The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: November 7, 2019
* * * * * * * * * * * * *
JOHN SQUADRONI, * Unpublished
*
Petitioner, * No. 16-1102V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH * Decision on Entitlement;
AND HUMAN SERVICES, * Ruling on the Record; Tetanus-
* Diphtheria-Pertussis (“Tdap”);
* Insufficient Proof of Causation.
Respondent. *
* * * * * * * * * * * * *
Howard S. Gold, Gold Law Firm, LLC, Wellesley Hills, MA, for petitioner.
Darryl R. Wishard, United States Department of Justice, Washington, DC, for respondent.
ENTITLEMENT DECISION1
On September 2, 2016, John Squadroni (“petitioner”) filed a claim pursuant to the
National Vaccine Injury Program.2 Petitioner alleged he suffered from “back pain, lumbar pain,
shoulder pain and sacral pain” as a result of receiving the Tetanus-diphtheria-pertussis (“Tdap”)
vaccination on March 14, 2014. Petition at ¶1 (ECF No. 1). On August 8, 2018, petitioner filed
a motion for a ruling on the record. Petitioner’s (“Pet.”) Motion (“Mot.”) (ECF No. 40).
Respondent filed a response on August 21, 2018. Respondent’s (“Resp.”) Response (ECF No.
41). Petitioner filed a reply on August 27, 2018. Pet. Reply (ECF No. 42). After a full review
of the entire record described below, I hereby DENY petitioner’s motion for a ruling resolving
entitlement in his favor. I hereby find that the petitioner has not established that the Tdap
1
Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this decision contains a
reasoned explanation for the action in this case, I am required to post it on the website of the United States Court of
Federal Claims. The court’s website is at http://www.uscfc.uscourts.gov/aggregator/sources/7. This means the
Ruling will be available to anyone with access to the Internet. Before the decision is posted on the court’s
website, each party has 14 days to file a motion requesting redaction “of any information furnished by that party:
(1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that
includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of
privacy.” Vaccine Rule 18(b). “An objecting party must provide the court with a proposed redacted version of the
decision.” Id. If neither party files a motion for redaction within 14 days, the decision will be posted on the
court’s website without any changes. Id.
2
The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et
seq. (hereinafter “Vaccine Act” or “the Act”). Hereafter, individual section references will be to 42 U.S.C. § 300aa
of the Act.
vaccination caused the onset of his back and shoulder pain. Moreover, petitioner has not
submitted preponderant evidence establishing a vaccine-related injury as required by the Act.
Therefore, petitioner is not entitled to compensation and his claim must be dismissed.3
I. Legal Standard
A petitioner must prove that he is entitled to compensation under the Vaccine Program.
The petitioner’s burden of proof is by a preponderance of the evidence. § 300aa-13(a)(1). A
petitioner may demonstrate entitlement in one of two ways. The first way is to show that he
suffered an injury listed on the Vaccine Injury table (a “Table” injury) with the requisite
vaccination, injury, and time frame as elucidated by the Qualifications and Aids to Interpretation
in which case causation is presumed. 42 U.S.C. § 100.3.
In this case, petitioner does not allege a Table injury. Therefore, petitioner has the
burden of demonstrating causation-in-fact by a preponderance of the evidence. See Cedillo v.
Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); § 300aa-13(a)(1). To
show causation-in-fact, petitioner must provide: “(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 the vaccination and injury.” Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005).
Petitioner must demonstrate that it was “more likely than not” that the vaccination in
question caused his injury in order to meet the preponderance of the evidence standard. Moberly
v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Petitioner does not
need to show proof to a medical certainty. Bunting v. Sec’y of Health & Human Servs., 931 F.2d
867, 873 (Fed. Cir. 1991). Petitioner must demonstrate that the vaccination in question was “not
only [a] but for cause of the injury but also a substantial factor in bringing about the injury.”
Moberly, 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1352-53 (Fed. Cir. 1999)); Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed.
Cir. 2006).
The Vaccine Act requires a special master to consider the record as a whole. The Vaccine
Act prohibits a special master from ruling in petitioners’ favor solely based on his own allegation
“unsubstantiated by medical records or medical opinion.” § 13(a)(1).
The process of making determinations in Vaccine Program cases for factual issues begins
with consideration of the medical records which are required to be filed with the petition. §
11(c)(2). A petitioner’s medical records “warrant consideration as trustworthy evidence.”
Cucuras v. Sec’y of Health & Human Servs., 993 F.2s 1525, 1528 (Fed. Cir. 1993). Medical
records that are created contemporaneously with the events they describe are presumed to be
accurate and complete. Cucuras, 993 F.2d at 1528. This presumption of accuracy and
completeness is based on the linked propositions that (1) sick people visit medical professionals;
(2) sick people honestly report their health problems to those professionals; and (3) medical
3
Pursuant to § 300aa-13(a)(1), in order to reach my decision, I have considered the entire record including all of the
medical records, statements, expert reports, and medical literature submitted by the parties. This decision discusses
the elements of the record I found most relevant to the outcome.
2
professionals record what they are told or observe when examining their patients in as accurate a
manner as possible, so that they are aware of enough relevant facts to make appropriate treatment
decisions. Cucuras, 993 F.2d at 1525. If the medical records are clear, consistent, and complete,
then they are afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-
1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005).
A diagnosis and an opinion from a treating physician may be considered in the evaluation
of a case. Capizzano v. Sec’y of Health & Human Servs., 440 F. 3d 1317, 1326 (Fed. Cir. 2006).
If contemporaneous physician’s notes are “all speculative,” a Special Master is permitted to find
that such evidence is not dispositive. See Moberly ex. rel. Moberly v. Sec’y of Health & Human
Servs., 592 F. 3d at 1323-25 (finding that speculative notations by treating physicians were
properly not dispositive on causation because “[while] several of petitioner’s treating physicians
noted the temporal relationship between [petitioner’s] vaccination and petitioner’s initial brief
seizures, none ever offered a solid statement…that the vaccination caused petitioner’s condition).”
Special masters should consider all of the above possibilities when evaluating the factual
evidence as part of his or her responsibility to “consider all relevant and reliable evidence in the
record.” La Londe, 110 Fed.Cl. at 204.
Petitioners often need to present a report from medical experts in support of their claim to
establish a sound and reliable medical theory. Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357, 1361 (Fed. Cir. 2000). In Vaccine Act cases, expert testimony is evaluated according
to the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc.,
509 U.S. 579, 594-96 (1993); see also Cedillo, 617 F.3d 1328, 1339 (Fed. Cir. 2010) (citing Terran
v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999)). “The Daubert factors
for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and has
been) tested; (2) whether the theory or technique has been subjected to peer review and publication;
(3) whether there is a known or potential rate of error and whether there are standards for
controlling the error; and (4) whether the theory or technique enjoys general acceptance within a
relevant scientific community.” Terran, 195 F.3d at 1316 n.2 (citing Daubert, 509 U.S. at 592-
95).
In Vaccine Program cases, the Daubert factors are used to weigh the proffered scientific
evidence to determine their reliability. Davis v. Sec’y of Health & Human Servs., 94 Fed. Cl. 53,
66-67 (2010) (“uniquely in this Circuit, the Daubert factors have been employed also as an
acceptable evidentiary-gauging tool with respect to persuasiveness of expert testimony already
admitted”), aff’d, 420 F. App’x 923 (Fed. Cir. 2011). The flexible use of the Daubert factors to
evaluate the persuasiveness and/or reliability of expert testimony in the Vaccine Program has been
routinely upheld. See, e.g., Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 742-45
(2009).
A special master’s decision may be “based on the credibility of the experts and the relative
persuasiveness of their competing theories” when both sides offer expert testimony. Broekelschen
v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe v. Sec’y
of Health & Human Servs., 219 F.3d 1357, 1362 9Fed. Cir. 2000)). However, nothing requires
the acceptance of an expert’s conclusion “connected to existing data only by the ipse dixit of the
expert,” especially if “there is simply too great an analytical gap between the data and opinion
3
proffered.” Snyder, 88 Fed. Cl. at 743 (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)).
II. Procedural History
Petitioner filed his claim in the Vaccine Program on September 2, 2016. Petition (ECF
No. 1). Petitioner alleged that he received the Adacel Tdap vaccination on March 14, 2014 and
subsequently suffered from back, lumbar, shoulder, and sacral pain as a result. Petition at ¶1.
This case was assigned to my docket on September 6, 2016. (ECF No. 3). Petitioner filed his
medical records on September 22, 2016. Pet. Exs. 1-6 (ECF No. 6).
On November 1, 2016, respondent filed his Rule 4(c) Report recommending against
compensation. Resp. Report at 1 (ECF No. 7). Respondent objected to compensation for two
reasons. First, respondent argued petitioner has a bilateral subdeltoid bursitis of unknown cause
which does not meet the requirements of a Shoulder Injury Related to Vaccine Administration
(“SIRVA”). Resp. Report at 7. Second, respondent argued the Tdap vaccine did not cause or
significantly aggravate petitioner’s pre-vaccination conditions of low back pain, joint
arthropathy, and lumbar stenosis. Id.
On November 9, 2016, I ordered both parties to file expert reports addressing the issue of
vaccine causation. See Scheduling Order (ECF No. 8). Petitioner filed an expert report from Dr.
M. Eric Gershwin on April 25, 2017. Pet. Ex. 7 (ECF No. 15). Respondent filed a responsive
report from Dr. Chester Oddis on July 10, 2017. Resp. Ex. A (ECF No. 23).
I held a Rule 5 status conference on September 20, 2017. During the status conference, I
noted that petitioner is proposing a vaccine causation theory whereby his “complicated emotional
state predisposed him to have a more extreme reaction to the vaccine.” Scheduling Order at 1
(ECF No. 24). I stated that there is a lack of a clear connection between the vaccine and
petitioner’s alleged injury. Id. As a result, I ordered petitioner to file psychiatric records, an
evaluation explaining his severe somatic response to the vaccination, and a supplemental expert
report addressing petitioner’s psychiatric reaction to vaccination and the physiological process of
pain moving from petitioner’s arms to other regions of his body. Id. at 2.
