ARDITI JOHN vs. MANKIND corporation THE ABOVE CASE HAS BEEN ASSIGNED TO: TRACK 3 DISCOVERY IS 450 DAYS AND RUNS FROM THE FIRST ANSWER OR 90 DAYS FROM SERVICE ON the FIRST DEFENDANT, WHICHEVER COMES FIRST.
ARDITI JOHN vs. MANKIND corporation THE ABOVE CASE HAS BEEN ASSIGNED TO: TRACK 3 DISCOVERY IS 450 DAYS AND RUNS FROM THE FIRST ANSWER OR 90 DAYS FROM SERVICE ON the FIRST DEFENDANT, WHICHEVER COMES FIRST.
ARDITI JOHN vs. MANKIND corporation THE ABOVE CASE HAS BEEN ASSIGNED TO: TRACK 3 DISCOVERY IS 450 DAYS AND RUNS FROM THE FIRST ANSWER OR 90 DAYS FROM SERVICE ON the FIRST DEFENDANT, WHICHEVER COMES FIRST.
ARDITI JOHN vs. MANKIND corporation THE ABOVE CASE HAS BEEN ASSIGNED TO: TRACK 3 DISCOVERY IS 450 DAYS AND RUNS FROM THE FIRST ANSWER OR 90 DAYS FROM SERVICE ON the FIRST DEFENDANT, WHICHEVER COMES FIRST.
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BERGEN CouNTy. couRThousE
SUPERIOR COURT LAW DIV
BERGEN COUNTY JUSTICE CTR RM 415
HACKENSACK ‘NJ _07601-7680
‘TRACK ASSIGNMENT NOTICE
COURT TELEPHONE No. (201) 527-2600
COURT HOURS
DATE: SEPTEMBER 16, 2010
Re. ARDITI JOHN VS. MANKIND CORPORATION
DOCKET: BER L -008783 10
HE ABOVE CASE HAS BEEN ASSIGNED TO: TRACK 3.
DISCOVERY IS 450 DAYS AND RUNS FROM THE FIRST ANSWER OR 90 DAYS
FROM SERVICE ON THE FIRST DEFENDANT, WHICHEVER COMES PIRST.
THE PRETRIAL JUDGE ASSIGNED IS: HON CHARLES E. POWERS
{EP YOU HAVE ANY QUESTIONS, CONTACT TEAM 003
ar: (201) 527-2600
If YOU BELIEVE THAT THE TRACK IS INAPPROPRIATE YOU MUST FILE A
CERTIFICATION OF GOOD CAUSE WITHIN 30 DAYS OF THE FILING OF YOUR PLEADING
PLAINTIFF MUST SERVE COPIES OF THIS FORM ON ALL OTHER PARTIES IN ACCORDANCE
WITH R.4:5A-2,
ATTENTION:
ATT: MARK D. LURTE
MCKENNA MCTINAIN LLP
36 PARK STREET
MONTCLAIR, NJ 07042-2929
\JUBBROILURIE LAW FIRM LLC
96 Park Street
Montelair, NJ 07042
(973) 509-0050
Fax: (973) 509-0054
Attomeys for Plaintiff,
John Arditi
PERBOR COURT OF NEW JERSEY
s ‘DIVISION: BERGEN COUN
DOCKET NO. a) > |
JOHN ARDITI,
Plaintiff
COMPLAINT AND JURY DEMAND
vs.
MANNKIND CORPORATION, PETER
% RICHARDSON and PATRICIA MAYER,
nS)
wp Defendants
hah ‘O
\ & Plaintiff, John Arditi, by way of Complaint against the Defendants, alleges as follows:
? FACTS COMMON TO ALL COUNTS
1. Plaintiff John Arditi (“Arditi”) currently resides in Spring City, Pennsylvania.
2. Upon information and belief, defendant MannKind Corporation (“MannKind” or
“MKC’), is a Delaware corporation, with a place of business at 61 South Paramus Road,
Paramus, New Jersey. MKC’s Paramus location is the headquarters and nerve center for all of
its clinical research and development operations, including clinical assessment and quality
systems management, biometrics and data management, clinical outsourcing, pulmonary
function testing, regulatory affairs, compliance, program management, and outsourcing
departments.3. ‘Upon information and belief, defendant Peter Richardson was, at all relevant
times, a resident of the State of New Jersey, and was MKC’s Chief Scientific Officer, with a
principal place of business at 61 South Paramus Road, Paramus, New Jersey.
4. ‘Upon information and belief, defendant Patricia Mayer was, at all relevant times,
a resident of the State of New Jersey, and was MKC’s Vice President, Worldwide Regulatory
Affairs.
