Twenty-Seven Years of Pharmaceutical Industry
Criminal and Civil Penalties: 1991-2017
(Chart Slide Set)
Sammy Almashat, M.D., M.P.H.
Ryan Lang, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Michael Carome, M.D.
Public Citizen’s Health Research Group
March 14, 2018
Full report available at:
https://www.citizen.org/our-work/health-and-safety/pharmaceutical-industry-penalties
1 1 1 2 3 1 1
3 3 2 3
9 8 8
10
14
26
36
42 44
57
60
21
18 17
21
0
10
20
30
40
50
60
70
Nu
mb
er
of
Sett
lem
en
ts
Year
Figure 1. Number of Pharmaceutical Industry Settlements, 1991 – 2017
10 22 1 10 7 4 3 100
489
889
552
967 999 1067
3976
1441 1429
4412 4339
2338
6348
3500
642
2208
1592
1304
0
1000
2000
3000
4000
5000
6000
7000
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
Figure 2. Pharmaceutical Industry Financial Penalties, 1991 – 2017
1 1 1 1 2
1 2 2 2
3
8 6
5 3
10 8
10
18 16
12 10
8
11 13
16
1 1 1 1 1 1 2
3
7
4
18
26 24
28
45
50
13
7
4 5
0
10
20
30
40
50
60
Nu
mb
er
of
Sett
lem
en
ts
Year
Federal
State
Figure 3. Number of Pharmaceutical Industry Settlements, 1991 –2017:
Federal vs. State*
10 22 1 8 5 4 58
404
889
552
961 960 1045
3872
1410
1122
4002
3812
1712
5555
3123
356
2071
1565
1249
2 2 3 42 85 6 39 23
104 32
307 410
527 625
793
377
287 137
27 55
0
1000
2000
3000
4000
5000
6000
Fin
an
cia
l P
en
alt
ies (
$ m
illi
on
s)
Year
Federal (F)
State (S)
Figure 4. Pharmaceutical Industry Financial Penalties, 1991 –2017:
Federal vs. State*
1 1 1 1 1 1 1 3
2 4
3 2
3 5
2 2 1
2 2 1 1
2 4
2
14
23 22
25
40
48
11
6
2 3
0
10
20
30
40
50
60
Nu
mb
er
of
Sett
lem
en
ts
Year
Multi-state
Single-state
Figure 5. Number of State Pharmaceutical Industry Settlements, 1991 –2017:
Multi-State vs. Single-State*
2 2 3
42
6
36
10
88
28
186
63
192
228
417
12
140
71
20**
47
85
3
13 16 4
121
347 335
397
376 365
147
66
8 8
0
50
100
150
200
250
300
350
400
450
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
Multi-state
Single-state
Figure 6. State Pharmaceutical Industry Financial Penalties, 1991 –2017:
Multi-State vs. Single-State*
1 2
3 1
3 3 1
2
8 6 6
9 10
25
32 34
40
52
55
20
17 15
19
1 1 1 1 2 2
1 3
1 3
7
2 4
5
1 1 1 2 1 1 1 1 1
2 1 1
0
10
20
30
40
50
60
Nu
mb
er
of
Sett
lem
en
ts
Year
Civil
Civil-Criminal
Criminal
Figure 7. Number of Pharmaceutical Industry Settlements, 1991 – 2017:
Civil vs. Criminal*
22 10 7 1 3 100
489 599 550
903
706
918
3796
903
1379
2466
3327
1901
4482
2676
622
2185
1298 1281
10 1 3
290
2 64
293 149 180
538
50
1946
1012
437
1866
825
21 23
294
23
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
Civil (Cv)
Criminal (Cr)
Figure 8. Pharmaceutical Industry Financial Penalties, 1991 –2017:
Civil vs. Criminal*
285
191 113
593
251
140 67
221
46
149 136
34
312
32 120
641
53 137
439
267
143 170
52 75
283
122
220
10
560
161 84
140
465
599 634
1162
961 888
2645
1203
