Private Sector Florida Whistleblower Act Amended Complaint.
Plaintiff Ramirez.
Plaintiff Ramirez.
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Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 1 of 25 PageID 153<br />
Richard F. Meyers, Esquire<br />
9340 North 56 th Street, Suite 220-A<br />
Temple Terrace, <strong>Florida</strong> 33617<br />
(813)985-6550<br />
(813)985-5282 (fax)<br />
Fla. Bar No. 0893315<br />
Thad M. Guyer, Pro Hac Vice pending (Oregon State Bar # 82144)<br />
On behalf of the Government Accountability Project<br />
1612 K Street NW, Suite 1100<br />
Washington, DC 20006<br />
Ph: 541.203.0690<br />
Fax: 1.888.866.4720<br />
Email: thad@guyerayers.com<br />
Attorneys for Plaintiff<br />
CARLOS RAMIREZ,<br />
IN THE UNITED STATES DISTRICT COURT<br />
FOR THE MIDDLE DISTRICT OF FLORIDA<br />
TAMPA DIVISION<br />
Plaintiff,<br />
v. Case No. 10-cv-02003-RAL-TGW<br />
FIRST AMENDED COMPLAINT<br />
BAUSCH & LOMB,<br />
PHARMACEUTICALS, INC.<br />
DEMAND FOR JURY TRIAL<br />
Defendant.<br />
__________________________________<br />
Plaintiff, through his counsel, alleges as follows:<br />
I. INTRODUCTION<br />
1. This is a whistleblower retaliation complaint by an employee, Plaintiff CARLOS<br />
RAMIREZ, against his former employer, Defendant BAUSCH & LOMB, INC., based upon the<br />
Defendant’s retaliatory removal of RAMIREZ from his employment because of protected<br />
disclosures he made under the <strong>Florida</strong> <strong>Private</strong> <strong>Whistleblower</strong> <strong>Act</strong>, Sections 448.101 et. seq,<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 1
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 2 of 25 PageID 154<br />
<strong>Florida</strong> Statutes. This is also a complaint for discrimination against the Plaintiff due to his<br />
national origin (Chilean) and disability (amblyopia, a monocular vision impairment), and for<br />
retaliation for objecting to employer’s discriminatory practices under <strong>Florida</strong> Statute, Chapter<br />
760, <strong>Florida</strong> Civil Rights <strong>Act</strong>.<br />
2. Plaintiff, formerly a Quality Coordinator in the Manufacturing Quality Assurance<br />
Department for the Defendant Bausch & Lomb, Inc., alleges herein that he was terminated from<br />
his job in retaliation for his disclosures of lack of product quality and safety and violations of<br />
laws, rules, and regulations and for objecting to the Defendant’s discriminatory practices.<br />
3. Plaintiff seeks reinstatement to his position as a Quality Coordinator of Bausch &<br />
Lomb, back pay and benefits, and compensatory damages, including an award for emotional<br />
distress, together with an award of reasonable costs and attorneys fees. If reinstatement is not<br />
found to be the appropriate remedy, then Plaintiff should be awarded front pay in lieu of<br />
reinstatement.<br />
II.<br />
PARTIES<br />
4. Plaintiff is a citizen of the Republic of Chile, and a legal resident alien of the United<br />
States for 20 years, and a resident of Hillsborough County, <strong>Florida</strong>. Plaintiff is of Hispanic<br />
descent, from the country of Chile, and is male.<br />
5. Defendant B&L is a corporation headquartered in New York, with its principal place<br />
of business in New York, doing business in Hillsborough County, <strong>Florida</strong>, engaged in an<br />
industry affecting commerce, and employing in excess of 15 employees. B&L employs over 20<br />
employees.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 2
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 3 of 25 PageID 155<br />
III.<br />
JURISDICTION AND VENUE<br />
6. This court has original jurisdiction under 28 U.S.C. § 1332, as the matter in<br />
controversy exceeds the sum or value of $75,000, exclusive of interest and costs, and is between<br />
citizens of different States.<br />
7. Venue lies in this United States District Court under 28 U.S.C. § 1991(b) and (c) by<br />
virtue of the fact that the Plaintiff resides in this judicial district, and the conduct complained of<br />
herein occurred in this judicial district.<br />
IV.<br />
PROCEDURAL BACKGROUND<br />
8. Plaintiff complied with the administrative prerequisites by filing his initial charge of<br />
discrimination based on national original and disability with the Equal Employment Opportunity<br />
Commission (EEOC) and <strong>Florida</strong> Commission on Human Relations on or about December 10,<br />
2008.<br />
9. The initial charge was amended on or about September 28, 2009, adding “retaliation”<br />
as an additional “cause of discrimination”.<br />
10. A Notice of Right to Sue was issued and mailed on or about March 4, 2010. A<br />
copy of the Dismissal and Notice of Rights was attached to the original complaint and<br />
incorporated by reference as Exhibit “A” to the original complaint.<br />
11. Plaintiff filed his original <strong>Complaint</strong> within ninety (90) days of receipt of the<br />
Notice of Rights.<br />
V. GENERAL FACTS<br />
12. Defendant B&L manufactures medical devices and pharmaceuticals including<br />
contact lenses, products for cleaning and disinfecting contact lenses, eye care products,<br />
prescription and over-the-counter pharmaceutical products for eye conditions including allergies,<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 3
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 4 of 25 PageID 156<br />
conjunctivitis, dry eye, glaucoma, and retinal diseases, nutritional supplements, and ophthalmic<br />
refractive and cataract surgical equipment and products.<br />
13. Defendant hired Plaintiff in February 2006. Plaintiff began his training on March<br />
6, 2006. Plaintiff was employed by B&L until his termination on November 11, 2008.<br />
14. In or about February 2006, as part of the screening process for hire, Plaintiff was<br />
subjected to a physical, including an examination of vision. At that time, Defendant learned<br />
