In the United States Court of Federal Claims
No. 02-1314V
Filed: May 5, 2017
*************************************
*
BRUCE ANDERSON and *
DONNA ANDERSON, as parents * Autism Spectrum Disorder;
of R.A., a minor * Measles-Mumps Rubella Vaccine;
* Mitochondrial Disease;
Petitioners, * Vaccine Act, 42 U.S.C. §§ 300aa-1
v. * to -34;
* Vaccine Rules of the United States
SECRETARY OF HEALTH AND * Court of Federal Claims (“Vaccine
HUMAN SERVICES, * Rules”) 23, 27.
*
Respondent. *
*
*************************************
Sylvia Chin-Caplan, Law Office of Sylvia Chin-Caplan, Boston, Massachusetts, Counsel for
Petitioners.
Lynn Elizabeth Ricciardella, United States Department of Justice, Civil Division, Washington,
D.C., Counsel for Respondent.
MEMORANDUM OPINION AND FINAL ORDER
BRADEN, Chief Judge.
Petitioners request review of the Special Master’s November 1, 2016 Decision denying an
award under the Vaccine Act.1
I. RELEVANT FACTUAL BACKGROUND.2
On December 10, 1998, R.A. was born to Donna and Bruce Anderson. 11/1/16 Dec. at 2.
Approximately two weeks later, R.A. was assessed as a well-child during an early pediatric visit.
1
The applicable statutory provisions of the Vaccine Act are codified at 42 U.S.C. §§
300aa-1 to -34 (2012).
2
The relevant facts were derived from: the transcript of the hearing convened by the
Special Master from December 8–9, 2015 (“12/8/15 TR at 1–406”), and the Special Master’s
November 1, 2016 Decision denying compensation, see Anderson v. Sec’y of Health & Human
11/1/16 Dec. at 2. During R.A.’s first year of life, he received routine childhood immunizations,
following a vaccination schedule established by his pediatrician. 11/1/16 Dec. at 2. No growth or
developmental concerns were noted. 11/1/16 Dec. at 3.
On December 13, 1999, R.A. received his first measles-mumps-rubella (“MMR”)3 and
Varicella vaccinations.4 11/1/16 Dec. at 3. Six days later, on December 19, 1999, R.A.’s mother
called the pediatrician to report that R.A. had a high fever and was slightly congested. 11/1/16
Dec. at 3. On December 20, 1999, R.A. was examined by his pediatrician. 11/1/16 Dec. at 3.
During that visit, the Andersons reported that R.A. had been suffering from a runny nose for
several days, followed by a high fever during the past day. 11/1/16 Dec. at 3. R.A.’s temperature
was recorded as 101.6 degrees Fahrenheit (“º F”); he was alert, awake, but had clear rhinorrhea5
and nasal congestion. 11/1/16 Dec. at 3. R.A.’s pediatrician diagnosed him with a viral
syndrome/viral upper respiratory infection. 11/1/16 Dec. at 3.
On that same day, R.A. was taken to an emergency room with a high fever recorded as
105.1º F. 11/1/16 Dec. at 3–4. The emergency room staff took blood cultures and started R.A. on
an antibiotic, and R.A. was discharged on that day. 11/1/16 Dec. at 4.
On December 21, 1999, the Andersons took R.A. to his pediatrician, to follow up to the
emergency room visit. 11/1/16 Dec. at 4. In the pediatrician’s office, R.A. registered a 102.2º F
fever, but he was described as awake and alert with clear rhinorrhea. 11/1/16 Dec. at 4. His
pediatrician assessed R.A. with a probable viral illness. 11/1/16 Dec. at 4. On December 22, 1999,
R.A.’s mother reported to his pediatrician that R.A.’s condition was improving and that he was
Servs., No. 02-1314V, 2016 WL 82562278 (Fed. Cl. Spec. Mstr. Nov. 1, 2016), ECF No. 106
(“11/1/16 Dec.”).
3
The MMR vaccine is a “combination of live attenuated measles, mumps, and rubella
viruses, administered subcutaneously for simultaneous immunization against measles, mumps, and
rubella in persons 12 months of age or older.” See DORLAND’S ILLUSTRATED MEDICAL
DICTIONARY 2016 (32d ed. 2012) (“DORLAND’S”) at 2016. Measles is a “highly contagious viral
disease caused by a paramyxovirus.” See id. at 1115. Although measles usually is benign,
“complications may sometimes occur, including secondary bacterial infections, such as otitis
media, pneumonia, or laryngitis.” See id. at 1116.
Mumps is “an acute infectious disease caused by a paramyxovirus called mumps virus.”
See id. at 1188. “[T]he principal manifestation is parotitis, usually associated with painful swelling
of one or both parotid glands and sometimes other salivary glands.” See id.
Rubella is “an acute, usually benign, infectious disease caused by viruses of genus
Rubivirus[.]” See id. at 1657.
4
Varicella vaccine is a “live attenuated virus vaccine prepared from human herpesvirus 3
(varicella-zoster virus) [that is] administered subcutaneously.” See DORLAND’S at 2017.
5
Rhinorrhea is “the free discharge of a thin nasal mucus.” See DORLAND’S at 1640.
2
eating and drinking well. 11/1/16 Dec. at 4. In January 2000, R.A. saw his pediatrician three
times. 11/1/16 Dec. at 4. On January 20, 2000, R.A. had a cold for two days with pink, swollen
eyes. 11/1/16 Dec. at 4. R.A.’s pediatrician diagnosed R.A. with conjunctivitis.6 11/1/16 Dec. at
4. On January 28, 2000, R.A. had a fever and was reported as clinging and fussy, with decreased
appetite and bright red and white tonsils. 11/1/16 Dec. at 4. R.A. was diagnosed with exudative7
tonsillitis. 11/1/16 Dec. at 4. On January 30, 2000, R.A. also had a red area at the base of his
penis that his pediatrician diagnosed as a probable penile adhesion due to pulling.8 11/1/16 Dec.
at 4.
On March 3, 2000, R.A. visited his pediatrician with a fever and sore throat, and was
diagnosed with pharyngitis and a viral-like rash. 11/1/16 Dec. at 4. On March 22, 2000, R.A.
again saw his pediatrician for a fifteen month well-child visit where it was noted that R.A. was
developing, walking well, and saying about five words. 11/1/16 Dec. at 4–5.
In June 2000, R.A. visited his pediatrician for an eighteen month well-child visit. 11/1/16
Dec. at 5. R.A. was described as a healthy eighteen-month old, however, two developmental
concerns were noted: R.A. did not “really follow commands” and would not point out pictures in
books. 11/1/16 Dec. at 5.
On September 11, 2000, R.A. visited his pediatrician for a twenty-one month well-child
visit. 11/1/16 Dec. at 5. The pediatrician observed developmental concerns and recommended a
speech and hearing evaluation. 11/1/16 Dec. at 5.
On December 6, 2000, R.A. visited his pediatrician for a two-year well-child visit. 11/1/16
Dec. at 5. Because R.A.’s developmental delays were more pronounced, his pediatrician
recommended that R.A. have a genetic consultation. 11/1/16 Dec. at 6.
Starting in January 2001, R.A. was tested for behavioral, genetic, and biological issues.
11/1/16 Dec. at 6.
On January 11, 2001, R.A. was evaluated by Laura Bailet, Ph.D., a neurocognitive
specialist. 11/1/16 Dec. at 6. The Andersons informed Dr. Bailet that R.A.’s motor coordination
was fair, but his language skills were poor. 11/1/16 Dec. at 6. Although R.A. spoke his first words,
6
Conjunctivitis is an “inflammation of the conjunctiva, generally consisting of
conjunctival hyperemia associated with a discharge.” See DORLAND’S at 405. The conjunctiva is
“the delicate membrane that lines the eyelids and covers the exposed surface of the sclera[.]” See
id.
7
Exudation is the “escaping of fluid, cells, and cellular debris from blood vessels and their
deposition in or on the tissues, usually as the result of inflammation.” See DORLAND’S at 665. The
adjective “exudative” refers to that process. See id.
8
“Penile adhesions in circumcised boys occur when the penile shaft skin adheres to the
glans of the penis.” See Children’s Hospital of Philadelphia, Penile Adhesion (2014), http://
www.chop.edu/conditions-diseases/penile-adhesions.
3
prior to turning one, subsequently he experienced very slow language progression, e.g., R.A. could
say a few words, but mostly he babbled and pointed to things he wanted. 11/1/16 Dec. at 6. But,
Dr. Bailet noted that “no history of frank language regression was reported.” 11/1/16 Dec. at 6.
On January 25, 2001, Dr. Bailet saw R.A. for a second evaluation when she concluded that R.A.
evidenced developmental delays and mild behavioral characteristics that could be associated with
autism. 11/1/16 Dec. at 6.
On January 31, 2001, R.A. also was evaluated by Dr. Daniel Shanks, a pediatric
neurologist. 11/1/16 Dec. at 6. Dr. Shanks recorded that there was no evidence of developmental
regression in R.A., as opposed to a more general failure to progress developmentally. 11/1/16
Dec. at 6. Dr. Shanks’ examination of R.A. also revealed no significant difficulties with motor
development, other than being clumsy and having loose joints. 11/1/16 Dec. at 6. Dr. Shanks
diagnosed R.A. with static encephalopathy,9 a communication disorder spectrum, and
recommended genetic testing. 11/1/16 Dec. at 6–7.
On February 5, 2001, R.A. received a genetic evaluation from Dr. Pamela Arn that revealed
normal chromosomes. 11/1/16 Dec. at 7. Dr. Arn noted that initially R.A.’s mother was concerned
about R.A.’s development when he was fifteen months old, but R.A.’s motor milestones were
normal, although his verbal skills were delayed. 11/1/16 Dec. at 7.
