The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-0149V
Filed: July 14, 2016
Unpublished
****************************
FRANCINE MACK, * Entitlement; Ruling on the Record;
* Decision Without a Hearing; Lack
Petitioner, * of Medical Opinion; Insufficient Proof;
* Influenza (”Flu”) Vaccine; Shoulder
v. * Injury; Bursitis; Special Processing
* Unit (“SPU”)
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
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James Mitchell, Richard Gage, PC, Cheyenne, WY for petitioner.
Sarah Duncan, U.S. Department of Justice, Washington, DC, for respondent.
DECISION 1
Dorsey, Chief Special Master:
On February 18, 2015, Francine Mack (“petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa–10, et seq. 2 (the “Vaccine Act” or “Program”), with two amended petitions filed
thereafter. The case was assigned to the Special Processing Unit (“SPU”) of the Office
of Special Masters.
Petitioner alleges that she suffered injuries to her shoulders following influenza
vaccinations on February 20, 2012, October 4, 2012, and December 5, 2013. Amended
1 Because this unpublished decision contains a reasoned explanation for the action in this case, the
undersigned intends to post it 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). In accordance with Vaccine Rule 18(b), petitioner has 14 days to
identify and move to redact medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits
within this definition, the undersigned will redact such material from public access.
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
Petition at ¶¶ 2-8; Second Amended Petition at ¶¶ 3-6. For the reasons discussed
herein, the undersigned must deny compensation.
I. Procedural History
Petitioner filed a petition for compensation under the Vaccine Act on February
18, 2015, alleging that she suffered a shoulder injury, including bursitis, as a result of an
influenza vaccination she received on December 5, 2013. Petition at ¶¶ 2-4. Petitioner
filed an affidavit with her petition, stating she received an influenza vaccination at the St.
Joseph Medical Center, and that her “left shoulder started to hurt immediately after
receipt of this vaccination.” Pet’r’s Affidavit, filed Feb. 18, 2015, at ¶¶ 4-5 (hereafter,
“Pet’r’s Feb. 18 Aff.”). Petitioner also stated in her affidavit that she has “suffered pain
and decreased range of motion as a result of this injury. This has effected [sic] [her]
ability to perform tasks of daily living and has effected [sic] [her] ability to work.” Id. at ¶
6. Petitioner filed medical records as Exhibits 1-8 and a statement of completion on
March 2, 2015. ECF Nos. 6, 7.
The initial status conference was held on March 17, 2015, with the SPU staff
attorney assigned to manage this case. During that call, petitioner’s counsel indicated
that his client’s claim included additional vaccines and injuries not stated in the petition.
He agreed to file an amended petition within 14 days, which clearly and accurately
stated his client’s allegations. See Sched. Order, issued Mar. 18, 2015 (ECF No. 9), at
1. Respondent’s counsel requested additional medical records, including earlier pre-
vaccination records, updated treatment records, any available vaccine administration
records such as consent forms for each claimed vaccination, and a supplemental
affidavit from petitioner. Id. Petitioner’s counsel stated he believed all available records
had been submitted, but would consult with petitioner regarding the requested records.
Petitioner’s counsel also agreed to obtain an affidavit from petitioner addressing, as
necessary, her pre-vaccination medical history in the absence of additional records; the
duration of her claimed injuries in the absence of supporting records; the non-existence
of any relevant workers’ compensation claims; and any other gaps or discrepancies
found in the record. Id. at 1-2.
Petitioner filed an amended petition on March 31, 2015, stating she received
influenza vaccinations on February 20, 2012, and October 4, 2012, in the office of
Fiertag and Ramos, P.A., in Baltimore, Maryland. Am. Petition at ¶ 2. According to the
petition, petitioner sought treatment for neck pain and bilateral arm pain on or about
June 22, 2012. Id. at ¶ 3. Petitioner received another influenza vaccine on December
5, 2013, and immediately felt pain in her shoulder. Id. at ¶¶ 4-5. Petitioner’s diagnoses
include bursitis. Id. at ¶ 6. Petitioner alleges that her symptoms, which are chronic,
were caused by the aforementioned influenza vaccinations. Id. at ¶ 8. Petitioner’s
amended petition neither identified the arms in which she received each of the three
vaccinations nor stated which vaccination caused which alleged injury. Petitioner filed a
second affidavit and a statement of completion on April 16, 2015. In this affidavit,
2
petitioner stated that prior to the February 20, 2012 vaccination she was in good health
and self-treated minor illnesses, “therefore no records exist for the time period of at
least three years prior to [her] February 20, 2012 vaccination.” Pet’r’s Aff., filed Apr. 16,
2015 (ECF No. 11), at ¶ 2 (hereafter, “Pet’r’s Apr. 16 Aff.”). Petitioner attested that her
shoulder pain, arm pain, and limitations in motion began following the first of the three
vaccinations, but that she did not seek formal medical care because of a lack of medical
insurance and financial constraints. Id. at ¶ 3.
A second status conference was held on April 30, 2015, with former Chief
Special Master Vowell. 3 During the conference, a number of evidentiary shortcomings
in petitioner’s case were discussed. See Sched. Order, issued Oct. 5, 2015 (ECF No.
13), at 1. Petitioner requested and was granted an opportunity to obtain additional
evidence, including medical records, insurance information, and affidavits from any
witnesses. Id. On May 28, 2015, petitioner’s counsel was granted subpoena authority
for records from petitioner’s former employer, St. Joseph’s Medical Center. ECF. No.
16. Petitioner filed the records from St. Joseph’s Medical Center on September 11,
2015, as Exhibit 10. ECF No. 22.
