P. v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

Filed: January 31, 2022

* * * * * * * * * ** * *

A.P., * PUBLISHED

*

Petitioner, * No. 17-784V

*

v. * Special Master Gowen

*

SECRETARY OF HEALTH * Shoulder Injury Related to Vaccine

AND HUMAN SERVICES, * Administration (“SIRVA”); Measles,

* Mumps, and Rubella (“MMR”);

Respondent. * Subcutaneous Injection; Causation-in

* Fact.

* * * * * * * * * * * * *

Anne C. Toale, Maglio Christopher and Toale, Sarasota, FL, for petitioner.

Meghan Murphy, U.S. Department of Justice, Washington, D.C., for respondent.

RULING ON ENTITLEMENT1

On June 12, 2017, A.P. (“petitioner”) filed a petition for compensation under the National

Vaccine Injury Compensation Program.2 Petitioner alleges that she suffered a Shoulder Injury

Related to Vaccine Administration (“SIRVA”) to her left shoulder as a result of receiving the

measles, mumps and rubella (“MMR”) vaccination on June 8, 2016. Petition at ¶¶ 1,7(ECF No.

1).

After the filing of multiple expert reports by both parties and several status conferences

with detailed orders, the petitioner filed motions for a Ruling on the Record and for Findings of

Fact and Conclusions of Law. After a review of the record as a whole, including expert reports,

medical records, affidavits and briefing by the parties, and for the reasons set forth below, I

1

Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2012), because this opinion contains a

reasoned explanation for the action in this case, I intend 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. Before the opinion

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 opinion. Id. If neither party files a motion for redaction within 14 days, the opinion will

be posted on the Court’s website without any changes. Id.

2

The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine

Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)

(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of

the Act.

hereby DENY petitioner’s Table Claim, but GRANT her petition for compensation as a cause in

fact claim.

I. Procedural History

Petitioner filed her claim on June 12, 2017, alleging she sustained a left shoulder injury

by the MMR vaccine administered to her on June 8, 2016. Petition; Petitioner Motion for

Findings of Facts and Conclusions of Law (“Pet. Mot.”) (ECF No. 49). This case was initially

referred to the Special Processing Unit (“SPU”). Petitioner filed medical records to support her

claim on June 26, 2017 and a statement of completion the same day. Petitioner’s Exhibits 1-6

(“Pet. Ex.”) (ECF Nos. 7 & 8). Petitioner also filed an affidavit from petitioner on August 28,

2017. Pet. Affidavit (“Aff.”) (ECF No. 10).

An initial status conference was held on August 28, 2017 by the former Chief Special

Master. Scheduling Order (ECF No. 11). After several extensions of time, respondent stated

that the review of the medical records had been completed and that settlement was not

appropriate for this case. Respondent’s (“Resp”) Status Report (ECF No. 15).

Respondent filed the Rule 4(c) report, stating that, “The facts of this case, as reflected in

the petition and accompanying documents have been reviewed by medical personnel of the

Division of Injury Compensation Programs at the Department of Health and Human Services

(“DICP”) and their opinion is that this case is not appropriate for compensation under the terms

of the Vaccine Act. Resp. Report (“Rept.”) at 1-2 (ECF. No. 17). Specifically, respondent stated

that petitioner is alleging a Table Injury, SIRVA, for receiving the MMR vaccine

subcutaneously, which does not fit the Table criteria. Resp. Rept. at 6. Respondent argued that

petitioner did not satisfy the Table criteria primarily because she received the MMR vaccination

subcutaneously; that the medical records do not demonstrate that petitioner had an onset of

shoulder pain within forty-eight hours of receiving the vaccination; and that petitioner did not

demonstrate she had suffered the residual effects or complications of her injury for more than six

months after the administration of the vaccine. Id. at 6-7. Further, respondent stated, petitioner

had not provided an expert report setting forth a reliable medical theory or logical sequence of

cause and effect. Id. at 8.

