Court Opinion

ID: 4197674
Source: CourtListenerOpinion
Date Created: 2017-08-21 20:03:40.7043+00
Date Added: 2024-06-11T14:40:34.068586
License: Public Domain

In the United States Court of Federal Claims
                                OFFICE OF SPECIAL MASTERS
                                        No. 14-1025V
                                        July 25, 2017
                                      Not to be Published

***************************************
CHRISTOPHER PURVIS,                            *
                                               *
      Petitioner,                              *    Not to be Published
                                               *
   v.                                          * Influenza (“flu”) vaccine;
                                               * diskitis; testicular pain;
SECRETARY OF HEALTH                            * not immune-mediated;
AND HUMAN SERVICES,                            * not autoimmune; dismissal
                                               *
      Respondent.                              *
***************************************
Howard S. Gold, Wellesley Hills, MA, for petitioner.
Ryan D. Pyles, Washington, DC, for respondent.

MILLMAN, Special Master

                                              DECISION 1

       On October 22, 2014, petitioner filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. §§ 300aa-10–34 (2006), alleging that the influenza (“flu”) vaccine he
received on August 15, 2013, caused burning pain in his back, abdomen, and testicles. Pet. ¶ 4.

        On July 7, 2017, the undersigned held a hearing. Testifying for petitioner was Dr. David
Axelrod, an immunologist and allergist. Testifying for respondent was Dr. Kathleen L. Collins,
an infectious disease specialist.

1
  Because this unpublished decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this unpublished decision on the United States Court of Federal
Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). Vaccine Rule 18(b) states that
all decisions of the special masters will be made available to the public unless they contain trade secrets
or commercial or financial information that is privileged and confidential, or medical or similar
information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a
decision is filed, petitioner has 14 days to identify and move to redact such information prior to the
document’s disclosure. If the special master, upon review, agrees that the identified material fits within
the banned categories listed above, the special master shall redact such material from public access.
       Dr. Axelrod’s explanation for flu vaccine causing petitioner’s diskitis was based on his
assumption that diskitis was an autoimmune disease because petitioner was ill, and that cytokines
from flu vaccine caused increased vascularization and nerve sensitivity. Dr. Collins’ response
was that spinal discs do not contain blood vessels or nerves and, therefore, whether or not
cytokines could breach the blood-brain barrier would be irrelevant to inflammation of his spinal
discs. Because the undersigned found Dr. Collins’ testimony more credible than Dr. Axelrod’s,
the undersigned DISMISSES this case.

                                             FACTS

       Petitioner was born on October 12, 1959. Med. recs. Ex. 1, at 1.

                                    Pre-vaccination records

       Petitioner gave a history in numerous medical records that a car hit him when he was a
pedestrian in 2009, and he has had back problems since then. Med. recs. Ex. 5, at 313. He has
been disabled since 2000. Id.

        On August 9, 2010, petitioner was at Lawrence & Memorial Hospital, complaining that
he flew over his motorcycle handlebars and landed on his right hip. Id. at 18. He complained of
pain in his right arm and shoulder, although the shoulder pain was chronic. Id.

        On August 12, 2010, petitioner saw Dr. Robert J. Keitner, Jr., in follow-up. Med. recs.
Ex. 4, at 2. Petitioner had a history of asthma, hypertension, hyperlipidemia, seizure disorder,
migraine headaches, depression, chronic pain, and probable post-traumatic injury. Id. Earlier
that year, he had acute renal insufficiency, probably related to excessive use of diuretics and
NSAIDs and inadequate fluid intake. Id. At the time of his visit, petitioner was taking

                                                2
Lamictal, 2 Klonopin, 3 Geodon, 4 Lexapro, 5 Ambien, 6 Zetia, 7 Clonidine,8 Trilipix, 9 and
Percocet. 10 Id. He also used Levitra for erectile dysfunction as needed. Id. He weighed 250
pounds. Id.

        On November 16, 2010, petitioner saw Dr. Keitner. Id. at 8. Petitioner had a history of
previous drug abuse and was on methadone 11 maintenance. Id. He had a history of hepatitis C
and cirrhosis. Id.