Petitioner requested four extensions of time to secure an additional expert report. (ECF
Nos. 25, 27, 29, 31). Following the fourth motion for an extension of time on April 21, 2018,
respondent filed a motion objecting to an additional extension of time and moved for summary
judgment. (ECF No. 32). On April 23, 2018, I granted petitioner’s motion for an extension of
time and deferred ruling on respondent’s motion for summary judgment. See Order (ECF No.
33).
Petitioner filed a self-reported pain calendar documenting his alleged condition on May
11, 2018. Pet. Ex. 8 (ECF No. 34). On the same day, petitioner filed an expert report from Dr.
Raymond Singer, PhD, a neuropsychologist, addressing causation. Pet. Ex. 9 (ECF No. 35). He
opined that the petitioner was in good health prior to the vaccine, not acknowledging any of his
prior musculoskeletal complaints, that there was a temporal relationship between the vaccine and
onset of symptoms and diagnosed a psychosomatic disorder for which a full neuropsychological
evaluation should be done. Pet. Ex. 9 at 9. This examination was never completed.
4
I held a status conference on May 31, 2018. During the status conference, I noted Dr.
Singer appeared to make his diagnosis based on petitioner’s medical records rather than a direct
evaluation even though he was rendering a psychological diagnosis. Scheduling Order at 1 (ECF
No. 37). Second, I noted the petitioner’s pain diary did not indicate if it was created at the time
petitioner was experiencing the pain. Id. Third, I stated that there may not be a sufficiently
strong logical nexus between vaccination and petitioner’s alleged injury such that a
psychological symptom amplification syndrome can be considered a vaccine injury. Id. at 2.
Petitioner contended his injury was back and shoulder pain that he experienced after the
vaccination and not that the vaccine caused his psychological condition. I ordered petitioner to
file an affidavit detailing how and when the filed pain calendar was created. Id. During the
status conference, the parties agreed to a ruling on the record and I ordered petitioner to file the
appropriate motion. Id. I also denied respondent’s earlier motion for summary judgment as
moot. Id.
On June 14, 2018, petitioner filed an affidavit stating he created the pain diary
contemporaneously. (ECF No. 38). On July 16, 2018, petitioner filed a motion to amend the
schedule for filing a motion for a ruling on the record. (ECF No. 39). Petitioner requested to
have until August 9, 2018 to file the motion. (ECF No. 39). Petitioner’s motion was granted on
July 17, 2018. Order Non-PDF, Granting Motion to Amend Schedule.
On August 8, 2018, petitioner filed a motion for a ruling on the record. Pet. Mot.
Respondent filed a response to the motion on August 21, 2018. Resp. Response. Petitioner filed
a reply on August 27, 2018. Pet. Reply (ECF No. 42).
This motion is now ripe for adjudication.
III. Relevant Medical Facts
A. Petitioner’s Medical Records Prior to Vaccination
Petitioner has a significant medical history of multiple chronic conditions including
hyperlipidemia, hypertension, osteoarthritis, diabetes, and ulnar nerve neuropathy. Pet. Ex. 4 at 5-
6. Petitioner had previously undergone neck surgery. Id.
The earliest medical record filed is petitioner’s visit with Dr. Anatoliy Fortenko for low
back pain on March 1, 2011. Id. The visit note stated petitioner had an episode of pain in the low
back and buttocks approximately three weeks prior that had since resolved. Id. Dr. Fortenko
diagnosed petitioner’s complaint as lumbosacral radiculopathy4 and facet arthropathy5 and
4
Lumbosacral radiculopathy is disease of the nerve roots in the lower back as a result of inflammation or
impingement by a tumor or bony spur. Dorland’s Illustrated Medical Dictionary 32nd ed. (2012) (hereinafter
“Dorland’s”) at 1571.
5
Facet arthropathy is also known as osteoarthritis that is centered within the facet joints with disk degeneration and
pain that is most common in the lumbar region. Dorland’s at 1344.
5
prescribed meloxicam.6 Id. at 7.
On a March 28, 2011 telephone encounter with Dr. Sherilynn Cooke, petitioner complained
of feeling ill after taking Amlodipine.7 Id. at 24-25. Petitioner stated during the phone call that
the prescribed meloxicam helped with his back and ankle pain. Id. During a subsequent telephone
encounter with Dr. Cooke on June 6, 2011, petitioner complained of continued back pain with
difficulty with urination and tingling/numbness around the cervical area. Id. at 31-32. Dr. Cooke
recommended a follow-up visit with Dr. Fortenko and continuing the meloxicam medication.
Petitioner spoke with Dr. Fortenko by telephone on June 9, 2011. Id. at 38. Petitioner reported
the severe back pain resolved with Aleve but there was still numbness in the left arm which
petitioner attributed to his previous neck surgery. Id.
During an October 18, 2011 telephone encounter with Dr. Cooke, petitioner complained of
occasional hip pain without pain radiating down the leg. Id. at 50-51. Dr. Cooke diagnosed
petitioner’s complaint as low back pain. Id.
Petitioner next saw a physician in-person on November 15, 2011. On November 15, 2011,
petitioner saw Dr. Ekaterina Malinovsky for left buttock and posterior thigh pain that had persisted
intermittently for a year. An MRI of petitioner’s lumbar spine showed “[m]ultilevel spondylotic
disc disease8 and facet joint arthropathy of the lumbar spine.” Pet. Ex. 4 at 61. Dr. Malinvosky
assessed petition with sciatica and stated the pain in petitioner’s buttock and leg could be due to a
muscle spasm rather than osteoarthritis. Id.
On January 29, 2013, petitioner called the Kaiser Permanente call center with a complaint
of severe pain in the right foot. Id. at 130-32. Petitioner stated that the pain was a flare-up of gout
which he attributed to eating crab salad. Id. Petitioner requested a cortisone shot for the pain. Id.
Petitioner saw Dr. Frank Shic on January 30, 2013. Dr. Shic noted great toe pain, assessed gout,
and administered a shot of lidocaine and depomedrol. Id. at 138. Petitioner’s active medical
history at this point matched that from March 1, 2011. Id. at 137.
Petitioner’s next substantive interaction with medical professionals was approximately
nine months later, on September 25, 2013, when he presented to Dr. Shic with lower back pain.
Id. at 190. Petitioner complained of lower back pain and Dr. Shic noted that petitioner endorsed
numbness and tingling after waking up one morning. Id. Dr. Shic noted that petitioner had an
MRI in 2011 that showed spondylotic changes and moderate to severe central stenosis at L4-L5
and L5-S1. Id. Dr. Shic’s physical examination found “exquisite right sided lumbar tenderness”,
assessed him with lower back pain and prescribed meloxicam. Id. at 191. In a telephone encounter
with Dr. Shic, on October 3, 2013 petitioner reported that his lower back pain was better. Id. at
200. Dr. Shic opined that petitioner’s lower back pain was likely due to osteoarthritis rather than
6
Meloxicam is a nonsteroidal anti-inflammatory drug (“NSAID”) that is commonly used to relieve the symptoms of
arthritis. Mayo Clinic, Meloxicam (Oral Route), https://www mayoclinic.org/drugs-supplements/meloxicam-oral-
route/description/drg-20066928, (last accessed July 19, 2019).
7
Amlodipine is a prescription drug used to treat high blood pressure.
8
Degenerative joint disease in the lumbar vertebrae and the vertebral disks that causes pain and stiffness. Dorland’s
at 1754.
6
a strain. Id. at 201.
Petitioner presented to Dr. Shic on March 14, 2014 with complaints of increased right jaw,
shoulder, and arm stiffness following a deer tick bite approximately two weeks prior and bilateral
hand pain. Id. at 262. Petitioner also reported “increased interpersonal stress with neighbor and
female crew team he was coaching.” Id. Dr. Shic’s physical exam showed “exquisite wrist
tenderness.” Id. at 263-64. Dr. Shic assessed petitioner with osteoarthritis of bilateral hands and
injected lidocaine and depomedrol into petitioner’s first MCP9 joints as treatment. Id. During the
visit, petitioner received the Pneumococcal Polysaccharide, 23 Valent (“PPV/23”) and Tdap
vaccinations in question. Id. at 265. The medical assistant’s note stated that petitioner had no
contraindications for the vaccinations. Id. Dr. Shic also assessed petitioner with “stress,” and
referred him to a Behavioral Medicine Specialist (“BMS”). Id. at 265.
B. Petitioner’s Medical Record Post-Vaccination
On March 26, 2014, petitioner called his primary care provider, complaining about “diffuse
muscle cramping after [T]dap shot and remembers having a similar reaction in college that lasted
three weeks.” Pet. Ex. 4 at 270. Dr. Shic noted that this was likely a side effect of the vaccine.
Id.
Petitioner saw Dr. April Young, a psychologist, on March 28, 2014. Id. at 277-78. She
noted that petitioner was referred by Dr. Shic for depression and stress. Id. at 277. Petitioner
reported depression with an onset of 30 years prior. Dr. Young recommended a functional
assessment and further supportive consultation. Id. A second appointment was scheduled for
April 11, 2014. Id.
In an April 9, 2014 telephone encounter with Dr. Shic, petitioner complained of ongoing
muscle aches after Tdap shot. Id. at 286-87. Dr. Shic diagnosed petitioner with myalgia and
ordered a creatine kinase test and complete blood count with differential for petitioner. Id.
Petitioner’s lab results from April 11, 2014 showed high LDLs, high cholesterol, high hemoglobin
A1c, and high blood glucose. Id. at 290-94. Petitioner had a normal creatine kinase and normal
white blood cell differential.10 Id.
