Private Sector Florida Whistleblower Act Amended Complaint.

Case 8:10-cv-02003-RAL-TGW Document 7-1 Filed 11/02/10 Page 1 of 25 PageID 153 

Richard F. Meyers, Esquire 

9340 North 56 th Street, Suite 220-A 

Temple Terrace, Florida 33617 

(813)985-6550 

(813)985-5282 (fax) 

Fla. Bar No. 0893315 

Thad M. Guyer, Pro Hac Vice pending (Oregon State Bar # 82144) 

On behalf of the Government Accountability Project 

1612 K Street NW, Suite 1100 

Washington, DC 20006 

Ph: 541.203.0690 

Fax: 1.888.866.4720 

Email: thad@guyerayers.com 

Attorneys for Plaintiff 

CARLOS RAMIREZ, 

IN THE UNITED STATES DISTRICT COURT 

FOR THE MIDDLE DISTRICT OF FLORIDA 

TAMPA DIVISION 

Plaintiff, 

v. Case No. 10-cv-02003-RAL-TGW 

FIRST AMENDED COMPLAINT 

BAUSCH & LOMB, 

PHARMACEUTICALS, INC. 

DEMAND FOR JURY TRIAL 

Defendant. 

__________________________________ 

Plaintiff, through his counsel, alleges as follows: 

I. INTRODUCTION 

1. This is a whistleblower retaliation complaint by an employee, Plaintiff CARLOS 

RAMIREZ, against his former employer, Defendant BAUSCH & LOMB, INC., based upon the 

Defendant’s retaliatory removal of RAMIREZ from his employment because of protected 

disclosures he made under the Florida Private Whistleblower Act, Sections 448.101 et. seq, 

First Amended Complaint, page 1


Florida Statutes. This is also a complaint for discrimination against the Plaintiff due to his 

national origin (Chilean) and disability (amblyopia, a monocular vision impairment), and for 

retaliation for objecting to employer’s discriminatory practices under Florida Statute, Chapter 

760, Florida Civil Rights Act. 

2. Plaintiff, formerly a Quality Coordinator in the Manufacturing Quality Assurance 

Department for the Defendant Bausch & Lomb, Inc., alleges herein that he was terminated from 

his job in retaliation for his disclosures of lack of product quality and safety and violations of 

laws, rules, and regulations and for objecting to the Defendant’s discriminatory practices. 

3. Plaintiff seeks reinstatement to his position as a Quality Coordinator of Bausch & 

Lomb, back pay and benefits, and compensatory damages, including an award for emotional 

distress, together with an award of reasonable costs and attorneys fees. If reinstatement is not 

found to be the appropriate remedy, then Plaintiff should be awarded front pay in lieu of 

reinstatement. 

II. 

PARTIES 

4. Plaintiff is a citizen of the Republic of Chile, and a legal resident alien of the United 

States for 20 years, and a resident of Hillsborough County, Florida. Plaintiff is of Hispanic 

descent, from the country of Chile, and is male. 

5. Defendant B&L is a corporation headquartered in New York, with its principal place 

of business in New York, doing business in Hillsborough County, Florida, engaged in an 

industry affecting commerce, and employing in excess of 15 employees. B&L employs over 20 

employees. 



III. 

JURISDICTION AND VENUE 

6. This court has original jurisdiction under 28 U.S.C. § 1332, as the matter in 

controversy exceeds the sum or value of $75,000, exclusive of interest and costs, and is between 

citizens of different States. 

7. Venue lies in this United States District Court under 28 U.S.C. § 1991(b) and (c) by 

virtue of the fact that the Plaintiff resides in this judicial district, and the conduct complained of 

herein occurred in this judicial district. 

IV. 

PROCEDURAL BACKGROUND 

8. Plaintiff complied with the administrative prerequisites by filing his initial charge of 

discrimination based on national original and disability with the Equal Employment Opportunity 

Commission (EEOC) and Florida Commission on Human Relations on or about December 10, 

2008. 

9. The initial charge was amended on or about September 28, 2009, adding “retaliation” 

as an additional “cause of discrimination”. 

10. A Notice of Right to Sue was issued and mailed on or about March 4, 2010. A 

copy of the Dismissal and Notice of Rights was attached to the original complaint and 

incorporated by reference as Exhibit “A” to the original complaint. 