       On February 24, 2011, petitioner saw Dr. Keitner again. Id. at 11. For the last two or

2
  Lamictal is “trademark for a preparation of lamotrigine.” Dorland’s Illustrated Medical
Dictionary 1000 (32d ed. 2012) (hereinafter, “Dorland’s). Lamotrigine is “an anticonvulsant
used in the treatment of partial seizures in adult patients . . . .” Id. at 1003.
3
  Klonopin is “trademark for a preparation of clonazepam.” Dorland’s at 989. Clonazepam is “a
benzodiazepine used as an anticonvulsant in the treatment of Lennox-Gastaut syndrome and of
atonic and myoclonic seizures and as an antipanic agent in the treatment of panic disorders . . . .”
Id. at 373. Benzodiazepine is “any of a group of compounds having a common molecular
structure and acting similarly as depressants of the central nervous system, their actions
including antianxiety, sedative, hypnotic, amnestic, anticonvulsant, and muscle relaxing effects.”
Id. at 209.
4
  Geodon is “trademark for a preparation of ziprasidone hydrochloride.” Dorland’s at 772.
Ziprasidone hydrochloride is “an antipsychotic used in the treatment of schizophrenia.” Id. at
2092.
5
  Lexapro is “trademark for a preparation of escitalopram oxalate.” Dorland’s at 1032.
Escitalopram oxalate is “a selective serotonin reuptake inhibitor (SSRI) . . .; used as an
antidepressant.” Id. at 647.
6
  Ambien is “trademark for a preparation of zolpidem tartrate.” Dorland’s at 57. Zolpidem
tartrate is “a non-benzodiazepine sedative-hypnotic . . . in the short-term treatment of insomnia.”
Id. at 2092.
7
  Zetia is “trademark for a preparation of ezetimibe.” Dorland’s at 2091. Ezetimibe is “an
inhibitor of intestinal cholesterol absorption . . . in the treatment of primary
hypercholesterolemia.” Id. at 667.
8
  Clonidine hydrochloride is “DQ ‫ܤ‬2-adrenergic agonist-antagonist . . .administered . . .as an
antihypertensive. . . .” Dorland’s at 373.
9
  Trilipix is “trademark for a preparation of fenofibric acid.” Dorland’s at 1967. Fenofibric acid
is “the active form of fenofibrate, used in combination with statins to reduce elevated serum
lipids.” Id. at 688.
10
   Percocet is “trademark for a combination preparation of oxycodone hydrochloride and
acetaminophen.” Dorland’s at 1409. Oxycodone is “an opioid agonist analgesic derived from
morphine.” Id. at 1356.
11
   Methadone hydrochloride is “a synthetic opioid analgesic, possessing pharmacologic actions
similar to those of morphine and heroin and similar potential for addiction; used as an analgesic
and as a narcotic abstinence syndrome suppressant in the treatment of heroin addiction . . . .”
Dorland’s at 1146.
                                                     3
three weeks, petitioner had noted significantly increasing chest tightness or wheezing and cough.
Id. He said he was smoking three or four cigarettes a day, but did not usually finish them. Id.

       On May 9, 2011, petitioner went to Lawrence & Memorial Hospital Emergency
Department after he fell in the shower, complaining of back pain that had lasted one month.
Med. recs. Ex. 5, at 64.

        On May 16, 2011, petitioner saw his orthopedist, Dr. Frank W. Maletz, because he had a
very nasty fall in the shower. Med. recs. Ex. 7, at 1. He slipped and fell backwards as his right
knee gave out. Id. He struck his lower back, twisted, hit his head on the side of the bathtub, and
injured his upper back as well. Id. Dr. Maletz wrote that petitioner was struggling significantly
with his lower back and had greater difficulty with his right knee. Id. Petitioner had Lidoderm 12
patches all over his lower lumbar spine and over the mid-shaft of his tibia. Id. Dr. Maletz was
very concerned about the limited range of motion petitioner displayed in his lower back as well
as the marked crepitation in his patellofemoral joint. Id. Petitioner had very poor extension of
his back and pain on deep palpation, primarily over the iliolumbar 13 ligaments on the left. Id.