A third status conference was held on October 2, 2015, with the assigned SPU
staff attorney. During the conference, petitioner’s counsel stated that the records
petitioner filed were not as illuminating as he had hoped; he also stated that no other
medical records were available. See Sched. Order, issued Oct. 5, 2015 (ECF No. 25),
at 1. Additionally, the SPU staff attorney and respondent’s counsel sought clarification
regarding the injection site of each of the vaccines, as petitioner had not explicitly stated
such in any of her filings, and it was not entirely clear from the medical records. Id.
After further discussion, petitioner’s counsel agreed to file a second amended petition
and another affidavit from petitioner to clarify this basic, yet important, issue. Id. at 1-2.
Petitioner filed a second amended petition on October 20, 2015, alleging she
received influenza vaccinations on October 4, 2012 and December 5, 2013. Second
Am. Petition at ¶ 2. Petitioner stated that the October 4, 2012 vaccination was in her
right shoulder, and that she “recall[ed] the vaccination on December 5, 2013 as being in
the left shoulder.” Id. at ¶ 3. Petitioner also stated that she reported a history of pain in
her shoulders following the administration of the aforementioned vaccines to Orthopedic
Specialist of Maryland. Id. at ¶ 4. Finally, she reiterated that she was diagnosed with
bursitis, and that “her chronic symptoms were caused by her influenza vaccines
administered October 4, 2012 and December 5, 2013.” Id. at ¶¶ 5-7. Petitioner made
no mention of the February 20, 2012 vaccination. On October 26, 2015, petitioner filed
another affidavit stating that she “believe[d] the flu vaccine on December 5, 2013 was
administered in [her] left arm.” Pet’r’s Aff., filed Oct. 26, 2015 (ECF No. 31), at ¶ 4
(hereafter, “Pet’r’s Oct. 26 Aff.”). She “recognize[d] that the dates and area of
3 The case was reassigned to the undersigned on September 23, 2015, following the retirement of Chief
Special Master Vowell. Notice of Reassignment, ECF No. 24.
3
administration of the vaccines ha[ve] been confusing” and that her statements “are in
conflict with [her] previous affidavit.” Id. at ¶¶ 4, 6. Petitioner also indicated, contrary to
previous assertions, that she had filed a Workers’ Compensation claim; however, she
had not yet collected any award. Id. at ¶ 9. No documentation related to this claim has
been filed.
On January 12, 2016, petitioner filed a motion for ruling on the record. Motion for
Ruling on the Record, filed Jan. 12, 2016 (ECF No. 34). On January 14, 2016,
respondent filed her Rule 4(c) Report and Motion to Dismiss, wherein she argued that
petitioner’s claim should not be compensated and instead, should be dismissed.
Respondent’s Rule 4(c) Report and Motion to Dismiss, filed Jan. 14, 2016 (ECF. No.
35), at 2. 4
The matter is now ripe for adjudication. The undersigned issues this ruling on
the record in response to petitioner’s motion for such ruling.
II. Medical History
Petitioner submitted limited pre-vaccination records. In her second affidavit,
petitioner stated that the dearth of records was due to her “good health” prior to
vaccination, and her ability to self-treat minor illnesses with her knowledge as a nurse.
Pet’r’s Apr. 16 Aff. at ¶ 2. Consequently, “no records exist for the time period of at least
three years prior to [her] February 20, 2012 vaccination.” Id. The following is based on
the few records filed by petitioner.
On February 20, 2012, petitioner received a flu vaccination in her right deltoid at
Feirtag and Ramos, P.A., in Baltimore, Maryland. Exhibit 1 at 5. 5
On June 2, 2012, petitioner presented to her primary care physician, Dr. Manuel
Ramos, complaining of “pain on side” and “nodule on l[eft] thumb.” Exhibit 1 at 12. On
June 22, 2012, petitioner underwent an MRI of the thoracic and cervical spine. Exhibit 3
at 5-6. The MRI report noted a history of “Neck pain and bilateral arm pain, neck
stiffness, mid-back pain symptoms for two months.” Id. at 5. The MRI revealed mild
degenerative changes in the upper-to-mid spine without evidence of canal or foraminal
stenosis, but mild-to-moderate central canal stenosis and bilateral foraminal narrowing
in the cervical spine. Id. at 6.
4Respondent filed a status report on Feb. 3, 2016 advising the undersigned that she intended her Rule
4(c) Report and Motion to Dismiss to serve as her response to Petitioner’s Motion for Ruling on the
Record. Status Rep., filed Feb. 3, 2016 (ECF No. 36).
5 There are contradictory notations in the record of this case regarding the date of this vaccination. For
the reasons discussed in footnote 11, below, the undersigned has concluded that the preponderance of
the evidence supports February 20, 2012, as the date of vaccination.
4
According to petitioner’s Employee Medical Activity History, she received another
flu vaccination on October 4, 2012, which was administered by “LH” in her “RD” [right
deltoid]. Exhibit 8 at 1. Petitioner provided no additional medical records relating to this
vaccination, but attested that she received this vaccination in her right arm. Pet’r’s Oct.
26 Aff. at ¶ 3.
On November 8, 2013, petitioner underwent a right shoulder MRI. Exhibit 3 at 8.
The MRI report noted a history of “Right shoulder and right arm pain. Limited range of
motion.” Id. This MRI, which was one year and nine months after the February 20,
2012 vaccination, was requested by Dr. Ramos, possibly during a visit reflected in an
undated record noting that an MRI was planned for petitioner’s right shoulder. Id. 6 The
MRI revealed moderate tendinosis of the subscapularis and supraspinatus tendons,
mild subacromial subdeltoid bursitis and “tiny subcoracoid bursa,” an intact rotator cuff,
mild AC joint osteoarthritis, and possible mild fraying of the superior labrum. Id.
