Medical (Heath) report

Medical (Heath) report
1
To whom it may concern:
The following report provides the basis for satisfying VCIP’s Althen burden, provides
clarity on Jessica Fouch’s wellness prior to the Tdap vaccination and finally summarizes her
documented health issues following the vaccination that persist to present.
Outline:
1. Summary of conclusion
2. Summary of medical history
3. Information from the Tdap vaccine risk literature
4. Althen theory
5. Description and impact of diagnosed illness
6. Final remarks and conclusions
Summary of conclusion:
Ms. Fouch’s post vaccine illness diagnosis is Dysautonomia. “Dysautonomia refers to an
abnormality of function of the autonomic nervous system. Dysautonomia is not a single disease
process. The autonomic nervous system may undergo injury as part of several different
degenerative neurologic and immunological diseases.
Dysautonomia is difficult to diagnose and is illusive to experienced physicians because of
the immunological and neurological influences, sometimes taking years to diagnose as the
patient seeks care from many physicians trying to get help and an understanding of why their
health is failing.
After treating Ms. Fouch and studying her history, I conclude by the preponderance of the
evidence, if not for her vaccination Ms. Fouch would not have experienced a negative reaction
and had been plagued with her progressing illness. The vaccination was a substantial factor if
not the sole reason for her injury and subsequent illness. Ms. Fouch’s claim demonstrates a
clear temporal association and follows a logical and relevant medical/scientific theory that is
supported both by medical records and the opinions of her treating physicians. Additionally, I
find no other reasonable theory, causal relationship and/or evidence that something other than
the vaccine caused the injury and her subsequent illness.
Summary of Medical History:
Quoting from the vaccine risk literature: “With any medicine, including vaccines, there is
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a chance of side effects. These are usually mild and go away on their own, but serious
reactions are also possible.” Ms. Fouch received the Sanofi Tdap lot # C3922AA, for this lot
there have been 41 adverse vaccine reaction cases reported on the VAERS database. I cannot
say this is significant, but it does indicate just as in the reported vaccine trials that injuries are
possible and vary in degree.
Ms. Fouch’s Medical records and pediatrician provide a basis for her good health prior to
the Tdap inoculation on June 18, 2011. In order to appreciate her complicated medical history
the evidence is examined. Her medical records are evidence of a normal healthy childhood. To
corroborate this her pediatrician, gymnastics coach, and long term friends have provided signed
legal documents to the VICP that state through medical, athletic performance, and social
friendships that Ms. Fouch was a healthy and thriving child through mid June 2011 pre-Tdap.
Additionally, Dr. McCurdy in her medical opinion provided an exhaustive review of Ms.
Fouch’s pre-Tdap medical history providing detailed evidence of normal wellness visits. I
revisited her records and came to the same conclusion that she did. Suffering from symptoms
from the Tdap reaction she was taken to urgent care where the doctor stated “possible reaction
to preservative in Tdap”. From that time her medical visits are vast dealing with this illness that
was triggered by the vaccine. It is understood that this type of reaction is rare, but we need treat
for what it is. In Dr. McCurdy’s medical opinion she states “Her medical visits are
overwhelming in the days, weeks and years following he Tdap inoculation in June 2011 which
indicate a dramatic change in her health. “Jessica’s post Tdap inoculation illness is
“qualitatively” different, before she was well with minor illnesses that resolved”. (1) What is
important to note is that she had an abundant life before the vaccine, but her ill symptoms from
the reaction follow the description in the vaccine risk literature. In the following weeks, months
and years she becomes progressively ill and is not able to live the abundant life she once had.
Following the Tdap vaccine her reaction included a mild fever, headache, tiredness, fatigue,
nausea, arm swelling, limb tingling, limb numbness, inability to focus, brain fog, anxiety, a
myriad of allergies, and stomachaches. As her illness progressed the consequences have been
vast and complicated with consistent headaches, fatigue, gastroperisis and physical wasting
among many others that will be described throughout this report.
The following list is not an exhaustive account of all her medical records (available in the
legal exhibits), but rather a summary of the data, labs and records found to be pertinent.
From the Medical Records:
• Jun 22, 2011 Peter J. Georgio MD, Urgent Care
o Headache
o Tired, ill feeling
o Pain and swelling in left arm
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o Doctors assessment: possible reaction to preservative in Tdap
• Jun 28, 2011 Maria Lui MD, General Practitioner
o Sought medical advice from families General Practitioner
o Reason: Reaction to vaccine and declining health
• Jul, 19 2011 Pantea Sharifi Hannauer MD, Pediatric & Adult Neurology
o Post-vaccine reaction and headaches
o Headaches
o Arm pain and swelling
o Doctors assessment: Likely the post-vaccine reaction triggered her
headaches and extreme fatigue
• Aug 9, 2011 Joshua Davidson MD, Immunology
• %CD3 Mature T-Cells Range 61-82 – Low 59
• %CD8 Suppressor T-Cells Range 17-36 – Low 14
• Helper/Suppressor Ratio Range 1-2.90 – High 2.26
• Sept 19, 2011 Maria Lui MD, General Practitioner
o Diagnosis – Persistent headache, nausea, vertigo and fatigue
§ Sedimentation Rate – 22mm/hr on 6/28/11 (range = 0-20)
§ Sedimentation Rate – 19mm/hr on 7/18/11(range = 0-20)
o Notes mentions history of Eustachian Tube disorder, allergies – Penicillin,
walnuts, cherries
o 2nd Opinion with Neurologist sought (patient referred to Dr. Hannauer, 2nd
opinion sought with Dr. Dyes)
• Sept 26, 2011 Mary Kay Dyes MD, Neurology
o Chronic Headaches
o Weight = 117 lbs Blood Pressure 115/60, Pulse 66 à well developed & well
nourished
o Neurological exam reported as normal
o Recommendations – Brain MRI
§ From Oct 10, 2011 MRI interpretation
• Examination degraded by dental hardware
• Report – Unremarkable
• Sept 27, 2011 Helen Mawhinney MD, Allergy & Immunology
o Persistent headaches, dizziness
o Nausea and vomiting
o Reported possible acute gastroenteritis
o Limb numbness
o Food Allergies and positive reaction to nickel
o Mild Nosebleeds
o No allergic reactions to alum, phosphate, formaldehyde, and 2-
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phenoxyethanol (Dr J. Davidson patch testing)
o Doctors assessment: Severe local reaction to Tdap
• Oct 6, 2011 David Armstrong DC
o Weight = 120 lbs Blood Pressure 121/74, Pulse 68
o Headache – back of head, forehead, temples
o Light-headedness, dizziness, pain in ears, ringing in ears
o Pain in the neck moving backward, muscle spasms in neck
o Pain, spasms, edema (inflammation), Myofacial tightness & tingling
• Nov 30, 2011 Deborah McCurdy MD, Rheumatology
• Thyroid Peroxidase Antibody 75920347 – Abnormal
o Thyroid Peroxidase Antibody Range <or= 20 IU/mL – High 20.9
• Comprehensive Metabolic Panel HIS756 – Order 75920337 – Abnormal
o Alkaline Phosphatase Range 31-103 U/L – High 123
• Histone Antibody, IgG HIS3097 – Order 75920333 – Abnormal
o Histone Antibody 0.0-0.9 Units – High 1.7
• Nov 30, 2011 Deborah McCurdy MD, Rheumatology
o Reported dizziness, seeing stars, Pain in eyes, Nausea
o Legs and arms fall asleep, bee type stings and feels cold
o Fatigue, Exercise intolerance, difficulty sleeping
o Joint pains/arthralgia’s that come and go
o Shortness of breath intermittently usually when lying down
o Memory and attention problems
o Abdominal pains
o Diarrhea
o Diptheria Toxoid AB Range 0.1 IU/uL or greater indication protection
§ Jessica’s reading was 1.620
o Tetanus Toxoid AB, EIA Range >0.15 IU/uL protection
§ Jessica’s reading was >7
o From the Doctors notes:
§ Reported new food allergies
§ Sedimentation Rate High – 22mL
§ Arthus Reaction
§ Peripheral blood B and T Lymphocytes showed minor deviations
from normal
• Mar 8, 2012 Quinton Gopen MD, Ear Nose and Throat
o Dizzy, limb numbness, headaches, nausea, pressure in ear.