        On May 21, 2011, petitioner had an MRI of his lumbar spine performed. Id. at 2. This
MRI was compared with a prior one done in August 2008. Id. Petitioner previously had a
hemangioma 14 in the L1 vertebral body. Id. At the L2-L3 vertebral level, there was
degenerative disc signal with degenerative endplate change and disc space narrowing. Id. At the
L3-L4 vertebral level, there was a diffuse disc bulge, which had slightly increased since the
August 2008 MRI with some increased degenerative disc signal. Id. At L4-L5, there was
degenerative disc signal and disc space narrowing with mild to moderate diffuse bulging. Id.
From L5-S1 of the lumbar and sacral spinal vertebrae, there were moderately severe
degenerative changes with degenerative endplate changes. Id. A superiorly migrating left-sided
disc herniation on the August 2008 study could be partially calcified in the current study. Id. at
3.

        On August 12, 2011, petitioner went to Lawrence & Memorial Hospital, complaining of
an abdominal lump. Med. recs. Ex. 5, at 105. He complained of pain in his left lower quadrant,
which was intermittent. Id. A CT scan of his abdomen and pelvis on September 16, 2011,
showed no significant abnormality. Id. at 111. Petitioner also gave a history that he had right
leg surgery in 2008 when a rod was placed in his right leg. Id. at 105.

12
   Lidoderm is “trademark for a preparation of lidocaine.” Dorland’s at 1034. Lidocaine is “a
drug having anesthetic, sedative, analgesic, anticonvulsant, and cardiac depressant activities,
used as a local anesthetic.” Id.
13
   Iliolumbar pertains “to the iliac and lumbar regions, or to the flank and loin.” Dorland’s at
914.
14
   Hemangioma is “a common type of vascular malformation, usually seen in infancy and
childhood, consisting of newly formed blood vessels that result from malformation of
angioblastic tissue of fetal life.” Dorland’s at 831.
                                                   4
        On September 19, 2011, petitioner saw Dr. Keitner. Med. recs. Ex. 4, at 20. Petitioner
complained of discomfort with slight swelling in the left lower quadrant of his abdomen and left
groin area near his hip. Id. Dr. Keitner examined him and found minimal tenderness, but no
mass. Id. Petitioner had chronic pain involving his lower back, left arm, and left shoulder with
some pain in his right hand and wrist. Id. A recent CT scan showed no abnormality of his
abdomen and pelvis except for a small right inguinal hernia, which was not the area where
petitioner noted pain. Id.

        On November 15, 2011, petitioner saw Dr. Keitner. Id. at 21. Petitioner complained of a
marked increase in cough, chest congestion, and sore throat over the past several days. Id.
Petitioner had a history of prostatitis. 15 Id. Dr. Keitner diagnosed petitioner with acute
bronchitis. Id. Petitioner asked for a check of his PSA 16 level. Id.

      On April 30, 2012, petitioner saw Dr. Keitner. Id. at 27. Petitioner complained of
symptoms of prostatitis. Id. Dr. Keitner prescribed Zithromax. 17 Id.

        On September 27, 2012, petitioner saw Dr. Keitner. Id. at 32. Petitioner said he started
smoking again because he was bored. Id. He had an increase in coughing and wheezing. Id. He
smoked about 12 cigarettes a day. Id. Dr. Keitner noted that petitioner’s hypertension was not
as well controlled as usual. Id. Petitioner blamed this on anxiety and stress for a number of
different reasons. Id.

        On March 26, 2013, petitioner saw Dr. Keitner. Id. at 35. Petitioner had asthma
associated with cigarette smoking, hypertension, gastroesophageal reflux disease,
hyperlipidemia, and erectile dysfunction. Id. Petitioner had been seeing a psychiatrist for a
history of bipolar disease and depression. Id. Other problems included chronic pain,
degenerative arthritis, migraine headaches, previous cocaine abuse for which he was on
methadone maintenance, hepatitis C, and acute bronchitis. Id. Recently, petitioner complained
of vague discomfort in his chest with deep breathing. Id. Petitioner was still smoking one-half
pack of cigarettes daily. Id. Lately, his psychiatrist reduced his dose of Klonopin and petitioner
had felt more jumpy and, sometimes, took additional Clonidine. Id.

