Jump v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 11-301V
Filed: November 6, 2015
* * * * * * * * * * * * * * *
H.J., * TO BE PUBLISHED
*
Petitioner, * Special Master Hamilton-Fieldman
*
v. *
* Rheumatoid Arthritis (“RA”); Entitlement;
SECRETARY OF HEALTH * Tetanus-Diphtheria-acellular-Pertussis
AND HUMAN SERVICES, * (“Tdap”) Vaccine; Immune Complexes.
*
Respondent. *
* * * * * * * * * * * * * * *
Ronald Homer, Conway, Homer & Chin-Caplan, Boston, MA, for Petitioner.
Linda Renzi, United States Department of Justice, Washington, DC, for Respondent.
RULING ON ENTITLEMENT1
On May 13, 2011, H.J. (“Petitioner”) filed a petition for compensation pursuant to the
National Childhood Vaccine Injury Act of 1986. 2 In her petition, she alleges that a Tetanus-
Diphtheria-acellular-Pertussis (“Tdap”) vaccine she received on October 10, 2008 caused her to
suffer from rheumatoid arthritis (“RA”).3 Petitioner alleges, pursuant to a medical theory based
1
This Ruling was originally filed on August 31, 2015. Ruling, ECF No. 59. On September 14,
2015, Petitioner requested her name be redacted to initials, and she moved to amend the ruling
accordingly. Motion, ECF No. 61. Respondent filed a Response to Petitioner’s Motion on
October 28, 2015 and the undersigned granted Petitioner’s Motion on October 30, 2015.
Response, ECF No. 64; Order, ECF No. 65. In the reissued Ruling, Petitioner’s name is replaced
with her initials; the remainder of the Ruling is unchanged.
2
The National Vaccine Injury Compensation Program is set forth in Part 2 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended,
42 U.S.C.A. ' 300aa-10-' 300aa-34 (2012) (“Vaccine Act” or the “Act”). All citations in this
decision to individual sections of the Vaccine Act are to 42 U.S.C.A. ' 300aa.
3
Rheumatoid Arthritis is “a chronic systemic disease primarily of the joints, usually
polyarticular, marked by inflammatory changes in the synovial membranes and articular
structures and by muscle atrophy and rarefaction of the bones. In late stages deformity and
1
on an immune complex mediated response and molecular mimicry, that her immune system was
predisposed to autoimmune diseases such as RA, and that the vaccine either caused her to
develop RA or significantly aggravated her pre-existing RA.4 Petitioner’s Post-Hearing Brief
(“Pet. Brief”) at 16-23, filed July 17, 2013. Respondent argues that Petitioner’s causation theory
lacks scientific and epidemiological support, and that it would be implausible “that it would only
take two days for an environmental trigger to cause RA symptoms.” Respondent’s Post-Hearing
Brief (“Resp. Brief”), filed July 17, 2013, at 18-22.
The undersigned finds that Petitioner’s theory and the medical records in the case have
satisfied the three-pronged test set forth in Althen v. Secretary of Health and Human Services.
418 F.2d 1274, 1278 (Fed. Cir. 2005). Specifically, Petitioner has established by preponderant
evidence that there is (1) a medical theory causally connecting the injury to the vaccination, (2)
with a logical sequence of cause and effect to establish that the vaccination she received was the
reason for her injury, and (3) that her injury followed her vaccination within a proximate time
period. Id. at 1278. Respondent has not rebutted Petitioner’s prima facie case by showing that
her injury was caused by unrelated factors. Therefore, Petitioner has established that she is
entitled to compensation.
I. PROCEDURAL HISTORY
Shortly after filing her Petition on May 13, 2011, Petitioner filed affidavits and several
medical records. See generally Petitioner’s Exhibits (“Pet. Exs.”) 1-8. On May 11 and 17, 2012,
Petitioner filed the expert report of Paul J. Utz, M.D., along with the doctor’s curriculum vitae
(“CV”) and a variety of medical literature the doctor used to support his opinion. See Pet. Exs. 9,
9A-J, 10. On October 5, 2012, Respondent filed both an expert report from Lianne S. Gensler,
M.D., Dr. Gensler’s CV, and a Rule 4(c) Report. See Respondent’s Exhibits (“Resp. Exs.”) A,
B.
Petitioner filed additional medical records on November 27, 2012 and January 3, 2013.
See Pet. Exs. 11-12. On January 4, 2013, Petitioner filed a supplemental expert report, with
supportive medical literature, from Dr. Utz. See Pet. Exs. 13, 13A. Over the next few months,
Petitioner filed three additional sets of medical records and one additional piece of medical
literature. See Pet. Exs. 14-16.5
ankylosis develop. The cause is unknown, but autoimmune mechanisms and virus infection have
been postulated.” Dorland’s Illustrated Medical Dictionary (“Dorland’s”), 157 (32nd. ed.
2012).
4
Petitioner did not argue significant aggravation in her petition, and no amended petition was
ever filed. The first time this argument is documented in the record is in Petitioner’s Pre-Hearing
Submission (“Pet. Submission”), filed April 29, 2013, at 1-2. See Subsection (V)(A), herein, for
disposition of this issue.
5
The case was reassigned to the undersigned on March 4, 2013.
2
On April 29, 2013, Petitioner filed a Pre-Hearing Submission and two additional medical
literature articles. See Pet. Exs. 17-18. Respondent filed medical articles in support of Dr.
Gensler’s expert report on April 19, 2013 and May 2, 2013. See Resp. Exs. A1-A3, C, D. On
May 9, 2013, Respondent filed her Pre-Hearing Submission, and on May 15, 2013 an entitlement
hearing was held in Washington D.C.
During the entitlement hearing, the undersigned referenced an article neither party had
presented as evidence, later filed as Court Exhibit 1.6 See Order, filed May 15, 2013, at 1. The
undersigned subsequently granted the parties an opportunity to file post-hearing briefs on the
new article; the parties, however, did not feel the article submitted by the undersigned required
additional briefing. Id.; Order, filed June 12, 2013, at 1-2. Respondent did, however, request to
file a post-hearing expert report from a new expert, in order to address certain statements
concerning immunology made by Dr. Utz during the hearing. See Order, filed June 12, 2013, at
1. The undersigned denied Respondent’s request, finding that it was clear from Dr. Utz’ first
expert report that he had claimed expertise in both rheumatology and immunology, and that
Respondent had therefore been on notice that Dr. Utz would be discussing both rheumatological
and immunological theories at the hearing. Id.
After the denial of Respondent’s request to file an additional expert report, Respondent’s
counsel requested a chance to file a post-hearing brief. Id. The undersigned granted this request
and ordered both parties to file simultaneous post-hearing briefs. Id. The parties filed their post-
hearing briefs on July 17, 2013. The case is now ripe for a decision on entitlement.