On April 12, 2001, R.A. was evaluated by Dr. Donald George, a gastroenterologist for
dietary control that could affect behavior. 11/1/16 Dec. at 7. Dr. George noted that the Andersons
became concerned about R.A.’s developmental delay in the fall of 2000 and R.A. began taking a
wide variety of supplements and proprietary vitamins, based on recommendations from
independent specialists that the Andersons consulted. 11/1/16 Dec. at 7.
On June 7, 2001, R.A. was evaluated by Dr. Karoly Horvath, a pediatric gastroenterologist
who performed endoscopies, biopsies, and microbiologic analysis of R.A.’s body fluid cultures,
but found no significant abnormalities or pathology. 11/1/16 Dec. at 7.
On November 12, 2001, R.A. was re-evaluated by Dr. Bailet. 11/1/16 Dec. at 7. At that
time, R.A. was 25 months old. Dr. Bailet observed that R.A.’s language skills were at an 18-month
level, but R.A. scored as moderate-to-severely autistic on the autism rating scale. 11/1/16 Dec. at
7.
9
Static means “at rest; in equilibrium; not in motion.” See DORLAND’S at 1767.
Encephalopathy refers to “any degenerative disease of the brain.” See id. at 614.
4
Beginning in 2001, R.A. started receiving treatment from Dr. Dan Rossignol and Dr.
Jeffrey Bradstreet,10 two “Defeat Autism Now” (“DAN!”) doctors.11 11/1/16 Dec. at 8. They
prescribed intravenous infusions of immunoglobulin, vitamin C, secretin, Solu-Medrol, and
glutathione. 11/1/16 Dec. at 8.
In 2001, R.A. also periodically was tested for various markers of metabolic abnormalities,
including ammonia, lactic acid, and liver enzymes aspartate transaminase and alanine
transaminase. 11/1/16 Dec. at 9. Dr. Bradstreet was of the opinion that some of R.A.’s tests were
significant, as they evidenced a low free and total carnitine,12 increased lactate, and increased
ammonia. 11/1/16 Dec. at 9–10. But, R.A.’s test results suggesting the existence of abnormal
biochemical markers were inconsistent; other tests showed that R.A.’s free and total carnitine,
lactate, and ammonia were normal. 11/1/16 Dec. at 10.
In May 2002, Dr. Bradstreet evaluated R.A. for a possible seizure disorder, and recorded
an electroencephalogram (“EEG”),13 that indicated episodes of 3-cycle spikes and waves lasting
less than 1.5 seconds. 11/1/16 Dec. at 9. Thereafter, R.A. was diagnosed with “absence
seizures.”14 11/1/16 Dec. at 9.
10
Dr. Bradstreet was a practicing physician who proposed a causal link between the MMR
vaccine and autism. See, e.g., Hearing Before The Committee On Government Reform, June 19,
2002, Serial No. 107-121, available at https://www.gpo.gov/fdsys/pkg/CHRG-107hhrg82358
/html/CHRG-107hhrg82358.htm (site last visited February 13, 2017).
11
In 2001, DAN! was composed of doctors and medical professionals who believed that
autism could be caused by vaccines. See Lisa Jo Rudy, What Was the DAN! (Defeat Autism Now)
Protocol?, VeryWell (Feb. 18, 2017), https://www.verywell.com/dan-defeat-autism-now-is-no-
more-3971489. DAN! doctors “[were] trained to treat autism as a biomedical disorder caused by
a combination of lowered immune response, external toxins from vaccines and other sources, and
problems caused by certain foods.” See Biomedical Treatment for Autism Spectrum Disorders,
Autism Society, http://www.autismlarimer.org/biomedical.html (last visited February 14, 2017).
Accordingly, DAN! doctors often recommended nutritional supplements, special diets, testing for
hidden food allergies, treatment of intestinal yeast or bacterial overgrowth, and detoxification of
heavy metals. See id.
12
Carnitine is a “betaine derivative found in skeletal muscle and liver; it is required for
mitochondrial beta oxidation of fatty acids, carrying the acyl group (fatty acids) across the
mitochondrial membrane to the matrix, where they are transferred back to coenzyme A prior to
oxidation . . . . Deficiency of carnitine leads to buildup of fatty acids in the body.” See DORLAND’S
at 297.
13
An electroencephalogram is “a recording of the potentials on the skull generated by
currents emanating spontaneously from nerve cells in the brain.” See DORLAND’S at 600.
14
Absence seizures are characterized by staring spells that last 1–10 seconds, and, unlike
grand mal seizures, do no result in the subject falling to the ground. 11/1/16 Dec. at 9 fn. 9.
5
In 2003, R.A. began receiving care at Progressive Pediatrics, where he received regular
intramuscular immunoglobulin from October 2003 until January 2005. 11/1/16 Dec. at 9. R.A.
also received three weekly treatments in a hyperbaric chamber during the summer of 2005. 11/1/16
Dec. at 9. R.A. continued to receive care at Progressive Pediatrics until at least 2010. 11/1/16
Dec. at 9. From 2003 until 2010, R.A.’s diagnosis was “active autism.”15 11/1/16 Dec. at 9.
On February 6, 2008, more than seven years after R.A. received the MMR vaccine, Dr.
Bradstreet concluded that “[R.A.] suffered neurological, gastrointestinal, and immune system
injuries and dysfunction as a result of encephalitis, chronic diarrhea, and inflammatory bowel
disease (IBD) from his [MMR] vaccination at 12 months of age.” 11/1/16 Dec. at 8 (bold and
emphasis added). This is the first medical record that linked the MMR vaccine to R.A.’s autism
diagnosis and placed the onset of his developmental symptoms at the time of vaccination. 11/1/16
Dec. at 8.
In 2008, R.A. was referred to Dr. John Shoffner, a specialist in mitochondrial disorders.
11/1/16 Dec. at 10. On July 22, 2008, Dr. Shoffner evaluated R.A. to determine whether his
developmental limitations were attributable to a defect in cellular energetics or another type of
metabolic disease. 11/1/16 Dec. at 10. Dr. Shoffner reviewed R.A.’s medical history and
conducted a series of tests, including muscle biopsies and metabolic studies. 11/1/16 Dec. at 10.
Thereafter, Dr. Shoffner diagnosed R.A. with a mitochondrial disease and renal tubule
dysfunction.16 11/1/16 Dec. at 10. This diagnosis relied on the timing of R.A.’s developmental
difficulties, including the fact that R.A. developed normally until his MMR vaccination at 12
months; but, after the vaccination, R.A. developed a high fever, but it was not associated with
concurrent neurological changes. 11/1/16 Dec. at 10–11. In addition, R.A. received another
vaccine at 16–17 months of age, that also was associated with a fever; and, by 17–18 months, R.A.
experienced a regression of skills, including a loss of speech, motor skills, cognitive ability, and
receptive/expressive speech. 11/1/16 Dec. at 11.17 Dr. Shoffner also relied on numerous
evaluations of metabolic marker tests, including free and total carnitine levels, lactose levels, and
the concentration of amino acids in R.A.’s cerebral spinal fluid, blood plasma, and urine. 11/1/16
Dec. at 11. Although other tests were within normal range, R.A.’s urine showed elevations of
multiple amino acids, including taurine, glutamine, and cysteine. 11/1/16 Dec. at 11. Based on
15
During this period, R.A. received a significant number of medications and supplements,
including: Gamunex immunoglobulin; Secreflo secretin; gluthathione and cysteine; Zyrtec;
Spironolactone; Methyl-B12; Digest Right 1; Nordic Natural Cod Liver Oil; Probiotic Pearls;
Ther-Biotic Complete; Nordic Natural ProEPA; calcium and magnesium tablets; Child Essence
Multi-Vitamin; FolaPro; L-carnitine; Coenzyme Q10; Ester-C; taurine; zinc; Nasalcrom; and Ayr
Saline. 11/1/16 Dec. at 9.
16
The renal tubule is a portion of the nephron, “the anatomical and functional unit of the
kidney.” See DORLAND’S at 1241.
17
Although Dr. Shoffner’s diagnosis relied upon a regression of skills, no regression of
skills was recounted in the pre-2008 medical records reviewed by the Special Master. 11/1/16
Dec. at 11.
6
the increased urine amino acids, Dr. Shoffner concluded that R.A. had a proximal renal tubule
defect also causing a generalized aminoaciduria.18 11/1/16 Dec. at 11.
On July 22, 2008, Dr. Shoffner performed a biopsy of R.A.’s skeletal muscles to conduct
enzymology tests. 11/1/16 Dec. at 11. Dr. Shoffner also assessed the functioning of mitochondria
Complexes I through IV to determine the activity of the enzymes.19 11/1/16 Dec. at 11. One of
two assays20 evaluating Complex I suggested reduced enzyme activity. 11/1/16 Dec. at 12. The
overall Complex I assay results, however, fell within the normal range to a 95 percent confidence
interval. 11/1/16 Dec. at 12. Only one of the two assays evaluating Complex IV indicated reduced
activity. 11/1/16 Dec. at 12. Dr. Shoffner’s biopsy also showed a reduction in citrate synthase—
an important enzyme marker in the mitochondria that provides a proxy measurement of
mitochondrial content in the muscle. 11/1/16 Dec. at 12. Dr. Shoffner also examined R.A.’s
muscle fibers, and observed a moderate size variation due to atrophy of R.A.’s Type II muscle
fibers. 11/1/16 Dec. at 12. Dr. Shoffner’s histochemical and immunochemical analyses, however,
were unremarkable. 11/1/16 Dec. at 12.