        On June 17, 2013, petitioner was at Lawrence & Memorial Hospital Emergency
Department, complaining of chest pain. Med. recs. Ex. 7, at 153. He gave a history of prior
myocardial infarction in the setting of cocaine abuse. Id. Petitioner became more agitated
during the course of his evaluation and left the Emergency Department against medical advice.

15
   Prostatitis is “inflammation of the prostate.” Dorland’s at 1530.
16
   PSA is “prostate-specific antigen.” Dorland’s at 1540.
17
   Zithromax is “trademark for a preparation of azithromycin.” Dorland’s at 2092.
Azithromycin is “an azalide antibiotic, derived from erythromycin, that inhibits bacterial protein
synthesis, effective against a wide range of gram-positive, gram-negative, and anaerobic
bacteria; used in the treatment of mild to moderate infections caused by susceptible organisms.”
Id. at 187.
                                                  5
Id. at 154. He said he had to go home because he left his fan and coffee pot on. Id. A chest x-
ray done before petitioner left showed minimal bibasilar opacities, which could represent
atelectasis. 18 Id. at 172.

       On July 23, 2013, petitioner saw Dr. Keitner. Id. at 42. Dr. Keitner diagnosed petitioner
with pre-diabetes, hyperlipidemia, and hypertension, suggesting metabolic syndrome. Id.

                                    Post-Vaccination Records

       On August 15, 2013, petitioner received flu vaccine. Med. recs. Ex. 3, at 1.

        On August 18, 2013, petitioner went to Lawrence & Memorial Hospital Emergency
Department, complaining of back pain. Med. recs. Ex. 5, at 216. He had been taking muscle
relaxants, methadone, and oxycodone, without any significant relief of the pain, which he said
went from the top of his hips to his back. Id. He did not have any weakness, paresthesias, or
radicular symptoms in his lower extremities. Id. He denied any fever, chills, or urinary
complaints. Id. He had no headache, nausea, vomiting, or trauma. Id. On physical
examination, petitioner was in mild discomfort without significant distress. Id. He had bilateral
paraspinal muscle tenderness and bilateral sacroiliac joint tenderness in his low back. Id. His
reflexes were normal. Id. Petitioner had a history of chronic low back pain. Id. He was on
extremely high doses of pain medication and complained of acute worsening of his lower back
pain. Id. Petitioner left the Emergency Department prior to completing his treatment. Id.

       On August 19, 2013, a CT scan of petitioner’s lumbar spine showed mild to moderate
lumbar spondylosis. 19 Id. at 242. The CT scan was compared to a May 22, 2006 exam. Id.
Mild disc space narrowing and endplate degenerative changes throughout the lumbar levels had
progressed slightly since the May 22, 2006 exam. Id.

        On August 26, 2013, petitioner saw Dr. Keitner. Med. recs. Ex. 4, at 43. Petitioner
complained of severe lower back pain. Id. He said that two weeks earlier, he received flu
vaccine in his left upper arm and, the next day, awoke with severe pain in his lower back on both
sides, which radiated to his testicles. Id. He said the pain did not radiate into his legs. Id. He
went to the emergency room twice and personnel told him to use Lidocaine patches. Id. He was
also using muscle relaxants, such as Soma, 20 his usual pain medicine Percocet, his daily
methadone, and Motrin. 21 Id. Petitioner had no problem urinating. Id. He did have an episode
of prostatitis the prior week, but Zithromax cleared it up. Id. Petitioner did not have any muscle
weakness. Id. On physical examination, petitioner did not have localized tenderness in the