II. MEDICAL HISTORY
A. Pre-Vaccination Medical History
Prior to receiving the Tdap vaccine on October 10, 2008, Petitioner’s medical history was
significant for several autoimmune diseases: Systemic Sclerosis,7 noted on July 21, 2000;
Sjogren’s syndrome,8 noted on May 9, 2005; Raynaud syndrome,9 noted on October 24, 2006;
6
Jinxia, S., et al., Prevalence and significance of antibodies to citrullinated human papilloma
virus-47 E2345-362 in rheumatoid arthritis, J. Autoimmun. 2008; 31(2): 131-35.
7
Systemic Sclerosis is “a systemic disorder of the connective tissue characterized by fibrosis
with hardening and thickening of the skin, as well as abnormalities of both microvasculature
(telangiectasias) and larger vessels (Raynaud phenomenon); there are also fibrotic degenerative
changes in body organs such as the heart, lungs, kidneys, and gastrointestinal tract. It may be
confined to the face and hands for long periods or may progress, spread diffusely, and become
generalized.” Dorland’s, 1679-80.
8
Sjogren’s syndrome is “a symptom complex of unknown etiology, usually occurring in middle-
aged or older women, marked by the triad of keratoconjunctivitis sicca with or without lacrimal
3
Pulmonary Fibrosis,10 also diagnosed October 24, 2006; and migraines, noted March 18, 2008.
Pet. Ex. 1 at 80. However, she had never been diagnosed with RA, and in 2003, Petitioner tested
negative for rheumatoid factor (“RF”), an antibody normally present in people diagnosed with
RA. Tr. at 14.
On October 24, 2006, Petitioner saw her treating rheumatologist at Kaiser Permanente
(“Kaiser”), Dr. Jeffrey Fong, for a follow-up visit in regards to a swollen finger on her left hand.
Pet. Ex. 1 at 289. During that visit, Dr. Fong noted that Petitioner was currently taking one to
two tablets of felodipine11 a day for her Raynaud phenomenon.12 Id. Upon examining
Petitioner, Dr. Fong noted that there was some sclerodactyly13 on Petitioner’s proximal
interphalangeal joints (that is, the joints between the first and second phalanges of the fingers,
also known as the “pip”) as well as some facial tightness. Id. at 290. Dr. Fong’s assessment was
scleroderma14 with mild sclerodactyly, facial involvement and mild upper back involvement, and
Raynaud phenomenon with a history of digital ulcerations and foreshortening. Id. Dr. Fong
directed Petitioner to return for a follow-up in two months. Id. at 291.
gland enlargement, xerostomia with or without salivary gland enlargement, and the presence of
connective tissue disease, usually rheumatoid arthritis but sometimes systemic lupus
erythematosus, scleroderma, or polymyositis. An abnormal immune response has been
implicated.” Dorland’s, 1848.
9
Raynaud phenomenon is “intermittent bilateral ischemia of the fingers, toes, and sometimes
ears and nose, with severe pallor and often paresthesias and pain, usually brought on by cold or
emotional stimuli and relieved by heat; it is usually due to an underlying disease or anatomical
abnormality. When it is idiopathic or primary it is called Raynaud disease.” Dorland’s, 1430.
Hereinafter, the term “Raynaud phenomenon” is used interchangeably with “Raynaud disease”
and “Raynaud syndrome.”
10
Pulmonary Fibrosis is “chronic inflammation and progressive fibrosis of the pulmonary
alveolar walls, with steadily progressive dyspnea, resulting finally in death from oxygen lack or
right heart failure.” Dorland’s, 704.
11
Felodipine is “a calcium channel blocking agent used as a vasodilator in the treatment of
hypertension.” Dorland’s, 687.
12
See supra note 11. Petitioner’s Raynaud phenomenon started when she was either 14 or 16,
after she was in a motor vehicle accident. Pet. Ex. 14 at 69; Pet. Ex. 1 at 310.
13
Sclerodactyly is “localized scleroderma of the digits, as in acrosclerosis.” Dorland’s, 1679.
See infra note 14 for a definition of scleroderma.
Scleroderma is “chronic hardening and thickening of the skin, a finding in various diseases.”
14
Dorland’s, 1679.
4
Petitioner returned to Dr. Fong’s office on January 18, 2007 for her follow-up
appointment. Pet. Ex. 1 at 297. Dr. Fong observed some mild blanching of Petitioner’s
extremities, but no ulcers. Id. at 298. Petitioner did have some mild sclerodactyly to her “MCP”
(metacarpophalangeal) joint15 with minimal facial involvement. Id. Petitioner’s joints were
evaluated as “ok” during this visit and she was ordered to continue taking felodipine for her
Raynaud phenomenon. Id.
Petitioner saw Dr. Fong again before her scheduled follow-up, on February 6, 2007,
because her Raynaud disease had worsened. Id. at 300. Petitioner indicated that her Raynaud
disease was worsening at work because her supervisor would not let her use a heater. Id. Dr.
Fong observed small digital ulcers on Petitioner’s right third digit, but with no clear infection.
Id. Petitioner also had small scars on her second digital area. Id. Dr. Fong concluded that
Petitioner’s disease had worsened, and he suggested she try the new Levitra16 pill and to continue
with her current dose of felodipine. Id. at 301.
On April 4, 2007, Petitioner presented to Dr. Fong with complaints that her “finger [was]
still turning color,” and that the sore on her finger was now “leaking mild clear yellow things.”
Pet. Ex.1 at 15. Petitioner informed Dr. Fong that she had stopped taking felodipine over a
month ago, and that the Levitra he had prescribed had been denied because her insurance would
not cover anything over 15 pills. Id. Dr. Fong directed Petitioner start Keflex,17 restart her
felodipine, start taking the Levitra (he changed the prescription to 15), and to take two Vicodin at
night as needed. Id.
Petitioner returned to Dr. Fong for a check up on May 22, 2007. Pet. Ex. 1 at 304. Dr.
Fong observed small scars on the digital tips of the second and third fingers on Petitioner’s right
hand as well as the third finger of her left hand. Id. Petitioner continued to have mild
sclerodactyly on her MCP joint, though Dr. Fong again noted that Petitioner’s joints were “ok.”
Id. Dr. Fong’s assessment was that Petitioner’s Raynaud phenomenon was stable, although she
continued to suffer from scleroderma. Id. Dr. Fong ordered Petitioner to continue with her
current medications and to take home blood pressure readings three to four times a week. Id. A
follow-up was scheduled for three to four months later. Id. at 305.
15
Metacarpophalangeal means “pertaining to the metacarpus and phalanges;” the metacarpus is
“the part of the hand between the wrist and the fingers, its skeleton being five cylindric bones
(metacarpals) extending from the carpus to the phalanges.” Dorland’s, 1142.
16
Levitra is “a phosphodiesterase inhibitor that relaxes the smooth muscle of the penis, thereby
facilitating blood flow to the corpus cavernosum; used to treat erectile dysfunction in impotence
therapy.” Dorland’s, 1031, 1868. Presumably it was prescribed for an off-label purpose. See,
e.g., Janis Kelly, PDE5 inhibitors look widely effective in Raynaud’s,
http://www.medscape.com/viewarticle/538492 (last visited Aug. 21, 2015).
