Reed v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-1670V
Filed: February 2, 2018
JENNIFER REED,
Special Processing Unit (SPU);
Petitioner, Entitlement; Ruling on the Record;
v. Decision Without a Hearing;
Causation-In-Fact; Tetanus-
SECRETARY OF HEALTH AND diphtheria-acellular pertussis
HUMAN SERVICES, (“Tdap”) Vaccine; Shoulder Injury
Related to Vaccine Administration
Respondent. (SIRVA)
Leah VaSahnja Durant, Law Offices of Leah V. Durant, PLLC, Washington, DC, for petitioner.
Darryl R. Wishard, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON ENTITLEMENT 1
Dorsey, Chief Special Master:
On December 20, 2016, Jennifer Reed (“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”), alleging that as a result of receiving
a tetanus-diphtheria-acellular pertussis (“Tdap”)vaccination on March 28, 2016, she
suffered from a shoulder injury related to vaccine administration (“SIRVA”). Petition at 1.
The case was assigned to the Special Processing Unit (“SPU”) of the Office of Special
Masters. For the reasons discussed herein, the undersigned finds that petitioner is
entitled to compensation.
1 Because this unpublished ruling contains a reasoned explanation for the action in this case, the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.
2 National 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).
I. Procedural History
Petitioner filed medical records in support of her December 20, 2016 petition.
Pet’s Exs. 1-5, ECF No. 6; Pet’s EXs. 6 & 7, ECF No. 9. An initial status conference was
held on February 17, 2017. Order, ECF No. 10. During that conference, a schedule was
set for respondent to file initial feedback in the case and petitioner was directed to provide
respondent with a settlement demand. Id.
Petitioner forwarded a settlement demand for respondent’s review on March 31,
2017. See Pet’s Status Report, ECF No. 14. On May 12, 2017, respondent filed a status
report stating that his review of the case was complete and an indicating an interest in
pursuing litigative risk settlement. Resp.’s Status Report, ECF No. 17. A schedule was
set for the parties to report on the progress of settlement discussions. Order, ECF No.
18.
On May 16, 2017, respondent informed the court via email that the parties had
reached a tentative settlement agreement and requested that the undersigned issue a 15-
week stipulation order. Order, ECF No. 19 (withdrawn). An October 13, 2017 deadline
was set for the filing of the parties’ stipulation of settlement. Id.
Less than one month later, respondent reported that the authorized representative
of the Attorney General had declined to grant settlement approval for the parties’
proposed tentative settlement. Resp.’s Status Report, ECF No. 20. The undersigned
ordered respondent to file a Rule 4(c) report, ECF No. 21, and withdrew the May 17, 2017
15-week stipulation order, ECF No. 23.
Respondent filed his Rule 4(c) report on June 28, 2017, ECF No. 22. In this report,
respondent argued that petitioner failed to meet her burden of proof and was not entitled
to compensation for her alleged vaccine injury. Resp.’s Rule 4(c) Report at 1 & 7.
Petitioner was afforded time to file additional evidence. Order, ECF No. 24. In
August 2017, petitioner filed affidavits from herself (Ex. 8), her coworker, Jolynn
LaChance (Ex. 9), and her daughter, Kiara Reed (Ex. 11). ECF Nos. 27 & 28. Petitioner
also filed her payroll records. ECF No. 27 (Ex. 10).
A status conference was held on September 5, 2017. Order, ECF No. 30.
Following that conference, respondent was directed to file a status report setting forth his
position in the case in light of petitioner’s newly filed evidence. Id.
Two days later, respondent filed a status report stating a position that the case
could not be settled and requesting a ruling on the record regarding entitlement. ECF No.
31. The undersigned ordered the parties to file concurrent motions for ruling by October
10, 2017.
On September 14, 2017, petitioner filed updated medical records (Exs. 12 & 13).
ECF No. 33. On October 6, 2017, Respondent filed a status report indicating that he
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would rely upon his June 28, 2017 Rule 4(c) report in lieu providing a motion for ruling.
ECF No. 34.
Petitioner filed her motion for ruling on the record on October 10, 2017, ECF No.
35. No responses were ordered and the matter is now ripe for ruling. See Order, ECF
No. 32.3
II. 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 the vaccinee for
whom she seeks compensation has “sustained, or endured the significant aggravation of
any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the Table).
