Medical Report

Medical Report ( Order ID: #250723 )

Let’s get the process started. Please find the attached starting documents to initiate the process:
1.File #1 Is a previous medical theory and report provided by a treating rheumatologist. Note: this report was rejected by the vaccine court because they do not want to alarm the public regarding the dangers of aluminum in vaccines. There is plenty of research to back up Dr. McCurdy’s theory, but the court simply rejected it. Filename: Exhibit 34
2.File #2 Final response to the Vaccine Injury Compensation Program (VICP). This is the report that the medical ghost writer is to finalize with advanced medical writing, substantiation and medical references. Filename: Jessica_Fouch Vaccine Injury R13
3.File #3 Examples of Cases upheld – This is just a good educational read regarding the burden the vaccine court is putting on the claimants (in this case my daughter). This is unfair, but important to understand prior to finalizing the report. Filename: Examples of Cases upheld
4.File #4 The diagnosis of dysautonomia from the testing and lab results, two treating physician reports: Exhibit 41 and Exhibit 47
Anyone can make my daughters vaccine injury complicated. The brilliance in the writing will need to keep things simple and pointed which I have tried to due in my draft report “Jessica_Fouch Vaccine Injury R13”, there is a lot of room for improvement. The basic truth is that she got the vaccine and then got very sick and has not been the same since. The vaccine court will argue that there is know scientific proof that ties her injury to the vaccine, this is what we need to do by the “preponderance of the evidence”. When done reading the report, it should be obvious that the vaccine was a trigger to illness and that to believe otherwise you would need dismiss the facts and have to use your own faith to believe some other unknown factor was the cause.

I will be providing more files and details as necessary to obtain a good report. Please be in touch to let me know how I can help you be as efficient as possible. I am not going to set a need date at this time, rather I would like to focus on getting the facts accurate and medical theory and references established. Since we know the court will not tolerate looking bad in the eyes of the public since claim outcomes are in the public, we need to write a paper that is based on current vaccine science.

Let’s get the process started. Please find the attached starting documents to initiate the process:
1.File #1 Is a previous medical theory and report provided by a treating rheumatologist. Note: this report was rejected by the vaccine court because they do not want to alarm the public regarding the dangers of aluminum in vaccines. There is plenty of research to back up Dr. McCurdy’s theory, but the court simply rejected it. Filename: Exhibit 34
2.File #2 Final response to the Vaccine Injury Compensation Program (VICP). This is the report that the medical ghost writer is to finalize with advanced medical writing, substantiation and medical references. Filename: Jessica_Fouch Vaccine Injury R13
3.File #3 Examples of Cases upheld – This is just a good educational read regarding the burden the vaccine court is putting on the claimants (in this case my daughter). This is unfair, but important to understand prior to finalizing the report. Filename: Examples of Cases upheld
4.File #4 The diagnosis of dysautonomia from the testing and lab results, two treating physician reports: Exhibit 41 and Exhibit 47
Anyone can make my daughters vaccine injury complicated. The brilliance in the writing will need to keep things simple and pointed which I have tried to due in my draft report “Jessica_Fouch Vaccine Injury R13”, there is a lot of room for improvement. The basic truth is that she got the vaccine and then got very sick and has not been the same since. The vaccine court will argue that there is know scientific proof that ties her injury to the vaccine, this is what we need to do by the “preponderance of the evidence”. When done reading the report, it should be obvious that the vaccine was a trigger to illness and that to believe otherwise you would need dismiss the facts and have to use your own faith to believe some other unknown factor was the cause.

I will be providing more files and details as necessary to obtain a good report. Please be in touch to let me know how I can help you be as efficient as possible. I am not going to set a need date at this time, rather I would like to focus on getting the facts accurate and medical theory and references established. Since we know the court will not tolerate looking bad in the eyes of the public since claim outcomes are in the public, we need to write a paper that is based on current vaccine science.
I
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Patient :15072701a ( )
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RR
Distribution K-Trend – 15 Minute
Time – Hours
Patient
Best Gamma Fit
K:12.9048
Lambda: 0.0145
Err:0.009664 (Bad Fit)
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VLF: 0.004 – 0.04 12603.51 MilliSeconds’?/ Hz
LF: 0.04 – 0.15 2207 .17 MilliSeconds ‘z / Hz
HF: 0. 15 – 0.4 4340.95 Mil[lSeconds’/ Hz
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Patient :15072701a
0
Parameters
Segments: 40
Dimension:3
DelaY: 1
Segments used for lorecast: all
Segments forecasted by others: all
Lambda ls:0.4923
Lambda 2s : -0.0031
Lambda 3s: -0.ó978
Avg relative forecast error::0.033 l9
Avg absolute forecast error:: 339.42038
Avg Neighborhood Size – 138.9
Avg Number of Neighbors- 30.0
Kaplan Yorke Dimension: 0.0000
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Woodland Hills, CA 91365
Holter ECG Report
Patient Data:Fouch, J
Day of Birth:
Age//Sex: 18/ Female
lD#: 15072701a
Physician: Stuppy
Referral
Medication:
lndication:
Report No:
Test Date:
Report Date:
Hookup Tech
Analyst
SVE/SW prematurity
000363
07t17t2015
07t27t2015
25t25
StartTime:
Start delay:
Recording Time:
Analyzed time:
Analyzed channel
Tape Quality
14:55D1
00 min
24 hrs 0 min
23hrs 59min
2
BASIC RHYTHM
Rhythm:
Total Beats:
Avg Rate:
Min Rate:
Max Rate:
Branch Block beats
AFib percent
Paced beats
ST ANALYSIS Type Max GH
No ST depression
EL 3.9 1
Median CH1:
Median CH2:
Median CH3:
96397
67
40 bpm at 01:04D2
162 bpm at 08:59D2
absent
0.00
absent
Lgth Time
1275.6 m 22:21D1
1.70 mm
Not measured
Not measured
Report Summary
ULAR ECTOPY
Total beats:
000:
SVT runs
lsolated Beats:
Paired beats:
RonT
Trigeminy Beats
Bigeminy Beats:
VT Beats:
lsolated SVE:
Paired:
SVT beats
000:
Bigeminy Runs
Runs:
SUPRAVENTRICULAR ECTOPY
beats:
1
0
0
0
0
0
0
0
1
0.0
0.0
I
0.4
0.1
0
9
0
0
HEART RATE VARIABILITY
SDNN:242 SDNN5: 127 PNN50:
TRIA: 942 SDANN: 204 RMSSD
BRADYCARDIA ( 50 bpm)
Bradycardia events/beats: 1 016 / 4631
Longest run’. 24 beats at 44 bpm at 23:00D1
PAUSES >2.0 sec: 102 Max
Min rate: 41 bpm at22.59D1
24.17 al l4:55D1
45
145
Interpretation:
The recording lasted for 23 hours and 59 minutes. The recording quality was poor.
The fastest heaft rate was 162 bpm and fhe slouresf hea¡t rate was 4O bpm.
One, single PVC was seen.
Rare, single SYE’S were noted.
10
Plinled27 July 2015 al l0:02 V2 21 Copyright Biomedical Systems 2013
Date:
St Louis, MO, USA
Report No: 000363 Fouch, J
GENERAL SUMMARY
Test Date:: 0711712015 PAGE 2
TIME
ENDING
HEART
MEAN
RATE
HI
TOTAL
BEATS
BBB
BEATS
PACED
BEATS
VE PER
1000 HB
SVE PER
1000 HB
Unknown
LO PACED TOTAL BEATS
SVE
TOTAL
VE
15:00
16:00
17.00
18:00
19:00
20:00
21.00
22:00
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
11:00
12:00
13:00
14:00
14:54
107
107
144
158
104
117
98
118
102
90
88
89
92
101
108
102
124
118
‘t62
324
4200
4978
4791
4333
4096
3710
3642
3132
2943
2928
3079
3056
3170
3455
3291
4348
4902
4666
5584
51 08
4667
4341
4055
3s98
72
70
83
79
73
68
62
61
52
49
49
51
50
53
57
55
74
83
83
94
85
77
73
67
66
61
50
47
52
52
49
48
44
4′,|
4’,|
41
40
41
41
43
44
47
54
53
70
54
55
54
53
52
59
06
32
08
‘t3
14
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
1
2
1
0
1
0
1
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.00
000
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.20
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.40
0.00
0.00
0.24
0.54
0.27
0.00
0.34
0.00
0.32
0.00
0.00
0.00
0.30
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Summary: 40 67 162 96397 0 0 0 1 0.01 I 0.09 0
PACEMAKER SUMMARY
TIME
ENDING LO
PACEO RATE
MEAN HI
PACED
TOTAL
Failure
to Capt
Fa¡lure
to Sense
15:00
16:00
17:00
18:00
19:00
20:00
21.00
22.00
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
11:00
12:00
13:00
14:00
14’5/’-
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
o
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
o
Summary: 0 0 0
11
Prinled2T July 2015 at 10:02 V2 21 Copyright Biomedical Syslems 2013 St Louis, MO, USA
Report No: 000363 Fouch, J
SUPRAVENTRICU LAR ECTOPY SUMMARY
Test Date:: 0711712015 PAGE 3
TIME
ENDING LO
HEART RATE SVE
MEAN HI TOTAL
SVE SVE SVT SVT
SINGLE PAIRED BEATS EVENTS
Sw (60s1
Susta¡ned
Afib/Aflutter
AFIB Events AFLUTTER
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
000
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
1
2
1
0
1
0
1
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
2
0
0
1
2
1
0
1
0
1
0
0
0
1
0
0
0
0
0
0
0
0
0
107
107
144
158
104
117
98
18
02
90
88
89
92
01
08
02
24
18
62
59
06
32
08
13
14
61
50
47
52
52
49
48
44
41
4’l
41
40
41
41
43
44
47
54
53
70
54
55
54
53
52
72
70
83
79
73
68
62
61
52
49
49
51
50
53
57
55
74
83
83
94
85
77
73
67
Þþ
15:00
16:00
17:00
18:00
19:00
20:00
21:0O
22:0O
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
’11:00
12:00
13:00
14:00
14:54
Summary: 40 67 162 9 I 00 0 0 0.00 0 0.00
VENTRICULAR ECTOPY SUMMARY
TIME VE
BIGEM NY
VE
END NG SINGLE PA RED
HEART RATE
MEAN HI
VE
TOTAL
VE w
BEATS
w
Events
VE
IVR
VE
R/T
VE
LO TRIGEMINY
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
o
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
f)
07
07
44
58
04
17
98
118
102
90
88
89
92
01
08
02
24
18
62
59
06
32
08
13
14
72
70
83
79
73
68
62
61
52
49
49
51
50
53
57
55
74
83
83
94
85
77
73
67
66
61
50
47
52
52
49
48
44
41
41
41
40
41
41
43
44
47
54
53
70
54
55
54
53
52
15 00
16 00
17 00
’18 00
19 00
20 00
21 00
2200
23 00
00 00
01 00
02 00
03 00
04 00
05:00
06:00
07:00
08:00
09:00
10:00
11:00
12:00
13:00
14:00
14.54
Summary: 40 67 162 I
12
V2 21 Copyright Biomedical Systems 2013
100 000 0 0
Pr¡nled27 July 2015 at 10:02 St Louis, MO, USA
Report No: 000363 Fouch, J
BRADYCARDIA SUMMARY
Test Date:: 0711712015 PAGE 4
TIME
ENDING LO
BRADY RATE
i,EAN
BRADY
EVENTS
BRADY
BEATS
PAUSES
>2SEC
15:00
16:00
17:00
18:00
19:00
20:00
21:OO
22:OO
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
I 1:00
12:OO
13:00
14:00
14:54
0
0
0
0
0
10
67
211
779
1002
1174
522
277
248
127
203
“t1
0
0
0
0
0
0
0
0
48
47
46
45
45
45
45
43
46
46
46
46
48
46
45
41
42
41
42
42
42
43
44
46
2
18
55
167
212
236
112
oo
65
30
50
3
I
2
I
10
4
2
1
4
3
4
“l
3
0
4
0
1
23
7
17
5
0
1
1
0
0
Summary: 41 45 1016 4631 102
l3
Pr¡nted 27 July 2015 at 10:02 V2 21 Copyright Biomedical Systems 2013 St Lou¡s, MO, USA
Report No: 000363 Fouch, J
HEART RATE AND ST TRENDS
Test Date:: 0711712015 PAGE 5
200
r60
120
80
40
l5:00D1 l6 17 l8 l9 20 21 22 23 0 1 2
fl{h,4S/ryl/4\ÈillÀ¡.1\¡r’ì/’$|¡t/li,\årì¡ryì|¡.r4Ã’l
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‘”
Up
Horiz
mm
mm
mm
mm
mm
l5:00D1 16 l8 9 0
hannel 2 sT and sT-slope
0mm
Up
Hor¡z
mm
mm
l5:00D1 16 l7 l8 19 20 21 22 23
hanne¡ 3 ST and STrSlope
0
Up
Horiz
mm
mm
mm
mm
mm
15:00D1 16 17 l8 l9 20 21 22 23 0
14
V2.21 Copyright Biomedicel Systems 2013
2
Prinled 27 July 2O1 5 at 1 0:02 St Louis, MO, USA
Report No: 000363 Fouch, J
HEART RATE AND ST TRENDS
Test Date:: 07/1712015 PAGE 6
200
‘t60
120
EO
4
03:00D2 4 7 I I t0 11 12 t3 14
0
Up
Horiz
mm
mm
mm
mm
mm
03:00D2 4 5 6 7 l0 12 14
hannel 2 sT and sT€lope
0
Up
Horiz
mm
mm
mm
mm
mm
03:00D2 4 I l0 11 12 14
hannel 5 sT and sT{ilope
Up
Horiz
mm
mm
mm
mm
mm
03:00D2 4 t0
15
V2.21 Copyright Biomedicel Syslems 2013
I 1l 12 3 14
Ptinled 27 July 2015 ãl 10:02 St.Louis, MO, USA
0.2 0.4 0.6 0.8 1 0
Fouch, J
Normal RR lnterval Distribution Table
1.2 ‘t.4 1.6
Length RR interval (seconds)
16
V2,21 Copyright Biomedic¿l Syslems 2013
1.8 2.0 2.2 2.4 2.6
Report No; 000363 Test Date:. 0711712015 PAGE 7
lnterual
ms
Succesive
Normals
Succesive
Normals
lnterval lnterval lnterval lnterval
m3 ms Nofmels ms ms
200
220
240
260
280
300
320
340
360
380
400
420
440
460
480
s00
520
540
560
580
600
620
640
660
680
0
0
1
3
1
I
235
296
334
380
261
297
237
183
263
417
450
922
1 330
1194
2316
3137
2500
4032
4413
700
720
740
760
780
800
820
840
860
880
900
920
940
960
980
1 000
1020
1040
1 060
I 080
1 100
1120
1140
1 160
1 180
3005
4383
4339
2809
3890
3729
2281
31 95
2731
1716
2451
2267
1429
2060
1387
2069
2111
1471
2257
2321
1 588
2269
2319
1382
2’,t03
1200
1220
1240
1260
1280
1 300
1320
1 340
1 360
1 380
1400
1420
1440
1460
1 480
1 500
1520
1540
1 560
1 580
1600
1620
1640
1660
1 680
1700
1720
1740
1760
1780
1 800
1820
1 840
1 860
1 880
1 900
1920
1 940
1 960
1 980
2000
2020
2040
2060
2080
2100
2120
2140
2160
2180
2200
2220
2240
2260
2280
2300
2320
2340
2360
2380
2400
2420
2440
2460
2480
2500
2520
2540
2560
2580
2600
2620
2640
2660
2680<
4
5
3
3
5
3
4
4
2
2
2
1
2
1
3
2
1
1
1
2
2
0
3
0
1
0
2
0
1
2
0
3
0
2
1
1
2
1
1
0
1
2
0
2
1
0
0
0
0
10
I 858
1146
1 551
1 333
812
1 106
929
516
626
470
228
227
157
82
76
39
24
17
20
b
11
4
6
6
4
Normal RR lnterval Distribution Histogram
of lntervals
0
0
5000
00
3500
3000
2000
1 500
I 000
500
RR 888
242
145
45
NRR
SD RR
NsO RR
Plinled27 July 2015 at 10:02 St Lou¡s, iIO, USA
Report No: 000363 Fouch, J
HEART RATE VARIABILITY
Test Date:: 0711712015 PAGE I
TIME
ENDING
MEAN
NORMAL RR RR
MODAL
RR
MODAL
FREQ
rMSSD
lndex
pNN50
lndex
SDNNS
lndex
SDANNS
lndex
Triangle
SONN lndex
15:00
16:00
17:0O
18:00
19:00
20:00
21:00
22:00
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
11:00
12:0O
13:00
14:00
14:54
323
4198
4965
4781
4322
4084
3698
3625
3124
2940
2924
3075
3053
31 68
3448
3279
4326
4869
4612
5571
51 03
4661
4331
4038
3s87
831
857
718
748
828
877
966
983
1147
1213
1226
‘1165
1177
1132
1040
1 091
817
725
691
628
705
770
825
886
913
812
849
691
706
789
789
812
804
1 ‘180
1225
1 180
1120
1 150
1 150
1052
1127
639
706
353
624
654
736
781
857
849
15
105
151
136
149
111
77
73
73
76
84
76
‘t07
90
98
95
110
215
‘t48
223
249
147
113
111
88
99
141
168
198
166
161
163
197
193
143
148
155
121
153
181
160
255
132
266
116
83
130
130
137
152
93
110
167
196
157
133
118
148
151
152
149
164
136
152
121
135
244
148
209
91
52
118
83
110
116
44
49
26
29
41
49
57
55
69
78
77
75
78
75
63
Þb
33
17
33
8
16
30
42
56
56
323
601
494
528
436
553
722
746
643
581
523
608
429
529
529
519
591
340
468
375
308
476
576
547
612
z4HtÐay.
Night:
9ö1U5 ööö
26264 1089 1
06
50
7
1
1 533
527
942 145
NIGHT VARIABILITY
Length RR ¡nterval <seconds>
17
V2 21 Copyright Biomedical Systems 2013
242
223 749 ‘165
45
66
127 204
24HR VARIABILITY
1.0 1.2 1.4 1.0 1.2 ‘1.4 1.6 1.8
2000
1750
1500
000
750
500
250
250
Plinled27 July 2015 at 10:02 St Louis, MO, USA
Report No: 000363 Fouch, J
PoinGarré Graphs
Test Date:: 0711712015 PAGE I
RRn-l
PoinCarré
400 600 800 1000 1200 1400 1600 1800 RRn
500 r000
Modif¡ed Po¡nCarré
1800
r600
l/t00
1200
1000
800
600
400
200
800
600
400
200
0
-200
.4{t0
-600
-800
200 -800 -600 .400 -200 0 200 400 600 800 dRRn
4500
4000
3500
3000
2500
2000
1500
1000
500
RR Distribution Histograms
All beats RR histogram
500 2000
Normal RR h¡stogram
Normal-Nofmal RR ratio h¡stogrem
1.50 2.50
18
V2 2’1 Copyright Biomedical Systems 2013
SDNN:
RMSSD:
PNN5O:
242
45
3000 3500 m¡ll¡seconds
milliseconds
4500
4000
3500
3000
2500
2000
1500
1000
500
4500
4000
3500
3000
2500
2000
r500
1000
500
Prinled2T July 2015 at 10:02
0.50 1.00 3.00 3.50
St Louis, MO, USA
Report No: 000363 Fouch, J Test Date:: 0711712015 PAGE 10
HEART RATE AND ECTOPIC HISTOGRAMS
Heart Rate MinrMex H¡stogram
200
160
120
80
40
5
20
l5
10
17 t8 19 20 12345678 14 1
20
l5
10
5
14D1 2122230 101112131
20
l5
t0
5
r4Dr l5 16 17 18 19 202122230
total / SVE s¡ngle
12345678910 12 14 l5
20
15
l0
5
19 20 21 22
14Dll5 16 17 18 19 20 21 22 23 o 1 2 3 4 5 6 7 8 9 lO 1’l 12 13 14 15
19
V221 Copynght Biomed¡cal Systems 2013
678910
20
15
l0
5
SVE pa¡r / beats
Plinled 27 July 201 5 at I 0:02 St Louis, MO, USA
Report No: 000363 Fouch, J
QT-T|me Analysis
Test Date.: 0711712015 PAGE 11
TIME
ENDING
TOTAL
Beats
QT at
6OBPM
#QT
270
#QT
295
#QT
320
#QT
345
#QT
495
#QT
470
#QT
445
#QT
120
#QT
395
#CIT
370
HR QT QT
Mean Mean Slope
15:00
16;00
17:00
18:00
19:00
20:00
21:00
22:00
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
11:00
12.00
13:00
14:00
14:54
421
430
401
371
380
380
391
384
379
394
403
409
414
402
396
388
385
359
346
3s6
377
375
394
387
399
207
1 566
2430
1 991
2425
2048
1807
1 536
300
175
260
167
603
363
1271
1 006
2308
2238
1 898
3705
4416
3655
3102
2391
2156
419
410
367
335
361
363
387
384
376
402
426
417
416
421
400
399
357
334
297
319
338
348
366
373
384
-0.26
-1.66
-1.46
-1.54
-1.82
-2.13
-2.76
-2.78
-2.04
-1.20
-2.52
-0.94
-0.18
-2.71
-2.36
-2.46
-1.97
-1.16
-0.97
-1.06
-1 59
-1.61
-1.99
-2.16
-2.84
0
5
137
353
49
29
27
117
10
1
0
0
1
7
50
18
201
346
1 051
707
17
78
80
93
0
2
234
324
108
125
43
51
16
0
0
0
0
3
27
33
317
95
231
506
653
186
130
56
78
0
57
302
439
410
315
122
86
19
7
I
3
1
2
48
33
409
699
254
2053
2157
1283
507
106
146
3
127
451
422
891
704
278
181
70
26
5
2
11
9
69
44
341
886
135
434
1245
1592
1041
320
179
21
137
594
354
713
521
596
282
98
9
12
1
11
44
59
75
377
192
223
5
333
490
900
1 603
810
65
504
497
98
243
351
425
498
Þt)
79
57
83
326
115
680
642
604
20
4
0
11
26
447
223
468
113
669
213
1
11
3
219
293
14
53
156
74
250
54
283
161
58
0
0
0
0
0
67
3
318
5
65
2
0
0
0
95
27
7
0
29
4
3
120
55
0
1
0
0
0
0
0
0
0
64
10
71
71
81
80
70
67
61
59
60
54
52
53
51
52
58
55
71
81
85
92
84
76
73
66
65
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
1
0
0
0
0
0
I
0
0
0
0
0
0
0
0
0
0
0
24Hr. 44024 76 359 -1.70 386 3387 3218 9459 9466 8460 6532 3013 477 12 0
25 HR QT Histogram
Percenj
6t
60
55
5(
4!
4(
aa
3(
2l
2t
l!
l(
I
F¡rst bin : 270
Binwidth : 25
400 650 Mill¡sec
St Lou¡s, MO, USA
20
Ptinled2T July 2015 at’10:02
300 350
V2 21 Copyright Biomedical Systems 2013
Report No: 000363 Fouch, J
QT-Time STATISTICS
Test Date:: 0711712015 PAGE 12
QT
Max
QT
Min
HR QT
Mean
QT
SD
QT
Slope
QT6O
bezett
QT6O QT6O
regress.
QT6O
Freder¡cia
TIME
ENDING
15:00
16:00
17:00
18:00
19:00
20:00
21:00
22.O0
23:00
00:00
01:00
02:00
03:00
04:00
05:00
06:00
07:00
08:00
09:00
10:00
1 1:00
12:00
13:00
14:00
14:54
TOTAL
Beats Mean
207
1 566
2430
1 991
2425
2048
1807
1 536
300
175
260
167
603
363
1271
1 006
2308
2238
1 898
3705
4416
3655
3102
2391
2156
345
225
203
135
233
225
240
235
275
263
333
320
28s
218
230
270
210
127
112
120
240
240
210
203
233
419
410
367
335
361
363
387
384
376
402
426
417
416
421
400
399
357
334
297
319
338
348
366
373
384
448
458
448
421
436
431
476
481
463
443
463
456
448
488
468
443
446
413
403
375
408
411
443
436
461
19.7
30.3
41.8
40.8
27.2
28.3
36.0
46.5
34.9
29.8
20.0
19.7
14.3
38.7
40.0
30.8
43.7
37.0
47.0
29.3
19.9
21.0
27.8
264
39.6
-0.26
-1.66
-1.46
-1.54
-1.82
-2.13
-2.76
-2.78
-2.04
-1.20
-2.52
-0.94
-0.18
-2.71
-2.36
-2.46
-197
-1.16
-0.97
-1.06
-1.59
-1 61
-1.99
-2.16
-2.84
421
430
401
371
380
380
391
384
379
394
403
409
414
402
396
388
385
3s9
346
356
377
375
394
387
399
456
448
428
388
390
384
392
382
378
383
397
394
384
395
395
382
388
389
354
396
400
393
406
393
401
443
435
407
374
383
379
391
382
377
387
403
398
389
400
396
385
381
374
343
373
382
381
394
388
396
443
435
406
369
380
377
390
382
377
389
406
401
394
403
396
387
377
370
334
368
378
377
392
386
395
71
71
81
80
70
67
61
59
60
54
52
53
51
52
58
55
71
81
85
92
84
76
73
66
65
24Hr. 44024 76 112 359 488 43 .9 -1.70 386 404 391 388
+50
0
-50
ü ül{rnr
D1 15 16 17 18 19 20 2122230 1 234 56 7 a 9 10 11 12 13
21
Pr¡nted 27 V2 21 Copyright Biomedical Systems 2013 July 2015 at 10:02 St Louis, MO, USA
QT-Rate An s
HR
from
TOTAL
Beets
HR OT #QT #QT
270 295
#oT
320
#c¡T
3¡15
#C¡T
370
#QT
395
#QT
420
#or
45
#QT
470
#or
Mean Mean 495
40
50
60
70
80
90
100
1′,lo
120
130
1 598
6552
7439
10626
9257
5065
1323
496
295
220
47
55
64
75
84
94
104
114
125
134
413
399
382
362
342
326
306
296
301
280
4
33
97
256
434
49′,|
441
239
127
173
3
36
79
320
895
1120
439
162
106
37
17
165
449
2018
391 0
2486
298
64
32
EI
65
468
1 508
3991
26’,18
651
98
20
28
3
156
1 801
2824
2558
868
197
42
10
1
0
747
2586
1648
993
430
118
5
,|
1
0
485
1207
755
459
101
2
0
0
0
1
118
248
79
30
1
0
0
0
0
0
3
I
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Report No: 000363
t0 20 30
Fouch, J
100 110 120 I
22
V2.21 Copyright Biomedical Systems 2013
Test Date:: 071’17120’15 PAGE 13
QT – Rate nce
-il–
ï- l
– – — l- )—
I
‘I
+i __l L
I
l
t
1- I
l.l
lf
!