According to petitioner’s Employee Medical Activity History, she received another
flu vaccination on December 5, 2013. Exhibit 8 at 4. Petitioner provided no additional
medical records relating to this vaccination; however, petitioner stated in an affidavit that
she believed it “was administered in [her] left arm.” Pet’r’s Oct. 26 Aff. at ¶ 4. 7
On January 11, 2014, petitioner again saw Dr. Ramos complaining of pain in her
left arm following a flu shot, and a problem with her right arm. 8 Exhibit 1 at 26. An MRI
of petitioner’s left shoulder followed on January 13, 2014. Exhibit 3 at 10. The MRI
report indicated petitioner had “[l]eft shoulder pain and upper extremity weakness
beginning several months prior to exam.” Id. The MRI showed no evidence of rotator
cuff tear, very mild arthritic changes of the AC joint space, and a mild degree of
subacromial and subdeltoid bursal fluid, which “may be related to mild degree of
bursitis.” Id. 9
6 This undated record from Dr. Ramos notes right shoulder pain after injection. Exhibit 1 at 17. However,
since it is undated, and there is no context for the notation (the record does not indicate the type of
injection or when it was administered), it is of little probative value.
7 An undated “Influenza Vaccine (Flu Shot) Consent Form” reflects that petitioner received a vaccination
in her “L. Deltoid”, indicating petitioner was injected in her left deltoid. Exhibit 10 at 10. Petitioner also
wrote on this form that she had had a bad reaction to a previous flu shot, with additional hand-written
notion of “sore muscle” and “my previous flu shot left my arm swollen tender + sore[.] MRI reveals a
frayed muscle that has bursitis + tendinitis.” Id. However, since this form is undated, it is of little
probative value.
8 Dr. Ramos notes “Flu shot (L) arm now pain” and “(R) arm gave out.” Exhibit 1 at 26.
9 On January 13, 2014, petitioner also had an MRI of her brain, citing a history of headaches and bilateral
extremity weakness. Exhibit 3 at 9. The MRI revealed a possible small micro adenoma, but otherwise
was a normal exam. Id.
5
On March 25, 2014, petitioner transitioned from the care of Dr. Ramos to Dr.
Allan Lanzo of the Orthopaedic Specialists of Maryland. Exhibit 5 at 1. Dr. Lanzo
reported that the reason for petitioner’s visit was sudden shoulder pain that manifested
after a flu vaccination and had persisted in an intermittent pattern for 9 months. Id.
Petitioner reported pain “in the left shoulder, right shoulder, left side of the neck and
right side of the neck.” Id. In his summary of the encounter, Dr. Lanzo wrote:
The patient comes in today with complaints of bilateral
shoulder pain. She has interesting history where she felt that
her right shoulder pain began after a flu vaccine a year ago
and her left shoulder pain began nine months later after a
second flu vaccine in that arm. She reports that both
shoulders are painful. She notes some occasional numbness
or tingling although that is not a predominant complaint. She
has some aching at rest, but most of her pain is in the
shoulders and radiating down into the arms and that is usually
post activity.
Id. at 3. Dr. Lanzo’s examination revealed petitioner had “some mild impingement
signs, but nothing dramatic.” Id. He also expressed skepticism as to a causal link
between petitioner’s vaccinations and her shoulder pain, noting that “[i]t is a little bit
unclear as to the mechanism of the connection between the flu vaccine and her ongoing
shoulder difficulties.” Id.
Petitioner saw a neurologist, Dr. James Wolf, on April 4, 2014, complaining of
right upper arm pain. Exhibit 6 at 1. Dr. Wolf stated petitioner did not have “any new
abnormalities on her exam” and referred her for an electrodiagnostic study and ordered
another MRI scan. Id.
On April 15, 2014, petitioner underwent an electromyography and nerve
conduction study on both arms and her left leg. Exhibit 7 at 1. One of the reasons for
the study was to understand petitioner’s symptoms following “a flu shot.” Id. A
handwritten note states “pain of upper arms since flu shots x2 years.” Id. at 2. The
study revealed no significant abnormalities, but did indicate a “minimal change of left
median” in the arm. Id. at 1.
III. Applicable Legal Standards
Under Section 13(a)(1)(A) of the Act, a petitioner must demonstrate, by a
preponderance of the evidence, that all requirements for a petition set forth in section
11(c)(1) have been satisfied. A petitioner may prevail on her claim if she has received a
vaccine covered by the Program and “sustained, or had significantly aggravated, any
illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the “Table”).
§ 11(c)(1)(A) and (C)(i). The most recent version of the Table, which can be found at 42
6
C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding
injuries, and the time period in which the particular injuries must occur after
vaccination. 10 § 14(a). If the petitioner establishes that she suffered such a “Table
Injury,” causation is presumed. Grant v. Sec’y of Health & Human Servs., 956 F.2d
1144, 1146–47 (Fed.Cir.1992).
If, however, the petitioner suffered an injury that either is not listed in the Table
or did not occur within the prescribed time frame, the petitioner must prove that the
claimed vaccine caused the alleged injury to receive compensation. § 11(c)(1)(C)(ii)
and (iii). In such circumstances, petitioner is said to assert a “non-Table” or “off-Table”
claim, and must prove her claim by preponderant evidence. § 13(a)(1)(A). A special
master is prohibited from making “such a finding “based on the claims of a petitioner
alone, unsubstantiated by medical records or by medical opinion.” § 13(a)(1). This
standard is “one of . . . simple preponderance, or ‘more probable than not’ causation.”