Based on Dr. Shoffner’s evaluation, R.A. was diagnosed with a “probable oxidative
phosphorylation disease,” a Complex I mitochondrial defect, and autism spectrum disorder with
proximal renal tubule defect.21 11/1/16 Dec. at 12. Following the recommendation of Drs.
Bradstreet and Shoffner, R.A.’s supplements were targeted to address mitochondrial function.
11/1/16 Dec. at 12.
On December 30, 2013, R.A. also was evaluated by Dr. Frances Kendall, a clinical
biochemical geneticist. 11/1/16 Dec. at 12. Dr. Kendall determined that there were two mutations
present in R.A. that have been linked to intellectual disability, neurodevelopmental disorders, and
18
Aminoaciduria refers to an “excess of amino acid acids in the urine.” See DORLAND’S
at 61.
The term “Complex I” describes a group of proteins in the mitochondria that are integral
19
to the production of cellular energy. 11/1/16 Dec. at 12 n.17. “Typically, five protein complexes
(referred to as Complex I–V) work in sequence in the mitochondria to produce cellular energy.”
11/1/16 Dec. at 12 n.17.
An assay is a “determination of the amount of a particular constituent of a mixture.”
20
DORLAND’S at 166.
Oxidative phosphorylation is “the formation of high energy phosphate bonds by
21
phosphorylation of the ADP to ATP coupled to transfer of electrons . . . via the electron transport
chain.” See DORLAND’S at 1439. The electron transport chain is a process that occurs within the
inner mitochondrial membrane, and is associated with the production of the molecule adenosine
triphosphate (“ATP”) from adenosine diphosphate (“ADP”) and phosphate. See DORLAND’S at
335. Phosphorylation is “the metabolic process of introducing a phosphate group into an organic
molecule.” See DORLAND’S at 1439.
7
autism. 11/1/16 Dec. at 12. Dr. Kendall, however, concluded that “it is purely speculative as to
whether or not they are causative for [R.A.].” 11/1/16 Dec. at 12.
After Dr. Shoffner’s evaluation, R.A.’s physical and mental development improved.
11/1/16 Dec. at 13. By December 2015, R.A. could maintain significant physical activity for 3–6
hours a day. 11/1/17 Dec. at 13. Although R.A.’s development improved with time, R.A.’s
abstract thinking was not as advanced as others his own age. 11/1/16 Dec. at 12–13.
II. PROCEDURAL HISTORY.
A. The Omnibus Autism Proceedings.
On October 1, 2002, Donna Anderson and Bruce Anderson (“Petitioners”), on behalf of
their son R.A., filed a Short-Form Petition for Vaccine Compensation under the National
Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10 to -34 (the “Vaccine Act”). By filing a
Short-Form Petition, Petitioners opted into the “Omnibus Autism Proceeding.” ECF No. 3.
The Omnibus Autism Proceeding was a consolidated proceeding instituted by the United
States Court of Federal Claims’ Office of Special Masters to adjudicate the principal issues in the
approximately 5,000 claims alleging a relationship between vaccines and autism spectrum
disorder. Autism General Order #1, AUTISM MASTER FILE (Fed. Cl. Spec. Mstr. July 3, 2002)
(establishing the Omnibus Autism Proceeding); 22 see also Hazlehurst v. Sec’y of Health & Human
Servs., 604 F.3d 1343, 1345 (Fed. Cir. 2010) (describing the purpose of the Omnibus Autism
Proceeding). During the Omnibus Autism Proceeding, Petitioners were represented by a panel of
attorneys known as the Petitioners’ Steering Committee (“PSC”). Autism General Order #1 at 4,
AUTISM MASTER FILE (Fed. Cl. Spec. Mstr. July 3, 2002).
On December 20, 2006, the PSC elected to pursue three separate theories of “general
causation,” regarding the relationship between vaccines and autism spectrum disorder. Autism
Update-May 25, 2007 at 6, AUTISM MASTER FILE (Fed. Cl. Spec. Mstr. May 25, 2007). The first
theory was that a combination of the MMR vaccine and thimerosal-containing vaccines23could
cause autism. Id. at 6. The second theory was that thimerosal-containing vaccines, alone, could
cause autism, and the third theory was that the MMR vaccine, alone, could cause autism. Id. at 6.
The PSC elected to pursue the three “general causation” theories through individual “test cases.”
Id. at 6–7. Petitioners’ case was selected as a “test case” for the third theory of “general causation,”
i.e., that the MMR vaccine, alone, could cause autism. ECF No. 24.
22
The Autism Master File constitutes the record of the Omnibus Autism Proceeding. The
complete file is maintained by the Clerk of the United States Court of Federal Claims and is
available for inspection. An electronic version of the file is maintained on the website of United
States Court of Federal Claims at http://www.uscfc.uscourts.gov.
23
Thimerosal is an “organomercurial antiseptic . . . used as a topical anti[-]infective and a
preservative in pharmaceutical preparations.” See DORLAND’S at 1918.
8
On January 26, 2007, Petitioners’ case was assigned to Special Master Vowell.
But, on September 29, 2008, the PSC decided not to pursue the third theory of “general
causation,” because it was not significantly “distinct” from the first theory, i.e., that the MMR
vaccine and thimerosal-containing vaccines, together, could cause autism. Autism Update-
September 29, 2008 at 3, AUTISM MASTER FILE (Fed. Cl. Spec. Mstr. Sept. 29, 2008).
On that same day, Special Master Vowell issued an Order, requiring Petitioners to file a
Status Report by October 17, 2008, explaining whether Petitioners preferred to remain in the
Omnibus Autism Proceeding and pursue their claim under the first or second theories of “general
causation” or pursue their case based on the third theory on an individual basis, outside of the
Omnibus Autism Proceeding. ECF No. 24.
On October 10, 2008, Petitioners filed a Status Report stating that Petitioners decided to
remain in the Omnibus Autism Proceeding, pending decisions on the “combined Thimerosal and
MMR” test cases, i.e., the cases brought under the PSC’s first theory of “general causation.” ECF
No. 25 at 1. Petitioners also represented they were not requesting a case-specific hearing. ECF
No. 25 at 1. On October 14, 2008, Special Master Vowell issued an Order, granting Petitioners’
request for this case to remain in the Omnibus Autism Proceeding. ECF No. 26 at 2.
In 2009, the Office of Special Masters issued decisions on the three test cases that relied
on the first theory of “general causation;” these decisions rejected the theory that a combination of
thimerosal-containing vaccines and the MMR vaccine could cause autism. See Cedillo v. Sec’y of
Health & Human Servs., No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009)
aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y of Health
& Human Servs., No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d 88
Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y of Health & Human
Servs., No. 01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706
(2009).24
In 2010, the Office of Special Masters issued decisions on the three test cases that relied
on the second theory of “general causation;” these decisions rejected the theory that thimerosal-
containing vaccines, alone, could cause autism. See Dwyer v. Sec’y of Health & Human Servs.,
No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec’y of Health &
Human Servs., No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v.
Sec’y of Health & Human Servs., No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12,
2010).25
On January 12, 2011, the Office of Special Masters issued an Autism Update to advise the
petitioners in the Omnibus Autism Proceeding that they either needed to pursue their claims as
24
The petitioners in Snyder did not appeal the decision of the United States Court of Federal
Claims to the United States Court of Appeals for the Federal Circuit.
25
The petitioners in the test cases brought under the second theory of “general causation”
did not appeal the decisions issued by the Office of Special Masters.
9
individual cases under a new causation theory or voluntarily dismiss their claims. Autism Update-
January 12, 2011 at 3, AUTISM MASTER FILE (Fed. Cl. Spec. Mstr. Jan. 12, 2011).
B. As An Individual Case.
On August 9, 2011, Petitioners filed a Motion, requesting that Special Master Vowell allow
Petitioners to obtain all medical records pertaining to R.A. and his mother, Donna Anderson. ECF
No. 28. On August 15, 2011, Special Master Vowell granted that Motion. ECF No. 29.
On November 14, 2011, Petitioners filed a Motion To Strike Petitioners’ Exhibits 1–7.
ECF No. 30. On that same day, Special Master Vowell granted the Motion. ECF No. 31. On
November 29, 2011, Petitioners filed Medical Records as Petitioners’ Exhibit 20. ECF No. 33.
On that same day, Special Master Vowell also issued a Scheduling Order, requiring Petitioners to
file an Amended Petition, Medical Records, and a Statement of Completion
On January 13, 2012, Petitioners filed Medical Records as Petitioners’ Exhibit 21. ECF
No. 34. On January 30, 2012, Petitioners filed the January 30, 2012 Affidavit of Bruce Anderson
as Petitioners’ Exhibit 22, and a May 21, 2011 Affidavit of Bruce Anderson and Donna Anderson
as Petitioners’ Exhibit 23. ECF No. 35. On that same day, Petitioners filed a Statement of
Completion, informing Special Master Vowell that all medical records were filed with the Office
of Special Masters. ECF No. 36.
On February 1, 2012, Petitioners filed an Amended Petition. ECF No. 39. On that same
day, Petitioners filed the February 1, 2012 Supplemental Affidavit of Bruce Anderson as
Petitioners’ Exhibit 24. ECF No. 38.
On March 1, 2012, Special Master Vowell convened a status conference to discuss the next
steps in the case, in light of the recently filed Amended Petition and Statement of Completion. On
March 2, 2012, Special Master Vowell issued an Order, requiring Petitioners to file an Expert
Report by May 1, 2012. ECF No. 40. That date subsequently was extended to August 28, 2012.