Plaintiff had medical condition affecting his left eye commonly known as amblyopia, a<br />
monocular vision impairment (“lazy eye”), an impairment that may be determined to constitute a<br />
disability under state or federal law.<br />
15. The U.S. Food and Drug Administration (“FDA”) enforces current Good<br />
Manufacturing Practices (cGMPs) and regulations consistent with its authority under the Federal<br />
Food, Drug, and Cosmetic <strong>Act</strong> of 1938, 21 U.S.C. § 351, as amended by the 1976 Medical<br />
Device Amendments. On November 9, 2005, Congress amended the Food, Drug and Cosmetic<br />
<strong>Act</strong> to classify all contact lenses and contact lens care products as medical devices under FDA’s<br />
regulatory authority.<br />
16. Plaintiff was required to perform a number of tasks in his job, including review of<br />
processing records to insure conformance to current Good Manufacturing Practice (cGMPs) and<br />
Standard Operating Procedures (SOPs), the release of production lines to manufacturing, the<br />
verification of products and components, the conduct of on-line inspections, the continuous<br />
monitoring of processes, the identification and report of non-conformances, the performance of<br />
investigations and development of corrective actions, and certifications.<br />
17. Current Good Manufacturing Practices (cGMPs) are regulatory requirements for<br />
all manufacturers of drugs and medical devices, codified at 21 C.F.R., Parts 210, 211, 600 and<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 4
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 5 of 25 PageID 157<br />
820. GMP regulations prescribe that a regulated entity must implement a set of standard<br />
operating procedures to ensure that drugs and medical devices are manufactured to be safe and<br />
effective through employee training, quality design, manufacture, labeling, testing, storage, and<br />
distribution. The requirements in these regulations and 21 C.F.R. Part 820 (hereafter “the<br />
CFRs”) govern the methods used in, and the facilities and controls used for, the design,<br />
manufacture, packaging, labeling, storage, installation, and servicing of all finished devices<br />
intended for human use. Defendant is required to conduct its business in compliance with<br />
various federal and state laws, rules, and regulations governing medical devices and drugs,<br />
including these cGMP regulations.<br />
18. The Standard Operating Procedures (SOPs) to which the Plaintiff was to ensure<br />
compliance constitute procedures mandated by the FDA and the CFRs to be in place and<br />
enforced by the Defendant. The Defendant promulgated specific SOPs designed to insure<br />
compliance with federal regulations, including, but not limited to:<br />
(1) SOP 60-021 “Cleaning and Sanitization of the Aseptic Core” setting<br />
forth specific comprehensive required procedures for cleaning the<br />
aseptic core;<br />
(2) SOP 61-064 “Proper Attire Within the Manufacturing Facility”<br />
mandating gowning, uniforms, and personal cleanliness to ensure<br />
clean and controlled manufacturing;<br />
(3) SOP 62-034 “Packing and Inspecting Filled Product Into Intermediate<br />
Trays” setting forth requirements for inspection, for stopping the line<br />
and documenting findings when inspection reveals internal foreign<br />
material or external cracks or physical defects. SOP 62-034 requires<br />
that caps not be missing, loose, crooked, or dented. SOP 62-034<br />
mandates stopping the filling process, documenting findings in the<br />
batch record, and placing a QA Hold per Policy PP 04, if any "internal<br />
foreign material" is found during the inspection process. The SOP<br />
defines internal foreign material as any particle or substance, including<br />
glass; which can be seen inside the bottle or in the solution during the<br />
visual inspection process.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 5
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 6 of 25 PageID 158<br />
(4) SOP 71-103, “Product Sampling” establishing a uniform procedure<br />
for determining what constitutes an appropriate sample size; and<br />
(5) SOP 71-017 “Visual Inspection” describing in extensive detail the<br />
procedure for the Quality Coordinator’s visual inspection of ointments,<br />
creams, gels, solutions, and suspensions, and rejection of products and<br />
documentation of inspection results. SOP 70-017 requires packaging<br />
tips to be correct in color, uniform in appearance, and free of particles,<br />
shavings, product or foreign residue. SOP 70-017 requires that glass<br />
units must be free of cracks.<br />
19. Defendant’s Policy PP-04, which is mandated by the federal regulations set forth<br />
below, states that all potential non-conformances must be documented on a Material Evaluation<br />
Report (MER) and accompanied by an investigation and samples of any defects, including<br />
adulteration or contamination. “Contamination”, under FDA rules, includes a non-conforming<br />
condition caused by the intrusion or presence of any foreign object in the manufacturing<br />
processes, containers, packaging or product produced. “Adulteration”, under FDA rules,<br />
includes any product unit or product batch that is not manufactured, processed, marketed or<br />
transported in accordance with federal regulations or the manufacturer’s approved SOPs.<br />
20. The MER serves as a primary and federally mandated reporting and evaluation<br />
mechanism for actual or potential manufacturing or use of non-conforming raw materials,<br />
components, in-process and/or finished products that do not meet approved manufacturing<br />
specifications. An MER investigation is necessary for assessing the impact on the contaminated,<br />
adulterated, or otherwise non-conforming or affected product and/or products or processes and<br />
for determining required corrective actions. The Material Review Board is responsible for the<br />