Petitioner saw Dr. Young again on April 11, 2014 where he reported pain for “the past
month after receiving his tetanus shot.” Id. at 297. He stated that he is “nearly paralyzed” and
unable to raise his arms, and had difficulty walking. Id. Dr. Young diagnosed petitioner with
depression. Id.
The same day, April 11, 2014, petitioner saw Dr. Shic for muscle cramps and ongoing
“diffuse shoulder and thigh myalgias.” Id. at 301. Petitioner also reported trouble sleeping. Id. A
physical exam revealed deltoid and quadriceps tenderness. Id. Dr. Shic assessed petitioner with
adverse drug reaction, “likely slowly resolving tdap reaction.” Id. at 302. Dr. Shic prescribed
9
The metacarpophalangeal joints (“MCP”) are located between the metacarpal bones and phalanges of the fingers.
10
Petitioner’s creatine kinase value was 28 U/L with a reference range of ≤ 200 U/L, petitioner’s white blood cell
count and count of white blood cell components were all within normal ranges. Pet. Ex. 4 at 293-94.
7
hydrocodone-acetaminophen. Id. Labs were pending to check for rhabomyolysis [sic].11 Id.
Petitioner contacted the Kaiser Permanente call center on April 14, 2014 complaining of
severe pain and pain on his scapula. Id. at 316. Petitioner stated he had stopped taking Vicodin,
but had taken “4 asa”12 which made him feel better four hours later. Id.
Dr. Shic returned petitioner’s call that same day to report the test results. Id. at 306. The
primary diagnosis was diabetes mellitus, type 2. Id. at 306. Petitioner was prescribed an oral tablet
of Metformin13 500 mg and a diabetes monitoring kit. Id. at 307. In a letter to petitioner dated
April 14, 2014, Dr. Shic wrote, “…you have diabetes which could explain some of your recent
symptoms.” Id. at 309.
In a telephone encounter on April 19, 2014 at 8:38 AM, with Dr. Eric Crisostomo,
petitioner reported moderate to severe right arm pain since Tdap vaccination. Id. at 322. Petitioner
stated that the pain may have extended to his other arm and legs. Id. at 322-23. Petitioner reported
pain with overhead arm movements but denied skin redness or swelling. Id. Dr. Crisostomo
commented that petitioner’s symptoms did not sound like an infection due to the lack of
inflammation but questioned if petitioner’s reaction was idiosyncratic. Id.
Later that day, petitioner saw Dr. Prathima Jayaram. Id. at 325-357. Petitioner reported
pain all over his body, especially in his upper body and indicated the pain has continued for one
month. Id. at 326-27. Petitioner reported the pain as 15 out of 10 and described his pain as
“stabbing.” Id. at 326. His range of motion in his bilateral shoulder was “significantly decreased.”
Id. Dr. Jayaram described the physical exam of petitioner’s upper extremities as “abnormal,” and
noted muscle tenderness and restricted range of active motion. Id. at 327. Dr. Jayaram assessed
petitioner with bilateral shoulder joint pain and hip pain with a differential diagnosis of
polymyalgia rheumatica (“PMR”).14 Id. Dr. Jayaram prescribed petitioner 15 mg/per day of
prednisone and referred petitioner to Dr. Sarah Beckman Gratton, a rheumatologist for further
evaluation. Dr. Jayaram ordered tests for a PMR diagnosis which came back negative except for
high ESR and CRP levels.15 Id. at 334-45. Petitioner had normal IgG and IgE levels and a negative
ANA. Id.
On April 21, 2014, petitioner met with Dr. Gratton. Id. at 352. Dr. Gratton noted that
11
Rhabdomyolysis is a disease involving the disintegration or dissolution of muscle and is associated with the
excretion of myoglobin in the urine. Dorland’s at 1637. Petitioner’s medical records do not indicate if these lab
results were reported and do not indicate if petitioner was ever diagnosed with rhabdomyolysis.
12
“ASA” refers to acetylsalicylic acid, the active ingredient of aspirin.
13
Metformin is a drug used to treat high blood sugar levels that are caused by a diabetes mellitus or sugar diabetes
called type 2 diabetes. https://www.mayoclinic.org/drugs-supplements/metformin-oral-route/description/drg-
20067074
14
Polymyalgia rheumatica is a syndrome characterized by joint and muscle pain and a high erythrocyte
sedimentation rate (“ESR”). Dorland’s at 1490.
15
Petitioner’s ESR level was 26 mm/hr with a reference range of 0-20 mm/hr. Petitioners CRP level was 4.4 mg/dL
with a reference range of ≤ 0.5 mg/dL.
8
petitioner was referred to rheumatology because of bilateral shoulder pain and upper arms, along
with corresponding bilateral hip and thigh pain,” and the symptoms got worse after receiving the
Tdap vaccination. Id. Petitioner reported pain in his right shoulder after the Tdap vaccination and
experienced subsequent stiffness in the right shoulder that progressed to the left shoulder. Id. He
stated the pain, “‘feels like a skewer’” from the right to the left arm. Id. at 353. In the
musculoskeletal examination of petitioner, Dr. Gratton found that he had a normal gait, tender
bilateral deltoid, and pain at the anterior hip against resistance. Id. at 356. In an exam of
petitioner’s joints, she found that petitioner had full nontender range of motion, no pain over
elbows, wrists, knees, ankles, mid-feet, or hips (with limited bilateral inner rotation). Id. Dr.
Gratton diagnosed petitioner’s symptoms as being consistent with bilateral deltoid bursitis. Id. at
358-59. Dr. Gratton stated that petitioner has “acute onset of soft tissue pain following vaccination
of the upper extremities and the proximal lower extremities with gradual improvement that he has
associated with Alka-Seltzer (with antihistamine component), raising question of immune system
activation.” Id. at 358. She stated, “Currently the symptoms and exam are consistent with bilateral
deltoid bursitis.” Id. She noted that “this is atypical for PMR in the process (the tenderness diffuse
UE at the start), he is young for this diagnosis and the ESR is very minimally elevated (normal for
age). Id. In her note, Dr. Gratton included an abstract for an article by Soriano, et al. 16 which
connects giant cell arteritis and PMR to the influenza (“flu”) vaccine. Id. at 359-61. She prescribed
him 10 mg/per day of prednisone and recommended he follow his blood-glucose level closely. Id.
at 359. Additionally, Dr. Gratton advised against shoulder injections, but petitioner also deferred
a referral to physical therapy. Id.
On April 23, 2014, petitioner saw his psychiatrist, Dr. Young for a follow-up visit. Dr.
Young documented that petitioner stated he had an “autoimmune reaction to the tetanus shot” and
was able to relate some of his physical pain to his “unresolved/unaddressed emotional issues.” Pet.
Ex. 4 at 371. Petitioner returned to Dr. Young on May 2, 2014 and reported that he stopped taking
medication to determine his pain level. Id. at 375. She noted that petitioner related his physical
difficulties to not being able to participate in the level of elite training he had been previously
engaging in and he described a “clear delineation [in] his well-being prior to and following neck
surgery.” Id. at 375.
On May 11, 2014, Dr. Gratton followed-up with petitioner. Pet. Ex. 4 at 379. She noted
that petitioner began the prednisone, in addition to Alka Seltzer and had improvement. Id.
Petitioner also took his Metformin. Id. He reported that he stopped taking the prednisone, but
pain on his left side returned, although not as severe. Id. He restarted taking prednisone and
reported feeling 80% better. Id. Petitioner also reported that he was able to sleep normally and
his symptoms in his hips resolved. Id. The note from the telephone encounter states that petitioner
was “treated for bursitis (vs. atypical PMR) possibly related to vaccination. If symptoms return
with slow taper of prednisone, will consider more typical treatment of PMR.” Id. Dr. Gratton
prescribed a prednisone taper over a four-week period. Id. at 381.
On May 27, 2014, petitioner called Dr. Gratton and reported issues relating to his
medication. Id. at 387. Petitioner reported that severe pain returned, mostly in his shoulders down
to his arms, when he stopped prednisone completely. Id. Dr. Gratton discussed a shoulder
16
Alex Soriano, et al., Giant Cell Arteritis and Polymyalgia Rheumatica After Influenza Vaccination: Report of 10
Cases and Review of the Literature, 21 Lupus 153 (2012).
9
injection and a faster prednisone taper. Id. Petitioner was referred to radiology for an x-ray of his
shoulders. Id.
On May 29, 2014, petitioner spoke to his primary care physician, Dr. Shic. Id. at 396. Dr.
Shic’s noted that petitioner was being seen by rheumatology and “started on prednisone for
idiosyncratic reaction to tetanus [vaccine].” Id. Dr. Shic diagnosed petitioner with adverse drug
reaction and noted that petitioner was not checking his blood sugars. Id. Dr. Shic ordered a repeat
HGA1c. Id.
On May 30, 2014, petitioner returned to psychologist, Dr. Young. Id. at 400. Petitioner
reported that if it was not for an ankle injury, broken neck (from a pickup basketball game) and
“the injection,” he would be an elite athlete. Id. He informed Dr. Young that he was planning on
going to the northwest to train over the summer to rebuild his muscles that “the injection” caused
to deteriorate. Id. Dr. Young diagnosed petitioner with an “adjustment disorder.” Id. at 399.
Petitioner had x-rays of his shoulders on June 16, 2014. Pet. Ex. at 407. The x-ray
impression was degenerative changes of bilateral acromioclavicular (“AC”) joints with no
evidence of calcific tendinopathy. Id. at 408. However, Dr. Gratton noted that the degenerative
changes in the AC joint are common “wear and tear” changes which do not explain petitioner’s
shoulder pain complaints. Id. at 415. Petitioner had additional labs completed on July 9, 2014
where his ESR and serum CRP were normal.17 Id. at 421.