18
   Atelectasis is “incomplete expansion of a lung or a portion of a lung . . . .” Dorland’s at 171.
19
   Spondylosis is “degenerative spinal changes due to osteoarthritis.” Dorland’s at 1754.
20
   Soma is “trademark for combination preparations of carisoprodol and aspirin.” Dorland’s at
1734. Carisoprodol is “a centrally acting skeletal muscle relaxant, for the symptomatic
management of acute, painful musculoskeletal disorders.” Id. at 296.
21
   Motrin is “trademark for preparations of ibuprofen.” Dorland’s at 1182.
                                                 6
lumbosacral area, but he did have mild muscle spasticity. Id. Dr. Keitner’s impression was
lower back muscle strain, possibly with acute inflammation. Id. Dr. Keitner wrote: “[I] doubt
relationship to recent influenza vaccination although this has been reported very rarely. Normal
reflexes and lack of muscle weakness make diagnosis of Guillain-Barre syndrome extremely
unlikely.” Id. Dr. Keitner prescribed a trial of Prednisone and said petitioner could also use
Flexeril. 22 Id.

        On September 17, 2013, petitioner went to Lawrence & Memorial Hospital Emergency
Department. Med. recs. Ex. 5, at 256. He complained of right leg pain. Id. Petitioner had a
history of chronic back pain and presented with right-sided thigh pain radiating down to his knee.
Id. There was no obvious injury or swelling. Id. On physical examination, petitioner’s leg was
soft and non-tender to palpation. Id. Dr. Melissa L. Monte could not reproduce his pain. Id.

        On September 20, 2013, petitioner saw Dr. Keitner. Med. recs. Ex. 4, at 44. Petitioner
still complained of severe lower back pain radiating into his buttocks. Id. He had no problems
urinating or defecating. Id. Dr. Keitner diagnosed petitioner with persistent, severe lower back
pain with significant muscle spasm. Id.

        On September 26, 2013, petitioner saw his orthopedist Dr. Maletz. Med. recs. Ex. 7, at 9.
Petitioner had a significant second-degree burn of his back. Id. His lumbar spine was the
problem. Id. Petitioner was developing significantly increased pain and muscle spasms. Id. For
his lumbar spine symptoms, he used all of the medicines prescribed for his left knee following
arthroscopic surgery, but much in excess of what was prescribed then. Id. On physical
examination, petitioner had multiple pain patches all over his back. Id.

        On September 27, 2013, petitioner went to Lawrence & Memorial Hospital Emergency
Department, complaining of right thigh pain and back pain. Med. recs. Ex. 5, at 287. Petitioner
had a history of chronic lower back pain, hepatitis C, hypertension, hyperlipidemia, and acute
myocardial infarction. Id. Petitioner stated he did not have urinary incontinence, urinary
retention, or bleeding. Id. He said he had been immobilized for the past couple of months
because of his back pain. Id. On physical examination, petitioner had no guarding of his
abdomen. Id. He had paraspinal lower back pain, but no midline lumbar, cervical, or thoracic
spinal tenderness. Id. He had good range of motion of his black with flexion and extension,
turning to the left as well as to the right. Id. He had mild tenderness of the right thigh. Id. at
288. Dr. Monte noted that the pain in petitioner’s right leg began one day earlier. Id. at 289.
Petitioner was concerned he had a blood clot. Id. Dr. Monte explained that, in light of his
physical examination, the risk of his having deep vein thrombosis was low. Id. Petitioner had a
deep vein sonographic evaluation, which showed no deep venous thrombosis in his right lower
extremity. Id. at 294.

22
   Flexeril is “trademark for a preparation of gallamine triethiodide.” Dorland’s at 717.
Gallamine triethiodide is “a quaternary ammonium compound used to induce skeletal muscle
relaxation . . . .” Id. at 755.
                                                  7
         On October 8, 2013, petitioner saw Dr. Keitner. Med. recs. Ex. 4, at 46. Petitioner
complained of poorly healing sores and an infection in his perianal area, which had been ongoing
for at least a month or more. Id. Petitioner had been on several different antibiotics: Cipro for
urinary tract infection in late September and then Keflex starting October 4, 2013. Id. He said
the infection started when he was having diarrhea about a month or so prior. Id. Dr. Keitner saw
two superficial skin ulcers on either side of the anal orifice, with minimal cellulitis, which
appeared to be slowly healing. Id.