On February 20, 2018, the case was transferred to my docket. Notice of Reassignment

(ECF No. 19). The undersigned held an initial status conference on March 28, 2018. Scheduling

Order (ECF No. 21). During the status conference, respondent’s counsel confirmed that the

main issue in the case was that petitioner received a subcutaneous injection rather than an

intramuscular injection and that subcutaneous injections were not covered by the Table for

SIRVA. Id. I ordered the petitioner to file a supplemental affidavit explaining why she did not

seek treatment for eight months after the initial period of approximately two months of treatment

and to file an expert report. Id. at 2.

Petitioner filed a supplemental affidavit on May 9, 2018. Pet. Ex. 9 (ECF No. 23). On

May 24, 2018, petitioner filed an expert report from an orthopedic surgeon, Dr. Domenick J.

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Sisto.3 Pet. Ex. 10 (ECF No. 26). Respondent filed an expert report from Geoffrey B. Abrams,

M.D.4 on December 20, 2018. Resp. Ex. A (ECF No. 28).

A Rule 5 status conference was held on February 26, 2019. Rule 5 Order (ECF No. 29).

The Rule 5 Order summarized petitioner’s expert, Dr. Sisto’s opinion that the subcutaneous

injection likely hit the posterior branch of the axillary nerve in the left shoulder area, and

respondent’s expert, Dr. Abrams disagreed with that theory. Id. at 3. After review of both

reports and the multiple articles submitted therewith, I indicated that it was plausible that the

subcutaneous injection of the MMR vaccination did cause petitioner’s shoulder injury and that

her symptoms were similar to those reported in multiple other SIRVA cases. Id. I also noted

that the petitioner had had a good recovery and I encouraged the parties to engage in informal

settlement discussions. Id.

After engaging in unfruitful settlement negotiations, the respondent filed a status report

requesting a status conference and that this case be set for an entitlement hearing. Resp. Status

Rept. (ECF No. 38). On January 9, 2020, petitioner filed a supplemental expert report by

Thomas Wright, M.D.5 Pet. Ex. 12 (ECF No. 39). Respondent filed a responsive supplemental

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Dr. Domenick J. Sisto, is a board-certified orthopedic surgeon. Pet. Ex. 11 at 1. Dr. Sisto currently works as an

orthopaedic surgeon at the Los Angeles Orthopaedic Institute, where is specializes in adults with knee and shoulder

injuries. He received his undergraduate degree at the University of Vermont in 1975 and received his medical

degree from George Washington University Medical School in 1979. Id. Dr. Sisto did his residency at the Hospital

for Special Surgery in New York City, then did a fellowship in sports medicine at the Kerlan-Jobe Orthopaedic

Clinic in Inglewood, California. Id. He was a clinical instructor at the Department of Orthopaedic Surgery at

UCLA School of Medicine between 1986-1988. Id. at 2. Dr. Sisto is licensed to practice medicine in New York,

California, and Connecticut. Id. at 2. He serves as an editor for Case Reports in Surgery and is a Principal

Reviewer for the American Journal of Sports Medicine. Id. at 3. Dr. Sisto has been the lead author in multiple

published medical articles on a variety of orthopedic topics, including arthroplasty of the knees, ACL reconstruction

and shoulder stability. Id. at 4-5.

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Dr. Geoffrey Abrams is a board-certified orthopedic surgeon. Resp. Ex. A at 1. He currently serves as an

Assistant Professor of Orthopedic Surgery at the Stanford University School of Medicine. Id. Dr. Abrams received

his undergraduate degree in 2000 from Stanford University and received his medical degree from the University of

California, San Diego. Resp. Ex. B at 1. He did a surgical internship at Stanford University Hospital and Clinics

from 2007-08 and completed his residency in 2012 at the same hospital in the Department of Orthopedic Surgery.