974
36
923
622
0
500
1000
1500
2000
2500
3000
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Fiscal Year
Defense
Pharmaceutical
Figure 9. Federal False Claims Act (FCA): Financial Penalties by Industry, Fiscal Year (FY) 1991 –2017*
1
2
1
3
2
3
5
4
6
16
10
8 8
5
7
5
6
1 1 1
2
1
2 2 2
5
4
2
3
5
4 4
2
6
4
2
3
4
8
10
0
2
4
6
8
10
12
14
16
18
Nu
mb
er
of
Sett
lem
en
ts
Year
qui tam
non-qui tam
Figure 10. Federal Pharmaceutical Industry Settlements, 1991 –2017:
Qui Tam (Whistleblower) vs. Non-Qui Tam*
8
889
49
700 775
978 746 1102
3853 3703
562
5410
3119
328
622
980 865
10 22 1 5 4 58
404 503
262 185 67
3872
663
21 149 109
1151
144 4 28
1449
585 384
0
1000
2000
3000
4000
5000
6000
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
qui tam
non-qui tam
Figure 11. Federal Pharmaceutical Industry Financial Penalties, 1991 –2017:
Qui Tam (Whistleblower) vs. Non-Qui Tam*
1 1 1 2
4
2 2
4
1 1 1 1 1 1 2 2
6
4
17
24
20
26
43
46
13
7
4 5
0
5
10
15
20
25
30
35
40
45
50
Nu
mb
er
of
Sett
lem
en
ts
Year
qui tam
non-qui tam
Figure 12. State Pharmaceutical Industry Settlements, 1991 –2017:
Qui Tam (Whistleblower) vs. Non-Qui Tam*
10 9 28 30
242
203 215
56
2 2 3
42
85
6
39
13
95
32
279
380
285
423
578
321
287
137
27
55
0
100
200
300
400
500
600
700
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
qui tam
non-qui tam
Figure 13. State Pharmaceutical Industry Financial Penalties, 1991 –2017:
Qui Tam (Whistleblower) vs. Non-Qui Tam*
204
117
63
28
16 12
12 8 6 Overcharging Government HealthPrograms (204)
Unlawful Promotion (117)
Kickbacks (63)**
Monopoly Practices (28)
Concealing Data (16)
Poor Manufacturing Practices (12)
Environmental Violations (12)
Financial Violations (8)
Illegal Distribution (6)
Figure 14. Types of Pharmaceutical Industry Violations, 1991 –2017*
1 1
2 1
4
2
4
6
4
16
19
26
29
37
41
5
3
1 2
0
5
10
15
20
25
30
35
40
45
Nu
mb
er
of
Sett
lem
en
ts
Year
Figure 15. Number of Pharmaceutical Industry Settlements Involving
Overcharging of Government Health Programs, 1991 – 2017
11299
6328
3585
2221
1771
1636
267
232
102
11205
Unlawful Promotion ($11,299)
Overcharging Government HealthPrograms ($6,328)
Financial Violations ($3,585)
Monopoly Practices ($2,221)
Poor Manufacturing Practices($1,771)
Kickbacks ($1,636)*
Concealing Data ($267)
Environmental Violations ($232)
Illegal Distribution ($102)
Multiple Violations ($11,205)**
Figure 16. Pharmaceutical Industry Financial Penalties by Type of Violation, 1991 –2017
2 2 3 50 6
430
36 37
676 624
2913
1091
1253
2220
1228
418
101 130 79
0
500
1000
1500
2000
2500
3000
3500
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
Figure 17. Pharmaceutical Industry Financial Penalties (86% federal)
for Unlawful Promotion, 1991 – 2017*
2 2 3 92 6
430
740
472
1211
624
3938
2347
1321
6012
2706
517 633
130
397
0
1000