5. Arditi is a seasoned pharmaceutical professional, with over 25 years experience in
pharmaceutical clinical trial auditing and Good Clinical Practices (“GCP”). He is a recognized
expert in this field, having written and lectured extensively on this subject, and has been an
‘adjunct university professor. Mr. Arditi has also been recognized for his loyalty and
professionalism, including awards for teamwork.
6. _Arditi commenced his employment with MKC in October 2006, as Head of GCP
Compliance with the job title of Senior Director - World Wide Regulatory Affairs., reporting to
MKC’s Paramus, New Jersey clinical research and development headquarters.
7. During the course of his employment, MKC distributed its Code of Business
Conduct and Ethics (“Code of Conduct”) to Arditi.
8. MKC distributed the Code of Conduct with the expectation and intent that its
employees, including Arditi, rely on the statements, guidance, directions and representations
contained in the Code of Conduct.
9. MKC’s Code of Conduct provides, in relevant part:
Disregard of the law will not be tolerated. Violation of domestic or foreign laws,
rules and regulations may subject an individual, as well as MannKind, to civil
and/or criminal penalties. You should be aware that conduct and records,
including emails, are subject to internal and extemal audits, and to discovery by
third parties in the event of a government investigation or civil litigation. It is ineveryone's best interests to know and comply with our legal and ethical
obligations.
10. MKC’s Code of Conduct further provides, in relevant part,
If you encounter a situation or are considering a course of action and its
appropriateness is unclear, discuss the matter promptly with your supervisor or
the Compliance Officer; even the appearance of impropriety can be very
damaging and should be avoided.
Ifyou are aware of a suspected or actual violation of Code standards by others,
‘you have a responsibility to report it. You ate expected to promptly provide a
‘compliance resource with a specific description of the violation that you believe
has occurred, including any information you have about the persons involved and
the time of the violation. Whether you choose to speak with your supervisor, the
Compliance Officer or National Hotline Services, you shouid do so without fear
of any form of retaliation. We will take prompt disciplinary action against any
‘employee who retaliates against you, up to and including termination of
employment,
(emphasis added).
11. The Code of Conduct further provides, in relevant part:
It is our policy to comply with all applicable laws that protect our employees,
including the employees of our subsidiaries, against unlawful retaliation as a
result of their lawful, good faith reporting of information regarding, or their
participation in, investigations involving corporate fraud or other violations of
federal and state law or the Code by the Company or any of its agents.
12. For the first three years, MKC recognized that Arditi’s performance was
exemplary, as evidenced by positive performance appraisals, and the respect of his staff and
colleagues for his undisputed knowledge, integrity, professionalism, loyalty and diligence.
13, Indeed, just months before Arditi’s termination, Richardson publicly
acknowledged, Arditi’s efforts and leadership:
Please find the latest update on our clinical site inspections which are now
complete. The most recent inspection of the Russian site for the 138 has finished,
once again, without a 483. In my opinion this is an outstanding achievement of
which Mannkind should feel very proud. We now await the completion of the
‘two remaining vendors: Medgraphics, which is presently proceeding smoothly
and next week our central laboratory (BARC) will be inspected as a GLP audit inEurope. John Arditi has seen the benefits of his diligent preparatory work in
setting our quality standards over the past years.
(emphasis added).
14, Unfortunately, MKC ultimately decided to fire Arditi precisely for his diligence
and insistence on quality standards, when it conflicted with MKC’s desire to withhold
information from the FDA for its short term financial self-interest, without consideration of the
legality of its actions or the resulting impact on public health, safety and finances.
15, More specifically, Arditi believed that MKC was committed to transparency and
compliance with all laws and regulations, and cared about the impact of its clinical trials and
products on the public health and safety. To that end, and relying on bis vast years of experience
and the representations contained in the Code of Conduct, Arditi understood that, if there were
concems over potentially fraudulent or suspicious clinical trial data, the FDA should be notified
about such issues before it approves a product as safe and effective, and before it allows such
product to be prescribed and sold to human patients.
16, Inaccordance with his reasonable understanding of MKC’s legal and ethical
obligations, and in accordance with MKC’s Code of Conduct, on or about November 9, 2009,
‘Arditi notified Mayer that he and one of his colleagues, Ms. Margaret Galluzzi, VP of Clinical
Operations, had confirmed audit concerns regarding potential fraud and scientific misconduct in
connection with one of MKC’s clinical sites.