Id. He has a subspecialty certificate in Orthopedic Sports Medicine. Id. at 2. Dr. Abrams is licensed to practice

medicine in the states of California and Illinois. Id. Dr. Abrams has authored or co-authored numerous medical

articles on various orthopedic topics. Id. at 2-5. He currently serves as the Director of Sports Medicine for Stanford

University Varsity Athletics, as well as, the Director of the Lacob Family Sports Medicine Center at Stanford

University. Resp. Ex. A at 1.

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Dr. Thomas Wright is a board-certified orthopedic surgeon. Pet. Ex. 13 at 2. He received his undergraduate

degree in biology from Emory University in 1979 and his medical degree from the University of Florida in 1983.

Id. Following medical school, he had an internship in General Surgery at the University of Florida and did a

residency in Orthopedic Surgery from 1984-1989. Id. Dr. Wright also had a fellowship at the Mayo Clinic in Hand

and Upper Extremity Surgery. Id. at 2. Dr. Wright currently serves as a professor of orthopedic surgery at the

University of Florida and is the Division Chief of the Hand and Upper Extremity surgery. Id. at 2. He also serves as

an affiliate professor of the University of Florida’s College of Public Health and Health Professions. Id. Dr. Wright

has also authored or co-authored numerous medical articles on the hand and upper extremity orthopedic topics. Id.

at 3-20. Dr. Wright also serves as a journal reviewer for multiple medical journals, including the Journal of Bone

and Joint Surgery, Journal of Hand Surgery, and Journal of Shoulder and Elbow Surgery. Id. at 31.

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report by Dr. Abrams on April 3, 2020. Resp. Ex. C (ECF No. 40). On May 14, 2020, petitioner

filed a responsive supplemental report by Dr. Wright. Pet. Ex. 15 (ECF No. 41).

A second Rule 5 status conference was held on August 11, 2020. Rule 5 Order (ECF No.

43). During this status conference, after reviewing the additional expert reports filed by both

parties and petitioner’s supplemental affidavit, I explained that the record, “[as the record] stands

today, supports petitioner’s claim and [she] has a high likelihood of success.” Id. at 2. The

undersigned again encouraged the parties to resolve the case informally. Id. Respondent was

ordered to file another expert report, responding to Dr. Wright’s responsive report. Id. at 3.

On October 6, 2020, respondent filed a second supplemental report by Dr. Geoffrey

Abrams and supporting medical literature. Resp. Ex. D (ECF No. 45). Petitioner filed

supporting medica literature on November 23, 2020. Pet. Ex. 18.

On November 23, 2020, petitioner filed the present motion for a Ruling on the Record

and filed a memorandum in support of her motion the same day. Pet. Mot. (ECF No. 48); Pet.

Memorandum (“Pet. Mem.”) (ECF No. 49).

Respondent filed a response to petitioner’s motion on January 27, 2021. Resp. Response

(ECF No. 52). On February 3, 2021, petitioner filed a reply to respondent’s response. Pet.

Reply (ECF No. 53).

This matter is now ripe for adjudication.

II. Evidence Submitted

a. Petitioner’s Medical Records

On June 2, 2016, petitioner was admitted to Baptist Medical Center in Jacksonville,

Florida for the delivery of her fifth child. Pet. Ex. 2 at 125; Pet. Ex. 9 at ¶ 2. Petitioner gave

birth to a healthy female infant without complications. Pet. Ex. 2 at 125. On June 8, 2016, prior

to being discharged, petitioner received the MMR vaccination in her left upper arm. Id. The

vaccine administration record provides that the vaccine was intended to be administered

subcutaneously. Id.

On June 9, 2016, petitioner contacted her OB/GYN, inquiring about contraceptives

covered by her insurance. Pet. Ex. 2 at 63. There was also an internal office note indicating that

petitioner’s first post-partum office visit was scheduled for July 18, 2016. Id.

On June 20, 2016, petitioner called her OB/GYN, this time complaining of left arm pain.