ECF No. 41.
On August 28, 2012, Petitioners filed a Motion For Extension Of Time And Approval Of
Expert’s Retainer Agreement. ECF No. 44. On September 12, 2012, the Government filed a
Response, opposing Petitioners’ Motion For Approval Of Expert’s Retaining Agreement, arguing
that the expert’s cost was unreasonably high. ECF No. 45. On October 15, 2012, Special Master
Vowell issued an order granting Petitioners’ Motion For Extension Of Time, but denying
Petitioners’ Motion For Approval Of Expert’s Retainer Agreement. ECF No. 47. Afterwards,
Petitioners filed several unopposed motions for extensions of time, within which to file their Expert
Reports and Medical Records; these motions were also granted by Special Master Vowell.
On August 11, 2014, Petitioners filed Medical Records as Petitioners’ Exhibit 25. ECF
No. 64. On August 19, 2014, Petitioners filed Medical Records, as Petitioners’ Exhibit 26. ECF
No. 65.
On October 1, 2014, after receiving additional extensions of time, Petitioners filed the
expert report of Dr. Ahm Mahbubul Huq, as Petitioners’ Exhibits 27 and 28. ECF No. 66.
10
* * *
On November 13, 2014, the case was reassigned to Special Master Brian H. Corcoran.
ECF No. 69 at 1. On December 5, 2014, Special Master Corcoran convened a telephone status
conference and issued a Scheduling Order requiring parties to submit a joint status report and
proposing dates for a hearing before February 13, 2015.
On February 6, 2015, the Government filed the Expert Report of Dr. Bruce Cohen as
Government’s Exhibits A–B (“Gov’t Exs. A–B”). ECF No. 71.
On March 10, 2015, Special Master Corcoran issued a scheduling order and set a hearing
date for December 8, 2015. ECF No. 74.
On May 11, 2015, Petitioners filed a Supplemental Expert Report by Dr. Huq, as
Petitioners’ Exhibit 29. ECF No. 76. On May 20, 2015, Petitioners filed six articles referenced
by Dr. Huq in his Expert Report. ECF No. 77. Petitioners explained that those articles were not
available when Dr. Huq’s report was filed. ECF No. 77.
On June 10, 2015, Petitioners filed Medical Records, as Petitioners’ Exhibits 30–36. ECF
No. 79 at 1. On that same day, Petitioners also filed additional Medical Records, as Petitioners’
Exhibits 37–38. ECF No. 80.
On September 3, 2015, Petitioners re-filed medical literature, as Petitioners’ Exhibits 27
and 29. ECF No. 82. On the same day, Petitioners also filed additional medical literature, as
Petitioners’ Exhibits 39–40, and also filed their Pre-Hearing Submissions. ECF Nos. 83, 84.
On September 18, 2015, Petitioners filed a Motion For Interim Attorney’s Fees and Costs.
ECF No. 85 at 1. On September 25, 2015, the Government filed a Response. ECF No. 86 at 1.
On October 2, 2015, the Government filed Pre-Hearing Submissions. ECF No. 87. On
October 21, 2015, the Government filed a Witness List. ECF No. 88. On October 27, 2015,
Petitioners filed medical records, as Petitioners’ Exhibit 41. ECF No. 89. On that same day,
Petitioners filed a Supplement to Petitioners’ Pre-Hearing Submission, that included a short
explanation of the medical articles and availability of the witnesses. ECF No. 90 at 1. Also on
that same day, Petitioners filed medical literature, the transcript of an August 26, 2009 meeting of
the Committee To Review Adverse Effects Of Vaccines, and a Powerpoint presentation from that
meeting, as Petitioner’s Exhibits 42–52. ECF Nos. 91, 92. Finally, on that same day, Petitioners
also filed a Reply Brief to the Government’s Pre-Hearing Submissions. ECF No. 93.
On October 29, 2015, Special Master Corcoran issued an Unpublished Decision, denying
Petitioners’ interim attorney’s fees and costs in response to Petitioners’ September 18, 2015
Motion. ECF No. 94.
From December 8–9, 2015, Special Master Corcoran convened an evidentiary hearing,
including testimony from the parties’ experts Drs. Huq and Cohen. 12/8/15 TR at 1–406.
Thereafter, Special Master Corcoran issued an Order advising the parties to file Post-Hearing
Briefs. ECF No. 96.
11
On May 10, 2016, the Government filed the Post-Hearing Brief. ECF No. 104. On the
same day, Petitioners also filed the Post-Hearing Brief. ECF No. 105.
On November 1, 2016, Special Master Corcoran issued a Decision Denying Compensation,
finding that Petitioners did not meet their burden to establish that the MMR vaccine had a
connection to R.A.’s autism spectrum disorder diagnosis. See Anderson v. Sec’y of Health &
Human Servs., No. 02-1314V, 2016 WL 8256278 at *28 (Fed. Cl. Spec. Mstr. Nov. 1, 2016);
11/1/16 Dec. at 41. On November 29, 2016, Petitioners filed a Motion For Interim Attorney’s
Fees And Expenses. ECF No. 107.
On December 1, 2016, Petitioners filed a Motion For Review (“Pet. Mem.”) with the
United States Court of Federal Claims. ECF No. 110. The case was assigned to the undersigned
judge. ECF No. 111. On December 16, 2016, the Government filed a Response to Petitioners’
November 29, 2016 Motion For Interim Attorney’s Fees And Expenses. ECF No. 113.
On January 3, 2017, the Government filed a Response to Petitioners’ December 1, 2016
Motion For Review. ECF No. 115.
III. DISCUSSION.
A. Jurisdiction.
The United States Court of Federal Claims has jurisdiction to review the decision of a
Special Master in a vaccine-related injury case, pursuant to 42 U.S.C. § 300aa-12(e)(2) and
Vaccine Rule of the United States Court of Federal Claims (“Vaccine Rule”) 23(a). After
reviewing the Special Master’s decision, the court may:
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision,
(B) set aside any findings of fact or conclusion of law of the special master found
to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law and issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with
the court’s direction.
42 U.S.C. § 300aa-12(e)(2); see also Vaccine Rule 27 (same).
B. Standard Of Review.
Congress authorized the United States Court of Federal Claims with jurisdiction to review
conclusions of law made by Special Masters under the Vaccine Act de novo, i.e., under a “not in
accordance with law” standard. See 42 U.S.C. § 300aa-12(e)(2)(B); see also Saunders v. Sec’y of
Health & Human Servs., 25 F.3d 1031, 1033 (Fed. Cir. 2004) (“Fact findings are reviewed by [the
United States Court of Appeals for the Federal Circuit], as by the [United States Court of Federal]
Claims Court judge, under the arbitrary and capricious standard; legal questions under the ‘not in
accordance with law’ standard; and discretionary rulings under the abuse of discretion standard.”
12
(quoting Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992)));
Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1527 (Fed. Cir. 1991) (“The ‘not in
accordance with the law’ aspect of the standard of review is . . . involved . . . [where there is]
dispute over statutory construction or other legal issues.”).
Factual findings of a Special Master should be set aside only if they are found to be
“arbitrary and capricious” or if the Special Master has abused his/her discretion in making these
findings. See 42 U.S.C. § 300aa-12(e)(2)(B). But, the United States Court of Appeals for the
Federal Circuit has held that there is “no uniform definition of this standard,” and instructed that
the decision of a Special Master may be found to be “arbitrary and capricious,” only if he/she:
relied on factors which Congress has not intended [the Special Master] to consider,
entirely failed to consider an important aspect of the problem, offered an
explanation for its decision that runs counter to the evidence . . . or is so implausible
that it could not be ascribed to a difference in view or the product of agency expertise.
Hines, 940 F.2d at 1527–28 (quoting Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983)). Discretionary rulings are to be reviewed under an “abuse of discretion
standard.” Munn, 970 F.2d at 870 n.10.
C. The Elements And Burden Of Proof In Vaccine Act Cases.
The Vaccine Act provides that a petitioner may receive compensation and other relief, if
injury can be established, either by causation-in-law or causation-in-fact. Causation-in-law is
established if one of the vaccines listed in the Vaccine Injury Table at 42 U.S.C. § 300aa-14(a)
(“Vaccine Table”) was administered and the “first symptom or manifestation of onset” of specific
adverse medical conditions associated with the use of each vaccine occurred within a time period
specified in the Vaccine Table. See 42 U.S.C. § 300aa-14(a); 42 C.F.R. § 100.3(a). And, the
Vaccine Table is to be read and interpreted by reference to “qualifications and aids to
interpretation,” that define the key terms used therein. 42 U.S.C. § 300aa-14(b).
Congress also afforded a petitioner with an opportunity to receive relief under the Vaccine
Act, even if the time period for the first symptom or manifestation of a specified injury is not listed
in the Vaccine Table, i.e., for an “off-Table” vaccine injury. See 42 U.S.C. §§ 300aa-
11(c)(1)(C)(ii), 300aa-13. In these cases, a petitioner must establish causation-in-fact, by offering
sufficient facts to establish each element of a vaccine injury claim, and meet the burden of proof
as to each element by a “preponderance of the evidence” standard. See 42 U.S.C § 300aa-13.
In Capizzano v. Secretary of Health & Human Services, 440 F.3d 1317 (Fed. Cir. 2006),
the United States Court of Appeals for the Federal Circuit re-affirmed the three-part test
established in Althen v. Secretary of Health & Human Services, 418 F.3d 1274, (Fed. Cir. 2005)
(“Althen”), for determining causation-in-fact in off-Table vaccine injury cases. Therein, a
petitioner is required to:
show by preponderant evidence that the vaccination brought about [the] injury by
providing:
(1) a medical theory causally connecting the vaccination and the injury;
13
(2) a logical sequence of cause and effect showing that the vaccination was the
reason for the injury; and
(3) a showing of a proximate temporal relationship between vaccination and
injury.