17, By way of background, during Arditi’s employment, MKC was focused primarily
‘on the discovery, development and potential commercialization of Afrezza ™ (insulin human)
Inhalation Powder, for the treatment of adults with type 1 or type 2 diabetes for the control of
hyperglycemia.18. As part of its Aftezza clinical development program, MKC contracted with
‘numerous sites, primarily in foreign and third world countries, (o enroll human patients to test
the safety and efficacy of Afrezza, with the ultimate goal of submitting a New Drug Application
CNDA") to the United States Food and Drug Administration (“FDA”) for the approval to sell
and market this product to human patients in the United States, and to be eligible for
reimbursement by federal and state Medicare and Medicaid programs, as well as by private
insurers.
19. MKC filed an NDA with the FDA for Afrezza in or about March 2009, including
clinical trial data from its clinical sites.
20. _Arditi was responsible for overseeing and reviewing, from a quality assurance
perspective, these clinical sites, to ensure that the sites complied with all applicable protocols,
and maintained complete and accurate records.
21. During the course of his review, Arditi noticed various issues with certain foreign
sites, and as a consequence, of potential issues regarding data that MKC has submitted to the
FDA in connection with its NDA for Afrezza.
22. For example, Arditi observed that all patients in Dr. Yuri G. Shvartz’s
‘(Shvartz”) site in Russia had consistent blood pressure readings over several months, even
though it would be expected that blood pressure should vary from time to time, indicating
potential protocol violations and/or fraudulent study results, including the possibility of fictitious
patients and/or that the site did not properly document potential safety issues in connection with
Afrezza.
23. _Arditi likewise noted potential fraud or scientific misconduct in connection with
trials conducted in Bulgaria and other sites.24. — Onor about November 9, 2009, Arditi notified his supervisor, Mayer, that he and
one of his colleagues, Ms. Margaret Galluzzi (“Galluzzi"), VP of Clinical Operations, had
confirmed his audit concerns regarding Dr. Schvarts’ site.
25. _Arditi further suggested to Mayer that, “To be consistent with the previous
determinations MKC must proceed with prompt notifications required under regulation.”
26. _Arditi also recommended that Dr. Schvartz provide further explanation as to
material inaccuracies in blood pressure and numerous other data recording.
27. _Arditi concluded that “immediate disclosure {to the FDA] is essential to fulfill
obligations and maintain sponsor integrity during inspectio
28. Unconvinced about the need for transparency to the FDA, Mayer asked Arditi to
provide a further synopsis. In response, Arditi wrote, in part:
Upon review of previous audit issues, our GCP compliance head noted trended
inaccuracies in reported blood pressure values across all patients by Dr. Shvartz’s
site. A 2005 documented explanation provided by Dr. Shvartz included his
practice of resting patients in sitting before making measurements that accounted
for such consistency. While MKC staff in 2005 appear to have accepted this
explanation, in our recent preparations for FDA inspection with Dr. Shvartz it was
explained to MKC stalf that site personnel estimated such BP values and rounded
to the nearest 0 of 5 estimated from a properly graduated sphygmomanometer.
Dr. Shvartz has offered documentation of his current perspective in explaining
these blood pressure measurements, MKC currently awaits this updated
documentation to add to current archive and share with FDA.
Given these recent developments, MKC would like to bring this matter to the
attention of FDA in the spirit of full disclosure and cooperation in helping to
make determinations on this GCP related matter.
29, Still unconvinced about the need for transparency, Mayer convened a meeting on
November 13, 2009, with Arditi, Galluzzi and Richardson. During this meeting, it became clear
that commercial interests trumped integrity and transparency, as well as MKC’s legal and ethical
obligations to provide candid, complete and accurate information to the FDA before it approvesadrug for human use and governmental reimbursement. As noted in the minutes of the
November 13 meeting:
. Mayer redirected with the challenge of how to present such concerns to the
FDA at this point. She noted J. Arditi’s insistence on early and complete
disclosure beginning on 30 Sep wien the previously unknown audit report was
discovered and the benefits of partnering with the FDA on recently revealed
issues. It was acknowledged that the impact of such disclosures were
problematic, however, J. Arditi emphasized early and conservative regulatory
adherence to maintain MKC high quality standing in dealing with such matters
with the agency, J. Arditi deferred to his management in deciding the Regulatory
‘Atfairs relationship they want to have. Reiterating and that his recommendations
were in order to fulfill consistency with his roles as independent GCP
compliance/QA.
30. Arditi also raised concern about Dr. Daskalova’s clinical site in Bulgaria. For
example, an audit of that site revealed that “There were numerous critical and significant
findings... It appeared there was inadequate oversight of the [Principal Investigator]
specifically with regard protocol adherence, Investigational Product (IP), source documentation,
safety reporting, study delegation, submission of required documentation to the Ethics
Committees, and study organization, possibly impacting data integrity at the site.”