+ì i
t
l +
Pfinled27 July 2015 at 10:02 St.Louis, MO, USA
ENHANCED ST ANALYSIS
Useable ST 1 23:38 hh:mm
Useable ST 2 00:00 hh:mm
Useable ST 3 00:00 hh:mm
Missing ST 1 00:20
Missing ST 2 23:58
Missing ST 3 23:58
Median ST 1 1.70 mm @ 1Omm/mV Eventthreshold: 1.0 mm
Median ST 2 Not Measured
Median ST 3 Not Measured
Enhanced ST Analysis by Episode
Event Ep¡sode
Durat¡on **
Above
Total **
Durat¡on Maximum mm Time of Slope
Onset DescriPt¡on
C1,>1.Omm,DEP,M&B
Threshold Above Med¡an Med¡an Easel¡ne Mex¡mum Angle
08:44:52D2 77
Rate
1 08:43:35D2 1.4 1.5 -3.52 -1.82 147
Report No: 000363 Fouch, J Test Date:: 0711712015 PAGE 14
r* l)uralionAbove’l’hreshold: Dural¡onolep¡sodefromonsellhresholdloofsellhreshold.
x++ Totol l)uralion Above Mediqn : Complete durql¡on of Ischemic Lvent, from the lime the Median wos broken to the relurn lo Med¡an
‘fh¡s ¡s signtfcant, becqrce threshold vqlues delerm¡ne lhe occurrence ofan event. tyh¡le lhe event ocluqlly begns qnd end\ al the
times when lhe ST dev¡qteslrom lhe Medion on lhe woy to and.from the threshold.
SUMMARY * Total l¡mes ore correcledfor overlopptng event
Total Computer ST Elevation
Total Computer ST Depression
Total Computer ST Deviation
Total Computer ST Deviation
> Threshold
> Threshold
> Threshold
> Threshold
M&B
M&B
M&B
Median Only
000 mn
1.39 min
1.39 min
0.00 min
23
Printed 27 July 2O15 al 10:02 V2 21 Copyright Biomedical Systems 2013 St Lou¡s, MO, USA
.2.63. mrñ (MedLañ). -:HR; 114 -2.1 1 mm.(Median): HR: 91 :3:52 rrim (Mþd¡än): HR:l4Z
:1.82 mn-r (Baseline) -0.41 mm.(Basel¡ne)
Report No: 000363 Fouch, J
ENHANCED ST EVENTS
24
V2.21 Copyright Biomedical Systems 20’13
Test Date:: 0711712015 PAGE 15
Printed 27 July 2015 at 10:02 St.Louis, MO, USA
Report No: 000363 Fouch, J
Significant ECG Summary
25
V2.21 Copyright B¡omedicel Systems 2013
Test Date:: 07/172015 PAGE 16
:H: -t^t^ til
VE Paír
16i47:27D1
sw
sec at l4:55:30D1 sec sec
Printed 27 July 2015 at l0:02 St.Louis, MO, USA
Report No: 000363 Fouch, J
STRIP LIST
Test Date:: 0711712015 PAGE 17
TIME
ENDING
STRIP
TYPE
RUN
LEN
HEART
STRIP LABEL RATE COMMENTS
16:00:00D1
16:47:27D1
18:00:00D1
20:00:00D1
2O:17:39D1
22:00:00D1
00:00:00D2
01:04:13D2
02:00:00D2
04:00:00D2
06:00:00D2
07:32:54D2
08:00:00D2
08:59:00D2
10:00:00D2
12.O0:0OD2
14:00:00D2
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Diagnostic
66 BPM
81 BPM
93 BPM
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
DIARY
SVE
DIARY
DIARY
SVE
DIARY
DIARY
MINIMUM HEART RATE
DIARY
DIARY
DIARY
VE
DIARY
MAXIMUM HEART RATE
DIARY
DIARY
DIARY
82 BPM
52 BPM
67 BPM
74 BPM
40 BPM
46 BPM
48 BPM
58 BPM
88 BPM
82 BPM
62 BPM
O1 BPM
93 BPM
03 BPM
Timed
Timed
Timed
Strip
Skip
Strip
DIARY STRIP LIST
TIME
ENDING STRIP LABEL
RUN
LEN
HEART
RATE COMMENTS
16:00:00D1
18:00:00D1
20:00:00D1
22:00:00D1
00:00:00D2
02:00:00D2
04:00:00D2
06:00:00D2
08:00:00D2
10:00:00D2
12:00:00D2
14:00:00D2
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
DIARY
26
V2.21 Copyright Biomedicál Systems 20’13
1
1
1
I
1
1
1
1
1
1
1
1
66 BPM
93 BPM
82 BPM
67 BPM
74 BPM
46 BPM
48 BPM
58 BPM
82 BPM
01 BPM
93 BPM
03 BPM
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Timed Strip
Ptin¡led27 July 2015 at 10:02 St Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 07117120’15 PAGE 18
DIARY
ST: 1.9
ST:0.0
ST:0.0
h
ST: 1.4
ST:0.0
ST: 0.0
27
V2.21 Copyright Biomedical Systems 2013 Printed 27 July 2015 al 10:02 St.Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAGE 19
T¡med Strip
l0 mm/Mv
N Ni
mmlMv
646N632N6S1 N714N
rrlrr-aY.Tq4lr11l ‘.
1.7
0.0
ST: 0.0
“vv.V'”-qnqrst-lÏV”
20:00:00D1 DIARY 82
N706N N N685N N 751 N 676 N 751
¡l
28
Prinled 27 July 201 5 at 1 0:02 V221 Copynghl Biomedical Systems 2013 St Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAGE 20
svE
1.8
0.0
0.0
67 BPM Timed
J”
ST: 2.0
ST:0.0
ST:0.0
29
Printed 27 July 2015 d lOiO2 V2.21 CopyrÍght Biomedical Systems 2013 St Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAGE 21
74 BPM Timed
J
ST: 1.8
ST:0.0
ST:0.0
:04:13D2 MINIMUM
—-l—l t
1.0
0.0
0.0
30
Pr¡nted 27 July 2015 at 10:02 V2.21 Copyright Biomedicel Systems 2013 St.Lou¡s, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAG,E22
DIARY
ST:2.1
ST:0.0
ST:0.0
Timed
l^t^l^r^l^l^ l^r^l^l^r^l^r^
0.0
1.5
0.0
3l
Printed 27 July 2015 at 10:02 V2 21 Copyright Biomedical Systems 2013 St.Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAGE 23
06:00:00D2 OIARY Str¡p
N
‘t’165 N N 985 N: N:
lû mmlMv
lÛ ÍriñrMv
ST: 2.1
ST:0.0
ST: 0.0
88 BPM
1.1
0.0
ST: 00
ST:
32
Ptinled2T July 2015 at’10:02 V2 21 Copyright Biomedical Systems 2013 St Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAGE24
08:00:00D2 DIARY Str¡p
10 mmrMv
lO mmrMv
N
ST:1.7
ST: 0.0
ST: 0.0
HEARTRATE 162
1û mmtMv
T375 T368 T
, A, A, /\,ArArArArAlÂAlA’A,ArA,A¡AtA, A,A,A,A, r, A, A, A r A, A, A I A, A, Ar /\, A,A r A, A, A, A. A, 4,,q, À
ST: 0.0
00
33
Ptiîled 27 July 2015 al’lO:02 V2 21 Copyright Biomedical Systems 2013 St Louis, lvlo, USA
Report No: 000363 Fouch, J
DIAGNOSTIC STRIPS
Test Date:: 0711712015 PAGE 25
10:00:00D2 Strip
10
lû mmtMv
N 609 N 616 N 631 578 N: N N 586: N 624 N: 624 N
À
ST:0.0
ST: 2.0
ST: 0.0
93 BPM
631 N 646 N N 714 N 751 N N 684
ST: 1.7
ST: 0.0
0.0
34
Plinted27 V2 21 Copyright Biomedical Systems 2013 July 2015 at 10:02 St Louis, MO, USA
Report No: 000363 Fouch, J
DIAGNOSTIG STRIPS
Test Date:: 0711712015 PAGE 26
ST: 1.2
ST:0.0
ST:0.0
35
Printed 27 July 2015 at 10:02 V2.21 Copyright Biomedicel Systems 2013 St Lou¡s, MO, USA
Report No: 000363 Fouch, J
Diary Events
Test Date:: 0711712015 PAGE27
16:00:00D1 T¡ p Ghannel 1,2and3
*.]*
HR: 74
ST:1.9
HR: 74
ST: 0.0
A
HR: 74
ST:0.0
HR: 74
ST:’1.8
HR: 74
ST:0.0
HR: 74
ST: 0.0
00:45D1 HR: 76
ST:1.7
HR: 76
ST:0.0
HR: 76
ST: 0.0
HR: 77
ST: 1.6
HR: 77
ST:0.0
HR: 77
ST: 0.0
medStr¡p Channel 1,2and
HR: 89
ST:1.7
HR: 89
ST: 0.0
HR: 89
ST: 0.0
:00:15D1 HR: 86
ST:1.6
HR: 86
ST: 0.0
HR: 86
ST: 0.0
I HR: 87
ST:1.6
HR: 87
ST: 0.0
HR: 87
ST: 0.0
HR: 86
ST:1.9
HR: 86
ST:0.0
HR: 86
ST: 0.0
36
Report No: 000363 Fouch, J
Diary Events
Test Date:: 0711712015 PAGE 28
20:00:00D1 Timed Strip Channel 1, 2 and 3 HR ST
HR: 80
ST:1.6
HR: 80
ST:0.0
HR: 80
ST: 0.0
HR: 77
ST:1.7
HR: 77
ST:0.0
HR: 77
ST:0.0
HR: 79
ST:1.6
HR: 79
ST:0.0
HR: 79
ST:0.0
HR: 78
ST:1.6
HR: 78
ST: 0.0
HR: 78
ST: 0.0
22:00:00D1 Timed Strip Channel 1, 2 and 3 HR ST
t- ^t
1
HR: 65
ST: 2.0
HR: 65
ST: 0.0
HR: 65
ST: 0.0
HR: 61
ST: 2.3
HR: 6l
ST: 0.0
HR: 61
ST:0.0
HR: 64
ST; 2.2
HR: 64
ST:0.0
HR: 64
ST:0.0
HR: 63
ST: 1.9
HR: 63
ST: 0.0
HR: 63
ST: 0.0
37
Report No: 000363 Fouch, J
Diary Events
Test Date:: 0711712015 PAGE 29
00:00:00D2 Timed Strip Channel l, 2 and 3
HR ST
HR:
ST:
68
1.9
HR: 68
ST:0.0
HR: 68
ST:0.0
HR: 64
ST: 1.9
HR: 64
ST:0.0
HR: 64
ST:0.0
HR: 6l
ST: 2.0
HR 61
ST: 0.0
HR: 61
ST:0.0
l0:01 :15D2 HR: 58
ST:2.0
HR: 58
ST:0.0
HR: 58
ST:0.0
02:00:00D2 Timed Strip Channel 1,2and3 HR ST
ï
I
HR: 50
ST:2.1
HR: 50
ST:0.0
HR: 50
ST:0.0
HR: 52
ST: 2.1
HR: 52
ST:0.0
HR: 52
ST: 0.0
HR: 51
ST:2.1
HR: 5l
ST:0.0
HR: 5l
ST:0.0
HR: 50
ST:2.2
HR: 50
ST:0.0
HR: 50
ST:0.0
15D2
38
Report No: 000363 Fouch, J
Diary Events
Test Date:: 0711712015 PAGE 30
00D2 Timed Strip HR ST
,
HR: 50
ST: 1.6
HR: 50
ST:0.0
HR: 50
ST: 0.0
:00:’15D2 HR: 52
ST:1.6
HR: 52
ST: 0.0
HR 52
ST:0.0
HR: 51
ST: 1.5
HR: 51
ST: 0.0
HR: 5l
ST:0.0
’15D2 HR: 51
ST: 1.5
HR: 51
ST:0.0
HR: 5l
ST:0.0
00D2 1,2and3
HR: 57
ST: 2.2
HR: 57
ST: 0.0
HR: 57
ST:0.0
:00:1 HR: 57
ST: 2.2
HR: 57
ST: 0.0
HR: 57
ST: 0.0
:45D2 HR: 58
ST:2.2
HR: 58
ST: 0.0
HR: 58
ST:0.0
HR: 60
ST: 2.1
HR: 60
ST: 0.0
HR: 60
ST: 0.0
39
Report No: 000363 Fouch, J
Diary Events
Test Date:: 0711712015 PAGE 31
08:00:00D2 Timed Strip Channel 1,2and3 HR ST
HR: 81
ST:’1.8
HR: 8l
ST: 0.0
A
HR: 8’l
ST:0.0
l8:00:1 HR: 78
ST:’1.8
HR: 78
ST: 0.0
HR: 78
ST:0.0
HR: 78
ST: 1.8
HR: 78
ST:0.0
HR: 78
ST:0.0
18:01:15D2 HR: 78
ST: 1.8
HR: 78
ST:0.0
HR: 78
ST:0.0
l0:00:00D2 Timed Strip Channel l, 2 and 3
HR ST
I
I
i
I
I
I
HR: 95
ST: 1.9
HR: 95
ST: 0.0
HR: 95
ST:0.0
1 HR
ST:
93
1.9
HR: 93
ST:0.0
HR: 93
ST:0.0
HR: 90
ST: 2.0
HR: 90
ST: 0.0
HR: 90
ST:0.0
HR: 91
ST: 1.9
HR: 91
ST:0.0
HR: 91
ST:0.0
:15D2
40
Report No: 000363 Fouch, J
Diary Events
Test Date:: 0711712015 PAGE 32
l2:00:00D2 Timed p 1,2and3 HR
I
L
HR: 9l
ST:1.8
HR: 9l
ST: 0.0
HR: 91
ST:0.0
HR: 89
ST: 1.8
HR: 89
ST:0.0
HR: 89
ST:0.0
HR: 90
ST:’1.9
HR: 90
ST:0.0
HR: 90
ST: 0.0
2:01 HR: 91
ST: 2.0
HR: 9l
ST:0.0
HR: 9l
ST: 0.0
14 med Str¡p Channel 1,2and3
HR: 92
ST: 1.3
HR: 92
ST: 0.0
HR: 92
ST:0.0
5D2 HR: 92
ST: 1.5
HR: 92
ST: 0.0
HR
ST:
92
0.0
4:00:45D2 HR: 89
ST: 1.6
HR: 89
ST: 0.0
HR 89
ST: 0.0
HR: 87
ST:1.4
HR: 87
ST: 0.0
HR: 87
ST: 0.0
41
ulagnos- I echs, lnc.
P2
P3
tccession # t5-57951
WILLIAM STUPPY, MD
637S LUCAS AVE #212
LOS ANGELES CA 9OOI7
USA Tel: l-323-464-4242 Fax’. t-310-899-0911
Code Test Name
Clinrcal & Research Laboraton’
l9ll0 66th Ave S Bldg G. Kent WA 9tt02i
Tel: (425) 251-0596
CLIA License # 50D0630141
Result / Notes
14 Borderline Low
Received : 0712412O15
Completed: 08/0312015
Reported : 0810312015
Reference ValuesÆ(ey
Low: 10-19 mg/1009 dry
20-160
;I-02 Exnanded GI Panel
SI
P3CA
P3ST
P3CD
P4
P5
P6S
P8S
P7S
Results For:
JESSICA FOUCH
Age/DOB : 18 / 05119/1997 Sex: Female
Patient’ s Tef : 310-937-7902
Specimen Collected z 07/2112015
Stool Cu. Fungi,Isol. & I D Candida species not albicans – Scant growth +1=Scant +2=Light
+3=M1derate +4=HeaW
Ova &, Parasites, x2 (Stool) No Ova or Parasites Seen
No Salmonella, Shigella, or E coli O157 isolated
No Yersinia, Vibrio, or Aeromonas isolated
No Proteus or Pseudomonas isolated
In general, early disturbalces in microfloral balance may be reflected in the non
expected and selective overgrowth of microbial species that are usually non dominant.
Please note: As of January lgth2013, stool culhres are performed utlliztngthe MALDI
TOF Mass Spectrometer which has not been cleared by the US Food and Drug
Administration. All CLIA required performance specifications for a lab developed test
have been validated by DTI and t’ound to be in compliance.
Bacterial Stool Cu.
Mixed Flora consísts predominantly of:
Nontoxigenic E. coli – Moderate growth
Moderate growth mixed Gram negative
rods/flora.
Light growth mixed Gram pos¡tive rods/flora.
Expected Findings:
– Moderate to heavy grovvth ot
mixed Gram (+) & O flora
– No pathogens should be detected.
Campylobacter Antigen Negative Normal: Negative
Shiga Toxin (Stool) Negat¡ve Normal: Negative
C. Difficile: Toxins A & B (Stool) Negative Normal: Negat¡ve
Giardia Antigen (Stool) Negative Normal: Negative
Cryptosporidium Antigen (Stool) Negatíve Normal: Negative
Toxoplasma Ab, SIgA (Saliva) Negative Normal: Negative
Entamoeba histolytica Ab, SIgA
(Saliva)
Not detected Normal: Not detected
Helicobacter pylori Ab,IgG (Saliva) <3 Negative: < 3 Ulml
Borde¡line:3-5.5 U/ml
Positive: >5.5 U/ml
TB2 lntestinal SIgA (Stool)
42
High:161-250
tB4
,taEnos- I ecns, lnc,
ccession: 15-57951 Continue Results For: FOUCH, JESSICA
Code Test Name Result / Notcs Reference Values/Ifuy
;I-02 Expanded GI Panel
tB3
3l
SC
RIC
-SOL
‘iagnosis Code: 536.9
lease Note: All exarnples of patient treatment or therap¡, are 1-or illustratjve and,/or educational purpose. Use this report in context
Ithe clinical picture and patient htstory before initiating hormone or other therapies or recommendations
OURTESY INTERPRETATiON of test and technical suppoft are available upon request, to Physicians Only
34
35
t2
t’t
II
t4
Note: As of February 1,2014 reference ranges have been updated to reflect ongoing
research and analysis
lntestinal Lysozyme (Stool )
< 0.5 Normal: <6 mg/1009 dry vvt
Bord. Elevated: È8
Elevated: >8
lpha Anti-Chymotrypsin (Stool) < 13
* Applicable with elevated lysozyme, small intestine iritation with normal lysozyme.
Normal: <60 mg/1009 dry vvt
Borderline Elev. : 60-1 00
Mild/Distal Colitis: 100-180 *
Colonic Inflammation: >180 *
Ch.vmotry,’psin is a marker enzyme for pancreatic exocrine ouþut.
Chvmotrypsin (Stool) 12 Normal: >9 U/í09
Low:49
Abnormally Low: <4
Occult Blood (Stool) Negative
A positive fecal occult blood may indicate the need tbr further diagnostic workup Tlrr.ee
negative results from specimens collected every other day are recommended to rule out
intermittent sources of blood in stool.
Normal: Negative
Fecal pH 6.8 Normal: &8.5
Milk (Casein) Ab. SIgA (Saliva) Negative Normal: Negative.
Soy (Protein) Ab SIgA (Saliva) Negative Narmal: Negative.
Egg (Albumin) Ab. SIgA (Saliva) Negative Normal: Negative.
Gliadins are proteins t-ound in wheat, rye, barley and other grains, which may trigger an
immune reaction in some individuals. A negative SlgA reaction to gliadin does not rule
out all adverse reactions to gluten. A positive SIgA response to gliadin may warrant
further dragnostíc workup and/or dietary elimination trial in some individuats Lab
results should be used in context ofthe entíre clinical picture
NorE: Patients on a gluten-free diet who have not been exposed to gluten for 3 months
or more should have a negative SIgA response to gliadin.
Gliadin Ab, SIgA (Saliva) <1 Negative Borderline: 13-15 U/ml
Positive: >15 U/ml
Roundworm (Ascaris lumbricoides)
StgA (Saliva)
Not detecled Normal Resu/f; Not detected
Trichinella spiralis SIgA (Saliva) Not detected Normal Result: Not detected
Tapeworm (T.solium) SIgA (Saliva) Not detected Normal Result: Not detected
43
Patie nr
Jessica L Fouch
DOB
05it9i1997
ID Age Sex He ight
tj 5’2.5
Date
Collected
07tl7/2015
Datc
Received
01122,2015
Date
Reportr’d
08,’03r201 5
Weiglrt
106
Acc#
503r t8 t8997
innxonru¡¡. TEST R
Iformone Evaluation Panel (Saliva)
Estradiol 5.27 Pgml
Prenrenopausal
Follicular
Luteal
Postmenopausal
Adolescent
l- r0
lr-t7
Progestcrone (LC/M S/MS) 277.00 pg/ml
Premenopausal
Follicular
Luteal
Mid Luteal
Postmcnopausal
Adolescent
I-il
t2-l7
Testos¡erone (LCIMS/MS) 27.30 pgml
3.5
2-5
0.5
0.i
0_5
8.0
5.0
l_5
1.2
0.6
50.0
75.0
75_0
40.0
r 2.0
s0.0
10.00
t30.0
300.0
500.0
95-0
4.1.0
300.0
38.70
44
Note : lìndoscrccn Rcsearch Lìr. INC is l’or rcsu’arch purposes only, We make rro rccommcndÃt¡ons fùr lreatment or üiûgnosis, lhue J
PatiL.nt
Jessica L Fouch
DOB
05i19t1997
ID Age
503t t8
Sex Heíght
r.’ 5’2.5
Dale
Collected
07117t2015
Date
Received
t7t22t2015
Date
Reported
08/03/2ùt 5
Weight
r06
Acc#
t8997
Methylation Panel (by LCIMS/MS)
0.66
Glycine
Methionine
Homocystine
Cystine
Glurathione
Homocysteine
Cysteine
Serine
Cystathioníne
Glutamic acid
277 -57
7. l9
0.30
2’1.89
0.ó6
0.54
34-81
t98.25
7-85
r 3.06
umoUg cr
umol/g cr
umol/g cr
umol/g cr
umol/g cr
umolig cr
umol,qg cr
umoUg cr
umoUg cr
umolig cr
99-50
2.57
0.00
20.50
0_70
0.00
6.00
25.90
4- t0
3.00
647.i0
10. il
2.90
49.40
2.46
1.63
9-3.70
2,15.00
30.30
I 6-80
Electrolyte 3 Panel (Saliva)
Sodium
Potassium
Chloride
t2.00
t8.t0
25.00
mmoliL
mmol,’L
mmolr’L
3. r0
3.-to
20.00
39.80
3 l-00
49.60
DHEA-S Panel (Saliva)
11.71
DHEA-S SArU 2.75
DHEA-S 8PM 4.77
DHEA-S I2AM 31.77
Note:[Results are confirmed by repeated analysis. ]
nmol/L
nmol/L
nmol/L
t.60
t.00
0.80
t 8.50
r 0.50
8.30
Cortisol Panel (Saliva)
¡.43
_1.8 t
e.9s
t 5.40
ó.84
6.44
1.r13
3.Et
9.95
nmol/L
nmoUL
nmol/L
nmol/L
nmol/L
nmof¡L
5.50
3.80
2.20
r.60
0.80
Ll0
14.80
13.20
9.40
4.40
3.30
9.40
Cortisol 8AM (LC/MS/MS)
Conisol l2Ptvl
Conísol 4PM
Cortisol 8PM
Cortisol l2AM
Cortisol 4AM
45
Notc: Lndoscrccn Researchrü, llrC is For ræarch purposes mlv. Wc makù no reconunelrdations lbr lreatmunt or d¡aunos¡s. Pagc 3
Patient
Jessica L Fouch
DOB
05!19i 199’l
fD Ag”
503 I l8
Ser l-lcight
F 5’2.i
Dute
Collectcd
01’17:2015
Date
Rcccivc-d
07t22iJÙt5
Dltc
Reported
08,’03 201-<
Weight
t06
Acc#
r 8997
UNITS
Branched Chain EssentÍal Amino Acids Panel (by LCIMS/MS)
30.17
31.t7′
Valine
Leucine
Isoleucinc
28.90
30.37
31.17
umol/g cr
umolig cr
umolig cr
1.19
6.28
4.1I
30.50
20.10
I1.40
Non-essential Amino Acids Panel (by LCIIUS/MS)
2.4t
30-59
4t2.31
2’71.57
0.9ó
2.41
?00.11
13.0ó
i0.59
0.63
412.31
13.21
I 1.93
34-81
198.25
tumolr’g cr
umol/g cr
umol/g cr
umol/g cr
rumol,’g cr
umolig cr
umol/g cr
umol/g cr
umollg cr
umollg cr
umolig cr’
umolg cr
99.50
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JournalofHealth&Biomedical Law, Vol. VI (2010): 79-107 0 2010Journalof Health &Biomedical Law Suffolk University Law School
Special Masters in the National Vaccine Injury Compensation Program: Placing a Heightened
Burden on Vaccine Program Petitioners by Straying from Precedent and Congressional
Intent
Meredith Daniels*
Vaccinations are an integral aspect of the success of modern public health initiatives and have greatly improved the quality of life and health of American citizens by preventing the spread of disease.’ Vaccinations are so important that all fifty states and the District of Columbia require mandatory immunizations for school attendance. 2 Despite the obvious benefits of vaccinations, the risk of adverse reactions exists. 3
* J.D. Candidate, Suffolk University Law School, 2010; B.A., Brown University, 2007. Ms. Daniels clerked at Conway, Homer &Chin-Caplan, P.C. in 2009-2010. Ms. Daniels may be reached at meredith.k.daniels@gmail.com.