On July 11, 2014, petitioner had a follow-up exam with Dr. Gratton. Id. at 422. Dr. Gratton
reviewed petitioner’s medical history, where she noted petitioner reported that he “has been in pain
for forty years. He was hit by cars when cycling on seven occasions, had numerous
injuries…broke his neck and ankle.” Id. The reported history again stated that following the Tdap
vaccination in the right shoulder, he experienced stiffness and pain that progressed to his left
shoulder. Id. Petitioner also reported that he had a similar vaccination following Tdap vaccination
in college that lasted for three weeks. Id. Petitioner had mild impingement on resisted shoulder
extension but did not have any pain to palpation or synovitis over elbows or wrists. Id. at 426.
On an August 15, 2014 telephone encounter with Dr. Shic, petitioner reported pain in the
lower sacrum area. Dr. Shic ordered an x-ray which was completed on August 29, 2014. The
sacrum/coccyx x-ray found minimal degenerative spurring of the sacroiliac joints without erosive
change, minimal degenerative endplate changes at the lower lumbar spine, and no definite fracture
or malalignment. Id. at 452. Dr. Shic conducted a physical exam of petitioner on the same day
and in the musculoskeletal exam, Dr. Shic found no lumbosacral tenderness. Id. at 457.
In a September 4, 2014 telephone encounter with Dr. Joseph Reena, petitioner reported
prednisone helped with his aches except for his sacrum pain. Id. at 470. Petitioner reported to Dr.
Gratton in a telephone encounter on September 5, 2014 that Aleve was helpful for his lower back.
Id. at 477. By September 16, 2014, petitioner had stopped taking Aleve and was taking aspirin for
the pain. Id. at 481.
An additional lab test on September 16, 2014 found normal CRP levels, normal ESR levels,
Petitioner’s ESR level was 10 mm/hr with a reference range of 0-20 mm/hr. Petitioner’s CRP level was 0.5
17
mg/dL with a reference range of ≤ 0.5 mg/dL. Pet. Ex. 4 at 421.
10
normal white blood cell levels (including neutrophils, lymphocytes, eosinophils, and basophils).
Id. at 492-94. A September 16, 2014 MRI of the lumbar spine without contrast showed
spondyloarthropathy in the lumbar spine which was most pronounced at the L4-L5 and L5-S1
levels. Id. at 499. The MRI impression stated there was mild interval progression since
petitioner’s previous MRI on February 13, 2011. Id. at 500. The differential diagnosis from the
MRI included post-inflammatory or traumatic changes due to a “subtle area of increased signal on
the T2 fat sat sequence in the right posterior paraspinal musculature.” Id. at 503.
In a September 24, 2014 visit with Dr. Linda Choe, a physiatrist, petitioner reported his
pain was not isolated within the sacral region. Id. at 506. Dr. Choe noted a normal heel and toe
gait with a slight shift to the left in petitioner’s spinal ribs and pelvis. Id. Dr. Choe also noted a
crease in the right lateral rib case and TTP right sacral region. Id. Dr. Choe assessed petitioner
with lumbar spondylosis. Id. at 507.
On October 5, 2014, petitioner saw David Morris, D.C., a chiropractor. Pet. Ex. 5.
Petitioner reported lower back pain, bilateral shoulder pain, buttock and tailbone pain and legs
numbing and tingling. Id. at 1. Dr. Morris found petitioner to have a severe antalgic lean to the
left from his lower back or pelvis as a result of muscle spasms that may have been due to
vaccinations. Pet. Ex. 5 at 4. Petitioner returned to Dr. Morris for six appointments. Id. at 5. A
note from October 22, 2014, states petitioner is “walking more without aggravation-less spasms.”
Id. On October 26, 2014, Dr. Morris noted, “severe deep aching in mid back.” Id. at 5.
On October 14, 2014, petitioner saw Dr. Philip Ranheim. Pet. Ex. 6. Petitioner reported
shoulder and sacrum pain after receiving the Tdap vaccination. Id. at 7. Dr. Ranheim documented
a normal physical exam. Id. at 6. Dr. Ranehim also reviewed petitioner’s medical records and
noted petitioner’s high blood sugars, stating, “Interestingly with the pain his blood sugars went as
high as 280-perhaps this was in conjunction with the prednisone but I’m not sure.” Id. at 5. Dr.
Ranheim assessed petitioner with an “abnormal pain and muscle spasm after vaccine reportedly”
but stated petitioner was doing better after seeing Dr. Morris. Pet. Ex 6 at 4.
Petitioner’s last filed medical record is a February 5, 2016 visit with Dr. Gratton. Id. at
558-59. Petitioner’s symptoms and medical history from the visit are not substantively different
from previous records. Id. at 558-59. The petitioner addresses the intervening interval of time
through his pain diary discussed below.
C. Petition
On September 2, 2016, petitioner filed his petition claiming a March 14, 2014 Tdap
vaccination caused his back pain, lumbar pain, shoulder pain, and sacral pain. Petition at 1.
Petitioner asserts that following the Tdap vaccination, he began to “feel unwell to the point of
unconsciousness.” Petition at ¶ 4. Petitioner asserts he had upper back spasms on the night of
March 16, 2014 which was assessed as a “likely [T]dap side effect” by Dr. Frank Shic on March
26, 2014. Id. at ¶¶ 6-7.
Petitioner asserts complaints of diffuse shoulder and thigh myalgias on April 11, 2014 for
which he was seen on April 21, 2014 by Dr. Sarah Gratton, a rheumatologist. Id. at ¶ 11. Petitioner
underwent prednisone therapy which led to some improvement in petitioner’s condition. Id.
11
Petitioner started to have pain in the sacrum18 area in October 2014. Id. at ¶ 13. Petitioner asserts
that he continues to experience “pain along the right side of the sacrum and the entire right leg.”
Id. at ¶ 14. As a result, petitioner asserts that he has been “unable to work or unable to participate
in his physical activities.” Id. at ¶ 15.
D. Dr. Gershwin’s Expert Report
On April 25, 2017, petitioner filed an expert report from Dr. M. Eric Gershwin.19 Pet. Ex.
7. Dr. Gershwin disagreed with the diagnoses provided by petitioner’s treating physicians. Id. at
2. Dr. Gershwin contended that petitioner’s myalgias that followed the Tdap vaccination was
misdiagnosed by petitioner’s rheumatologist, Dr. Gratton. Id. at 1-2. Dr. Gershwin opined that
the elevated levels of petitioner’s ESR and CRP were consistent with his poorly controlled diabetes
rather than indicative of atypical PMR. Id. Dr. Gershwin asserted that as a result of the PMR
misdiagnosis and incorrect subsequent treatment, petitioner’s problems “became persistent”
instead of resolving. Id.
Dr. Gershwin stated that petitioner had a history of “significant musculoskeletal problems
prior to the vaccine” but that it was “more likely than not that he did develop some myalgias
following [vaccination].” Id. Dr. Gershwin contended, however, that petitioner was
presumptively misdiagnosed with polymyalgia rheumatica when there was no significant evidence
to support that diagnosis. Id. at 2. He stated that petitioner’s elevated inflammatory makers of
ESR and CRP were more consistent with petitioner’s poorly controlled diabetes, but instead he
was misdiagnosed with PMR and treated with steroids. Id. at 2. The waxing and waning dosages
of steroids only made petitioner’s myalgias worse and the suggestion that his myalgias could be
autoimmune made the petitioner’s response “emotional,” and his problems became chronic. Id. at
2. Dr. Gershwin concluded that petitioner was instead suffering from fibromyalgia. Id. at 2. He
stated, “I should note that vaccination does not produce fibromyalgia.” Id. Dr. Gershwin
continued, stating, “It is [petitioner’s] somatic reaction to the events that occurred following the
vaccine that led to his diffuse pain syndrome.” Id. In his review of petitioner’s medical records,
18
The sacrum is the triangular bone below the lumbar vertebrae. The sacrum is directly above the coccyx (tailbone).
Dorland’s Illustrated Medical Dictionary 32nd ed, (2012) (hereinafter “Dorland’s”) at 1662.
19
Dr. Gershwin received his bachelor’s degree summa cum laude from Syracuse University in 1966 and his M.D.
from Stanford University in 1971. Pet. Ex. 7a at 1. Dr. Gershwin received a Master’s Degree in Astronomy and
Astrophysics from the Centre for Astrophysics and Supercomputing in Melbourne, Australia in 2002. Id. Dr.
Gershwin completed his internship and residency at the Tufts-New England Medical Center in Boston, MA in 1973.
Id. at 2. Dr. Gershwin was a Clinical Associate in Immunology and the National Institutes of Health from 1973 to
1975. Id. Since 1975, Dr. Gershwin held academic appointments as Assistant Professor of Medicine in
Rheumatology and Allergy, Professor of Medicine in Rheumatology and Allergy, The Jack and Donald Chia
Professor of Medicine in the Division of Rheumatology/Allergy and Clinical Immunology, and Distinguished
Professor of Medicine in the Division of Rheumatology/Allergy and Clinical Immunology at the University of
California, Davis. Id. at 1-2. Dr. Gershwin is board certified in internal medicine with a subspecialty of
rheumatology and board certified in allergy and clinical immunology. Id. Dr. Gershwin is the Director of the
Allergy-Clinical Immunology Program and Chief of the Division of Rheumatology/Allergy and Clinical
Immunology at the University of California School of Medicine, Davis. Id. Dr. Gershwin is the holder of multiple
patents related to rheumatology and immunology, is an editor on multiple immunology journals, and has extensively
published original research articles and books related to immunology. Id. at 2, 6, 9-123. Dr. Gershwin has served as
an expert witness in multiple Vaccine Program cases.
12
Dr. Gershwin noted that petitioner complained of muscle cramps and diffuse myalgias starting
approximately two weeks after petitioner’s Tdap vaccination on March 14, 2014. Id. at 1. Dr.