§ 11(c)(1)(C)(i). The most recent version of the Table, which can be found at 42 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. § 14(a). If
petitioner establishes that the vaccinee has suffered a “Table Injury,” causation is
presumed.
If, however, the vaccinee suffered an injury that either is not listed in the Table or
did not occur within the prescribed time frame, petitioner must prove that the administered
vaccine caused injury to receive Program compensation on behalf of the vaccinee. §
11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-Table or [an] off-
Table” claim and to prevail, petitioner must prove her claim by preponderant evidence. §
13(a)(1)(A). 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, petitioners 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 Circuit Court has indicated that petitioners “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 v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Circuit Court added that "[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
reiterated these requirements in its Althen decision. See 418 F.3d at 1278. Althen
requires a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
3
Petitioner filed additional updated medical records (Pet.’s Ex. 14) on January 29, 2018, ECF No. 36.
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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.
Id. All three prongs of Althen must be satisfied. Id.
Section 11(c)(1) also contains requirements concerning the type of vaccination
received and 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, a 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) (emphasis added).
III. Analysis - Althen Prongs
a. 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, 451 F.3d at 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).
i. SIRVA Injury
Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed
on the Vaccine Injury Table (“Table”). See Vaccine Injury Table: Qualifications and aids
to interpretation. 42 C.F.R. § 100.3(c)(10). Although petitioner’s claim was filed before
SIRVA was added to the Table, and thus cannot be found to be a SIRVA Table injury, the
undersigned’s findings were informed by the Qualifications and Aids to Interpretation for
SIRVA criteria used to evaluate such claims. The criteria are as follows:
A vaccine recipient shall be considered to have suffered SIRVA if such recipient
manifests all of the following: (i) No history of pain, inflammation or dysfunction of the
affected shoulder prior to intramuscular vaccine administration that would explain the
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alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after
vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced
range of motion are limited to the shoulder in which the intramuscular vaccine was
administered; and (iv) No other condition or abnormality is present that would explain the
patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis,
mononeuropathies, or any other neuropathy). Id.; see also National Vaccine Injury
Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132,
Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R,
and Johann-Liang R, 2010, Shoulder injury related to vaccine administration (SIRVA),
Vaccine 28(51):8049-8052).
1. The elements of petitioner’s SIRVA claim
The undersigned’s findings and conclusions are as follows:
a. Petitioner did not have a history of pain, inflammation or dysfunction of the
affected shoulder prior to vaccine intramuscular administration.
The undersigned reviewed Ms. Reed’s medical history prior to her Tdap
vaccination. Petitioner did not have a history of pain, inflammation or dysfunction of her
right shoulder prior to vaccination.4 Thus, petitioner satisfies this criterion.
b. Onset occurred within the specified time frame.
Respondent argues that petitioner has not established that her right shoulder pain
began within 48 hours from her March 28, 2016 Tdap vaccination. Resp.’s Rule 4(c)
Report at 6. In support of this assertion respondent refers to the call placed by petitioner
to her gynecologist’s office on April 8, 2016. 5 Id. at 6. Respondent infers that petitioner’s
report of difficulty raising her arm for three days prior to the call equates to her pain
starting at that point three days earlier, or, eight days after vaccination. On the contrary,
petitioner’s call to her gynecologist does not appear to state when her pain started.
Instead, petitioner related that she was experiencing pain at the Tdap injection site and
difficulty raising her arms for three days. The undersigned does not agree that this report
specifies the onset of petitioner’s pain.
Likewise, respondent refers to a report provided by petitioner to her primary care
physician on April 13, 2016 as a basis for finding that petitioner’s pain began more than
48 hours after her March 28, 2016 Tdap vaccination. Resp.’s Rule 4(c) Report at 6. The
records from that appointment include the following history: “right arm pain which started
after a tetanus injection . . . patient received a tetanus vaccination at her GYNs office
approximately 2-1/2 weeks ago on March 28 and one week after the injection she started
4
Petitioner was previously treated for thoracic syrinx during which she reported pain numbness down her
arms and pain in her back and left shoulder. Pet.’s Ex. 2 at 11-12.
5
Respondent incorrectly states that petitioner placed the call to her primary care physician rather than her
gynecologist’s office were the shot was administered. Compare Resp.’s Rule 4(c) Report at 6, with Resp.’s
Rule 4(c) Report at 2 & Pet.’s Ex. 2 a 7 (gynecologist’s records).