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1279-80 (Fed. Cir. 2005)
(referencing Hellebrand v. Sec’y of Health & Human Servs., 999 F.2d 1565, 1572-73
(Fed. Cir. 1993). The Federal Circuit has held that to establish an off-Table injury,
petitioner must “prove . . . that the vaccine was not only a but-for cause of the injury but
also a substantial factor in bringing about the injury.” Shyface v. Sec’y of Health &
Human Servs., 165 F.3d 1344, 1351 (Fed. Cir 1999). Id. at 1352. The received
vaccine, however, need not be the predominant cause of the injury. Id. at 1351.
The Federal Circuit has indicated that petitioner “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant, 956 F.2d at 1148). Additionally, "[t]here must be a ‘logical sequence of cause
and effect showing that the vaccination was the reason for the injury.’” Id. The Federal
Circuit subsequently restated these requirements in its Althen decision. Althen requires
a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (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.
418 F.3d at 1278. All three prongs of Althen must be satisfied. Id.
10The Vaccine Act authorizes the Secretary of the Department of Health and Human Services to
“promulgate regulations” to periodically modify the Vaccine Injury Table. § 14(c). The updates are
contained in the Code of Federal Regulations (C.F.R.), as cited above.
7
Section 11(c)(1) also contains requirements concerning the type of vaccination
received and the geographic location where it was administered, the duration or
significance of the injury, and the lack of any other award or settlement. See §
11(c)(1)(A),(B),(D) and (E). With regard to duration, whether a Table or non-Table
claim, the petitioner must establish she
(i) suffered the residual effects or complications of such
illness, disability, injury, or condition for more than 6 months
after the administration of the vaccine, or (ii) died from the
administration of the vaccine, or (iii) suffered such illness,
disability, injury, or condition from the vaccine which resulted
in inpatient hospitalization and surgical intervention.
§ 11(c)(1)(D).
IV. Analysis
Petitioner alleges in three petitions that influenza vaccinations she received on
February 20, 2012, October 4, 2012, and December 5, 2013, caused her to suffer
painful injuries to her shoulders. Pet. at ¶¶ 2-6; Am. Petition at ¶¶ 2-8; Second Am.
Petition at ¶¶ 3-7. Although not explicitly stated, petitioner is essentially claiming what is
known as shoulder injury related to vaccine administration or “SIRVA.”
Respondent opposes compensation in this case, arguing that petitioner has not
produced sufficient evidence to support any of her claims. See Respondent’s Rule 4(c)
Report and Motion to Dismiss, filed Jan. 14, 2016.
After a thorough review of the record, the undersigned finds petitioner has
provided evidence sufficient to establish receipt of the three vaccinations, but, as
discussed in greater detail below, has not established that the vaccinations actually
caused the alleged injuries. Specifically, petitioner has failed to satisfy all three prongs
of Althen for each claimed injury—she has not provided sufficient evidence to establish
a medical theory of causation; she has not set forth a logical sequence of cause and
effect showing the claimed vaccinations caused any of her alleged injuries; and she has
not established a proximal temporal relationship between two of the vaccinations and
the corresponding alleged injuries. Each vaccination is addressed in turn.
1. Petitioner’s February 20, 2012 Vaccination
The first vaccination to allegedly injure petitioner was an influenza vaccine given
into her right arm on February 20, 2012. 11 Am. Petition at ¶ 2; Exhibit 1 at 5. Petitioner,
11 The medical records provide contradictory dates for the February vaccination. The “Vaccine
Administration, Assessment, and Consent Form” reflects that petitioner signed the form on February 15,
2012, and indicates that it was administered on that date to her right deltoid. Exhibit 1 at 5. Petitioner’s
8
however, made no mention of this vaccination in her Second Amended Petition, so it is
unclear whether she has abandoned this allegation. Out of an abundance of caution,
the undersigned assumes petitioner did not abandon the claim and considers it herein.
a. Alleged Injury
Petitioner claims that her chronic symptoms, including shoulder pain, arm pain,
limitations in motion, and bursitis, were caused in part by the February 20, 2012
influenza vaccination. Am. Petition at ¶¶ 2-8; Pet’r’s Apr. 16 Aff. at ¶ 3. In support of
her claim, petitioner refers to the records of her treatment for neck pain and bilateral
arm pain on June 22, 2012. Am. Petition at ¶ 3; See Exhibit 3 at 5-6. However, the
record does not show the neck and bilateral arm pain was attributed or associated with
petitioner’s February 20, 2012 vaccination. Moreover, petitioner attested that she did
not seek any formal treatment for her vaccine-related injuries because she lacked
medical insurance and had financial constraints. Pet’r’s Apr. 16 Aff. at ¶ 3.
b. A Medical Theory Causally Connecting the Vaccination and Injury
To satisfy the first Althen prong, the petitioner must show that the vaccination in
question can cause the injury alleged. See Pafford v. Sec’y of Health & Human Servs.,
2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19
(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). The petitioner must offer a medical theory
which is reputable and reliable. See, e.g., Pafford v. Sec’y of Health & Human Servs.,
451 F.3d 1352, 1355 (reputable); Moberly v. Sec’y of Health & Human Servs., 592 F.3d
1315, 1324 (Fed. Cir. 2010) (reliable). The petitioner must prove this prong by
preponderant evidence. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d
1339, 1350 (Fed. Cir. 2010).