418 F.3d at 1278.
If a petitioner establishes causation-in-fact, then the burden of proof shifts to the
Government to establish that a factor unrelated to the vaccine was the cause of a petitioners’ injury.
See 42 U.S.C. § 300aa-13(a)(1)(B); see also Althen, 418 F.3d at 1278 (“If [a petitioner] satisfies
this burden, [she/he] is entitled to recover [damages] unless [the Government] shows, by a
preponderance of evidence, that the injury was in fact caused by factors unrelated to the vaccine.”)
(internal quotation marks omitted).
D. The Special Master’s November 1, 2016 Decision.
1. R.A. Did Not Suffer From A Secondary Mitochondrial Disease.
In this case, the Special Master first emphasized the “important point” that R.A. did not
suffer from a “primary” mitochondrial disease. 26 11/1/16 Dec. at 35. Therefore, the relevant
inquiry was whether R.A. suffered from a “secondary” mitochondrial disease.”27 11/1/16 Dec. at
35. Dr. Huq,28 Petitioners’ expert, opined that R.A. had “mitochondrial dysfunction”29 that was
significant enough to precipitate R.A.’s subsequent developmental problems. 11/1/16 Dec. at 16.
Dr. Huq’s determination was based on R.A.’s clinical history and physician opinions, and medical
evidence of: (1) dysfunction of the central nervous system, (2) gastrointestinal system problems
26
Mitochondria are cellular organelles that are present in the body’s cells and are primarily
responsible for creating energy. See DORLAND’S at 1169 (“Mitochondria generate energy[.]”).
According to Dr. Cohen, “primary” mitochondrial disease results from pathogenic mutations in
genes that regulate mitochondrial function. 11/1/16 Dec. at 23. Patients with a primary
mitochondrial disease have such symptoms as: loss of vision; dystonia; severe encephalopathy;
and eventually death. 11/1/16 Dec. at 23.
27
“Secondary” mitochondrial disease, however, is manifested by impairments to
mitochondrial function that do not result from pathogenic gene mutations, but may be triggered by
environmental stimuli, such as chemotherapy or poisons. 11/1/16 Dec. at 23.
28
Dr. Huq is a board-certified neurologist with a special qualification in child neurology
and clinical genetics. 11/1/16 Dec. at 15; see also Pet. Ex. 28 (Curriculum vitae of Ahm Mahbubul
Huq). The vast majority of Dr. Huq’s patients, however, do not have mitochondrial disorders.
1/1/16 Dec. at 15 n.21. Therefore, the Special Master weighed this factor as diminishing the value
of Dr. Huq’s testimony. 11/1/16 Dec. at 15 n.21.
Dr. Huq used the term “mitochondrial dysfunction” to describe conditions that result
29
from mitochondria that are not properly functioning, but do not manifest as “primary”
mitochondrial disease. 11/1/16 Dec. at 35.
14
(diarrhea), (3) musculoskeletal system issues (hyperextensibility), and (4) liver dysfunction (i.e.,
elevated liver enzymes). 11/1/16 Dec. at 16.
In contrast, Dr. Cohen,30 the Government’s expert, testified that there was no credible
medical evidence that R.A. had a secondary mitochondrial disease. 11/1/16 Dec. at 23–24. The
Special Master agreed, finding that the “medical record does not support that conclusion, and the
[physician] opinion and testing results relied upon for the diagnosis are either based on
demonstrably incorrect assumptions or inconclusive evidence.” 11/1/16 Dec. at 35.
Dr. Huq testified that R.A.’s history of diarrhea evidenced multisystem dysfunction, a
symptom of mitochondrial disease. 11/1/16 Dec. at 16. But, Dr. Cohen explained that patients
suffering from secondary mitochondrial disease would experience symptoms more severe than
chronic diarrhea. 11/1/16 Dec. at 24. The Special Master found Dr. Cohen’s reasoning more
persuasive, because Dr. Huq “inflat[ed] a less severe gastrointestinal problem . . . into an alarming
warning sign.” 11/1/16 Dec. at 36.
Dr. Huq testified that tests performed on R.A., from 2001 through 2010, evidenced
“bioclinical abnormalities” that were indirect markers of mitochondrial dysfunction. 11/1/16 Dec.
at 17. These abnormalities included: mildly elevated lactic levels; low free and total carnitine
levels; multiple amino acids in the urine; and elevated liver enzymes. 11/1/16 Dec. at 17. But,
Dr. Cohen questioned the reliability of the test results. 11/1/16 Dec. at 36. The Special Master
determined that Dr. Cohen persuasively established that “the lactic acid test results were
untrustworthy, and would under more generally accepted diagnostic approaches today be deemed
of far less utility in evaluating the presence of mitochondrial dysfunction.” 11/1/16 Dec. at 36.
The Special Master also found that “the enzymology testing failed to appropriately standardize
results by using the marker enzyme citrate synthase, and positive results were otherwise
inconsistent or not replicated.” 11/1/16 Dec. at 36. Therefore, the Special Master concluded that
“the test results… are not robust or trustworthy enough to find it ‘more likely than not’ that R.A.
possessed mitochondrial dysfunction.” 11/1/16 Dec. at 36.
Based on the test results, in 2008, Dr. Shoffner also diagnosed R.A. with mitochondrial
dysfunction. 11/1/16 Dec. at 24. Again, Dr. Cohen challenged this diagnosis, because Dr.
Shoffner’s assumptions about R.A.’s medical history were, in his professional judgment, not
accurate. 11/1/16 Dec. at 36. Dr. Shoffner also assumed that R.A. had experienced a regression
of skills. 11/1/16 Dec. at 36. The Special Master, however, observed that R.A.’s medical records
did not evidence signs of regression, a matter conceded by Dr. Huq. 11/1/16 Dec. at 19–20, 37.
Although the Special Master acknowledged that Dr. Shoffner was one of R.A.’s treating
physicians, nevertheless that fact alone did “not mean that [Dr. Shoffner’s] opinion automatically
[was] entitled to the level of deference and evidentiary weight given to contemporaneous treater
30
Dr. Cohen is a board-certified neurologist with 22 years of experience in mitochondrial
disease and disorders. 11/1/16 Dec. at 22–23; see also ECF No. 71-2 (Curriculum vitae of Bruce
H. Cohen). Approximately 75% of Dr. Cohen’s clinical practice concerns patients with
mitochondrial disease; as such he has seen thousands of patients during the past 15 years. 11/1/16
Dec. at 22–23. Dr. Cohen also taught courses on mitochondrial disease, and served on the Editorial
Board for the journals Mitochondrion and Pediatric Neurology. 11/1/16 Dec. at 22.
15
records in many Program cases—especially when, as here, he reached his conclusion long after
the immediately relevant time period.” 11/1/16 Dec. at 36 (citing Nuttall v. Sec’y of Health &
Human Servs., 122 Fed. Cl. 821, 832 (2015) (determining that a treating physician was not entitled
to deference when he treated the patient after the alleged vaccine injury occurred)). In addition,
the Special Master found that Dr. Shoffner’s diagnosis was unreliable, because “the testing results
he obtained were too erratic, with some supporting Petitioners’ argument while others did not.”
11/1/16 Dec. at 37.
In sum, the Special Master afforded more weight to Dr. Cohen’s testimony than Dr. Huq’s,
primarily because of Dr. Cohen’s clinical experience with patients with mitochondrial diseases.
11/1/16 Dec. at 37. And, “Dr. Cohen persuasively established that, based on his own professional
experience, [that] R.A.’s history [was] not that of a child suffering from any form of mitochondrial
disease.” 11/1/16 Dec. at 37.
2. Petitioners Did Not Satisfy the Althen Factors.
In this case, the Special Master determined that he did not need to evaluate the Althen
factors, “because Petitioners [could] not establish the keystone of their argument [i.e., presence of
mitochondrial disease].” 11/1/16 Dec. at 37. Nevertheless, the Special Master briefly addressed
each of the Althen factors. 11/1/16 Dec. at 37.
a. The First Althen Factor—A Reliable Causation Theory.
The Special Master found that “Petitioners . . . failed to offer a reliable scientific theory
linking the MMR vaccine to autism,” because “much of the scientific basis for [Petitioners’] theory
assumed developmental regression, which . . . R.A. did not experience.” 11/1/16 Dec. at 37.
Although Dr. Huq opined that R.A.’s developmental injury began with administration of the MMR
vaccine, that induced a response and initiated a cascade of events, leading to inflammation,
exacerbated by immune dysfunction, and culminating in R.A.’s subsequent development of
autism, the Special Master found that “Petitioners have offered little persuasive or reliable support
for the proposition that the MMR vaccine could initiate the ‘inflammatory cascade’ they posit
eventually, and over many months’ time, result[ed] in autism.” 11/1/16 Dec. at 38.
In addition, the Special Master found that “Petitioners’ theory relating to the connection
between mitochondrial disease and autism was similarly unreliable.” 11/1/16 Dec. at 38. The
medical literature proffered by Dr. Huq, discussed a causal reaction only in cases of primary
mitochondrial disease, that R.A. did not have. 11/1/16 Dec. at 38
The Special Master also observed that “the theory that a vaccine (in particular, the MMR
vaccine) could cause autism is one that has been consistently unsuccessful” in the Omnibus Autism
Proceeding and subsequent decisions. 11/1/16 Dec. at 38–39; see also Hardy v. Sec’y of Health &
Human Servs., No. 08-108V, 2015 WL 7732603 at *4–5 (Fed. Cl. Spec. Mstr. Nov. 3, 2015)
(referencing eleven unsuccessful autism claims, and six others that were rejected without trial).