o Comprehensive 14-organ system review of systems revealed; Positive for
fever, chills, headaches, nosebleeds, sinusitis, pain in the legs, nausea,
limited motion in joints, blacking out, depression, and/or anxiety.
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o Minimal retraction of eardrum
• Jun 1, 2012 Deborah McCurdy MD, Rheumatology
• Urinalysis, Routine HIS2690 – Order 91723758 – Abnormal
o Protein Range Negative – Trace
o Leukocyte Esterase Negative – Trace
o RBCS Range 0-11 cells/uL – 19
o Squamous Epithelial Range 0-17 cells/uL – 21
• IgE HIS1102 – Order 91723738
o IGE Range <20 IU/mL – 223
• Histone Antibody, IgG – Order 91723726 – Abnormal
o Histone Antibody Range 0.0-0.9 Units – 1.4
• Jun 25, 2012 Dr Garcia, Pediatric Allergy & Immunology
o New Food Allergies started after Jun – 2011 Tdap
o Mouth Ulcers, Diarrhea os per HPI
o Joint Pain – Knee, hip, shoulder
o Very Positive for all pollens
• Jul 17, 2012 Lonnie Zeltzer MD, Pediatric Pain Management
o Headaches, fatigue, joint pain as well as lupus symptoms
o Pain in neck and shoulders
o Exercise intolerance – increased pain with activity
o Problems with focusing
o Reported feelings of fullness
o Nausea in the mornings
o Limb numbness
o Random Joint Pains
o Elevated Sed rate of 22mL by July 2011 (1 month after vaccine) was at the
high end of the normal range at 19mL
o In Aug 2011 her peripheral blood B and T lymphocytes showed minor
abnormalities
o Medical deduction from Dr Helen Mawhinney MD – concludes that Jessica
experienced a hypersensitivity reaction to Tdap, her opinion was the inciting
agent was the pertussis component
• Jul 25, 2012 Deborah McCurdy MD, Rheumatology
o Post Immunization positive histone antibodies and allergies
o Allergies – all plants, many fruits and walnuts – causes blisters
o Diarrhea
• Jul 27, 2012 Deborah McCurdy MD, Rheumatology
o Post Immunization positive histone antibodies and allergies
o Allergies – all plants, many fruits and walnuts – causes blisters
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o Diarrhea
o Arms and hands, sensation of pins and needles in arms and fingers,
numbness in arms
o Tension in shoulders
o Abdomen – nausea
o Legs – pins and needles
• Oct 22, 2012 Deborah McCurdy MD, Rheumatology
o Nauseated
o Headache spikes
o Missed a few days school
o Headache and dizzy spells
o Diarrhea and nausea
o Arthralgia’s
• Oct 24, 2012 Deborah McCurdy MD, Rheumatology
• Urinalysis, Routine HIS2690 – Order 102824775 – Abnormal
o Blood Range Negative – 2+
o Protein Range Negative – Trace
o RBCS Range 0-11 cells/uL – 181
• Comprehensive Metabolic Panel HIS756 – Order 91723762 – Abnormal
o Alkaline Phosphatase Range 31-103 U/L – 106
• Histone Antibody, IgG – Order 91723760 – Abnormal
o Histone Antibody Range 0.0-0.9 Units – 1.4
• Feb, 15 2013 Deborah McCurdy MD, Rheumatology
o Less limb tingling
o Random bruises on knees
o Immune system stronger
o Headache worse
o Focusing issues, feels foggy
o Can’t remember as well, takes longer to do work
o School modification required
o Unable to exercise
o Ulcers in mouth
o Hip and shoulders tight
o Sleeping broken up
o Allergies – fruits and vegetables
o Arthritis
o Impression – Post Tdap immunization reaction, headache and myalgia/
arthralgia
• Jul 31, 2013 Deborah McCurdy MD, Rheumatology
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o Weight = 109 lbs 12.6 oz Blood Pressure 116/66, Pulse 66
o Positive histone antibodies (1.4) persisted despite treatment with plaquenil
o Sleep was better
o Headache gets worse less often, consistent but spikes to 8 or 9 out of 10
approx 3 times a week. Bitemporal headache with pain at base of occiput
§ When focusing mentally headache gets worse
o Arthralgia – left sided, knee, wrist and elbow aching for approx 1 month
§ Prior visits arthralgia’s had been intermittent bi-laterally
o Numbness/paresthesias – happens approx twice a week, previously daily and
even multiple times daily
• Oct 23, 2013 Quinton Gopen MD, Ear Nose & Throat
o Stated drug induced rheumatoid arthritis
o Recommending another ENT Jennifer Long, MD ENT, specializing in throat
• Oct 30, 2013 Jennifer Long MD, PHD, Ear Nose and Throat, specializing in throat
o Throat pain, bilateral larynx
o Deep Ear pain
o Joint pain, headaches, nausea, vomiting and anxiety
o From the video laryngostroboscopy
§ Larynx – severe posterior commissure edema and erythema – video
laryngostroboscopy
§ Excessive post anteroposterior tension in the larynx with shortened
aryepiglottic folds and blunting of the anterior commissure
o Doctors impression – laryngopharyngeal reflux with a component of muscle
tension of dysphonia, referred for voice therapy
• Oct 30, 2013 Deborah McCurdy MD, Rheumatology
o Concentration Deficit, post-vaccination syndrome
o Chronic Headache
o Chronic Pain
o Weight 105 lbs
• Nov 14, 2013 Lisa Bolden SLP (Speech and Language Pathologist)
o Diagnosis – Mild dysphonia
o Otolaryngological diagnosis APR and muscle tension dysphonia
o Medical necessity – voice problem interferes with communication for ADLs
o Pain level – 4 to 7 on a 10 scale for last two months
• Nov 19, 2013 Deborah McCurdy MD, Rheumatology
o Weight = 105 lbs 3.1 oz Blood Pressure 125/78, Pulse 87
o Weird feeling like in a fog
o Dizzy spells over last couple of months, suspect here is ear issues (ref Dr.
Gopen)
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o From Labs on Oct 30, 2013:
§ Potassium – 3.5 mmol/L (Range 3.6 – 5.4)
§ Glucose – 160 mg/dL (Range 65 – 99)
§ Red blood cell count – 3.91 x 10E6/uL (Range 3.96 – 5.09)
§ Hep A Ab – Reactive (Range Non-reactive)
§ Varicella IgG – 2.13 (Range <= 0.90)
§ Histone Antibody IgG – 1.5 (Range 0 – 0.9) – weak positive
• Histone antibodies present in > 90% of SLE (both drug induced
and idiopathic) cases.