        On October 9, 2013, petitioner had an MRI of his lumbar spine performed. Med. recs.
Ex. 7, at 10. This MRI was compared to the scan done in May 2011. Id. Petitioner had lumbar
lesions involving the L1, L4, and T11 vertebral bodies, which were present on the May 2011
exam. Id. They were nonspecific but could represent a benign etiology, such as hemangiomas.
Id. There was abnormal irregularity of the endplates of L2-L3 with high T2 signal seen in the
disc space at this level, as well as paravertebral soft tissue and heterogeneous signal seen in the
region of the right psoas muscle. Id. There was subluxuation/retrolisthesis23 at this level
measuring about 0.6 cm. Id. Spondylosis was detailed at the following vertebral levels from L1
to S1:
    x L1-L2 (mild diffuse disc osteophyte 24 complex and facet hypertrophy);
    x L2-L3 (as in L1-L2 and at least moderate central canal stenosis 25 with neural foramen 26
        encroachment particularly on the right side);
    x L3-L4 (diffuse disc ossific complex with facet hypertrophy thickening ligamentum
        flavum and mild mass effect on the nerve roots as they exited laterally bilaterally);
    x L4-L5 (diffuse disc ossific complex with facet hypertrophy thickening ligamentum
        flavum with a focal extrusion in the central and left paracentral location measuring about
        1.2 x 0.8 cm, and at least moderate central canal stenosis, mass effect on the thecal sac
        and the nerve roots particularly on the left side and nerve root exiting medially inferior,
        plus moderate left neural foramen encroachment); and
    x L5-S1 (diffuse disc osteophyte complex with facet hypertrophy with a diffuse extrusion
        extending slightly caudal, plus mild bilateral neural foramen encroachment, focal area
        signal alteration in the right aspect of the sacrum which was nonspecific but could
        represent a hemangioma).
Id. at 10-11.

       The radiologist’s conclusion for the October 9, 2013 MRI examination of petitioner’s
lumbar spine was that petitioner’s disc disease had progressed compared to his May 2011 MRI
examination. Id. at 11.

23
   Subluxation is “an incomplete or partial dislocation.” Dorland’s at 1791. Retrolisthesis is also
known as retrospondylolisthesis, which is “posterior displacement of one vertebral body on the
subjacent body.” Id. at 1636.
24
   Osteophyte is “a bony excrescence or osseous outgrowth.” Dorland’s at 1348.
25
   Stenosis is “an abnormal narrowing.” Dorland’s at 1769.
26
   Foramen is “a natural opening or passage, especially one into or through a bone.” Dorland’s at
729.
                                                 8
       Also on October 9, 2013, a CT scan was performed on petitioner’s pelvis and lumbar
spine. Id. at 13. This was compared with CT scans of petitioner’s abdomen and pelvis on
September 16, 2011 and his lumbar spine on August 19, 2013. Id. The lumbar spine showed
destruction of the endplates and irregularity of the disc space of the L2-L3 level. Id. There were
marginal disc osteophyte complexes with osteopenia. 27 Id. There was also retrolisthesis at the
L2-L3 level. Id. The pelvis showed nonspecific calcification, which could represent phleboliths.
Id. There was also osteopenia and mild osteoarthritic changes of the bilateral hip joints. Id. The
impression was that the findings were most consistent with diskitis/osteomyelitis involving the
L2-L3 level, spondylosis, and osteopenia. Id.

        On October 11, 2013, petitioner went to Lawrence & Memorial Hospital where he signed
out against medical advice. Id. at 15. Dr. Jeffrey A. Salkin wrote the discharge summary, saying
that the plan for dealing with petitioner’s diskitis was intravenous antibiotics, an infectious
disease consult, and a special procedure biopsy. Petitioner said this was inconvenient for him.
Id.

        On October 23, 2013, petitioner saw Dr. Keitner. Med. recs. Ex. 4, at 50. Petitioner still
complained of discomfort and a rash in the perirectal area. Id. He completed his course of
antibiotics (Cephalexin) and there was improvement. Id. He noted more redness now and some
redness around the urethral meatus and glans penis. Id. Dr. Keitner noted on physical
examination that the rectal rash looked like Candida. 28 Id. Petitioner also had mild erythema
around the glans penis without discharge. Id. Dr. Keitner prescribed Diflucan and Nystatin
cream. Id.