17
Keflex is an antibiotic. Dorland’s, 330-31; 978.
5
Petitioner went back to Kaiser on July 13, 2007 for a complaint unrelated to her Raynaud
disease or scleroderma. Pet. Ex. 1 at 306. Petitioner saw nurse practitioner Phyllis Moore, who
performed a physical examination. Id. at 306-07. During the examination, Nurse Moore noted
that Petitioner had no joint tenderness, deformity or swelling. Id. at 307. As of this visit,
Petitioner was taking felodipine, Cephalexin, Hydrocodone-Acetaminophen, and prenatal
vitamins. Id. at 306.
On August 13, 2007, Petitioner returned to Kaiser and saw Anne Regenstein, M.D., for a
pregnancy consultation. Id. at 310. During this visit, Petitioner informed Dr. Regenstein that her
major health concerns were the periodic ulcers on her hands. Id. Petitioner also informed Dr.
Regenstein that she was physically active, taking spin and kickboxing classes three times a week.
Id. Dr. Regenstein noted that Petitioner was not currently on any medications and that, overall,
her disease seemed under control. Id. at 311. Before discussing with Petitioner the risks
involved with getting pregnant, Dr. Regenstein planned to consult with Dr. Fong in order to have
a more informed discussion with Petitioner. Id. This discussion took place on August 16, 2007.
Id. at 312. Dr. Regenstein and Dr. Fong and were in agreement that Petitioner was doing fairly
well and had a good prognosis for pregnancy. Id.
On August 29, 2007, Petitioner saw a nurse practitioner for an “Endocrine Consult”
precipitated by some abnormal thyroid results from the lab. Pet. Ex. 1 at 314. The
endocrinologist diagnosed Petitioner with hyperthyroidism.18 Id. at 316. During this visit,
Petitioner indicated that she had stopped her medications because she wanted to get pregnant,
and that her cold intolerance was less problematic during the warmer months. Id. at 315.
Petitioner saw Dr. Fong on September 17, 2007. Id. at 318. Dr. Fong noted that
Petitioner had a mild increase in her Raynaud syndrome, but no pain or ulcers. Id. During the
examination, Dr. Fong noted that Petitioner’s joints were “ok” and that her extremities had some
mild blanching but no ulcers. Id. at 319. Dr. Fong recommended that Petitioner consider taking
Levitra or nifedipine19 if her Raynaud returned, and to see him for a follow-up in three months.
Id. at 320.
18
Hyperthyroidism is “a condition caused by excessive production of iodinated thyroid
hormones; characteristics include goiter tachycardia or atrial fibrillation, widened pulse pressure,
palpitations, fatigability, nervousness and tremor, heat intolerance and excessive sweating,
warm, smooth, moist skin, weight loss, muscular weakness, excessive defecation, emotional
lability, and ocular signs such as stare, slowing of eyelid movements, photophobia, and
sometimes exophthalmos.” Dorland’s, 897. Both experts stated that Petitioner’s thyroid disease
was autoimmune in nature. See Pet. Ex. 9 at 6; Tr. at 109.
19
Nifedipine is “a calcium channel blocking agent used as a coronary vasodilator in the
treatment of coronary insufficiency and stable angina pectoris, and as an antihypertensive.”
Dorland’s, 1276.
6
On January 28, 2008, Petitioner returned to Dr. Fong’s office. Pet. Ex. 1 at 322.
Petitioner complained of a mild increase in her Raynaud phenomenon with some small ulcers
which had improved. Id. Petitioner also complained that she had experienced periodic mild
aches in her fingers and left knee. Id. at 323. On observation, Dr. Fong noted that Petitioner had
some mild sclerodactyly and some cyanosis20 on a couple of fingers. Id. Dr. Fong again noted
that Petitioner’s joints were “ok” though he listed joint pains in his assessment of Petitioner’s
condition. Id. at 323-24. Doctor Fong prescribed nifedipine for Petitioner’s Raynaud and
hydrocodone for any severe pain. Id.
Petitioner returned to Kaiser several times following her January 28, 2008 appointment
with Dr. Fong; however, none of the visits were with Dr. Fong, and none of them had any
relation to her Raynaud disease, scleroderma or Sjogren’s syndrome (although she did complain
of worse “dry mouth due to Sjogren’s syndrome” at a June 30, 2008 appointment regarding a
sinus infection). Id. at 327-42. Moreover, none of these visits mentions any concerns with
Petitioner’s joints.
B. Post Vaccination Medical History
On October 10, 2008, Petitioner received the Tdap vaccine Adacel for prophylactic
purposes. Pet. Ex. 1 at 345; Pet. Ex. 5 at 1. During this visit, Petitioner was examined by her
primary care doctor’s nurse practitioner (“NP”) Ms. Lunde. Pet. Ex. 1 at 343. Petitioner
informed NP Lunde that she had been experiencing left elbow pain for the last six weeks. Id.
Petitioner explained that the pain was worse in the mornings. Id. Upon examination, NP Lunde
noted no joint tenderness, deformity, or swelling. Id. at 344. However, Petitioner’s elbow did
have lateral tenderness and muscular tenderness. Id. NP Lunde concluded that Petitioner was
suffering from an elbow sprain. Id. at 346.
On October 16, 2008, six days after receiving the vaccine, Petitioner called Dr. Fong’s
office and requested an appointment. Pet. Ex. 1 at 91. On October 20, 2008, Petitioner again
called Dr. Fong’s office requesting an appointment, which was scheduled for October 31, 2008.
Id. at 92. Petitioner called Kaiser on October 24, 2008, seeking an earlier appointment. No
earlier appointments were available, so Petitioner spoke on the phone with Kenneth Lee M.D. Id.
at 93-95. Petitioner indicated that her chief symptoms were pain and stiffness in all of her joints
as well as swollen fingers that began after she received the Tdap vaccine. Id. Dr. Lee prescribed
three 600mg Ibuprofen tablets a day for pain. Id. at 93.
Petitioner had an appointment with Dr. Fong on October 31, 2008 with a chief complaint
of joint pain. Pet. Ex. 1 at 352. Petitioner indicated that the joint pain started after her Tdap shot
and that she was experiencing swelling and moderate migratory pain. Id. at 352-53. Upon
examination, Dr. Fong noted that Petitioner had swelling and tenderness on the pip joint of her
20
Cyanosis is “a bluish discoloration, especially of the skin and mucous membranes due to
excessive concentration of deoxyhemoglobin in the blood.” Dorland’s, 452.
7
right fifth finger, swelling and tenderness on her right second, third, and fourth
metatarsophalangeal21 joints (“MTP joints”), and tenderness in her knees, especially her right,
although no warmth or swelling was noted. Id. at 354. Dr. Fong noted that Petitioner’s wrists,
MCP joints, other pip joints, elbows, shoulders, ankles, and left foot were “ok.” Id. Dr. Fong’s
assessment was that Petitioner was suffering from inflammatory polyarthritis. Id. at 355.