• Feb 5, 2014 Maria Garcia-Lloret MD, Pediatric Immunology, Allergy & Rheumatology
o Chronic headache
o Chronic pain
o Weight – 98 lb 5.8oz
• Feb 5, 2014 Deborah McCurdy MD, Rheumatology
o Weight = 98 lbs 5.2 oz Blood Pressure 108/71, Pulse 57
o Continued sequelae after Tdap vaccine
o Weight loss, muscle loss and weakness
o Headache, brain fog, vision changes
o Joints got worse without GLA
o Fatigue is stable, but doing more makes the headache worse
o She feels too tired to do anything
o Optimistic outlook
o Constipated – 3 weeks straight
o Allergies – many fruits
o Feeling bloated all day
o Abdominal pain, myopathy
• Feb 19, 2014 Jennifer Long MD, PHD, Ear Nose and Throat, specializing in throat
o Video Laryngoscopy with Stroboscopy and medical speech evaluation
§ Normal vocal fold mobility, posterior commissure, has mild (1+
edema and erythema)
§ Mucosal waves are preserved, glottal closure is complete
§ Jessica presents with resolved dysphonia
• Apr 14, 2014 Stacy Pineles MD, Ophthalmology
§ Assessment & Plan – blurry vision, occasional black spots and
difficulty in dark lighting
§ OCT of Macula and nerve fiber layer, Humphrey visual field – normal
• Apr 24, 2014 Joyce Matsumoto MD, Neurology
o Weight = 85 lbs 8.6 oz Blood Pressure 111/71, Pulse 67
o Headaches
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o Brain Fog, not associated with headaches worsening
o Dizziness, fainted once
o Feeling of fullness quickly (3 meals a day)
o Joint Pain
o Sleep is not restful
o Constipation, diarrhea, nausea
o There are days when nothing she sees or hears sinks in, but things will catch
up when she has better mental clarity
o Exercise intolerance – headache worsens, light exertion is beneficial
o Neuro Exam – Normal
§ Transformed Migraine/Chronic daily headache is a likely large
component of her problem, which is likely triggered by her reaction to
the vaccine.
o Apr 28, 2014 Deborah McCurdy MD, Rheumatology
o Weight loss – unclear etiology – 82lb 10.8oz
• Apr 30, 2014 Maria Garcia-Lloret MD, Allergy/Immunology
o Weight loss (no recordings found), lost 30 lbs since 2012
o Allergies to foods and pollens
o Wants to eat, but gets full fast
o Referred to Peds GI to evaluate for delayed gastric emptying
• May 5, 2014 Lonnie Zeltzer MD, Allergy
o Weight = No recording found, Blood Pressure 80/51, Pulse 46, BMI 14.76
o Post vaccination reaction with multiple symptoms
o More energy with physical Therapy
o When standing from a sit her head pulses and hearing goes out
o Mind fogginess
• May, 2014 Deborah McCurdy MD, Rheumatology
o Weight = 79 lbs 2.3 oz Blood Pressure 91/57, Pulse 52
o Significant weight loss over the last 6 months
o Physical Exam – Normal
o From 4/28/14 Labs
o MCH Concentration 35.9 (Range 31.5 – 35.5)
o Neutrophil Percent, Auto 29.0 (Range 38.7 – 78.9%)
o Lymphocyte Percent, Auto 29.0 (Range 38.7 – 78.9%)
o Glucose 61 (Range 65 – 99 mg/dL)
o Albumin 5.3 (Range 3.7 – 5.1 g/dL)
o ALT (SGPT) 50 (Range 4 – 45 U/L)
o Sedimentation rate = 6 (Range 0- 22 mm/hr)
o Food Allergies – Abnormal (see labs)
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o Assessment – Ongoing sequelae from a vaccine injury, headaches, weight
loss, muscle loss and weakness, brain fog, vision changes, myopathy, and
abdominal pain, sore throat.
• May 21, 2014 Eleheh Vahabnezhad MD, Pediatric Gastroenterology
o Gastric Issues, gastric emptying tests (lab report 22%)
o Weight – 77 lbs 9.6oz
• May 21, 2014 Elaheh Vahabnezhad MD, GI
o Weight = 77 lbs 9.6 oz Blood Pressure 91/60, Pulse 97
o Feelings of fullness with little food, lasts unusually long
o In October had a “cyst like” 1 – 1.5 inch bump along her left buttocks that
comes and goes on its own, but can last for several weeks at a time.
o Noted allergies to pollen, fruits, tree nuts. Apples, bananas, broccoli cause
blisters in mouth.
o Chronic headache and fatigue
o Occasional joint pain
o Headache gets worse with exercise
o Gets dizzy when going from sit to stand
o Throat tightness
o Assessment – Gastroperisis, recommends possible nutritional therapy
• May 23, 2014 Reena Gupta MD
o Weight = 80 lbs, no records for blood pressure or pulse
o Complicated medical history
o Headaches
o Anxiety
o Other, ASIA
o Review of Systems
o Fatigue, unexpected weight loss
o Blurry vision
o ENT – allergies, dizziness, ear pain, headaches, mouth sores, sore throat,
throat pain, voice change.
§ Ears – right pinna is significant for a normal helix, tragus and ear
lobule.
§ Nose – Septum is significant for deviation, intranasal exam is
consistent with hypertrophied inferior turbinates
o GI – Nothing unusual noted
o Decision making process:
§ Diagnosis, Dysphonia, acute, throat pain, autoimmune disease,
classified elsewhere.
• Aug – Sept, 2014 UCLA Ronald Reagan Medical Center
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o Need Medical Records to develop summary
o Vaccine Injury
o Malnutrition
o Headaches
o Lupus like symptoms
o Anxiety
o Bradycardia, syncope
o Other, ASIA
o July 17, 2015 William Stuppy, MD (FCAP, FACP, FACG)
o Headache and Fatigue Persisting
o Prickly sensations and parasthesis
o Previous Meds = Prednisone and plaquenil
o Gastric Empyting (2014)
o Hepatitis – liver biopsy (UCLA)
o Amenorrhea
o Doctors diagnosis: Dysautonomia
o Plan: Sabre Sciencesà HRV, HP4, CH2
o Aug 7, 2015 William Stuppy, MD (FCAP, FACP, FACG)
o Low, low energy
o Gastric complaints, uneasy, nausea, bloating, occasional pain in between meals
o Doctors diagnosis: Dysautonomia, Adrenal dysregulation
o Plan: Sabre Sciencesà Increase DHEA, Lyme test
o Aug 24, 2015 William Stuppy, MD (FCAP, FACP, FACG)
o Started Sabre Science 2 weeks ago
o Weight = 105 Lbs
o Lyme panel pending
o Plan: Hyperbaric Oxygen Therapy (HBOT)
o Sept 5, 2015 William Stuppy, MD (FCAP, FACP, FACG)
o Poor response to Sabre Science (SS) cream, patient treatment discontinued
o Still Fatigued
o Better since off SS creams
o Developed Otitis Externa after Hyperbaric Oxygen Therapy (HBOT)
o Assessment: Dysautonomia, hepatitis concurrent resolved, Lyme?
o Plan: Repeat Lyme test, treatment: Olaloa, contact SS regarding creams &
methylation disorder
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o October 23, 2015 Michael Arata, MD PC
o Weight = 105 lbs Blood Pressure 94/53, Pulse 50
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o Severe Mental Fog
o Chronic Fatigue
o Weakness
o Chronic Headaches
o Urinary urgency
o Digestive discomfort, malnutrition
o Sleep disturbances
o Visual disturbances
o Doctors Assessment: Based on the blood work the Progesterone and Estrogen is
low, Progesterone is very important for brain metabolism, need to look at
optimizing these.
o December 16, 2015 Michael Arata, MD PC
o Weight = 98 lbs, Blood Pressure 95/Undefined, Pulse 51
o Consistent symptoms & Doctors assessment
o December 23, 2015 Michael Arata, MD PC
o Weight = not noted, Blood Pressure 97/56, Pulse 52
o Consistent symptoms & Doctors assessment
A review of Fouch’s medical records provides documented evidence that she suffered a
reaction to the vaccination, which manifested in a myriad of symptoms:
• Pain where the shot was given. The medical records document that Ms. Fouch had pain
and redness where the shot was given. .