11. Plaintiff filed his original Complaint within ninety (90) days of receipt of the 

Notice of Rights. 

V. GENERAL FACTS 

12. Defendant B&L manufactures medical devices and pharmaceuticals including 

contact lenses, products for cleaning and disinfecting contact lenses, eye care products, 

prescription and over-the-counter pharmaceutical products for eye conditions including allergies, 



conjunctivitis, dry eye, glaucoma, and retinal diseases, nutritional supplements, and ophthalmic 

refractive and cataract surgical equipment and products. 

13. Defendant hired Plaintiff in February 2006. Plaintiff began his training on March 

6, 2006. Plaintiff was employed by B&L until his termination on November 11, 2008. 

14. In or about February 2006, as part of the screening process for hire, Plaintiff was 

subjected to a physical, including an examination of vision. At that time, Defendant learned 

Plaintiff had medical condition affecting his left eye commonly known as amblyopia, a 

monocular vision impairment (“lazy eye”), an impairment that may be determined to constitute a 

disability under state or federal law. 

15. The U.S. Food and Drug Administration (“FDA”) enforces current Good 

Manufacturing Practices (cGMPs) and regulations consistent with its authority under the Federal 

Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 351, as amended by the 1976 Medical 

Device Amendments. On November 9, 2005, Congress amended the Food, Drug and Cosmetic 

Act to classify all contact lenses and contact lens care products as medical devices under FDA’s 

regulatory authority. 

16. Plaintiff was required to perform a number of tasks in his job, including review of 

processing records to insure conformance to current Good Manufacturing Practice (cGMPs) and 

Standard Operating Procedures (SOPs), the release of production lines to manufacturing, the 

verification of products and components, the conduct of on-line inspections, the continuous 

monitoring of processes, the identification and report of non-conformances, the performance of 

investigations and development of corrective actions, and certifications. 

17. Current Good Manufacturing Practices (cGMPs) are regulatory requirements for 

all manufacturers of drugs and medical devices, codified at 21 C.F.R., Parts 210, 211, 600 and 



820. GMP regulations prescribe that a regulated entity must implement a set of standard 

operating procedures to ensure that drugs and medical devices are manufactured to be safe and 

effective through employee training, quality design, manufacture, labeling, testing, storage, and 

distribution. The requirements in these regulations and 21 C.F.R. Part 820 (hereafter “the 

CFRs”) govern the methods used in, and the facilities and controls used for, the design, 

manufacture, packaging, labeling, storage, installation, and servicing of all finished devices 

intended for human use. Defendant is required to conduct its business in compliance with 

various federal and state laws, rules, and regulations governing medical devices and drugs, 

including these cGMP regulations. 

18. The Standard Operating Procedures (SOPs) to which the Plaintiff was to ensure 

compliance constitute procedures mandated by the FDA and the CFRs to be in place and 

enforced by the Defendant. The Defendant promulgated specific SOPs designed to insure 

compliance with federal regulations, including, but not limited to: 

(1) SOP 60-021 “Cleaning and Sanitization of the Aseptic Core” setting 

forth specific comprehensive required procedures for cleaning the 

aseptic core; 

(2) SOP 61-064 “Proper Attire Within the Manufacturing Facility” 

mandating gowning, uniforms, and personal cleanliness to ensure 

clean and controlled manufacturing; 

(3) SOP 62-034 “Packing and Inspecting Filled Product Into Intermediate 

Trays” setting forth requirements for inspection, for stopping the line 

and documenting findings when inspection reveals internal foreign 

material or external cracks or physical defects. SOP 62-034 requires 

that caps not be missing, loose, crooked, or dented. SOP 62-034 

mandates stopping the filling process, documenting findings in the 

batch record, and placing a QA Hold per Policy PP 04, if any "internal 

foreign material" is found during the inspection process. The SOP 

defines internal foreign material as any particle or substance, including 

glass; which can be seen inside the bottle or in the solution during the 

visual inspection process. 



(4) SOP 71-103, “Product Sampling” establishing a uniform procedure 

for determining what constitutes an appropriate sample size; and 

(5) SOP 71-017 “Visual Inspection” describing in extensive detail the 

procedure for the Quality Coordinator’s visual inspection of ointments, 

creams, gels, solutions, and suspensions, and rejection of products and 

documentation of inspection results. SOP 70-017 requires packaging 

tips to be correct in color, uniform in appearance, and free of particles, 

shavings, product or foreign residue. SOP 70-017 requires that glass 

units must be free of cracks. 