final disposition, dissemination, filing and retention of MERs.<br />
21. Plaintiff has always performed his job in a competent manner or better. On<br />
October 31, 2007 and again on January 18, 2008, the Plaintiff received awards from Defendant<br />
for “focus on excellence.”<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 6
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 7 of 25 PageID 159<br />
22. After being employed by B&L for one year, Plaintiff began applying for other<br />
positions and promotions, which in reverse chronological order were: (a) Compounder I (March<br />
2008); (b) Production Data Associate (January 2008); (c) Administrative Assistant (November<br />
2007); (d) Documentation Analyst (June 2007); (e) Group Leader II (May 2007); and (f) Group<br />
Leader II/Manufacturing (April 2007). Plaintiff was qualified and credentialed for the positions<br />
he sought.<br />
23. Although Hispanics received some of the positions applied for by Plaintiff, their<br />
national origin was Puerto Rican. Upon information and belief, the Plant Manager participated<br />
in the decisions regarding the promotion. The Plant Manager is of Puerto Rican national origin<br />
and showed favoritism to Puerto Rican applicants. Plaintiff’s national origin is Chilean.<br />
VI.<br />
FACTS REGARDING PROTECTED ACTIVITY<br />
24. On or about June 2007, Plaintiff first complained to B&L that he was being<br />
bypassed from promotion based on his national origin.<br />
25. On March 13, 2008, Plaintiff reported that he discovered certain batches and/or<br />
units of B&L’s Muro 128® Ointment for corneal edema were contaminated with foreign<br />
particulate around the dispensing tube tip. Plaintiff stopped the production line, and the “set up”<br />
mechanical technician was instructed to make corrective adjustments to the production line.<br />
After the restart of the line, Plaintiff observed defects on the product tube tips, including fibrousappearing<br />
contaminants and tube caps adulterated by disconfiguration. Plaintiff twice requested<br />
that medication-filling operator MARILYN GUADALUPE halt the line. GUADALUPE ignored<br />
his requests, resulting in uncontaminated and/or unadulterated “good” units being comingled<br />
with apparently contaminated and/or adulterated units. Plaintiff informed his Manufacturing<br />
Team Leader PAMERLY THOMAS that he would submit email notifications, an allowed<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 7
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 8 of 25 PageID 160<br />
process to report non-conforming conditions, to the Quality Team Leader ANITA MUJAGIC<br />
and Manufacturing Manager KENNETH PATTERN regarding the contamination/adulteration,<br />
and the operator refusal to stop the line. Later Plaintiff met with THOMAS, the Quality Group<br />
Leader, and the Manufacturing Filling Operator to emphasize his concerns about the<br />
contamination/adulteration of the product. Additionally, Plaintiff forwarded a report about his<br />
concerns to MUJAGIC on March 14, 2008.<br />
26. On March 18, 2008, Plaintiff observed anomalies while performing required<br />
Quality Control activities on Line 10 for the manufacture of B&L’s Soothe®XP Emollient<br />
(Lubricant), which are eye drops containing a lipid restorative Restoryl. Plaintiff asked the<br />
manufacturing operator to stop the line when he observed units with apparent contaminants<br />
located at the dispensing tube tips. He notified the “set up” mechanical technician of need for a<br />
machine adjustment on the production line. In the meantime, Plaintiff observed manufacturing<br />
defects on production Line A, again requiring an unplanned stopping of the production there.<br />
Upon moving to start a protocol run on Line 1, Plaintiff observed the production line operating<br />
without an attending operator to monitor the medication filling machine operations. He objected<br />
and requested the “set up” mechanical technician to stop the line. When Plaintiff returned again<br />
to the Line 10 production line to recheck its status, Plaintiff discovered that the Quality Group<br />
Leader had closed Plaintiff’s non-conformity comment in the batch folder record and assigned<br />
another Quality Control associate to replace Plaintiff.<br />
27. On March 19, 2008, Plaintiff reported nine units on the medication filling line<br />
with foreign particulates at the dispensing tips in violation of the prescribed accept/reject criteria<br />
for quality control. After corrective mechanical adjustments to the line were attempted, Plaintiff<br />
still found thirty medication units after each adjustment to be defective. Thereupon, the Quality<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 8
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 9 of 25 PageID 161<br />
Group Leader ordered the Plaintiff to record only two defective units in the batch folder, an<br />
inaccurate production anomaly number low enough to allow manufacturing to continue within<br />
the SOPs. The Quality Group Leader also assigned an alternate Quality Control associate to<br />
enter the understated anomaly reports on the incident into the official records.<br />
28. On March 25, 2008, Plaintiff was working the manufacturing fill line #4 for<br />
product albuterol sulfate, a drug inducing bronchial smooth muscle relaxation to aid breathing.<br />
The manufacturing operators completed a production run of three hundred units without<br />
compliance with bottle container testing and quality control procedures. Upon inspection, the<br />
Plaintiff discovered broken glass on the production line. Plaintiff stopped the line and<br />
segregated all units based on the control set point of the preceding quality control check. When<br />
the Plaintiff attempted to remove these 300 units per the SOPs, he was ordered not to do so.<br />
Chemistry/Environmental Associate WANDA ROSARIO subsequently informed the Plaintiff<br />