• Swelling of the entire arm where the shot was given, severe pain.
• Fever
• Headache
• Tiredness
• Malaise
• Nausea
• Stomachache
• Body Ache, Sore Joints
In Ms. Fouch’s case her adverse reaction was severe, as stated in the vaccine risk
literature, Figure 1 “A severe allergic reaction could occur after any vaccine (estimated less than
1 in a million doses).” Unfortunately for Jessica she was a one in a million, she exhibited
severe swelling at the injection site, had pain and an onset of a severe headache an hour after the
vaccine followed by a myriad of new painful and debilitating symptoms that progressed from
then until the present.
The proceeding information summarizes her progressing symptoms that followed the
original reaction symptoms beyond what has been discussed above:
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• Limb tingling
• Limb numbness
• Limbs randomly falling asleep
• Bee type stinging sensations
• Exercise intolerance
• Brain fog
• Delayed mental processing
• Fatigue
• Feeling of fullness
• Gastroperisis, physical wasting
From the medical records Jessica’s doctors provided a consistent diagnosis of a reaction
to the vaccine. The unfortunate reality is that her illness though seen by many physicians has
been very difficult to arrive at the exact diagnosis; this is often the case for persons suffering
from Dysautonomia. In most cases the person suffering may not get an accurate diagnosis for
years, even from the most experienced physicians. It is only from the families’ persistence to
find a cause and treatment through many doctor visits and through the hiring of a concierge
physician who sought out doctors specializing in the Autonomic Nervous System (ANS), was a
Dysautonomia specialist found. From the preceding medical reports the following information
summarizes Ms. Fouch’s treating physician’s diagnoses:
• Dr. Georgio – from the medical report – “possible reaction to preservative in Tdap”
• Dr. Hannauer – from the medical report – “Likely the post-vaccine reaction triggered her
headaches and extreme fatigue”
• Dr. Davidson – from the medical report – “post vaccine reaction”
• Dr. Mahwinney – from the medical report – “reaction to pertussis ingredient”
• Dr. McCurdy – from the medical report “vaccine reaction”, “myalgia/arthralgia and most
recently from her expert opinion “ASIA”
• Dr. Matsumoto – from the medical report – “Transformed Migraine/Chronic daily headache is
a likely large component of her problem, which is likely triggered by her reaction to the
vaccine”.
• Dr. Stuppy – from the medical report – “Dysautonomia”
• Dr. Gold – from her expert opinion – “Dysautonomia”
• Dr. Arata – from the medical report – “Autonomic Dysfunction”
To disregard her treating physician’s medical reports and opinions would be a disservice
to them and Ms. Fouch who is the one suffering the consequences.
Information from the vaccine literature:
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Ms. Fouch’s early post Tdap symptoms manifested consistent with a vaccine reaction as
documented in the Vaccine Risk Literature, her symptoms are highlighted in Figure 1, many of
which persist to present. After becoming ill from the vaccine, she has been seen by many
doctors and specialists to help understand the root cause of the illness and to find treatments in
an effort to regain her health and active life. From the lab work there are evidences of a
reaction to the vaccine, she had a higher than normal sedimentation rate indicating
inflammation. Any level of inflammation is known to cause varied forms of ill health in
individuals. She also had indications of abnormal T-cells, B & T Lymphocytes, new food and
pollen allergies, and high anti-histone antibodies beyond 6 months of having the vaccine, this is
more than likely the cause of her autoimmune and neurological symptoms and subsequent
autonomic dysfunction. The fact that she continues to have ill health from the onset of the
vaccine suggests that it was a trigger causing a reaction and cascading ill health effects that
continue. This will be discussed further under the Althen Theory later in this report.
Quoting from the vaccine risk literature: “With any medicine, including vaccines, there is a
chance of side effects. These are usually mild and go away on their own, but serious reactions
are also possible. Brief fainting spells can follow a vaccination, leading to injuries from falling.
Sitting or lying down for about 15 minutes can help prevent these. Tell your doctor if you feel
dizzy or light-headed, or have vision changes or ringing in the ears.” This is why vaccines are
tested and why continued studies are done to ensure that safety is progressing along with
medicines being used to help the public from disease and from vaccine injuries.
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Figure 1 Vaccine Reaction Literature
In Ms. Fouch’s first 14 years of life she had 48 medical visits most of which were routine
well checks or vaccine related. Following her adverse reaction to the Tdap on June 18, 2011 she
has had over 400 medical related visits to address the injury, symptoms and related
complications.
Althen theory:
1) A medical theory causally connecting the vaccination and the injury
The proceeding information summarizes a plausible theory for Jessica’s vaccine reaction
based on the medical facts and and/or interpretation of lab reports, symptoms and personal
evaluation of Ms. Fouch’s condition.
Mild problems following Tdap (Did not interfere with activities)
• Pain where the shot was given (about 3 in 4 adolescents or 2 in 3 adults)
• Redness or swelling where the shot was given (about 1 person in 5)
• Mild fever of at least 100.4°F (up to about 1 in 25 adolescents or 1 in 100 adults)
• Headache (about 3 or 4 people in 10)
• Tiredness (about 1 person in 3 or 4)
• Nausea, vomiting, diarrhea, stomach ache (up to 1 in 4 adolescents or 1 in 10 adults)
• Chills, body aches, sore joints, rash, swollen glands (uncommon)
Moderate problems following Tdap
(Interfered with activities, but did not require medical attention)
• Pain where the shot was given (about 1 in 5 adolescents or 1 in 100 adults)
• Redness or swelling where the shot was given (up to about 1 in 16 adolescents or 1 in 25
adults)
• Fever over 102°F (about 1 in 100 adolescents or 1 in 250 adults)
• Headache (about 3 in 20 adolescents or 1 in 10 adults)
• Nausea, vomiting, diarrhea, stomach ache (up to 1 or 3 people in 100)
• Swelling of the entire arm where the shot was given (up to about 3 in 100).
Severe problems following Tdap
(Unable to perform usual activities; required medical attention)
• Swelling, severe pain, bleeding and redness in the arm where the shot was given (rare).