         On November 22, 2013, petitioner saw Dr. Keitner. Id. at 51. Petitioner’s perirectal and
perineal Candida infection finally cleared up, as did his Candida balanitis. Id. Since his prior
visit, petitioner’s lower back pain was a little better, but he still had significant muscle spasticity.
Id. Petitioner’s psychiatrist discontinued Klonopin and Ambien, which upset petitioner
considerably. Id.

        On December 5, 2013, petitioner returned to his orthopedist Dr. Maletz. Med. recs. Ex.
7, at 16. Dr. Maletz writes that petitioner had lumbar discopathy from L2-L3 to L5-S1. He also
had bilateral knee pain. Dr. Maletz attributed much of petitioner’s problem at L3-L4 and L4-L5
to degeneration. Id.

        On March 11, 2014, petitioner saw Dr. Keitner. Med. recs. Ex. 4, at 55. About four or
five days previously, petitioner developed severe low back pain. Id. Dr. Keitner wrote, “He has
had low back pain before, and this has been attributed to disk disease . . . .” Id. Dr. Maletz,
petitioner’s orthopedist, said petitioner would need an eight-hour surgery, and it might not work.
Id. Petitioner was taking methadone and Percocet. Id. He got a Fentanyl patch from his brother,

27
     Osteopenia is “any decrease in bone mass below the normal.” Dorland’s at 1347.
28
     Candida is a yeast-like fungal infection. Dorland’s at 280.
                                                   9
which relieved the pain for several days. Id. On physical examination, petitioner had minimal
tenderness over the L4-L5 region of his back, without radiation. Id. Dr. Keitner’s impression
was acute low back pain with a history of longstanding lumbar disc disease. Id.

                                  Treating Physicians’ Opinions

        The Federal Circuit in Capizzano emphasized that the special masters are to evaluate
seriously the opinions of petitioner’s treating doctors since “treating physicians are likely to be in
the best position to determine whether a logical sequence of cause and effect show[s] that the
vaccination was the reason for the injury.” 440 F.3d at 1326. See also Broekelschen v. Sec’y of
HHS, 618 F.3d 1339, 1347 (Fed. Cir. 2010); Andreu v. Sec’y of HHS, 569 F.3d 1367, 1375
(Fed. Cir. 2009).

       On August 21, 2013, Dr. Keitner, petitioner’s personal care physician, opined that he
doubted flu vaccine had anything to do with petitioner’s complaints of back and testicular pain.

       None of petitioner’s doctors prescribed the type of drugs someone with an autoimmune
or immune-mediated disease would receive, e.g., plasmapheresis, intravenous immunoglobulin,
or prednisone. They did prescribe pain-relievers and muscle relaxants which he had already
been taking for years. In fact, he was on so many drugs including methadone that he may have
had diskitis before flu vaccination but the anti-pain drugs masked the diskitis until the pain
became too much.

        The treating doctors, believing petitioner’s diskitis was due to an infection, planned to
have petitioner receive intravenous antibiotics, an infectious disease consultation, and a biopsy to
find the source of his infection. Petitioner however chose to leave the hospital against medical
advice. Thus, these procedures were never performed nor was a culture done to find the source
of his infection.

                                           DISCUSSION

       To satisfy his burden of proving causation in fact, petitioner must prove by preponderant
evidence: “(1) a medical theory causally connecting the vaccination and the injury; (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.” Althen v. Sec’y
of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion
in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148 (Fed. Cir. 1992):

               A persuasive medical theory is demonstrated by “proof of a logical
               sequence of cause and effect showing that the vaccination was the
               reason for the injury[,]” the logical sequence being supported by
               “reputable medical or scientific explanation[,]” i.e., “evidence in
               the form of scientific studies or expert medical testimony[.]”

                                                 10
Althen, 418 F.3d at 1278.

       Without more, “evidence showing an absence of other causes does not meet petitioners’
affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.