Pet. Ex. 2 at 138. Under Chief Complaint it provided, “Pt calling stating unable to move left

arm. Pt states [illegible] after given shot in arm after delivery. Pt states now 2 weeks later

unable to move arm at all. Pt denies any swelling or pain. Pt states arm is ‘frozen.’” Id.

Petitioner had an appointment the following day on June 21, 2016. Id. at 109. At this

appointment, it was noted that petitioner’s weight was 161.2. Id. The record states, “Pt s/p

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vaginal delivery 6/6/16 c/o unable to move left arm.” Id. An MRI of petitioner’s left shoulder

was ordered. Id. at 58, 62.

Petitioner had an MRI of her left shoulder performed on June 24, 2016. Pet. Ex. 2 at 6.

The MRI revealed a partial thickness tear of the distal infraspinatus tendon at insertion along the

bursal surface (approximately 50% thickness). Id. On June 27, 2016, Dr. Tiffany Wells

reviewed petitioner’s MRI and observed that it demonstrated a “50% tear in infraspinatus tendon

(part of rotator cuff),” and requested that petitioner be referred to orthopedics. Pet. Ex. 2 at 61.

On June 28, 2016, petitioner presented to Jacksonville Orthopaedic Institute for an

evaluation of her left shoulder. Pet. Ex. 4 at 43. Petitioner reported that her pain had been

present for approximately three weeks. Id. Petitioner reported she had stiffness in the shoulder

and was no longer able to raise her arm overhead. Id. Additionally, petitioner described her pain

as diffuse in location and sharp in quality. Id. At this appointment, petitioner associated the

onset of her pain to the vaccination she received before being discharge from the hospital after

delivery of her fifth child. Id. The record provides:

She notes that she gave birth three weeks ago and afterwards was offered the measles,

mumps and rubella vaccine. She states that after they injected into her lateral left

shoulder, she began to have increased intense pain and range of motion problems.

Pet. Ex. 4 at 43. Petitioner stated that her pain was a 5/10. Id. A physical exam of the left

shoulder revealed that petitioner’s range of motion was restricted with pain, her flexion and

abduction was restricted to 90 degrees (compared to the right shoulder of 180 degrees), and that

her internal rotation was only to L2 (compared to the right of internal rotation to T12). Id. at 44.

Orthopedist, Dr. Michael Adams, observed that petitioner had strength of 4/5 with external

rotation and abduction, she had generalized tenderness to palpation at “about the deltoid girdle,”

and her bicipital groove was tender to the touch. Id. Dr. Adams reviewed the MRI from June

24, 2016 and observed that it showed, “increased signal along the bursal surface of the

infraspinatus tendon consistent with partial thickness tear,” and that petitioner had “some fluid in

the biceps sheath proximally.” Id. Dr. Adams diagnosed her with left shoulder joint pain and a

left partial acute rotator cuff tear. Id. at 44-5. Dr. Adams recommended a steroid injection. Id.

at 45. Under “Plan,” he noted that petitioner had asked about post injection injuries. Id. He

wrote, “I do not think it is out of the realm of question that she had post-injection stiffness and

pain, but I am unclear at this time that the rotator cuff is a consequence of her vaccination.” Id.

Dr. Adams gave petitioner a physical therapy prescription. On the prescription it

explains, “36-year-old female with 3 weeks of left shoulder pain post vaccination. Partial

thickness bursal sided rotator cuff tear on MRI.” Id. at 27. The prescription was for six weeks of

physical therapy 2-3 times a week. Id. He also gave her a steroid injection. Id. at 45.

Petitioner had her first physical therapy appointment on July 4, 2016. Pet. Ex. 5 at 28.

The note provides, “[Petitioner] states that the initial onset occurred on 6/01/2016 when she

reports she had a baby 4 weeks ago and reports insidious onset of [left] shoulder pain.” Id.

Petitioner also reported that she received a shot in the hospital, “which caused a lot of neck pain

and then a few days later her shoulder began getting stiff and she began having pain.” Id.