A severe allergic reaction could occur after any vaccine (estimated less than 1 in a
million doses)
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• Jessica had an arthus reaction, headache and an onslaught of negative autoimmune and
neurological symptoms and a myriad of new allergies brought on following the 2011
Tdap inoculation. Jessica had no other traumatic events in close proximity that may have
triggered her illness.
o Arthus Reaction – Etymology: Nicholas M. Arthus, French physiologist, 1862-
1945 – “a rare, severe, immediate nonatopic hypersensitivity reaction to the
injection of a foreign substance, that usually is not irritating but in certain
individuals is antigenic. The reaction is thought to involve the formation of an
antigen-antibody complex that activates complement. Acute local inflammation,
usually in the skin and marked by edema, hemorrhage, and necrosis, occurs at the
site of injection.” From the medical reports Ms. Fouch had an Arthus Reaction.
Ms. Fouch had a localized reaction that was characterized by pain, swelling,
induration and edema. Hers occurred within 48 hours. The reaction was due to
circulating antigen-antibody complexes formed when there was a large amount of
circulating antibodies prior to injection of the antigen. This resulted in massive
swelling at the injection site that involved the entire limb.
o Fever – Fever is a common systemic reaction that was observed in Ms. Fouch’s
condition post immunization. This typically occurs within 72 hours of
immunization, which was true in Ms. Fouch’s case. The known theory here is that
the injected proteins affected her bodies heat regulation causing a low-grade fever.
o Nausea – from the medicaldictionary.com: “an unpleasant sensation vaguely
referred to the epigastrium and abdomen, with a tendency to vomit. Nausea may be
a symptom of a variety of disorders, some minor and some more serious. Nausea is
usually felt when nerve endings in the stomach and other parts of the body are
irritated. The irritated nerves send messages to the center in the brain that controls
the vomiting reflex. When the nerve irritation becomes intense, vomiting results.
Nausea and vomiting may be set off by nerve signals from many other parts of the
body besides the stomach. For example, intense pain in almost any part of the body
can produce nausea. The reason is that the nausea-vomiting mechanism is part of
the involuntary autonomic nervous system. Nausea can also be precipitated by
strong emotions.” As described in the definition, the theory here is that nerves in
Ms. Fouch’s stomach were irritated from her bodies’ response/negative reaction to
one or more of the vaccine ingredients.
o Chronic Immunological Issues: The VICP medical respondents have pointed out
that Ms. Fouch had a history of illness since her 1998 case of Eustachian tube
dysfunction at the age of 21 months, and then later in 2009 at the age of 11 years a
case of “influenza”. Though both of these illnesses occurred, they were normal
fleeting childhood illnesses that are not related to each other and further were many
years apart and by the unremarkable medical history were not chronic. The
Jessica Fouch
18
evidence is clear in her childhood medical records and more importantly her lack
of medical attention and reported general well-being and ability to thrive prior to
the 2011 Tdap inoculation. After studying the medical records, I note that Ms.
Fouch did not have a history of headaches, she did have one episode of a sinus
pressure headache, but not a chronic and consistent history of headaches. There is
no doubt that Ms. Fouch as an adolescent was a high achiever and goal driven in
all areas academically, athletically and socially. With this in mind, it is possible
that her immunity was low at the time of the Tdap, she had a demanding schedule
and was likely putting internal pressure on herself to maintain her stellar
performance in all areas of life. There were indications of her low immunity
following the flu in 2009 at age 11, she mentioned more frequent common colds
than before. This may indicate a low or compromised immune system. I cannot
argue that she was a thriving and driven individual with no impact on her life,
because she obviously was, but as seen in the annuls of medical history, highly
driven people can carry a lot of stress and not even realize it until the perfect storm
hits. My medical opinion is that the perfect or more appropriately stated
“imperfect” storm occurred in her life when the Tdap was administered in June
2011 at age 14 triggered a disease process. Please reference figure 2 to see a
graphic picture of her medical history, which clearly provides a picture of health
pre-Tdap.
Jessica Fouch
19
Figure 2 – J. Fouch Doctor Visits since Birth
Jessica Fouch
20
o We know from the annuls of medical history that vaccines are generally safe for
most people, in this rare case Ms. Fouch was not most people, following the
vaccination she got very sick fast, with a myriad of neurological and autoimmune
complications. The graph in figure 2 demonstrates a remarkable medical history
following the Tdap vaccine.
o The science behind the theory: It is understood in the medical community that
acellular vaccines are immunogenic and their responses vary by vaccine. Pertussis
antibody levels rapidly wane, but promptly increase after vaccination, acellular
vaccines generate mixed Th1/Th2 responses in individuals. Individual reactions to
vaccines are unique to the person, most of the immunized are able to establish a
positive immune response creating an immunity to the diseases intended, however,
there are a rare few who react adversely, these adverse reactions are also unique to
the person, they cannot be put into a perfect box or unfortunately into a convenient
vaccine injury table. The medical community may generalize for convenience, but
I want to be careful not doing this in Ms. Fouch’s case, though her abnormal
ranges in sedimentation rate, T-cells, anti-histone antibodies, negative traces of
protein and leukocyte esterase, and minor deviations in peripheral blood B and T
lymphocytes are just above or below normal, they shouldn’t be ignored or
dismissed, why? Because they have triggered a negative response that is impacting
the patients health. Out of convenience for a particular cause or argument, we “the
medical professional” can’t dismiss the facts and say “it is likely she had another
virus or she was “probably” sick before the vaccine was given”. When there is an
illness where there was none before, the job of the medical professional is to
assess, diagnose and put together a supportive treatment plan to improve health.
When bacteria infects the cells of the respiratory tract, in this case the acellular
pertussis ingredient, both innate and adaptive immune responses are stimulated.
The innate immune response develops very quickly and controls bacteria
replication during the early stages of the body’s response, Ms. Fouch’s system did
this quite well. While the innate immune system recognizes bacteria-infected cells
through mechanisms that are not antigen-specific, the cytokines produced during
this early phase of the host’s defense do facilitate activation of subsequent antigenspecific
adaptive immune mechanisms, this is where things fell apart for Ms.
Fouch. An important element of the transition from the innate to the adaptive
immune response is the stimulation of Toll-like receptors (TLRs) in endosomes of
antigen-presenting cells (primarily dendritic cells). TLRs recognize and bind to
structural components such as single-stranded viral RNA, which are shared by
different pathogens, and are important triggers of the “danger signal”. Stimulation
of immunological memory from prior exposure to viral antigens (by natural
infection with the virus or through vaccination) also stimulates specific pathways
Jessica Fouch
21
in the adaptive immune response. Stimulation of immunological memory
accelerates the adaptive response, which is delayed during a primary exposure to
the antigen. A major aspect of the adaptive immune response involves virus
binding to immunoglobulin receptors on B lymphocytes, which subsequently
differentiate to plasma cells that produce virus-specific antibodies. Activation of
the adaptive immune response occurs through peptides derived from viral proteins,
which are presented on antigen-presenting cells to the T lymphocytes. Helper T
cells, through the production of cytokines, contribute to B cell proliferation and
differentiation to plasma cells, and to the activation and proliferation of virusspecific
cytotoxic T lymphocytes (CTLs). The “innate immune response” is
stimulated when cells are infected with viral, bacterial or fungal pathogens. The
bacteria/virus induces chemokine and cytokine production by infected epithelial
cells and monocytes/macrophages. These chemokines attract immune cells to the
site of infection, including macrophages, neutrophils and natural killer (NK) cells,
causing inflammation which was proven in Ms. Fouch’s case with a high
sedimentation rate. These in turn produced additional cytokines, chemokines and
other antiviral proteins. This process activates a number of immune cells,
including those of the adaptive immune response. Implications for the
immunopathogenesis of the virus; high levels of cytokines are produced in the
inflammatory, antiviral response to large quantities of virus or bacteria that may be
produced in the absence of an adaptive immune response. The adaptive immune
system must mount a primary response, which may or may not be delayed because
of a lack of prior exposure. The Th cells are critical in understanding Ms. Fouch’s
illness. In a natural viral infection, the Th 1 cells “help” in fighting the intruder.