that she witnessed broken glass containers being processed on Filling Line #4, but that the line<br />
operators failed to follow the required SOPs for prescribed remedial action. The anomaly was<br />
not recorded in the batch folder records as required by SOPs by those responsible for said<br />
records.<br />
29. On March 27, 2008, Plaintiff attended a meeting with Quality Team Leader<br />
MUJAGIC and THOMAS in which he attempted to address his quality and safety concerns<br />
described above, as well as the negative responses and hostile reactions he received and was still<br />
receiving as a result of expressing those concerns to production technicians and supervisors.<br />
30. On April 4, 2008, Plaintiff met with Manufacturing Manager PATTERN to<br />
discuss and seek resolution to his quality and safety concerns described above.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 9
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 10 of 25 PageID 162<br />
31. On May 13, 2008, the Plaintiff discovered seven non-conforming units<br />
warranting rejections while assisting a colleague with her hourly quality control inspection<br />
duties. When said colleague reported this to Quality Group Leader GORDON, he instructed her<br />
to ignore the non-conformities and enter no reported findings to the contrary.<br />
32. On May 14, 2008, the Plaintiff observed that a line operator failed to change her<br />
prescribed personal protective clothing though it was considered contaminated after contact with<br />
the production floor, in violation of SOP 60-029-24. Plaintiff reported this nonconformity to the<br />
Training Certification Specialist JO GALLO, who agreed that there was a violation and<br />
suggested that the Plaintiff himself educate the operator to proper application of said SOP. This<br />
ad hoc supervisory and training protocol also violated the SOPs and CFRs governing training<br />
and supervision.<br />
33. On May 20, 2008, the Plaintiff informed THOMAS and Manufacturing Group<br />
Leader ANDRE BENT that he had detected a non-conforming manufacturing process due the<br />
presence of an unidentified bottle container with improperly labeled product. An MER and<br />
disciplinary action resulted as to the offending associates for violation of SOPs.<br />
34. On May 21, 2008, the Plaintiff reported to Defendant’s Chemistry Management<br />
staff DOUG COMMERCE and JUDITH RODRIGUEZ that Associate MADELINE<br />
GUADALUPE had failed to log into an operating production. Accurate personnel logging is<br />
critical to required trace-back procedures in the event of subsequently discovered<br />
contamination/adulteration. The Plaintiff also reported 53,300 units of Fluress (Fluorescein and<br />
Benoxinate) anesthetic agent solution being contaminated/adulterated due to the presence of<br />
glass fragments in the packaging stage. The Plaintiff complained that this<br />
contamination/adulteration incident shared the same root cause and the same associates as prior<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 10
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 11 of 25 PageID 163<br />
events, meriting investigation and corrective action under SOPs. The Plaintiff complained that<br />
the required documentation per the SOP was missing or improperly recorded.<br />
35. On May 21, 2008, following up on discussions the Plaintiff had with WANDA<br />
ROSARIO about the recurring breakages on production line 4, the Plaintiff requested that<br />
ROSARIO identify the SOPs governing the cleaning steps an operator must follow to remediate<br />
glass contamination/adulteration.<br />
36. On May 30, 2008, the Plaintiff expressed concern to Quality Group Leader<br />
GORDON that he had not received the SOP prescribed level of training sufficient to enable him<br />
to enter training form certifications in the Defendant’s data system.<br />
37. In or about June 2008, the Plaintiff complained about being bypassed from<br />
promotion based on his national origin after being denied the Compounder I position in May<br />
2008.<br />
38. On June 10, 2008, the Plaintiff notified THOMAS and GORDON that he<br />
discovered excess unit counts in the filling production line. THOMAS and GORDON told the<br />
Plaintiff to take no action other than discarding the excess unit. The Plaintiff objected because<br />
SOPs set forth a specific procedure governing responses to excess unit counts. SOP 60-021<br />
“Cleaning and Sanitization of the Aseptic Core” also specifies that the sanitization process<br />
include a line clearance of rejected filled and empty containers at the end of each working shift.<br />
Later that day, the Plaintiff objected to THOMAS that a filling associate was present inside the<br />
manufacturing area without wearing prescribed personal protective clothing, in violation of SOP<br />
61-064, which prescribes guidelines for “Proper Attire Within the Manufacturing Facility”.<br />
39. On June 12, 2008, in response to the Quality Control Supervisor’s inquiries, the<br />
Plaintiff objected to her accusatorial interrogation of him as to justifications for his prior<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 11
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 12 of 25 PageID 164<br />
stopping of production lines. He explained that Defendant’s failure to properly respond to<br />
nonconformities had mandated his actions. He further suggested that the Defendant was in effect<br />
ratifying the wrongful and/or illegal conduct of its employees in its inadequate responses to the<br />
nonconformities.<br />
40. From June 16 -30, 2008, the scheduled manufacturing operations were shut<br />
down. During this time, the Plaintiff attended a meeting conducted by the new Quality<br />
Assurance Direction WENDY GOULD. During said meeting, the Plaintiff raised many of his<br />
above stated concerns, in the presence of all attendees, and urged review of the apparent<br />