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Additionally, petitioner reported that her cortisone injection had helped “a lot.” Id. At this

appointment, petitioner reported her pain as a 2 to 3 out of 10. Id. She also reported that she had

pain while doing her hair, lifting her shoulder and her shoulder feels stiff. Id. The physical

therapist noted that petitioner had 65% function of her upper left extremity and that petitioner

explained that most of her pain was in the anterior lateral shoulder. Id. Petitioner was tender on

upper trapezoid, supraspinatus tendon, biceps tendon long head, posterior cuff, and parascapular

muscles. Id. Further, her physical examination showed that she had reduced strength upon

shoulder flexion, abduction, and on external and internal rotation. Id. at 29-30. Petitioner’s

assessment was, “Signs and symptoms are characteristic of left partial acute rotator cuff

tear….[Patient] presents with significant loss of shoulder function, strength and active range of

motion.” Id. at 30. The plan was for her to attend physical therapy 2-3 times per week for 8

weeks. Id.

On August 1, 2016, petitioner had a follow-up appointment with orthopedist, Dr. Adams.

Pet. Ex. 4 at 22. Under “History of Present Illness,” it was noted that petitioner had left shoulder

pain that had been present for 2 months. Id. It explained, “It started after a post-delivery vaccine

and was severe in intensity and diffuse in nature, associated with significantly decreased range of

motion.” Id. Petitioner reported that her pain was “dull and mild in severity,” and that her pain

level was a 1 out of 10, but it had increased in intensity during physical therapy. Id. A physical

exam of petitioner’s left shoulder showed she had full range of motion and her strength was five

out of five. Id. at 23. Despite these findings, he suggested that petitioner finish physical therapy.

Id. Dr. Adams also explained, “We did review some scientific evidence of post vaccine injection

rotator cuff tear when placed in the wrong place. It does appear at this time though, that she is

healing appropriately. No further corticosteroid injection recommended at this time.” Id. at 23.

On August 5, 2016, petitioner had another physical therapy appointment with therapist,

Kurtis P. Mullaney. Pet. Ex. 5 at 6. While petitioner’s active range of motion for her left

shoulder was documented as “within normal limits,” her strength on flexion, abduction and

external rotation was documented as 4+/5, while her right shoulder had 5/5 strength. Id.

Therapist Mullaney noted that petitioner’s general progression towards the treatment goals was

at 90 percent, but she was still lacking external strength. Id.

Petitioner was discharged from physical therapy on August 10, 2016. Pet. Ex. 5 at 4.

Therapist Mullaney wrote, “The patient notes functional improvements increased ability to

reach, increased ability to lift, and improved independence with ADL’s. Shoulder feels good.”

Id. at 4. Petitioner’s active range of motion for her left shoulder was documented as “within

normal limits.” Id. However, she again demonstrated decreased strength on flexion, abduction,

and external rotation. Id. Petitioner was assessed as, “General progression towards the patient’s

remaining treatment goals is presently at 80 percent. Knows [Home Exercise Program] well and

had no questions about program.” Id.

On April 14, 2017, petitioner returned to Dr. Adams for a follow-up of her left shoulder

with persistent pain. Pet. Ex. 6 at 22. He wrote, “Initially she was seen in August 2016 with

post vaccination pain in the shoulder and diagnosed by MRI with partial bursal sided rotator cuff

tear.” Id. Petitioner reported that she had improvement for about one month following her

physical therapy and the corticosteroid injection she received. Id. She described her pain as

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located in posterior aspect of her shoulder, which was dull and burning in quality and moderate

in severity. Id. Petitioner reported that her pain was a 5 out of 10 and pain was worse with

lifting and reaching. Id. On physical exam petitioner demonstrated a full range of motion, but

with pain from “80 to 120 degrees of flexion and abduction.” Id. at 23. Her strength was

recorded as a 4 out of 5 and she showed one positive impingement sign. Id. Dr. Adams

recommended petitioner have an additional MRI to evaluate for “persistence of tear or additional

pathology,” given her persistent symptoms and failure to respond to injection and therapy. Id. at

23.