Gershwin cited literature concerning fibromyalgia’s relationship with a patient’s stress response
system20 as well as how fibromyalgia’s heightened pain sensitivity can foreshadow chronic pain.21
Although Dr. Gershwin put the label of fibromyalgia on the petitioner’s condition, the focus of his
analysis was on the contribution of psychological stress, victimization and the modulation of pain
information in the development of his pain syndrome.
Dr. Gershwin posits that petitioner became “fixated over a common reaction” following
the Tdap vaccination that was amplified by his treating physicians’ suggestion that his condition
could be PMR, an autoimmune condition. Id. at 2. This fixation then precipitated further somatic
issues. Id. Dr. Gershwin concluded that without the Tdap vaccination, in tandem with the incorrect
treatment of petitioner as a result of a misdiagnosis, petitioner suffered his long-term pain injuries.
Id. Dr. Gershwin stated the “timing of the ‘aches’ following the vaccination was appropriate”
without reference to the medical record or analysis. Id. at 3.
E. Dr. Oddis’ Expert Report
On July 10, 2017, respondent filed a responsive expert report from Dr. Chester Oddis.22
Resp. Ex. A. Dr. Oddis opined that petitioner’s pain pre-dated the Tdap vaccination, stating that,
“[petitioner’s] symptoms are really on a continuum and that they essentially don’t vary
significantly from the first time that he presented to his family doctor in 2011.” Resp. Ex. A at 3.
Dr. Oddis noted that petitioner complained of diffuse musculoskeletal symptoms that included,
back, shoulder, hip and neck pain on several occasions prior to the vaccination. Id. He observed
that the day the petitioner received the vaccination, petitioner was complaining of increased jaw,
shoulder, arm and bilateral hand pain. Id.; see also Pet. Ex. 4 at 263.
Dr. Oddis disagreed with petitioner’s treating rheumatologist on the diagnosis of PMR and
agreed with Dr. Gershwin that petitioner’s symptoms were inconsistent with PMR. Id. at 3. Dr.
Oddis explained that PMR is characterized by significant morning stiffness of the proximal upper
and lower extremity musculature that often lasts several hours and the inflammatory markers are
20
Lesley M. Arnold, The Pathophysiology, Diagnosis and Treatment of Fibromyalgia, 33 Psychiatric Clinics of
North America 375 (June 2010). [Pet. Ex. 7D].
21
Roland Staud, Abnormal Pain Modulation in Patients with Spatially Distributed Chronic Pain: Fibromyalgia, 35
Rheumatic Disease Clinics of North America 263 (May 2009). [Pet. Ex. 7S].
22
Dr. Oddis received his bachelor’s degree in biochemistry from the University of Pittsburgh in 1976 followed by
his M.D. from the Pennsylvania State University College of Medicine in 1980. Resp. Ex. B at 1. Dr. Oddis
completed his internship and residency in internal medicine at the Pennsylvania State University College of
Medicine in 1984 and a fellowship in rheumatology at the University of Pittsburgh School of Medicine in 1987. Id.
Dr. Oddis has held academic positions at the University of Pittsburgh School of Medicine, Division of
Rheumatology and Clinical Immunology since 1987. Id. at 2. Dr. Oddis currently is a Professor of Medicine in the
Division of Rheumatology and Clinical Immunology, the Associate Director of the Rheumatology Fellowship
Training Program, and Director of the Myositis Center at the University of Pittsburgh. Id. Dr. Oddis is board
certified in internal medicine and rheumatology. Dr. Oddis is an active medical researcher and has published
extensively in the field of rheumatology and myositis. Id. at 4-24. Dr. Oddis is an active clinical practitioner at the
University of Pittsburgh. Id. at 25. Dr. Oddis has served as an expert witness in multiple Vaccine Program cases.
13
invariably elevated. Id. Further, the peak age group for PMR are those in their seventies and
eighties. Id. Dr. Oddis stated that petitioner is quite young for the PMR diagnosis; had only a
slightly elevated ESR-and the degree of elevation was not within the range associated with PMR.
Id.
Dr. Oddis disagreed with Dr. Gershwin’s diagnosis of fibromyalgia. Resp. Ex. at 3. Dr.
Oddis observed that petitioner was never diagnosed with fibromyalgia and stated that whether
petitioner actually has fibromyalgia is a moot point. Id. at 4. Dr. Oddis, once again, emphasized
that petitioner’s pain syndrome predated the administration of the Tdap vaccination. Id. He argued
that Dr. Gershwin’s recommendation of counseling ignored the fact that petitioner received
psychological counseling within days of receiving the vaccination and that counseling continued
simultaneously with petitioner’s treatment for pain. Id.; see also Pet. Ex. 4 at 262, 296, 370. Dr.
Oddis stated that petitioner’s treating psychiatrist did not attribute petitioner’s chronic pain or any
exacerbation of pain related to the Tdap vaccination as the cause of petitioner’s depression or
anxiety. Id. at 4.
Dr. Oddis attributed the amplification of petitioner’s pain syndrome to his longstanding
depression, anxiety and significant interpersonal problems. Id. As a result, he argued, the Tdap
vaccine “gave the petitioner another presumptive cause for his chronic pain.” Id. Dr. Oddis
concluded that petitioner’s chronic musculoskeletal complaints and pain syndrome “clearly
predated” the Tdap vaccination. Id.
F. Dr. Singer’s Expert Report
On May 14, 2018, petitioner filed a supplemental expert report from Dr. Raymond
Singer, PhD.23 Pet. Ex. 9. Dr. Singer is a neuropsychologist with experience in forensic matters
involving toxic insult. In this case, Dr. Singer was asked to address two questions I posed in the
Rule 5 Order: 1) Why did petitioner experience such an intense psychiatric reaction to the
vaccination? 2) How do you explain the physiological process of the pain moving from the
arm/shoulder to the lower body and then on to multiple places on the upper and lower body?
See Rule 5 Order at 2. Dr. Singer prefaced his report with various references to the Tdap
package insert and to the presence of aluminum and formaldehyde in the formula without
addressing their role in petitioner’s condition. Pet. Ex. 9 at 2-5. He then focused his report on
23
Dr. Singer is a forensic and clinical neuropsychologist. Pet. Ex. 10 at 2. He received his bachelor’s degree in
psychology in 1972 from the University of Rochester. Id. Dr. Singer then received a master’s degree and a PhD in
psychology from Washington State University in 1975 and 1978, respectively. Id. Dr. Singer received training as a
post-doctoral fellow in environmental epidemiology through the National Institutes of Health, Environmental Health
Sciences from 1979 to 1981 and as a fellow at the Mount Sinai School of Medicine Department of Community
Medicine, Environmental Sciences Laboratory from 1981 to 1982. Id. at 2-3. Dr. Singer was a post-doctoral fellow
in biological psychiatry through the National Institutes of Health at New York University Medical center in 1978.
Id. at 3. Dr. Singer is a fellow in the National Academy of Neuropsychology, American College of Professional
Neuropsychology, American Psychological Association, and Association for Psychological Science. Id. Dr. Singer
has served as a consultant for neuropsychological, neurobehavioral, and neurotoxicological diagnostics and as an
expert witness in toxic chemical litigation since 1983. Id. at 4. Dr. Singer has conducted research and published
extensively in the area of neuropsychology and neurotoxicology. Id. at 7-19.
14
the questions raised in the Rule 5 Order. Id. Dr. Singer provided a summary of psychosomatic
symptoms:
Psychosomatic symptoms [are] a way to describe medically unexplained symptoms,
symptoms of unknown origin, hypochondria and somatoform disorders. Other terms
include somatic symptoms, functional somatic syndromes and deception syndromes. A
simplified view of the condition uses the term “symptom amplification.”
Id. at 5.
Dr. Singer explained that when petitioner first presented to his rheumatologist, Dr.
Gratton, petitioner explained that the pain progressed from his right to his left arm and that “this
type of progression of pain is not typical.” Id. Dr. Singer also observed that the petitioner’s
description of the pain traveling from the shoulder to the buttocks/groin area is “not entirely
consistent with an infectious process which would spread more locally or along nerve patterns.”
Id. at 6. Dr. Singer opined that the petitioner’s local reaction to the Tdap vaccination created a
“cascading series of events, both physical and mental, made worse by petitioner’s psychological
vulnerabilities.” Id. at 8.
Dr. Singer referenced the petitioner’s psychological history from Dr. Young’s progress
note from April 23, 2014, in which she documented that petitioner thought he had a prior reaction
to Tdap in college that caused him to move like a zombie. Id. at 6; see also Pet. Ex. 4 at 371.
Petitioner expressed to Dr. Young that he was “crucified” by the school where he was coaching
and that he could “do miracles,” but was fired and accused of stealing others’ work. Id. Petitioner
also explained that he felt “burned in his work and romantic relationships despite always doing his
best.” Id. Petitioner also discussed “his tendency to shove his emotional pain ‘in the closet’ only
to have it explode and burst open after the experience he had on the ‘reality show of Long Beach.’”
Id.
Dr. Singer reviewed this background, noting that the petitioner had a history of depression
which is commonly associated with psychosomatic illness and is seen as an amplifier of potential
symptoms. Id.at 7. Dr. Singer stated that petitioner’s reference to “moving like a zombie” did
not describe a medical condition and “had the flavor of a psychosomatic movement condition.”