shortcomings in business ethics within the Quality Department.<br />
41. On July 14, 2008, the Plaintiff observed defects in the product similar to those<br />
referenced above and reported these to the maintenance mechanic and operator. Plaintiff<br />
requested that operator GUDALUPE stop the line, but GORDON overruled the Plaintiff. Later<br />
that day, the Plaintiff was called to a meeting with THOMAS, GUADALUPE, and GORDON in<br />
which he was subjected to hostile questions as to his justifications in stopping the production line<br />
being operated by GUADALUPE. The Plaintiff informed the attendees of his reasons, and<br />
offered proof in the form of a defect sample bottle he had secured.<br />
42. On July 15, 2008, the Plaintiff reported to MQA Manager MONICA BRIGGS,<br />
Team Leader Quality ANITA MUJAGIC, and HR Representative JAVIER CALLEJAS of many<br />
of the anomalies referenced above and the ongoing resistance and hostility he was facing for<br />
stopping the line in order to adhere to production and safety standards. The Plaintiff expressed<br />
his view that the Defendant was committing and ratifying violations of the CFRs and SOPs. The<br />
Plaintiff produced the secured sample referenced above to BRIGGS, CALLEJAS, and<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 12
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 13 of 25 PageID 165<br />
MUJAGIC and requested review of security camera media to verify that he had taken the<br />
prescribed actions to prevent shipping of defective product into the market.<br />
43. On July 16, 2008, the Plaintiff requested copies of certain Transaction History<br />
Inquiry reports to document the appropriate of his remedial responses to the above anomalous<br />
events.<br />
44. On July 17, 2008, the Plaintiff informed GORDON that he lacked the prescribed<br />
training to perform the inspection duties assigned to him on the Ocucoat® Viscoelastic<br />
production line, an ophthalmic surgical aid. Despite this, he was not given the prescribed<br />
training.<br />
45. On July 18, 2008, the Plaintiff informed QA Manager BRIGGS that, as to one or<br />
more of the anomalous events described above, Defendant was acting in violation of the CFRs.<br />
MQA section manager BONEWHITT admonished Plaintiff about the retaliation another<br />
whistleblower had suffered from complaining about violations when he previously mentioned<br />
the CFR violations.<br />
46. On July 22, 2008, Plaintiff’s prior legal counsel informed Defendant’s<br />
CALLEJAS that the Plaintiff had retained a law firm to protect himself from violations of his<br />
legal rights in employment.<br />
47. On July 25, 2008, the Plaintiff reported to Environmental Associate WANDA<br />
ROSARIO that it appeared that one of the production lines had been unmonitored during the<br />
second shift on July 24, 2008. Required documentation demonstrating mandated monitoring was<br />
absent from official records in violation of SOPs.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 13
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 14 of 25 PageID 166<br />
48. On October 10, 2008, the Plaintiff’s prior counsel, reiterated to CALLEJAS the<br />
Plaintiff’s concerns regarding defective products and inappropriate management pressures to<br />
certify defective products as having met prescribed inspection criteria.<br />
49. On November 3, 2008, when the Plaintiff reported back to work following<br />
approved Family Medical Leave that commenced August 4, 2008, Defendant managers<br />
CALLEGAS and MUJAGIC called him into a meeting. They questioned him regarding his<br />
retention of legal counsel to assert his employment rights. The Plaintiff referenced these<br />
supervisors to the history of his compliance reports and complaints and the failure to remediate<br />
the resulting hostile work environment and other retaliatory actions. The Plaintiff then requested<br />
of MUJAGIC that he be retrained pursuant to SOP 80-010, which requires retraining for Quality<br />
Coordinators who have been absent for over one month. MUJAGIC questioned the need for such<br />
SOP compliance.<br />
50. On November 4, 2008, Plaintiff undertook the required post-absence review of<br />
current SOP revisions. THOMAS summoned Plaintiff to the line, where WALKER informed<br />
Plaintiff that he was needed to start the production line. Having not yet completed the required<br />
SOP currency review, or otherwise having completed mandated training, Plaintiff informed<br />
WALKER he could not accept responsibility for the production line, which Plaintiff reiterated to<br />
GORDON.<br />
51. The next day, November 5, 2008, the Plaintiff questioned MUJAGIC and<br />
CALLEJAS as to regulatory compliance regarding recently completed production and packaging<br />
runs. They refused to answer.<br />
52. On November 10, 2008, the Plaintiff communicated the above referenced<br />
concerns to FDA officials.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 14
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 15 of 25 PageID 167<br />
VII.<br />
FACTS REGARDING ADVERSE ACTIONS<br />
53. The adverse actions taken against the Plaintiff exhibit a pattern of retaliation for<br />
the above referenced protected activity. These adverse actions included:<br />
54. Plaintiff was subjected to the ongoing maintenance and failure to abate a hostile<br />
work environment against him, which included abusive and berating language, insults, ridicule,<br />
threats, and hostile interrogations.<br />
55. On March 13, 2008, THOMAS verbally abused Plaintiff because he stopped<br />
the production line and stated his intent to contacting higher management regarding compliance<br />
violations.<br />
56. On or about March 25, 2008, Plaintiff’s Second Shift Quality Group Leader<br />
threatened Plaintiff with words to the effect that, “remember HR leaves at 17:00, after that you<br />
are stuck with us”, and “I don’t know how much you need your job but...”.<br />