Here, petitioner has not filed the report of a medical expert or offered any medical
theory showing that the February 20, 2012 influenza vaccination could have caused or
aggravated her alleged injuries. Further, there is nothing in the medical records from a
physician or other medical professional providing such a theory. 12 Petitioner, therefore,
has failed to satisfy the first Althen prong.
c. A Logical Sequence of Cause and Effect
amended petition, second affidavit, and Employee Medical Activity History reflect the vaccine was
received on February 20, 2012. Am. Petition at ¶ 2; Pet’r’s Apr. 16 Aff. At ¶ 2; Exhibit 8 at 1. Based on
the record as a whole, the undersigned finds that, by a preponderance of evidence, petitioner’s vaccine
was administered on February 20, 2012.
12 Petitioner was afforded ample opportunity to secure a medical opinion setting forth a causal theory.
Petitioner’s motion for a ruling on the record, which was filed voluntarily, unequivocally states that
petitioner “submitted all the evidence that [she] believes the Chief Special Master needs to issue a ruling
in this case.” Motion for Ruling on the Record, filed Jan. 12, 2016 (ECF No. 34). Thus, petitioner cannot
claim she was deprived of the opportunity to submit evidence in support of this prong.
9
To satisfy the second Althen prong, the petitioner must prove that the vaccine
she received did cause her injury. Pafford, 2004 WL 1717359, at *4. The petitioner
must provide preponderant evidence of causation. See Capizzano v. Sec’y of Health &
Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). In determining whether the
petitioner has met this burden of proof under this prong, the special master must
consider the opinions of any treating physicians who conclude that the claimed vaccine
was the cause of the alleged injury. Id. Any diagnosis, conclusion, or medical judgment
contained in the record must be considered when determining if compensation is
appropriate. § 13(b)(1).
Here, petitioner has not furnished evidence that the February 20, 2012
vaccination caused or contributed to her reported injuries. None of petitioner’s treating
medical professionals attributed her condition to the vaccination she received. For
example, when petitioner first sought treatment for neck pain and bilateral arm pain in
June of 2012, there was no mention of an influenza vaccination. See Exhibits 1 at 12,
14; 3 at 6. Further, petitioner did not submit a medical opinion supporting causation
from any treating physician or other qualified expert.
The medical records petitioner provided attributed her symptoms to other causes,
including degenerative changes in petitioner’s spine. See, e.g., Exhibit 3 at 6 (indicating
her neck and bilateral arm pain was due to “Mild degenerative changes in the upper-to-
mid thoracic and cervical spine”).
For all these reason, petitioner has not established a logical sequence of cause
and effect showing that the February 20, 2012 vaccination caused or aggravated her
alleged injuries. She has failed to satisfy the second Althen prong.
d. A Proximate Temporal Relationship between Vaccination and
Injury
The third Althen prong requires the petitioner to provide preponderant evidence
that the first symptom or onset of the injury “occurred within a timeframe for which . . . it
is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of Health and
Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The petitioner must show that
the injury did not occur too soon or too long after vaccination. Id.
Here, petitioner claims that her “shoulder and arm pain and limitations in motion
began following [her] vaccine on February 20, 2012,” and that she did not seek any care
due to a lack of medical insurance and financial constraints. Pet’r’s Apr. 16 Aff. at ¶ 3.
However, contemporaneous medical evidence indicates petitioner’s symptoms first
occurred in April 2012. Exhibit 3 at 5 (a June 2012 record noting that petitioner had
experienced symptoms including neck pain and bilateral arm pain, neck stiffness, mid-
back pain “for two months”). This medical evidence outweighs petitioner’s unsupported
10
assertions. Indeed, the undersigned may not make a finding based on the claims of a
petitioner alone, unsubstantiated by medical records or by medical opinion. § 13(a).
Therefore, when viewing the record as a whole, the undersigned finds that the earliest
onset of petitioner’s injuries was April 2012, at least six weeks after her February 20,
2012 vaccination.
The Secretary has proposed amending the Vaccine Injury Table to add the injury
of SIRVA. See Revisions to the Vaccine Injury Table, 80 Fed. Reg. at 45,132. 13
According to the proposal, the timeframe for onset is less than or equal to 48 hours. Id.
at 45,136. In petitioner’s case, 48 hours after vaccination would be February 22, 2012.
The undersigned recognizes that the proposed time frame does not mean that a
petitioner cannot not obtain compensation for a claim involving a later onset (even one
that is substantially later), but the petitioner must provide evidence establishing that the
later onset is medically acceptable to infer causation.
In petitioner’s case, even based on the earliest date of onset (April 1, 2012), the
time between vaccination and onset is at least 42 days (21 times the length of time set
forth in the proposed table change), and petitioner has provided no evidence that an
onset occurring at that time is medically acceptable to infer causation. Petitioner has
failed to provide evidence of a proximate temporal relationship between vaccination and
injury, and thus, has failed to fulfill the third Althen prong.