However, Dr. Fong was unable to identify a cause for the polyarthritis, noting that it could be
post-tetanus serum sickness, scleroderma-related, or possibly an overlap syndrome22 with
Rheumatoid Arthritis (“RA”). Id. Dr. Fong prescribed a trial of prednisone, two 5mg tablets
every morning for a week, after which Petitioner was to taper the dosage over the next two
weeks. Id. at 356. Petitioner was to make an appointment to see Dr. Fong again in three months.
Id.
On November 12, 2008, Petitioner called NP Lunde and indicated that the prednisone Dr.
Fong had prescribed was not working. Id. at 96-97. Petitioner indicated that her arm was sore
for two days after getting the Tdap vaccine and that she had been experiencing pain in her joints
since receiving the shot. Id. Petitioner called NP Lunde again on November 19, 2008, after
being unable to get in contact with Dr. Fong. Id. at 100. Petitioner reiterated that the prednisone
was not working and that she was still experiencing joint pain. Id. Petitioner also indicated that
her hands had started swelling since taking the prednisone. Id. That same day, Petitioner
submitted a VAERS23 report stating that two days after receiving her Tdap vaccine she started
experiencing joint pain in her elbows, knees, hands, shoulders and feet. Pet. Ex. 6 at 2.
Petitioner listed October 13, 2008, three days after she received the vaccine, as the date of the
onset of her symptoms. Id.
On November 20, 2008, Petitioner underwent X-Rays of her hands and feet to evaluate
her for possible RA. Pet. Ex. 1 at 102-07. The radiologist found the X-Rays of Petitioner’s right
foot to be unremarkable. Id. at 104. Petitioner’s left foot showed “[n]onspecific subchondral
Metatarsophalangeal means “pertaining to the metatarsus and the phalanges of the toes.”
21
Dorland’s, 1145.
22
Overlap syndrome is “any of a group of connective tissue disorders that either combine
scleroderma with polymyositis or systemic lupus erythematosus or combine systemic lupus
erythematosus with rheumatoid arthritis or polymyositis.” Dorland’s, 1842. See also Tr. at 89-
90.
23
VAERS (“Vaccine Adverse Events Reporting System”) is a database created, pursuant to the
Vaccine Act, by the FDA and the Centers for Disease Control and Prevention to receive reports
about adverse events which may be associated with vaccines. See Vaccine Adverse Event
Reporting System, available at https://vaers.hhs.gov/about/index. See also Nance v. Sec’y of
Health & Human Servs., No. 06-0730V, 2010 WL 3291896, at *9 (Fed. Cl. Spec. Mstr. July 30,
2010) (discussing that VAERS is a surveillance system that accepts “voluntarily submitted”
reports of events from manufacturers, health care workers and patients, and the experiences
reported are unsolicited and reflect a concern of a possible relationship to vaccination).
8
lucency along the navicular bone [and] … along the head of the third proximal phalanx,” id. at
103, and her hands also showed nonspecific subchondral lucency. Id. at 105-06. Dr. Fong
reviewed these X-Rays on December 3, 2008, noting that they were “good”—with “[n]o signs of
arthritis damage to bones or joints.” Id. at 285.
Petitioner also had lab work done in late 2008. Pet. Ex. 1 at 361. Dr. Fong called
Petitioner on December 3, 2008, to inform her that the lab results showed “[h]igh CCP and RF.”
Pet. Ex. 1 at 108.24 Dr. Fong’s suspected diagnosis was “[RA] superimposed on scleroderma.”
Id.
Petitioner returned to Dr. Fong’s office on December 12, 2008, with a chief complaint of
RA. Pet. Ex. 1 at 359. Petitioner noted no improvement in her RA symptoms from either low
dose prednisone or hydroxychloroquine.25 Id. Petitioner reported “trouble” with her hands,
wrists, knees and feet. Id. Petitioner also complained that she was having trouble walking and
that she was experiencing morning stiffness lasting half the day, swelling, and severe achy and
sharp pain. Id. at 359-60. On observation, Dr. Fong noted that Petitioner had polyarthritis in her
pip, MCP bilaterally, and her left wrist. Id. at 360. Petitioner’s knees were warm and tender
with mild swelling in the left one. Id. Petitioner was also displaying swelling and pain in her
MTP. Id. at 361. However, Dr. Fong observed that there was no polyarthritis in Petitioner’s
elbows and shoulders and that Petitioner’s ankles were “ok.” Id. at 360. Dr. Fong’s assessment
was that Petitioner suffered from RA which was probably in overlap with her scleroderma. Id. at
362. To help treat Petitioner’s pain, Dr. Fong injected her with DepoMedrol26 and Xylocaine27
in both of her knees and her left wrist. Id. Dr. Fong also prescribed methotrexate28 for
24
“CCP” is cyclic citrullinated peptide. Tr. at 14. Measurement of anti-CCP antibody levels has
recently been discovered as a more specific tool than rheumatoid factor (“RF”) to diagnose the
existence of RA. Tr. at 14-15, 126-27.
25
Hydroxychloroquine sulfate is “a … compound with antiprotozoal and anti-inflammatory
properties, used for suppression and treatment of malaria, for suppression of lupus
erythematosus, and as an anti-inflammatory disease-modifying antirheumatic drug in treatment
of rheumatoid arthritis.” Dorland’s, 881.
26
Depomedrol is a medication “administered topically as anti-inflammatory, by intramuscular
injection in replacement therapy for adrenocortical insufficiency, and by intra-articular,
intramuscular, intralesional, or soft-tissue injection as an anti-inflammatory and
immunosuppressant in a wide variety of disorders.” Dorland’s, 492, 1154.
27
Xylocaine is “a trademark for preparations of lidocaine.” Dorland’s, 2088.
28
Methotrexate is “a folic acid antagonist that acts by inhibiting synthesis of DNA, RNA,
thymidylate, and protein …. Used as an antipsoriatic and antiarthritic in the treatment of severe,
recalcitrant, disabling psoriasis and severe rheumatoid and psoriatic arthritis.” Dorland’s, 1151.
9
Petitioner, with instructions to increase the dosage each month if her symptoms did not improve.
Id. at 363.
Following her December 12, 2008 appointment, Petitioner participated in multiple
physical therapy sessions to help with her RA, and also continued to see Dr. Fong for regular
follow-up visits. Id. at 367-442; see generally Pet. Ex. 11. For the most part, Petitioner’s RA
improved, although she still experienced pain and swelling in multiple joints.29 Petitioner was
seen by Elena Torello, M.D. on May 7, 2010 for a routine physical exam required by her college
program. Id. at 438-39. During the examination, Dr. Torello noted that Petitioner’s fingers were
puffy but that her arthritis was asymptomatic. Id. This was attributed to Petitioner’s usage of
Humira.30 Id. Petitioner continued to improve and on December 20, 2010, Petitioner reported
that she was able to participate in vigorous activities and was exercising on the stationary bike
for 30 minutes every other day. Pet. Ex. 11 at 118. Humira continued to be effective in
controlling Petitioner’s RA symptoms, although she experienced a flare in symptoms around
April 10, 2012. Id. at 192-93.
