UNITED STATES DISTRICT COURT FOR THEDISTRICT OF MASSACHUSETTS-----------------------------------------------------xUNITED STATES OF AMERICA, et al.,
ex rel.
JEFFREY J. BIERMAN,CASE NO.: 05-10557(EFH)Plaintiff,v.SECONDAMENDED ANDSUPPLEMENTALCOMPLAINT ANDJURY DEMANDORTHOFIX INTERNATIONAL N.V.,ORTHOFIX, INC., ORTHOLOGIC CORP.,DJO INCORPORATED, REABLE LEAVE TO FILETHERAPEUTICS, INC., BIOMET INC., GRANTED ONEBI, L.P., EBI HOLDINGS, INC, JUNE 9, 2010EBI MEDICAL SYSTEMS, INC.,BIOELECTRON, INC.,and SMITH & NEPHEW, INC.Defendants.------------------------------------------------------x
Case 1:05-cv-10557-EFH Document 121 Filed 06/11/10 Page 1 of 117
TABLE OF CONTENTSPageINTRODUCTION...............................................................................................................1JURISDICTION AND VENUE..........................................................................................6PARTIES.............................................................................................................................6SUMMARY OF FRAUDULENT SCHEME .................................................................11MEDICARE REIMBURSEMENT FOR OSTEOGENESIS STIMULATORS...............21HCPCS Codes and Coverage Criteria.........................................................................22Medicare Fee Schedule...............................................................................................23Medicare Reimbursements from 1998 to 2008...........................................................24Medicare Reimbursement Rules.................................................................................25Procedure for Making Claims.....................................................................................27CLINICAL STUDIES.......................................................................................................29RELATOR’S DISCOVERY OF FRAUDULENT SCHEME..........................................33FALSE CLAIMS ACT VIOLATIONS............................................................................48DAMAGES.......................................................................................................................58CAUSES
OF
ACTION......................................................................................................60DEMAND FOR RELIEF................................................................................................109DEMAND FOR JURY TRIAL ......................................................................................114EXHIBIT A: SUMMARY CLAIMS DATAEXHIBIT B: REPRESENTATIVE SMITH & NEPHEW DATAEXHIBIT C: REPRESENTATIVE INDIVIDUAL CLAIMS
Case 1:05-cv-10557-EFH Document 121 Filed 06/11/10 Page 2 of 117
1
INTRODUCTIONPlaintiff/relator, Jeffrey J. Bierman, in the name of and on behalf of the UnitedStates of America, the State of California, the City of Chicago, the State of Delaware, theState of Florida, the State of Georgia, the State of Hawaii, the State of Illinois, the Stateof Indiana, the State of Louisiana, the State of Massachusetts, the State of Michigan, theState of Nevada, the State of New Hampshire, the State of New Mexico, the State of NewYork, the State of Tennessee, the State of Texas, the State of Virginia, and the District of Columbia, by his attorneys, Getnick & Getnick, as and for his complaint, alleges asfollows:1.
As more fully alleged herein, this action arises out of a scheme or schemes todefraud the United States of America and other governments (referred tocollectively herein as “the government”) perpetrated by the defendants,commencing in or about 1993 and continuing to the date hereof. The defendantsmake false and fraudulent claims for payment, and/or make, use or cause to bemade or used, false records and statements to get false claims paid to thegovernment for certain items of durable medical equipment (“DME”) used bypatients in their homes, namely noninvasive osteogenesis stimulators (referred toherein for convenience simply as “osteogenesis stimulators”), covered byMedicare, Medicaid, and other federal and state purchasers of DME.Osteogenesis stimulators, which are also known as bone growth stimulators, areportable, non-sterile, battery-operated devices that use pulsed electromagneticfields or ultrasound waves purportedly to promote bone growth in non-healing
Case 1:05-cv-10557-EFH Document 121 Filed 06/11/10 Page 3 of 117
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