57. On June 10, 2008, in response to the Plaintiff’s concerns regarding improper attire<br />
in violation of SOPs, THOMAS informed Plaintiff she was unwilling to discuss the problem and<br />
dismissively rebuked him with words to the effect of “go to HR”.<br />
58. On June 12, 2008, GORDON forbade Plaintiff from (a) observing work lines<br />
during his lunch hour as other employees could; (b) observing or making compliance reports<br />
about production lines to which he was not assigned; or (c) communicating his compliance<br />
concerns directly to manufacturing leaders without prior approval of GORDON. Plaintiff was<br />
also admonished against emailing other department’s managers about his compliance concerns.<br />
59. On July 14, 2008, Defendant managers and Human Resources falsely accused and<br />
reprimanded Plaintiff for improperly stopping the production line and breaching protocol by not<br />
first communicating with the operator of the offending line. BRIGGS verbally reprimanded<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 15
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 16 of 25 PageID 168<br />
Plaintiff for securing the above referenced defective product samples in his locker which he<br />
offered as proof of Defendant’s noncompliant operations and admonished him to cease similar<br />
evidence collection without management approval.<br />
60. On July 17, 2008, GORDON refused Plaintiff adequate training to perform his<br />
duties on the OcuCoat® line.<br />
61. On July 18, 2008, Plaintiff was issued a written warning for lack of collaboration<br />
and credibility.<br />
62. On October 25, 2008, Plaintiff’s position was posted on-line as an open job<br />
position.<br />
63. On November 4, 2008, Defendant again denied Plaintiff requested training.<br />
64. On November 5, 2008, the Defendant issued the Plaintiff a written warning for<br />
making copies from a batch folder documenting the above referenced glass<br />
contamination/adulteration and providing those copies to his legal counsel. Defendant refused to<br />
provide the Plaintiff with a copy of the warning. CALLEJAS informed the Plaintiff that<br />
Defendant would be investigating the issue while the Plaintiff was absent on vacation and unable<br />
to effectively participate in said investigation.<br />
65. On November 11, 2008, Defendant terminated Plaintiff, on the stated grounds of<br />
insubordination for Plaintiff’s “refus[al] to perform his duties as requested…”<br />
VIII. CLAIMS FOR RELIEF<br />
FIRST CLAIM FOR RELIEF: VIOLATION OF THE FLORIDA CIVIL RIGHTS ACT<br />
COUNT I – FCRA (National Origin)<br />
66. Plaintiff realleges and incorporates by reference Paragraphs 1 through 65, as<br />
though set forth herein verbatim.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 16
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 17 of 25 PageID 169<br />
67. This action is based on a violation of the <strong>Florida</strong> Statute, Chapter 760, <strong>Florida</strong><br />
Civil Rights <strong>Act</strong>.<br />
68. B&L, via its agents, representatives, and employees, discriminated against<br />
Plaintiff because of his national origin.<br />
69. As a result of B&L’s unlawful employment practices, Plaintiff has been damaged.<br />
70. WHEREFORE, the Plaintiff, respectfully prays that this Honorable Court take<br />
jurisdiction of the subject matter and parties hereto, and grant his request for trial by jury, declare<br />
that the Defendant violated the rights of Plaintiff as protected by the laws of the State of <strong>Florida</strong>,<br />
and award back pay, front pay, prejudgment interest, compensatory damages for mental anguish,<br />
emotional distress, embarrassment, humiliation, loss of enjoyment of life, loss of dignity,<br />
impairment of working ability and earning capacity and loss of reputation, reasonable attorney’s<br />
fees pursuant to <strong>Florida</strong> Statute, § 760.11 and costs, and such other relief as deemed appropriate<br />
by this Court.<br />
COUNT II – FCRA (Disability)<br />
71. Plaintiff realleges and incorporates by reference Paragraphs 1 through 70, as<br />
though set forth herein verbatim.<br />
72. This action is based on a violation of the <strong>Florida</strong> Statute, Chapter 760, <strong>Florida</strong><br />
Civil Rights <strong>Act</strong>.<br />
73. B&L, via its agents, representatives, and employees, discriminated against<br />
Plaintiff because of his disability.<br />
74. B&L failed to provide Plaintiff a reasonable accommodation for his disability.<br />
75. As a result of B&L’s unlawful employment practices, Plaintiff has been damaged.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 17
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 18 of 25 PageID 170<br />
76. WHEREFORE, the Plaintiff, respectfully prays that this Honorable Court take<br />
jurisdiction of the subject matter and parties hereto, and grant his request for trial by jury, declare<br />
that the Defendant violated the rights of Plaintiff as protected by the laws of the State of <strong>Florida</strong>,<br />
and award back pay, front pay, prejudgment interest, compensatory damages for mental anguish,<br />
emotional distress, embarrassment, humiliation, loss of enjoyment of life, loss of dignity,<br />
impairment of working ability and earning capacity and loss of reputation, reasonable attorney’s<br />
fees pursuant to <strong>Florida</strong> Statute, § 760.11 and costs, and such other relief as deemed appropriate<br />
by this Court.<br />
COUNT III – FCRA (Retaliation)<br />
77. Plaintiff realleges and incorporates by reference Paragraphs 1 through 76, as<br />
though set forth herein verbatim.<br />
78. This action is based on a violation of the <strong>Florida</strong> Statute, Chapter 760, <strong>Florida</strong><br />
Civil Rights <strong>Act</strong>.<br />
79. B&L, via its agents, representatives, and employees, retaliated against Plaintiff<br />