31. For example, the audit revealed that Dr. Daskalova did not have adequate
oversight over Afrezza with regard to treatment arm assignment, drug accountability, verification
of subject compliance and accurate dispensing. In fact, it could not even be confirmed that the
clinical trial subject were on the correct assigned treatment arm, and there appeared to be
fraudulent documentation, including records from the site that patients had received clinical trial
kits from the site, when the packing slips indicated that those kits were not even delivered to the
site until weeks or even months later. Dr. Daskalova could not explain these discrepencies.
32. ‘The Daskalova audit further revealed that it could not even be confirmed that the
patients who were enrolled in the site had met the necessary requirements for inclusion in thestudy. Dr. Dasklova could not find any documentation to confirm that these patients were
properly enrolled in the study.
33. The Dasklova audit further found that patients had not been provided with
updated safety information, as required by the clinical study protocol. Further, according to the
audit, it was impossible to determine whether safety tests had been performed on patients and
that the integrity of the data could not be confirmed. The audit also found that “Accurate safety
reporting over the study period of three years could not be confirmed.”
34. A follow up audit of Daskalova’s site also revealed potential fraud in connection
with patient enrollment. More specifically, although all initial meetings with patients were
supposed to be one on one to review relevant safety information, and to obiain their signed
informed consent forms (“ICFs”), several ICFs had the same date and time, indicating potential
fictitious and fraudulent patient enrollment. Dr. Daskalova could not explain this discrepancy.
35. The audit also could not confirm that Investigational Product had actually arrived
at the site before being dispensed per the Drug Accountability Log.
36. The follow up audit further found that adverse events were not always captured or
accurately reported.
37. _ Asaresult of these, and other, audit findings, Arditi reasonably believed that
these audits, as well as other reports, revealed concern that fraudulent clinical study data was
submitted to the company, and that the company had accordingly submitted potentially
fraudulent and misleading date to the FDA in connection with its NDA seeking approval of
‘Afrezza. Recognizing the potential violations of law, rules, regulations and public policy, Arditi
advocated that the company should further investigate this situation and disclose these facts to
the FDA in connection with its review of the Afrezza NDA, so that the FDA could make a fulland informed decision regarding the safety and efficacy of Afrezza before it approved the drug to
be sold and marketed to human patients in the United States, and be eligible for reimbursement
by federal, state and private insurers.
38. Ultimately, MKC decided not to disclose any potential problems to the FDA out
of concem that, if the FDA was notified of these concems, it might delay approval of MKC’s
‘New Drug Application for Afrezza.
39, Incontravention of both New Jersey’s Conscientious Employee Protection Act
(“CEPA”) and MKC’s non-retaliation policy, Arditi suffered increasingly blatant retaliation as a
result of his insistence that MKC maintain the highest standards of business ethics.
40. For example, Mayer refused to deal with Arditi, kept information from him
critical to his ability to perform his job, and dragged her feet on responding to his various
requests.
41. Indeed, MKC’s attempts at undermining Arditi’s quality initiatives is evident
from its failure to approve budgets or respond to his proposed audit plans, making sure that he
did not uncover any issues that might need to be reported to the FDA.
42. Mayer’s non-communication resulted in unneeded frustration, and necessitated
‘Arditi to adopt a more direct approach with her, for which he suffered further retaliation. In
‘essence, Atditi was faced with a no-win situation: (1) receive no response from Mayer, resulting
in Arditi’s inability to perform his job, and receive an unsatisfactory rating on his job goals, and
possibly put the company in jeopardy; or (2) press Mayer and try to get her attention, and receive
an unsatisfactory rating on his communication style.
43. Significantly, Mayer unreasonably delayed providing a performance evaluation to
‘Arditi, When she finally did so, shortly after Arditi raised his concerns about various foreignclinical trial sites and potential fraud and scientific misconduct, the retaliation for raising his.
concerns was blatant and, for the first time, Arditi’s performance was somehow deemed
unsatisfactory.
44. Arditi’s stance with regard to transparency, and management's refusal to comply
with its legal and ethical obligations, were clearly the motivating forces behind this evaluation.
For example, Mr, Arditi was rated “Improvement Required” for Teamwork, based on his
disagreement with the team to withhold information from the FDA.
45. Similarly, Arditi was rated negatively with regard to “Communication” and
“Trust and Respect” because management did not want to hear his insistence on complying with
Jaws, regulations and GCPs.