III. QUALIFICATIONS OF THE EXPERTS
A. Petitioner’s Expert: Paul Utz, M.D.
Paul J. Utz, M.D., testified on behalf of Petitioner. See Tr. at 2. Dr. Utz is currently a
full professor at Stanford University School of Medicine. Tr. at 6. At Stanford, Dr. Utz runs the
M.D./Ph.D. program, is the adult rheumatology fellowship director, teaches an immunology
class (among others) to medical students, and regularly sees patients in clinic and on rounds. Tr.
at 6-7. Dr. Utz received a medical degree from Stanford University, was a Clinical Fellow in
Immunology and Rheumatology at Brigham and Women's Hospital, and was an instructor at
Harvard Medical School. See Tr. at 5-6; Pet. Ex. 10.
B. Respondent’s Expert: Lianne S. Gensler, M.D.
Lianne S. Gensler, M.D., testified on behalf of Respondent. See Tr. at 2. Dr. Gensler is
currently an assistant clinical professor of medicine at the University of California, San
Francisco, where she is the director of the ankylosing spondylitis clinic, performing
epidemiologic research and clinical trial research. Tr. at 107. In addition, Dr. Gensler has a
29
During a visit with Dr. Fong on September 3, 2009, Petitioner stated that her arthritis pain had
been worse for the last three weeks since she stopped using prednisone. Pet. Ex. 1 at 414. This
was the first visit with Dr. Fong since being diagnosed with RA at which Petitioner did not
indicate she was feeling better.
30
Humira is “a recombinant human IgG1 monoclonal antibody that binds to and blocks the
action of tumor-necrosis factor α, used to alleviate the signs and symptoms of and inhibit the
progression of structural damage in rheumatoid arthritis.” Dorland’s, 25, 873.
10
clinical practice where she sees many RA patients. Tr. at 107-08. She received her medical
degree from the University of California, Irvine, and did her residency, fellowship, and chief
residency at University of California, San Francisco. Tr. at 106.
IV. APPLICABLE LEGAL STANDARD
To receive compensation under the Program, Petitioner must prove either 1) that she
suffered a “Table Injury” — i.e., an injury falling within the Vaccine Injury Table31 —
corresponding to one of her vaccinations, or 2) that Petitioner suffered an injury that was actually
caused by a vaccine. See 42 U.S.C.A. § 300aa-13(a)(1)(A); see also § 300aa-11(c)(1).
Petitioner must show that the vaccine was “not only a but-for cause of the injury but also a
substantial factor in bringing about the injury.” Moberly v. Sec’y of Health & Human Servs., 592
F.3d 1315, 1321-22 (Fed. Cir. 2010) (quoting Shyface v. Sec’y of Health & Human Servs., 165
F.3d 1344, 1352-53 (Fed. Cir. 1999)). Petitioner has not claimed a Table Injury, and an
examination of the record has not revealed any possible Table Injury.
Absent a Table Injury, Petitioner must satisfy all prongs of the test established by the
Federal Circuit in Althen v. Secretary of the Department of Health and Human Services. 418
F.3d 1274, 1279 (Fed. Cir. 2005). The Althen test requires the petitioners to set forth: “(1) a
medical theory causally connecting the vaccination and the injury (“Althen Prong One”); (2) a
logical sequence of cause and effect showing that the vaccination was the reason for the injury
(“Althen Prong Two”); and (3) a showing of a proximate temporal relationship between
vaccination and injury (“Althen Prong Three”).” Id. To establish entitlement to compensation
under the Program, a petitioner is required to establish each of the three prongs of Althen by a
preponderance of the evidence. Id.
The preponderance of the evidence standard has been interpreted to mean that the
Petitioner must show that the fact is more likely than not. Moberly v. Sec’y of Health & Human
Servs., 592 F.3d 1315, 1322 n. 2 (Fed. Cir. 2010). Proof of medical certainty is not required.
Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). “[T]he purpose
of the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft
of complete and direct proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280.
In determining whether Petitioner is entitled to compensation, the undersigned will
consider all relevant, material contained in the record. 42 U.S.C.A. § 300aa-13(b)(1). That
material can include circumstantial evidence. Capizzano v. Sec’y of Health & Human Servs.,
440 F.3d 1317, 1325 (Fed. Cir. 2006). As the finder of fact, the undersigned is “entitled—
indeed, expected—to make determinations as to the reliability of the evidence presented…and, if
31
The Vaccine Injury Table “lists the vaccines covered under the Act; describes each vaccine's
compensable, adverse side effects; and indicates how soon after vaccination those side effects
should first manifest themselves. Claimants who show that a listed injury first manifested itself
at the appropriate time are prima facie entitled to compensation.” Bruesewitz v. Wyeth LLC, 562
U.S. 223, 228 (2011) (citing 42 U.S.C.A. § 300aa-14(a)).
11
appropriate, as to the credibility of the persons presenting that evidence.” Moberly, 592 F.3d at
1326. The Vaccine Act was created to award compensation to vaccine-injured persons “quickly,
easily, and with certainty and generosity.” Graves v. Sec’y of Health & Human Servs., 109 Fed
Cl. 579, 595 (2013) (quoting H.R. Rep. No. 99-908 at 3). Therefore, “close calls regarding
causation are resolved in favor of injured” petitioners. Althen, 418 F.3d at 1280; see also
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999).
If Petitioner satisfies all three prongs of Althen by a preponderance of the evidence, she
establishes a prima facie case. Walther v. Sec’y of Health & Human Servs., 485 F.3d 1146,
1149-51 (Fed. Cir. 2007). After Petitioner has established a prima facie case, the burden shifts to
Respondent to demonstrate, also by a preponderance of the evidence, that the injury was actually
caused by factors unrelated to the administration of the vaccine. Walther, 485 F.3d at 1151; 42
U.S.C.A. § 300aa–13(a)(1)(B). Accordingly, “[i]f the evidence is seen in equipoise, then the
government has failed in its burden of persuasion and compensation must be awarded.” Knudsen
v. Sec’y of Health & Human Servs., 35 F.3d 543, 550 (Fed. Cir. 1994).
V. ANALYSIS
A. Causation-in-Fact Versus Significant Aggravation
Both experts opined that, from a medical perspective, Petitioner was “more likely than
not in the preclinical stage32 of RA at the time of her vaccination.” Pet. Ex. 9 at 8-9, Tr. at 138.