because of his complaints about discrimination and B&L’s failure to promote him on the basis of<br />
his national origin. As a result of B&L’s unlawful employment practices, Plaintiff has been<br />
damaged.<br />
80. WHEREFORE, the Plaintiff, respectfully prays that this Honorable Court take<br />
jurisdiction of the subject matter and parties hereto, and grant his request for trial by jury, declare<br />
that the Defendant violated the rights of Plaintiff as protected by the laws of the State of <strong>Florida</strong>,<br />
and award back pay, front pay, prejudgment interest, compensatory damages for mental anguish,<br />
emotional distress, embarrassment, humiliation, loss of enjoyment of life, loss of dignity,<br />
impairment of working ability and earning capacity and loss of reputation, reasonable attorney’s<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 18
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 19 of 25 PageID 171<br />
fees pursuant to <strong>Florida</strong> Statute, § 760.11 and costs, and such other relief as deemed appropriate<br />
by this Court.<br />
COUNT IV: NEGLIGENT SUPERVISION/TRAINING/RETENTION<br />
81. Plaintiff realleges and incorporates by reference Paragraphs 1 through 80, as<br />
though set forth herein verbatim.<br />
82. This is a common law action of negligent supervision, training and/or retention.<br />
During the course of Plaintiff’s employment with B&L, B&L via its agents, representatives, and<br />
employees in supervisory or management positions, had a duty to Plaintiff to properly supervise,<br />
train and discipline his supervisors regarding the legal responsibilities of an employer under<br />
<strong>Florida</strong> law regarding discrimination and retaliatory treatment.<br />
83. During the course of Plaintiff’s employment with B&L, B&L via its agents,<br />
representatives, and employees in supervisory or management positions, failed in its duty to<br />
properly supervise, train and discipline Plaintiff’s supervisors regarding the legal responsibilities<br />
of an employer under <strong>Florida</strong> law regarding discrimination and retaliatory treatment.<br />
84. As a direct and proximate result of B&L’s negligent breach of duty, Plaintiff<br />
suffered permanent and/or continuing injuries and sustained the following past and future<br />
damages:<br />
A. Mental pain;<br />
B. Severe emotional distress in the form of fear, nervousness, anxiety, worry and<br />
indignity;<br />
C. Embarrassment;<br />
D. Humiliation;<br />
E. Loss of enjoyment of life;<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 19
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 20 of 25 PageID 172<br />
F. Impairment of working ability and earning capacity;<br />
G. Loss of dignity; and<br />
H. Future pay.<br />
85. WHEREFORE, the Plaintiff respectfully prays that this Honorable Court take<br />
jurisdiction of the subject matter and parties hereto, grant his request for trial by jury, enter<br />
judgment against Defendant and award compensatory damages, consequential damages, costs,<br />
interest and such other relief as deemed appropriate by this Court.<br />
SECOND CLAIM FOR RELIEF:<br />
VIOLATION OF FLORIDA’S PRIVATE WHISTLE BLOWER ACT<br />
86. Plaintiff realleges and incorporates by reference Paragraphs 1 through 85, as<br />
though set forth herein verbatim.<br />
87. This is an action for violation of <strong>Florida</strong>’s <strong>Private</strong> <strong>Whistleblower</strong> <strong>Act</strong> §§448.1010-<br />
448.105, <strong>Florida</strong> Statutes (<strong>Whistleblower</strong> <strong>Act</strong>) with damages in excess of $15,000.<br />
88. Plaintiff is within the protected class of individuals as defined under <strong>Florida</strong><br />
Statutes §448.01.<br />
89. Defendant is, and at all material times, was an “employer” within the meaning of<br />
<strong>Florida</strong> Statutes §448.101.<br />
90. During his employment with B&L, the Plaintiff objected to, or refused to<br />
participate in an activity, policy or practice in violation of a law, rule, or regulation. The<br />
Defendant as a manufacturer of medical devices and drugs was required to conduct its business<br />
in compliance with federal and state law and regulations, including the following regulations<br />
governing training, cleaning, appropriate attire, quality control, process and procedure control,<br />
and investigations of complaints, the violations of which Plaintiff objected to:<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 20
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 21 of 25 PageID 173<br />
1. Training (medical devices and drugs): 21 C.F.R. §820.25 (a) and (b) requires<br />
Defendant, as a manufacturer of medical devices, to proactively identify training needs<br />
and provide training for personnel to correctly perform the work activities. 21 C.F.R.<br />
§ 211.22 requires the Defendant, as a manufacturer of drugs, to train its employees in<br />
cGMPs and SOPs with sufficient frequency and consistency to ensure continuing<br />
familiarity and to assure drug product safety and quality.<br />
2. Processes (medical devices): 21 C.F.R. §820.70 requires that the Defendant control<br />
production processes to ensure that a device conforms to its specifications, standards and<br />
codes, including developing SOPs to define and control the manner of production.<br />
3. Hygiene and Dress (medical devices): 21 C.F.R. § 820.70 (d) requires Defendant to<br />
maintain requirements for personnel clothing and cleanliness to prevent contamination or<br />
adulteration of product.<br />
4. Hygiene and Dress (drugs): 21 C.F.R § 211.28 requires the Defendant to maintain<br />
requirements for personnel clothing and cleanliness to prevent contamination or<br />
adulteration of any product or equipment.<br />
5. Corrective action (medical devices): 21 C.F.R. §820.100 requires the Defendant<br />
maintain procedures for implementing corrective and preventive action, including<br />