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to notice intense pain involving her right upper arm.” Pet.’s Ex. 3 at 42. As this record is
somewhat ambiguous as to whether petitioner intended to report the intensity of her pain
increasing after one week, or starting after one week, the undersigned will instead
consider the evidence of onset as a whole taking into account petitioner’s proffered
affidavits and payroll records.
Relying on his Rule 4(c) report which was filed prior to petitioner’s affidavits and
payroll records (Pet.’s Exs. 8-11), respondent has not provided a brief on the issue of
onset that evaluates all of petitioner’s evidence.
Petitioner claims that she immediately began to have pain in her right shoulder
following the vaccination at issue. Pet.’s Ex. 8 ¶ 3. Petitioner states that her pain was so
severe she was unable to immediately return to work. Id. at ¶4. Petitioner’s payroll
records confirm that she did not clock-in for two days following her Tdap vaccination and
was afforded two hours of sick leave on March 31, 2016. Pet.’s Ex. 10. Ms. Jolynn
LaChance, petitioner’s coworker, also recalls petitioner being unable to work on March
29, 2016 due to severe shoulder pain. Pet.’s Ex. 9. Petitioner’s daughter, Kiara Reed,
also averred that during a visit with her mother on March 28, 2016 after the vaccination
petitioner reported being in extreme pain. Pet.’s Ex. 11.
Based upon the evidence set forth in the medical records, affidavits, and payroll
records the undersigned finds that the onset of petitioner’s shoulder pain was within 24
hours of the March 28, 2016 Tdap vaccination, and therefore, is within the specified time
frame of <48 hours.
c. Pain and reduced range of motion are limited to the shoulder in which the
intramuscular vaccine was administered.
The evidence submitted by petitioner includes medical records detailing the
treatment which she sought for pain in her right shoulder over nearly two years since her
March 2016 Tdap vaccination. A summary of these records follows below.
Petitioner reported pain in her right arm to her gynecologist on April 8, 2018, and
was prescribed a Lidoderm patch for the pain. Pet.’s Ex. 2 at 7. On April 13, 2016,
petitioner was seen by Angela Karavasilis, D.O. for continued right arm pain. Pet.’s Ex. 3
at 42. Dr. Karavasilis noted that petitioner had “tenderness to palpation over the right
bicep tendon and in the general area of her R humerus. She has significant weakness to
isometric resistance on the right compared to the left upper extremity.” Id. at 44.
Petitioner was referred for an x-ray and evaluation by an orthopedist. Id. at 45.
Petitioner’s April 13, 2016 right shoulder x-ray revealed “no evidence for fracture,
dislocation or arthritic joint disease.” Pet.’s Ex. 3 at 135.
On April 15, 2016, petitioner was seen by an orthopedic surgeon6 for continued
“right arm pain after tetanus shot.” Pet.’s Ex. 3 at 142. The records from this encounter
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The records generated by petitioner’s orthopedist, Dr. Albert Tom, incorrectly state the date of petitioner’s
Tdap vaccination as April 1, 2016.
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include the following history: “developed soreness at the injection site and [is unable]
(sic) to move her arm complaining of intense pain . . . pain is primarily over the anterior
arm and biceps region to the length of the bicep.” Id. The orthopedist’s impression was
“right anterior arm pain along the biceps muscle and tendon, right shoulder pain, onset of
symptoms after tetanus shot.” Id. at 144. Petitioner was referred to physical therapy. Id.
Petitioner began physical therapy on May 11, 2016, and was scheduled for
continued therapy sessions twice a week for six to eight weeks. Pet.’s Ex. 5 at 157. By
August 24, 2016, petitioner had completed 14 physical therapy sessions. Pet.’s Ex. 5 at
69. During that time, petitioner remained under the care of her orthopedist and received a
cortisone injection in her right shoulder on June 30, 2016. Pet.’s Ex. 3 at 148-49; Pet.’s
Ex. 7 at 3. Petitioner saw a second orthopedist, Dr. Anthony R. Marino, on August 24,
2016. Pet.’s Ex. 4 at 25.
Having not seen significant improvement in her pain after physical therapy and
cortisone treatment, petitioner underwent right shoulder arthroscopic debridement and
right shoulder arthroscopic acromioplasty on September 27, 2016. Pet.’s Ex. 5 at 15.