See also Pet. Ex. 9, Tab E.33 The undersigned therefore struggled with whether this case should
be analyzed as one asserting causation-in-fact or significant aggravation. Petitioner had not had
any laboratory test results confirming that preclinical state, however, see Pet. Ex. 1 at 55, nor did
she have symptoms of RA prior to vaccination.34 Application of the Act is triggered by “the first
symptom or manifestation of onset” of an alleged vaccine-related injury. 42 U.S.C.A. § 300aa-
16(a)(2). Because the undersigned now finds that the first symptom or manifestation of
Petitioner’s RA did not occur until after vaccination, the undersigned views Petitioner’s theory as
one of causation-in-fact rather than significant aggravation, and will analyze it accordingly.
32
Preclinical means “before a disease becomes clinically recognizable.” Dorland’s at 1508. It is
also defined as “[b]efore the onset of disease.” Stedman’s Medical Dictionary at 1553 (28th. ed.
2006).
33
Deane, K., et. al., The number of elevated cytokines and chemokines in preclinical seropositive
rheumatoid arthritis predicts time to diagnosis in an age-dependent manner, Arthritis Rheum.
2010; 62(11): 3161-72, at 3161-62 (“Multiple studies have demonstrated that levels of disease-
related biomarkers may be elevated prior to the onset of symptomatic rheumatoid arthritis;” this
“preclinical” period of RA “may be present for many years prior to the onset of articular
symptoms.”)
34
The lack of pre-vaccination RA symptoms was disputed by Respondent. Discussion of that
issue can be found in the Althen Prong Two analysis below.
12
B. Althen Prong One: Medical Theory
To satisfy the first prong of the Althen test, Petitioner must provide “a medical theory
causally connecting the vaccination and the injury.” Althen, 418 F.3d at 1278 (quoting Grant v.
Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir.1992)). Petitioner’s theory
must show that it is more likely than not that the vaccine she received “can” cause the type of
injury Petitioner alleges the vaccine caused. Pafford v. Sec’y of Health & Human Servs., 451
F.3d 1352, 1355-56 (Fed. Cir. 2006).
The medical theory set forth by the Petitioner must be “legally probable, not medically or
scientifically certain.” Knudsen, 35 F.3d at 548-49. However, the theory cannot be baseless or
completely speculative; it must be informed by “sound and reliable medical or scientific
explanation.” Id. at 548; see also Veryzer v. Sec’y of Health & Human Servs., 98 Fed. Cl. 214,
223 (2011) (noting that under 42 U.S.C.A. § 300aa-13(b)(1) and Vaccine Rule 8(b)(1), special
masters must consider only evidence that is both “relevant” and “reliable”). When a petitioner
proffers a medical opinion to support her theory, the basis for the opinion and the reliability of
that basis must be considered in determining how much weight to afford the offered opinion.
See Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010)
(“The special master’s decision often times is based on the credibility of the experts and the
relative persuasiveness of their competing theories.”); Perreira v. Sec’y of Health & Human
Servs., 33 F.3d 1375, 1377 n. 6 (Fed. Cir. 1994) (“An expert opinion is no better than the
soundness of the reasons supporting it”) (citing Fehrs v. United States, 620 F.2d 255, 265 (Ct.
Cl. 1980)).
As noted above, both parties’ experts agreed that Petitioner was in the preclinical stage of
RA before her vaccination.35 Pet. Ex. 9 at 8-9; Tr. at 138. Both experts also agreed that
Petitioner suffered from more than one connective tissue disorder and that she satisfied the
criteria for overlap syndrome. Pet. Ex. 9 at 8; Resp. Ex. A at 6. Petitioner’s theory of causation
therefore focused on the potential impact of a Tdap vaccine on an individual with overlap
syndrome and preclinical RA. Dr. Utz opined that an individual with preclinical RA “is at
increased risk to develop overt disease if they encounter an environmental trigger such as an
infection, vaccination, ultraviolet radiation, or certain chemicals.” Pet. Ex. 9 at 8. He also
argued that “subjects with preexisting inflammatory conditions such as Systemic Sclerosis,
Sjögren’s syndrome, or autoimmune thyroid disease are at increased risk to develop another
inflammatory condition such as RA following immunizations with Tdap, influenza, hepatitis B,
or other vaccines.” Pet. Ex. 9 at 10. Finally, Dr. Utz noted that “[m]any arthritides including. .
.RA. . .are postulated to be. . .or known to be. . .caused by exposure to an infectious antigen or
foreign antigen” such as that presented by a vaccine. Pet. Ex. 9 at 13.
35
Dr. Gensler argued, alternatively, that Petitioner’s RA was actually symptomatic before she
received the vaccine. That argument is addressed in the Althen Prong Two analysis.
13
In support of these arguments, Dr. Utz cited two articles identifying tetanus vaccination
and a pulmonary infection as environmental triggers, exposure to which caused RA in the
subjects of the articles. See Pet. Ex. 9, Tab H;36 Pet. Ex. 9, Tab I.37 In support of his opinion that
vaccination could trigger RA in patients with preexisting inflammatory conditions, Dr. Utz also
argued that the percentage of patients excluded from the study cohort in the Ray and Black study
because of preexisting inflammatory conditions was far greater “than one would expect by
chance alone.” Pet. Ex. 9 at 10; see also Pet. Ex. 9, Tab G.38
Dr. Utz asserted that abrupt onset of severe disease would be consistent with his theory
that the introduction of an antigen to an individual with a predisposed, hyperactive immune
system can trigger an immune complex-mediated inflammatory response from existing B and T
lymphocytes. Pet. Ex. 9 at 8-9, 13; Tr. at 25. Dr. Utz stated that six to twenty-one days would
be “a very typical window for development of such an immune response.” Pet. Ex. 9 at 13.
Thereafter, the disease process would become autoimmune as the patient’s T cells began
identifying and attacking the linear peptides in the patient’s own cells in place of the original
antigen. Tr. at 172; see also Pet. Ex. 9 at 11-13.
Dr. Gensler declined to opine on the immunological aspects of the Prong One theory
offered by Petitioner. Dr. Gensler is not an immunologist and did not believe her expertise was
sufficient to allow her to testify in this area. Tr. at 143-44. However, from her expertise as a
rheumatologist, and using epidemiological evidence, Dr. Gensler did question the part of
Petitioner’s theory that concerns the triggering potential of vaccines. Tr. at 144-50. Dr. Gensler
testified that no environmental trigger is needed to prompt the onset of RA in a patient with
overlap syndrome or preclinical RA. Tr. at 127-29. Dr. Gensler testified that she rarely sees an
environmental trigger associated with the onset of RA in her patients. Tr. at 128.
Dr. Gensler also cited the Institute of Medicine (IOM) publication, Adverse Effects of
Vaccines—Evidence and Causality [hereinafter “IOM publication”], which concluded that there
was not enough evidence to accept or reject a causal relationship between Tdap and the
development of RA. Resp. Ex. A at 6; Resp. Ex. A1. 39 Dr. Gensler noted that, according to the
36
Sharma, A., et al., Vaccination as a triggering agent for the development of rheumatoid
arthritis, Int. J. Rheum. Dis. 2011; 14(1): 8-9.