Petitioner had a second MRI of her left shoulder on April 21, 2017. Pet. Ex. 6 at 12. The

MRI found abnormal bursal surface signal of the distal anterior supraspinatus adjacent to the

footplate. Id. The radiologist, Dr. Brad Talley, opined that the abnormal signal was more related

to tendinosis rather than a low-grade bursal surface partial tear. Id. Additionally, “a tiny sliver

of fluid” was found in the subacromial subdeltoid bursa. Id. at 13.

Petitioner returned to Dr. Adams on April 26, 2017 following her left shoulder MRI. Pet.

Ex. 6 at 9. At this appointment, petitioner reported that her pain was a 4-5 out of 10. Id. Dr.

Adams wrote that he had reviewed the MRIs and the MRI report from April 21, 2017. Id. at 10.

He noted that petitioner had “mild abnormal signal on the bursal side of the anterior

supraspinatus which may represent a partial tear.” Id. at 10-11. He also wrote, “There is some

persistent tenosynovitis in the proximal biceps tendon which is consistent with review from MRI

from last year.” Id. at 11. He diagnosed petitioner with left shoulder joint pain, left partial

chronic rotator cuff tear, and left shoulder bursitis. Id.

b. Petitioner’s Affidavit

On May 8, 2018, petitioner executed a detailed affidavit. Pet. Affidavit (“Aff.”) (ECF

No. 23). Petitioner stated that while getting ready to leave Baptist Medical Center on June 8,

2016 after the birth of her fifth child, the nurse, Christy, recommended she receive an MMR

booster. Pet. Aff. at ¶¶ 2-3. She explained that the nurse, Christy, administered the shot at

approximately 5:30 pm to the back of her upper left arm. Id. at ¶ 3. Petitioner stated, “As I

received the shot, the pain was excruciating,” and she had asked the nurse if it “was going into

the muscle.” Id. Petitioner stated, “the pain was so intense I felt like it was going into my bone.

I almost came up off the bed that I was sitting on!” Id. Even though petitioner had been given

Percocet and ibuprofen for afterbirth pains from labor, she could still feel the pain. Id. at ¶ 4.

Petitioner also described how the vaccine was administered to her by the nurse on June 8,

2016. Id. at ¶ 6. She explained that the nurse had her sit up on the bed, the nurse stood next to

and over her to give the injection. Id. Petitioner stated that she “felt the shot being given and it

was high on my upper arm towards the back.” Id. The shot was “immediately and unusually

painful.” Id. In addition to the shoulder pain, petitioner began to experience “terrible neck

pain,” which she described as pain on her left side that “radiated down into [her] left shoulder.”

Id. at ¶ 7. Petitioner stated that, “The neck pain started after the shoulder pain.” Id. She

explained that from Wednesday until Monday, June 13th, 2016, her arm and should became stiff.

Id. Petitioner explained that by Wednesday, June 15th, she could not lift her arm. Id. Petitioner

stated that her arm was “weak and shaky,” and she could not lift it up to a 90 degree angle of her

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body. Id. Petitioner stated that she was unable to wash or brush her hair or apply deodorant. Id.

She explained that the pain and range of motion, “…made taking care of my newborn and my

other children extremely difficult. I was trying to nurse my newborn and yet I couldn’t move my

left arm.” Id. Petitioner thought that it was a minor side effect from the MMR shot, but it was

not getting better, but worse. Id.