46. Perhaps most telling, Mayer wrote:
1 am concemed about John’s judgment, particularly when he is charged with
documenting company internal discussions. This specific behavior raises
‘questions about John’s capability to host health authority inspection in
MannKind’s best interests. In addition, it is not of John’s strengths to find
consensus during internal discussions and to document and support the consensus
reached during discussion.
47. Inessence, Mayer suggested that Arditi whitewash discussions and
documentations, to show consensus when none existed, and to create a false favorable paper trail
in the event of investigation or litigation. Indeed, as noted in MKC’s Code of Conduct, “You
should be aware that conduct and records, including emails, are subject to internal and external
audits, and to discovery by third parties in the event of a government investigation or civil
litigation.” Put simply, Mayer reprimanded Arditi for his refusal to create a false and fraudulent
paper tral in the event that the government conducted an audit of MKC’s clinical trial results
48. Further, Mayer’s concern over Arditi’s interactions with health authorities shows
‘clear intention to commit fraud on the FDA, so that the FDA would approve Afrezza, unaware
10of potential issues regarding that product’s safety and efficacy. As Mayer herself notes, she was
concerned that Arditi might speak transparently to governmental agencies when he believes that
such actions are legally and ethically appropriate and in the public interest, but may not be in
MKC’ perceived short term commercial interests.
49. Mayer’s evaluation not only violated CEPA, it also violated MKC’s Code of
Conduct. According to the Code of Conduct, “The compliance environment within each
supervisor's assigned area of responsibility will be a significant factor in evaluating the quality
of that individual's performance. In addition, any employee who makes an exemplary effort to
implement and uphold our legal and ethical standards will be recognized for that effort in his or
her performance review.” Clearly, MKC’s decision not to comply with its own Code of Conduct
highlights its retaliatory animus and hypocrisy.
50. Defendants further overruled and blocked Arditi’s attempt to conduct additional
and follow up audits to determine whether there had been further fraud and misconduct in the
clinical data submitted to the FDA in its Afrezza NDA. Despite Arditi’s repeated petition and
proposals and need to follow up on compliance concems, defendants blocked his budget and
requisitions, and delayed approving Arditi’s budge for more than six months in order to obstruct
any discovery of fraud and scientific misconduct.
51. Defendants also blocked the conduct of routine and “for cause” audits in order to
avoid dealing with reporting of known compliance and fraudulent concerns. These audits are
required to be conducted under both company policy and by FDA standards.
52, Defendants also denied Arditi aocess to any budget reports in order to allow
‘manipulation of facts surrounding his spending and significant savings contributions to the
budget for 2009 and continuing.
153. Ina further misguided attempt to muzzle, and ultimately terminate, Arditi, Mayer
micro-managed Arditi, looking to set him up for failure and to fabricate reasons to terminate his
‘employment.
54. More specifically, through his leadership, Arditi saved over $400,000, which he
sought to use for necessary and appropriate audits.
55. Although nothing had been finalized regarding the use of such funds, and even.
though Arditi signed no contract or purchase order committing these funds, he was abruptly
terminated on May 11, 2010, based on the spurious ground that he exceeded his authority in
authorizing and/or signing imaginary purchase orders.
56. Upon information and belief, the termination decision was made by Mayer and
Richardson.
57. Mayer, Richardson and MKC terminated Arditi’s employment due to his
objection and refusal to withhold information from the FDA conceming potential safety concerns
surrounding Afrezza and its clinical study data, resulting in potential fraud on the FDA and the
public, and in violation of law and public policy.
FIRST COU!
58, PlaintifT incorporates by reference the allegations and facts contained in the
preceding paragraphs as though the same were set forth at length herein.
59, _Arditi, who has substantial business education and many decades’ experience in
the pharmaceutical industry, had a genuine, sincere and objectionably reasonable belief that
MKC’s strategies, decisions and actions violated ethical and legal standards, were fraudulent,
breached clear mandates of public policy, and implicate public health and safety.
260. Arditi repeatedly voiced his objections to Defendants about said strategies,
decisions and actions.
61. Inretaliation for Arditi’s opposition, resistance and/or refusal to endorse, promote
and participate in said strategies, decisions and actions, Defendants retaliated against Arditi in
determining his compensation, demeaning his ethics, stifling his dissent and, ultimately,
terminating his employment.
62, Defendants’ actions constitute retaliation in violation of the New Jersey
Conscientious Employee Protection Act (CEPA), N.J.S.A. 34:19-1 et seq.
63. Asa direct and proximate result of Defendants’ illegal retaliation, Arditi has
suffered, and will continue to suffer, damages, including but not limited to physical and
emotional damages, economic harm, stress, damage to his reputation as well as disruption in his
professional and personal life.