2000
3000
4000
5000
6000
7000
Fin
an
cia
l P
en
alt
ies (
$ m
illio
ns)
Year
Figure 18. Pharmaceutical Industry Financial Penalties (92% federal)
for Settlements Involving Unlawful Promotion, 1991 – 2017
State Recoveries per $1,000
Medicaid prescription
drug expenditures*
Total Financial
Penalties
($ millions)**
Number of
Settlements and
Judgments
ROI (dollars recovered
per enforcement dollar
spent)***
FCA as of
2017****
Hawaii $147.09 $83.75 2 $5.44 Y
New Mexico $89.07 $34.10 2 $1.31 Y
South Carolina $47.64 $169.00 2 $9.66 Y
Texas $35.96 $584.10 19 $2.41 Y
Louisiana $35.89 $298.84 55 $4.45 Y
Pennsylvania $33.85 $163.90 8 $2.16
Idaho $32.65 $38.10 16 $4.54
Kentucky $28.39 $138.54 20 $4.22
Mississippi $26.61 $112.80 14 $3.35
Alabama $24.19 $124.25 9 $10.02
Alaska $18.97 $15.00 1 $1.18 Y
Utah $18.08 $28.50 3 $1.30 Y
West Virginia $14.80 $44.50 2 $2.54 Y
Wisconsin $8.41 $46.25 6 $2.45 Y
Nevada $8.38 $9.50 1 $0.45 Y
Montana $7.84 $5.90 1 $0.67 Y
Massachusetts $7.53 $50.60 9 $0.89 Y
Connecticut $5.64 $27.60 2 $1.55 Y
California $5.61 $163.30 3 $0.42 Y
New Hampshire $4.40 $3.40 1 $0.35 Y
Oregon $4.13 $7.99 5 $0.38 Y
Maryland $4.06 $15.00 1 $0.37 Y
Missouri $3.87 $37.00 3 $1.42 Y
Kansas $3.72 $5.70 2 $0.38 Y
North Carolina $2.11 $25.93 2 $0.40 Y
Iowa $1.58 $4.30 2 $0.33 Y
Illinois $1.56 $18.50 3 $0.14 Y
Ohio $1.26 $12.44 2 $0.15
Florida $1.13 $15.00 2 $0.06 Y
New Jersey $0.22 $1.30 1 $0.02 Y
New York $0.19 $5.58 5 $0.01 Y
Total / Median $7.84 [median] $2,290.67 204 $ 1.18 [median] 25/31
State Number of
Settlements
and
Judgments
Verifiable
Financial
Penalties
($ millions)*
FCA** State Number of
Settlements
and
Judgments
Verifiable
Financial
Penalties
($ millions)*
FCA**
Arizona 32 $25.25 New Jersey 24 $31.90 Y
Florida 32 $66.17 Y South Dakota 24 $13.24 Y
Texas 32 $109.95 Y Delaware 23 $13.54 Y
Massachusetts 31 $26.12 Y Hawaii 23 $1.18 Y
North Carolina 31 $39.96 Y Nebraska 23 $3.69 Y
Vermont 31 $19.06 Y Minnesota 22 $0.00 Y
California 30 $51.45 Y North Dakota 22 $0.00
Maryland 30 $11.12 Y Colorado 21 $15.70 Y
Wisconsin 30 $17.46 Y Kentucky 21 $11.06
Illinois 29 $51.45 Y New Mexico 21 $4.81 Y
Nevada 29 $17.19 Y Rhode Island 20 $10.50 Y
Tennessee 29 $27.05 Y Montana 19 $4.48 Y
Washington 29 $25.21 Y Oklahoma 18 $0.00 Y
District of Columbia 28 $14.92 Y South Carolina 18 $0.00 Y
Michigan 28 $8.89 Y Indiana 17 $17.98 Y
New York 28 $56.14 Y Alabama 16 $0.00
Ohio 28 $29.76 West Virginia 16 $1.85 Y
Connecticut 27 $14.44 Y Virginia 15 $10.22 Y
Pennsylvania 27 $35.56 Louisiana 13 $2.94 Y
Missouri 26 $22.03 Y Alaska 12 $2.86 Y
Oregon 26 $33.21 Y Mississippi 12 $1.12
Arkansas 25 $9.60 Y New Hampshire 12 $5.00 Y
Idaho 25 $15.64 Utah 12 $1.65 Y
Iowa 25 $12.70 Y Georgia 10 $4.63 Y
Kansas 25 $0.70 Y Wyoming 8 $0.00 Y
Maine 25 $9.88 Y
State Number of
Settlements
and
Judgments
