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  • I.

    INTRODUCTION................................................................................................................. 1

  • n.

    PARTIES .............................................................................................. ,', .. ,............... ,.. ,"" 6

    • III.

      JURISDICTION AND VENUE ..... ,................................ ,."", ...... "" .. ,... ,... " ..................., 8

    • IV.

      THE REGULATORY ENVIRONMENT...................................................................... , 9

      • A.

        THE FEDERAL AND STATE FALSE CLAIMS ACTS ............................................................ 10

      • B.

        THE ANTI-KICKBACK STATUTE ...................................................................................... 10

    • C.

      THE MEDICAID REBATE STATUTE AND RELATED LEGiSLATION ................................... 11

    • D.

      STATES' PROHIBITION ON SUBSTITUTION AND MANDATED COST SAVINGS ............ 13

    • E.

      THE ILLINOIS INSURANCE FRAUD CLAIMS PREVENTION ACT (ICFPA) ....................... 14

  • V.

    THE KICKBACKS-FOR-SWITCHES SCHEMES........................................................ 15

    • A.

      THE MARKET SHARE AGREEMENTS ............................................................................... 16

    • B.

      LISITZA LEARNS OF THE FIRST ILLEGAL MARKET SHARE AGREEMENT BETWEEN BRISTOL MYERS SQUIBB AND OMNICARE............................................................................... 17

    • C.

      BRISTOL MYERS SQUIBB AND OMNICARE DEVELOP A SCHEME To ILLEGALLY SOLICIT PERMISSION FROM TREATING PHYSICIANS FOR WHOLESALE SWITCHING TO MONOPRIL. 19

    • D.

      BRISTOL MYERS SQUIBB'S ILLEGAL MARKET SHARE AGREEMENTS ENDANGERED THE HEALTH AND WELFARE OF LONG-TERM CARE FACILITY PATIENTS RECEIVING PHARMACEUTICALS FROM OMNICARE .................... ,... ,.... ,.. ,.. ,." .. ".,',., ... ,... ,.. " ... ,... ,............ ,' 23

    • E.

      AFTER THE SUCCESS OF THE BRISTOL MYERS SQUIBBIMONOPRIL PAL PROGRAM, OTHER DEFENDANT MANUFACTURERS ENTER INTO SIMILAR SCHEMES WITH OMNICARE WITH SIMILAR RESULTS AND RISKS ,................................................................................... ,.. 27

    • F.

      DEFENDANT MANUFACTURER PFIZER AND OMNICARE ENTER INTO A MARKET SHARE AGREEMENT WITH RESPECT TO LIPITOR .............................................................................. 28

    • G.

      DEFENDANT MANUFACTURER PFIZER AND OMNICARE ENTER INTO A MARKET SHARE AGREEMENT WITH RESPECT TO ACCUPRIL ............................................................... 32

    • H.

      DEFENDANT MANUFACTURER ORTHO McNEIL AND OMNICARE ENTER INTO A MARKET SHARE AGREEMENT WITH RESPECT TO LEVAQUIN .............................................. , 35

    • I.

      DEFENDANT MANUFACTURER JANSSEN AND OMNICARE ENTER INTO A MARKET SHARE AGREEMENT WITH RESPECT TO RISPERDAL ............................................................. 39

    • J.

      DEFENDANT MANUFACTURER ORTHO McNEIL AND OMNICARE ENTER INTO A MARKET SHARE AGREEMENT WITH RESPECT TO ULTRAM/ULTRACET .............................. 45

    • K.

      DEFENDANT MANUFACTURER BRISTOL MYERS SQUIBB AND OMNICARE ENTER INTO A MARKET SHARE AGREEMENT WITH RESPECT TO ABILIFY ............................................... 47

  • VI.

    OMNICARE'S ELIGIBILITY FOR MEDICAID REIMBURSEMENT IS

CONTINGENT UPON ITS ACTUAL AND CERTIFIED COMPLIANCE WITH ALL

APPLICABLE FEDERAL AND STATE REGULATIONS .................................................. 50 VII. THE DEFENDANT MANUFACTURERS CAUSED FALSE CLAIMS TO BE SUBMITTED FOR THEIR PREFERRED MEDICATIONS IN VIOLATION OF THE FEDERAL AND STATE FALSE CLAIMS ACTS ................................................................. 55

A.

THE KICKBACKS-FOR-SWITCHES SCHEME AND ACCOMPANYING PAL SOLICITATIONS

CREATED FALSE CLAIMS.,., .............. " ... ,', ... ,', .. ,"',." .. ,., ....................... ,., .. " .. ".,',.,.,.,', ... ,........ 55 B. THE K!CKBACKS-FOR-SWITCHES SCHEME VIOLATED THE ANTI-KICKBACK STATUTE, RENDING ALL CLAIMS SUBMITTED TO THE GOVERNMENT FOR DRUGS COVERED BY THE MARKET SHARE AGREEMENTS FALSE CLAIMS ..................................................................... , 58

C.

THE KICKBACKS-FOR-SWITCHES SCHEME VIOLATED FEDERAL AND STATE FALSE

C L A I M S A C T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . " . " . . " . . . , . . . . , . . . . , . . . . . . . . . . . . . . . . . . " . , . , . . . . . . . , . . , . , ' , . . . . . . . . . . " . . . . . . . , . . . . , . . . ,

"" 60

11

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