64. Defendants’ actions have been extreme and outrageous, and were actuated by
actual malice and/or wanton and willful disregard for Arditi and for laws, regulations, public
policy and public health and safety.
WHEREFORE, Arditi demands judgment against Defendants, jointly and severally, for
damages, including back pay, front pay, compensatory and punitive damages, counsel fees, pre~
judgment and post-judgment interest, Court costs and fees, and such other relief as the Court
‘may deem just and appropriate under the circumstances.
SECOND COUNT
65. Plaintiff incorporates by reference the allegations and facts contained in the
preceding paragraphs as though the same were set forth at length herein.
1366. _Arditi, who has substantial business education and many decades’ experience in
the pharmaceutical industry, had a genuine, sincere and objectionably reasonable belief that
MKC’s strategies, decisions and actions violated ethical and legal standards, were fraudulent,
breached clear mandates of public policy, and may implicate public health and safety.
67. Arditi repeatedly voiced his objections to Defendants about said strategies,
decisions and actions.
68. _ In retaliation for Arditi's opposition, resistance and/or refusal to endorse, promote
and participate in said strategies, decisions and actions, Defendants retaliated against Arditi
determining his compensation, demeaning his ethics, stifling his dissent and, ultimately,
terminating his employment.
69. Defendants” actions constitute wrongful retaliation and termination of Arditi’s
employment in violation of New Jersey Court precedents recognizing employee protection with
respect to a refusal to take part in and/or promote an employer's practice that violates a clear
‘mandate of publie policy.
70. Asacdirect and proximate result of Defendants’ illegal retaliation, Arditi has
suffered, and will continue to suffer, damages, including but not limited to physical and
emotional damages, economic harm, stress, damage to his reputation as well as disruption in his
professional and personal life.
71. Defendants’ actions have been extreme and outrageous, and were actuated by
actual malice and/or wanton and willful disregard for Arditi and for laws, regulations, public
policy and public health and safety.
WHEREFORE, Arditi demands judgment against Defendants, jointly and severally, for
damages, including back pay, front pay, compensatory and punitive damages, counsel fees, pre-
14judgment and post-judgment interest, Court costs and fees, and such other relief as the Court
may deem just and appropriate under the circumstances.
THIRD COUNT
72. Plaintiff incorporates by reference the allegations and facts contained in the
preceding paragraphs as though the same were set forth at length herein.
73. MKC has adopted a Code of Conduct for all officers, directors and employees.
74, The Code of Conduct provides, in relevant part, that the company strictly
prohibits any retaliation for reporting potential violations and other issues in good faith under
this policy.
75. ‘The Code of Conduct further provides, in relevant part, that any retaliation for
raising concerns in good faith will not be permitted, and will result in appropriate discipline, up
to and including termination of employment.
76. — MKC distributed the Code of Conduct with the intention and expectation that
employees would rely on the statements, guidance and direction contained within the Code of
Conduct,
77. Arditi reasonably relied on, and complied with, the Code of Conduet by promptly
reporting any concerns that he might have.
78. Arditi reasonably relied on the Code of Conduct in believing that he could raise
concems to senior management without fear that he could be terminated in response.
79. Defendants have breached the Code of Conduct, and their obligations to Arditi, by
terminating his employment due to the fact that he raised concerns in good faith.
15,80. Defendants have breached the Code of Conduct, and their obligations to Arditi, by
failing to handle his reports sensitively, promptly and in a manner consistent with Company
policy.
81. Asaresult of Defendants” breaches of the Code of Conduct, Arditi has suffered,
and will continue to suffer, damages, including but not limited to physical and emotional
damages, economic harm, stress, damage to his reputation as well as disruption in his
professional and personal life.
82. Defendants’ actions have been extreme and outrageous, and were actuated by
actual malice and/or wanton and willful disregard for Arditi.
WHEREFORE, Arditi demands judgment against Defendants, jointly and severally, for
damages, including back pay, front pay, compensatory and punitive damages, counsel fees, pre
judgment and post-judgment interest, Court costs and fees, and such other relief as the Court
‘may deem just and appropriate under the circumstances
FOURTH COUNT
83. Plaintiff incorporates by reference the allegations and facts contained in the
preceding paragraphs as though the same were set forth at length herein.
84. There is an implicit covenant of good faith and fair dealing implicit in every
contractual obligation, including Defendants’ obligations pursuant to the Code of Conduct.
85. Defendants have breached their obligation of good faith and fair dealing to Arditi
by retaliating against him for reporting potential violations of law and company policy in good
faith.
1686. Defendants have breached their obligation of good faith and fair dealing to Arditi,
by failing to handle his reports sensitively, promptly and in a manner consistent with Company
policy.