Verifiable
Financial
Penalties
($ millions)*
FCA** State Number of
Settlements
and
Judgments
Verifiable
Financial
Penalties
($ millions)*
FCA**
Louisiana 68 $301.78 Y Mississippi 26 $113.92
Texas 51 $694.05 Y New Jersey 25 $33.20 Y
Idaho 41 $53.74 Maine 25 $9.88 Y
Kentucky 41 $149.60 Arkansas 25 $9.60 Y
Massachusetts 40 $76.72 Y Hawaii 25 $84.93 Y
Wisconsin 36 $63.71 Y Alabama 25 $124.25
Pennsylvania 35 $199.46 South Dakota 24 $13.24 Y
Florida 34 $81.17 Y Delaware 23 $13.54 Y
New York 33 $61.72 Y New Mexico 23 $38.91 Y
California 33 $214.75 Y Nebraska 23 $3.69 Y
North Carolina 33 $65.89 Y Minnesota 22 $0 Y
Illinois 32 $69.95 Y North Dakota 22 $0
Arizona 32 $25.25 Colorado 21 $15.70 Y
Oregon 31 $41.20 Y Rhode Island 20 $10.50 Y
Vermont 31 $19.06 Y Montana 20 $10.38 Y
Maryland 31 $26.12 Y South Carolina 20 $169.00 Y
Ohio 30 $42.20 West Virginia 18 $46.35 Y
Nevada 30 $26.69 Y Oklahoma 18 $0 Y
Tennessee 29 $27.05 Y Indiana 17 $17.98 Y
Washington 29 $25.21 Y Virginia 15 $10.22 Y
Missouri 29 $59.03 Y Utah 15 $30.15 Y
Connecticut 29 $42.04 Y New Hampshire 13 $8.40 Y
District of Columbia 28 $14.92 Y Alaska 13 $17.86 Y
Michigan 28 $8.89 Y Georgia 10 $5 Y
Iowa 27 $17.00 Y Wyoming 8 $0 Y
Kansas 27 $6.40 Y
Company* Total Financial
Penalties
($ millions)
Percent of
Total**
Number of
Settlements***
GlaxoSmithKline $7,901 20.4% 32
Pfizer $4,728 12.2% 34
Johnson & Johnson $2,857 7.4% 20
Teva $1,990 5.1% 16
Merck & Co. $1,840 4.8% 22
Abbott $1,840 4.8% 16
Eli Lilly $1,742 4.5% 15
Schering-Plough $1,339 3.5% 6
Novartis $1,275 3.3% 21
Mylan $1,180 3.1% 22
AstraZeneca $1,035 2.7% 13
Amgen $901 2.3% 12
TAP $875 2.3% 1
Bristol-Myers Squibb $815 2.1% 14
Serono $704 1.8% 1
Purdue $646 1.7% 5
Allergan $601 1.6% 2
Daiichi Sankyo $586 1.5% 8
Boehringer Ingelheim $441 1.1% 16
Cephalon $425 1.1% 1
Other**** $4,100 10.6% 196
Total $37,822 97.9% 473
Company** Number of
Federal
Settlements
Total Federal
Financial
Penalties
($ millions)
Percent of
Total***
Pfizer 14 $4,416 12.7%
GlaxoSmithKline 9 $7,413 21.3%
Novartis 9 $1,150 3.3%
Bristol-Myers Squibb 8 $747 2.1%
Teva 7 $1,770 5.1%
Merck 7 $1,662 4.8%
Johnson & Johnson 6 $2,246 6.5%
AstraZeneca 6 $936 2.7%
Schering-Plough 5 $1,308 3.8%
Abbott 4 $1,687 4.9%
Mylan 4 $1,012 2.9%
Sanofi 4 $328 0.9%
Novo Nordisk 4 $95 0.3%
Eli Lilly 3 $1,480 4.3%
Amgen 3 $802 2.3%
Daiichi Sankyo 3 $539 1.6%
Bayer 3 $291 0.8%
Endo 3 $232 0.7%
Mallinckrodt 3 $139 0.4%
Hoffman-La Roche 3 $20 0.1%
Others**** 34 (17 different
companies)
$1,586 4.6%
Total 142 $29,858 85.9%
Company Total Penalty
($ millions)
Year Violation(s)* Major Drug Products Involved
(if applicable and known)**
Laws Violated (if
known)***
Qui
tam‡
GlaxoSmithKline $3,400 2006 Financial violations
GlaxoSmithKline $3,000 2012 Unlawful promotion; Kickbacks;
Concealing data; Overcharging govt.