19. Defendant’s Policy PP-04, which is mandated by the federal regulations set forth 

below, states that all potential non-conformances must be documented on a Material Evaluation 

Report (MER) and accompanied by an investigation and samples of any defects, including 

adulteration or contamination. “Contamination”, under FDA rules, includes a non-conforming 

condition caused by the intrusion or presence of any foreign object in the manufacturing 

processes, containers, packaging or product produced. “Adulteration”, under FDA rules, 

includes any product unit or product batch that is not manufactured, processed, marketed or 

transported in accordance with federal regulations or the manufacturer’s approved SOPs. 

20. The MER serves as a primary and federally mandated reporting and evaluation 

mechanism for actual or potential manufacturing or use of non-conforming raw materials, 

components, in-process and/or finished products that do not meet approved manufacturing 

specifications. An MER investigation is necessary for assessing the impact on the contaminated, 

adulterated, or otherwise non-conforming or affected product and/or products or processes and 

for determining required corrective actions. The Material Review Board is responsible for the 

final disposition, dissemination, filing and retention of MERs. 

21. Plaintiff has always performed his job in a competent manner or better. On 

October 31, 2007 and again on January 18, 2008, the Plaintiff received awards from Defendant 

for “focus on excellence.” 



22. After being employed by B&L for one year, Plaintiff began applying for other 

positions and promotions, which in reverse chronological order were: (a) Compounder I (March 

2008); (b) Production Data Associate (January 2008); (c) Administrative Assistant (November 

2007); (d) Documentation Analyst (June 2007); (e) Group Leader II (May 2007); and (f) Group 

Leader II/Manufacturing (April 2007). Plaintiff was qualified and credentialed for the positions 

he sought. 

23. Although Hispanics received some of the positions applied for by Plaintiff, their 

national origin was Puerto Rican. Upon information and belief, the Plant Manager participated 

in the decisions regarding the promotion. The Plant Manager is of Puerto Rican national origin 

and showed favoritism to Puerto Rican applicants. Plaintiff’s national origin is Chilean. 

VI. 

FACTS REGARDING PROTECTED ACTIVITY 

24. On or about June 2007, Plaintiff first complained to B&L that he was being 

bypassed from promotion based on his national origin. 

25. On March 13, 2008, Plaintiff reported that he discovered certain batches and/or 

units of B&L’s Muro 128® Ointment for corneal edema were contaminated with foreign 

particulate around the dispensing tube tip. Plaintiff stopped the production line, and the “set up” 

mechanical technician was instructed to make corrective adjustments to the production line. 

After the restart of the line, Plaintiff observed defects on the product tube tips, including fibrousappearing 

contaminants and tube caps adulterated by disconfiguration. Plaintiff twice requested 

that medication-filling operator MARILYN GUADALUPE halt the line. GUADALUPE ignored 

his requests, resulting in uncontaminated and/or unadulterated “good” units being comingled 

with apparently contaminated and/or adulterated units. Plaintiff informed his Manufacturing 

Team Leader PAMERLY THOMAS that he would submit email notifications, an allowed 



process to report non-conforming conditions, to the Quality Team Leader ANITA MUJAGIC 

and Manufacturing Manager KENNETH PATTERN regarding the contamination/adulteration, 

and the operator refusal to stop the line. Later Plaintiff met with THOMAS, the Quality Group 

Leader, and the Manufacturing Filling Operator to emphasize his concerns about the 

contamination/adulteration of the product. Additionally, Plaintiff forwarded a report about his 

concerns to MUJAGIC on March 14, 2008. 

26. On March 18, 2008, Plaintiff observed anomalies while performing required 

Quality Control activities on Line 10 for the manufacture of B&L’s Soothe®XP Emollient 

(Lubricant), which are eye drops containing a lipid restorative Restoryl. Plaintiff asked the 

manufacturing operator to stop the line when he observed units with apparent contaminants 

located at the dispensing tube tips. He notified the “set up” mechanical technician of need for a 

machine adjustment on the production line. In the meantime, Plaintiff observed manufacturing 

defects on production Line A, again requiring an unplanned stopping of the production there. 

