbandlstory
- ophthalmology
- opthalmicpharmaceutical
- bauschlomb
- eye-products
- eyenews
- carlos-ramirez
- standard-operating-procedures
- good-manufacturing-practices
- code-of-federal-regulations
- joseph-papa
- ophthalmologycare
- scotus
- chile
- retaliation
- whistleblower
- quality-control
- tampa
- bauschandlomb
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Case 8:10-cv-02003-MSS-TGW Document 189 Filed 04/02/15 Page 4 of 12 PageID 2955<br />
Good Manufacturing Practice Regulations (“GMP’s”) 1 and whether his remarks<br />
constituted protected activity that was sufficiently close in time to demonstrate causation.<br />
Id. at 832. If not, the Circuit Court stated that this Court should consider Ramirez’s<br />
multiple instances of alleged protected activity that occurred prior to the time that he went<br />
on FMLA leave as evidence of causality. Id. at 833. The Circuit Court stated that, if<br />
necessary, this Court may consider the additional incidents of alleged protected activity<br />
(and not just those events which occurred during the three-month window prior to<br />
Ramirez’s termination, largely comprised of his FMLA leave) because Ramirez did not<br />
rely solely on temporal proximity to establish a causal connection. Id.<br />
a. Whether Ramirez’s Remarks at the November 3, 2008 Meeting<br />
Constituted Protected Activity Sufficiently Close in Time to Establish<br />
a Causal Connection<br />
Upon his return to work on November 3, 2008, Ramirez attended a meeting with<br />
Human Resources Representative Javier Callejas (“Callejas”) and Quality Team Leader<br />
Anita Mujagic (“Mujagic”). (Dkt. 86-9) Notes from that meeting indicate that when<br />
asked if Ramirez had anything he would like to share before returning to work, he<br />
indicated that some of his issues were: “Violation of SOP’s and GMP’s” and “Issues with<br />
nonconformance documents.” (Id.) Ramirez’s work journal 2 indicates that he informed<br />
1<br />
GMP’s are regulatory requirements for all manufacturers of drugs and medical devices, codified at<br />
21 C.F.R., Parts 210, 211, 600 and 820. The FDA requires that registrants manufacture their<br />
products in accordance with their SOPs, which must be approved by the FDA. (Dkt. 88-1 at P. 6)<br />
2<br />
Despite B&L’s objection to the consideration of Ramirez’s work journal on summary judgment as<br />
inadmissible hearsay, the Court finds that the work journal may be properly considered to the extent<br />
that it is reducible to admissible evidence at trial. See Macuba v. Bedoer, 193 F.3d 1316, 1322-24<br />
(11th Cir. 1999). Ramirez’s sworn deposition testimony confirms that the journal was made by him<br />
and contains his personal observations of the events in question. (Dkt. 77-3 at P. 6; Dkt. 88-3 at P.<br />
6; Dkt. 88-4 at P. 2) Ramirez could be called to testify at trial regarding his statements made during<br />
this meeting, not for the truth of the matter asserted but for the fact that the Defendant was made<br />
aware of Ramirez’s perceptions. See Jones v. UPS Ground Freight, 683 F.3d 1283, 1294 (11th Cir.<br />
A. 8<br />
4