H. R. REP. No. 99-908, at 4 (1986), reprintedin1986 U.S.C.C.A.N. 6344, 6345 (explaining vaccinations are considered “one of the most … effective public health initiatives . . . ever undertaken”). Federal and state immunization programs reduced the number of infections and
deaths from polio, measles, mumps, rubella, diphtheria and smallpox. See Erica A. Little, The Role of Special Masters in Off-Table Vaccination Compensation Cases: Assuring Flexibiity Over Certainty, 16 FED. CIR. B.J. 355, 355 (2007) (stating “[m]any trumpet childhood immunizations as one of the most successful public health efforts in the United States”).
2 See Randall B. Keiser, Doa Vu All OverAgain? The NationalChildhood Vaccine Injury Compensation Act of 1986, 47 FOOD & DRUG L.J. 15, 15 (1992) (explaining most states require immunizations for diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio for children in grade levels kindergarten through twelfth grade); see also SUBCOMM. ON HEALTH AND THE ENv’TOF THE HOUSE COMM. ON ENERGY AND COMMERCE, 99th Cong., 2d Sess., REPORT ON CHILDHOOD
IMMUNIZATIONS 1 (Comm. Print 1986).
3 H.R. REP. No. 99-908.Congress recognized that “[w]hile most of the Nation’s children enjoy
greater benefit from immunization programs, a small but significant number have been gravely injured.” Id. at 4. In referencing House Reports, Congress is attributed because: 1) the Federal Circuit, the interpreter of the laws of the Vaccine Program, references Congress when citing to the same House Reports, and 2) Congress adopted the House Report as part of its legislative history when the Vaccine Act was passed. Between 2001 and 2005, over 330,000 Vaccine Adverse Event Reporting System (“VAERS”) reports were filed. See Illinois Vaccine Awareness
79
80 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1
Congress established the Vaccine Injury Compensation Program4 to compensate individuals injured from the administration of vaccinations “quickly, easily, and with certainty and generosity.”5 To achieve this goal, instead of bringing suit against vaccine manufacturers, a petitioner must move his case through the Vaccine Program, which allows petitioners compensation without comprehensive tort litigation.6 The federal
Coalition, Vaccine Adverse Event Reporting System: Reportsfrom March 6, 2001 to March 5, 2005, http://www.vaccineawareness.org/VAERS/2001-2005. About 85% of vaccine adverse event reports concern relatively minor events, such as ordinary fevers or redness and swelling at the injection site; the remaining 15% describe serious events such as seizures, high fevers, life threatening illnesses or deaths. Id. Between 2001 and 2005, 1,017 cases were adjudicated in the Vaccine Program and 364 petitioners were compensated. National Vaccine Injury Compensation Program Statistics Report (Jan. 20, 2010), http://www.hrsa.gov/Vaccinecompensation/ Docs/StatisticsReport.pdf.
4 National Childhood Vaccine Injury Act, 42 U.S.C. 5§300aa-1-300aa-34 (1986) (establishing Vaccine Injury Compensation Program). For convenience, future references will be to the
“Vaccine Act,” the “Program,” or the “Vaccine Program.”
sShyface v. Sec’y of Health &Human Servs., 165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting H.R. REP. No. 99-908, at 3). The Federal Circuit Court observed in Brice v. Sec’yofHealth&Human Servs.:
In establishing the Vaccine Program, two concerns motivated Congress. First, it was concerned that tort liability would make production of vaccines economically unattractive, potentially discouraging vaccine manufacturers from remaining in the market. See H.R. REP. No. 99-908, at 6-7 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6347-48. Congress thus included in the Act certain federal modifications of state tort law, including limits on punitive damage awards and a rule that a vaccine manufacturer shall not be held liable in post-Act cases if an injury resulted from unavoidable side effects provided the vaccine was properly prepared and accompanied by proper directions and warnings. See 42 U.S.C. §§ 300aa-22(b)(1), 300aa-23(d). Second, Congress was concerned that the traditional tort system was inadequate to compensate many who were injured by vaccines.
240 F.3d 1367, 1368 (Fed. Cir. 2001). Since the establishment of the Vaccine Program, 7,387 cases have been adjudicated; of those, 2,404 petitioners have been compensated for their injuries. National Vaccine Injury Compensation Program, Claims Filed and Compensated or Dismissed by Vaccine (Nov. 3, 2009), http://www.hrsa.gov/Vaccinecompensation/Docs/ClaimsFiled CompenDismiss.pdf.
6 Knudsen ex relKnudsen v. Sec’y of Health &Human Servs.,35 F.3d 543, 549 (Fed. Cir. 1994); U.S. Court of Federal Claims, Vaccine Program/Office of Special Masters, http://www.uscfc.uscourts.gov/vaccine-programoffice-special-masters (last visited Mar. 31, 2010). All vaccine claims are managed and adjudicated by the congressionally created Office of Special Masters, which currently consists of one chief special master and seven associate special masters who are appointed to serve for four-year terms. Id. The Office of Special Masters is established within the U.S. Court of Federal Claims, which appoints special masters and to which the special masters’ decisions are appealed. Id. Decisions may subsequently be appealed to the Federal Circuit Court of Appeals and then to the United States Supreme Court. Id.
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 81
statute, 42 U.S.C. §§ 300aa-1-300aa-34, the documented congressional intent for the Program, and the Federal Circuit case law provides the means of interpretation that should prevail in a vaccine claim.
Recently, special masters in the U.S. Court of Federal Claims applied standards in conflict with congressional intent and Federal Circuit case law, acting as a barrier for petitioners to receive compensation. Instead of using the standards set forth in the Vaccine Program, special masters are heightening the burden for petitioners by imposing more standards for causation than required by statute and case law and questioning the credibility of petitioners’ expert witnesses against precedent.7 The heightened standards in these cases may have severe ramifications, such as an increase in costs due to more appeals, as well as more cases potentially moving out of the Vaccine Program, which increase the number of lawsuits against vaccine manufacturers, in direct opposition to the original purpose of the Vaccine Program.8
Part I of this note will examine the established precedent of the Vaccine Program through congressional intent, the federal statute, and case law, as well as outline the process by which cases move through the vaccine program. Because the Vaccine Program is relatively new, case law from the Federal Circuit within the past decade will specifically be explored. Part II will observe recent cases in which special masters have failed to apply these established standards and precedent. Part III will explore the effects of the incorrect application of standards and precedent. Part IV will examine Wilkerson v. Sec) of Health &Human Servs.9 Finally, Part V will discuss legal, policy, and
7See, e.g., Hager v. Sec’y of Health &Human Servs., No. 01-307V, 2008 WL 4763736 (Fed. Cl. Spec. Mstr. Oct. 15, 2008) (imposing standards for expert witnesses in direct conflict with Federal Circuit precedent); Rotoli v. Sec’y of Health &Human Servs., No. 99-644V, 2008 WL 4483739 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Myers v. Sec’y of Health &Human Servs., No. 99-631V, 2008 WL 4483747 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Torbett v. Sec’y of Health &Human Servs., No. 99-660V, 2008 WL 4483738 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Porter v. Sec’y of Health &Human Servs., No. 99-639V, 2008 WL 4483740 (Fed. Cl. Spec. Mstr. Oct. 2, 2008). SeegeneralyLampe v. Sec’y of Health &Human Servs.,219 F.3d 1357, 1373-74 (Fed. Cir. 2000) (noting when a highly qualified expert presents a biologically plausible theory linking an injury to a vaccine, the issue should not be one of credibility).
8See H.R. REP. No. 99-908, at 6-7 (noting Vaccine Program was established to compensate individuals who injured from vaccinations, as well as protect vaccine manufacturers from liability). Before a lawsuit may be filed against a vaccine manufacturer, federal law requires the submission of a claim under the National Vaccine Injury Compensation Program. ChristopherJ. Rogers, A Primeron the NationalVaccine Injury CompensationPgram,21UTAH B.J. 25, 25 (2008); 42 U.S.C. § 300aa-12 (2006) (stating petitioners who are not compensated within the Program may file traditional tort litigation suit against vaccine manufacturers).
9 593 F.3d 1343 (Fed. Cir. 2010).
82 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1
consumer concerns with recent actions of the special masters. This section will also survey the potential long-term ramifications of the recent actions of the special masters in certain cases and how they may have a detrimental effect on the Vaccine Program as a
whole.
I. Purpose, Reasoning, and Precedent of the National Vaccine Injury Compensation Program
A. Congressional Intent
Two concerns motivated Congress in establishing the Vaccine Program. First, Congress was concerned that tort liability would make production of vaccines economically unattractive, potentially discouraging vaccine manufacturers from remaining in the market.10 Second, Congress was concerned that the traditional tort system was inadequate to compensate many who were injured by vaccines.” Congress’s principal findings that required the establishment of the Vaccine Program were as follows:
1) The availability and use of vaccine to prevent childhood diseases is among the Nation’s top public health priorities;
2) The Federal government has the responsibility to ensure that all children in need of immunization have access to them and to ensure that all children who are injured by vaccine have access to sufficient compensation for their injuries; and
10Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1368 (Fed. Cir. 2001). Congress included in the Act certain federal modifications of state tort law, including limits on punitive damage awards and a rule that a vaccine manufacturer shall not be held liable in post-Act cases if an injury resulted from unavoidable side effects provided the vaccine was properly prepared and accompanied by proper directions and warnings. Id. Between 1980 and 1986, individuals brought damages claims totaling $3.5 billion; as a result of liability concerns, many pharmaceutical .companies stopped producing and distributing vaccines. Katherine E. Strong, Note, Proving Causation Under the Vaccine Injury Act A New ApproachbforA New Day, 75 GEO. WASH. L. REV. 426, 434 (2007) (stating by 1985 only four manufacturers were still producing mandated vaccines).
” Brice, 240 F.3d at 1368. Upon enacting the Vaccine Act, Congress recognized that “[w]hile most of the Nation’s children enjoy greater benefit from immunization programs, a small but
significant number have been gravely injured.” H.R. REP. No. 99-908, at 4.
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 83 3) Private or non-governmental activities have proven inadequate in
achieving either of these goals.12
Thus, the Vaccine Program was established for two purposes: (1) to protect the Nation’s vaccine supply and encourage the developments of new and safer vaccines,13 and (2) to compensate persons injured by vaccineS.14
Congress stated two overriding concerns that led to the development of this legislation: (1) the inadequacy of the current approach to compensating those injured by vaccines, and (2) the instability and unpredictability of the vaccine market.15 Congress hoped the Vaccine Program would reduce the number of lawsuits against vaccine manufacturers, while simultaneously promoting the “development of new and improved vaccines.”16 Congress stated that awards “can be made to vaccine injured persons quickly, easily, and with certainty and generosity.”‘ 7
B. The Process
All vaccine claims are managed and adjudicated by the congressionally created Office of Special Masters, which currently consists of one Chief Special Master and seven Associate Special Masters who are appointed by the U.S. Court of Federal Claims to serve for four-year terms.’ 8 The U.S. Court of Federal Claims hears appeals from the special masters’ decisions.’ 9 Special masters make the initial decision for compensation
12 H.R. REP. No. 99-908, at 5 (1986).
13 Since the Vaccine Program was established in 1988, the following vaccines have been developed and added to the Vaccine Table: hepatitis B vaccine (“hep B”), baemophilusinfluenzae
typeb vaccine (“Hib”), varicella vaccine, rotavirus vaccine, pneumococcal conjugate vaccines, hepatitis A vaccine, the adult “flu” vaccine, meningococcal vaccine, and the human papillomavirus vaccine. See 42 U.S.C. § 300aa-14 (2006).
14 See Brice, 240 F.3d at 1368; H.R. REP. No. 99-908, at 5 (1986).
‘5 H.R. REP. No. 99-908, at 7 (1986).
16 H.R. REP. No. 99-908, at 4. Congress also hoped the Vaccine Program would help create “a new system for compensating individuals who have been injured by immunizations routinely administered.” Id. at 3.
17 H.R. REP. No. 99-908, at 18.Congress intended that the Vaccine Program provide individuals a swift, flexible, and less adversarial alternative to the often costly and lengthy traditional tort litigation. See U.S. Court of Federal Claims, Vaccine Program/OfficeofSpecialMasters, http://www. uscfc.uscourts.gov/vaccine-programoffice-special-masters, (last visited Mar. 31, 2010).
18 U.S. Court of Federal Claims, Vaccine Program/Office of Special Masters, http://www.uscfc. uscourts.gov/vaccine-programoffice-special-masters, (last visited Mar. 31, 2010).
19 Id. Special masters actively and frequently interact with the parties (generally counsel representing petitioner and a Department ofJustice attorney representing Secretary of Health and Human Services). Id.
84 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1
under the Program.20 After appealing special masters’ decisions to the U.S. Court of Federal Claims, decisions may be subsequently appealed to the Federal Circuit Court of
Appeals and then to the Supreme Court.21
Under the Vaccine Act, when reviewing a decision of a special master on a motion for review, the Court of Federal Claims has jurisdiction to “undertake a review of the record of the proceedings.”2 The court may take any of the following actions: (1) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (2) set aside any findings of fact or conclusions of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law and issue its own findings of fact and conclusions of law, or (3) remand the petition to the special master for further action in accordance with the court’s direction. 23 The Vaccine Act requires the Court of Federal Claims to analyze conclusions of law made by a special master to determine whether they are in accordance with law and may set aside factual findings by a special master if they find them to be arbitrary or capricious or if a special master has abused his or her discretion in making such findings.24 Prior to 1989, the appellate courts in the Vaccine Program had the option of either “adopt[ing] the findings of the special master as [their] own judgment, or mak[ing] a de novo determination of any matter and issu[ing] judgment accordingly.”25 Congress amended the statute in 1989, eliminating the ability of U.S. Court of Federal Claims to conduct a de novo review of the special master’s decision. 26
20 Conway, Homer and Chin-Caplan, P.C., VaccineProgram: The Process,www.ccandh.com/vl.asp, (last visited on Mar. 31, 2010). Compensation that may be awarded for a vaccine-related injury include: reasonable compensation for past and future medical care, custodial care and rehabilitation costs, a $250,000 cap for actual and projected pain and suffering and emotional distress, lost earnings, and reasonable attorneys’ fees and costs. Id.
21 U.S. Court of Federal Claims, Vaccine Program/Ofice of Spedal Masters, http://www.uscfc. uscourts.gov/vaccine-programoffice-special-masters, (last visited Mar. 31, 2010).
2 42 U.S.C. §300aa-12(e)(2) (2006).See alsoR. FED. CL., Appendix. B, R. 27.
2 42 U.S.C. § 300aa-12(e)(2).
24 See 42 U.S.C. §300aa-12(e). The Federal Circuit has commented that “reversible error is extremely difficult to demonstrate if the special master has considered the relevant evidence of
record, drawn plausible inference and articulated a rational basis for the decision.” Lampe v. Sec’y of Health &Human Servs.,219 F.3d 1357, 1360 (Fed. Cir. 2000) (explaining arbitrary and
capricious standard of review is difficult for appellant to satisfy).
25 Keiser, supra note 2, at 23 (italics added).
26 See Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239, § 6601(h), 103 Stat. 2106, 2289 (codified at 42 U.S.C. § 300aa-12(e) (2006)). The statutory standard of review applicable to the factual findings of a special master in a Vaccine Act case require the Court of Federal Claims to uphold a special master’s findings unless the court concludes that those findings are arbitrary and capricious. See 42 U.S.C. § 300aa-12(e)(2)(B); Saunders v. Sec’y of Health &Human Servs.,25 F.3d 1031, 1033 (Fed. Cir. 1994); Munn v. Sec’y of Health &Human
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 85 C. Case and Statutory Law
A petitioner must meet several requirements before bringing a case under the National Childhood Vaccine Injury Act of 1986. The requirements set forth in 42 U.S.C. § 300aa-11, are that a petitioner must: (1) receive the vaccine in the United States,27 (2) be injured from a vaccine listed on the Vaccine Injury Table,28 (3) not previously collected an award or settlement for such vaccine-related injuries,29 and (4) either suffered residual effects of injury for more than six months, died from the administration of the vaccine, or required inpatient hospitalization and surgical intervention. 30 If these requirements are met, a successful petition in the Vaccine Program can be brought in two ways.3′ First, a petitioner may bring a claim if they sustained an injury set forth in a statutorily set Vaccine Injury Table32 with the initial listed symptom occurring within the time period defined in the table.33 A vaccine is the presumed cause of an injury if the petitioner establishes that his or her table injury occurred within the time period set forth in the table.M However, because of the narrowly defined injuries set forth on the Vaccine Injury Table, proving a table injury is difficult.35 As a result, most petitioners in the Vaccine Program bring a petition under the second option, commonly called off-table cases, encompassing injuries not listed on
Servs.,970 F.2d 863, 870 (Fed. Cir. 1992) (noting arbitrary and capricious standard is “well understood to be the most deferential possible”).
27 See 42 U.S.C. §300aa-11(1)(B)(i) (2006).
28 See 42 U.S.C. §300aa-11(1)(A); see also 42 U.S.C. §300aa-14 (2006). The Vaccine Injury Table
groups the vaccines by antigen and outlines the injuries for each of the groups of vaccines, as well as the time frame in which the symptoms appear. Id.
29 See 42 U.S.C. §300aa-11(1)(E).
30 See 42 U.S.C. §300aa-11(1)(D).
31 See 42 U.S.C. §5 300aa-1-300aa-34 (2006).
32 See 42 U.S.C. §300aa-14 (2009).
33 See 42 U.S.C. § 300aa-11(c)(1)(C)(i) (2006). A petitioner may have “sustained, or had significantly aggravated any … injury … set forth in the Vaccine Injury table … and the first symptom . . . of the . . . injury . .. occurred within the time period [defined in the table] after vaccine administration.” Id.
34 See Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (2005) (describing statutory prescription for causation if injury is included as table injury).
35 See U.S. Department of Health and Human Services, Vaccine Table, available at http://www.hrsa.gov/vaccinecompensation/table.htm (last visited Mar. 31, 2010). For example, if a petitioner experienced anaphylactic shock zero to four hours after the administration of a tetanus toxoid-containing vaccine (such as DTaP, Tdap, Td, etc.), causation is presumed. Id. See generally 42 U.S.C. 5 300aa-14 (2006). For example, seizures are not sufficient to satisfy the definition of encephalopathy under § 14, a petitioner must also demonstrate several other symptoms. Id.
JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1 the Vaccine Injury Table.36
Off-table cases must be proven by a preponderance of the evidence.37 To establish by preponderant evidence that a vaccine caused an off table injury, the vaccine must be the “but for” cause of the petitioner’s injury and a substantial factor in bringing about that injury.38 In this regard, the Federal Circuit ruled that the vaccine may be only one of several concurrent causes of the injury.39 It need not be the sole cause or even the predominant cause; rather, it need only be a “substantial factor.”40 In order to be eligible for compensation, a petitioner must file his or her petition with the court within three years from the onset of symptoms.41 The Federal Circuit held that the first symptom or manifestation of onset is the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large.42
Althen v. Sec’yofHealth&Human Servs.states that a petitioner will prevail in an off-table case upon establishing that: “(1) a medical theory causally connect[s] the vaccination and the injury; (2) a logical sequence of cause and effect show[s] that the
36 See 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I) (2006) (explaining petitioner may seek compensation from injury “not set forth in the [table] . . . but which was caused by a vaccine [in the table].. . .”). 37 See 42 U.S.C. § 300aa-13(a)(1)(A) (2006); Althen, 418 F.3d at 1274 (“The purpose of the
Vaccine Act’s preponderance standard is to allow the finding of causation in a filed bereft of complete and direct proof [as to] how vaccine affect the human body”); Bunting v. Sec’y of Health &Human Servs.,931 F.2d 867, 873 (Fed. Cir. 1991) (“The standard of proof required by the Act is simple preponderance of evidence; not scientific certainty . . . . [I]t is not plaintiff’s burden to disprove every possible ground of causation suggested by defendant nor must the
findings of the court meet the standards of the laboratorian”).
38 See Shyface, 165 F.3d at 1352 (discussing necessity of adequate causation).
39 See id. Further, a petitioner may be compensated if the vaccine was shown to have significantly aggravated an underlying condition. See 42 U.S.C. § 300aa-33(4) (2006). The term “significant aggravation” means any change for the worse in a preexisting condition that results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. Id.
40 Shyface, 165 F.3d at 1352-53. A petitioner need not eliminate all possible alternative causes of injury, however, as a practical matter, proof of a “logical sequence of cause and effect” will eliminate potential likely alternatives. Id. at 1353.See also Walther v. Sec’y of Health &Human Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007).
41 42 U.S.C. § 300aa-16(a)(2) (2006) (stating “if a vaccine injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation . .. for such injury after the expiration of [thirty-six] months after the date of the occurrence of the first symptom or manifestation of onset .. . of such injury”). If the petitioner is deceased, the statute of limitations is twenty-four months from the date of the vaccination. Id.
42 See 42 U.S.C. § 300aa-16(a)(2) (2006); Markovich v. Sec’y of Health &Human Servs.,477 F.3d 1353 (Fed. Cir. 2007) (explaining definition of “manifestation of onset” for purposes of 42 U.S.C. §300aa-16(a)(2) (2006)).
86
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vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between [the] vaccination and the injury.”43 Each element of this three- prong Althen test can be satisfied by circumstantial evidence consisting of medical records or a medical opinion.44 Further, evidence used to satisfy one prong of the test may overlap to satisfy another prong.45
A petitioner is not required to satisfy any element of the three-prong Althen test with scientific certainty.46 Rather, a petitioner need only demonstrate with circumstantial evidence the existence of causation between the vaccine and the injury.47 In this regard, a differential diagnosis of a treating physician sufficiently meets the reliability standard set forth in Daubert v. Merrell Dow Pharm., Inc.48 and may be used as indirect evidence of causation. 49 In light of the Act’s purpose, scientific and objective confirmation of the biologic mechanism by which the vaccine caused the injury with additional medical documentation to establish a theory of causation to fulfill the first Althen prong is unnecessary.o Requiring scientific certainty to prove the biologic mechanism would thwart the purpose of the Act by requiring “sequence[s] hitherto
43 Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cit. 2005) [hereinafter “Althen test”]. The Althen test was established in response to other tests created and applied by special masters heightening the petitioner’s evidentiary burden. Seegeneraly id.
44 See id.at 1278 (explaining logical sequence of cause and effect can be supported by “reputable medical or scientific explanation” or “evidence in the form of . .. expert medical testimony”).
45 See Capizzano v. Sec’y of Health &Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (holding “[w]e see no reason why evidence used to satisfy one of the Althen … prongs cannot overlap to satisfy another prong”).
4 See Althen, 418 F.3d at 1280.
47 See id.
48 509 U.S. 579, 597 (1993) (holding requirement that expert’s testimony pertain to scientific knowledge establishes standard of evidentiary reliability).
49 See Kelley v. Sec’y of Health &Human Services, 68 Fed. Cl. 84, 90 n.7 (Fed. Cir. 1994). The Federal Circuit also stated:
The assessment of whether a proffered theory of causation is “reputable” can involve assessment of the relevant scientific data. Medical literature and epidemiological evidence must be viewed, however, not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.
Andreuex. rel.Andreuv. Sec’y of Health &Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). soSee Kelley v. Sec’y of Health &Human Servs., 68 Fed. Cl. 84, 87-88 (Fed. Cl. 2005) (quoting Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278-81 (Fed. Cir. 2005)) (emphasizing requiring proof of biological mechanisms of causation would be inconsistent with purpose and nature of Vaccine Program). Further, “determination of causation in fact under the Vaccine Act involves ascertaining whether a sequence of cause and effect is logical’ and legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Health &Human Servs.,35 F.3d 543, 548-49 (Fed. Cir. 1994).