37
Iwata, H., et al., Emergence of erosive polyarthritis coincident with Mycobacterium kansassi
pulmonary infection in a patient with systemic sclerosis-rheumatoid arthritis overlap syndrome,
Clin. Exp. Rheumatol. 1999; 17(6): 757-58.
38
Ray, P., Black, S., et al., Risk of rheumatoid arthritis following vaccination with tetanus,
influenza and hepatitis B vaccines among persons 15-59 years of age, Vaccine 2011; 29(38):
6592-97.
39
Committee to Review Adverse Effects of Vaccines, Institute of Medicine of the National
Academies, Adverse Effects of Vaccines – Evidence and Causality, 567-571.
14
IOM publication, there was no increase of reported cases of RA within five years after receiving
a vaccine. Resp. Ex. A at 6.
The undersigned often relies on epidemiological evidence such as that underlying the
IOM publication. However, particularly in the Prong One context, its persuasiveness is tempered
by the fact that, while it may show that a vaccine has not caused a particular injury, at least to a
statistically relevant extent, it cannot show that the vaccine cannot cause that particular injury.
In the present case the epidemiological evidence was also of limited value because, as Dr. Utz
pointed out, well-done studies like this are generally limited to patients with healthy immune
systems; patients with abnormal immune systems are excluded, and Petitioner’s theory is
premised on the vaccinee having a compromised immune system. Pet. Ex. 9 at 10; Tr. at 74-76.
The undersigned agrees with Respondent that an environmental trigger is not required for
preclinical RA to develop into clinical RA. However, the undersigned finds persuasive
Petitioner’s theory that an environmental trigger such as a vaccine can cause preclinical RA to
develop into clinical RA. The triggering role of the vaccine postulated by Petitioner explains to
the undersigned’s satisfaction an acute and severe onset of an otherwise chronic condition, and
the transition from an inflammatory condition to an autoimmune one. The undersigned finds
Petitioner’s theory sufficiently persuasive to meet Petitioner’s burden of proof under Althen
Prong One.
C. Althen Prong Two: Logical Sequence of Cause and Effect
To satisfy the second prong of the Althen test, Petitioner must establish “a logical
sequence of cause and effect showing that the vaccination was the reason for the injury.” Althen,
418 F.3d at 1278. That is, Petitioner must show, by preponderant evidence, that the vaccination
Petitioner received did cause the injuries she alleges they caused. Capizzano v. Sec’y of Health
& Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Petitioner may satisfy her burden by
presenting circumstantial evidence and reliable medical opinions; she is not required to offer
“epidemiologic studies, rechallenge, the presence of pathological markers or genetic disposition,
or general acceptance in the scientific or medical communities to establish a logical sequence of
cause and effect.” Id. at 1325.
Prior to vaccination, Petitioner suffered from several autoimmune diseases – systemic
sclerosis (scleroderma), Sjögrens syndrome, and autoimmune thyroid disease. Pet. Ex. 9 at 13;
Tr. at 109. The experts agreed she met the criteria for overlap syndrome. Id. Petitioner was
tested for RF in 2003, with negative results. Pet. Ex. 1 at 55. Results for both RF and anti-CCP
were significantly elevated by November 20, 2008, six weeks after her vaccination. Pet. Ex. 1 at
361. The preexisting overlap syndrome, coupled with the positive serology within weeks of
symptom onset, led both experts to conclude that Petitioner had preclinical RA at the time of
vaccination. Pet. Ex. 9 at 8; Tr. at 81-82, 116, 126-31.
15
Dr. Utz emphasized that although Petitioner “had an immune system that was already
abnormal,” Tr. at 82, “her blood tests, history, and examination provided no evidence whatsoever
that she had RA.” Pet. Ex. 9 at 8; see also Tr. at 25-26 (“Nowhere in the medical record could I
find evidence that she had synovitis, which is inflammation in the joints, or even significant
morning stiffness [prior to receiving the vaccine].”) He also emphasized that the onset of
Petitioner’s symptomatic RA was “abrupt,” Pet. Ex. 9 at 8-9, 13 (“explosive”); Tr. at 12, 14
(“acute”), 22, 25, 82 (“severe”), as opposed to having developed “insidiously,” as is the normal
course of RA development. Tr. at 21-22, 39, 122. This “explosive” onset, Dr. Utz argued,
supports his conclusion that Petitioner’s RA was triggered by an environmental factor, namely,
the vaccine, which activated existing T cells and antigen-antibody immune complexes to cause
the inflammatory symptoms. Tr. at 25-26, Pet. Ex. 9 at 13.
Dr. Gensler did not agree that the vaccine caused Petitioner’s RA, because she concluded
that Petitioner’s symptomatic RA was a manifestation of the overlap syndrome that predated the
vaccine. Tr. at 136-37. Although Dr. Gensler conceded that Petitioner did not carry a diagnosis
of RA prior to October 10, 2008, Tr. at 137, Dr. Gensler cited several places in Petitioner’s
medical records on the basis of which she concluded that Petitioner’s RA symptoms predated the
vaccine.
Dr. Gensler first cited the elbow pain that was part of the reason Petitioner was at the
doctor’s office the day she received her vaccine. Pet. Ex. 1 at 83. Petitioner saw NP Lunde for
this visit, with “[complaints of left] elbow pain [for] 6 weeks, pain worse in am.” Id. NP
Lunde’s musculoskeletal exam notes state “no joint tenderness, deformity, or swelling. [Left]
elbow lateral tenderness muscuilar tenderness noted.” Id. at 84. NP Lunde diagnosed an elbow
sprain and directed Petitioner to “use elbow support.” Id. at 85. Dr. Gensler testified that it is
very difficult to diagnose RA symptoms in an elbow joint—in her experience, residents
misdiagnose it almost 80% of the time, and “nurse practitioners are almost invariably wrong.”
Tr. at 118. Therefore, Dr. Gensler concluded, NP Lunde misdiagnosed Petitioner’s elbow pain
as a sprain when in fact it was a symptom of her developing RA. Tr. at 116-19.
The post-vaccination X-Rays of Petitioner’s hands and feet were also cited by Dr.
Gensler as evidence that clinical RA onset predated Tdap vaccination. Tr. at 123-25; Pet. Ex. 1
at 102-07. The X-Rays were performed to “[e]valuate for rheumatoid arthritis.” Pet. Ex. 1 at
103-06. The radiologist at Petitioner’s treating facility found the X-Rays of Petitioner’s right
foot to be unremarkable. Pet. Ex. 1 at 104. Petitioner’s left foot showed “[n]onspecific
subchondral lucency along the navicular bone [and] … along the head of the third proximal
phalanx,” id. at 103, and her hands also showed nonspecific subchondral lucency. Id. at 105-06.