Id. at 7. He observed that petitioner was able to relate some of the physical pain to unresolved and
unaddressed emotional issues, stating, “This is practicably the definition of a psychosomatic
illness, namely conversion disorder.” Id. Dr. Singer related petitioner’s statement that he
“shove[d] his emotional pain in the closet only to have it explode and burst open,” to a
psychosomatic illness, “where buried and suppressed unconscious emotion wreak havoc on bodily
function.” Id. Dr. Singer also observed that the petitioner’s sense of victimization is consistent
with the psychological mechanism thought to underlie psychosomatization. Id. He explained that
that in the petitioner’s statements about how he was accused of stealing others’ work and fired
from his job and how petitioner used the term “crucified” to describe his treatment by the school
where he was coaching are indicative of a sense of victimization. Id. Dr. Singer stated that
victimization is a feeling of frustration that can be put into the body and experienced as pain and
other illnesses. Id. at 8.
Dr. Singer opined, “Prior to the vaccine administration, the claimant was in good
15
health….Absent the [Tdap] shot, [petitioner] would not have suffered the physical and emotional
pain he was experiencing during this time.” Id. at 9. However, when Dr. Singer made his
assessment, he overlooked petitioner’s history of pre-existing musculoskeletal pain complaints,
including those on the day of the vaccination. Additionally, Dr. Singer did not acknowledge that
petitioner was experiencing emotional stress the day he received the vaccine, the same day he was
referred to a mental health specialist.
As for the temporal association to petitioner’s pain and the vaccination, Dr. Singer stated
that “prior to vaccination, the [petitioner] was in good health….The treating physicians opined that
[petitioner] was suffering from a reaction to the tetanus vaccine.” Id. at 8. He concluded that
petitioner’s reaction was made more severe and long-lasting as a result of [petitioner’s] probable
psychosomatic conversion disorder, which amplified the symptoms for this patient.” Id.
G. Petitioner’s Pain Journal
On May 11, 2018, petitioner filed his pain journal as an exhibit. Pet. Ex. 8 (ECF No. 34).
The pain journal begins on March 14, 2014 (the date of vaccination in question) with an entry
stating, “appointment with Dr. Shic. Received barrage of boosters. Went home and within the
hour felt intoxicated and slept hard till late next morning.” Pet. Ex. 8 at 1. Within the pain journal,
discomfort and pain are noted immediately on March 15, 2014 with an entry of “[s]ight [sic] of
injection very sore. Felt very tired. Right shoulder very stiff and painful.” Id.
Over the course of March 2014, petitioner had similar symptoms with increasing levels of
pain. Petitioner documents on March 27, 2014 that the pain was “near paralyzing” and his body
was “hunched and look[ed] twisted.” Id. Throughout 2014, petitioner documented “[d]ifficulty
walking” and the pain is described as located in his right rib cage on April 10, 2014. Id. at 2.
Over the course of the next several months, petitioner documents the level of pain and
location on a daily basis (i.e. “Pain but somewhat tolerable,” “Still sore in shoulders and lower
back,” “General soreness in shoulders to painful upper body,” “Exquisite pain in upper right
buttocks,” etc.) as short entries on a calendar. Pet. Ex. 8 at 1-11. For the time period between
March 14, 2014 and February 11, 2016, petitioner makes detailed entries for specific dates that
document his activity and treatment during the day as well as how he feels. Some of the entries
repeat verbatim for a period of a week to two weeks. Entries from April 10, 2014 through April
23, 2014 is exemplative of this:
“April 11, 2014: Pain in lower right rib cage, otherwise somewhat tolerable. Difficulty
breathing, walking, sleeping.”
Pet. Ex. 8 at 2. This entry was repeated every day for the next two weeks.
Petitioner also submitted an affidavit affirming that the pain calendar was created at the
time the events were occurring and not prepared in anticipation of litigation. Pet. Supp. Affidavit
(ECF No. 38).
H. Petitioner’s Affidavit
On September 22, 2016, petitioner filed an affidavit. Pet. Affidavit (ECF No. 6). He
16
recalled that after receiving the vaccination he “began to feel unwell to the point of
unconsciousness.” Pet. Aff. at ¶ 4. The following day, petitioner felt very sore and exhausted. Id.
Two days later, petitioner stated that his jaw, shoulders and arms went into severe spasms that
woke him up. Id. at ¶ 5. Petitioner stated that it felt “as if I was being skewered through the arm
and shoulders. It felt as if my arms were pinned and my back and shoulders arched backward. It
was difficult to walk and impossible to get any real sleep.” Id. at ¶ 6. Petitioner described the
level of pain as ranging from “the feeling of [my] skin being pierced to the flesh being torn from
the bone,” and it lasted until January 2015. Id. at ¶¶ 8-9. He explained that the most pain he
experienced was along the right side of the sacrum and his entire right leg, affecting his mobility.
Id. at ¶ 16. The petitioner indicated that prior to the vaccination, he was in his “usual health” with
no fever. Id. at ¶ 14. He stated that he continued with physical therapy to strengthen and straighten
his body from the injury. Id. at ¶ 17.
IV. Parties’ Arguments
A. Petitioner’s Motion for Ruling on the Record
Petitioner argued that following vaccination, he felt tired and sore the night of the
vaccination. Pet. Mot. at 6 (citing Pet. Ex. 8 at 1). Over time, petitioner cites to his pain journal
that muscle spasms and pain in the jaw, neck, and shoulders manifested. Pet. Mot. at 7. Petitioner
also cited to the medical record where Dr. Shic and Dr. Gratton make references to petitioner’s
vaccination as a suspected cause as well as the lack of an infection. Id. (citing Pet. Ex. 4 at 302,
322, 359). Petitioner asserted that the vaccine injury in question is the back, shoulder, and regional
pain allegedly caused by the Tdap vaccine. Id. at 11-12.
Petitioner argued he does not have the burden of proving a specific scientific biological
mechanism in order to prevail in his case, citing to Knudsen. Pet. Mot. at 6 (citing Knudsen v.
Sec’y of Health & Human Servs., 35 F.3d 543 (Fed. Cir. 1994). Under prong one of Althen,
petitioner recited the theories offered by Drs. Gershwin and Singer. Id. at 7-10. Under prong two
of Althen, petitioner stated there was no alternate cause and offers the following sequence of
events: (1) petitioner received the Tdap vaccination on March 14, 2014;24 (2) petitioner
experienced shoulder and back pain thereafter; (3) treating physicians stated that the condition was
“likely [a] Tdap side effect;” (3) Drs. Gershwin and Singer opined that the timing of the aches was
appropriate and made worse due to petitioner’s existing medical condition. Pet. Mot. at 10.
Under prong three of Althen, petitioner stated the proximate temporal relationship is met
as petitioner received the vaccination on March 14, 2014 and reported symptoms beginning March
15, 2014. Pet. Mot. at 10-11; see also Pet. Ex. 8 at 1.
Petitioner also responded to Dr. Oddis’ expert report. Petitioner argued that Dr. Oddis
discounted the petitioner’s complaints listed in the post-vaccination medical record and the
notations of treating physicians who state petitioner’s pain was due to vaccination. Pet. Mot. at
13. Petitioner also argued that respondent has not offered evidence in support of alternate
causation. Id. (citing Pafford v. Sec’y of Health & Human Servs., 64 Fed. Cl. 19, 35 (2005), aff’d,
24
Petitioner’s motion mistakenly states he received the “flu vaccine on the morning of March 14, 2014.” Pet. Mot.
at 10. Petitioner received the Tdap and PPV vaccinations on March 14, 2014.
17
451 F.3d 1352 (Fed. Cir. 2006)).
B. Respondent’s Response to Petitioner’s Motion for Ruling on the Record
Following a recitation of the relevant medical facts, respondent first stated that petitioner
has not established that he has suffered a medically-recognized injury by preponderant of the
evidence. Resp. Response at 7; see also Broekelschen, 618 F.3d at 1346; Lombardi v. Sec’y of
Health & Human Servs., 656 F.3d 1343, 1352 (Fed. Cir. 2011). Respondent argued that
petitioner’s pain calendar is insufficient evidence of a vaccine-related injury because it does not
contain any details prior to the vaccine, raising the question of the reliability of the calendar and it
only contains subjective symptoms post-vaccine. Id. at 8. Respondent also stated that petitioner’s
experts, Drs. Gershwin and Singer do not actually identify a vaccine-related injury, rather they
allege petitioner experienced a somatic reaction to the vaccination. Id. Respondent cited to Ruiz,
Reape, Pless, and Bailey where somatic reactions to vaccinations were not found to be
compensable. Id. at 8 (citing Ruiz v. Sec’y of Health & Human Servs., No. 02-156V, 2007 WL
5161612 (Fed. Cl. Spec. Mstr. Mar. 14, 2007); Reape v. Sec’y of Health & Human Servs., No.
151146V, 2017 WL 1246325 (Fed. Cl. Spec. Mstr. Mar. 3, 2017); Pless v. Sec’y of Health &
Human Servs., No. 16-271V, 2017 WL 836610 (Fed. Cl. Spec. Mstr. Feb. 6, 2017); Bailey v. Sec’y
of Health & Human Servs., No. 06-464V, 2008 WL 482359 (Fed. Cl. Spec. Mstr. Feb. 12, 2008)).
Respondent stated that at best, petitioner showed a local reaction to vaccination, but no sequalae
lasted more than six months, his pre-existing medical conditions explain the post-vaccination
reaction, and somatic reactions are not compensable in the Vaccine Program. Id.
Then respondent argued petitioner has failed to meet his burden by preponderant evidence
under the Althen test. Respondent asserted that neither Dr. Gershwin nor Dr. Singer stated a theory
of causation connecting the petitioner’s injury to the Tdap vaccine. Id. at 9. Respondent stated
that Dr. Gershwin opined that petitioner suffered from fibromyalgia, vaccines do not cause
fibromyalgia, and petitioner’s somatic response led to his diffuse pain syndrome. Id. at 6.
Respondent argued that Dr. Singer also does not provide a theory of causation but instead focuses
only on the temporal relationship of the Tdap vaccination to petitioner’s muscle aches. Id. at 10.