88 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1 unproven in medicine”5′ and surpass the preponderance standard demanded by
Congress. 52
When reviewing the record to determine if the Althen test is met, a special master must consider the opinions of treating physicians.53 In this regard, the treating physician offers a medical opinion that is quite probative in establishing a logical sequence of cause and effect.54 The Federal Circuit noted that physicians are in the best position to determine causation; their opinions are presumed to meet a sufficient level of reliability and are thus favored in vaccine cases.15 To remove all doubt, the Federal Circuit reaffirmed the probative value of the opinions of treating physicians in satisfying this prong in Andreu ex. rel.Andreuv. Sec’ ofHealth&HumanServs., stating that “treating physicians are likely in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.”5 6 The opinions of treating physicians contained in medical records can be sufficient to demonstrate a logical sequence of cause and effect between the vaccine and the injury.57 For example, the court noted that a treating physician may rely on the close temporal proximity between a vaccine and an injury in concluding that there is a logical sequence
of cause and effect between a vaccine and injury.58
Finally, in proving a prima facie case, a petitioner need not eliminate all possible alternate causes of injury.59 As a practical matter, however, proof of a “logical sequence
5′ Althen v. Sec’y of Health and Human Servs. 418 F.3d 1274, 1280 (Fed. Cir. 2005). “The standard of proof required by the [Vaccine] Act is simple preponderance of evidence; not scientific certainty . . . .[I]t is not plaintiffs burden to disprove every possible ground of causation suggested by defendant nor must the findings of the court meet the standards of the laboratorian.” Bunting v. Sec’y of Health &Human Servs.,931 F.2d 867, 873 (Fed. Cir. 1991)
(citations and internal quotation marks omitted).
52 See Buning, 931 F.2d at 873. The Federal Circuit consistently recognized the uncertainty of the science relating to vaccine injuries stating, “to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program.” Knudsen, 35 F.3d at 549.
53 See Capizzano v. Sec’y of Health &Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
5 Seeid.
5 Seeid.
56 Andreu ex.rel. Andreu v. Sec’y of Health &Human Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009) (quotingCapiZgano, 440 F.3d at 1326). Further, the Federal Circuit held that conclusive proof is unnecessary and not congruent with the law, stating that the special master had “imposed upon [petitioners] an elevated evidentiary burden requiring them to submit conclusive proof in the medical literature” to show a vaccine caused an injury. See id.at 1375.
57 Seeid.at 1376.
58 See id.
5 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999). In all
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of cause and effect”6o will eliminate potential alternatives.61 In any event, once a petitioner has made a prima facie case, the burden of proof shifts, and the government must prove that the “injury… described in the petition is due to factors unrelated to the. . . vaccine.” 62 In such a case, the government must not merely prove the existence of an alternative cause but that such an alternative actually caused the injury.63 Aspecial master should weigh the evidence contained in the “record as a whole.”M The Federal Circuit held where the evidence is found in equipoise, the court should enter judgment in favor of the petitioner.65
II. Examples of Special Masters’ Incorrect Application of Precedents and Standards
Instead of using the standards 66 set forth in the Vaccine Program, special masters heightened the burden for petitioners by: (1) imposing more standards of causation than required by statute and case law, and (2) questioning the credibility of petitioners’ expert witnesses in certain cases in opposition to established precedent.67
vaccine injuries, genetic susceptibility plays a role. See id. Frequently, non-vaccine environmental factors also contribute to the injury. See id. When concurrent forces cause a single harm, the Federal Circuit has held the burden is on the government to show that the alternative cause is so predominant that the vaccine is insignificant; it must eliminate the vaccine as a substantial contributing factor. See id. Once a petitioner has made a prima facie case, the burden of proof shifts and the government must prove that an alternative cause exists and that it actually caused the injury.See Knudsen ex rel. Knudsen v. Sec’y of Health &Human Servs.,35 F.3d 543, 549 (Fed. Cit. 1994).
60 Walther v. Sec’y of Health &Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007).
61 See id.
62 42 U.S.C. § 300aa-13(a)(1)(B) (2006).The U.S. Department of Justice represents the Secretary of Health and Human Services in all Vaccine Program proceedings.
63 See Knudsen, 35 F.3d at 549. Further, as the Federal Circuit pointed out in Walther, “the petitioner generally has the burden on causation, but when there are multiple independent potential causes, the government has the burden to prove that the covered vaccine did not cause the harm.” 485 F.3d 1146, 1151 (Fed. Cir. 2007).
6 42 U.S.C. §300aa-13(a)(1)(A).
65 See Knudsen, 35 F.3d at 550 (suggesting if evidence establishes equally plausible etiologies for injury then petitioner should prevail).
66 The standards and initiatives as established supra, Congressional intent, 42 U.S.C. §§ 300aa-l- 300aa-34, and the decisions from the U.S. Federal Court of Claims and the U.S. Federal Circuit.
67 See generaly, e.g., Rotoli v. Sec’y of Health &Human Servs., No. 99-644V, 2008 WL 4483739 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Myers v. Sec’y of Health &Human Servs., No. 99-631V, 2008 WL 4483747 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Torbett v. Sec’y of Health &Human Servs., No. 99-660V, 2008 WL 4483738 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Porter v. Sec’y of Health &Human Servs., No. 99-639V, 2008 WL 4483740 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Hager v. Sec’y of Health &Human Servs., No. 01-307V, 2008 WL 4763736 (Fed. Cl. Spec. Mstr. Oct. 15,
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This section will explore several recent cases where special masters’ decisions have been either appealed by petitioners for incorrectly applying standards or have already been deemed arbitrary and capricious and overturned by the appellate courts. 68
A. Imposing More Standards for Causation than Required by Case Law and Statute
The three-prong test from Althen resulted from a special master’s decision to impose a five-prong test for petitioners to meet in order to receive compensation in the Program.69 The five-prong test required that petitioner provide proof of: “(1) medical plausibility, (2) confirmation of medical plausibility from the medical community and
literature, (3) an injury recognized by the medical plausibility evidence and literature, (4) a medically acceptable temporal relationship between the vaccination and the onset of the alleged injury, and (5) the elimination of other causes.”70 The special master determined that because the petitioner did not provide peer-reviewed literature, she did not qualify for compensation.71 Upon review, the Federal Circuit determined that the application of the five-prong test was contrary to law, stating that both prongs two and three of the test “contravene the plain language of the statute.” 72 The Federal Circuit held that requiring medical literature “impermissibly”73 raised petitioner’s burden and was in direct conflict with the statute’s allowance of medical opinion as proof.74 Finally, the Federal Circuit noted that the role of the special master is “not to craft a new legal standard.”7 5
2008).
68 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 71 (Fed. Cl. 2009);Campbell v.
Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 369 (Fed. Cl. 2009).
69 See Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1274 (2005) (discussing five-
prong test the special master used from Stevens v. Sec’y of Health &Human Servs., No. 99- 594V, 2001 WL 387418 (Fed. Cl. Spec. Mstr. Mar. 30, 2001), and establishing three-prong Althen test).
7 0 Althen, 418 F.3d at 1279 (outlining five-prong test the special master employed).
71 See id. (citing Althen v. Sec’y of Health &Human Servs., No. 00-170V, 2003 WL 21439669, at *14 (Fed. Cl. Spec. Mstr. Jun. 3, 2003)).
72 Id. at 1281.See also 42 U.S.C. § 300aa-12(a)(1) (2006) (stating petitioner must prove causation in fact by “preponderance of the evidence,” substantiated by medical records or medical
opinion).
7 Althen, 418 F.3d at 1280.
74 See id.; see also42 U.S.C. §300aa-13(a)(1).
7 Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005) (explaining role of special master is to “assist the courts by judging the merits of individual claims on a case by case basis”). See also 42 U.S.C. § 300aa-13(a)(1).
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Despite the Federal Circuit’s explanation that special masters are not to construct new legal standards, in CapiZano v. Secy of Health &Human Sen’s.,the special master created a new “disjunctive”7 6 four-prong test for petitioners to meet in order to receive compensation for vaccine-related injuries.77 This new test required that in order to show the second prong of the Althen test, a logical sequence of cause and effect between the injury and the vaccination, a petitioner must show one of the following: (1) epidemiologic studies, (2) rechallenge,78 (3) the presence of pathological markers or genetic disposition, or (4) general acceptance in the scientific or medical community.79 The Federal Circuit determined that the special master’s approach was “inconsistent with allowing ‘the use of circumstantial evidence envisioned by the preponderance standard.”’80 Because the petitioner’s treating physicians repeatedly associated the petitioner’s injury with the vaccine, the Federal Circuit determined that the petitioner fulfilled the requirement of a logical sequence of cause and effect as outlined by 42 U.S.C. §300aa-13(a)(1).81
In Andreu v. SecjyofHealth&HumanSen’s.,the Federal Circuit again found that a special master imposed higher standards for causation on the petitioner than required by statute and case law, stating:
In Althen … we expressly rejected the [five-prong] test, concluding that requiring “objective confirmation” in the medical literature prevents
76 Capizzano v. Sec’y of Health &Human Servs., 440 F.3d 1317, 1322 (Fed. Cir. 2006). 77 Id.
78 When two or more administrations of a vaccine to the same person are followed by the same adverse event, positive rechallenge is said to occur. M. Miles Braun, Vacine Adverse Event Reporting System (VAERS): Usefulness and Limitations, INSTITUTE FOR VACCINE SAFETY, http://www.vaccinesafety.edu/VAERS.htm (last visited Mar. 31, 2010). Positive rechallenge
represents stronger evidence than temporal association of a since adverse event. Id.
79 See Capitzano,440F.3d at 1325.
80 Id. The Federal Circuit went on to state that the new requirements impermissibly raised the
claimant’s burden under the Vaccine Act, and hindered the system created by Congress, “in which close calls regarding causation are resolved in favor of injured claimants.” Id. at 1325-26.
81See Capi-Zano,440F.3d at 1325-26 (stating “medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether ‘a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’ (quoting Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005))); see also 42 U.S.C. § 300aa-13(a)(1) (“The special master or court may not make . . . a finding [of causation] based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion”).
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“the use of circumstantial evidence . . . and negates the system created by Congress” . . . . Here, however, the special master resurrected the defunct [five-prong] test in an effort to discredit [petitioner’s medical expert]’s theory of causation. 82
In Andreau, the Federal Circuit held that the special master erred in requiring proof of confirmation of medical plausibility from the medical community and literature in order to establish causation of the vaccine to the petitioner’s injury.83
B. Incorrect Credibility Determination Of Petitioners’ Expert Witnesses
Special masters also recently questioned the credibility of petitioners’ expert witnesses against established precedent discussed hereinafter; as such, their rulings have been deemed arbitrary and capricious and were overturned by the appellate courts.84 In Rotoli, five petitioners alleged that the hepatitis B vaccine caused them to suffer autoimmune hepatitis.85 The special master for these five petitioners determined that the petitioners’ expert immunologist, who testified on behalf of all five petitioners, was neither credible nor truthful when he testified that vaccine caused these injuries, and dismissed all five petitions.86 On appeal, the Court of Federal Claims determined that
82 Andreuex.rel. Andreu v. Sec’y of Health &Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (concluding requiring “objective confirmation” in medical literature prevents “the use of circumstantial evidence … and negate[s] the system created by Congress through the Vaccine Act” (citingAlthen, 418 F.3d at 1280)).
83 See Andreu, 569 F.3d at 1379.
84 See, e.g., Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 81-82, (Fed. Cl. 2009)
(holding special master imposed standards for expert witnesses in direct conflict with Federal Circuit precedent); see alsoAndreu, 569 F.3d at 1379 (noting “special master framed her rejection of [petitioner’s expert’s] theory of causation under the rubric of a ‘credibility’ determination” (citing Andreuex. rel. Andreu v. Sec’y of Health &Human Servs., No. 98-817V, 2008 WL 2517179 at *8)); Campbell v. Sec’y of Health &Human Servs., 90 Fed. Cl. 369, 383 (Fed. Cl. 2009) (finding special master improperly framed his rejection of petitioner’s claim under rubric of expert witness’s credibility determination).
85 Rotoli, 89 Fed. Cl. at 76-77. The petitioners alleged that the hepatitis B vaccine, which they each received in three doses in the 1990s, caused them to suffer autoimmune hepatitis and
associated injuries. Id.
86 See Rotoli v. Sec’y of Health &Human Servs., No. 99-644V, 2008 WL 4483739; Myers v. Sec’y of Health &Human Servs., No. 99-631V, 2008 WL 4483747; Torbett v. Sec’y of Health &Human Servs., No. 99-660V, 2008 WL 4483738; Porter v. Sec’y of Health &Human Servs., No. 99-639V, 2008 WL 4483740; Hager v. Sec’y of Health &Human Servs., No. 01- 307V, 2008 WL 4763736. The special master held joint hearings and, in each case, found by a preponderance of the evidence that the petitioner failed to establish a medical theory causally connecting the hepatitis B vaccine to autoimmune hepatitis. Id. The special master dismissed all five petitions
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“[i]n these five cases, the special master’s analysis of the petitioners’ evidence of causation ran afoul of the Federal Circuit’s standards regarding credibility determinations.”87 The Court of Federal Claims found that the special master erroneously founded the rejection of the petitioners’ theory of causation on an assessment of the petitioners’ expert’s “poor”88 credibility.89 The special master’s discussion of petitioners’ expert’s credibility “permeated”90 his analysis of the petitioners’ claims.91 References to the credibility of petitioners’ expert also pervaded the special master’s analyses of the medical theory proposed by all five petitioners and of the specific evidence of causation in each of the five cases. 92 By couching his rejection of petitioners’ expert’s testimony in terms of credibility, the special master expected his analysis to be “virtually not reviewable on appeal.” 93
and threatened to deny the fees of the petitioners’ expert and their attorneys. Id. He also advised the petitioners to accept his decisions as final and warned the petitioners and their attorneys that special masters’ decisions with respect to findings of credibility were “virtually unreviewable” by
higher courts. Id.
87 Rotoi, 89 Fed.Cl. at 80, No. 99-644V, 2009 WL 2868840, at *5 (2009). The court issued a single, consolidated Opinion and Order for all five cases because of the substantial overlap of the legal and factual issues in each. Id.at 77, 2009 WL 2868840, at *1.
88 Rotoi, No. 99-644V, 2008 WL 4483739, at *7.
89 See Rotoli, No. 99-644V, 2008 WL 4483739, at *7 (noting expert’s retreat from proposed theory is “poor mark on his credibility as an expert”). While considerable deference must be accorded to the credibility determinations of special masters this does not mean that a special master can “cloak the application of an erroneous legal standard in the guise of a credibility determination, and thereby shield it from appellate review.” Andreuex. rel.Andreuv. Sec’y of Health &Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health &Human Servs.,991 F.2d 1570, 1575 (Fed. Cir. 1992). See also Lampe v. Sec’y of Health &Human Servs.,219 F.3d 1357, 1373-74 (Fed. Cir. 2000) (noting when a highly qualified expert presents a biologically plausible theory linking an injury to a vaccine, the issue should not be one of credibility).
90 Id.
91 See id. The special master included a nine-page section (a substantial portion of the total length of his decision) entitled “Additional Comments Regarding [Petitioners’ Expert]” in which he questioned not only “[Petitioners’ expert’s] persuasiveness but also his truthfulness” as a result of various weaknesses in the evidence underlying [petitioner’s expert’s] claims and [petitioner’s expert’s] “demeanor.” See, e.g., Rotoli, No. 99-644V, 2008 WL 4483739 at *22-30.”[The evidence from each case solely supports a finding that [petitioner’s expert] lacks credibility.” Id. at *2 9 .
92 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 81 (Fed. Cl. 2009).In reviewing
the evidence, including the medical literature, the special master did not follow precedent and establish simply whether petitioner’s expert’s medical theory of causation was supported by the weight of that evidence. Instead, he went so far as to conclude that the “questions about the basis for [petitioner’s expert’s] statements . . . have led to a question about [petitioner’s expert’s]
veracity.” See, e.g., Rotoi, No. 99-644V, 2008 WL 4483739, at *30.
93 See, e.g., Rotoi, No. 99-644V, 2008 WL 4483739, at *4 (noting a “decision about the persuasiveness of an expert is virtually not reviewable on appeal” (citing Bradley v. Sec’y of
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The U.S. Court of Federal Claims found that the special master violated precedent set forth in Andreu v. Sec’yofHealth&r”HumanServs.94 and erroneously used his assessment of petitioners’ expert’s credibility as a basis for rejecting the expert’s testimony regarding causation.95 Moreover, the court found that the pervasiveness of the comments regarding to the expert’s credibility throughout the special master’s decisions made it impossible to review the special master’s evaluation of the evidence separately from his erroneous credibility determination. 96 Accordingly, the U.S. Court of Federal Claims found that the special master framed his rejection of the petitioners’ theory of causation “under the rubric of a ‘credibility’ determination,”97 which constituted a legal error, resulting in the court setting aside the special master’s findings.”
Similarly, in Campbell v. Secy of Health &Human Sers.,99 the special master denied relief to the petitioner based on a credibility determination. 00 In Campbell, the special master based his decision to deny the petitioner compensation in substantial part on his finding that respondent’s expert was more credible than petitioner’s expert.’01 Because there was no genuine issue with regard to petitioner’s expert’s candor or truthfulness, the special master ran afoul of the Federal Circuit’s standards regarding the use of credibility determinations.102
Health &Human Servs.,991 F.2d 1570, 1575 (Fed. Cir. 1993))).
9 Andreuex.rel. Andreu v. Sec’y of Health &Human Servs., 569 F.3d 1367 (Fed. Cir. 2009).
9s See Rotoli, 89 Fed.Cl. at 81-82.
96 See id. at82 (noting “the special master’s error has tainted his entire causation analysis”).
97 See id. (citingAndreu, 569 F.3d at 1379).
98 See 42 U.S.C. 5 300aa-12(e)(2)(B) (2006). The court discarded the special masters decisions, re- examined the evidence, and issued new findings in each case. See generalyRotoli, 89 Fed. Cl. 71. The court found that three petitioners were entitled to compensation and that two petitioners were not. Id.
99 Campbell,90Fed. Cl. 369 (2009).
0 The special master denied relief to the petitioner on the grounds that she “has not established that the theories offered by her expert [to explain how the influenza vaccine could cause the onset of rheumatoid arthritis] are reliable,” and “even if her expert’s theories were reliable, she experienced signs and symptoms of rheumatoid arthritis within the time predicted by her expert.” Campbell v. Sec’y of Health &Human Servs., No. 07-465V, 2009 WL 2252550, at *1 (Fed. Cl. Spec. Mstr. July 7, 2009).
101 See Campbell 90 Fed.Cl. at 382 (stating “[bjecause there was no genuine issue with regard to [petitioner’s expert’s] candor or truthfulness, the special master ran afoul of the Federal Circuit’s
standards regarding the use of credibility determinations”).
102 In Andreu, the Federal Circuit held that “[w]hile considerable deference must be accorded to the credibility determinations of special masters, this does not mean that a special master can cloak the application of an erroneous legal standard in the guise of a credibility determination, and thereby shield it from appellate review.” Andreuex. rel. Andreu v. Sec’y of Health &Human
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As in Andren and Rota/i, the special master in Campbell”cloak[ed] much of his rejection of petitioner’s theory of causation ‘under the rubric of a ‘credibility’ determination’ regarding . . . petitioner’s expert witness.” 103 Similar to the result in
Roto/i, petitioner’s expert in this case was a “highly qualified expert witness whose extensive credentials [were] not in dispute.”104 At the conclusion of the expert opinion evaluation, the special master cited the petitioner’s expert’s credibility as a primary reason for finding that the petitioner had not established a proximate temporal relationship between her vaccination and her injury under the third prong of Althen.105 Like in Rotoli, the special master expected his analysis of whether petitioner had established causation in fact to be “virtually not reviewable on appeal”10 6 because in this case he couched his rejection of petitioner’s claim in terms of credibility.107 Despite the special master’s attempt to insulate his decision from review by the “incantation of magic words,” 08 the U.S. Court of Federal Claims found that he erroneously relied on an assessment of petitioner’s expert’s credibility as a basis for rejecting petitioner’s expert’s testimony.109 Further, the special master’s error tainted his entire analysis of whether petitioner established causation in fact.” 0 The Court of Federal Claims ruled
Servs.,569 F.3d 1367, 1379 (Fed. Cir. 2009). The Federal Circuit clarified that “[a] trial court makes a credibility determination in order to assess the candor of a fact witness, not to evaluate whether an expert witness’ medical theory is supported by the weight of the epidemiological evidence.” Id.
103 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 81 (Fed. Cl. 2009) (citingAndren, 569 F.3d at 1379).
104 See Rotoli, 89 Fed. Cl. at 81 (emphasis in original). “[W]here a highly qualified expert … presents a biologically plausible theory of causation in a vaccine case, the issue is not one of credibility.” See id.(citingAndreu, 569 F.3d at 1379).
105 Specifically, the special master stated that “[the factors that contributed] to the finding that [respondent’s expert] was more persuasive than [petitioner’s expert] … underlie the analysis of
the three factors from Althen [that follows].” Id.at 83.
106 Roto/, 89 Fed. Cl. at 82.
107 Id. at 81. “A decision about the persuasiveness of a witness is virtually not reviewable on
appeal.” Id. (upholding a special mater’s credibility determination regarding a non-expert witness (citing Bradley v. Sec’y of Health &Human Servs.,991 F.2d 1570, 1575 (Fed. Cir. 1993))).
108 See Campbell v. Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 384 (Fed. Cl. 2009).
109 See id. As stated supra, an evaluation of the credibility of an expert witness should be reserved for “assess[ing the candor of a fact witness” and petitioner’s expert’s candor is not in dispute. Andreuex. rel.Andreuv. Sec’y of Health &Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). 110 See Campbell,90Fed. Cl. at 384.
Not only did the special master expressly base his finding that [petitioner] did not establish a proximate temporal relationship primarily on his evaluation of [petitioner’s expert’s] credibility, see Entitlement Decision at *11, but, by the special master’s own averment, his evaluation of the experts pervaded his
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“[i]n accord with Andreuand 42 U.S.C. § 300aa-12(e)(2)(B), the court finds that the special master improperly framed his rejection of [petitioner’s] claim ‘under the rubric of a ‘credibility’ determination’ and thereby sets aside the special master’s findings as legal
error.””‘
III. The Effects of the Incorrect Application of Standards and Precedent
Special masters recently drifted from using established precedent and documented congressional intent, heightening the burden on petitioners in the Vaccine Program.112 If this trend continues, the ramifications will extend beyond simply making compensation in the Vaccine Program more difficult and could jeopardize the very foundation of the Vaccine Program itself.113 The above-mentioned cases may have deeper ramifications, for example, an increase in costly appeals. This section will discuss concerns regarding the effect on the appellate process, as the appellate courts have overturned several cases decided by special masters.114 This section will also address a competing policy concern.
A. Effect on the Appellate Process
One of the goals of the Vaccine Program as stated by Congress in its
establishment was to compensate petitioners injured by enumerated vaccines.”5 analysis of the remaining factors under Althen.
Id.
111 Id. at 384 (citingAndreu, 569 F.3d at 1379 (citation omitted); Rotoli, 89 Fed.Cl. at 81-82). The special master’s ruling was vacated and remanded. Campbell,90Fed. Cl. at 388.
112 See Rotoli v. Sec’y of Health and Human Servs.,89 Fed.Cl. 71, 82 (Fed. Cl. 2009) (noting special master’s decisions in these cases were “arbitrary and capricious”).
113 See Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1367 (Fed. Cit. 2001).If the courts are pushing petitioners out of programs by denying compensation based on a narrow determination of what “manifestation of onset” means, petitioners may then move into tort litigation to be compensated, defeating the purpose of the Vaccine Program. See H.R. REP. No. 100-391(I) (1987), reprintedin1987 U.S.C.C.A.N. 2313-1 (noting Congressional intent is to leave state law unaffected); see also 42 U.S.C. § 300aa-22 of the Vaccine Act (explaining state law applies to civil action brought for vaccine-related injury or death).
114 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 82 (Fed. Cl. 2009) (holding special masters’ credibility determination decisions to be arbitrary and capricious); see also Campbell v. Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 383 (Fed. Cl. 2009) (holding special master cloaked applications of an erroneous legal standard by stating it was a credibility determination).
11s See Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1368 (Fed. Cit. 2001). The Federal Circuit Court observed in establishing the Vaccine program. See id. Two specific concerns motivated Congress, one being that Congress was concerned that the traditional tort
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Congress established the Vaccine Injury Compensation Program to compensate individuals “quickly, easily and with . .. generosity.”” 6 Many petitioners who meet the three-prong test set forth in Althen v. Sec ofHealth&Human Servs.”7 and should be compensated are either not getting compensated or their compensation is being postponed.”8 Beyond the negative effect of postponing the compensation of petitioners, failing to compensate petitioners who meet the requirements of Althen will have the effect of increasing the length of time for each case through the appeals process.” 9 This will lead to an increased cost for the government and the Vaccine Program because attorneys’ fees and costs, such as expert witness fees, are awarded by the government as established by the Vaccine Act.120 This costs the government and the vaccine fund more money.121 If a petitioner who satisfies the three-prong test from Althen v. Sec’y of Health &Human Sews. is awarded compensation at the Special Master level, instead of having to appeal his case to the Court of Federal Claims or the Federal Circuit to be compensated, attorneys’ fees would be much less. It is likely an underlying reason that Congress intended for petitioners to be awarded quickly because the Vaccine Program awards attorneys’ fees and costs, which, if the process is not expedited, have the possibility to grow exponentially higher than if the petitioner was awarded
system was inadequate to compensate many who were injured by vaccines. See id.
116 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting
H.R. REP. No. 99-908 (1986)).
“7 See Althen v. Sec’y of Health and Human Serys., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (outlining three-prong test). Petitioners must satisfy by a preponderance of evidence the following: “(1) a medical theory causally connect[s] the vaccination and the injury; (2) a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Id.