Upon moving to start a protocol run on Line 1, Plaintiff observed the production line operating 

without an attending operator to monitor the medication filling machine operations. He objected 

and requested the “set up” mechanical technician to stop the line. When Plaintiff returned again 

to the Line 10 production line to recheck its status, Plaintiff discovered that the Quality Group 

Leader had closed Plaintiff’s non-conformity comment in the batch folder record and assigned 

another Quality Control associate to replace Plaintiff. 

27. On March 19, 2008, Plaintiff reported nine units on the medication filling line 

with foreign particulates at the dispensing tips in violation of the prescribed accept/reject criteria 

for quality control. After corrective mechanical adjustments to the line were attempted, Plaintiff 

still found thirty medication units after each adjustment to be defective. Thereupon, the Quality 



Group Leader ordered the Plaintiff to record only two defective units in the batch folder, an 

inaccurate production anomaly number low enough to allow manufacturing to continue within 

the SOPs. The Quality Group Leader also assigned an alternate Quality Control associate to 

enter the understated anomaly reports on the incident into the official records. 

28. On March 25, 2008, Plaintiff was working the manufacturing fill line #4 for 

product albuterol sulfate, a drug inducing bronchial smooth muscle relaxation to aid breathing. 

The manufacturing operators completed a production run of three hundred units without 

compliance with bottle container testing and quality control procedures. Upon inspection, the 

Plaintiff discovered broken glass on the production line. Plaintiff stopped the line and 

segregated all units based on the control set point of the preceding quality control check. When 

the Plaintiff attempted to remove these 300 units per the SOPs, he was ordered not to do so. 

Chemistry/Environmental Associate WANDA ROSARIO subsequently informed the Plaintiff 

that she witnessed broken glass containers being processed on Filling Line #4, but that the line 

operators failed to follow the required SOPs for prescribed remedial action. The anomaly was 

not recorded in the batch folder records as required by SOPs by those responsible for said 

records. 

29. On March 27, 2008, Plaintiff attended a meeting with Quality Team Leader 

MUJAGIC and THOMAS in which he attempted to address his quality and safety concerns 

described above, as well as the negative responses and hostile reactions he received and was still 

receiving as a result of expressing those concerns to production technicians and supervisors. 

30. On April 4, 2008, Plaintiff met with Manufacturing Manager PATTERN to 

discuss and seek resolution to his quality and safety concerns described above. 



31. On May 13, 2008, the Plaintiff discovered seven non-conforming units 

warranting rejections while assisting a colleague with her hourly quality control inspection 

duties. When said colleague reported this to Quality Group Leader GORDON, he instructed her 

to ignore the non-conformities and enter no reported findings to the contrary. 

32. On May 14, 2008, the Plaintiff observed that a line operator failed to change her 

prescribed personal protective clothing though it was considered contaminated after contact with 

the production floor, in violation of SOP 60-029-24. Plaintiff reported this nonconformity to the 

Training Certification Specialist JO GALLO, who agreed that there was a violation and 

suggested that the Plaintiff himself educate the operator to proper application of said SOP. This 

ad hoc supervisory and training protocol also violated the SOPs and CFRs governing training 

and supervision. 

33. On May 20, 2008, the Plaintiff informed THOMAS and Manufacturing Group 

Leader ANDRE BENT that he had detected a non-conforming manufacturing process due the 

presence of an unidentified bottle container with improperly labeled product. An MER and 

disciplinary action resulted as to the offending associates for violation of SOPs. 

34. On May 21, 2008, the Plaintiff reported to Defendant’s Chemistry Management 

staff DOUG COMMERCE and JUDITH RODRIGUEZ that Associate MADELINE 

GUADALUPE had failed to log into an operating production. Accurate personnel logging is 

critical to required trace-back procedures in the event of subsequently discovered 

contamination/adulteration. The Plaintiff also reported 53,300 units of Fluress (Fluorescein and 

Benoxinate) anesthetic agent solution being contaminated/adulterated due to the presence of 

glass fragments in the packaging stage. The Plaintiff complained that this 

contamination/adulteration incident shared the same root cause and the same associates as prior 



events, meriting investigation and corrective action under SOPs. The Plaintiff complained that 

the required documentation per the SOP was missing or improperly recorded. 

35. On May 21, 2008, following up on discussions the Plaintiff had with WANDA 

ROSARIO about the recurring breakages on production line 4, the Plaintiff requested that 

ROSARIO identify the SOPs governing the cleaning steps an operator must follow to remediate 

glass contamination/adulteration. 