Respondent stated that Dr. Singer did not provide any additional evidence as to why the timing of
petitioner’s alleged injury was medically appropriate, and this is insufficient to establish vaccine
causation. Id.
Finally, respondent asserted that none of petitioner’s treating physicians opined that the
Tdap vaccination did cause petitioner a vaccine-related injury. Respondent acknowledged that
some of petitioner’s treating physicians made reference to the Tdap vaccination and petitioner’s
complaints relating back to the vaccination. Id. However, respondent observed that petitioner’s
treating physicians, like Dr. Gratton, stated, “With diffuse nature was not a localized allergy type
reaction. He did not have typical allergy reaction from vaccination. It is difficult to know what
occurred prior.” Id. at 9-10; Pet. Ex. 4 at 559.
C. Petitioner’s Reply
Petitioner filed a reply to Respondent’s Response on August 27, 2018. Pet. Reply (ECF
No. 42). Petitioner first argued that the pain journal is a reliable, sound piece of evidence as the
journal started post-vaccination where petitioner felt far different from his pre-vaccination state.
18
Pet. Reply at 2. Petitioner argued that the pain calendar adds credibility to the complaints he made
to treating physicians. Id.
Next, petitioner argued that the compensable vaccine-related injury was his “back and
shoulder pain” following the vaccine made worse by his “preexisting psychological condition.”
Pet. Reply at 2. Petitioner argued that respondent’s reliance on Ruiz and Pless is misplaced,
arguing that those cases were concerned with the compensability of a psychological injury caused
by vaccination. Petitioner asserted that he is not alleging a psychological injury but rather that the
Tdap vaccination caused a localized response that was made worse by petitioner’s pre-existing
psychological condition. Id.
Finally, petitioner responded to respondent’s criticism of Dr. Singer’s expert report.
Petitioner argues that the majority of expert reports are conducted based on the medical records
without an examination. Id. Additionally, Dr. Singer’s qualifications and background in
neurotoxicology is uniquely suited to evaluate petitioner’s alleged injury. Id. at 4. Finally,
petitioner noted that respondent did not file a responsive report to Dr. Singer’s report. Id.
V. Discussion
A. Onset of Petitioner’s Symptoms
Petitioner alleged that the Tdap vaccination he received on March 14, 2014 caused him to
suffer a reaction diagnosed as “back pain, lumbar pain, shoulder pain, and sacral pain.” Petition
at Preamble. However, the record establishes that these symptoms and other symptoms petitioner
associated with the Tdap vaccine, pre-dated the vaccination.
Two years prior to the vaccination, petitioner had complained of low-back pain to Dr.
Fortenko. Pet. Ex. 4 at 5-6. He continued to complain of lower-back pain from March to
November 2011 in multiple telephone calls to his primary care health provider. Id. at 24-25; 31-
32; 38. He also reported occasional hip pain. Id. at 50-51. An MRI performed on November 15,
2011 revealed multilevel spondylotic disc disease and facet joint arthropathy of the lumbar spine
most severely involving the L4-5 and L5-S1 levels. Id. at 61.
In September 2013, petitioner saw Dr. Shic complaining of lower back without weakness
and numbness or tingling after waking up. Pet. Ex. 4 at 190. Petitioner explained that an MRI in
2011 showed spodylotic changes and moderate to severe central stenosis at the L4-L5 and L5-S1
levels. Id. A physical exam showed petitioner had exquisite right sided lumbar tenderness. Id.
On October 2, 2013, petitioner called his primary care provider complaining of lower back
pain. Pet. Ex. 4 at 197. Dr. Shic spoke to petitioner the following day where petitioner reported
that his pain “has gotten remarkably better since this morning.” Id. at 200. Dr. Shic noted that
petitioner’s low back is “likely due to degenerative joint disease vs. strain,” and encouraged
petitioner to call back if exacerbation of the pain occurred. Id.
On March 14, 2014, the day petitioner received the Tdap vaccination, he had sought
treatment for bilateral shoulder pain, jaw pain, right knee pain and a tick bite that occurred two
weeks prior to the appointment. Id. at 262. Petitioner explained he experienced, “increased right
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jaw, shoulder and arm stiffness after having been bitten by a deer tick.” Id. Petitioner also
reported, “increased interpersonal stress with neighbor and female crew team he was coaching.”
Id. Two days after the vaccination, an entry in petitioner’s pain journal for March 16, 2014 stated,
“Right shoulder and arm, right knee very stiff and painful. Great deal of pain around jaws and
necks.” Pet. Ex. 8 at 1 (emphasis added). On March 20, 2014, petitioner wrote, “Back arched, left
and right shoulders and arms. Jaw and neck, right leg very painful and extremely stiff.” Id.
On April 19, 2014, petitioner had a follow-up appointment for symptoms “all over his
body, especially in his upper body.” Id. at 325. Petitioner was evaluated by Dr. Jayaram. Id. She
wrote that petitioner presented with pain in the right and left shoulders, pain in the hips to the
thighs, hands feeling swollen and aching, and reduced range of motion of the bilateral shoulders.
Id. at 326. Petitioner reported to Dr. Jayaram that he, “had [a] tick bite when working outdoors in
early March. Got the tick out within minutes. Started to get aching pain in the right arm and jaw
couple of days after the tick bite.” Id. The physical exam was recorded as “abnormal exam of
both upper [extremities],” with “muscle tenderness of the upper arm.” He was diagnosed with
bilateral shoulder joint pain and hip pain. Id. at 327. When petitioner saw his rheumatologist, Dr.
Gratton, on April 21, 2014, petitioner again reported bilateral pain in the shoulders and upper arms
and hips to thighs that “got worse after the [Tdap] injection.” Id. at 353.
The petitioner’s symptoms of right jaw pain, shoulder and arm stiffness that petitioner
asserts began after the Tdap vaccination are the same symptoms that petitioner associated with a
deer tick bite that occurred two weeks prior. In his affidavit, petitioner stated, “The night of March
16, 2014, I woke abruptly when my back, jaw, shoulder and arms went into severe spasm.” Pet.
Aff. at ¶ 5. It may be that petitioner experienced these symptoms on the night of March 16, 2014,
but he was already experiencing pain in his bilateral shoulders, arms and jaw prior to receiving the
Tdap vaccination. Further, petitioner had a history of lower-back and hip pain that existed at least
two years prior to the vaccination, as evidence in the petitioner’s medical records prior to receiving
the vaccination and two MRIs showing multilevel spondylotic disc disease with progression.
The record establishes that most of petitioner’s symptoms of pain began prior to the
vaccination and cannot be attributed to the Tdap vaccination he received on March 14, 2014.
B. Petitioner’s Injury
The petitioner has failed to establish that he suffered a “vaccine-related injury.” A
petitioner asserting an “off-Table” injury must specify the vaccine-related injury and shoulders the
burden of proof on causation. Broekelschen at 1346. Identifying an injury is prerequisite to
applying the Althen analysis. Id. Petitioner must show that he suffers from a “defined” and
“medically recognized” injury, not “merely…a symptom or manifestation of an unknown injury.”
Lombardi at 1353. Medical recognition of the injury claimed is critical. Id. As the Federal Circuit
reiterated in Lasnetski, a “petitioner needs to make a showing of at least one defined and
recognized injury,” Lasnetski v. Sec’y of Health & Human Servs., 696 Fed.Appx. 497, 504 (Fed.
Cir. 2017) (emphasis added) (citing Lombardi at 1353).
When determining whether petitioner has adequately proven a demonstrable injury, special
masters analyze petitioner’s complete medical records filed into the record. § 300aa-11(c)(2).
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Medical records created contemporaneously with the events they describe are presumed to be
accurate and complete such that they present all relevant information on a petitioner’s health
problems. Cucuras, at 1528. Subsequent statements made by third parties that contradict
contemporaneous medical records are less persuasive to special masters than the medical records.
Campbell ex rel. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006).
Petitioner argued that the vaccine injury is “back and shoulder pain, in addition to regional
pain” and this injury is well documented in the medical records. Pet. Mot. at 11. Petitioner asserted
that he had a somatic disorder which made him react physically to a confirmed local reaction more
severely than he would have had he not had an existing somatic disorder. Id. Petitioner stated that
his treating physician, Dr. Shic, noted that petitioner experienced a reaction to the Tdap
vaccination. Petitioner made it clear that he was not alleging that the vaccine caused his
psychological disorder, but rather it was his existing underlying psychological disorder that made
him experience a more severe reaction. Pet. Reply at 2.
Respondent argued that petitioner does not have a compensable injury. Resp. Response at
9. Respondent stated that at best, petitioner showed a local reaction to vaccination, but no sequalae
lasted more than six months, his pre-existing medical conditions explain the post-vaccination
reaction, and somatic reactions are not compensable in the Vaccine Program. Id.
Here, petitioner does not allege a defined and recognized injury. Instead, petitioner argued
his injury is “back and shoulder pain and regional pain,” which was made worse by this
psychological reaction. Pet. Mot. at 11. However, these are symptoms of a non-specific injury
and do not constitute a defined recognized injury sufficient for compensation under the Act. A
“vaccine-related injury” must “be more than just a symptom or manifestation of an unknown
injury,” because such a symptom or manifestation could indicate any number of different
underlying injuries, each with its own pathology, making it impossible for the court to accurately
determine causation. See Lombardi at 1352 (citing Broekelschen at 1349).