2. Petitioner’s October 4, 2012 Vaccination
The second vaccination to allegedly injure petitioner was an influenza vaccine
given into her right shoulder on October 4, 2012. Second Am. Petition at ¶ 3; Exhibit 8
at 1; Pet’r’s Oct. 26 Aff at ¶3. 14
a. Alleged Injury
Petitioner claims that her chronic symptoms, including shoulder pain and bursitis,
were caused in part by the October 4, 2012 influenza vaccination. Second Am. Petition
at ¶¶ 3-7. While petitioner attests that she reported pain in her arm and shoulders
related to the flu vaccine (Pet’r’s Oct. 26 Aff at ¶ 5), the record shows no evidence of
petitioner reporting any shoulder pain until November 2013, more than a year after the
13 Available at https://federalregister.gov/a/2015-17503.
14Respondent argues that petitioner has not provided adequate proof of her October 4, 2012 influenza
vaccination. Resp’t’s Rule 4(c) Report and Motion to Dismiss, filed Jan. 14, 2016, at 13. However, based
on petitioner’s affidavit and employment records, the undersigned finds that she has shown, by a
preponderance of the evidence, that she received the vaccination in her right shoulder on October 4,
2012. Second Am. Petition at ¶ 3; Exhibit 8 at 1; Pet’r’s Oct. 26 Aff at ¶3.
11
October 4, 2012 vaccination (Exhibit 3 at 8; see also Exhibit 1 at 17 15). On November
8, 2013, petitioner underwent an MRI of her right shoulder for a history of “Right
shoulder and right arm pain. Limited range of motion.” Exhibit 3 at 8. The MRI showed
moderate tendinosis of the subscapularis tendon and supraspinatus tendon; mild
subacromial subdeltoid bursitis and tiny subcoracoid bursa; mild AC joint osteoarthritis;
and possible mild fraying of the superior labrum. Id. However, the record does not
show that the right shoulder and right arm pain were attributed or associated with
petitioner’s October 4, 2012 vaccination.
b. A Medical Theory Causally Connecting the Vaccination and Injury
To satisfy the first Althen prong, the petitioner must show that the vaccination in
question can cause the injury alleged. See Pafford, 2004 WL 1717359, at *4. The
petitioner must offer a medical theory which is reputable and reliable. See, e.g.,
Pafford, 451 F.3d at 1355 (reputable); Moberly, 592 F.3d at 1324 (reliable). The
petitioner must prove this prong by preponderant evidence. Broekelschen, 618 F.3d at
1350.
Here, petitioner has not filed the report of a medical expert or offered any medical
theory showing that the October 4, 2012 influenza vaccination could have caused or
aggravated her alleged injuries. Further, there is nothing in the medical records from a
physician or other medical professional providing such a theory. Petitioner, therefore,
has failed to satisfy the first Althen prong.
c. A Logical Sequence of Cause and Effect
To satisfy the second Althen prong, the petitioner must prove that the vaccine
she received did cause her injury. Pafford, 2004 WL 1717359, at *4. The petitioner
must provide preponderant evidence of causation. See Capizzano, 440 F.3d at 1326.
In determining whether the petitioner has met this burden of proof under this prong, the
special master must consider the opinions of any treating physicians who conclude that
the claimed vaccine was the cause of the alleged injury. Id. Any diagnosis, conclusion,
or medical judgment contained in the record shall be considered when determining if
compensation is appropriate. § 13(b)(1).
Here, petitioner has not provided evidence that the October 4, 2012 vaccination
caused or contributed to her injuries. None of petitioner’s treating medical professionals
attributed her condition to the vaccination she received. For example, when petitioner
first sought treatment for right shoulder pain, right arm pain, and limited range of motion
in November of 2013, there was no mention of the influenza vaccination. See Exhibits 1
15This undated record from Dr. Ramos reflects a complaint of right shoulder pain after injection. Because
the record notes that an MRI was planned for petitioner’s right shoulder, it is possible that this visit
occurred contemporaneously with the MRI. Even if the visit occurred in October 2013, it would have
taken place a year after petitioner received her October 4, 2012 vaccination.
12
at 16; 3 at 8. Further, it was not until March of 2014 when petitioner first mentioned any
alleged relationship between her October 2012 influenza vaccination and her injury.
Exhibit 5 at 1. Although petitioner was diagnosed with mild bursitis, which can be
caused by an errant vaccination, there is no indication in petitioner’s record of when it
was onset or any statement, notation, or opinion from a medical professional indicating
her vaccination was the cause.
Moreover, petitioner did not submit a medical opinion supporting causation from
any treating physician or other qualified expert. Instead, petitioner’s medical records
reflect a treating physician questioning whether her injuries were caused by her flu
vaccination. On March 25, 2014, petitioner saw Dr. Allan Lanzo, an orthopedic
specialist, complaining of right shoulder pain that “she felt…began after a flu vaccine a
year ago….” Exhibit 5 at 3. Dr. Lanzo opined that “[i]t is a little bit unclear as to the
mechanism of the connection between the flu vaccine and her ongoing shoulder
difficulties.” Id.
For all these reason, petitioner has not established a logical sequence of cause
and effect showing that the October 4, 2012 vaccination caused or aggravated her
alleged injuries. She has failed to satisfy the second Althen prong.
d. A Proximate Temporal Relationship between Vaccination and
Injury
The third Althen prong requires the petitioner to provide preponderant evidence
that the first symptom or onset of the injury “occurred within a timeframe for which . . . it
is medically acceptable to infer causation-in-fact.” de Bazan, 539 F.3d at 1352. The
petitioner must show that the injury did not occur too soon or too long after vaccination.
Id.
Petitioner’s various petitions and affidavits have inconsistently reported when the
onset of her injury occurred. In her initial petition, petitioner claimed that her “chronic
symptoms were caused by her influenza vaccination administered on December 5,
2013.” Petition at ¶ 5. In petitioner’s Amended Petition, she claimed her “shoulder
began to hurt immediately after receipt of [the December 5, 2013] influenza
vaccination.” Am. Petition at ¶ 5. In her affidavit filed in support of her Amended
Petition, petitioner claimed that her “shoulder and arm pain and limitations in motion
began following [her] vaccine on February 20, 2012.” Pet’r’s Apr. 16 Aff. at ¶ 3. In
petitioner’s Second Amended Petition, petitioner claimed “a history of pain in her
shoulders following administration of the [October 4, 2012 and December 5, 2013]
vaccines.” Second Am. Petition at ¶ 4.