Petitioner stated that she told her OB/GYN on June 20, 2016 that she was unable to move

her left arm and she was able to meet with an orthopedist a week later. Id. at ¶ 8. Petitioner

stated that the prescribed physical therapy and injectable cortisone gave her improvement by the

time the therapy sessions ended in August. Id. at ¶ 8. She explained that, “Over the course of

therapy, including my injection, my shoulder pain was reduced and therapy ended on August 5,

2016….After that point, I had motion in my arm but the pain in the back of my upper arm and

shoulder returned after a month or so, and I had not regained strength in my arm.” Id. She stated

that her doctor told her that the rotator cuff should heal completely since “the tear was only

50%.” Id. She stated that, “However…the pain and stiffness, while never completely gone,

started to worsen, so I saw my orthopedist in April 2017.” Id.

Petitioner stated that between August 2016 and April 2017 her shoulder/arm symptoms

did not completely disappear, but reduced, so that she could get on with her life. Id. at ¶ 9. She

explained that as the wife of a pastor, she is very involved in her husband’s church and “keeping

it running,” as well as, home schooling her children. Id. Petitioner stated that she would, “assist

in physical activities,” that she was “always involved in the kids’ games, including more physical

ones,” and that she even participated in helping build her new home while pregnant, but she was

unable to do these things even after she completed her physical therapy in August 2016. Id. She

concluded, stating, “During the gap in treatment, as I noted above and told my orthopedist, the

left shoulder pain persisted and affected my ability to be [as] physical as I had been.” Id.

c. Petitioner’s Expert Reports

1. Dr. Domenick J. Sisto, MD

Petitioner submitted an expert report from Dr. Domenick J. Sisto, an orthopedist on

August 24, 2018. Pet. Ex. 10 (ECF No. 26). Dr. Sisto reviewed petitioner’s medical records and

wrote, “Following my review of the medical records it is clear that this patient sustained an

injury to her left shoulder following the injection of the vaccination that she had sometime in the

early aspect of June 2016.” Pet. Ex. 10 at 12. He also stated that, “My review reveals no

previous records of any problems with the shoulder….” Id.

Dr. Sisto also noted that petitioner associated the onset of her shoulder pain to her MMR

vaccination on June 8, 2016 to her orthopedist, Dr. Michael Adams. He wrote, “Her complains

are clearly outlined in the report dated June 28, 2016 from Dr. Michael Adams at the

Jacksonville Orthopedic Institute, who documented a post-vaccination injection stiffness of the

shoulder.” Id. at 12. Dr. Sisto observed that petitioner’s medical records from Dr. Adams,

“clearly show that her complaints were secondary to the injection.” Id.

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Dr. Sisto explained that, “It is well diagnosed and recognized that post-injection

syndrome is unfortunately very common following vaccinations where the medication is given

either intramuscularly or subcutaneously….” Pet. Ex. 10 at 12. He opined that injections given

intramuscularly or subcutaneously can irritate the axillary nerve, which runs approximately 1

inch deep to the deltoid musculature. Id. He opined that a 5/8 inch needle used for subcutaneous

injection or a one inch needle used for intramuscular injection can “cause irritation and

disruption of the axillary nerve and deltoid function.” Id. Dr. Sisto stated that, “The deltoid

muscle is the main muscle that moves the shoulder and certainly can be irritated by an injection.”

Id.

With regards to the onset of petitioner’s shoulder pain and dysfunction, Dr. Sisto wrote,

“The timing of [stiffness and pain] is obviously consistent with post-injection syndrome. She

had immediate pain and sought treatment after injection.” Id. at 13. He opined, “….this is

clearly a case of shoulder stiffness and irritation of the axillary nerve following her injection.”

Id.

Subsequently, petitioner informed the Court that Dr. Sisto was unable to continue as an

expert in this case due to personal reasons. Pet. Mot. at n.1.

2. Dr. Thomas W. Wright

On January 9, 2020, petitioner filed a supplemental expert report from Dr. Thomas W.

Wright, an orthopedic surgeon. Pet. Ex. 12 (ECF No. 39). In his first report, Dr. Wright stated,

“It is my opinion that [petitioner] sustained an injection site injury to her left shoulder due to the

MMR vaccine injection on 6/8/2016.” Pet. Ex. 12 at 1. He noted that petitioner had no pre-

existing history of pain in her left shoulder. Id. He also stated, “….the pain started immediately

after the injection and persisted [for] at least 10 months.” Id.