Dr. Fong reviewed these X-Rays on December 3, 2008, and noted that they were “good,” with
“[n]o signs of arthritis damage to bones or joints.” Id. at 285. Dr. Gensler did not personally
review the X-Rays. Tr. at 124, 143. However, in Dr. Gensler’s experience, radiologists
misdiagnose erosions about 50 percent of the time, so it is not significant that the radiologist who
examined the X-Rays did not diagnose these lucencies as possible erosions. Tr. at 126. She also
doubted that Dr. Fong personally reviewed the X-Rays. Tr. at 143. Dr. Gensler opined that the
16
non-specific subchondral lucencies are suggestive of erosions, particularly in a patient with “this
disease and demographics.” Tr. at 124. Since erosions take time to develop, she opined, it is
likely that Petitioner had RA before the Tdap vaccination. Tr. at 125-26.
The undersigned has no doubt that Dr. Gensler is a highly qualified rheumatologist who
has treated thousands of patients. She has physically examined those patients and reviewed their
X-Rays. As qualified as she is, however, she did not examine Petitioner, and she did not review
Petitioner’s X-Rays. Contemporaneous medical records are trustworthy documentation of a
patient’s diagnosis and treatment. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525,
1528 (Fed. Cir. 1993). The undersigned will not override the contemporaneous conclusions of
Petitioner’s own treating professionals based only on Dr. Gensler’s opinion that those treaters’
evaluations were wrong. The undersigned finds that the pre-diagnosis elbow pain and the post-
diagnosis X-Rays did not show that Petitioner had clinical symptoms of RA before October 10,
2008.
The undersigned found the Prong One theory offered by Dr. Utz to be persuasive; by
preponderant evidence Petitioner has shown that the vaccine can cause RA in a patient with
overlap syndrome and preclinical disease. Pafford v. Sec’y of Health & Human Servs., 451 F.3d
1352, 1355-56 (Fed. Cir. 2006). The facts of Petitioner’s case as set forth herein support the
application of that theory to her case. The undersigned concludes that Petitioner has shown by
preponderant evidence that the vaccine did cause her clinical RA, and she has therefore met her
burden of proof under Prong Two of Althen.
D. Althen Prong Three: Temporal Association
To satisfy the third prong of Althen, petitioners must produce preponderant evidence of
“a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278.
This prong helps to establish the connection between the causal theory of Prong One and the
more fact-based cause and effect arguments of Prong Two by demonstrating “that the onset of
symptoms occurred within a timeframe from which, given the medical understanding of the
disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of
Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). Petitioner may meet her timing
burden by showing: (1) when the condition for which she seeks compensation first appeared after
vaccination, and (2) whether the period of symptom onset is “medically acceptable to infer
causation.” Shapiro v. Sec’y of Health & Human Servs., No. 99-552V, 2011 WL 1897650, at
*13 (Fed. Cl. Spec. Mstr. Apr. 27, 2011), aff’d in relevant part and vacated on other grounds,
101 Fed. Cl. 532, 536 (2011).
The onset of RA is usually “insidious.” Tr. at 21-22, 39, 122. However, under the theory
of causation advanced by the Petitioner, where the manifestation of RA is caused by an
environmental trigger administered to an individual with preclinical RA and overlap syndrome,
onset occurs abruptly and within a fairly short time after the trigger is introduced. Dr. Utz stated
that six to twenty-one days would be an appropriate time frame for such an immune response.
Pet. Ex. 9 at 13.
17
Dr. Gensler testified that her reading of the VAERS report and other records indicated
that Petitioner had identifiable RA symptoms no more than two days after administration of the
Tdap vaccine. Tr. at 130; see also Pet. Ex. 6 at 1, Pet. Ex. 9 at 5. Dr. Gensler relied on three
different reports made by Petitioner to support this conclusion. Tr. at 130. First, in her October
24, 2008 request for an appointment, Petitioner indicated that she he had been experiencing joint
swelling “ever since” the day of the vaccination. Pet. Ex. 1 at 94; Tr. at 130. Second, Petitioner
reported three weeks of joint pain when she was examined by her rheumatologist on October 31,
2008, which would mean her joint pain began on October 10, 2008—the date of vaccination.
Pet. Ex. 9 at 5; Tr. at 130. Finally, in her Nov. 19, 2008 VAERS report, Petitioner reported that
her joint pain began two days after vaccination. Pet. Ex. 6 at 1; Tr. at 130.
Dr. Utz relied more on the contemporaneous records following the vaccination, rather
than information recollected by Petitioner on a later date. Tr. at 99-100. He gave less weight to
the statements of Petitioner on October 31, 2008 (complaining of “[three] weeks of joint pain
post tetanus shot,” Pet. Ex. 1 at 352), and Petitioner’s VAERS Report of November 19, 2008
(reporting that joint pain began two days after vaccination). Pet. Ex. 13 at 5-6; Pet Ex. 6 at 1; Tr.
at 99-100. Dr. Utz opined that Petitioner’s RA symptoms began as early as 6 days after
receiving the vaccine October 10, 2008. Tr. at 99. He based this opinion on the calls Petitioner
made to her rheumatologist.40 Tr. at 97. Based on the time frame of these calls, Dr. Utz used a
holistic approach to determine onset of RA, placing onset between the first call, when she merely
requested an appointment, and the third call when she complained of swelling in her fingers and
stiffness in her joints. Pet. Ex. 13 at 6. Dr. Utz reasoned that if her symptoms had started earlier,
then she would have called earlier. Pet. Ex. 13 at 6. Dr. Utz testified that the X-Rays taken of
Petitioner on November 20, 2008 did not indicate bone mineralization or evidence of erosions,
further supporting his theory that RA onset was six to fourteen days after vaccination. Tr. at 161,
23.
The undersigned gives more weight to the approach taken by Dr. Utz because it is based
on contemporaneous evidence rather than recollections of the Petitioner. Absent
contemporaneous examination by a competent medical professional, it is impossible to determine
the precise date of Petitioner’s first RA symptom. Therefore, the undersigned concludes that the
first symptom of Petitioner’s RA occurred between six and fourteen days after vaccination. As
this timing is consistent with Petitioner’s Prong One theory, the undersigned concludes that the
evidence presented satisfies Petitioner’s burden to show an appropriate temporal association
between the vaccination and the injury under Prong Three of Althen.
40
Petitioner called her rheumatologist to seek an appointment on Oct. 16, 2008; she called again
to seek an appointment on October 20, 2008; and on Oct 24, 2008, she called her rheumatologist
with complaints of “pain and stiffness in all her joints,” as well as “swollen fingers.” Pet. Ex. 9
at 6; Pet. Ex. 1 at 91-95.
18
VI. CONCLUSION
For the reasons set forth above, the undersigned finds that Petitioner has shown by
medical records and competent medical opinion that her alleged medical condition was “more
likely than not” vaccine-caused, and that she is entitled to compensation. This case is now ready
to proceed in damages.
IT IS SO ORDERED.
s/Lisa D. Hamilton-Fieldman
Lisa D. Hamilton-Fieldman
Special Master
19