The medical records also contain inconsistent reporting as to when petitioner first
experienced symptoms of the injuries she relates to her October 4, 2012 vaccination.
According to petitioner’s medical records, she first complained of right shoulder and arm
13
pain and limited range of motion in November of 2013, which is 13 months after the
October 4, 2012 vaccination. Exhibits 1 at 16; 3 at 8. There is no reference or other
indication that petitioner, or any medical professional, attributed the problems she
reported at that visit to her vaccination. 16 The first instance where petitioner attributed
any injury to her vaccination was during a March 25, 2014 visit to an orthopedic
specialist—but even then she provided conflicting reports as to the onset of her alleged
injuries: she reported the “onset of shoulder pain [was] sudden (after a flu vaccine) and
ha[d] been occurring in an intermittent pattern for 9 months”; however, she also “felt that
her right shoulder pain began after a flu vaccine a year ago….” Exhibits 5 at 1, 3. If
petitioner’s assertions are accurate, her right shoulder pain would have first occurred
either in June or April of 2013—approximately eight or six months, respectively, after
petitioner’s October 2012 vaccine.
The undersigned may not make a finding based on the claims of the petitioner
alone, unsubstantiated by medical records or by medical opinion. § 13(a). Therefore,
when viewing the record as a whole, the undersigned finds that the earliest onset of
petitioner’s injuries was April of 2013, at least six months after the October 4, 2012
vaccination.
As discussed above, the Secretary’s proposal to add the injury of SIRVA to the
Vaccine Injury Table includes a time frame for onset of less than or equal to 48 hours.
In petitioner’s case, 48 hours after vaccination would be October 6, 2012. The
undersigned recognizes that the proposed time frame does not mean that a petitioner
cannot not obtain compensation for a claim involving a later onset (even one that is
substantially later), but the petitioner must provide evidence establishing that the later
onset is medically acceptable to infer causation.
Here, even assuming the earliest date of onset (April 2013), the time between
vaccination and onset is approximately six months, and petitioner has provided no
evidence that an onset occurring at that time is medically acceptable to infer causation.
Petitioner has failed to provide evidence of a proximate temporal relationship between
vaccination and injury, and thus, has failed to fulfill the third Althen prong. 17
3. Petitioner’s December 5, 2013 Vaccination
16 As previously discussed, an undated record from Dr. Ramos (Exhibit 1 at 17) notes right shoulder pain
after injection. The undated record, however, provides no context for the notation (the record does not
indicate the type of injection or when it was administered), and, most importantly, does not establish when
petitioner first experienced the alleged symptoms. The record is therefore given little weight.
17 Petitioner also failed to demonstrate that she “suffered the residual effects of such … injury, or
condition for more than 6 months after administration of the vaccine.” See § 11(c)(1)(D).
14
The third vaccination to allegedly injure petitioner was an influenza vaccine given
into her left shoulder on December 5, 2013. Second Am. Petition at ¶¶ 2-3, 7; Exhibit 8
at 4; Pet’r’s Oct. 26 Aff. at ¶ 4. 18
a. Alleged Injury
Petitioner claims that her chronic symptoms, including shoulder pain and bursitis,
were caused in part by the December 5, 2013 influenza vaccination. Second Am.
Petition at ¶¶ 3- 7. While petitioner attests that she reported pain in her arm and
shoulders related to the flu vaccine (Pet’r’s Oct. 26 Aff. at ¶ 5), the record shows no
evidence of petitioner complaining of any shoulder pain until January 11, 2014, when
she reported pain in her left arm following a flu shot (Exhibit 1 at 26). A subsequent
MRI of petitioner’s left shoulder on January 13, 2014, showed mild degree of
subacromial and subdeltoid bursal fluid and a mild degree of bursitis. Exhibits 1 at 19; 3
at 10. However, the record does not indicate the left shoulder pain was attributed or
associated with petitioner’s December 5, 2013 vaccination.
b. A Medical Theory Causally Connecting the Vaccination and Injury
To satisfy the first Althen prong, the petitioner must show that the vaccination in
question can cause the injury alleged. See Pafford, 2004 WL 1717359, at *4. The
petitioner must offer a medical theory which is reputable and reliable. See, e.g.,
Pafford, 451 F.3d at 1355 (reputable); Moberly, 592 F.3d at 1324 (reliable). The
petitioner must prove this prong by preponderant evidence. Broekelschen, 618 F.3d at
1350 (Fed. Cir. 2010).
Here, petitioner has not filed the report of a medical expert or offered any medical
theory showing that the December 5, 2013 influenza vaccination could have caused or
aggravated her alleged injuries. Further, there is nothing in the medical records from a
physician or other medical professional providing such a theory. Petitioner, therefore,
has failed to satisfy the first Althen prong.
c. A Logical Sequence of Cause and Effect
To satisfy the second Althen prong, the petitioner must prove that the vaccine
she received caused her injury. Pafford, 2004 WL 1717359, at *4. The petitioner must
provide preponderant evidence of causation. See Capizzano, 440 F.3d at 1326. In
determining whether the petitioner has met this burden of proof under this prong, the
special master must consider the opinions of any treating physicians who conclude that
18Respondent argues that petitioner has not provided adequate proof of her December 5, 2013 influenza
vaccination. Resp’t’s Rule 4(c) Report and Motion to Dismiss, filed Jan. 14, 2016, at 13. However, based
on petitioner’s affidavit and employment records, the undersigned finds that she has shown, by a
preponderance of the evidence, that she received the vaccination in her left shoulder on December 5,
2013. Second Am. Petition at ¶¶ 2-3, 7; Exhibit 8 at 4; Pet’r’s Oct. 26 Aff. at ¶4.
15
the claimed vaccine was the cause of the alleged injury. Id. Any diagnosis, conclusion,
or medical judgment contained in the record shall be considered when determining if
compensation is appropriate. § 13(b)(1).