procedures for analyzing all existing data to identify and remedy any existing or potential<br />
quality problems, as well as to detect recurring quality problems and causes.<br />
6. Quality Control (drugs): 21 C.F.R. § 211.22 requires the Defendant have a quality<br />
control unit invested with responsibility and authority to approve or reject all<br />
components, drug product containers, packaging material, labeling, and drug products,<br />
and the authority to review production records to assure that no errors have occurred.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 21
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 22 of 25 PageID 174<br />
The responsibilities and procedures applicable to the unit must be followed and in<br />
writing.<br />
7. Microbial control (drugs): 21 C.F.R. 211.113 requires the Defendant have appropriate<br />
written procedures to prevent contamination and adulteration.<br />
8. Testing (drugs): 21 C.F.R. 211.165 requires the Defendant to create and follow<br />
adequate sampling and testing plans to ensure drug quality and to reject drugs failing to<br />
meet standards or specifications.<br />
9. Documentation (drugs): 21 C.F.R. 211.188 requires the Defendant to maintain batch<br />
production and control records with complete information about the drug production,<br />
including the personnel involved in the process, and the results of any investigation into<br />
product discrepancies.<br />
10. Production Record Review (drugs): 21 C.F.R. 211.192 requires that the Defendant<br />
have the quality control unit review and approve all drug product production and control<br />
records to ensure compliance with SOPs and to thoroughly investigate and record any<br />
discrepancies or failures to meet specifications.<br />
11. Investigations Required (drugs): 21 C.F.R. § 211.198 requires the Defendant to<br />
follow written procedures to handle all complaints about a drug product, including how<br />
and whether to conduct a formal investigation or report to the FDA.<br />
91. Defendant had knowledge of each of the Plaintiff’s disclosures, complaints,<br />
reports and protected activity set forth above in the “Facts Regarding Protected <strong>Act</strong>ivity” section<br />
hereof, including his reports of violations of SOPs, cGMPs, and CFR sections. Each of said<br />
disclosures, complaints and reports demonstrate that the Defendant violated one or more of the<br />
laws, rules and regulations enumerated in paragraphs 90.1 to 90.11.<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 22
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 23 of 25 PageID 175<br />
92. The Defendant took each of the retaliatory personnel actions against Plaintiff set<br />
forth above in the “Facts Regarding Adverse <strong>Act</strong>ions” section hereof, because the Plaintiff<br />
objected to, or refused to participate in, the above listed activities, policies, or practices of the<br />
Defendant which were or would have been in violation of the laws, rules, or regulations set forth<br />
in paragraphs 90.1 to 90.11.<br />
93. In retaliating against and terminating the Plaintiff though use of the above<br />
referenced adverse actions, Defendant was in violation of the <strong>Florida</strong> <strong>Whistleblower</strong> <strong>Act</strong>. Said<br />
violation inflicted upon the Plaintiff the economic, non-economic, compensatory, special,<br />
monetary, career, and emotional damages set forth above in the First Claim for Relief.<br />
94. The Plaintiff is entitled to the recovery of reasonable attorney’s fees and costs<br />
pursuant to § 448.104, <strong>Florida</strong> Statutes.<br />
95. Based on the foregoing, the Plaintiff requests the following relief:<br />
A. The Plaintiff should be reinstated to his former position with back pay, retirement<br />
contributions, pay raises and cost of living increases, seniority privileges, and all other benefits,<br />
together with the monetary value of all lost benefits, including the value of lost retirement<br />
benefits and health insurance; and upon such reinstatement, the court should enjoin the defendant<br />
from engaging in such unlawful employment practices, and order such other affirmative action as<br />
may be appropriate;<br />
B. If the Plaintiff is not reinstated, then Plaintiff should be awarded back pay or wages<br />
lost and benefits, and for such legal or equitable relief as may be appropriate;<br />
C. Under all claims, if Plaintiff is not reinstated, then Plaintiff should be awarded<br />
monetary damages for front pay and benefits, including retirement benefits and health insurance,<br />
reduced to present value, for a term of years to be determined at trial;<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 23
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 24 of 25 PageID 176<br />
D. Under all claims, Plaintiff should be awarded compensatory damages, the exact<br />
amount to be determined at trial;<br />
E. Under all claims, Plaintiff should be awarded interest on back pay and lost wages, and<br />
such other equitable and affirmative relief as may be appropriate; and;<br />
F. Plaintiff should be awarded his reasonable attorney's fees and litigation expenses and<br />
damages related to seeking medical care and treatment associated with this matter.<br />
Respectfully submitted,<br />
s/Richard F. Meyers, Esquire<br />
Richard F. Meyers, Esquire<br />
9340 North 56 th Street, Suite 220-A<br />
Temple Terrace, <strong>Florida</strong> 33617<br />
(813)985-6550<br />
(813)985-5282 (fax)<br />
Fla. Bar No. 0893315<br />
Trial Counsel<br />
Thad M. Guyer, Pro Hac Vice Pending<br />
(Oregon Bar # 82144)<br />
E-mail tmguyer@tmguyer.com<br />
Trial Counsel<br />
Attorneys for Plaintiff<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 24
Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 25 of 25 PageID 177<br />
First <strong>Amended</strong> <strong>Complaint</strong>, page 25