The treating doctors considered multiple diagnoses over the time course at issue in this
case. Even though the petitioner’s primary care physician, Dr. Shic, initially indicated petitioner
experienced some reaction to the Tdap vaccination, neither him nor his rheumatologist, settled on
a consistent condition or injury that could be related to the Tdap vaccination. Dr. Shic initially
noted that petitioner likely experienced an “Adverse effect of drug. Note: likely tdap side effect,”
after petitioner reported “diffuse muscle cramping.” Pet. Ex. 4 at 270. Later, however, Dr. Shic
contacted the petitioner to explain to petitioner that he had diabetes, “which could explain some of
your recent symptoms.” Id. at 310. Petitioner’s rheumatologist, Dr. Gratton, first diagnosed
petitioner with bilateral bursitis, but also considered a differential diagnosis of polymyalgia
rheumatica. Pet. Ex. 4 at 359. However, later Dr. Gratton stated, in a note to Dr. Linda May, “I
am having a hard time at this point finding a treatable diagnosis for him. If his symptoms are the
same [in] the pelvis region when I see him, do you have any thoughts at this point?” Id. at 551.
Eventually, in September 2014, Dr. Gratton diagnosed petitioner with multiple joint pain and low
back pain. Pet. Ex. 4 at 486. Subsequently, when petitioner presented to Dr. Gratton after a two-
year gap in appointments, she diagnosed him with lumbar radiculopathy and hypertension. Id. at
559.
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Petitioner’s experts also did not identify a specific injury to which petitioner suffered
following the Tdap vaccination. Dr. Gershwin stated that “it is more likely than not that
[petitioner] did develop some myalgias following the Tdap,” however, he continued by opining
that petitioner was misdiagnosed with polymyalgia rheumatica, and a more appropriate diagnosis
was “poorly controlled diabetes,” and fibromyalgia. Pet. Ex. 7 at 1-2. Further, Dr. Gershwin
stated, “I should note that vaccination does not produce fibromyalgia.” Id.
Dr. Singer, a neuropsychologist, did not identify a defined or recognized injury either.
Instead, Dr. Singer opined that petitioner may have been suffering from “brachial neuritis (a
condition associated with the tetanus vaccine, see vaccine package insert), even though “the
claimant did not receive a diagnosis of brachial neuritis.” Pet. Ex. 9 at 8. However, there is nothing
in the medical records to suggest that petitioner’s doctors were considering brachial neuritis, nor
are any of the symptoms petitioner was exhibiting after the vaccination consistent with brachial
neuritis. Further, Dr. Singer’s reference to brachial neuritis was well outside his field of expertise
as a neuropsychologist.
Dr. Singer opined that petitioner was in good health prior to receiving the vaccine, but had
an existing “probable psychosomatic conversion disorder,” that made petitioner’s “reaction more
severe and long-lasting.” Pet. Ex. 9 at 8. However, Dr. Singer ignored petitioner’s pre-existing
pain problems to support his conclusion that there was a temporal association between the vaccine
administration and the onset of petitioner’s symptoms. Pet. Ex. 9 at 8. The medical records
demonstrate the petitioner was experiencing bilateral shoulder pain, right jaw pain, right knee pain
and lower back pain the day he received the Tdap vaccine. Additionally, petitioner indicated he
was experiencing stress in his life related to an interpersonal issue with a neighbor and a female
crew team he had been coaching, so much so, that his primary care physician referred him to a
mental health specialist. See Pet. Ex. 4 at 262, 265.
Petitioner’s complaints of a migratory pain condition which none of his treating physicians
could attribute to any particular injury or condition created a significant problem in demonstrating
he suffered an immune mediated illness or mechanical injury that could be related to the vaccine.
In the months following the vaccination, petitioner complained of right arm pain, then left arm
then simultaneously both arms and shoulder pain as well as back, buttocks and leg pain, jaw pain
and “exquisite wrist pain” all of which he attributes to a vaccine reaction. See. Pet. Ex. 4 at 353,
423, 457. His low back, buttock and leg pain, at times referred to as sciatica, could easily be
attributed to the MRI documented spondylotic disc disease, facet arthropathy, and spinal stenosis
at L4-5 and L5-S1 with no causal relationship to the vaccination. See Pet. Ex. 4 at 507. His other
symptoms are more difficult to categorize or relate to one another on a physiological basis.
To their credit, petitioner’s experts, Dr. Gershwin and Dr. Singer did not propose a specific
autoimmune or musculoskeletal diagnosis. Although Dr. Gershwin labeled petitioner’s condition
as fibromyalgia, not attributable to a vaccine, the focus of his report was on the petitioner’s
underlying psychological vulnerability, pre-existing musculoskeletal issues, misdiagnosis of an
autoimmune disorder and consequent over-treatment leading to petitioner’s mental fixation on the
possibility of having a debilitating disease caused by the Tdap vaccine.
Dr. Singer’s report also focused on petitioner’s mental status at the time he received the
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vaccine. Dr. Singer stated that petitioner had a “probable psychosomatic conversion disorder,”
which amplified petitioner’s pain symptoms. However, Dr. Singer does not consider the vaccine
to be the cause of petitioner’s conversion disorder-instead he attributes petitioner’s underlying,
psychological vulnerabilities to be the cause of petitioner’s severe and long-lasting pain. Further,
Dr. Singer’s only statement of vaccine causation is “there is a temporal relationship between the
vaccine administration and the onset of symptoms,” which is insufficient alone to sustain a Vaccine
claim. See Althen, 418 F. 3d at 1278.
In response to respondent’s argument that somatic reactions are not compensable.
petitioner argued that his vaccine injury is generalized back and shoulder pain and not a
psychological disorder, therefore respondent’s reliance on these cases were misplaced. Pet. Reply
at 2. Petitioner specifically argues that the respondent’s reliance on Ruiz is misplaced. Id. In Ruiz,
the Special Master dismissed the claim, finding that the petitioner had no organic basis for her
symptoms, but instead was diagnosed with a conversion disorder. Ruiz v. Sec’y of Health &
Human Servs., No. 02-156V, 2007 WL 5161612 (Fed. Cl. Spec. Mstr. Mar. 14, 2007). The Court
of Federal Claims affirmed the Special Master’s decision, finding that the petitioner failed to
establish that the vaccine caused or significantly aggravated her psychological condition and only
established a temporal proximity between the vaccine and the onset of her psychological condition.
Ruiz v. Sec’y of Health & Human Servs., 2007 WL 5161754, Fed. Cl. (2007). Respondent also
cited to Pless, where the Special Master dismissed the case, finding that the petitioner’s treating
physicians attributed her physical complaints to somatization instead of a vaccine-related injury.
Pless v. Sec’y of Health & Human Servs., No. 16-271V, 2017 WL 836610 (Fed. Cl. Spec. Mstr.
Feb. 6, 2017). In Pless, the petitioner’s underwent numerous tests that came back normal and her
treating physician suspected that petitioner had a functional somatic disorder. Pless, 2017 WL
836610*4. The respondent also cited to Bailey, where the former Chief Special Master Campbell-
Smith, dismissed the petition, finding that the petitioner failed to establish that the flu vaccine
caused him to suffer a post-vaccinal encephalopathy and reactive depression. Bailey v. Sec’y of
Health & Human Servs., No. 06-464V, 2008 WL 482359 (Fed. Cl. Spec. Mstr. Jan. 31, 2008). In
Bailey, the petitioner’s treating physicians uniformly agreed that there was no evidence of a
neurological basis for the petitioner’s complaints and it was suggested that petitioner was
susceptible to somatoform disorders. 2008 WL 482359*7.
Petitioner’s case is no different than the cases discussed above. In Ruiz, Pless and Bailey,
none of the petitioners’ treating physicians could identify a biological explanation for their alleged
symptoms, but instead pointed to a psychological condition that may have explained their
symptoms. Here, petitioner’s own treating physicians are unable to identify a physiological
explanation for his pain symptoms, offering multiple explanations, including uncontrolled
diabetes, lumbar spondylosis, osteoarthritis and even a self-reported tick bite that occurred two
weeks prior to receiving the vaccine. It is petitioner’s experts that opined petitioner’s migratory
pain complaints were better explained by a psychological reaction to multiple stressors in his life
that happened to coincide with the administration of the Tdap vaccine.
The Vaccine Act requires a petitioner to allege a “defined and recognized injury,” that
defines injury as a “vaccine-related injury” as an “illness, injury, condition or death.” §300aa-
11(c); §300aa-333(5). While the Act does not require a petitioner to allege a specific diagnosis, a
defined and recognized injury must be more than “merely a symptom or manifestation of an
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unknown injury.” Lombardi, 656 F.3d at 1353. Here, petitioner has not presented evidence of a
defined or recognized injury. Rather petitioner presented evidence of a series of migratory pain
complaints (symptoms) to which his treating physicians are unable to attribute to a specified injury,
illness or condition. Instead, petitioner’s treating physicians offer varying explanations for his
migratory pains. Further, petitioner’s experts were unable to offer a physiological explanation for
petitioner’s migratory pain and opined that petitioner’s pain was attributable to a psychological
reaction to co-existing stressors in his life, including a transient reaction to the vaccine. The
significant list of traumatic life events in the petitioner’s history provided more than fertile ground
for somatization with the occurrence of the post vaccinal pain, providing a psychologically
explanation for his somatic symptoms.
Petitioner has not shown a recognized injury, an autoimmune basis for his pain or a local
mechanical injury to his left shoulder that persisted for more than six months. Thus, his condition
cannot be causally related to the Tdap vaccine. Therefore, petitioner has not demonstrated a
compensable injury to which three-pronged Althen analysis can be applied.
VI. Conclusion
The petitioner’s pain complaints can be attributed to both his pre-existing musculoskeletal
history that is well documented in the medical record and also as a likely product of
psychologically based symptom amplification. This is not to say that petitioner did not actually
experience pain secondary to the complex. However, petitioner has failed to establish that the
Tdap vaccine he received on March 14, 2014 was the cause of his migratory pain complaints.
Further, the petitioner has failed to establish that his pain complaints manifested to a “recognized
and definable injury,” as required by the Vaccine Act.
Accordingly, the petitioner is not entitled to compensation and the petition is DISMISSED.
IT IS SO ORDERED.
s/Thomas L. Gowen
Thomas L. Gowen
Special Master
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