In this case Ms. Fouch’s protective response to the pertussis antigen is fought with
the Th 2 cells which is a “humoral” response. Her body produced a large quantity
of specific antibodies to block the antigen, however, the antibodies could not get
into the cells to fight them or could not kill the infected cells. Therefore, Ms.
Fouch’s body had no choice other than to internalize the foreign antigen, not
manifesting as pertussis, but rather setting in motion a chronic illness with a Th2
antibody response. Essentially, her body could not neutralize and/or expel the
intruding foreign antigen manifesting in a negative immune reaction. A
predominant Th1 response would have generated a cell-mediated action serving to
both neutralize the foreign antigen by producing antibodies and to stimulate the
immune cells necessary to kill any cells carrying it. When this Th1 response was
suppressed, unfortunately for Ms. Fouch, it became hazardous to her health. The
induction of the Th2 response drove the foreign antigen deeper into her interior
causing a chronic illness. Having a balance of Th1/Th2 cells in the body creates
immune balance and is required for optimum health. Chronically infected cells,
like nerve cells, can trick the immune system into reacting to, and attacking similar
Jessica Fouch
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nerve cells resulting in a negative autoimmune response, this is indicated in her
IGg high histone antibodies (1.7 units) and high IGE (223 IU/mL). With Th2-
dominance the person is more susceptible to intracellular organisms such as viruses
and is, therefore, more prone to chronic ear, respiratory, and gastrointestinal
infections. Ms. Fouch has and continues to suffer from gastrointestinal issues.
These type of illnesses triggered by vaccines are rare, but for the misfortunate like
Ms. Fouch some explanation is needed to both help future vaccine studies and
support her treatment plan.
o Allergic Reaction: Ms. Fouch did not have a severe anaphylaxis reaction
following the 2011 Tdap vaccine, but she did exhibit mild or acquired Anaphylaxis
symptoms, which were manifested in her bradycardia symptoms (Near-fainting or
fainting (syncope), dizziness, weakness, fatigue, easily tiring during physical
activity). These symptoms occurred following the vaccine and persist to this day.
Additionally, she developed many new allergies that manifested in tongue and
mouth tingling and blistering, if these reactions were not noticed immediately she
may have had severe complications. Adverse reactions to vaccines can be local or
systemic and can be immediate or delayed in onset. Contact hypersensitivity
reactions to vaccine constituents in susceptible individuals can be identified by
patch testing. Ms. Fouch was known to have only a cherry fruit and a penicillin
allergy prior to the Tdap vaccination in 2011. Along with her negative immune
response and neurological issues she also had an onslaught of new allergies, these
symptoms are not a coincidence, rather they are a result of her reaction to the
vaccine. Dr. Davidson MD and Dr. Garcia-Loret MD immunology performed a
battery of potential allergen patch testing as well as known allergens from the
vaccine ingredients, Ms. Fouch was found to have a myriad of pollen, nut and food
allergies following the vaccine, but nothing of note from the vaccine ingredients
tested. In this case either the vaccine component is present in insignificant
amounts or possibly insufficient to provoke elicitation in patch testing. As known
in the medical profession there is a unique interaction when the ingredients are
given intramuscularly that provide a reaction from a different mechanism than in
patch testing. This fact is demonstrated in article (add ref and information). Every
vaccination will produce allergy antibodies. And the more potent a vaccine with
aluminum or toxoid additives (adjuvants), the greater the risk for allergy and life
threatening anaphylaxis to any of the injected ingredients, this is a widely
recognized risk of vaccination as published in CDC literature. This risk of
anaphylaxis and allergy has become a reality for a rising number of children over
the last 20 years as vaccines have increased in number and potency. Allergic
sensitization occurs when a protein(s) that is ingested, inhaled or injected, manages
to evade enzymatic modification or detoxification and gain access to the
Jessica Fouch
23
bloodstream. If it persists in the blood, the protein is deemed a threat and the body
sets up a defense that includes antibodies such as IgE (immunoglobulin epsilon) on
subsequent exposure to the protein this antibody triggers the release of histamine.
Histamine causes inflammation and the contraction of smooth muscle. Symptoms
include hives, constricted airways, vomiting, diarrhea, a drop in blood pressure and
possibly death. Again, it is well understood in the medical community and
published in the vaccine statistics that allergic reactions are rare, but have been
documented in medical research. Please review Figure 3, which outlines where
Ms. Fouch’s histamine production is abnormal causing her chronic problems.
Figure 3 – J. Fouch Histamine Production
o There are resulting health issues with abnormal histamine production. There
has been much research describing the various chemicals released by cells,
Jessica Fouch
24
especially the Th cells and the receptors on cell membranes capable of reacting
to these chemicals. The chemicals (cytokines, interleukins) released by T cells
act as signals interacting with satellite dish like receptors on all cell membranes,
especially the cells of the nervous system. Similarly, chemical communication
signals from the nervous system (neurotransmitters, neurohormones) can react
with T-cell satellite dishes. T-cell chemicals can react and affect the entire
brain. The concept that science now employs is psychoneuroimmunology. So,
what you think can affect your nervous and immune systems as well as the
immune and nervous system affecting how you think. Think of this as an
inverse placebo effect. When the immune system is out of balance and
depressed, it sends out interleukins which react with the brain, generating
anxiety, depressed moods and depressed thinking related to ill health, “what
will go wrong next” or “I can’t do this or that anymore because I have a
headache or chronic fatigue”, “my friends won’t understand” etc. This type of
thinking excites the sympathetic (flight or fight) nervous system and the cycle
keeps on streaming out of control. This of course is complicated, but provides
some insight into what Ms. Fouch is going through. Once in a pattern of
immune imbalance as seen with a Th2 vaccine-conditioned immune responses
produce abnormal neurological and psychological patterns which can then
affect all other body systems. Patterns of subluxation have been shown to result
from and enhance sympathetic activity. Therefore, patterns of immune
imbalance can generate subluxation and vice versa. Once in this illness pattern
following the vaccine, Ms. Fouch’s x-rays showed subluxation and through
chiropractic intervention/correction of otherwise chronic subluxation. Other
factors that condition as well as support a Th2-dominant immune pattern and
should be avoided is stress or anything that harms normal Gram-negative
bacteria and suppress Th1 cells such as highly processed sugars, caffeine, transfatty
acids, or anything creating oxidative damage.
2) A logical sequence of cause and effect showing that the vaccination was the
reason for the injury
• Ms. Fouch’s adverse reaction followed the vaccine reaction information referenced in
Figure 1 above. She received the vaccine and then symptoms manifested. Shortly after
the inoculation she felt warm was light headed, dizzy, felt tired, had a severe headache
and not long after her arm was severely swollen. A logical sequence has been established
backed by medical and symptomatic evidence has been outlined in “Althen theory #1”
above.