36. On May 30, 2008, the Plaintiff expressed concern to Quality Group Leader 

GORDON that he had not received the SOP prescribed level of training sufficient to enable him 

to enter training form certifications in the Defendant’s data system. 

37. In or about June 2008, the Plaintiff complained about being bypassed from 

promotion based on his national origin after being denied the Compounder I position in May 

2008. 

38. On June 10, 2008, the Plaintiff notified THOMAS and GORDON that he 

discovered excess unit counts in the filling production line. THOMAS and GORDON told the 

Plaintiff to take no action other than discarding the excess unit. The Plaintiff objected because 

SOPs set forth a specific procedure governing responses to excess unit counts. SOP 60-021 

“Cleaning and Sanitization of the Aseptic Core” also specifies that the sanitization process 

include a line clearance of rejected filled and empty containers at the end of each working shift. 

Later that day, the Plaintiff objected to THOMAS that a filling associate was present inside the 

manufacturing area without wearing prescribed personal protective clothing, in violation of SOP 

61-064, which prescribes guidelines for “Proper Attire Within the Manufacturing Facility”. 

39. On June 12, 2008, in response to the Quality Control Supervisor’s inquiries, the 

Plaintiff objected to her accusatorial interrogation of him as to justifications for his prior 



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 



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. 



48. On October 10, 2008, the Plaintiff’s prior counsel, reiterated to CALLEJAS the 

Plaintiff’s concerns regarding defective products and inappropriate management pressures to 

certify defective products as having met prescribed inspection criteria. 

49. On November 3, 2008, when the Plaintiff reported back to work following 

approved Family Medical Leave that commenced August 4, 2008, Defendant managers 

CALLEGAS and MUJAGIC called him into a meeting. They questioned him regarding his 

retention of legal counsel to assert his employment rights. The Plaintiff referenced these 

supervisors to the history of his compliance reports and complaints and the failure to remediate 

the resulting hostile work environment and other retaliatory actions. The Plaintiff then requested 

of MUJAGIC that he be retrained pursuant to SOP 80-010, which requires retraining for Quality 

Coordinators who have been absent for over one month. MUJAGIC questioned the need for such 

SOP compliance. 

50. On November 4, 2008, Plaintiff undertook the required post-absence review of 

current SOP revisions. THOMAS summoned Plaintiff to the line, where WALKER informed 

Plaintiff that he was needed to start the production line. Having not yet completed the required 

SOP currency review, or otherwise having completed mandated training, Plaintiff informed 

WALKER he could not accept responsibility for the production line, which Plaintiff reiterated to 

GORDON. 

51. The next day, November 5, 2008, the Plaintiff questioned MUJAGIC and 

CALLEJAS as to regulatory compliance regarding recently completed production and packaging 

runs. They refused to answer. 

52. On November 10, 2008, the Plaintiff communicated the above referenced 

concerns to FDA officials. 



VII. 

FACTS REGARDING ADVERSE ACTIONS 

53. The adverse actions taken against the Plaintiff exhibit a pattern of retaliation for 

the above referenced protected activity. These adverse actions included: 

54. Plaintiff was subjected to the ongoing maintenance and failure to abate a hostile 

work environment against him, which included abusive and berating language, insults, ridicule, 

threats, and hostile interrogations. 

55. On March 13, 2008, THOMAS verbally abused Plaintiff because he stopped 

the production line and stated his intent to contacting higher management regarding compliance 

violations. 

56. On or about March 25, 2008, Plaintiff’s Second Shift Quality Group Leader 

threatened Plaintiff with words to the effect that, “remember HR leaves at 17:00, after that you 

are stuck with us”, and “I don’t know how much you need your job but...”. 

57. On June 10, 2008, in response to the Plaintiff’s concerns regarding improper attire 

in violation of SOPs, THOMAS informed Plaintiff she was unwilling to discuss the problem and 

dismissively rebuked him with words to the effect of “go to HR”. 

58. On June 12, 2008, GORDON forbade Plaintiff from (a) observing work lines 

during his lunch hour as other employees could; (b) observing or making compliance reports 

about production lines to which he was not assigned; or (c) communicating his compliance 

concerns directly to manufacturing leaders without prior approval of GORDON. Plaintiff was 

also admonished against emailing other department’s managers about his compliance concerns. 

