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!Hcl^S Office Filed Under Seal IN THE UNITED STATES DISTRICT COURT P FOR THE DISTRICT OF MASSACHUSETTS !^D !HCL^S OFFICE Civil Action No. 03-10641-NG-RWZ Civil Action No. 11-10398-NG-RWZ UNITED STATES OF AMERICA, et at, ex rel GREGORY W. THORPE and BLAIR HAMRICK, Plaintiffs, v. SMITH KLINE BEECHAM, INC., and GLAXOSMITHKLINE PLC d/b/a GLAXOSMITHKLINE, Defendants. SEVENTH AMENDED COMPLAINT FILED UNDER SEAL PURSUANT TO 31 U.S.C. §§ 3729 etseq. Matthew J. Fogelman, Esquire FOGELMAN & FOGELMAN LLC 100 Wells Avenue William J. Leonard, pro hac vice Newton, MA 02459 Richard P. Limburg, pro hac vice Kimberly D. Sutton, pro hac vice Brian P. Kenney Alex P. Basilevsky,/>/"6> hac vice M. Tavy Deming OBERMAYER REBMANN MAXWELL & Emily C. Lambert HIPPEL LLP KENNEY & McCAFFERTY, PC One Perm Center, 19th floor 3031 Walton Road, Suite C202 1617 John F. Kennedy Boulevard Plymouth Meeting, PA 19462 Philadelphia, PA 19103 A Homeys for Plaintiffs-Relators Gregory W. Thorpe and Blair Hamrick 4612364 TABLE OF CONTENTS I. BACKGROUND.....................................................................................................2 II. PARTIES ................................................................................................................4 III. JURISDICTION AND VENUE............................................................................6 IV. GENERAL ALLEGATIONS...............................................................................7 A. Drugs Marketed By GSK For Off-Label Use...............................................12 1. Advair ...................................................................................................13 2. Amerge..................................................................................................15 3. Flonase .................................................................................................15 4. Flovent HFA and Flovent Diskus .......................................................16 5. Imitrex ..................................................................................................16 6. Lamictal................................................................................................17 7. Paxil......................................................................................................18 8. Valtrex ..................................................................................................19 9. Wellbutrin.............................................................................................20 10. Zofran.................................................................................................21 11. Zyban ..................................................................................................21 V. GSK’S RETALIATORY DISCHARGE OF RELATORS THORPE AND HAMRICK ...........................................................................................................22 A. Relator Thorpe’s Employment with GSK ....................................................22 B. Relator Hamrick’s Employment with GSK.................................................29 VI. APPLICABLE LAW...........................................................................................36 A. Law Relating to Distribution of Prescription Medication For Uses Not Approved By the Food and Drug Administration.........................36 4612612 i B. Regulations Excluding Reimbursement for Off- Label Prescription Drug Uses by Government-Funded Health Care Programs................40 1. The Social Security Act and Medicaid .........................................40 C. Health Care Programs Harmed by GSK’s Unlawful Off-Label Promotions................................................................................................43 1. Medicare and Medicare Part D ....................................................44 2. The Railroad Retirement Medicare Program...............................45 3. Federal Employee Health Benefit Plans ......................................46 4. TriCare...........................................................................................46 5. The Veterans Administration........................................................46 6. Other Programs Harmed..............................................................47 D. The Anti-Kickback Statute and GSK’s Systematic Statutory Violation In the Marketing and Sale of Prescription Medications......48 E. GSK’s Use of “FaxBacks” and Medical Journal Articles for Off-Label Promotion In Violation of the FDCA and The False Claims Act.................................................................................................50 VII. GSK’S OFF-LABEL MARKETING OF ADVAIR .........................................53 A. GSK’s Off-Label Marketing of Advair for the Treatment of Mild Asthma ......................................................................................................55 1. GSK’s Improper Use of Speakers and National Thought Leaders to Promote the Off-Label Marketing of Advair For Mild Asthma ...........................................................................60 a. GSK Employed Ghostwriters to Author Favorable Journal Articles for Advair and Mild Asthma ........................................64 2. GSK’S Off-Label Marketing of Advair in Pediatrics...................65 3. GSK Aggressively Targeted High Medicaid Markets for Off-Label Use of Advair................................................................68 B. GSK’s Off-Label Marketing of Advair for the Treatment of COPD.................................................................................70 4612612 ii 1. GSK’s Improper Use of Speakers and National Thought Leaders to Promote the Off-Label Use of Advair for COPD.....................82 2. GSK’s Use of Faxbacks and Journal Articles in the Off-Label Marketing of Advair for COPD ....................................................88 3. GSK Routinely Violated the Anti-Kickback Statute in its Marketing Activities for Advair ...................................................89 VIII. GSK’S OFF-LABEL MARKETING OF AMERGE AND IMITREX...........91 A. Off-Label Promotion of Imitrex and Amerge Beyond Migraine.........93 1. Marketing For Mild Headache.....................................................93 2. Marketing for Sinus and Tension Headache ...............................97 3. Off-Label Promotion for Menstrual Migraine, Prophylaxis and Use During Pregnancy........................................................101 B. Promotion of Imitrex and Amerge Off-Label to Children.................103 C. Use of Peer-to-Peer Marketing to Promote Imitrex and Amerge Off-Label.................................................................................................107 D. GSK Targeted Physicians Who Treat Beneficiaries of Government Funded Healthcare Programs...............................................................111 IX. GSK’S OFF-LABEL MARKETING OF LAMICTAL .................................112 A. Off-Label Promotion to Bipolar Patients ............................................112 1. Off-Label Promotion for all Bipolar Disorders .........................113 2. GSK’s Improper Use of National Thought Leaders to Promote the Off-Label Marketing of Lamictal .........................................116 3. GSK’s Off-Label Marketing to Psychiatrists..............................117 B. GSK’S Off-Label Promotion of Lamictal Resulted in Patient Harm ......................................................................................................121 C. GSK Targeted Federal Health Care Programs for Off-Label Use ...........................................................................................................124 4612612 iii X. GSK’S OFF-LABEL MARKETING OF LOTRONEX.................................126 A. GSK Compensated Physicians to Lecture Off-Label on Lotronex ...127 B. Marketing of Lotronex Off-Label to Men ...........................................128 XI. GSK’S OFF-LABEL MARKETING OF PAXIL ...........................................129 1. Paxil’s Approval History.............................................................130 2. GSK's Seamless Continuation of SKB's Off-Label Paxil and Paxil CR Promotion Post Merger ......................................130 3. Off-Label Promotion of Paxil and Paxil CR to Children..........132 4. Marketing of Paxil and Paxil CR Off-Label to Adults..............135 5. GSK's Off-Label Promotion of Paxil and Paxil CR Caused Substantial Improper Medicaid Expenditures...........................138 XII. GSK’S OFF-LABEL MARKETING OF VALTREX....................................139 1. GSK Violated The Anti-Kickback Statute Through Its Systematic Compensation of Physician Speakers For Off-Label Programs On Valtrex..................................................................140 2. GSK Promoted Valtrex Off-Label for Lifetime Suppression ....144 XIII. GSK’S OFF-LABEL MARKETING OF WELLBUTRIN IR, WELLBUTRIN SR AND WELLBUTRIN XL ...............................................144 1. Off-Label Promotion of the Wellbutrin as the “Happy, Horny, Skinny Drug” ..............................................................................147 2. Off-Label Promotion for ADHD in Children and Adults .........154 3. Off-Label Promotion of Wellbutrin for Depressive Symptoms, Including Anxiety........................................................................156 4. Off-Label Promotion of Wellbutrin for Smoking Cessation .....159 5. Off-Label Promotion to Obstetricians........................................160 6. GSK’s Off-Label Marketing Efforts Targeted High Volume
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