87. Asaresult of Defendants’ breaches of the Code of Conduct, Arditi has suffered,
and will continue to suffer, damages, including but not fimited to physical and emotional
damages, economic harm, stress, damage to his reputation as well as disruption in his
professional and personal life.
WHEREFORE, Arditi demands judgment against Defendants, jointly and severally, for
damages, including back pay, front pay, compensatory and punitive damages, counsel fees, pre~
judgment and post-judgment interest, Court costs and such other relief as the Court may deem.
|just and appropriate under the circumstances.
EXETH COUNT
88. Plaintiff incorporates by reference the allegations and facts contained in the
preceding paragraphs as though the same were set forth at length herein.
89. Defendants acted willfully, deliberately and intentionally to inflicted upon Arditi
severe emotional distress up to and including the date of Arditi’s wrongful termination.
90. Asadirect and proximate result of Defendants’ intentional infliction of emotional
distress, Arditi has in the past suffered and will in the future continue to suffer, from severe
emotional distress and anxiety.
WHEREFORE, Arditi demands judgment against Defendants, jointly and severally. for
damages, including back pay, front pay, compensatory and punitive damages, counsel fees, pre-
judgment and postjudgment interest, Court costs and such other relief as the Court may deem
just and appropriate under the circumstances.
7JURY DEMAND
Plaintiff hereby demands a trial by jury on all issues herein.
DESIGNATION OF TRIAL COUNSEL
Pursuant to R.4:25-4, Plaintiff hereby designate Mark D. Lurie, Esq. as trial counsel in
the within matter.
CERTIFICATION PURSUANT TO RULE 4:5-1
‘The undersigned hereby certifies that, to the best of my knowledge and information, this,
dispute is not the subject of any other action pending in any other court or a pending arbitration
proceeding and is not aware of any additional parties who should be joined in this action at this
time.
LURIE LAW FIRM LLC
Attomeys for Plaintiff
18CIVIL CASE INFORMATION STATEMENT
(cis)
Use for initial Law Division
Civil Part pleadings (not motions) under Rule 4:5-1
Pleading will be rejected for filing, under Rule 1:5-6(c),
if information above the black bar is not completed
or attorney's signature is not affixed
"ATTORNEY /PRO SE NAME
TELEPHONE NUMBER ‘COUNTY OF VENUE
Mark D. Lurie (973) 509-0050 Bergen
eas aT
‘acne TST
a maar
96 Park Street ‘Complaint
Montclair, NJ_07042
JURYDEMAND =f Yes 1] No.
NAME OF PARTY (e4., John Doe, Paint)
John Arditi
‘CAPTION
John Arditiv. Mankind Corporation, Peter Richardson and Patricia
Mayer
‘CASE TYPE NUMBER (See reverse side for isting)
616
RELATED GASES PENDING?
O ves No
TS THIS A PROFESSIONAL MALPRACTICE CASE? ves MNO
IE YOU HAVE CHECKED “YES,” SEE NJ.S.A.24'53 A 27 AND APPLICABLE CASE LAW
REGARDING YOUR OBLIGATION TO FILE AN AFFIDAVIT OF MERIT,
IF YES, LIST DOCKET NUMBERS
‘DO YOU ANTICIPATE ADDING ANY PARTIES
(arising out of same transaction or occurance)?
O yes
THE INFC
‘DOPARTIES HAVE A CURRENT, PASTOR
eran
(CASE CHARACTERISTICS FOR PURPOSES OF DETERMINING IF CASE IS APPROPRIATE FOR MEDIATION
TF YES, 1S THAT RELATIONSHIP
(NAME OF DEFENDANT'S PRIMARY INSURANCE COMPANY (known)
FO
M CANNOT
RECURRENT RELATIONSHIP? I BeLOVERENPLOTEE 1 Frevomccioor 1] Onn (expiain)
mves Ono Fama Gl busness
[DOES THE STATUTE GOVERNING THIS CASE PROVIDE FORPAYMENT OF FEES BY THELOSINGPARTY? lM ves LINO
ACCELERATED DISPOSITION
‘USE THIS SPACE TO ALERT THE COURT TO ANY SPEGIAL CASE CHARACTERISTICS THAT MAY WARRANT INDIVIDUAL MANAGEMENT OR
TBO YOU GR YOUR CLIENT REED AR BABII ASCONMOORTIONS?
TF VES, PLEASE IDENTIFY HE REQUESTED ATCOMMODATION
O yes Bo
"WUL AN INTERPRETER GE NEEDED? TF VES, FOR WHAT NGINGE?