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3) A showing of a proximate temporal relationship between vaccination and
injury
• Ms. Fouch received the vaccine on June 18 2011, shortly after she felt warm (temp was
measured at home at ~1020
F), was light headed, dizzy, felt tired, had a severe headache
and not long after her arm was severely swollen. Note in paragraph #2 below
highlighted, the vaccine manufacture states that many people do not have serious side
effects. Although rare, this indicates that some do. In Ms. Fouch’s case the vaccine
triggered her negative reaction, which began the disease process outlined herein under
“Althen theory #1”.
• What are the risks? The risks stated by Sanofi Pasteur the Tdap manufacturer and CDC
risk literature are similar, the manufacture’s literature is quoted below and as stated in the
literature; “This is not a complete list of possible side effects”. This simply indicates that
the literature is not comprehensive and cannot possibly list every possible outcome.
1) “SIDE EFFECTS:
Pain, swelling, or redness at the injection site may occur. Headache, tiredness,
body aches, nausea, diarrhea, fever, chills, vomiting, or sore/swollen joints may also
occur. Acetaminophen or ibuprofen (non-aspirin) may be used to reduce soreness. If
any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision
changes, numbness/tingling, or seizure-like movements have happened after vaccine
injections. Tell your health care provider right away if you have any of these
symptoms soon after receiving an injection. Sitting or lying down may relieve
symptoms.
Remember that your doctor has prescribed this medication because he or she has
judged that the benefit to you is greater than the risk of side effects. Many people
using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: high
fever (higher than 104 degrees F/40 degrees C), muscle weakness, difficulty
breathing.
A very serious allergic reaction to this drug is rare. However, get medical help
right away if you notice any symptoms of a serious allergic reaction, including: rash,
itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble
breathing.
This is not a complete list of possible side effects. If you notice other effects not
listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects.”
Description and Impact of diagnosed illness:
Jessica Fouch
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What is dysautonomia?
Dysautonomia is a medical term utilized for a group of complex conditions that are
caused by a malfunction of the autonomic nervous system (ANS). The ANS regulates all of the
unconscious functions of our bodies, including our cardiovascular system, gastrointestinal
system, metabolic system and endocrine system. A malfunction of the ANS can cause
debilitating symptoms and may pose significant challenges for effective medical treatment.
Who gets dysautonomia?
Researchers have discovered a genetic predisposition toward developing dysautonomia
conditions. A genetic predisposition does not mean that everyone in that family is destined to
develop the conditions.
Childhood dysautonomia conditions typically (but not always) strike adolescents after the
onset of puberty, often after a period of very rapid growth. There is a female to male ratio of
five to one. Some of the patients report a sudden development of symptoms after a viral illness,
immunization or trauma. Others may see a more gradual onset. Although very rare, children
may be born with serious non-familial forms of dysautonomia. There is also a distinctive form
of dysautonomia called Familial Dysautonomia (FD) that has been identified in individuals of
Ashkenazi Jewish descent.
Symptoms
Symptoms: -tachycardia (fast heart rate) -bradycardia (slow heart rate) -orthostatic
hypotension (low blood pressure when upright) -orthostatic intolerance (the inability to remain
in an upright position) -syncope and near syncope (fainting) -severe dizziness -excessive
fatigue -migraines -gastrointestinal issues -nausea -insomnia -shortness of breath –
thermoregulatory issues
Ms. Fouch’s diagnosis
Abnormal heart rate variability – The recording lasted for 23 hours and 59 minutes. The
fastest heart rate was 162 bpm and the slowest heart rate was 40 bpm. More specific details can
be found in the Holter ECG Report from Innovative Ambulatory Solutions.
Jessica Fouch
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Impact:
Anxiety -tremulousness -frequent urination -cognitive impairment (brain fog) -visual
blurring or tunneling –seizures. Various medications are commonly utilized and each is fine
tuned to the particular patient. Medications will also typically require ongoing adaptations as
the patient physiologically develops and changes. The hope is to be able to obtain enough
symptom relief to initiate a gentle reconditioning program.
In people suffering from dysautonomia, the autonomic nervous system loses that balance,
and at various times the parasympathetic or sympathetic systems inappropriately predominate.
Symptoms can include frequent vague but disturbing aches and pains, faintness (or even actual
fainting spells), fatigue and inertia, severe anxiety attacks, tachycardia, hypotension, poor
exercise tolerance, gastrointestinal symptoms, sweating, dizziness, blurred vision, numbness
and tingling, pain, and — quite understandably — anxiety and depression. Sufferers of
dysautonomia can experience all these symptoms or just a few of them.
They can experience one cluster of symptoms at one time, and another set of symptoms at
other times. The symptoms are often fleeting and unpredictable, but on the other hand they can
be triggered by specific situations or actions. (Some people have symptoms with exertion, for
instance, or when standing up, or after ingesting certain foods.) And since people with
dysautonomia are usually normal in every other way, when the doctor does a physical exam he
or she often finds no abnormalities.
Because the physical exam and laboratory tests are usually quite normal, doctors (being
trained in the sciences, and thus, trained to expect objective evidence of disease) often write
people with dysautonomia off as being nuts (or, less unkindly, as being “anxious”).
What the VICP should know:
Children who have dysautonomia struggle with some of the most basic functions that
healthy people take for granted, beginning with getting out of bed in the morning. Each day and
each moment brings new and unexpected obstacles. Yet, young individuals with dysautonomia
face each day with profound courage and incredible strength, despite the betrayal of an
uncooperative body.
Dysautonomia conditions are widely unknown. Because of this, there exists a shocking
ignorance about the lifestyle impact on these young people and their families. What
dysautonomia patients need most is support, understanding and encouragement to help them
deal with this complex, debilitating and poorly understood group of disorders.
Debra L. Dominelli is the president/founder of Dysautonomia Youth Network of America, Inc.
Jessica Fouch
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The symptoms of dysautonomia conditions are usually “invisible” to the untrained eye.
The child can appear to be as healthy as other children. The manifestations occur internally, and
although the symptoms are quantifiable and verifiable medically, they often are not visible on
the outside. Symptoms can be unpredictable, may come and go, appear in any combination and
may vary in severity (wax and wane).
Often patients become more symptomatic after a stressor or activity. Patients may find
themselves involuntarily limiting their lifestyle activities in order to compensate for their
conditions. Symptoms can sometimes be so severe that some children may require placement in
homebound teaching programs for health impaired students; others will be able to attend school,
often with modifications in their educational plans. The social isolation experienced by not
being able to attend school or community activities is one of the hardest things for these
children to deal with.
Since youth with dysautonomia are usually normal in appearance, it can be a hard
condition for people to understand. Even general physicians sometimes miss the clues leading
to a proper diagnosis. Families often find themselves desperately traveling great distances to the
few pediatric dysautonomia specialists throughout the country for a proper diagnosis and
innovative treatment.
The financial burden placed upon these families is often significant. Chronic illness
counseling is at times recommended to help the patients and their families deal with the impact
of the conditions on their lives.
Treatment:
Today Ms. Fouch is still seeking weekly medical attention mainly neurological feedback to
address her “brain fog/mental fatigue and neurological processing issues”, chiropractic to
ensure optimal spinal function to support autonomic functions and physical therapy to protect
against muscle atrophy and bone density. Additionally, she reports constant headache that
varies in intensity, fatigue, occasional prickling in limbs, stiff/achy joints, stomachaches, and
malaise or a general ill feeling.