Here, petitioner has not provided evidence that the December 5, 2013
vaccination caused or contributed to her injuries. None of petitioner’s treating medical
professionals attributed her condition to the vaccination she received. For example,
while petitioner apparently reported left shoulder pain following a flu vaccination (Pet’r’s
Oct. 26 Aff. at ¶ 5), the medical records indicate she did not seek any treatment for
shoulder pain until January of 2014. See Exhibits 1 at 26; 3 at 10. Further, on January
13, 2014 petitioner claimed that the shoulder pain began “several months prior to exam”
(Exhibit 3 at 10), and later on March 25, 2014 claimed that she had been experiencing
left shoulder pain for approximately 3 months (Exhibit 5 at 3). Although petitioner was
diagnosed with mild bursitis and showed signs of mild impingement, there is no
indication in the record that the injuries were attributed to the December 5, 2013
vaccination. Exhibits 1 at 26; 3 at 10; 5 at 3.
Moreover, petitioner did not submit a medical opinion supporting causation from
the treating physician or another expert, but did submit medical records indicating a
treating physician questioned whether her injuries could have been caused by the flu
vaccination. On March 25, 2014, Dr. Allan Lanzo, noted that “[i]t is a little bit unclear as
to the mechanism of the connection between the flu vaccine and her ongoing shoulder
difficulties.” Exhibit 5 at 3.
For all these reason, petitioner has not established a logical sequence of cause
and effect showing that the December 5, 2013 vaccination caused or aggravated her
alleged injuries. She has failed to satisfy the second Althen prong.
d. A Proximate Temporal Relationship between Vaccination and
Injury
The third Althen prong requires the petitioner to provide preponderant evidence
that the first symptom or onset of the injury “occurred within a timeframe for which . . . it
is medically acceptable to infer causation-in-fact.” de Bazan, 539 F.3d at 1352. The
petitioner must show that the injury did not occur too soon or too long after vaccination.
Id.
Here, petitioner statements regarding the onset of her injuries have been
inconsistent. In her first petition, she claimed her shoulder began to hurt immediately
after receipt of [the December 5, 2013] influenza vaccination.” Petition at ¶ 2-3; Pet’r’s
Feb. 18 Aff. at ¶ 5. However, petitioner’s Second Amended Petition claims that she
experienced pain in her shoulders following the administration of both the October 4,
2012 and December 5, 2013 vaccinations. Second Am. Petition at ¶¶ 3-4. The medical
records provide some clarity. On January 11, 2014 petitioner presented to Dr. Ramos,
16
who indicated “Flu shot [left] arm now pain[.]” Exhibit 1 at 26. Further, Dr. Ramos
ordered a left shoulder MRI for petitioner based on a history of “Left shoulder pain and
upper extremity weakness beginning several months prior to exam[.]” Exhibit 3 at 10. If
this is accurate, petitioner’s left shoulder pain would have first occurred either in
October or November of 2013, before petitioner even received the December 5, 2013
vaccination.
Despite petitioner’s inconsistent statements, there is preponderant evidence that
petitioner’s left shoulder pain occurred immediately after her December 5, 2013
vaccination. Specifically, the undersigned credits the above-described January 11,
2014 medical record and petitioner’s February 18, 2015 affidavit. As already discussed,
the proposal to add the injury of SIRVA to the Vaccine Injury Table includes a time
frame for onset of less than or equal to 48 hours. Here, the onset of petitioner’s claimed
injuries to her left shoulder was immediate. Petitioner has therefore established a
proximate temporal relationship between vaccination and injury, and thus, fulfilled the
requirements of the third Althen prong. However, establishing temporal association is
not sufficient to establish causation-in-fact. Grant, 956 F.2d at 1148.
e. Six month requirement
Ignoring all other defects, petitioner still would not be entitled to compensation
under the Vaccine Program based on the December 5, 2013 vaccination because she
has not demonstrated that she “suffered the residual effects of such … injury, or
condition for more than 6 months after administration of the vaccine.” § 11(c)(1)(D).
Petitioner only provided medical records through April 15, 2015 (Exhibit 7 at 1), despite
ample opportunity to supplement the record. Petitioner asserts that she has suffered
the residual effects of her alleged vaccine-related injuries for more than six months, and
that her symptoms continue. Second Am. Petition at ¶ 8; Pet’r’s Oct. 26 Aff. at ¶ 7.
However, there are no medical records to support this statement, and the undersigned
“may not make such a finding based on the claims of a petitioner alone.” § 13(a)(1).
Therefore, in addition to not meeting the first two Althen prongs, petitioner has
not demonstrated that she has suffered the residual effects of her alleged injuries for
more than six months.
V. Conclusion
For the reasons set forth above, petitioner has failed to establish entitlement to
compensation under the Vaccine Act. This case is dismissed for insufficient proof. The
Clerk of the Court is directed to enter judgment in accordance with this decision. 19
19 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party filing a notice
renouncing the right to seek review.
17
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
18