118 See supranote68.
119 See U.S. Court of Federal Claims, supra note 6. The Office of Special Masters is established within the U.S. Court of Federal Claims which appoints special masters and to which the special masters’ decisions are appealed. Id. Decisions may be subsequently appealed to the Federal Circuit Court of Appeals, and then to the Supreme Court. Id.
120 See 42 U.S.C § 300aa-15(e) (2006) (outlining attorneys’ fees and costs). “In awarding compensation on a petition filed under section 300aa-1 1 of this title the special master or court shall award as part of such compensation an amount to cover reasonable attorneys’ fees, and other costs incurred in any proceeding on such petition.” Id. Attorneys for petitioners work to establish a case with expert testimony and medical records must wait to be paid; long delays in compensation may cause petitioners to have trouble finding an attorney willing to represent them in a vaccine case. Lisa J. Steel, NaionalChildhoodVacdne Injury CompensadonProgram: Is This The Best We CanDoForOur Children?,63 GEO. WASH. L. REV. 144, 164-65 (1994).
121 The VICP, funded by a $0.75 tax on each vaccination given, is a no fault system designed to compensate the injured while protecting healthcare providers and vaccine manufacturers from lawsuits. Lawyers.com, NaionalInjuryCompensationProgram, http://personal-injury.lawyers.com/ National-Vaccine-Injury-Compensation-Program.htrml (last visited Mar. 31, 2010).
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compensation at the special master level.
B. Competing Policy Concern
Without question, vaccines are an important part of a modern society because they contribute to a healthy and disease free environment.122 In several congressional hearings since the establishment of the Vaccine Program, Congressman Henry Waxman, a primary architect of the Program, continually articulated the importance of vaccines and stated his concern at the prospect of public outcry regarding the risks of adverse reaction from vaccines.123 Congressman Waxman stated “today, we are becoming complacent about our success against infectious diseases. Unlike our parents and grandparents, we aren’t terrorized every year by paralytic polio and whooping cough epidemics. This makes it easier to forget the value of vaccines and to focus on their potential risks.” 24 Congressman Waxman also re-emphasized one of the primary purposes of the Program is to compensate individuals who are entitled to compensation, and if a person is injured after a vaccination and there exists no connection between the
122 See H.R. REP. No. 99-908, 99th Cong. (2nd Sess. 1986).
123 See Vaccines: FindingaBalanceBetweenPublicSafetyandPersonalChoice- HearingonInformationand
Technology Risk vs. Benefits of Vaccinations Before the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999) (statement of Congressman Henry A. Waxman); The NationalInjuryCompensationProgram: Is it Working as CongressIntended?: Before the H. Government Reform Comm., 107th Cong. (Nov. 1, 2001); U.S. Representative Dan Burton (R-IN) Holds Hearing on Mandatory Vaccinations: Hearing on Risks Versus Benefits of Vaccination Programs Before the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999). Congressman Waxman stated:
Vaccines have saved more lives than any other medical intervention in history.. . Thanks to universal immunization, the United States has made tremendous progress against polio, diphtheria, whooping cough, and other diseases ….Without vaccination, American children would be vulnerable to . . . catastrophic epidemics.
Vaccines: Finding a Balance Between Public Safety and Personal Choice- Hearing on Information and Technology Risk vs. Benefits of VaccinationsBefore the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999) (statement of Congressman Henry A. Waxman).
124 Id. Congressman Waxman later emphasized:
I don’t want this country to become lax in the area of vaccinating our kids because I don’t want these diseases to come back and I don’t want people looking at a hearing like this and thinking “Oh, my gosh. More people are hurt than helped … when the child is immunized.”
The NationalInjuryCompensationProgram: Is it Working as Congress Intended?: Before the H. Comm. on Gov’t Reform, 107th Cong. (Nov. 1, 2001). See also U.S. RepresentativeDan Burton (R-IN) Holds HearingonMandatoryVaccinations:HearingonRisksVersusBenefitsofVaccinationProgramsBeforetheH. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999); Lynda Hurst, Vaccine Phobia Runs Deep, Toronto Star, Oct. 30, 2009, http://www.thestar.com/news/article/718829 (highlighting public concerns surrounding vaccinations).
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 99 injury and the vaccine, these are not the individuals that should be compensated under
the Program.125
Chief Special Master Gary Golkiewicz commented on Congressman Waxman’s policy statements at a meeting of the Advisory Commission on Childhood Vaccines.126 Chief Special Master Golkiewicz outlined Congressman Waxman’s statements as two
competing policy objectives: (1) a stated purpose of the Program-promoting receipt and production of vaccines by protecting manufacturers from liability and compensating individuals who have sustained a vaccine-related injury, and (2) “protecting the integrity of vaccines .. . that vaccine does not cause every injury that follows immunization.” 27 Chief Special Master Golkiewicz stated that there is a tension between these two policy objectives, which significantly affects the outcomes of cases in the vaccine program.128
As demonstrated previously, several Federal Circuit opinions overturned some decisions of special masters and compensated individuals who were not compensated at the special master level.129 Chief Special Master Golkiewicz explained that recent Federal Circuit decisions set a standard that leans more toward providing for compensation, which reduces the pool of potential cases against vaccine manufacturers
125 Congressman Waxman stated:
The purpose of the program was not to replace the tort system with a[n] adversarial litigious framework, but to move to a more reasoned source for resolving the claim and getting people compensated who were entitled to be compensated. Now, there is the question: are injuries the people suffered related to the vaccine? Because if you have people come forward and say, well, I had a vaccination and then I had some terrible result, but you can’t show that it was related to the vaccine, that’s not the purpose of the vaccine compensation system, to award people money if there is no connection between the two.
The National Injug Compensation Program: Is it Working as Congress Intended?: Before the H. Comm. on Gov’t Reform, 107th Cong. (Nov. 1, 2001). See also U.S. Representative Dan Burton (R-IN) Holds HearingonMandatoU Vaccinations: Hearingon Risks Versus Benefits of Vaccination ProgramsBefore the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999).
126 Transcript, Advisory Commission on Childhood Vaccines Meeting, March 6-7, 2008, U.S.
Department of Health and Human Services, National Vaccine Injury Compensation Program, available at http://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm (last visited Mar. 31, 2010).
127 See id. In outlining these objectives, Chief Special Master Golkiewiczstated”I am not taking issues or pointing fingers.” Id.
128 See id. Golkiewicz stated that the competing policy concerns create “a tension that affects dramatically the litigation of the cases, the parties’ arguments and ultimately who wins.” Id.
129 See, e.g., Rotok, 89 Fed. Cl. 71; Andreu, 569 F.3d 1367; Capijano,440F.3d 1317; Althen, 418 F.3d 1274.
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in congruence with the policy objective demonstrated by the purpose of the Vaccine Program.130 Chief Special Master Golkiewicz then explained that proponents of the competing policy concern of protecting the integrity of vaccines would likely believe that
recent Federal Circuit opinions compensating individuals were incorrectly decided.131 IV. Wilkerson v. Sec’yofHealth&Human Servs.:132 First Symptom or
Manifestation of Onset
A case must be filed within thirty-six months from the first symptom or manifestation of onset to be timely filed in the Vaccine Program.’3 3 Wilkerson v. Secy of Health &Human Servs.,a case regarding the issue of what constitutes the first symptom or manifestation of onset, was appealed to the Federal Circuit after the special master dismissed the case as untimely, and the Court of Federal Claims denied the petitioner’s motion for review.134 The Federal Circuit upheld the special master’s decision to deny the petition based on timeliness.’35 In this case, the petitioner alleged that several
130 Transcript, Advisory Commission on Childhood Vaccines Meeting, March 6-7, 2008, U.S. Department of Health and Human Services, National Vaccine Injury Compensation Program, available at http://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm (last visited Mar. 31, 2010) (explaining by setting a standard where more cases are compensated, Federal Circuit reduces pool of potential cases “seeking redress against the manufacturer or administrator”).
131 Transcript, Advisory Commission on Childhood Vaccines Meeting, March 6-7, 2008, U.S. Department of Health and Human Services, National Vaccine Injury Compensation Program, availableathttp://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm. Chief Special Master Golkiewicz stated, “I … think it is fair to say advocates of policy protected vaccines believe the Federal Circuit opinions are incorrect.” Id.
132 ’33
Wilkerson, 593 F.3d 1343 (Fed. Cir. 2010). See 42 U.S.C. § 300aa- 16(a)(2) (2006).
If a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation
of such injury.
Id.
13 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343 (Fed. Cir. 2010); Wilkerson
v. Sec’y of Health &Human Servs., No. 05-232V, 2009 WL 1583527 (Fed. Cl. 2009); Wilkerson v. Sec’y of HHS, No. 05-232V, 2008 WL 4636329 (Fed. Cl. Spec. Mstr. Sept. 30, 2008). The Federal Circuit rendered a decision on January 27, 2010, upholding the special master’s decision and denying the petition based on timeliness. A similar case now pending before the Federal Circuit involves the same issue of law, specifically the proper interpretation of 42 U.S.C. 5 300aa-
16(a)(2).Cloer v. Sec’y of Health &Human Servs.,85 Fed. Cl. 141 (Fed. Cl. 2008), appealdocketed, (Fed. Cir. 2009) (No. 05-1002; renumbered No. 2009-5052).
13 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343 (Fed. Cir. 2010).
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 101
mercury-containing vaccines caused him to suffer mercury toxicity and attention deficit hyperactive disorder (“ADHD”).136 Both parties submitted a physician’s expert report addressing the date of onset of petitioner’s ADHD symptoms; both medical experts agreed that, more probably than not, petitioner’s symptoms first appeared on or before
November 3, 2001.137
The court denied the petitioner compensation because the petitioner filed on February 17, 2005, more than thirty-six months from the first symptom of petitioner’s injury on November 3, 2001.138 Petitioner argued that petitioner’s injury, ADHD, is a condition that requires a manifestation of onset event to trigger the statute of limitations and that its first symptom is not sufficient.139 The Federal Circuit, following Markovich v. Secjy of Health &Human Sews.,140 held that first symptom or manifestation of onset of injury means that either a symptom or a manifestation of onset can trigger the running of the statute, whichever is first.’41 Markovichstated that the manifestation of onset is the first event objectively recognizable as a sign of a vaccine injury by the medical
136 See id. Petitioner received his first vaccination on his day of birth (May 30, 1997) and, by September 1998, received multiple vaccinations. Id. By the end of 1999, petitioner began
misbehaving. Id. At preschool, in 2001, petitioner had difficulty playing well with other children, disturbed class, and hurt classmates. By 2003, a physician treating [petitioner] suspected that he may have ADHD and referred him to a clinic for testing. Wilkerson, 593 F.3d at 1343-44.A licensed clinical social worker concluded that he “clearly” met the diagnostic criteria for the disorder. Id.at 1343. A pediatrician corroborated this diagnosis in January 2004. Id.
137 See Wilkerson, 593 F.3d at 1344.
138 See id. The special master, Court of Federal Claims, and the Federal Circuit determined that the phrase “manifestation of onset” refers to when the onset manifested itself retrospectively to the current medical community. Id.
139 See id.at 1345 (noting petitioner argued, while symptoms began by 2001, injury was not recognizable to contemporaneous medical community until later). See generally Setnes ex relSetnes v. U.S., 57 Fed. Cl. 175 (Fed. Cl. 2003).Addressing 42 U.S.C. § 300aa-16(a)(2) (2006), the Court of Federal Claims has held:
A statute is to be construed in a manner that gives meaning and effect to all its terms . . . .Under respondents interpretation, there would be no discernable difference between “first symptom” and “manifestation of onset.” The statue, as respondent asks the court to read it, would require that the petition be filed within 36 months of the “occurrence of the first symptom or manifestation of [the first symptom].” Such a construction renders “manifestation of onset’ meaningless and leads to a nonsensical result.
Id.at 180 (citations omitted).
140 Markovich, 477 F.3d at 1360 (Fed. Cir. 2007) (holding “first symptom or ‘manifestation of
onset,’ for the purposes of § 300aa-16(a)(2) is the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large”).
141 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343, 1345 (Fed. Cir. 2010) (quotingMarkovich, 477 F.3d at 1360).
102 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1 profession at large. 142
The Department of Justice (representing the Secretary of Health and Human Services), began to review the medical records of 5,000 autistic petitioners presently participating in the Vaccine Program’s OMNIBUS Autism Proceeding based on the narrow construct 43 of the first symptom or manifestation of onset from Wilkerson and Markovich.144 This review resulted in motions to dismiss the claims of autism petitioners.145
V. Conclusion
A. Effect on Vaccine Program
Decisions of special masters that are incongruent with congressional intent or Federal Circuit precedent may also have a detrimental effect on the Vaccine Program as a whole. By working against the Program’s established legislative purpose of compensating individuals “quickly, easily, and with certainty and generosity,”l46 special
142 See Markovich, 477 F.3d at 1460 (explaining use of the words “first” and “or” require statute of limitations commence with whichever event occurs first).
143 See Markovich, 477 F.3d at 1360.
The Vaccine Act’s statute of limitations must be strictly and narrowly construed because it is “a condition on the waiver of sovereign immunity by the United States, and courts should be careful not to interpret [a waiver] in a manner that would extend the waiver beyond that which Congress intended.”
Id.
44 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343 (Fed. Cir. 2010); Markovich
v. Sec’y of Health &Human Servs.,477 F.3d 1353 (Fed. Cir. 2007).
14 These cases will have “timeliness” hearings to elicit fact witness testimony, expert testimony, or both. See Brief of Petitioner-Appellant at n.14, Wilkerson v. Sec’y of Health &Human Servs., No. 2009-5090, 2009 WL 2610095 (Fed. Cir. Aug. 3, 2009) (listing following cases: Small v. Sec’y of Health &Human Servs., No. 02-1616V; Killiam v. Sec’y of Health &Human Servs., No. 02- 1735V; Manco v. Sec’y of Health &Human Servs., No. 02-1961V; Chistoffer v. Sec’y of Health &Human Servs., 03-398V; Hunter v. Sec’y of Health &Human Servs., No. 07-717V; Wagner v. Sec’y of Health &Human Servs., No. 03-378V; Sherman v. Sec’y of Health &Human Servs., No. 07-289V; Hokkanen v. Sec’y of Health &Human Servs., No. 03-1753; Nuttal v. Sec’y of Health &Human Servs., No. 07-810V). Prior to Markovich, the U.S. Court of Federal Claims issued a decision in Setnes, 57 Fed. Cl. 175. In Setnes, the court ruled that the words “manifestation of onset” have distinct meaning. Id. In that case, the court recognized that some illnesses, like autism, have an insidious onset, and for the purposes of the statute of limitations, the manifestation of onset is when the illness becomes “evident.” Id. at 180.
146 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting H.R. REP. No. 99-908 (1986)); Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1368 (Fed. Cir. 2001) (outlining congressional intent in creating program).
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 103
masters rendered decisions in certain cases that are inconsistent with the stated congressional intent.147 By dismissing Federal Circuit precedent, establishing higher burdens for petitioners, and narrowly interpreting the Act, special masters are making decisions in certain cases that conflict with the purpose of the Vaccine Program. 148
There are also potential economic concerns for the Program when special masters deny deserving petitioners compensation in certain cases. By denying requisite compensation at the special master level, the special masters are effectively costing the Vaccine Program more money in attorneys’ fees and costs, as well as the cost of the
appellate process.
B. Effect on Petitioners
Consumers injured from vaccines have a statutory right to be compensated for their losses.149 By denying compensation for claims that satisfy the three-prong Althen test, petitioners continue to wait for compensation to take care of medical bills, lifestyle changes (such as necessary physical, occupational, and speech therapy), or expenses related to death injuries. Petitioners are waiting longer to be compensated, if at all, and experience a longer, more stressful, and litigious process than the legislatively directed “quick” and “generous” process.150
147 The Vaccine Injury Compensation Program benefits consumers, parties injured from vaccines, as well as the vaccine companies, as it was established in an effort to stabilize U.S. vaccine supplies while also preserving vaccine companies’ assets for research into safer vaccines. Lawyers.com, supra note 121. See also Brice, 240 F.3d at 1368.
148 See Shyface, 165 F.3d at 1351 (quoting H.R. REP. No. 99-908 (1986)). The Federal Circuit Court observed that Congress established the vaccine program to encourage vaccine companies to remain in the market and to adequately compensate many who were injured from vaccines. Brice, 240 F.3d at 1368.
149 National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-1-300aa-34 (1986) (establishing program where petitioners are granted compensation for injury resulting from administration of vaccines covered under Act).
15 See, e.g., Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 82 (Fed. Cl. 2009) (holding special master’s decisions to be “arbitrary and capricious”); Campbell v. Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 384 (Fed. Cl. 2009) (holding special master cloaked applications of erroneous legal standard by stating it was a credibility determination). Petitioners in these cases were forced to wait for the Federal Circuit decision’s appeal process to obtain compensation for their injuries, despite Congressional intent that compensation be quick. See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting H.R. REP. No. 99-908, at 3).
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Further, many of the petitioners were mandated to receive these vaccines, such as childhood vaccines before entering school or vaccines before employment at certain facilities, or have voluntarily received vaccines in an attempt to protect themselves and others from the spread of disease, an action that Congressman Waxman iterates as paramount to public health. When individuals are injured from a vaccine, the federal statute outlines that they should be promptly and adequately compensated for their injuries.1st Also, many of these petitioners are parents of children who either continue to experience severe problems or who have died from vaccine complications.152 Denying compensation and forcing petitioners to continue in the appeals process for compensation subjects these individuals and their families to more adversity and litigation than necessary, certainly more than the Vaccine Program intended.153
Finally, because petitioners’ attorneys’ fees and costs are awarded through the Vaccine Program, postponing compensation could also lead to an inability for firms representing these petitioners to stay in business.1 54 Unlike many other law firms, those that handle cases in the Vaccine Program do not secure a retainer prior to working on the case and must themselves pay the necessary expenses for the collection of medical records or filing fees because fees are generally awarded post-litigation, with the exception of interim fees.155
‘ See 42 U.S.C. §§ 300aa-1-300aa-34 (2006) (establishing National Injury Compensation Program, where petitioners are granted compensation for injury resulting from administration of vaccines covered under the Act). The Federal Circuit Court observed that “Congress established
the [vaccine program] … to provide compensation for vaccine-related injuries and death.” Brice, 240 F.3d at 1368.
152 See Wilkerson v. Sec’y Health &Human Servs.,593 F.3d 1343, 1343 (Fed. Cir. 2010) (noting appellant parent); Cloer v. Sec’y of Health &Human Servs., 85 Fed. Cl. 141 (Fed. Cl. 2008), appealdocketed, No. 2009-5052 (Fed. Cir. 2009).
153 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (confirming Congress established Vaccine Injury Compensation Program to compensate individuals “quickly, easily, and with certainty and generosity”).
15 See 42 U.S.C § 300aa-15(e) (2006) (outlining attorneys’ fees and costs). “In awarding compensation on a petition filed under section 300aa-1 1 of this title the special master or court shall award as part of such compensation an amount to cover reasonable attorneys’ fees, and other costs incurred in any proceeding on such petition.” Id.
155 See 42 U.S.C § 300aa-15(e) (stating “[i]n awarding compensation on a petition filed under section 300aa-1 1 of this title the special master or court shall award as part of such compensation an amount to cover reasonable attorneys’ fees . . . .”); Christopher J. Rodgers, A Pimer on the National Vaccine Injury Compensation Program, 21 UTAH B. J. 25, 27 (2008) (noting discovery is completed before petition is filed with court requiring petitioner’s attorneys to obtain and submit complete medical records of injured party by time petition is filed).
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 105 C. Public Health Concern
If petitioners cannot seek legal remedy in the Program, they may be able to bring a tort claim against vaccine manufacturers because statutes of limitation are tolled for minors at the state level.’56 Congress established the Vaccine Program to make awards to “vaccine-injured persons quickly, easily and with certainty and generosity.”‘ 57 The primary goal of the Act was to limit lawsuits against vaccine manufacturers and Congress believed this would best be accomplished by directing potential lawsuits into a generous forum: the Vaccine Program.158
If courts continue to narrowly interpret first symptom or manifestation of onset, it may have the effect of pushing petitioners out of the Vaccine Program, giving petitioners the opportunity to sue vaccine companies.’59 This could pose a risk to consumers, as it did prior to the establishment of the Vaccine Program, when vaccine
156 See Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1372-74 (Fed. Cir. 2001) (discussing limitation period). The Federal Circuit observed, “[w]e need not decide in this case whether a petitioner who fails to file a timely petition under the Program may still pursue traditional tort remedies.” Id. at 1368.However, this determination is both relevant and important; all fifty states toll statues of limitations for minors and for brain-damaged individuals. See John H. Derrick, Tolling of Statute of Limitations, on Account of Minority of Injured Child, as Applicable to Parent’s or Guardian’sRight of Action Arising Out of Same Injut, 49 A.L.R.4th 216, § 2 (1986). Congress noted “[i]t is not the Committee’s intention to preclude court actions under applicable law. The Committee’s intent . . . is to leave otherwise applicable law unaffected, except as expressly altered by the Act.” H.R. REP. NO. 100-391(I) (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1.Further, the Vaccine Act does not provide that untimely petitioners in the Program forfeit all rights to civil litigation, as it expressly states that unless otherwise provided, “[s]tate law shall apply to a civil action brought for a vaccine-related injury or death.” 42 U.S.C. § 300aa-22(a).
1s7 See Andrews v. Sec’y of Health &Human Servs.,33 Fed. Cl. 767 (Fed. Cl. 1995).
The Vaccine Injury Compensation Program was designed to replace the state law civil tort system with a simple, fair and expeditious means for compensating vaccine injured persons. The [P]rogram was established to make awards to “vaccine-injured persons quickly, easily and with certainty and generosity.” H.R. REP. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6344. The intent to be generous is demonstrated in Congress’ recognition and acceptance of the fact that persons might be compensated under the act for illnesses that are not vaccine related. H.R. REP. No. 908 at 18, reprinted in
1986 U.S.C.C.A.N. at 6359.Id.at 770-71.
158 See id. See generaly42 U.S.C. 5§ 300aa-1-300aa-34 (2006).
159 See 42 U.S.C. §300aa-22(a) (asserting state law shall apply to civil action brought for vaccine- related injury or death); see also Derrick,supranote 156 (explaining statutes of limitations are tolled for minors at state level).
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manufacturers were faced with tort litigation from persons injured by vaccines.160 If vaccine manufacturers again have suits brought against them, their incentives to make vaccines and to create new vaccines would be hindered, which could lead to a vaccine shortage.161 The Vaccine Program was established in an effort to protect vaccine manufacturers, in turn, protecting the nation’s vaccine supply and the health of the American public from infectious disease. If petitioners are pushed out of the Program and bring suit against vaccine manufacturers, vaccine supplies and public health may once again be jeopardized.
Undoubtedly, vaccines play an important role in modem society; their benefits are ample, and their positive effects are widespread. The introduction and extensive use of vaccines has resulted in a dramatic decline in the United States in the morbidity, disability, and mortality rates caused by a variety of infectious diseases, including diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B virus, small pox and varicella.162 Prevalent use of vaccines in the United States eliminated or nearly eliminated infectious diseases that were once terrifying household names. 163 However, vaccines can have detrimental effects, as “a small but significant number [of vaccinated persons] have been gravely injured.”16” The federal government has addressed this with the establishment of the no-fault program to compensate petitioners who have been
injured from vaccinations: The National Vaccine Injury Compensation Program.
In establishing the Vaccine Program, Congress outlined the purpose and reasoning, and early cases paved the way for precedent that compensated those who had been injured from vaccinations. Special masters recently strayed from established
160 See National Injury Compensation Program,supra note 121 (noting prior to the Vaccine Program the rising number of lawsuits filed against healthcare providers and vaccine manufacturers based on injuries and deaths attributed to vaccines caused a number of vaccine manufacturers to discontinue manufacturing vaccines).
161 See National Injury Compensation Program, supra note 121. Congress responded by passing the National Childhood Vaccine Injury Act of 1986, aimed at stabilizing U.S. vaccine supplies
while also preserving vaccine companies’ assets for research into safer vaccines. Id.
162 Fangjun Zhou et al., Economic Evaluation ofthe 7-Vaccine Routine ChildhoodImmuniZation Schedule in the UnitedStates,2001, 159 ARCHIVES OF PEDIATRICS &ADOLESCENT MED. 1136, 1136 (2005).
163 National Institute of Allergy and Infectious Diseases, Vaccines, http://www3.niaid.nih.gov/ topics/vaccines/understanding/vaccineBenefits.htm (last visited Mar. 31, 2010).
164 H.R. REP. No. 99-908, at 4 (1986).Between 2001 and 2005, over 330,000 VAERS reports were filed. See Vaccine Adverse Event Reporting System: Reports from March 6, 2001 to March 5, 2005, http://www.vaccineawareness.org/VAERS/2001-2005 (last visited Mar. 31, 2010). About 85% of vaccine adverse event reports concern relatively minor events, such as ordinary fevers or redness and swelling at the injection site; the remaining 15% describe serious events such as seizures, high fevers, life threatening illnesses or deaths. Id.
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purpose and precedent and heightened the burden on petitioners, making it more difficult to be compensated for an injury caused from a vaccine. These effects have the propensity not only to further injure legitimate petitioners but also to undermine the Vaccine Program itself.