Petitioner returned to Dr. Marino for a post-operative follow-ups on October 5, 2016 and
November 2, 2016 and reported soreness and pain in her right shoulder. Pet.’s Ex. 4 at
2, 27. Dr. Marino’s post-operative assessment was “right shoulder tendonitis and
subacromial irritation.” Id. at 28.
Petitioner began a long-term pain management program for her right shoulder in
May 2017. Pet.’s Exs. 12 & 14 passim (pain management records from May 2017 –
January 2018).
Petitioner returned to orthopedist, Dr. Marino, on June 7, 2017, for a follow up of
her right shoulder. Pet.’s Ex. 13 at 2. On examination, petitioner had “some pain with
resistive function.” Id. Dr. Marino offered petitioner another cortisone shot and
recommended that she try relieving her pain with ice and anti-inflammatories with a hope
for improvement over the long term. Id. No further intervention was recommended. Id.
Based on the records of petitioner’s ongoing treatment summarized above, the
undersigned finds that the pain and decreased range of motion petitioner experienced are
limited to her right shoulder in which she received the Tdap vaccine. Thus, petitioner has
satisfied this criteria.
d. No other condition or abnormality is present that would explain the patient’s
symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial
neuritis, mononeuropathies, or any other neuropathy).
There is no evidence in the record that demonstrates any type of condition or
abnormality that would explain petitioner’s symptoms. See Pet.’s Ex. 3 at 135 (x-ray
negative for fracture, dislocation, or arthritic disease).
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ii. Logical sequence of cause and effect showing the vaccine was
the reason for the injury
Guided by the criteria for evaluating a Table SIRVA injury, the undersigned finds
that petitioner has shown, by a preponderance of the evidence, a logical sequence of
cause and effect showing that her March 28, 2016 Tdap vaccine was the reason for her
shoulder injury. The SIRVA criteria provides a perfectly logical sequence of cause and
effect including (1) no history of pain, inflammation or dysfunction of the affected shoulder
prior to intramuscular vaccine administration that would explain the alleged signs,
symptoms, examination findings, and/or diagnostic studies occurring after vaccine
injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of
motion are limited to the shoulder in which the intramuscular vaccine was administered;
and (iv) No other condition or abnormality is present that would explain the patient’s
symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis,
mononeuropathies, or any other neuropathy). The undersigned has found, infra, that
petitioner has satisfied all these requirements and thus has satisfied Althen prong two.
iii. Proximate temporal relationship between vaccination and injury
“The proximate temporal relationship prong [under Althen] requires preponderant
proof that the onset of symptoms occurred within a timeframe for which, given the medical
understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-
fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir.
2008). This analysis involves two inquiries: (1) considering the medical basis of the
proffered theory, how long after vaccination would onset or worsening of the disease
occur; and (2) did onset or worsening of the disease actually occur in the expected
timeframe. The first inquiry necessarily intersects with the prong one analysis. See
Langland v. Sec’y of Health & Human Servs., 109 Fed. Cl. 421, 443 (2013); Veryzer v.
HHS, 100 Fed. Cl. 344, 356 (2011).
As discussed above, under the SIRVA criteria, the onset of the symptoms of
petitioner’s shoulder injury must begin within 48 hour or less of the vaccination. The
undersigned has found that the onset of petitioner’s shoulder injury began within 24 hours
of the vaccination, and thus, petitioner has satisfied Althen prong two.
IV. Conclusion
A cause-in-fact injury is established when petitioner demonstrates by a
preponderance of the evidence: (1) She received a vaccine set forth on the Vaccine Injury
Table; (2) She received the vaccine in the United States; (3) She sustained or had
significantly aggravated an illness, disease, disability, or condition caused by the vaccine;
and (4) the condition has persisted for more than six months. § 13(a)(1)(A). To satisfy
the burden of proving causation in fact, petitioner must establish each of three factors
announced by the Federal Circuit in Althen v. Sec’y of Health & Human Servs. by
preponderant evidence: (1) a medical theory causally connecting the vaccination and the
injury; (2) a logical sequence of cause and effect showing that the vaccination was the
reason for the injury; and (3) a proximate temporal relationship between vaccination and
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injury. 418 F.3d 1274, 1278 (Fed. Cir. 2005). Proof of medical certainty is not required.
Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991).
In light of all of the above, and in view of the submitted evidence, including
the medical records and the parties’ respective motions, the undersigned finds
petitioner entitled to Vaccine Act compensation.
IT IS SO ORDERED.
s/ Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
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