Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015 (Chart Book)
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Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015 (Chart Book) March 31, 2016 Sammy Almashat, M.D., M.P.H. Sidney M. Wolfe, M.D. Michael Carome, M.D. ––––––––––––––––––– www.citizen.org Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) About Public Citizen Public Citizen is a national nonprofit organization with more than 400,000 members and supporters. We represent consumer interests through lobbying, litigation, administrative advocacy, research, and public education on a broad range of issues, including consumer rights in the marketplace, product safety, financial regulation, safe and affordable health care, campaign finance reform and government ethics, fair trade, climate change, and corporate and government accountability. About this Document On March 31, 2016, Public Citizen published a report that catalogs and analyzes all major financial settlements, with accompanying criminal and civil penalties, reached between pharmaceutical manufacturers and federal and state governments. This document contains all charts presented in that report. The full report is available at: www.citizen.org/hrg2311. See Appendix 2 of that report for the methodology used in compiling the data presented in these charts. See Appendix 3 for an explanation of changes made to some of the pre-2013 data presented in the previous 2012 iteration (available at www.citizen.org/hrg2073) of this report. 2 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Table of Contents Figure 1. Number of Pharmaceutical Industry Settlements, 1991 – 2015 Figure 2. Pharmaceutical Industry Financial Penalties, 1991 – 2015 Figure 3. Number of Pharmaceutical Industry Settlements, 1991 – 2015: Federal vs. State Figure 4. Pharmaceutical Industry Financial Penalties, 1991 – 2015: Federal vs. State Figure 5. Number of State Pharmaceutical Industry Settlements, 1991 – 2015: Multi-State vs. Single-State Figure 6. State Pharmaceutical Industry Financial Penalties, 1991 – 2015: Multi-State vs. Single-State Figure 7. Number of Pharmaceutical Industry Settlements, 1991 – 2015: Civil vs. Criminal Figure 8. Pharmaceutical Industry Financial Penalties, 1991 – 2015: Civil vs. Criminal Figure 9. Federal False Claims Act (FCA): Financial Penalties by Industry, Fiscal Year (FY) 1991 – 2015 Figure 10. Federal Pharmaceutical Industry Settlements, 1991 – 2015: Qui Tam (Whistleblower) vs. Non-Qui Tam Figure 11. Federal Pharmaceutical Industry Financial Penalties, 1991 – 2015: Qui Tam (Whistleblower) vs. Non-Qui Tam Figure 12. State Pharmaceutical Industry Settlements, 1991 – 2015: Qui Tam (Whistleblower) vs. Non-Qui Tam Figure 13. State Pharmaceutical Industry Financial Penalties, 1991 – 2015: Qui Tam (Whistleblower) vs. Non-Qui Tam Figure 14. Types of Pharmaceutical Industry Violations, 1991 – 2015 Figure 15. Pharmaceutical Industry Financial Penalties by Type of Violation, 1991 – 2015 Figure 16. Types of Pharmaceutical Industry Violations, Jul. 19, 2012 – Dec. 31, 2015 Figure 17. Pharmaceutical Industry Financial Penalties by Type of Violation, Jul. 19, 2012 – Dec. 31, 2015 Table 1. Single-state Settlement Totals, 1991 – 2015 Table 2. Multi-state Settlement Totals, 1991 – 2015 3 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Table 3. Overall State Settlement Totals, 1991 – 2015 Table 4. Pharmaceutical Company Penalties: Worst Offenders, 1991-2015 Table 5. Pharmaceutical Company Penalties: Repeat Offenders, 1991-2015 Table 6. Pharmaceutical Company Penalties: Worst Offenders, Jul. 19, 2012 – Dec. 31, 2015 Table 7. Twenty Largest Settlements and Judgments, 1991 – 2015 Table 8. Twenty Largest Settlements and Judgments, Jul. 19, 2012 – Dec. 31, 2015 Table 9. Definitions of the Types of Violations by Pharmaceutical Companies Table 10. Pharmaceutical Company Penalties: Worst Offenders, 2006-2015 (not included in published report) Table 11. Pharmaceutical Company Penalties: Repeat Offenders, 2006-2015* (not included in published report) 4 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 1. Number of Pharmaceutical Industry Settlements, 1991 – 2015 70 60 60 57 50 44 42 40 36 30 26 21 Number of of Settlements Number 20 18 14 10 9 10 8 8 3 3 3 2 2 2 1 1 1 1 1 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 5 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 2. Pharmaceutical Industry Financial Penalties, 1991 – 2015 7000 6348 6000 5000 4412 4339 3976 4000 3500 3000 