JournalofHealth&Biomedical Law, Vol. VI (2010): 79-107 0 2010Journalof Health &Biomedical Law Suffolk University Law School
Special Masters in the National Vaccine Injury Compensation Program: Placing a Heightened
Burden on Vaccine Program Petitioners by Straying from Precedent and Congressional
Intent
Meredith Daniels*
Vaccinations are an integral aspect of the success of modern public health initiatives and have greatly improved the quality of life and health of American citizens by preventing the spread of disease.’ Vaccinations are so important that all fifty states and the District of Columbia require mandatory immunizations for school attendance. 2 Despite the obvious benefits of vaccinations, the risk of adverse reactions exists. 3
* J.D. Candidate, Suffolk University Law School, 2010; B.A., Brown University, 2007. Ms. Daniels clerked at Conway, Homer &Chin-Caplan, P.C. in 2009-2010. Ms. Daniels may be reached at meredith.k.daniels@gmail.com.
H. R. REP. No. 99-908, at 4 (1986), reprintedin1986 U.S.C.C.A.N. 6344, 6345 (explaining vaccinations are considered “one of the most … effective public health initiatives . . . ever undertaken”). Federal and state immunization programs reduced the number of infections and
deaths from polio, measles, mumps, rubella, diphtheria and smallpox. See Erica A. Little, The Role of Special Masters in Off-Table Vaccination Compensation Cases: Assuring Flexibiity Over Certainty, 16 FED. CIR. B.J. 355, 355 (2007) (stating “[m]any trumpet childhood immunizations as one of the most successful public health efforts in the United States”).
2 See Randall B. Keiser, Doa Vu All OverAgain? The NationalChildhood Vaccine Injury Compensation Act of 1986, 47 FOOD & DRUG L.J. 15, 15 (1992) (explaining most states require immunizations for diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio for children in grade levels kindergarten through twelfth grade); see also SUBCOMM. ON HEALTH AND THE ENv’TOF THE HOUSE COMM. ON ENERGY AND COMMERCE, 99th Cong., 2d Sess., REPORT ON CHILDHOOD
IMMUNIZATIONS 1 (Comm. Print 1986).
3 H.R. REP. No. 99-908.Congress recognized that “[w]hile most of the Nation’s children enjoy
greater benefit from immunization programs, a small but significant number have been gravely injured.” Id. at 4. In referencing House Reports, Congress is attributed because: 1) the Federal Circuit, the interpreter of the laws of the Vaccine Program, references Congress when citing to the same House Reports, and 2) Congress adopted the House Report as part of its legislative history when the Vaccine Act was passed. Between 2001 and 2005, over 330,000 Vaccine Adverse Event Reporting System (“VAERS”) reports were filed. See Illinois Vaccine Awareness
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Congress established the Vaccine Injury Compensation Program4 to compensate individuals injured from the administration of vaccinations “quickly, easily, and with certainty and generosity.”5 To achieve this goal, instead of bringing suit against vaccine manufacturers, a petitioner must move his case through the Vaccine Program, which allows petitioners compensation without comprehensive tort litigation.6 The federal
Coalition, Vaccine Adverse Event Reporting System: Reportsfrom March 6, 2001 to March 5, 2005, http://www.vaccineawareness.org/VAERS/2001-2005. About 85% of vaccine adverse event reports concern relatively minor events, such as ordinary fevers or redness and swelling at the injection site; the remaining 15% describe serious events such as seizures, high fevers, life threatening illnesses or deaths. Id. Between 2001 and 2005, 1,017 cases were adjudicated in the Vaccine Program and 364 petitioners were compensated. National Vaccine Injury Compensation Program Statistics Report (Jan. 20, 2010), http://www.hrsa.gov/Vaccinecompensation/ Docs/StatisticsReport.pdf.
4 National Childhood Vaccine Injury Act, 42 U.S.C. 5§300aa-1-300aa-34 (1986) (establishing Vaccine Injury Compensation Program). For convenience, future references will be to the
“Vaccine Act,” the “Program,” or the “Vaccine Program.”
sShyface v. Sec’y of Health &Human Servs., 165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting H.R. REP. No. 99-908, at 3). The Federal Circuit Court observed in Brice v. Sec’yofHealth&Human Servs.:
In establishing the Vaccine Program, two concerns motivated Congress. First, it was concerned that tort liability would make production of vaccines economically unattractive, potentially discouraging vaccine manufacturers from remaining in the market. See H.R. REP. No. 99-908, at 6-7 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6347-48. Congress thus included in the Act certain federal modifications of state tort law, including limits on punitive damage awards and a rule that a vaccine manufacturer shall not be held liable in post-Act cases if an injury resulted from unavoidable side effects provided the vaccine was properly prepared and accompanied by proper directions and warnings. See 42 U.S.C. §§ 300aa-22(b)(1), 300aa-23(d). Second, Congress was concerned that the traditional tort system was inadequate to compensate many who were injured by vaccines.
240 F.3d 1367, 1368 (Fed. Cir. 2001). Since the establishment of the Vaccine Program, 7,387 cases have been adjudicated; of those, 2,404 petitioners have been compensated for their injuries. National Vaccine Injury Compensation Program, Claims Filed and Compensated or Dismissed by Vaccine (Nov. 3, 2009), http://www.hrsa.gov/Vaccinecompensation/Docs/ClaimsFiled CompenDismiss.pdf.
6 Knudsen ex relKnudsen v. Sec’y of Health &Human Servs.,35 F.3d 543, 549 (Fed. Cir. 1994); U.S. Court of Federal Claims, Vaccine Program/Office of Special Masters, http://www.uscfc.uscourts.gov/vaccine-programoffice-special-masters (last visited Mar. 31, 2010). All vaccine claims are managed and adjudicated by the congressionally created Office of Special Masters, which currently consists of one chief special master and seven associate special masters who are appointed to serve for four-year terms. Id. The Office of Special Masters is established within the U.S. Court of Federal Claims, which appoints special masters and to which the special masters’ decisions are appealed. Id. Decisions may subsequently be appealed to the Federal Circuit Court of Appeals and then to the United States Supreme Court. Id.
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statute, 42 U.S.C. §§ 300aa-1-300aa-34, the documented congressional intent for the Program, and the Federal Circuit case law provides the means of interpretation that should prevail in a vaccine claim.
Recently, special masters in the U.S. Court of Federal Claims applied standards in conflict with congressional intent and Federal Circuit case law, acting as a barrier for petitioners to receive compensation. Instead of using the standards set forth in the Vaccine Program, special masters are heightening the burden for petitioners by imposing more standards for causation than required by statute and case law and questioning the credibility of petitioners’ expert witnesses against precedent.7 The heightened standards in these cases may have severe ramifications, such as an increase in costs due to more appeals, as well as more cases potentially moving out of the Vaccine Program, which increase the number of lawsuits against vaccine manufacturers, in direct opposition to the original purpose of the Vaccine Program.8
Part I of this note will examine the established precedent of the Vaccine Program through congressional intent, the federal statute, and case law, as well as outline the process by which cases move through the vaccine program. Because the Vaccine Program is relatively new, case law from the Federal Circuit within the past decade will specifically be explored. Part II will observe recent cases in which special masters have failed to apply these established standards and precedent. Part III will explore the effects of the incorrect application of standards and precedent. Part IV will examine Wilkerson v. Sec) of Health &Human Servs.9 Finally, Part V will discuss legal, policy, and
7See, e.g., Hager v. Sec’y of Health &Human Servs., No. 01-307V, 2008 WL 4763736 (Fed. Cl. Spec. Mstr. Oct. 15, 2008) (imposing standards for expert witnesses in direct conflict with Federal Circuit precedent); Rotoli v. Sec’y of Health &Human Servs., No. 99-644V, 2008 WL 4483739 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Myers v. Sec’y of Health &Human Servs., No. 99-631V, 2008 WL 4483747 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Torbett v. Sec’y of Health &Human Servs., No. 99-660V, 2008 WL 4483738 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Porter v. Sec’y of Health &Human Servs., No. 99-639V, 2008 WL 4483740 (Fed. Cl. Spec. Mstr. Oct. 2, 2008). SeegeneralyLampe v. Sec’y of Health &Human Servs.,219 F.3d 1357, 1373-74 (Fed. Cir. 2000) (noting when a highly qualified expert presents a biologically plausible theory linking an injury to a vaccine, the issue should not be one of credibility).
8See H.R. REP. No. 99-908, at 6-7 (noting Vaccine Program was established to compensate individuals who injured from vaccinations, as well as protect vaccine manufacturers from liability). Before a lawsuit may be filed against a vaccine manufacturer, federal law requires the submission of a claim under the National Vaccine Injury Compensation Program. ChristopherJ. Rogers, A Primeron the NationalVaccine Injury CompensationPgram,21UTAH B.J. 25, 25 (2008); 42 U.S.C. § 300aa-12 (2006) (stating petitioners who are not compensated within the Program may file traditional tort litigation suit against vaccine manufacturers).
9 593 F.3d 1343 (Fed. Cir. 2010).
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consumer concerns with recent actions of the special masters. This section will also survey the potential long-term ramifications of the recent actions of the special masters in certain cases and how they may have a detrimental effect on the Vaccine Program as a
whole.
I. Purpose, Reasoning, and Precedent of the National Vaccine Injury Compensation Program
A. Congressional Intent
Two concerns motivated Congress in establishing the Vaccine Program. First, Congress was concerned that tort liability would make production of vaccines economically unattractive, potentially discouraging vaccine manufacturers from remaining in the market.10 Second, Congress was concerned that the traditional tort system was inadequate to compensate many who were injured by vaccines.” Congress’s principal findings that required the establishment of the Vaccine Program were as follows:
1) The availability and use of vaccine to prevent childhood diseases is among the Nation’s top public health priorities;
2) The Federal government has the responsibility to ensure that all children in need of immunization have access to them and to ensure that all children who are injured by vaccine have access to sufficient compensation for their injuries; and
10Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1368 (Fed. Cir. 2001). Congress included in the Act certain federal modifications of state tort law, including limits on punitive damage awards and a rule that a vaccine manufacturer shall not be held liable in post-Act cases if an injury resulted from unavoidable side effects provided the vaccine was properly prepared and accompanied by proper directions and warnings. Id. Between 1980 and 1986, individuals brought damages claims totaling $3.5 billion; as a result of liability concerns, many pharmaceutical .companies stopped producing and distributing vaccines. Katherine E. Strong, Note, Proving Causation Under the Vaccine Injury Act A New ApproachbforA New Day, 75 GEO. WASH. L. REV. 426, 434 (2007) (stating by 1985 only four manufacturers were still producing mandated vaccines).
” Brice, 240 F.3d at 1368. Upon enacting the Vaccine Act, Congress recognized that “[w]hile most of the Nation’s children enjoy greater benefit from immunization programs, a small but
significant number have been gravely injured.” H.R. REP. No. 99-908, at 4.
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 83 3) Private or non-governmental activities have proven inadequate in
achieving either of these goals.12
Thus, the Vaccine Program was established for two purposes: (1) to protect the Nation’s vaccine supply and encourage the developments of new and safer vaccines,13 and (2) to compensate persons injured by vaccineS.14
Congress stated two overriding concerns that led to the development of this legislation: (1) the inadequacy of the current approach to compensating those injured by vaccines, and (2) the instability and unpredictability of the vaccine market.15 Congress hoped the Vaccine Program would reduce the number of lawsuits against vaccine manufacturers, while simultaneously promoting the “development of new and improved vaccines.”16 Congress stated that awards “can be made to vaccine injured persons quickly, easily, and with certainty and generosity.”‘ 7
B. The Process
All vaccine claims are managed and adjudicated by the congressionally created Office of Special Masters, which currently consists of one Chief Special Master and seven Associate Special Masters who are appointed by the U.S. Court of Federal Claims to serve for four-year terms.’ 8 The U.S. Court of Federal Claims hears appeals from the special masters’ decisions.’ 9 Special masters make the initial decision for compensation
12 H.R. REP. No. 99-908, at 5 (1986).
13 Since the Vaccine Program was established in 1988, the following vaccines have been developed and added to the Vaccine Table: hepatitis B vaccine (“hep B”), baemophilusinfluenzae
typeb vaccine (“Hib”), varicella vaccine, rotavirus vaccine, pneumococcal conjugate vaccines, hepatitis A vaccine, the adult “flu” vaccine, meningococcal vaccine, and the human papillomavirus vaccine. See 42 U.S.C. § 300aa-14 (2006).
14 See Brice, 240 F.3d at 1368; H.R. REP. No. 99-908, at 5 (1986).
‘5 H.R. REP. No. 99-908, at 7 (1986).
16 H.R. REP. No. 99-908, at 4. Congress also hoped the Vaccine Program would help create “a new system for compensating individuals who have been injured by immunizations routinely administered.” Id. at 3.
17 H.R. REP. No. 99-908, at 18.Congress intended that the Vaccine Program provide individuals a swift, flexible, and less adversarial alternative to the often costly and lengthy traditional tort litigation. See U.S. Court of Federal Claims, Vaccine Program/OfficeofSpecialMasters, http://www. uscfc.uscourts.gov/vaccine-programoffice-special-masters, (last visited Mar. 31, 2010).
18 U.S. Court of Federal Claims, Vaccine Program/Office of Special Masters, http://www.uscfc. uscourts.gov/vaccine-programoffice-special-masters, (last visited Mar. 31, 2010).
19 Id. Special masters actively and frequently interact with the parties (generally counsel representing petitioner and a Department ofJustice attorney representing Secretary of Health and Human Services). Id.
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under the Program.20 After appealing special masters’ decisions to the U.S. Court of Federal Claims, decisions may be subsequently appealed to the Federal Circuit Court of
Appeals and then to the Supreme Court.21
Under the Vaccine Act, when reviewing a decision of a special master on a motion for review, the Court of Federal Claims has jurisdiction to “undertake a review of the record of the proceedings.”2 The court may take any of the following actions: (1) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (2) set aside any findings of fact or conclusions of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law and issue its own findings of fact and conclusions of law, or (3) remand the petition to the special master for further action in accordance with the court’s direction. 23 The Vaccine Act requires the Court of Federal Claims to analyze conclusions of law made by a special master to determine whether they are in accordance with law and may set aside factual findings by a special master if they find them to be arbitrary or capricious or if a special master has abused his or her discretion in making such findings.24 Prior to 1989, the appellate courts in the Vaccine Program had the option of either “adopt[ing] the findings of the special master as [their] own judgment, or mak[ing] a de novo determination of any matter and issu[ing] judgment accordingly.”25 Congress amended the statute in 1989, eliminating the ability of U.S. Court of Federal Claims to conduct a de novo review of the special master’s decision. 26
20 Conway, Homer and Chin-Caplan, P.C., VaccineProgram: The Process,www.ccandh.com/vl.asp, (last visited on Mar. 31, 2010). Compensation that may be awarded for a vaccine-related injury include: reasonable compensation for past and future medical care, custodial care and rehabilitation costs, a $250,000 cap for actual and projected pain and suffering and emotional distress, lost earnings, and reasonable attorneys’ fees and costs. Id.
21 U.S. Court of Federal Claims, Vaccine Program/Ofice of Spedal Masters, http://www.uscfc. uscourts.gov/vaccine-programoffice-special-masters, (last visited Mar. 31, 2010).
2 42 U.S.C. §300aa-12(e)(2) (2006).See alsoR. FED. CL., Appendix. B, R. 27.
2 42 U.S.C. § 300aa-12(e)(2).
24 See 42 U.S.C. §300aa-12(e). The Federal Circuit has commented that “reversible error is extremely difficult to demonstrate if the special master has considered the relevant evidence of
record, drawn plausible inference and articulated a rational basis for the decision.” Lampe v. Sec’y of Health &Human Servs.,219 F.3d 1357, 1360 (Fed. Cir. 2000) (explaining arbitrary and
capricious standard of review is difficult for appellant to satisfy).
25 Keiser, supra note 2, at 23 (italics added).
26 See Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239, § 6601(h), 103 Stat. 2106, 2289 (codified at 42 U.S.C. § 300aa-12(e) (2006)). The statutory standard of review applicable to the factual findings of a special master in a Vaccine Act case require the Court of Federal Claims to uphold a special master’s findings unless the court concludes that those findings are arbitrary and capricious. See 42 U.S.C. § 300aa-12(e)(2)(B); Saunders v. Sec’y of Health &Human Servs.,25 F.3d 1031, 1033 (Fed. Cir. 1994); Munn v. Sec’y of Health &Human
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 85 C. Case and Statutory Law
A petitioner must meet several requirements before bringing a case under the National Childhood Vaccine Injury Act of 1986. The requirements set forth in 42 U.S.C. § 300aa-11, are that a petitioner must: (1) receive the vaccine in the United States,27 (2) be injured from a vaccine listed on the Vaccine Injury Table,28 (3) not previously collected an award or settlement for such vaccine-related injuries,29 and (4) either suffered residual effects of injury for more than six months, died from the administration of the vaccine, or required inpatient hospitalization and surgical intervention. 30 If these requirements are met, a successful petition in the Vaccine Program can be brought in two ways.3′ First, a petitioner may bring a claim if they sustained an injury set forth in a statutorily set Vaccine Injury Table32 with the initial listed symptom occurring within the time period defined in the table.33 A vaccine is the presumed cause of an injury if the petitioner establishes that his or her table injury occurred within the time period set forth in the table.M However, because of the narrowly defined injuries set forth on the Vaccine Injury Table, proving a table injury is difficult.35 As a result, most petitioners in the Vaccine Program bring a petition under the second option, commonly called off-table cases, encompassing injuries not listed on
Servs.,970 F.2d 863, 870 (Fed. Cir. 1992) (noting arbitrary and capricious standard is “well understood to be the most deferential possible”).
27 See 42 U.S.C. §300aa-11(1)(B)(i) (2006).
28 See 42 U.S.C. §300aa-11(1)(A); see also 42 U.S.C. §300aa-14 (2006). The Vaccine Injury Table
groups the vaccines by antigen and outlines the injuries for each of the groups of vaccines, as well as the time frame in which the symptoms appear. Id.
29 See 42 U.S.C. §300aa-11(1)(E).
30 See 42 U.S.C. §300aa-11(1)(D).
31 See 42 U.S.C. §5 300aa-1-300aa-34 (2006).
32 See 42 U.S.C. §300aa-14 (2009).
33 See 42 U.S.C. § 300aa-11(c)(1)(C)(i) (2006). A petitioner may have “sustained, or had significantly aggravated any … injury … set forth in the Vaccine Injury table … and the first symptom . . . of the . . . injury . .. occurred within the time period [defined in the table] after vaccine administration.” Id.
34 See Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (2005) (describing statutory prescription for causation if injury is included as table injury).
35 See U.S. Department of Health and Human Services, Vaccine Table, available at http://www.hrsa.gov/vaccinecompensation/table.htm (last visited Mar. 31, 2010). For example, if a petitioner experienced anaphylactic shock zero to four hours after the administration of a tetanus toxoid-containing vaccine (such as DTaP, Tdap, Td, etc.), causation is presumed. Id. See generally 42 U.S.C. 5 300aa-14 (2006). For example, seizures are not sufficient to satisfy the definition of encephalopathy under § 14, a petitioner must also demonstrate several other symptoms. Id.
JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1 the Vaccine Injury Table.36
Off-table cases must be proven by a preponderance of the evidence.37 To establish by preponderant evidence that a vaccine caused an off table injury, the vaccine must be the “but for” cause of the petitioner’s injury and a substantial factor in bringing about that injury.38 In this regard, the Federal Circuit ruled that the vaccine may be only one of several concurrent causes of the injury.39 It need not be the sole cause or even the predominant cause; rather, it need only be a “substantial factor.”40 In order to be eligible for compensation, a petitioner must file his or her petition with the court within three years from the onset of symptoms.41 The Federal Circuit held that the first symptom or manifestation of onset is the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large.42
Althen v. Sec’yofHealth&Human Servs.states that a petitioner will prevail in an off-table case upon establishing that: “(1) a medical theory causally connect[s] the vaccination and the injury; (2) a logical sequence of cause and effect show[s] that the
36 See 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I) (2006) (explaining petitioner may seek compensation from injury “not set forth in the [table] . . . but which was caused by a vaccine [in the table].. . .”). 37 See 42 U.S.C. § 300aa-13(a)(1)(A) (2006); Althen, 418 F.3d at 1274 (“The purpose of the
Vaccine Act’s preponderance standard is to allow the finding of causation in a filed bereft of complete and direct proof [as to] how vaccine affect the human body”); Bunting v. Sec’y of Health &Human Servs.,931 F.2d 867, 873 (Fed. Cir. 1991) (“The standard of proof required by the Act is simple preponderance of evidence; not scientific certainty . . . . [I]t is not plaintiff’s burden to disprove every possible ground of causation suggested by defendant nor must the
findings of the court meet the standards of the laboratorian”).
38 See Shyface, 165 F.3d at 1352 (discussing necessity of adequate causation).
39 See id. Further, a petitioner may be compensated if the vaccine was shown to have significantly aggravated an underlying condition. See 42 U.S.C. § 300aa-33(4) (2006). The term “significant aggravation” means any change for the worse in a preexisting condition that results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. Id.
40 Shyface, 165 F.3d at 1352-53. A petitioner need not eliminate all possible alternative causes of injury, however, as a practical matter, proof of a “logical sequence of cause and effect” will eliminate potential likely alternatives. Id. at 1353.See also Walther v. Sec’y of Health &Human Servs., 485 F.3d 1146, 1151 (Fed. Cir. 2007).
41 42 U.S.C. § 300aa-16(a)(2) (2006) (stating “if a vaccine injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation . .. for such injury after the expiration of [thirty-six] months after the date of the occurrence of the first symptom or manifestation of onset .. . of such injury”). If the petitioner is deceased, the statute of limitations is twenty-four months from the date of the vaccination. Id.
42 See 42 U.S.C. § 300aa-16(a)(2) (2006); Markovich v. Sec’y of Health &Human Servs.,477 F.3d 1353 (Fed. Cir. 2007) (explaining definition of “manifestation of onset” for purposes of 42 U.S.C. §300aa-16(a)(2) (2006)).
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vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between [the] vaccination and the injury.”43 Each element of this three- prong Althen test can be satisfied by circumstantial evidence consisting of medical records or a medical opinion.44 Further, evidence used to satisfy one prong of the test may overlap to satisfy another prong.45
A petitioner is not required to satisfy any element of the three-prong Althen test with scientific certainty.46 Rather, a petitioner need only demonstrate with circumstantial evidence the existence of causation between the vaccine and the injury.47 In this regard, a differential diagnosis of a treating physician sufficiently meets the reliability standard set forth in Daubert v. Merrell Dow Pharm., Inc.48 and may be used as indirect evidence of causation. 49 In light of the Act’s purpose, scientific and objective confirmation of the biologic mechanism by which the vaccine caused the injury with additional medical documentation to establish a theory of causation to fulfill the first Althen prong is unnecessary.o Requiring scientific certainty to prove the biologic mechanism would thwart the purpose of the Act by requiring “sequence[s] hitherto
43 Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cit. 2005) [hereinafter “Althen test”]. The Althen test was established in response to other tests created and applied by special masters heightening the petitioner’s evidentiary burden. Seegeneraly id.
44 See id.at 1278 (explaining logical sequence of cause and effect can be supported by “reputable medical or scientific explanation” or “evidence in the form of . .. expert medical testimony”).
45 See Capizzano v. Sec’y of Health &Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (holding “[w]e see no reason why evidence used to satisfy one of the Althen … prongs cannot overlap to satisfy another prong”).
4 See Althen, 418 F.3d at 1280.
47 See id.
48 509 U.S. 579, 597 (1993) (holding requirement that expert’s testimony pertain to scientific knowledge establishes standard of evidentiary reliability).
49 See Kelley v. Sec’y of Health &Human Services, 68 Fed. Cl. 84, 90 n.7 (Fed. Cir. 1994). The Federal Circuit also stated:
The assessment of whether a proffered theory of causation is “reputable” can involve assessment of the relevant scientific data. Medical literature and epidemiological evidence must be viewed, however, not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.
Andreuex. rel.Andreuv. Sec’y of Health &Human Servs., 569 F.3d 1367, 1380 (Fed. Cir. 2009). soSee Kelley v. Sec’y of Health &Human Servs., 68 Fed. Cl. 84, 87-88 (Fed. Cl. 2005) (quoting Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278-81 (Fed. Cir. 2005)) (emphasizing requiring proof of biological mechanisms of causation would be inconsistent with purpose and nature of Vaccine Program). Further, “determination of causation in fact under the Vaccine Act involves ascertaining whether a sequence of cause and effect is logical’ and legally probable, not medically or scientifically certain.” Knudsen v. Sec’y of Health &Human Servs.,35 F.3d 543, 548-49 (Fed. Cir. 1994).
88 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1 unproven in medicine”5′ and surpass the preponderance standard demanded by
Congress. 52
When reviewing the record to determine if the Althen test is met, a special master must consider the opinions of treating physicians.53 In this regard, the treating physician offers a medical opinion that is quite probative in establishing a logical sequence of cause and effect.54 The Federal Circuit noted that physicians are in the best position to determine causation; their opinions are presumed to meet a sufficient level of reliability and are thus favored in vaccine cases.15 To remove all doubt, the Federal Circuit reaffirmed the probative value of the opinions of treating physicians in satisfying this prong in Andreu ex. rel.Andreuv. Sec’ ofHealth&HumanServs., stating that “treating physicians are likely in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.”5 6 The opinions of treating physicians contained in medical records can be sufficient to demonstrate a logical sequence of cause and effect between the vaccine and the injury.57 For example, the court noted that a treating physician may rely on the close temporal proximity between a vaccine and an injury in concluding that there is a logical sequence
of cause and effect between a vaccine and injury.58
Finally, in proving a prima facie case, a petitioner need not eliminate all possible alternate causes of injury.59 As a practical matter, however, proof of a “logical sequence
5′ Althen v. Sec’y of Health and Human Servs. 418 F.3d 1274, 1280 (Fed. Cir. 2005). “The standard of proof required by the [Vaccine] Act is simple preponderance of evidence; not scientific certainty . . . .[I]t is not plaintiffs burden to disprove every possible ground of causation suggested by defendant nor must the findings of the court meet the standards of the laboratorian.” Bunting v. Sec’y of Health &Human Servs.,931 F.2d 867, 873 (Fed. Cir. 1991)
(citations and internal quotation marks omitted).