59. On July 14, 2008, Defendant managers and Human Resources falsely accused and 

reprimanded Plaintiff for improperly stopping the production line and breaching protocol by not 

first communicating with the operator of the offending line. BRIGGS verbally reprimanded 



Plaintiff for securing the above referenced defective product samples in his locker which he 

offered as proof of Defendant’s noncompliant operations and admonished him to cease similar 

evidence collection without management approval. 

60. On July 17, 2008, GORDON refused Plaintiff adequate training to perform his 

duties on the OcuCoat® line. 

61. On July 18, 2008, Plaintiff was issued a written warning for lack of collaboration 

and credibility. 

62. On October 25, 2008, Plaintiff’s position was posted on-line as an open job 

position. 

63. On November 4, 2008, Defendant again denied Plaintiff requested training. 

64. On November 5, 2008, the Defendant issued the Plaintiff a written warning for 

making copies from a batch folder documenting the above referenced glass 

contamination/adulteration and providing those copies to his legal counsel. Defendant refused to 

provide the Plaintiff with a copy of the warning. CALLEJAS informed the Plaintiff that 

Defendant would be investigating the issue while the Plaintiff was absent on vacation and unable 

to effectively participate in said investigation. 

65. On November 11, 2008, Defendant terminated Plaintiff, on the stated grounds of 

insubordination for Plaintiff’s “refus[al] to perform his duties as requested…” 

VIII. CLAIMS FOR RELIEF 

FIRST CLAIM FOR RELIEF: VIOLATION OF THE FLORIDA CIVIL RIGHTS ACT 

COUNT I – FCRA (National Origin) 

66. Plaintiff realleges and incorporates by reference Paragraphs 1 through 65, as 

though set forth herein verbatim. 



67. This action is based on a violation of the Florida Statute, Chapter 760, Florida 

Civil Rights Act. 

68. B&L, via its agents, representatives, and employees, discriminated against 

Plaintiff because of his national origin. 

69. As a result of B&L’s unlawful employment practices, Plaintiff has been damaged. 

70. WHEREFORE, the Plaintiff, respectfully prays that this Honorable Court take 

jurisdiction of the subject matter and parties hereto, and grant his request for trial by jury, declare 

that the Defendant violated the rights of Plaintiff as protected by the laws of the State of Florida, 

and award back pay, front pay, prejudgment interest, compensatory damages for mental anguish, 

emotional distress, embarrassment, humiliation, loss of enjoyment of life, loss of dignity, 

impairment of working ability and earning capacity and loss of reputation, reasonable attorney’s 

fees pursuant to Florida Statute, § 760.11 and costs, and such other relief as deemed appropriate 

by this Court. 

COUNT II – FCRA (Disability) 





73. B&L, via its agents, representatives, and employees, discriminated against 

Plaintiff because of his disability. 

74. B&L failed to provide Plaintiff a reasonable accommodation for his disability. 

75. As a result of B&L’s unlawful employment practices, Plaintiff has been damaged. 











COUNT III – FCRA (Retaliation) 





79. B&L, via its agents, representatives, and employees, retaliated against Plaintiff 

because of his complaints about discrimination and B&L’s failure to promote him on the basis of 

his national origin. As a result of B&L’s unlawful employment practices, Plaintiff has been 

damaged. 











COUNT IV: NEGLIGENT SUPERVISION/TRAINING/RETENTION 



82. This is a common law action of negligent supervision, training and/or retention. 

During the course of Plaintiff’s employment with B&L, B&L via its agents, representatives, and 

employees in supervisory or management positions, had a duty to Plaintiff to properly supervise, 

train and discipline his supervisors regarding the legal responsibilities of an employer under 

Florida law regarding discrimination and retaliatory treatment. 

83. During the course of Plaintiff’s employment with B&L, B&L via its agents, 

representatives, and employees in supervisory or management positions, failed in its duty to 

properly supervise, train and discipline Plaintiff’s supervisors regarding the legal responsibilities 

of an employer under Florida law regarding discrimination and retaliatory treatment. 

84. As a direct and proximate result of B&L’s negligent breach of duty, Plaintiff 

suffered permanent and/or continuing injuries and sustained the following past and future 

damages: 

A. Mental pain; 

B. Severe emotional distress in the form of fear, nervousness, anxiety, worry and 

indignity; 

C. Embarrassment; 

D. Humiliation; 

E. Loss of enjoyment of life; 



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 



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: 



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. 