Fortunately for Ms. Fouch, she has had medical support of her illness since the 2011
TDAP, none more traumatic than her hospital stay in 2014. Too often symptoms get dismissed
if they don’t exactly fit the description of what it is supposed to look like under a typical
scenario. When her malnutrition became severe Dr. McCurdy’s request to get Jessica to the
hospital was lifesaving. Using an IV for hydration, good foods and a balanced approach for her
recovery has been critical. Even with an improved nutritional status we do not know what is
lurking, but we do know that her road remains bumpy. She continues to possess autoimmune
Jessica Fouch
29
disease symptoms that have been reported and will need to be supported going forward (i.e.
headache, fatigue, weakness, brain fog, stomach aches etc). As read in Dr. Rose (medical
respondent) et al’s Lyme disease study it was made clear that doctors take different approaches
to treating patients (i.e. patients are treated differently for the same problem). This was
certainly true in Ms. Fouch’s hospital stay. Her stay was approximately 3 weeks long that
involved many doctors, some that understood her plight and became more invested, and others
with limited time only reacted to what they saw in front of them, which was a malnourished
young adolescent. These approaches really made a difference in how the doctors cared for her.
Ms. Fouch was rightly treated for malnourishment as a priority. As per the hospital records,
during her stay some doctors treated her as if it was a self-induced eating behavior, if the time
was taken to understand her background, in hindsight it is it clear that her symptoms pointed to
an autonomic dysfunction. Ms. Fouch also had been suffering from autoimmune symptoms
since June of 2011 and further, had reported feelings of fullness (Gastroperisis symptoms) as
early as April 2012. Today, Ms. Fouch continues to have gastric issues. She is continuing her
nourishment with a balanced organic food diet that has increased over time to 3000+ calories
daily. Her weight has been stabilizing, but does still fluctuate by several lbs. She is currently
below 100 lbs. which is low for her age, height and more importantly her calorie intake.
Pre-TDAP Ms. Fouch was a healthy person full of life, she was active in school,
gymnastics and socially with her friends. Today she struggles with an autonomic dysfunction
that continues to make a “normal” consistent life impossible, but rather one that has to be
carefully managed to minimize debilitating symptoms.
Ms. Fouch’s treating caregivers have made a big difference in her ability to cope, she could
not be doing what she is doing without them!
• Chiropractic – John Bergman, DC has taken Jessica’s fragile skeletal structure and
reduced/eliminated subluxation enabling her ANS to function the best it can. The
evidence is in the x-rays. The before and after x-rays are incredibly positive. Without
this treatment Jessica would be struggling even more mightily than she is.
• Metabolic & Functional Medicine – Michael Arata, M.D., has prescribed neurofeedback
therapies that have been helpful. These therapies are enabling Jessica to have more
mental space to function. The evidence is in the before and after neurological brain map
reports.
• Rheumatology – Dr. Debra McCurdy, MD continues to see Jessica and provide a good
baseline and support for her, tracking blood work etc.
• Psychology – Dr. Kelly Mother, PhD is helping Jessica cope with the reality of her illness
and provide the psychological therapy to support her mental health.
• Physical Therapy – Amy Kramer, DPT is supporting Ms. Fouch’s physical conditioning
via specific exercises.
Jessica Fouch
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The ensuing question is why do these treatments help? Are they curative or simply
supportive? The answer is in the presenting evidence that they are supportive. At times Ms.
Fouch has to miss appointments, when she does she regresses. Certainly there is a mental
aspect to this (placebo effect), but there is also an organic effect on the benefit obtained through
these treatments. What is happening in biological terms that can explain her illness and how the
benefits tie to her diagnosis? Ms. Fouch is receiving these treatments under her parents health
insurance, going forward into adulthood Jessica will need health care support to receive
beneficial treatments.
Final remarks and conclusions:
This report provides a clear evaluation of Ms. Fouch’s childhood health prior to her Tdap
inoculation on June 18, 2011. This evaluation is established through her medical records,
childhood pediatrician letter and letter from her gymnastics coach. Next the report establishes
evidence in justification of the three-pronged Althen test. 1) A reliable medical theory has been
clearly established by treating physicians and medical references. 2) In Jessica’s case a sound
logical sequence of cause and effect showed that the Tdap vaccine in fact could cause a
negative autoimmune response demonstrated by the vaccine manufacturer and CDC vaccine
risk literature, and the fact that Jessica exhibits autoimmune reactive symptoms that are
substantiated by medical lab work and expert medical opinion. 3) The proximate temporal
relationship between vaccination and injury has been established under prongs #1 and #2 and is
further supported by Jessica’s treating physician’s medical records and expert opinions.
In conclusion, Ms. Fouch was a healthy adolescent until she received the Tdap vaccine on
June 18, 2011 when soon after she exhibited adverse symptoms as outlined in the vaccine risk
literature and has become chronically ill from a negative autoimmune response that has
impacted her nervous system since that time. Based on the preponderance of the evidence and a
rational Althen theory it is more likely than not from a statistical probability standpoint that Ms.
Fouch was injured by the vaccine that has triggered her ill health.
Ms. Fouch’s post vaccine illness satisfies the Althen burden set forth by the VICP. Ms.
Fouch suffers from Dysautonomia, which is difficult to diagnose and is illusive to experienced
physicians, sometimes taking years to diagnose as the patient seeks care from many physicians
trying to get help and understanding of why their health is failing. By the preponderance of the
evidence, if not for her vaccination Ms. Fouch would not have experienced a negative reaction
and had been plagued with this illness. The vaccination was a substantial factor if not the sole
reason for her injury and subsequent illness. Ms. Fouch’s claim demonstrates a clear temporal
association and a logical and relevant medical/scientific theory that is supported both by
Jessica Fouch
31
medical records and the opinions of her treating physicians. Additionally, there is no reasonable
theory, causal relationship and/or evidence that something other than the vaccine caused the
injury and subsequent illness.
Jessica Fouch
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References (this needs a lot of work):
1) Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition.
Walker HK, Hall WD, Hurst JW, editors. Boston: Butterworths; 1990.
https://www.ncbi.nlm.nih.gov/books/NBK400/
2) Respondent’s Exhibit E – Fouch v. HHS, No. 13-799V Expert Report of Carlos D.
Rose, M.D.
3) VAERS – CDC Tdap Vaccine Information Statements (VIS)
http://www.cdc.gov/vaccines/hcp/vis/vis-statements/tdap.html
http://www.cdc.gov/vaccines/hcp/vis/vis-statements/tdap.pdf
4) RxList – the Internet drug index – Adacel Tdap Side Effects Risks
http://www.rxlist.com/adacel-side-effects-drug-center.htm
http://www.hindawi.com/journals/jt/2014/491316/
5) CDC Public Health Statement – Aluminum CAS # 7429-90
http://www.atsdr.cdc.gov/ToxProfiles/tp22-c1-b.pdf
6) Adacel Tdap Description – http://www.drugs.com/pro/adacel-tdap.html
http://www.hindawi.com/journals/jt/2014/491316/
7) CDC – Vaccine Side Effects/Risks – http://www.cdc.gov/vaccines/parents/vaccinedecision/side-effects.html
8) Blood Differential Test – Written by Heather Ross and Tim Jewell, Medically
Reviewed by Judith Marcin, MD on August 30, 2016
http://www.healthline.com/health/blood-differential#2
9)

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)).
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).
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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.