52 See Buning, 931 F.2d at 873. The Federal Circuit consistently recognized the uncertainty of the science relating to vaccine injuries stating, “to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program.” Knudsen, 35 F.3d at 549.
53 See Capizzano v. Sec’y of Health &Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006).
5 Seeid.
5 Seeid.
56 Andreu ex.rel. Andreu v. Sec’y of Health &Human Servs., 569 F.3d 1367, 1375 (Fed. Cir. 2009) (quotingCapiZgano, 440 F.3d at 1326). Further, the Federal Circuit held that conclusive proof is unnecessary and not congruent with the law, stating that the special master had “imposed upon [petitioners] an elevated evidentiary burden requiring them to submit conclusive proof in the medical literature” to show a vaccine caused an injury. See id.at 1375.
57 Seeid.at 1376.
58 See id.
5 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999). In all
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of cause and effect”6o will eliminate potential alternatives.61 In any event, once a petitioner has made a prima facie case, the burden of proof shifts, and the government must prove that the “injury… described in the petition is due to factors unrelated to the. . . vaccine.” 62 In such a case, the government must not merely prove the existence of an alternative cause but that such an alternative actually caused the injury.63 Aspecial master should weigh the evidence contained in the “record as a whole.”M The Federal Circuit held where the evidence is found in equipoise, the court should enter judgment in favor of the petitioner.65
II. Examples of Special Masters’ Incorrect Application of Precedents and Standards
Instead of using the standards 66 set forth in the Vaccine Program, special masters heightened the burden for petitioners by: (1) imposing more standards of causation than required by statute and case law, and (2) questioning the credibility of petitioners’ expert witnesses in certain cases in opposition to established precedent.67
vaccine injuries, genetic susceptibility plays a role. See id. Frequently, non-vaccine environmental factors also contribute to the injury. See id. When concurrent forces cause a single harm, the Federal Circuit has held the burden is on the government to show that the alternative cause is so predominant that the vaccine is insignificant; it must eliminate the vaccine as a substantial contributing factor. See id. Once a petitioner has made a prima facie case, the burden of proof shifts and the government must prove that an alternative cause exists and that it actually caused the injury.See Knudsen ex rel. Knudsen v. Sec’y of Health &Human Servs.,35 F.3d 543, 549 (Fed. Cit. 1994).
60 Walther v. Sec’y of Health &Human Servs., 485 F.3d 1146, 1150 (Fed. Cir. 2007).
61 See id.
62 42 U.S.C. § 300aa-13(a)(1)(B) (2006).The U.S. Department of Justice represents the Secretary of Health and Human Services in all Vaccine Program proceedings.
63 See Knudsen, 35 F.3d at 549. Further, as the Federal Circuit pointed out in Walther, “the petitioner generally has the burden on causation, but when there are multiple independent potential causes, the government has the burden to prove that the covered vaccine did not cause the harm.” 485 F.3d 1146, 1151 (Fed. Cir. 2007).
6 42 U.S.C. §300aa-13(a)(1)(A).
65 See Knudsen, 35 F.3d at 550 (suggesting if evidence establishes equally plausible etiologies for injury then petitioner should prevail).
66 The standards and initiatives as established supra, Congressional intent, 42 U.S.C. §§ 300aa-l- 300aa-34, and the decisions from the U.S. Federal Court of Claims and the U.S. Federal Circuit.
67 See generaly, e.g., Rotoli v. Sec’y of Health &Human Servs., No. 99-644V, 2008 WL 4483739 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Myers v. Sec’y of Health &Human Servs., No. 99-631V, 2008 WL 4483747 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Torbett v. Sec’y of Health &Human Servs., No. 99-660V, 2008 WL 4483738 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Porter v. Sec’y of Health &Human Servs., No. 99-639V, 2008 WL 4483740 (Fed. Cl. Spec. Mstr. Oct. 2, 2008); Hager v. Sec’y of Health &Human Servs., No. 01-307V, 2008 WL 4763736 (Fed. Cl. Spec. Mstr. Oct. 15,
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This section will explore several recent cases where special masters’ decisions have been either appealed by petitioners for incorrectly applying standards or have already been deemed arbitrary and capricious and overturned by the appellate courts. 68
A. Imposing More Standards for Causation than Required by Case Law and Statute
The three-prong test from Althen resulted from a special master’s decision to impose a five-prong test for petitioners to meet in order to receive compensation in the Program.69 The five-prong test required that petitioner provide proof of: “(1) medical plausibility, (2) confirmation of medical plausibility from the medical community and
literature, (3) an injury recognized by the medical plausibility evidence and literature, (4) a medically acceptable temporal relationship between the vaccination and the onset of the alleged injury, and (5) the elimination of other causes.”70 The special master determined that because the petitioner did not provide peer-reviewed literature, she did not qualify for compensation.71 Upon review, the Federal Circuit determined that the application of the five-prong test was contrary to law, stating that both prongs two and three of the test “contravene the plain language of the statute.” 72 The Federal Circuit held that requiring medical literature “impermissibly”73 raised petitioner’s burden and was in direct conflict with the statute’s allowance of medical opinion as proof.74 Finally, the Federal Circuit noted that the role of the special master is “not to craft a new legal standard.”7 5
2008).
68 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 71 (Fed. Cl. 2009);Campbell v.
Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 369 (Fed. Cl. 2009).
69 See Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1274 (2005) (discussing five-
prong test the special master used from Stevens v. Sec’y of Health &Human Servs., No. 99- 594V, 2001 WL 387418 (Fed. Cl. Spec. Mstr. Mar. 30, 2001), and establishing three-prong Althen test).
7 0 Althen, 418 F.3d at 1279 (outlining five-prong test the special master employed).
71 See id. (citing Althen v. Sec’y of Health &Human Servs., No. 00-170V, 2003 WL 21439669, at *14 (Fed. Cl. Spec. Mstr. Jun. 3, 2003)).
72 Id. at 1281.See also 42 U.S.C. § 300aa-12(a)(1) (2006) (stating petitioner must prove causation in fact by “preponderance of the evidence,” substantiated by medical records or medical
opinion).
7 Althen, 418 F.3d at 1280.
74 See id.; see also42 U.S.C. §300aa-13(a)(1).
7 Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005) (explaining role of special master is to “assist the courts by judging the merits of individual claims on a case by case basis”). See also 42 U.S.C. § 300aa-13(a)(1).
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Despite the Federal Circuit’s explanation that special masters are not to construct new legal standards, in CapiZano v. Secy of Health &Human Sen’s.,the special master created a new “disjunctive”7 6 four-prong test for petitioners to meet in order to receive compensation for vaccine-related injuries.77 This new test required that in order to show the second prong of the Althen test, a logical sequence of cause and effect between the injury and the vaccination, a petitioner must show one of the following: (1) epidemiologic studies, (2) rechallenge,78 (3) the presence of pathological markers or genetic disposition, or (4) general acceptance in the scientific or medical community.79 The Federal Circuit determined that the special master’s approach was “inconsistent with allowing ‘the use of circumstantial evidence envisioned by the preponderance standard.”’80 Because the petitioner’s treating physicians repeatedly associated the petitioner’s injury with the vaccine, the Federal Circuit determined that the petitioner fulfilled the requirement of a logical sequence of cause and effect as outlined by 42 U.S.C. §300aa-13(a)(1).81
In Andreu v. SecjyofHealth&HumanSen’s.,the Federal Circuit again found that a special master imposed higher standards for causation on the petitioner than required by statute and case law, stating:
In Althen … we expressly rejected the [five-prong] test, concluding that requiring “objective confirmation” in the medical literature prevents
76 Capizzano v. Sec’y of Health &Human Servs., 440 F.3d 1317, 1322 (Fed. Cir. 2006). 77 Id.
78 When two or more administrations of a vaccine to the same person are followed by the same adverse event, positive rechallenge is said to occur. M. Miles Braun, Vacine Adverse Event Reporting System (VAERS): Usefulness and Limitations, INSTITUTE FOR VACCINE SAFETY, http://www.vaccinesafety.edu/VAERS.htm (last visited Mar. 31, 2010). Positive rechallenge
represents stronger evidence than temporal association of a since adverse event. Id.
79 See Capitzano,440F.3d at 1325.
80 Id. The Federal Circuit went on to state that the new requirements impermissibly raised the
claimant’s burden under the Vaccine Act, and hindered the system created by Congress, “in which close calls regarding causation are resolved in favor of injured claimants.” Id. at 1325-26.
81See Capi-Zano,440F.3d at 1325-26 (stating “medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether ‘a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’ (quoting Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005))); see also 42 U.S.C. § 300aa-13(a)(1) (“The special master or court may not make . . . a finding [of causation] based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion”).
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“the use of circumstantial evidence . . . and negates the system created by Congress” . . . . Here, however, the special master resurrected the defunct [five-prong] test in an effort to discredit [petitioner’s medical expert]’s theory of causation. 82
In Andreau, the Federal Circuit held that the special master erred in requiring proof of confirmation of medical plausibility from the medical community and literature in order to establish causation of the vaccine to the petitioner’s injury.83
B. Incorrect Credibility Determination Of Petitioners’ Expert Witnesses
Special masters also recently questioned the credibility of petitioners’ expert witnesses against established precedent discussed hereinafter; as such, their rulings have been deemed arbitrary and capricious and were overturned by the appellate courts.84 In Rotoli, five petitioners alleged that the hepatitis B vaccine caused them to suffer autoimmune hepatitis.85 The special master for these five petitioners determined that the petitioners’ expert immunologist, who testified on behalf of all five petitioners, was neither credible nor truthful when he testified that vaccine caused these injuries, and dismissed all five petitions.86 On appeal, the Court of Federal Claims determined that
82 Andreuex.rel. Andreu v. Sec’y of Health &Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009) (concluding requiring “objective confirmation” in medical literature prevents “the use of circumstantial evidence … and negate[s] the system created by Congress through the Vaccine Act” (citingAlthen, 418 F.3d at 1280)).
83 See Andreu, 569 F.3d at 1379.
84 See, e.g., Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 81-82, (Fed. Cl. 2009)
(holding special master imposed standards for expert witnesses in direct conflict with Federal Circuit precedent); see alsoAndreu, 569 F.3d at 1379 (noting “special master framed her rejection of [petitioner’s expert’s] theory of causation under the rubric of a ‘credibility’ determination” (citing Andreuex. rel. Andreu v. Sec’y of Health &Human Servs., No. 98-817V, 2008 WL 2517179 at *8)); Campbell v. Sec’y of Health &Human Servs., 90 Fed. Cl. 369, 383 (Fed. Cl. 2009) (finding special master improperly framed his rejection of petitioner’s claim under rubric of expert witness’s credibility determination).
85 Rotoli, 89 Fed. Cl. at 76-77. The petitioners alleged that the hepatitis B vaccine, which they each received in three doses in the 1990s, caused them to suffer autoimmune hepatitis and
associated injuries. Id.
86 See Rotoli v. Sec’y of Health &Human Servs., No. 99-644V, 2008 WL 4483739; Myers v. Sec’y of Health &Human Servs., No. 99-631V, 2008 WL 4483747; Torbett v. Sec’y of Health &Human Servs., No. 99-660V, 2008 WL 4483738; Porter v. Sec’y of Health &Human Servs., No. 99-639V, 2008 WL 4483740; Hager v. Sec’y of Health &Human Servs., No. 01- 307V, 2008 WL 4763736. The special master held joint hearings and, in each case, found by a preponderance of the evidence that the petitioner failed to establish a medical theory causally connecting the hepatitis B vaccine to autoimmune hepatitis. Id. The special master dismissed all five petitions
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“[i]n these five cases, the special master’s analysis of the petitioners’ evidence of causation ran afoul of the Federal Circuit’s standards regarding credibility determinations.”87 The Court of Federal Claims found that the special master erroneously founded the rejection of the petitioners’ theory of causation on an assessment of the petitioners’ expert’s “poor”88 credibility.89 The special master’s discussion of petitioners’ expert’s credibility “permeated”90 his analysis of the petitioners’ claims.91 References to the credibility of petitioners’ expert also pervaded the special master’s analyses of the medical theory proposed by all five petitioners and of the specific evidence of causation in each of the five cases. 92 By couching his rejection of petitioners’ expert’s testimony in terms of credibility, the special master expected his analysis to be “virtually not reviewable on appeal.” 93
and threatened to deny the fees of the petitioners’ expert and their attorneys. Id. He also advised the petitioners to accept his decisions as final and warned the petitioners and their attorneys that special masters’ decisions with respect to findings of credibility were “virtually unreviewable” by
higher courts. Id.
87 Rotoi, 89 Fed.Cl. at 80, No. 99-644V, 2009 WL 2868840, at *5 (2009). The court issued a single, consolidated Opinion and Order for all five cases because of the substantial overlap of the legal and factual issues in each. Id.at 77, 2009 WL 2868840, at *1.
88 Rotoi, No. 99-644V, 2008 WL 4483739, at *7.
89 See Rotoli, No. 99-644V, 2008 WL 4483739, at *7 (noting expert’s retreat from proposed theory is “poor mark on his credibility as an expert”). While considerable deference must be accorded to the credibility determinations of special masters this does not mean that a special master can “cloak the application of an erroneous legal standard in the guise of a credibility determination, and thereby shield it from appellate review.” Andreuex. rel.Andreuv. Sec’y of Health &Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health &Human Servs.,991 F.2d 1570, 1575 (Fed. Cir. 1992). See also Lampe v. Sec’y of Health &Human Servs.,219 F.3d 1357, 1373-74 (Fed. Cir. 2000) (noting when a highly qualified expert presents a biologically plausible theory linking an injury to a vaccine, the issue should not be one of credibility).
90 Id.
91 See id. The special master included a nine-page section (a substantial portion of the total length of his decision) entitled “Additional Comments Regarding [Petitioners’ Expert]” in which he questioned not only “[Petitioners’ expert’s] persuasiveness but also his truthfulness” as a result of various weaknesses in the evidence underlying [petitioner’s expert’s] claims and [petitioner’s expert’s] “demeanor.” See, e.g., Rotoli, No. 99-644V, 2008 WL 4483739 at *22-30.”[The evidence from each case solely supports a finding that [petitioner’s expert] lacks credibility.” Id. at *2 9 .
92 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 81 (Fed. Cl. 2009).In reviewing
the evidence, including the medical literature, the special master did not follow precedent and establish simply whether petitioner’s expert’s medical theory of causation was supported by the weight of that evidence. Instead, he went so far as to conclude that the “questions about the basis for [petitioner’s expert’s] statements . . . have led to a question about [petitioner’s expert’s]
veracity.” See, e.g., Rotoi, No. 99-644V, 2008 WL 4483739, at *30.
93 See, e.g., Rotoi, No. 99-644V, 2008 WL 4483739, at *4 (noting a “decision about the persuasiveness of an expert is virtually not reviewable on appeal” (citing Bradley v. Sec’y of
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The U.S. Court of Federal Claims found that the special master violated precedent set forth in Andreu v. Sec’yofHealth&r”HumanServs.94 and erroneously used his assessment of petitioners’ expert’s credibility as a basis for rejecting the expert’s testimony regarding causation.95 Moreover, the court found that the pervasiveness of the comments regarding to the expert’s credibility throughout the special master’s decisions made it impossible to review the special master’s evaluation of the evidence separately from his erroneous credibility determination. 96 Accordingly, the U.S. Court of Federal Claims found that the special master framed his rejection of the petitioners’ theory of causation “under the rubric of a ‘credibility’ determination,”97 which constituted a legal error, resulting in the court setting aside the special master’s findings.”
Similarly, in Campbell v. Secy of Health &Human Sers.,99 the special master denied relief to the petitioner based on a credibility determination. 00 In Campbell, the special master based his decision to deny the petitioner compensation in substantial part on his finding that respondent’s expert was more credible than petitioner’s expert.’01 Because there was no genuine issue with regard to petitioner’s expert’s candor or truthfulness, the special master ran afoul of the Federal Circuit’s standards regarding the use of credibility determinations.102
Health &Human Servs.,991 F.2d 1570, 1575 (Fed. Cir. 1993))).
9 Andreuex.rel. Andreu v. Sec’y of Health &Human Servs., 569 F.3d 1367 (Fed. Cir. 2009).
9s See Rotoli, 89 Fed.Cl. at 81-82.
96 See id. at82 (noting “the special master’s error has tainted his entire causation analysis”).
97 See id. (citingAndreu, 569 F.3d at 1379).
98 See 42 U.S.C. 5 300aa-12(e)(2)(B) (2006). The court discarded the special masters decisions, re- examined the evidence, and issued new findings in each case. See generalyRotoli, 89 Fed. Cl. 71. The court found that three petitioners were entitled to compensation and that two petitioners were not. Id.
99 Campbell,90Fed. Cl. 369 (2009).
0 The special master denied relief to the petitioner on the grounds that she “has not established that the theories offered by her expert [to explain how the influenza vaccine could cause the onset of rheumatoid arthritis] are reliable,” and “even if her expert’s theories were reliable, she experienced signs and symptoms of rheumatoid arthritis within the time predicted by her expert.” Campbell v. Sec’y of Health &Human Servs., No. 07-465V, 2009 WL 2252550, at *1 (Fed. Cl. Spec. Mstr. July 7, 2009).
101 See Campbell 90 Fed.Cl. at 382 (stating “[bjecause there was no genuine issue with regard to [petitioner’s expert’s] candor or truthfulness, the special master ran afoul of the Federal Circuit’s
standards regarding the use of credibility determinations”).
102 In Andreu, the Federal Circuit held that “[w]hile considerable deference must be accorded to the credibility determinations of special masters, this does not mean that a special master can cloak the application of an erroneous legal standard in the guise of a credibility determination, and thereby shield it from appellate review.” Andreuex. rel. Andreu v. Sec’y of Health &Human
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As in Andren and Rota/i, the special master in Campbell”cloak[ed] much of his rejection of petitioner’s theory of causation ‘under the rubric of a ‘credibility’ determination’ regarding . . . petitioner’s expert witness.” 103 Similar to the result in
Roto/i, petitioner’s expert in this case was a “highly qualified expert witness whose extensive credentials [were] not in dispute.”104 At the conclusion of the expert opinion evaluation, the special master cited the petitioner’s expert’s credibility as a primary reason for finding that the petitioner had not established a proximate temporal relationship between her vaccination and her injury under the third prong of Althen.105 Like in Rotoli, the special master expected his analysis of whether petitioner had established causation in fact to be “virtually not reviewable on appeal”10 6 because in this case he couched his rejection of petitioner’s claim in terms of credibility.107 Despite the special master’s attempt to insulate his decision from review by the “incantation of magic words,” 08 the U.S. Court of Federal Claims found that he erroneously relied on an assessment of petitioner’s expert’s credibility as a basis for rejecting petitioner’s expert’s testimony.109 Further, the special master’s error tainted his entire analysis of whether petitioner established causation in fact.” 0 The Court of Federal Claims ruled
Servs.,569 F.3d 1367, 1379 (Fed. Cir. 2009). The Federal Circuit clarified that “[a] trial court makes a credibility determination in order to assess the candor of a fact witness, not to evaluate whether an expert witness’ medical theory is supported by the weight of the epidemiological evidence.” Id.
103 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 81 (Fed. Cl. 2009) (citingAndren, 569 F.3d at 1379).
104 See Rotoli, 89 Fed. Cl. at 81 (emphasis in original). “[W]here a highly qualified expert … presents a biologically plausible theory of causation in a vaccine case, the issue is not one of credibility.” See id.(citingAndreu, 569 F.3d at 1379).
105 Specifically, the special master stated that “[the factors that contributed] to the finding that [respondent’s expert] was more persuasive than [petitioner’s expert] … underlie the analysis of
the three factors from Althen [that follows].” Id.at 83.
106 Roto/, 89 Fed. Cl. at 82.
107 Id. at 81. “A decision about the persuasiveness of a witness is virtually not reviewable on
appeal.” Id. (upholding a special mater’s credibility determination regarding a non-expert witness (citing Bradley v. Sec’y of Health &Human Servs.,991 F.2d 1570, 1575 (Fed. Cir. 1993))).
108 See Campbell v. Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 384 (Fed. Cl. 2009).
109 See id. As stated supra, an evaluation of the credibility of an expert witness should be reserved for “assess[ing the candor of a fact witness” and petitioner’s expert’s candor is not in dispute. Andreuex. rel.Andreuv. Sec’y of Health &Human Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009). 110 See Campbell,90Fed. Cl. at 384.
Not only did the special master expressly base his finding that [petitioner] did not establish a proximate temporal relationship primarily on his evaluation of [petitioner’s expert’s] credibility, see Entitlement Decision at *11, but, by the special master’s own averment, his evaluation of the experts pervaded his
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“[i]n accord with Andreuand 42 U.S.C. § 300aa-12(e)(2)(B), the court finds that the special master improperly framed his rejection of [petitioner’s] claim ‘under the rubric of a ‘credibility’ determination’ and thereby sets aside the special master’s findings as legal
error.””‘
III. The Effects of the Incorrect Application of Standards and Precedent
Special masters recently drifted from using established precedent and documented congressional intent, heightening the burden on petitioners in the Vaccine Program.112 If this trend continues, the ramifications will extend beyond simply making compensation in the Vaccine Program more difficult and could jeopardize the very foundation of the Vaccine Program itself.113 The above-mentioned cases may have deeper ramifications, for example, an increase in costly appeals. This section will discuss concerns regarding the effect on the appellate process, as the appellate courts have overturned several cases decided by special masters.114 This section will also address a competing policy concern.
A. Effect on the Appellate Process
One of the goals of the Vaccine Program as stated by Congress in its
establishment was to compensate petitioners injured by enumerated vaccines.”5 analysis of the remaining factors under Althen.
Id.
111 Id. at 384 (citingAndreu, 569 F.3d at 1379 (citation omitted); Rotoli, 89 Fed.Cl. at 81-82). The special master’s ruling was vacated and remanded. Campbell,90Fed. Cl. at 388.
112 See Rotoli v. Sec’y of Health and Human Servs.,89 Fed.Cl. 71, 82 (Fed. Cl. 2009) (noting special master’s decisions in these cases were “arbitrary and capricious”).
113 See Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1367 (Fed. Cit. 2001).If the courts are pushing petitioners out of programs by denying compensation based on a narrow determination of what “manifestation of onset” means, petitioners may then move into tort litigation to be compensated, defeating the purpose of the Vaccine Program. See H.R. REP. No. 100-391(I) (1987), reprintedin1987 U.S.C.C.A.N. 2313-1 (noting Congressional intent is to leave state law unaffected); see also 42 U.S.C. § 300aa-22 of the Vaccine Act (explaining state law applies to civil action brought for vaccine-related injury or death).
114 See Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 82 (Fed. Cl. 2009) (holding special masters’ credibility determination decisions to be arbitrary and capricious); see also Campbell v. Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 383 (Fed. Cl. 2009) (holding special master cloaked applications of an erroneous legal standard by stating it was a credibility determination).
11s See Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1368 (Fed. Cit. 2001). The Federal Circuit Court observed in establishing the Vaccine program. See id. Two specific concerns motivated Congress, one being that Congress was concerned that the traditional tort
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Congress established the Vaccine Injury Compensation Program to compensate individuals “quickly, easily and with . .. generosity.”” 6 Many petitioners who meet the three-prong test set forth in Althen v. Sec ofHealth&Human Servs.”7 and should be compensated are either not getting compensated or their compensation is being postponed.”8 Beyond the negative effect of postponing the compensation of petitioners, failing to compensate petitioners who meet the requirements of Althen will have the effect of increasing the length of time for each case through the appeals process.” 9 This will lead to an increased cost for the government and the Vaccine Program because attorneys’ fees and costs, such as expert witness fees, are awarded by the government as established by the Vaccine Act.120 This costs the government and the vaccine fund more money.121 If a petitioner who satisfies the three-prong test from Althen v. Sec’y of Health &Human Sews. is awarded compensation at the Special Master level, instead of having to appeal his case to the Court of Federal Claims or the Federal Circuit to be compensated, attorneys’ fees would be much less. It is likely an underlying reason that Congress intended for petitioners to be awarded quickly because the Vaccine Program awards attorneys’ fees and costs, which, if the process is not expedited, have the possibility to grow exponentially higher than if the petitioner was awarded
system was inadequate to compensate many who were injured by vaccines. See id.
116 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting
H.R. REP. No. 99-908 (1986)).
“7 See Althen v. Sec’y of Health and Human Serys., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (outlining three-prong test). Petitioners must satisfy by a preponderance of evidence the following: “(1) a medical theory causally connect[s] the vaccination and the injury; (2) a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Id.
118 See supranote68.
119 See U.S. Court of Federal Claims, supra note 6. The Office of Special Masters is established within the U.S. Court of Federal Claims which appoints special masters and to which the special masters’ decisions are appealed. Id. Decisions may be subsequently appealed to the Federal Circuit Court of Appeals, and then to the Supreme Court. Id.