Therefore, the Special Master determined that Petitioners failed to satisfy the first Althen factor.
11/1/16 Dec. at 40.
16
b. The Second Althen Factor—Sequence Of Cause And Effect.
The Special Master also found that R.A.’s medical record “d[id] not allow the conclusion
that R.A. experienced any reaction to the MMR vaccine.” 11/1/16 Dec. at 40. Dr. Cohen’s opinion
was that the high fever R.A. experienced, within a week of the MMR vaccination, was viral and
not a reaction from the MMR vaccine. 11/1/16 Dec. at 40. As such, the Special Master reasoned
that “[Petitioners’] allegations [were] contradicted by the contemporaneous medical records,
which identify nothing about developmental problems for R.A. prior to . . . six months after the
[MMR] vaccination.” 11/1/16 Dec. at 40.
The Special Master also discounted Dr. Shoffner’s diagnosis of mitochondrial disease,
because “the test results Dr. Shoffner relied upon were overall inconclusive and had too much
variability to conclude that R.A. suffered from a true metabolic disorder casually related to the
MMR vaccine.” 11/1/16 Dec. at 40. Therefore, the Special Master determined that Petitioners
failed to satisfy the second Althen factor. 11/1/16 Dec. at 40.
c. The Third Althen Factor—A Medically Acceptable Timeframe.
In addition, the Special Master acknowledged that “viewed loosely, the facts of this case
would fit the timeframe that Petitioners urge flows from their theory.” 11/1/16 Dec. at 41. R.A.’s
“inflammatory cascade” was triggered within a week of the MMR vaccination, but R.A. did not
exhibit developmental problems, such as being unable to follow commands or point to pictures in
books, until six months later. 11/1/16 Dec. at 41. The Special Master determined that “[viewed]
carefully, [Petitioners’] proposed timeframe d[id] not work, and ultimately reflect[ed] the temporal
reasoning rejected by controlling precedent.” 11/1/16 Dec. at 41 (citing LaLonde v. Sec’y of Health
& Human Servs., 746 F. 3d 1334, 1341 (Fed. Cir. 2014) (holding that a temporal correlation alone
is not enough to demonstrate causation). Accordingly, the Special Master found that, even if he
assumed that the MMR vaccine could trigger a developmental injury, Petitioners offered no
“literature or reliable scientific support” to show why the cognitive developmental injury did not
manifest until six months later. 11/1/16 Dec. at 41. Therefore, the Special Master determined that
Petitioners failed to satisfy the third Althen factor. 11/1/16 Dec. at 41.
E. Petitioners’ December 1, 2016 Motion For Review.
1. Petitioners’ Arguments.
Petitioners first argue that the Special Master erroneously applied the doctrine of collateral
estoppel to preclude Petitioners from presenting evidence regarding the role of measles
immunosuppression, fever, and cytokine activation in the subsequent development in R.A.’s
mitochondrial dysfunction and autistic-like sequelae. Pet. Mem. at 10. In this case, the Special
Master erroneously decided that a factual finding by another special master in a “test case” in the
Omnibus Autism Proceeding, was binding on Petitioners. Pet. Mem. at 9–10; see also
Snyder v. Sec’y of Health & Human Servs., No. 01-162, 2009 WL 332044 at *104 (Fed. Cl. Spec.
Mstr. Feb. 12, 2009) (“[P]etitioners have failed to demonstrate that the MMR vaccine caused
immunosuppression. There is no evidence that children receiving the vaccine have higher rates of
infection in the months after vaccination than children who do not receive the vaccine.”), aff’d 88
17
Fed. Cl. 706 (2009). Petitioners, however, were not party to Snyder, and therefore the Special
Master’s reliance on Snyder was erroneous as a matter of law. Pet. Mem. at 17.
Petitioners then identify six other areas where the Special Master erred. The Special Master
failed to acknowledge inconsistent testimony and contradictory evidence by Dr. Cohen that R.A.
did not suffer from mitochondrial dysfunction. Pet. Mem. at 17. Dr. Huq testified that R.A.
suffered from a mitochondrial dysfunction, and Petitioners proffered a medical study (the “Anitha
Article”),31 that demonstrated abnormal mitochondrial gene expression and electron transport
chain activity in the cerebellum, frontal, and temporal lobes of autistic children, and these brain
regions affect social communication, language function, and behavior. Pet. Mem. at 20–21.
Petitioners also proffered a post-mortem study of brain tissue taken from individuals with autism
(the “Chauhan Article”),32 that found a reduction of mitochondrial electron transport chain
complexes in those same parts of the brain. Pet. Mem. at 21. Initially, Dr. Cohen agreed with Dr.
Huq that “the post mortem brain studies conducted by Anitha and Chauhan showed altered
mitochondrial expression in the areas of the brain, from which autistic symptoms arise.” Pet. Mem.
at 22 (citing 12/8/15 TR at 375). But, Dr. Cohen subsequently declared these studies flawed,
because mitochondrial proteins degrade quickly upon death at room temperature. Pet. Mem. at
22. Dr. Cohen, however, did not offer any support for this statement. Pet. Mem. at 22.
Nevertheless, the Special Master approvingly cited Dr. Cohen’s testimony in his decision. Pet.
Mem. at 22 (citing 11/1/16 Dec. at 28).
The Special Master also ignored considerable agreement between the experts on a subset
of metabolic patients who are vulnerable to the effects of vaccination. Pet. Mem. at 23–24. Dr.
Huq testified that there are “certain individuals with inborn error of metabolism” that “could be
particularly vulnerable, and they need extra attention before we vaccinate them.” Pet. Mem. at 24.
Petitioners proffered Petitioners’ Exhibits 47 and 50 (the “Klein Article” and the “Menni Article”)
that discuss that these individuals experienced a “four-fold” risk of hospitalization within weeks
of vaccination.33 Pet. Mem. at 24. Dr. Cohen offered no comment on these articles, nor did the
Special Master. Pet. Mem. at 24–25. The Special Master, however, admitted that the articles
proffered by Petitioners support the theory that primary mitochondrial diseases are associated with
autism. Pet. Mem. at 25. The Special Master, however, found fault with Dr. Huq’s position that
secondary mitochondrial disorders can also lead to an autistic-like phenotype, although Dr. Cohen
agreed that a small percentage of patients had both mitochondrial dysfunction and autism. Pet.
31
Ayyapan Anitha et. al., Brain Region-Specific Altered Expression And Association Of
Mitochondria-Related Genes In Autism, 3 MOLECULAR AUTISM 12 (2012).
32
Abha Chauhan et. al., Brain Region-Specific Deficit In Mitochondrial Electron
Transport Chain Complexes In Children With Autism, 117 J. NEUROCHEMISTRY 209 (2011).
33
These articles were: Nicola P. Klein et. al., Evaluation Of Immunization Rates And Safety
Among Children With Inborn Errors Of Metabolism, 127 J. PEDIATRICS 1139 (2011) (Pet. Ex. 47);
Francesa Menni et. al, Vaccination In Children With Inborn Errors Of Metabolism, VACCINE
(2012), http://dx.doi.org/10.1016/j.vaccine.2012.10.012 (Pet. Ex. 50).
18
Mem. at 25. By faulting Dr. Huq’s position, the Special Master ignored “considerable agreement”
between the experts. Pet. Mem. at 25.
The Special Master failed to acknowledge numerous instances where the parties agreed on
the underlying facts. Pet. Mem. at 25. Both parties agreed that mitochondria create energy for the
body and, as a natural by-product of that energy production, generate waste products in the form
of reactive oxygen species (“ROS”). Pet. Mem. at 25–26. Both parties agreed that the body has
natural compensatory mechanisms to contain the toxic effects of ROS and when those
compensatory mechanisms fail, symptoms emerge. Pet. Mem. at 26. Both parties agreed that
fevers can occur within a week after MMR vaccination. Pet. Mem. at 26. Both parties also agreed
that R.A. was considered to be healthy at his one year old evaluation. Pet. Mem. at 26. Moreover,
both parties agreed that, in primary mitochondrial disease, “clinical deterioration” may result at
the end of a viral illness due to the body’s inability to handle “oxidative stress.” Pet. Mem. at 26.
The Special Master’s failure to acknowledge those underlying facts when making his decision was
arbitrary and capricious. Pet. Mem. at 25.
The Special Master failed to consider the logical sequence between R.A.’s vaccination and
his injuries. Pet. Mem. at 27–29. In arguing this, Petitioners posit that R.A. had a mitochondrial
dysfunction, so that the MMR vaccine induced a febrile response and initiated a cascade of
inflammation, that further exacerbated the underlying mitochondrial dysfunction, finally leading
to an autistic-like phenotype. Pet. Mem. at 28. Petitioners explain that R.A.’s regression was
gradual, because the body’s compensatory mechanisms were at work; significant impairment or
regression was not apparent until the body’s threshold limit was exceeded. Pet. Mem. at 28–20.
But this process evidences a logical sequence of cause and effect between R.A.’s vaccination and
his injuries. Pet. Me. at 29.
The Special Master’s credibility findings were arbitrary and capricious, because he failed
to take into account “numerous inconsistences” between Dr. Cohen’s testimony and medical
literature published by Dr. Cohen. Pet. Mem. at 29–42. For example, Dr. Cohen disputed Dr.