The responsibilities and procedures applicable to the unit must be followed and in 

writing. 

7. Microbial control (drugs): 21 C.F.R. 211.113 requires the Defendant have appropriate 

written procedures to prevent contamination and adulteration. 

8. Testing (drugs): 21 C.F.R. 211.165 requires the Defendant to create and follow 

adequate sampling and testing plans to ensure drug quality and to reject drugs failing to 

meet standards or specifications. 

9. Documentation (drugs): 21 C.F.R. 211.188 requires the Defendant to maintain batch 

production and control records with complete information about the drug production, 

including the personnel involved in the process, and the results of any investigation into 

product discrepancies. 

10. Production Record Review (drugs): 21 C.F.R. 211.192 requires that the Defendant 

have the quality control unit review and approve all drug product production and control 

records to ensure compliance with SOPs and to thoroughly investigate and record any 

discrepancies or failures to meet specifications. 

11. Investigations Required (drugs): 21 C.F.R. § 211.198 requires the Defendant to 

follow written procedures to handle all complaints about a drug product, including how 

and whether to conduct a formal investigation or report to the FDA. 

91. Defendant had knowledge of each of the Plaintiff’s disclosures, complaints, 

reports and protected activity set forth above in the “Facts Regarding Protected Activity” section 

hereof, including his reports of violations of SOPs, cGMPs, and CFR sections. Each of said 

disclosures, complaints and reports demonstrate that the Defendant violated one or more of the 

laws, rules and regulations enumerated in paragraphs 90.1 to 90.11. 



92. The Defendant took each of the retaliatory personnel actions against Plaintiff set 

forth above in the “Facts Regarding Adverse Actions” section hereof, because the Plaintiff 

objected to, or refused to participate in, the above listed activities, policies, or practices of the 

Defendant which were or would have been in violation of the laws, rules, or regulations set forth 

in paragraphs 90.1 to 90.11. 

93. In retaliating against and terminating the Plaintiff though use of the above 

referenced adverse actions, Defendant was in violation of the Florida Whistleblower Act. Said 

violation inflicted upon the Plaintiff the economic, non-economic, compensatory, special, 

monetary, career, and emotional damages set forth above in the First Claim for Relief. 

94. The Plaintiff is entitled to the recovery of reasonable attorney’s fees and costs 

pursuant to § 448.104, Florida Statutes. 

95. Based on the foregoing, the Plaintiff requests the following relief: 

A. The Plaintiff should be reinstated to his former position with back pay, retirement 

contributions, pay raises and cost of living increases, seniority privileges, and all other benefits, 

together with the monetary value of all lost benefits, including the value of lost retirement 

benefits and health insurance; and upon such reinstatement, the court should enjoin the defendant 

from engaging in such unlawful employment practices, and order such other affirmative action as 

may be appropriate; 

B. If the Plaintiff is not reinstated, then Plaintiff should be awarded back pay or wages 

lost and benefits, and for such legal or equitable relief as may be appropriate; 

C. Under all claims, if Plaintiff is not reinstated, then Plaintiff should be awarded 

monetary damages for front pay and benefits, including retirement benefits and health insurance, 

reduced to present value, for a term of years to be determined at trial; 



D. Under all claims, Plaintiff should be awarded compensatory damages, the exact 

amount to be determined at trial; 

E. Under all claims, Plaintiff should be awarded interest on back pay and lost wages, and 

such other equitable and affirmative relief as may be appropriate; and; 

F. Plaintiff should be awarded his reasonable attorney's fees and litigation expenses and 

damages related to seeking medical care and treatment associated with this matter. 

Respectfully submitted, 

s/Richard F. Meyers, Esquire 

Richard F. Meyers, Esquire 

9340 North 56 th Street, Suite 220-A 

Temple Terrace, Florida 33617 

(813)985-6550 

(813)985-5282 (fax) 

Fla. Bar No. 0893315 

Trial Counsel 

Thad M. Guyer, Pro Hac Vice Pending 

(Oregon Bar # 82144) 

E-mail tmguyer@tmguyer.com 

Trial Counsel 

Attorneys for Plaintiff

Private Sector Florida Whistleblower Act Amended Complaint.

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