120 See 42 U.S.C § 300aa-15(e) (2006) (outlining attorneys’ fees and costs). “In awarding compensation on a petition filed under section 300aa-1 1 of this title the special master or court shall award as part of such compensation an amount to cover reasonable attorneys’ fees, and other costs incurred in any proceeding on such petition.” Id. Attorneys for petitioners work to establish a case with expert testimony and medical records must wait to be paid; long delays in compensation may cause petitioners to have trouble finding an attorney willing to represent them in a vaccine case. Lisa J. Steel, NaionalChildhoodVacdne Injury CompensadonProgram: Is This The Best We CanDoForOur Children?,63 GEO. WASH. L. REV. 144, 164-65 (1994).
121 The VICP, funded by a $0.75 tax on each vaccination given, is a no fault system designed to compensate the injured while protecting healthcare providers and vaccine manufacturers from lawsuits. Lawyers.com, NaionalInjuryCompensationProgram, http://personal-injury.lawyers.com/ National-Vaccine-Injury-Compensation-Program.htrml (last visited Mar. 31, 2010).
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compensation at the special master level.
B. Competing Policy Concern
Without question, vaccines are an important part of a modern society because they contribute to a healthy and disease free environment.122 In several congressional hearings since the establishment of the Vaccine Program, Congressman Henry Waxman, a primary architect of the Program, continually articulated the importance of vaccines and stated his concern at the prospect of public outcry regarding the risks of adverse reaction from vaccines.123 Congressman Waxman stated “today, we are becoming complacent about our success against infectious diseases. Unlike our parents and grandparents, we aren’t terrorized every year by paralytic polio and whooping cough epidemics. This makes it easier to forget the value of vaccines and to focus on their potential risks.” 24 Congressman Waxman also re-emphasized one of the primary purposes of the Program is to compensate individuals who are entitled to compensation, and if a person is injured after a vaccination and there exists no connection between the
122 See H.R. REP. No. 99-908, 99th Cong. (2nd Sess. 1986).
123 See Vaccines: FindingaBalanceBetweenPublicSafetyandPersonalChoice- HearingonInformationand
Technology Risk vs. Benefits of Vaccinations Before the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999) (statement of Congressman Henry A. Waxman); The NationalInjuryCompensationProgram: Is it Working as CongressIntended?: Before the H. Government Reform Comm., 107th Cong. (Nov. 1, 2001); U.S. Representative Dan Burton (R-IN) Holds Hearing on Mandatory Vaccinations: Hearing on Risks Versus Benefits of Vaccination Programs Before the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999). Congressman Waxman stated:
Vaccines have saved more lives than any other medical intervention in history.. . Thanks to universal immunization, the United States has made tremendous progress against polio, diphtheria, whooping cough, and other diseases ….Without vaccination, American children would be vulnerable to . . . catastrophic epidemics.
Vaccines: Finding a Balance Between Public Safety and Personal Choice- Hearing on Information and Technology Risk vs. Benefits of VaccinationsBefore the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999) (statement of Congressman Henry A. Waxman).
124 Id. Congressman Waxman later emphasized:
I don’t want this country to become lax in the area of vaccinating our kids because I don’t want these diseases to come back and I don’t want people looking at a hearing like this and thinking “Oh, my gosh. More people are hurt than helped … when the child is immunized.”
The NationalInjuryCompensationProgram: Is it Working as Congress Intended?: Before the H. Comm. on Gov’t Reform, 107th Cong. (Nov. 1, 2001). See also U.S. RepresentativeDan Burton (R-IN) Holds HearingonMandatoryVaccinations:HearingonRisksVersusBenefitsofVaccinationProgramsBeforetheH. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999); Lynda Hurst, Vaccine Phobia Runs Deep, Toronto Star, Oct. 30, 2009, http://www.thestar.com/news/article/718829 (highlighting public concerns surrounding vaccinations).
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 99 injury and the vaccine, these are not the individuals that should be compensated under
the Program.125
Chief Special Master Gary Golkiewicz commented on Congressman Waxman’s policy statements at a meeting of the Advisory Commission on Childhood Vaccines.126 Chief Special Master Golkiewicz outlined Congressman Waxman’s statements as two
competing policy objectives: (1) a stated purpose of the Program-promoting receipt and production of vaccines by protecting manufacturers from liability and compensating individuals who have sustained a vaccine-related injury, and (2) “protecting the integrity of vaccines .. . that vaccine does not cause every injury that follows immunization.” 27 Chief Special Master Golkiewicz stated that there is a tension between these two policy objectives, which significantly affects the outcomes of cases in the vaccine program.128
As demonstrated previously, several Federal Circuit opinions overturned some decisions of special masters and compensated individuals who were not compensated at the special master level.129 Chief Special Master Golkiewicz explained that recent Federal Circuit decisions set a standard that leans more toward providing for compensation, which reduces the pool of potential cases against vaccine manufacturers
125 Congressman Waxman stated:
The purpose of the program was not to replace the tort system with a[n] adversarial litigious framework, but to move to a more reasoned source for resolving the claim and getting people compensated who were entitled to be compensated. Now, there is the question: are injuries the people suffered related to the vaccine? Because if you have people come forward and say, well, I had a vaccination and then I had some terrible result, but you can’t show that it was related to the vaccine, that’s not the purpose of the vaccine compensation system, to award people money if there is no connection between the two.
The National Injug Compensation Program: Is it Working as Congress Intended?: Before the H. Comm. on Gov’t Reform, 107th Cong. (Nov. 1, 2001). See also U.S. Representative Dan Burton (R-IN) Holds HearingonMandatoU Vaccinations: Hearingon Risks Versus Benefits of Vaccination ProgramsBefore the H. Comm. on Gov’t Reform, 106th Cong. (Aug. 3, 1999).
126 Transcript, Advisory Commission on Childhood Vaccines Meeting, March 6-7, 2008, U.S.
Department of Health and Human Services, National Vaccine Injury Compensation Program, available at http://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm (last visited Mar. 31, 2010).
127 See id. In outlining these objectives, Chief Special Master Golkiewiczstated”I am not taking issues or pointing fingers.” Id.
128 See id. Golkiewicz stated that the competing policy concerns create “a tension that affects dramatically the litigation of the cases, the parties’ arguments and ultimately who wins.” Id.
129 See, e.g., Rotok, 89 Fed. Cl. 71; Andreu, 569 F.3d 1367; Capijano,440F.3d 1317; Althen, 418 F.3d 1274.
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in congruence with the policy objective demonstrated by the purpose of the Vaccine Program.130 Chief Special Master Golkiewicz then explained that proponents of the competing policy concern of protecting the integrity of vaccines would likely believe that
recent Federal Circuit opinions compensating individuals were incorrectly decided.131 IV. Wilkerson v. Sec’yofHealth&Human Servs.:132 First Symptom or
Manifestation of Onset
A case must be filed within thirty-six months from the first symptom or manifestation of onset to be timely filed in the Vaccine Program.’3 3 Wilkerson v. Secy of Health &Human Servs.,a case regarding the issue of what constitutes the first symptom or manifestation of onset, was appealed to the Federal Circuit after the special master dismissed the case as untimely, and the Court of Federal Claims denied the petitioner’s motion for review.134 The Federal Circuit upheld the special master’s decision to deny the petition based on timeliness.’35 In this case, the petitioner alleged that several
130 Transcript, Advisory Commission on Childhood Vaccines Meeting, March 6-7, 2008, U.S. Department of Health and Human Services, National Vaccine Injury Compensation Program, available at http://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm (last visited Mar. 31, 2010) (explaining by setting a standard where more cases are compensated, Federal Circuit reduces pool of potential cases “seeking redress against the manufacturer or administrator”).
131 Transcript, Advisory Commission on Childhood Vaccines Meeting, March 6-7, 2008, U.S. Department of Health and Human Services, National Vaccine Injury Compensation Program, availableathttp://www.hrsa.gov/vaccinecompensation/GolkewiczTranscript.htm. Chief Special Master Golkiewicz stated, “I … think it is fair to say advocates of policy protected vaccines believe the Federal Circuit opinions are incorrect.” Id.
132 ’33
Wilkerson, 593 F.3d 1343 (Fed. Cir. 2010). See 42 U.S.C. § 300aa- 16(a)(2) (2006).
If a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation
of such injury.
Id.
13 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343 (Fed. Cir. 2010); Wilkerson
v. Sec’y of Health &Human Servs., No. 05-232V, 2009 WL 1583527 (Fed. Cl. 2009); Wilkerson v. Sec’y of HHS, No. 05-232V, 2008 WL 4636329 (Fed. Cl. Spec. Mstr. Sept. 30, 2008). The Federal Circuit rendered a decision on January 27, 2010, upholding the special master’s decision and denying the petition based on timeliness. A similar case now pending before the Federal Circuit involves the same issue of law, specifically the proper interpretation of 42 U.S.C. 5 300aa-
16(a)(2).Cloer v. Sec’y of Health &Human Servs.,85 Fed. Cl. 141 (Fed. Cl. 2008), appealdocketed, (Fed. Cir. 2009) (No. 05-1002; renumbered No. 2009-5052).
13 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343 (Fed. Cir. 2010).
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mercury-containing vaccines caused him to suffer mercury toxicity and attention deficit hyperactive disorder (“ADHD”).136 Both parties submitted a physician’s expert report addressing the date of onset of petitioner’s ADHD symptoms; both medical experts agreed that, more probably than not, petitioner’s symptoms first appeared on or before
November 3, 2001.137
The court denied the petitioner compensation because the petitioner filed on February 17, 2005, more than thirty-six months from the first symptom of petitioner’s injury on November 3, 2001.138 Petitioner argued that petitioner’s injury, ADHD, is a condition that requires a manifestation of onset event to trigger the statute of limitations and that its first symptom is not sufficient.139 The Federal Circuit, following Markovich v. Secjy of Health &Human Sews.,140 held that first symptom or manifestation of onset of injury means that either a symptom or a manifestation of onset can trigger the running of the statute, whichever is first.’41 Markovichstated that the manifestation of onset is the first event objectively recognizable as a sign of a vaccine injury by the medical
136 See id. Petitioner received his first vaccination on his day of birth (May 30, 1997) and, by September 1998, received multiple vaccinations. Id. By the end of 1999, petitioner began
misbehaving. Id. At preschool, in 2001, petitioner had difficulty playing well with other children, disturbed class, and hurt classmates. By 2003, a physician treating [petitioner] suspected that he may have ADHD and referred him to a clinic for testing. Wilkerson, 593 F.3d at 1343-44.A licensed clinical social worker concluded that he “clearly” met the diagnostic criteria for the disorder. Id.at 1343. A pediatrician corroborated this diagnosis in January 2004. Id.
137 See Wilkerson, 593 F.3d at 1344.
138 See id. The special master, Court of Federal Claims, and the Federal Circuit determined that the phrase “manifestation of onset” refers to when the onset manifested itself retrospectively to the current medical community. Id.
139 See id.at 1345 (noting petitioner argued, while symptoms began by 2001, injury was not recognizable to contemporaneous medical community until later). See generally Setnes ex relSetnes v. U.S., 57 Fed. Cl. 175 (Fed. Cl. 2003).Addressing 42 U.S.C. § 300aa-16(a)(2) (2006), the Court of Federal Claims has held:
A statute is to be construed in a manner that gives meaning and effect to all its terms . . . .Under respondents interpretation, there would be no discernable difference between “first symptom” and “manifestation of onset.” The statue, as respondent asks the court to read it, would require that the petition be filed within 36 months of the “occurrence of the first symptom or manifestation of [the first symptom].” Such a construction renders “manifestation of onset’ meaningless and leads to a nonsensical result.
Id.at 180 (citations omitted).
140 Markovich, 477 F.3d at 1360 (Fed. Cir. 2007) (holding “first symptom or ‘manifestation of
onset,’ for the purposes of § 300aa-16(a)(2) is the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large”).
141 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343, 1345 (Fed. Cir. 2010) (quotingMarkovich, 477 F.3d at 1360).
102 JOURNAL OF HEALTH &BIOMEDICAL LAW VOL. VI NO. 1 profession at large. 142
The Department of Justice (representing the Secretary of Health and Human Services), began to review the medical records of 5,000 autistic petitioners presently participating in the Vaccine Program’s OMNIBUS Autism Proceeding based on the narrow construct 43 of the first symptom or manifestation of onset from Wilkerson and Markovich.144 This review resulted in motions to dismiss the claims of autism petitioners.145
V. Conclusion
A. Effect on Vaccine Program
Decisions of special masters that are incongruent with congressional intent or Federal Circuit precedent may also have a detrimental effect on the Vaccine Program as a whole. By working against the Program’s established legislative purpose of compensating individuals “quickly, easily, and with certainty and generosity,”l46 special
142 See Markovich, 477 F.3d at 1460 (explaining use of the words “first” and “or” require statute of limitations commence with whichever event occurs first).
143 See Markovich, 477 F.3d at 1360.
The Vaccine Act’s statute of limitations must be strictly and narrowly construed because it is “a condition on the waiver of sovereign immunity by the United States, and courts should be careful not to interpret [a waiver] in a manner that would extend the waiver beyond that which Congress intended.”
Id.
44 See Wilkerson v. Sec’y of Health &Human Servs.,593 F.3d 1343 (Fed. Cir. 2010); Markovich
v. Sec’y of Health &Human Servs.,477 F.3d 1353 (Fed. Cir. 2007).
14 These cases will have “timeliness” hearings to elicit fact witness testimony, expert testimony, or both. See Brief of Petitioner-Appellant at n.14, Wilkerson v. Sec’y of Health &Human Servs., No. 2009-5090, 2009 WL 2610095 (Fed. Cir. Aug. 3, 2009) (listing following cases: Small v. Sec’y of Health &Human Servs., No. 02-1616V; Killiam v. Sec’y of Health &Human Servs., No. 02- 1735V; Manco v. Sec’y of Health &Human Servs., No. 02-1961V; Chistoffer v. Sec’y of Health &Human Servs., 03-398V; Hunter v. Sec’y of Health &Human Servs., No. 07-717V; Wagner v. Sec’y of Health &Human Servs., No. 03-378V; Sherman v. Sec’y of Health &Human Servs., No. 07-289V; Hokkanen v. Sec’y of Health &Human Servs., No. 03-1753; Nuttal v. Sec’y of Health &Human Servs., No. 07-810V). Prior to Markovich, the U.S. Court of Federal Claims issued a decision in Setnes, 57 Fed. Cl. 175. In Setnes, the court ruled that the words “manifestation of onset” have distinct meaning. Id. In that case, the court recognized that some illnesses, like autism, have an insidious onset, and for the purposes of the statute of limitations, the manifestation of onset is when the illness becomes “evident.” Id. at 180.
146 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting H.R. REP. No. 99-908 (1986)); Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1368 (Fed. Cir. 2001) (outlining congressional intent in creating program).
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masters rendered decisions in certain cases that are inconsistent with the stated congressional intent.147 By dismissing Federal Circuit precedent, establishing higher burdens for petitioners, and narrowly interpreting the Act, special masters are making decisions in certain cases that conflict with the purpose of the Vaccine Program. 148
There are also potential economic concerns for the Program when special masters deny deserving petitioners compensation in certain cases. By denying requisite compensation at the special master level, the special masters are effectively costing the Vaccine Program more money in attorneys’ fees and costs, as well as the cost of the
appellate process.
B. Effect on Petitioners
Consumers injured from vaccines have a statutory right to be compensated for their losses.149 By denying compensation for claims that satisfy the three-prong Althen test, petitioners continue to wait for compensation to take care of medical bills, lifestyle changes (such as necessary physical, occupational, and speech therapy), or expenses related to death injuries. Petitioners are waiting longer to be compensated, if at all, and experience a longer, more stressful, and litigious process than the legislatively directed “quick” and “generous” process.150
147 The Vaccine Injury Compensation Program benefits consumers, parties injured from vaccines, as well as the vaccine companies, as it was established in an effort to stabilize U.S. vaccine supplies while also preserving vaccine companies’ assets for research into safer vaccines. Lawyers.com, supra note 121. See also Brice, 240 F.3d at 1368.
148 See Shyface, 165 F.3d at 1351 (quoting H.R. REP. No. 99-908 (1986)). The Federal Circuit Court observed that Congress established the vaccine program to encourage vaccine companies to remain in the market and to adequately compensate many who were injured from vaccines. Brice, 240 F.3d at 1368.
149 National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-1-300aa-34 (1986) (establishing program where petitioners are granted compensation for injury resulting from administration of vaccines covered under Act).
15 See, e.g., Rotoli v. Sec’y of Health &Human Servs.,89 Fed. Cl. 71, 82 (Fed. Cl. 2009) (holding special master’s decisions to be “arbitrary and capricious”); Campbell v. Sec’y of Health &Human Servs.,90 Fed. Cl. 369, 384 (Fed. Cl. 2009) (holding special master cloaked applications of erroneous legal standard by stating it was a credibility determination). Petitioners in these cases were forced to wait for the Federal Circuit decision’s appeal process to obtain compensation for their injuries, despite Congressional intent that compensation be quick. See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (quoting H.R. REP. No. 99-908, at 3).
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Further, many of the petitioners were mandated to receive these vaccines, such as childhood vaccines before entering school or vaccines before employment at certain facilities, or have voluntarily received vaccines in an attempt to protect themselves and others from the spread of disease, an action that Congressman Waxman iterates as paramount to public health. When individuals are injured from a vaccine, the federal statute outlines that they should be promptly and adequately compensated for their injuries.1st Also, many of these petitioners are parents of children who either continue to experience severe problems or who have died from vaccine complications.152 Denying compensation and forcing petitioners to continue in the appeals process for compensation subjects these individuals and their families to more adversity and litigation than necessary, certainly more than the Vaccine Program intended.153
Finally, because petitioners’ attorneys’ fees and costs are awarded through the Vaccine Program, postponing compensation could also lead to an inability for firms representing these petitioners to stay in business.1 54 Unlike many other law firms, those that handle cases in the Vaccine Program do not secure a retainer prior to working on the case and must themselves pay the necessary expenses for the collection of medical records or filing fees because fees are generally awarded post-litigation, with the exception of interim fees.155
‘ See 42 U.S.C. §§ 300aa-1-300aa-34 (2006) (establishing National Injury Compensation Program, where petitioners are granted compensation for injury resulting from administration of vaccines covered under the Act). The Federal Circuit Court observed that “Congress established
the [vaccine program] … to provide compensation for vaccine-related injuries and death.” Brice, 240 F.3d at 1368.
152 See Wilkerson v. Sec’y Health &Human Servs.,593 F.3d 1343, 1343 (Fed. Cir. 2010) (noting appellant parent); Cloer v. Sec’y of Health &Human Servs., 85 Fed. Cl. 141 (Fed. Cl. 2008), appealdocketed, No. 2009-5052 (Fed. Cir. 2009).
153 See Shyface v. Sec’y of Health &Human Servs.,165 F.3d 1344, 1351 (Fed. Cir. 1999) (confirming Congress established Vaccine Injury Compensation Program to compensate individuals “quickly, easily, and with certainty and generosity”).
15 See 42 U.S.C § 300aa-15(e) (2006) (outlining attorneys’ fees and costs). “In awarding compensation on a petition filed under section 300aa-1 1 of this title the special master or court shall award as part of such compensation an amount to cover reasonable attorneys’ fees, and other costs incurred in any proceeding on such petition.” Id.
155 See 42 U.S.C § 300aa-15(e) (stating “[i]n awarding compensation on a petition filed under section 300aa-1 1 of this title the special master or court shall award as part of such compensation an amount to cover reasonable attorneys’ fees . . . .”); Christopher J. Rodgers, A Pimer on the National Vaccine Injury Compensation Program, 21 UTAH B. J. 25, 27 (2008) (noting discovery is completed before petition is filed with court requiring petitioner’s attorneys to obtain and submit complete medical records of injured party by time petition is filed).
2010 JOURNAL OF HEALTH &BIOMEDICAL LAW 105 C. Public Health Concern
If petitioners cannot seek legal remedy in the Program, they may be able to bring a tort claim against vaccine manufacturers because statutes of limitation are tolled for minors at the state level.’56 Congress established the Vaccine Program to make awards to “vaccine-injured persons quickly, easily and with certainty and generosity.”‘ 57 The primary goal of the Act was to limit lawsuits against vaccine manufacturers and Congress believed this would best be accomplished by directing potential lawsuits into a generous forum: the Vaccine Program.158
If courts continue to narrowly interpret first symptom or manifestation of onset, it may have the effect of pushing petitioners out of the Vaccine Program, giving petitioners the opportunity to sue vaccine companies.’59 This could pose a risk to consumers, as it did prior to the establishment of the Vaccine Program, when vaccine
156 See Brice v. Sec’y of Health &Human Servs., 240 F.3d 1367, 1372-74 (Fed. Cir. 2001) (discussing limitation period). The Federal Circuit observed, “[w]e need not decide in this case whether a petitioner who fails to file a timely petition under the Program may still pursue traditional tort remedies.” Id. at 1368.However, this determination is both relevant and important; all fifty states toll statues of limitations for minors and for brain-damaged individuals. See John H. Derrick, Tolling of Statute of Limitations, on Account of Minority of Injured Child, as Applicable to Parent’s or Guardian’sRight of Action Arising Out of Same Injut, 49 A.L.R.4th 216, § 2 (1986). Congress noted “[i]t is not the Committee’s intention to preclude court actions under applicable law. The Committee’s intent . . . is to leave otherwise applicable law unaffected, except as expressly altered by the Act.” H.R. REP. NO. 100-391(I) (1987), reprinted in 1987 U.S.C.C.A.N. 2313-1.Further, the Vaccine Act does not provide that untimely petitioners in the Program forfeit all rights to civil litigation, as it expressly states that unless otherwise provided, “[s]tate law shall apply to a civil action brought for a vaccine-related injury or death.” 42 U.S.C. § 300aa-22(a).
1s7 See Andrews v. Sec’y of Health &Human Servs.,33 Fed. Cl. 767 (Fed. Cl. 1995).
The Vaccine Injury Compensation Program was designed to replace the state law civil tort system with a simple, fair and expeditious means for compensating vaccine injured persons. The [P]rogram was established to make awards to “vaccine-injured persons quickly, easily and with certainty and generosity.” H.R. REP. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6344. The intent to be generous is demonstrated in Congress’ recognition and acceptance of the fact that persons might be compensated under the act for illnesses that are not vaccine related. H.R. REP. No. 908 at 18, reprinted in
1986 U.S.C.C.A.N. at 6359.Id.at 770-71.
158 See id. See generaly42 U.S.C. 5§ 300aa-1-300aa-34 (2006).
159 See 42 U.S.C. §300aa-22(a) (asserting state law shall apply to civil action brought for vaccine- related injury or death); see also Derrick,supranote 156 (explaining statutes of limitations are tolled for minors at state level).
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manufacturers were faced with tort litigation from persons injured by vaccines.160 If vaccine manufacturers again have suits brought against them, their incentives to make vaccines and to create new vaccines would be hindered, which could lead to a vaccine shortage.161 The Vaccine Program was established in an effort to protect vaccine manufacturers, in turn, protecting the nation’s vaccine supply and the health of the American public from infectious disease. If petitioners are pushed out of the Program and bring suit against vaccine manufacturers, vaccine supplies and public health may once again be jeopardized.
Undoubtedly, vaccines play an important role in modem society; their benefits are ample, and their positive effects are widespread. The introduction and extensive use of vaccines has resulted in a dramatic decline in the United States in the morbidity, disability, and mortality rates caused by a variety of infectious diseases, including diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B virus, small pox and varicella.162 Prevalent use of vaccines in the United States eliminated or nearly eliminated infectious diseases that were once terrifying household names. 163 However, vaccines can have detrimental effects, as “a small but significant number [of vaccinated persons] have been gravely injured.”16” The federal government has addressed this with the establishment of the no-fault program to compensate petitioners who have been
injured from vaccinations: The National Vaccine Injury Compensation Program.
In establishing the Vaccine Program, Congress outlined the purpose and reasoning, and early cases paved the way for precedent that compensated those who had been injured from vaccinations. Special masters recently strayed from established
160 See National Injury Compensation Program,supra note 121 (noting prior to the Vaccine Program the rising number of lawsuits filed against healthcare providers and vaccine manufacturers based on injuries and deaths attributed to vaccines caused a number of vaccine manufacturers to discontinue manufacturing vaccines).
161 See National Injury Compensation Program, supra note 121. Congress responded by passing the National Childhood Vaccine Injury Act of 1986, aimed at stabilizing U.S. vaccine supplies
while also preserving vaccine companies’ assets for research into safer vaccines. Id.
162 Fangjun Zhou et al., Economic Evaluation ofthe 7-Vaccine Routine ChildhoodImmuniZation Schedule in the UnitedStates,2001, 159 ARCHIVES OF PEDIATRICS &ADOLESCENT MED. 1136, 1136 (2005).
163 National Institute of Allergy and Infectious Diseases, Vaccines, http://www3.niaid.nih.gov/ topics/vaccines/understanding/vaccineBenefits.htm (last visited Mar. 31, 2010).
164 H.R. REP. No. 99-908, at 4 (1986).Between 2001 and 2005, over 330,000 VAERS reports were filed. See Vaccine Adverse Event Reporting System: Reports from March 6, 2001 to March 5, 2005, http://www.vaccineawareness.org/VAERS/2001-2005 (last visited Mar. 31, 2010). About 85% of vaccine adverse event reports concern relatively minor events, such as ordinary fevers or redness and swelling at the injection site; the remaining 15% describe serious events such as seizures, high fevers, life threatening illnesses or deaths. Id.
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purpose and precedent and heightened the burden on petitioners, making it more difficult to be compensated for an injury caused from a vaccine. These effects have the propensity not only to further injure legitimate petitioners but also to undermine the Vaccine Program itself.