PFIZER LIPITOR YOLSUZLUKLARI

AŞAĞIDAKİ SUÇLARDAN DOLAYI PFIZER’E AÇILAN DAVA , SUÇLAMALAR VE ALDIĞI CEZA. DOSYANIN TAMAMI EKLİ DOSYADA

FIFTH AMENDED COMPLAINT
FOR VIOLATIONS OF THE FEDERAL
FALSE CLAIMS ACT [31 U.S.C. § 3729
et seq.]; CALIFORNIA FALSE CLAIMS
ACT [Cal. Govt. Code § 12650 et seq.];
DELAWARE FALSE CLAIMS AND
FALSE REPORTING ACT [6 Del. C.
§ 1201]; FLORIDA FALSE CLAIMS
ACT [Fla. Stat. Ann. § 68.081 et seq.];
HAWAII FALSE CLAIMS ACT [Haw.
Rev. Stat. § 661-21 et seq.]; ILLINOIS
WHISTLEBLOWER REWARD AND
PROTECTION ACT [740 Ill. Comp. Stat.
§ 175 et seq.]; INDIANA FALSE
CLAIMS AND WHISTLEBLOWER
PROTECTION ACT [Ind. Code Ann.
§ 5-11-5.5-1 et seq.]; LOUISIANA
MEDICAL ASSISTANCE PROGRAM
INTEGRITY LAW [La. Rev. Stat.
§ 46:437.1 et seq.]; MASSACHUSETTS
FALSE CLAIMS LAW [Mass Gen Laws
ch.12 § 5 et seq.]; MICHIGAN
MEDICAID FALSE CLAIMS ACT
[Mich. Comp. Laws. § 400.601 et seq.];
MONTANA FALSE CLAIMS ACT
[Mont. Code Ann. § 17-8-401 et seq.];
NEVADA FALSE CLAIMS ACT [Nev.
Rev. Stat. Ann. § 357.010 et seq.]; NEW
HAMPSHIRE FALSE CLAIMS ACT
[N.H. Rev. Stat. Ann. § 167:61 et seq.];
NEW MEXICO MEDICAID FALSE
CLAIMS ACT [N.M. Stat Ann. § 27-2F-1
et seq.]; TENNESSEE FALSE CLAIMS
ACT AND TENNESSEE MEDICAID
FALSE CLAIMS ACT [Tenn. Code Ann.
§ 4-18-101 et seq. and § 71-5-181 et seq.];
TEXAS MEDICAID FRAUD
PREVENTION LAW [Tex. Hum. Res.
Code Ann. § 36.001 et seq.]; VIRGINIA
FRAUD AGAINST TAXPAYERS ACT
[Va. Code Ann. § 8.01-216.1 et seq.];
DISTRICT OF COLUMBIA
PROCUREMENT REFORM
AMENDMENT ACT [D.C. Code Ann.
§ 1-1188.13 et seq.]; NEW YORK
LABOR LAW § 740; NEW YORK
HUMAN RIGHTS LAW (“HRL”) NEW
YORK EXECUTIVE LAW § 290; NEW
YORK CITY HUMAN RIGHTS LAW
“NYCHRL” [N.Y.C. Admin. Code § 8-
101]; and TITLE VII OF THE CIVIL
RIGHTS ACT of 1964, as amended,