Huq’s finding that R.A. had a multisystem dysfunction. Pet. Mem. at 30. But, Dr. Cohen
previously published an article listing multi-organ system involvement as a symptom of metabolic
disorders and R.A. exhibited symptoms associated with injuries to multiple organs, including
muscle hypotonia, autism spectrum disorder, gastrointestinal problems, proximal renal tubular
dysfunction, and fatigue. Pet. Mem. at 30.
Finally, the Special Master failed to consider relevant evidence and the record as a whole
in finding no temporal relationship between the December 13, 1999 MMR vaccination and R.A.’s
symptoms and autistic-like phenotype. Pet. Mem. at 42–45. R.A.’s “inflammatory cascade” was
triggered within a week of vaccination, and then his symptoms “slowly agglomerated” until he
evidenced developmental issues six months later. Pet. Mem. at 43. Petitioners argue that this
timing is medically appropriate in R.A.’s case because “from the complex pathophysiology of this
complex interaction . . . you would expect a slow gradual evolution of the phenotype.” Pet. Mem.
at 44.
In support of this argument, Petitioners cite Paluck v. Secretary of Health & Human
Services, 786 F. 3d 1373 (Fed. Cir. 2015), wherein the United States Court of Appeals for the
Federal Circuit affirmed the United States Court of Federal Claims’ determination that the
19
petitioners’ medical theory satisfied the third Althen factor when expert testimony indicated that
vaccine induced neurodegeneration proceeds in two phases. Pet. Mem. at 45. In that case, the
first phase, “immune system activation,” occurred within a week of immunization. Pet. Mem. at
45. The second phase involved a downward spiral of activity between the mitochondria and
oxidative stress, leading to the death of brain cells and neurodegeneration. Pet. Mem. at 45. Based
on the expert testimony in Paluck, “no rigid time frame exist[s] as to when neuronal death could
be expected to occur” because the emergence of neurological regression is dependent upon the
severity and type of mitochondrial disorder. Pet. Mem. at 45–46 (citing Paluck, 786 F.3d at 1381).
Therefore, the third Althen factor was met. Pet. Mem. at 46.
For these reasons, Petitioners argue that they presented a prima facie case by preponderant
evidence that R.A. is entitled to compensation, and the Special Master’s November 1, 2016
Decision should be set aside. Pet. Mem. at 46–47.
2. The Government’s Response.
The Government responds that Petitioners are “re-argu[ing] the same evidence that was
considered and found unpersuasive by the [S]pecial [M]aster, and improperly ask[ing] this Court
to reweigh the evidence in the hope this Court will reach a different result.” Gov’t Mem. at 10.
The Special Master properly concluded the medical record Petitioners’ proffered was “too erratic,
with some [of Dr. Shoffner’s test results] supporting Petitioners’ argument while others did not,”
but “credited Dr. Cohen’s detailed testimony about each metabolic, biochemical, and genetic test
performed on R.A. that simply did not reflect mitochondrial disease or dysfunction.” Gov’t Mem.
at 14. “Simply put, R.A.’s purported mitochondrial dysfunction was not supported by
preponderant evidence and the [S]pecial [M]aster . . . properly rejected it.” Gov’t Mem. at 14.
As to the first Althen factor, Petitioners’ collateral estoppel argument is meritless. Gov’t
Mem. at 16. Nothing in the record suggests that Petitioners were barred from proffering evidence
on the role of measles immunosuppression. Gov’t Mem. at 16. The Special Master also did not
commit legal error, by citing a factual finding from the Omnibus Autism Proceeding test case
Snyder, since Petitioners voluntary opted into the Omnibus Autism Proceeding. Gov’t Mem. at
16.
With respect to Petitioners’ argument that the Special Master ignored “considerable
agreement” between the parties’ experts, Petitioners “failed to explain why this particular evidence
is so material that it outweighs all of the other evidence upon which the Special Master relied.”
Gov’t Mem. at 18.
As to the second Althen factor, the Special Master considered R.A.’s medical history and
determined “to the extent Petitioners have attempted to establish onset in late December 1999,
their allegations are contradicted by the contemporaneous medical records, which identify nothing
about developmental problems for R.A. prior to June of 2000—six months after vaccination.”
Gov’t Mem. at 19. Therefore, Petitioners failed to meet their evidentiary burden to establish the
logical sequence of cause and effect. Gov’t Mem. at 19.
Finally, with respect to Petitioners’ argument regarding the third Althen factor, the Special
Master found no temporal relationship. Gov’t Mem. at 19. Moreover, Petitioners failed to explain
20
“why it took so long [after R.A. received the MMR vaccine until the developmental side of the
injury manifested] without any demonstrable change in R.A., and the record itself also provides
no illumination on this point.” Gov’t Mem. at 20 (quoting 11/1/16 Dec. at 41).
3. The Court’s Resolution.
a. Regarding The Special Master’s Finding That R.A. Did Not
Suffer From “Mitochondrial Dysfunction.”
Petitioners’ medical theory was that R.A. suffered from an underlying secondary
mitochondrial disease or “mitochondrial dysfunction” that was aggravated by the December 13,
1999 MMR vaccination, and this aggravation, in turn, caused developmental regression
manifesting as autism spectrum disorder. 11/1/16 Dec. at 1–2, 35.
The Special Master, however, determined that Petitioners failed to meet their burden to
establish by preponderant evidence that R.A. suffered from mitochondrial dysfunction. 11/1/16
Dec. at 35.34 In coming to this conclusion, the Special Master weighed the expert testimony
proffered by both parties. 11/1/16 Dec. at 35–37. The Special Master found the Government’s
expert, Dr. Cohen, more persuasive than Petitioners’ expert, Dr. Huq, because Dr. Cohen was the
“far more experienced medical practitioner when it comes to the subject of mitochondrial diseases
and disorders, with more demonstrable expertise studying, diagnosing, and treating the condition,”
and he “persuasively established” that R.A.’s medical history did not evidence any form of
mitochondrial disease. 11/1/16 Dec. at 37.
Although Petitioners object to the Special Master’s credibility determination and
subsequent factual finding on numerous grounds, as fact finder, the Special Master was tasked
with assessing the reliability of expert testimony. See Porter v. Sec’y of Health & Human Servs.,
663 F.3d 1242, 1250 (Fed. Cir. 2011) (“[The United States Court of Appeals for the Federal
Circuit] has unambiguously explained that special masters are expected to consider the credibility
of expert witnesses in evaluating petitions for compensation under the Vaccine Act.”). The Special
Master’s “unique position to see the witnesses and hear their testimony,” requires the court to
afford substantial deference to the Special Master’s credibility determination. See Doe v. Sec’y of
Health & Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010) (“Because of the special master’s
unique position to see the witnesses and hear their testimony, such credibility assessments are
‘virtually unreviewable on appeal.’” (quoting Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1360 (2000)).
The Special Master provided a rational basis for his credibility determination, and the
November 1, 2016 Decision also reflects that he carefully considered the relevant evidence of
record, drew plausible inferences, and articulated a rational basis for his finding that R.A. did not
suffer from mitochondrial dysfunction. See Lampe, 219 F.3d at 1360. Therefore, it is not for the
34
Both parties agreed that R.A. did not suffer from the primary form of mitochondrial
disease, that is caused by an inborn genetic abnormality. 11/1/16 Dec. at 35; see also 12/8/15 TR
at 169 (“[THE GOVERNMENT]: Would it be fair, in your opinion, to characterize R.A. as having
secondary mitochondrial disorder? [DR. HUQ]: Yes.” (emphasis added)).
21
court to “reweigh the factual evidence, or to assess whether the [S]pecial [M]aster correctly
evaluated the evidence. And of course we do not examine the probative value of the evidence or
the credibility of the witnesses. These are all matters within the purview of the fact finder.” See
Munn, 970 F.2d at 871.
b. Regarding The First Althen Factor.
i. Regarding “Collateral Estoppel.”
With respect to the first Althen factor, Petitioners argue that the Special Master committed
legal error by improperly applying the doctrine of collateral estoppel to preclude Petitioners “from
presenting additional evidence on the role of measles immunosuppression . . . and its role in the
subsequent development of R.A.’s mitochondrial dysfunction and autistic-like sequelae.” Pet.
Mem. at 10. But, review of the record and the transcript of the December 8–9, 2015 hearing
demonstrates that the Special Master did not “preclude” Petitioners from proffering any evidence.
Dr. Huq testified that the measles component of the MMR vaccine can have an immunosuppressive
effect that affects mitochondrial function, and was allowed to testify to this effect, over an
objection by the Government’s counsel that he was not an immunologist. 12/8/2015 TR at 140–
42, 153. In addition, Petitioners were not precluded from proffering medical literature regarding
the immunosuppressive effect of the measles vaccination.35 Therefore, the record evidences that
the Special Master did not preclude Petitioners from proffering any medical evidence.
Petitioners also argue that the Special Master improperly relied on a factual finding in the
Omnibus Autism Proceeding test case Snyder for the proposition that the MMR vaccine’s “alleged
immuno-suppressive capacity” was a “discredited concept.” 11/1/16 Dec. at 38; see also Snyder,
2009 WL 332044, at *104 (“[P]etitioners have failed to demonstrate that the MMR vaccine caused
immunosuppression. There is no evidence that children receiving the vaccine have higher rates of
infection in the months after vaccination than children who do not receive the vaccine.”).
The Special Master’s citation of a factual finding from the Omnibus Autism Proceeding
was not improper, because Petitioners elected to take part in that Proceeding by filing a Short Form
Petition. ECF No. 3. Moreover, after Petitioners’ initial causation theory was abandoned by the
PSC,36 Petitioners nevertheless elected to continue to pursue their claim through the Omnibus
Autism Proceeding under the “combined Thimerosal and MMR” theory.” ECF No. 25. Snyder
Petitioners proffered, as Petitioners’ Exhibit 29, Tab O, Lars Smedman et. al.,
35
Immunosuppression After Measles Vaccination, 83 ACTA PAEDIATR 164 (1994).