health programs
Paxil; Wellbutrin; Advair; Lamictal;
Zofran; Imitrex; Lotronex; Flovent;
Valtrex; Avandia
FCA; FDCA Y
Pfizer $2,300 2009 Unlawful promotion ; Kickbacks Bextra; Geodon; Zyvox; Lyrica FCA; FDCA Y
Johnson & Johnson $2,006 2013 Unlawful promotion; Kickbacks;
Concealing data
Risperdal; Invega; Natrecor FCA; FDCA Y
Abbott $1,500 2012 Unlawful promotion; Kickbacks;
Concealing data
Depakote FCA; FDCA; Anti-
Kickback Statute
Y
Eli Lilly $1,415 2009 Unlawful promotion Zyprexa FCA; FDCA Y
Teva $1,200 2015 Monopoly practices Federal Trade
Commission Act
Merck $950 2011 Unlawful promotion Vioxx FCA; FDCA
TAP $875 2001 Overcharging govt. health programs;
Kickbacks
Lupron FCA; Anti-Kickback
Statute; Prescription
Drug Marketing Act
Y
Pfizer (Wyeth) $785 2016 Overcharging govt. health programs Protonix False Claims Act Y
Amgen $762 2012 Unlawful promotion; Kickbacks;
Overcharging govt. health programs
Aranesp; Enbrel; Neulasta FCA; FDCA Y
GlaxoSmithKline $750 2010 Poor manufacturing practices Kytril; Bactroban; Paxil CR;
Avandamet
FCA; FDCA Y
Serono $704 2005 Unlawful promotion; Kickbacks;
Monopoly practices
Serostim FCA Y
Merck $650 2008 Overcharging govt. health programs;
Kickbacks
Zocor; Vioxx; Pepcid FCA; Medicaid Rebate
Statute
Y
Purdue $600 2007 Unlawful promotion Oxycontin FCA
Allergan $600 2010 Unlawful promotion Botox FCA; FDCA Y
AstraZeneca $520 2010 Unlawful promotion; Kickbacks Seroquel FCA; Anti-Kickback
Statute
Y
Bristol-Myers Squibb $515 2007 Kickbacks; Unlawful promotion;
Overcharging govt. health programs
Abilify; Serzone FCA; FDCA Y (Ven-
a-Care)
Schering Plough $500 2002 Poor manufacturing practices FDA Current Good
Manufacturing Practices
Daiichi Sankyo $500 2013 Poor manufacturing practices;
Concealing data
Cefaclor; Cefadroxil; Amoxicillin;
Amoxicillin/Clavulanate; Sotret;
Gabapentin; Ciprofloxacin
FCA; FDCA Y
Type of Violation Description
Overcharging Government Health
Programs
Inflating the average wholesale price (AWP) of products, failing to give
the lowest market price to government health programs, or failing to
pay required rebates to any government health program
Unlawful Promotion Off-label promotion of drug products or other deceptive marketing
practices (e.g., downplaying health risks of a product)
Monopoly Practices Unlawfully attempting to keep monopoly patent pricing privileges on
products, or collusion with other companies undertaken with the
purpose of increasing the market share of a particular product
Kickbacks Kickbacks (e.g., monetary payments) to providers, hospitals, or other
parties to influence prescribing patterns in favor of the company
Concealing Data Concealing results of company-sponsored studies, or other data, from
the federal or state governments or the general public, or falsifying data
submitted to the federal government
Poor Manufacturing Practices Selling drug products that fail to meet FDA standards or specifications
(e.g., contaminated or adulterated products, or products that fail to
meet size or dosage specifications)
Environmental Violations Clean Air Act and Clean Water Act violations, or failing to meet federal
emissions standards
Financial Violations* Accounting, tax, or investor fraud, or insider trading
Illegal Distribution** Distributing an unapproved pharmaceutical product or illegally
distributing an approved pharmaceutical product (such as failing to
monitor suspicious purchases of dangerous drugs, such as opioids)