O ves BN
Teer that confidential porsonalidentifor have been redactod (Yom documents now aubvitied to the Cour and willbe
redacted rom al documents uied inte ie
in accordance with Rule 1:38-7(b).
ATTORNEY SIGNATURE: fads SY) 7
Tiocive 07/01/2010, CN T0517 English
Una
age 1 of2« , CIVIL CASE INFORMATION STATEMENT
(cis)
Use for initial pleadings (not motions) under Rule 4:5-1
CASE TYPES (Choose one and enter number of case type in appropriate space on the reverse side.)
‘Track! - 150 days’
151 NAME CHANGE
175 FORFEITURE
302 TENANCY
309. REAL PROPERTY (other than Tenancy, Contract, Condemnation, Complex Commercial or Construction)
‘502 BOOK ACCOUNT (debt collection matters ont)
510 UM or UIM CLAIM (coverage issues only)
511 ACTION ON NEGOTIABLE INSTRUMENT
512 LEMONLAW.
801 SUMMARY ACTION
‘802 OPEN PUBLIC RECORDS ACT (summary action)
969 OTHER (briefly Sescrbe nature of acon)
Track l - 300 days" discovery
‘CONSTRUCTION
EMPLOYMENT (other than CEPA or LAD)
‘CONTRACTICOMMERCIAL TRANSACTION
‘AUTO NEGLIGENCE - PERSONAL INJURY
PERSONAL INJURY
‘AUTO NEGLIGENCE — PROPERTY DAMAGE,
621 UM or UIM CLAIM (includes bodily injury)
TORT-OTHER
Track i; 450 days: discovery
‘CIVIL RIGHTS
Sor CONDEMNATION
‘ASSAULT AND BATTERY
MEDICAL MALPRACTICE
PRODUCT LABILITY
PROFESSIONAL MALPRACTICE
‘Toxic TORT
DEFAMATION
616 WHISTLEBLOWER / CONSCIENTIOUS EMPLOYEE PROTECTION ACT (CEPA) CASES
617. INVERSE CONDEMNATION
618 LAW AGAINST DISCRIMINATION (LAD) CASES
Track IV - Active Case Management by Individual Judge / 450 days’ discovery
4156 ENVIRONMENTALIENVIRONMENTAL COVERAGE LITIGATION
303 MT. LAUREL
‘508 COMPLEX COMMERCIAL
‘513 COMPLEX CONSTRUCTION
‘514 INSURANCE FRAUD
(620 FALSE CLAIMS ACT
701 ACTIONS IN LIEU OF PREROGATIVE WRITS.
Centrally Managed Litigation (Track IV)
‘280 Zenon
1285 Styker Trident Hip implants
288 Prudential Tort Ligation
88888
g
egageaee
Mass Tort (Track t¥)
‘248 CIBA GEIGY 281 BRISTOLMYERS SQUIBB ENVIRONMENTAL
206 HORMONE REPLACEMENT THERAPY (HRT) 282 FOSAMAX
271 ACCUTANE 283 DIGITEK
272 BEXTRAICELEBREX 284 NUVARING
274 RISPERDAL/SEROQUELZYPREXA 288 LEVAQUIN
275 ORTHO EVRA 287 YAZIYASMINIOCELLA
277 MAHWAH TOXIC DUMP SITE 601 ASBESTOS
278 ZOMETNAREDIA 819 VIOXX
273 GADOLINIUM
1 you bolieve this casa roquires a track other than that provid above, please indicate the resson on Side 4,
in the space under “Case Charactoritics.
Please check of each applicable category
0 Verbal Threshold CO Putative Class Action Cl Title 9
‘Efecive 0770172010, ON 10517-English page 2 of2LURIE LAW FIRM LLC
"A LIMITED LIABILITY COMPANY
"ATTORNEY ATLAW
96 PARK STREET
MONTCLAIR, NJ 07042
(a7) 59.0050
EACSAME (79) 508.005
WWW LURIELAWFIRMCOM
Maze asc} OY)
September 13, 2010
VIA CERTIFIED MAIL
Clerk, Civil Division
Bergen County Justice Center
10 Main Street
Hackensack. NJ 07601
Re: _ Arditi v. MannKind Corporation et al.
mpl
Dear Sir/Madam:
‘This office represents the plaintiff, John Arditi, in the above captioned action.
Enclosed for filing are an original and two copies of:
1. Plaintiff's Complaint and Jury Demand; and
2. Civil Case Information Statement; and
Thave also enclosed a check for the filing fees.
Kindly stamp cach document as “fied” and retum a copy inthe enclosed self-addressed
stamped envelope.
Tob
Mark DiLurie
Enel.
Ce: John Arditi -