36
Petitioners’ individual case was initially selected as a “test case” for the theory that the
MMR vaccine, alone, could cause autism. ECF No. 24. But, on September 29, 2008, the PSC
decided not to pursue the third theory of “general causation,” because it was not significantly
“distinct” from the first theory, i.e., that the MMR vaccine and thimerosal-containing vaccines,
together, could cause autism. Autism Update-September 29, 2008 at 3, AUTISM MASTER FILE
(Fed. Cl. Spec. Mstr. Sept. 29, 2008).
22
was one of the three test cases adjudicated under that theory. See 2009 WL 332044, at *2
(explaining that Snyder was a test case brought under the theory “that a combination of the MMR
vaccine and [thimerosal containing vaccines], acting in concert, cause [autism spectrum
disorder]”). By participating in the Omnibus Autism Proceeding, Petitioners agreed to allow the
Office of Special Masters to apply conclusions reached in that test case to Petitioners’ claim. See
Autism General Order #1 at 3–4, AUTISM MASTER FILE (Fed. Cl. Spec. Mstr. July 3, 2002) (“The
[Office of Special Masters] will inquire into the general causation issues involved in these cases-
-i.e., whether the vaccinations in question can cause autism and/or similar disorders, and if so in
what circumstances; and then, . . . the conclusions reached in that general inquiry will be applied
to the individual cases.” (emphasis added)).
For these reasons, the court has determined that the Special Master did not commit a legal
error by citing a factual finding from the Omnibus Autism Proceeding.
ii. Regarding Evidence Of A Vulnerable Subset Of
Metabolic Patients.
Petitioners also argue that the Special Master “ignored” proffered medical literature,
specifically the Klein Article and the Menni Article, that evidenced that children with metabolic
disorders are more likely to be hospitalized within the weeks following a vaccination than children
without metabolic disorders. Pet. Mem. at 24. But, although the Special Master did not expressly
discuss these articles in the November 1, 2016 Decision, there is a presumption that the Special
Master reviewed all proffered evidence unless he stated otherwise. See Hazlehurst, 604 F.3d at
1352 (“Even if the [S]pecial [M]aster had made no explicit reference to [certain] evidence . . . we
would presume that she considered that evidence.”); see also Medtronic, Inc. v. Daig Corp., 789
F.2d 903, 906 (Fed. Cir. 1986) (“We presume that a fact finder reviews all evidence unless . . .
explicitly express[ed] otherwise.”).
In any event, these proffered articles discussed children with primary mitochondrial
disease; i.e., mitochondrial disease that arises due to an inherited genetic abnormality. Pet. Ex. 47
at 1140 (Klein) (explaining that the article’s findings applied to children with inherited or “inborn”
metabolic disorders); Pet. Ex. 50 at 1 (Menni) (same); see also 12/8/15 TR at 217–18 (testimony
of Dr. Cohen explaining that primary mitochondrial disease is based on an inherited genetic
abnormality). But, both parties agreed that R.A. did not suffer from primary mitochondrial disease.
11/1/16 Dec. at 35; see also 12/8/15 TR at 169 (testimony of Dr. Huq that R.A. suffered from a
secondary mitochondrial disease).
For these reasons, the court has determined that the Special Master did not err with respect
to the proffered medical literature regarding vaccination of children with inborn metabolic
disorders. See 42 U.S.C. § 300aa-13(a)(1), (b) (providing that the Special Master is required to
review the “record as a whole,” including medical records, reports, and “all other relevant medical
and scientific evidence”); see also Medtronic, Inc., 789 F.2d at 906 (“We presume that a fact finder
reviews all evidence unless . . . explicitly express[ed] otherwise.”).
23
iii. Regarding Agreement Between The Experts.
Petitioners also argue that the Special Master’s rejection of their causation theory was
“arbitrary and capricious,” because he “fail[ed] to acknowledge the numerous instances where the
parties agreed on the underlying facts[.]” Pet. Mem. at 25. But, the areas of agreement identified
by Petitioners either consist of generally accepted medical principles or are otherwise immaterial.
Petitioners first argue that Drs. Cohen and Huq agreed that mitochondria generate energy
for the human body through a series of complex biochemical reactions, including oxidative
phosphorylation, and that the waste created by this process can be harmful in the absence of the
mitochondria’s compensatory mechanisms. Pet. Mem. at 25–26. The first ground of agreement
does not concern a novel medical principle, nor is it specific to R.A.’s case. See, e.g., DORLAND’S
at 1169 (“Mitochondria generate energy[.]”). The second ground of agreement again is not specific
to R.A.’s case, and simply describes why a mitochondrial defect can result in injury. The other
areas of agreement identified by Petitioners are similarly immaterial: both experts agreed that R.A.
was healthy at his one year evaluation; both experts agreed that, in primary mitochondrial
disease,37 clinical deterioration can occur at the end of a viral illness; and both experts agreed that
the measles vaccine can cause a fever, but Dr. Cohen subsequently testified that R.A.’s December
1999 fever was caused by a virus and not by the MMR vaccine (a conclusion shared by R.A.’s
contemporaneous treating physicians). Pet. Mem. at 26; see also 11/1/16 Dec. at 40 (explaining
that R.A.’s December 1999 fever was diagnosed as viral). Petitioners fail to demonstrate why the
agreement as to these facts rendered the Special Master’s finding with respect to the first Althen
factor arbitrary and capricious or otherwise contrary to law. See Munn, 970 F.2d at 871 (holding
that the court should not reweigh the factual evidence reviewed by the Special Master).
c. Regarding The Second Althen Factor.
With respect to the second Althen factor, Petitioners argue that the Special Master failed to
consider “relevant evidence” regarding the cause and effect between R.A.’s pre-existing
mitochondrial dysfunction, the December 13, 1999 MMR vaccination, and R.A.’s subsequent
autism spectrum disorder. Pet. Mem. at 27. Petitioners emphasize that R.A.’s December 20, 1999
fever was the “initiating event” of a developmental regression. Pet. Mem. at 28. Although R.A.’s
developmental regression arose gradually, this was because the body possesses compensatory
mechanisms and a “reserve capacity” of neurons, that would have slowed the manifestation of any
neurological injuries such that they did not arise until months after the December 13, 1999
vaccination. Pet. Mem. at 28–29.
Petitioners offer no grounds upon which to conclude that the Special Master’s findings that
R.A.’s medical history provided no evidence of a neurological regression, as conceded by Dr. Huq,
and R.A. did not suffer from any “tailing or progressively concerning symptoms” following the
December 20, 1999 fever, were “arbitrary and capricious.” 11/1/16 Dec. at 40. For this reason,
the court has determined that the Special Master’s finding that Petitioners had not established the
37
Both parties agreed that R.A. did not suffer from the “primary” form of mitochondrial
disease. 11/1/16 Dec. at 35.
24
second Althen factor was not arbitrary, capricious, or contrary to law. See Hazlehurst, 604 F.3d at
1349 (holding that the court should not “second-guess the [S]pecial [M]aster’s fact-intensive
conclusions, particularly where the medical evidence of causation is in dispute.”).
d. Regarding The Third Althen Factor.
With respect to the third Althen factor, Petitioners argue that, in Paluck, the United States
Court of Appeals for the Federal Circuit affirmed the United States Court of Federal Claims’
reversal of a Special Master who found no proximate temporal relationship between a vaccination
and a subsequent “neurodegeneration [i.e., regression].” See 786 F.3d at 1383–84. In that case,
however, the Special Master set a “hard and fast deadline of three weeks between vaccination and
the onset of clinically apparent symptoms of neurological injury.” See id. at 1783. Moreover, the
vaccinated child suffered a “precipitous and well-documented” neurological regression, the first
symptom of which manifested twenty-three days after the vaccination. See id. at 1376, 1381, 1384.
By five months after the vaccination, the Paluck child had fewer language skills than he had prior
to the vaccination, and by nine months after his vaccination his brain had degenerated to the point
where he had “no purposeful movements.” See id. at 1382.
In this case, the Special Master did not arbitrarily set a “hard and fast” deadline, but instead
found that Petitioners failed to explain why, in R.A.’s case, there was no sign of any neurological
injury or developmental problem until six months after the December 13, 1999 vaccination.
11/1/16 Dec. at 41. In addition, the Special Master found no evidence that R.A. suffered from a
regression, while in Paluck the child showed the first symptoms of regression within twenty-three
days of vaccination and then further regressed over the following months. 11/1/16 Dec. at 19, 40
(explaining that Dr. Huq conceded there was no evidence of regression).
For these reasons, the court has determined that the Special Master’s finding with respect
to the third Althen factor was not arbitrary, capricious, or contrary to law. See Pafford v. Sec’y of
Health & Human Servs., 451 F.3d 1352, 1358 (“[T]he Special Master’s requirement for strong
temporal evidence is consistent with the third prong of the Althen test . . . . [W]ithout some
evidence of temporal linkage, the vaccination might receive blame for events that occur weeks,
months, or years outside of the time in which scientific or epidemiological evidence would expect
an onset of harm.”).
IV. CONCLUSION.
For these reasons, the court denies Petitioners’ December 1, 2016 Motion For Review. The
Clerk of Court is directed to enter judgment accordingly.
IT IS SO ORDERED.
s/ Susan G. Braden
SUSAN G. BRADEN
Chief Judge
25