TABLE OF CONTENTS
PAGE
I. INTRODUCTION....................................................................1
II. PARTIES...............................................................................4
III. JURISDICTION AND VENUE ................................................................................................6
IV. BACKGROUND.....................................................................7
A. Overview: Drug Coverage under Federal Healthcare Programs .........................7
B. The FDA Regulatory System...................................................8
C. Prescription Drug Payment Under Federal Health Care Programs ....................11
1. The Medicaid Program .........................................................11
2. The Medicare Program .........................................................14
3. Reimbursement Under Other Federal Health Care Programs..16
D. Insufficient Evidence Of Safety And Efficacy For Off-Label Uses. .....................17
E. False Claims Submitted For Off-Label Non-Compendium Usage Of Lipitor, In
Violation Of Pre-Conditions Of Payment And Corporate Integrity Agreements..22
F. The FDA-Approved Indications For Lipitor..........................................................27
G. The NCEP ATP III Guidelines: Goals And Cutpoints .........................................29
V. ALLEGATIONS.........................................................................33
A. Pfizer’s “Stealth” Marketing and Its Impact on Physicians...................................33
1. Strategy of Covert Influence: The Parke-Davis Marketing Study.............34
2. Covert Influence Through “Educational Programs” And CME ................35
3. Covert Influence Through “Detailing” ......................................................36
4. Covert Influence And Off-Label Promotion..............................................38
B. Pfizer’s Illegal Off-Label Marketing Targeted Moderate Risk Americans ...........39
C. Misrepresenting The Lipitor Label And The Guidelines To Encourage Off-Label
Use .........................................................................................................................40
Case 1:04-cv-00704-ERK-ALC Document 78 Filed 02/11/10 Page 3 of 168
-ii-
D. Pfizer’s Lipitor “Operating Plan” And Deceptive Marketing Materials ...............41
1. Pfizer’s False And Misleading ATP-III “Guidelines” Presentation ..........44
2. Best Medical Group Practices....................................................................45
3. Other Physician Detailing - The Hard Sell At Ventura County Ambulatory
Care Network.............................................................................................47
4. Pfizer’s False And Misleading Targeting Of PBDMs And Consultants ...48
5. Pfizer’s False And Misleading Targeting Of Physicians...........................50
a. Lipid Goal Manager.......................................................................50
b. Lipitor.com Professional................................................................54
6. Pfizer’s Misrepresentation Of TNT To Promote Lower Is Better .............56
7. Pfizer’s Selective Reporting of Clinical Trial Data ...................................59
8. Pfizer’s Targeting Of Moderate Risk Patients With Hypertension ...........60
9. Pfizer’s Illegal Off-Label Marketing To Chronic Kidney Disease Patients,
Including Those With End Stage Renal Disease .......................................62
a. Pfizer Has Targeted Patients With CKD .......................................62
b. Pfizer Has Targeted Patients With ESRD......................................66
c. Pfizer Has Compromised The Distribution Of Critical Clinical
Trial Information............................................................................67
d. Pfizer Relies On Off-Label Messages In Medical Journal Review
Articles...........................................................................................68
e. The Impact Of Pfizer’s Illegal ESRD Off-Label Marketing .........70
10. Pfizer’s False And Misleading Targeting Of Patients ...............................70
11. Pfizer’s Promoted And Disseminated Inaccurate Computerized Risk
Calculators With The Purpose And Effect Of Expanding The Off-Label
Use Of Lipitor ............................................................................................72
12. Getting To Goal .........................................................................................76
13. Software vs. Paper NCEP Guidelines........................................................77
14. Off-Label Promotion..................................................................................78
Case 1:04-cv-00704-ERK-ALC Document 78 Filed 02/11/10 Page 4 of 168
-iii-
15. Omitting/Downplaying Side Effects..........................................................80
16. “Speaker Fees”...........................................................................................81
17. Pfizer Reveals, And Presents Evidence Of, Its Off-Label Marketing
Campaign To The Investment Community................................................81
18. Pfizer’s Improper Use Of “Third Party” Organizations And Continuing
Medical Education Programs.....................................................................84
a. Off-Label Promotion Of Lipitor Through The National Lipid
Education Council..........................................................................87
b. Off-Label Promotion Of Lipitor Through The ESLM Program....94
c. Off-Label Promotion of Lipitor Through VBWG And COACH ..96
d. Off-Label Promotion of Lipitor Through Other Organizations...100
e. Conclusion ...................................................................................101
19. Pfizer’s Sampling Program ......................................................................101
a. Limiting Supply Of Lower Dosage Samples Increases False
Claims ..........................................................................................103
b. Samples To Physicians ................................................................105
c. Sampling Raises Additional Safety Concerns .............................106
d. Sampling Corrupts The Physician-Patient Relationship..............106
E. A Case Study: Pfizer’s Aggressive Targeting Of An Ohio Doctor Leads Directly
To Off-Label Prescribing Of Lipitor....................................................................107
VI. False Claims for Off-Label Use Submitted to Government Healthcare Programs ...............111
A. NHANES .............................................................................................................111
1. Off-Guideline Prescription of Lipitor ......................................................111
2. Individual Claims.....................................................................................115
B. Pfizer’s Own Analysis of the Effects of Its False and Misleading NCEP-Based
Programs ..............................................................................................................116
C. Individual Claims.................................................................................................119
VII. Pfizer Violated The Anti-Retaliation Provisions Of The False Claims Act.........................121