2338 2208 2000 Financial Penalties ($ millions)($ Penalties Financial 1441 1429 1067 967 999 1000 889 549 642 489 100 10 22 1 10 7 4 3 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 6 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 3. Number of Pharmaceutical Industry Settlements, 1991 – 2015: Federal vs. State* 60 50 50 45 40 30 28 26 Federal 24 State 20 18 18 Number of of Settlements Number 16 13 12 11 10 10 10 10 8 8 8 7 7 6 5 4 3 3 2 2 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 0 Year Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 *State settlements refer to those in which the federal government neither was involved in the investigation responsible for the settlement nor was a party to the final settlement, as determined through a review of the press release and, when available, the official settlement document. All other cases were classified as federal, including joint federal-state cases (e.g., those involving Medicaid). 7 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 4. Pharmaceutical Industry Financial Penalties, 1991 – 2015: Federal vs. State* 6000 5555 5000 4002 4000 3872 3812 3123 3000 Federal (F) State (S) 2071 2000 1712 1410 Financial Penalties ($ millions)($ Penalties Financial 1122 1045 961 960 889 1000 793 625 549 527 377 404 410 356 307 287 85 104 137 10 22 1 8 2 5 2 4 3 5842 6 39 22 32 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 *State settlements refer to those in which the federal government neither was involved in the investigation responsible for the settlement nor was a party to the final settlement, as determined through a review of the press release and, when available, the official settlement document. All other cases were classified as federal, including joint federal-state cases (e.g., those involving Medicaid). 8 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 5. Number of State Pharmaceutical Industry Settlements, 1991 – 2015: Multi-State vs. Single-State Settlements* 60 50 48 40 40 30 Multi-state 25 23 Single-state 22 20 Number of of Settlements Number 14 11 10 6 5 4 4 3 3 3 2 2 2 2 2 2 1 1 1 1 1 1 1 1 1 1 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 *Single-state settlements were those in which only one state was a party to the final settlement, as gleaned from the information provided in the press release. All other state settlements were classified as multi-state. 9 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 6. State Pharmaceutical Industry Financial Penalties, 1991 – 2015: Multi- State vs. Single-State Settlements* 450 417 400 397 376 365 347 350 335 300 250 228 192 Multi-state 200 186 Single-state 147 150 140 121 Financial Penalties ($ millions)($ Penalties Financial 100 85 88 71 63 66 42 50 36 28 13 16 10 12 2 2 3 6 3 4 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 *Single-state settlements were those in which only one state was a party to the final settlement, as gleaned from the information provided in the press release. All other state settlements were classified as multi-state. 10 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 7. Number of Pharmaceutical Industry Settlements, 1991 – 2015: Civil vs. Criminal* 60 55 52 50 40 39 34 32 30 Civil 25 Civil-Criminal Criminal 20 20 Number of of Settlements Number 17 10 9 10 8 7 6 6 5 4 3 3 3 3 3 3 2 2 2 2 2 11 1 1 1 11 1 1 1 1 1 1 1 1 1 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 *“Civil” refers to all solely civil settlements. “Civil-Criminal” refers to settlements with both a civil and criminal financial penalty. “Criminal” refers to cases with only a criminal component. All criminal and civil- criminal settlements were federal. All state settlements were civil. 11 Public Citizen Pharmaceutical Industry Settlements: 1991-2015 (Chart Book) Figure 8. Pharmaceutical Industry Financial Penalties, 1991 – 2015: Civil vs. Criminal* 5000 4500 4482 4000 3796 3500 3327 3000 2676 2500 2466 2185 Civil (Cv) Criminal (Cr) 1946 2000 1853 1866 1500 1379 Financial Penalties ($ millions)($ Penalties Financial 1012 903 918 903 1000 825 706 622 599 549 489 538 485 500 290 293 149 180 100 64 10 22 1 10 7 1 3 3 50 21 23 0 Source: Public Citizen, Twenty-Five Years of Pharmaceutical Industry Criminal Year and Civil Penalties: 1991-2015. See full report at: www.citizen.org/hrg2311 *All criminal penalties were federal. All state penalties were civil. In mixed civil-criminal settlements, the civil and criminal portions were separated out and added to their corresponding categories here.