        Petitioner must show not only that but for flu vaccination, he would not have had burning
pain in his back, abdomen, and testicles, but also that flu vaccine was a substantial factor in
causing burning pain in his back, abdomen, and testicles. Shyface v. Sec’y of HHS, 165 F.3d
1344, 1352 (Fed. Cir. 1999).

       The Vaccine Act does not permit the undersigned to rule for petitioner based on his
claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-
13(a)(1).

        Moreover, petitioner is required to prove that his alleged vaccine injury lasted for more
than six months. 42 U.S.C. § 300aa-11(c)(1)(D)(i). Nothing in the medical records supports a
conclusion that petitioner’s stomach and testicular pain and his genital infection lasted more than
six months. What remains is petitioner’s attempt to prove that flu vaccine caused his back pain.

        Dr. Axelrod based his opinion on autoimmune illness by rejecting that petitioner’s
diskitis could be due to an infection. However, the failure to find the source of the infection is
not sufficient legally to satisfy petitioner’s burden to prove a prima facie case. As the Federal
Circuit stated in Grant, 956 F.2d at 1149, not knowing any other factor than the vaccine predated
the alleged injury is insufficient to satisfy petitioner’s burden of proof. Petitioner has to provide
affirmative evidence of causation.

        Dr. Axelrod’s thesis relies on there being blood vessels and nerves within the spinal disc.
However, Dr. Collins testified there are no blood vessels or nerves within a spinal disc. Blood
vessels go around a spinal disc, not through it. Nerve fibers exit the spinal cord but do not sit
within spinal discs. See Exhibit C, a schematic drawing of an intervertebral disc. Dr. Axelrod
did not refute Dr. Collins’ testimony. Dr. Collins testified that vertebral osteomyelitis is not
autoimmune.

        Dr. Axelrod’s thesis that flu vaccine causes a rise in cytokines, thus breaching the blood-
brain barrier, has nothing to do with vertebral discs. The blood-brain barrier, as Dr. Collins
explained, deals with the central nervous system (the brain and spinal cord). The vertebral discs
are outside the spinal cord and do not contain nerve tissue. Dr. Axelrod’s thesis that flu vaccine
produces cytokines, which increase vascular tissue and affect nerve tissue, is thus irrelevant to
the cause of petitioner’s diskitis at the L2-L3 level. Dr. Collins persuasively proved that spinal
discs do not contain blood vessels or nerve tissue. Therefore, Dr. Axelrod’s thesis is not
credible.

                                                 11
       Dr. Axelrod admitted on cross-examination that no one in the medical community
believes that flu vaccine causes diskitis.

                                           Althen Analysis

                                              Prong One

        Petitioner has failed to prove that flu vaccine can cause diskitis because the theory that
cytokines increase vascular tissue and affect nerve tissue has nothing to do with spinal discs and
spinal disc inflammation.

                                              Prong Two

       Petitioner has failed to prove that there is a logical sequence of cause and effect in the flu
vaccination he received and his diskitis. There is nothing logical about flu vaccine causing
inflammation of petitioner’s lumbar discs, particularly in light of petitioner’s long history of
degenerative disc disease. If petitioner had had an adverse reaction to flu vaccination due to
cytokine inflammation increasing vasculature and affecting nerve tissues from cytokine
permeation of the blood-brain barrier, his symptoms would not have been restricted to his back,
abdomen, and testicles. He would have had systemic symptoms, such as fever.

                                             Prong Three

       Petitioner has failed to prove that any time period, much less one day, is appropriate for
influenza vaccine to cause diskitis.

                                           CONCLUSION

       The petition is DISMISSED for failure to make a prima facie case. In the absence of a
motion for review filed pursuant to RCFC Appendix B, the Clerk of Court is directed to enter
judgment herewith. 29

IT IS SO ORDERED.

July 25, 2017                                                           /s/ Laura D. Millman
DATE                                                                        Laura D. Millman
                                                                            Special Master

        29
          Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either
separately or jointly, filing a notice renouncing the right to seek review.
                                                   12