Dr. Wright stated that he did not believe that petitioner’s axillary nerve was directly

injured with the injection, but instead, the injection could have started a local inflammatory

process near the nerve, which can cause pain. Id. He opined that petitioner had “a direct

injection into the subacromial space and possibly into the infraspinatus which might explain the

edema in the infraspinatus on the initial MRI.” Id. He opined that, “An injection into the

subacromial space can be responsible for initiating a major inflammatory event in the

subacromial bursae resulting in persistent, severe pain.” Id.

Dr. Wright referenced the article Vaccination-related shoulder dysfunction, by Bodor and

Montalvo, to support his opinion. Pet. Ex. 14.6 The Bodor article examined two case reports

where two healthy individuals developed shoulder and arm pain, weakness and loss of range of

motion following vaccination. Id. at 1. The authors hypothesized that the vaccine was injected

into the subdeltoid bursa in the two individuals, which caused a “robust local immune and

inflammatory response.” Id. at 2. Using ultrasound, the authors measured the location of the

subacromial bursa and found that it extended from 3.0 to 6.0 cm beyond the lateral border of the

acromion. Id. at 2. They also measured the depth below the skin of the subacromial bursa and

found that it lay between 0.8 cm to 1.6 cm below the skin. Id. Bodor and Montalvo explain,

6

Bodor, M. and Montalvo, E., Vaccination-related shoulder dysfunction, 25 Vaccine 585-587 (2007). [Pet. Ex. 14].

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“Given that the subdeltoid bursa is continuous with the subacromial bursa, this led to

subacromial bursitis, bicipital tendonitis, and inflammation of the shoulder capsule.” Id. at 2.

The authors explained that the first individual developed adhesive capsulitis or frozen shoulder

and the second patient had moderate to severe reduction of shoulder range of motion. Id. at 2-3.

Bodor and Montalvo observed that both patients received multiple injections for the pain to

resolve, “consistent with a primary inflammatory etiology rather than a mechanical overuse

problem.” Id. at 3. Further, the authors recommended that “future influenza and pneumococcal

vaccination guidelines [should] specify that injections should not be performed in the upper third

of the deltoid muscle. Id. at 3.

Petitioner filed a supplemental report from Dr. Wright on May 14, 2020. Pet. Ex. 15

(ECF No. 41). Dr. Wright’s supplemental report was a response to respondent’s expert report

from Dr. Abrams.

Dr. Wright stated that while the exact location of the injection given petitioner was not

known, “it is most likely that she was injected in the subacromial space, based on her positive

response to the subacromial steroid injection, and possibly in the infraspinatus.” Pet. Ex. 15 at 3

(original emphasis). Dr. Wright, responding to Dr. Abrams, stated that Dr. Abrams was

assuming that the MMR vaccine was administered in the recommended site of administration for

subcutaneous vaccines by the Centers for Disease Control (“CDC”). Id. at 3; see also Resp. Ex.

C at 1. The CDC diagram Dr. Abrams included in his report, showing the recommended site for

a subcutaneous administration for the MMR vaccine, highlighted an area on the posterior triceps

muscle about half-way down the upper arm. Resp. Ex. C at 1. Dr. Wright noted that aside from

petitioner’s chart, which notes that petitioner received the vaccine in her “left upper,” arm, it

does not provide the precise site of administration. Pet. Ex. 15 at 3.

Dr. Wright also explained that the package insert for the MMR vaccine itself provides

site administration instructions. Pet. Ex. 15 at 3. The package insert provides, “The dose for any

age is 0/5 ml administered subcutaneously, preferably into the outer aspect of the upper arm.”

Id. Dr. Wright asserted that the package insert provides a much broader charge with regard to

site administration compared to the CDC recommendation and the triceps muscle is not

specified. Id.

Dr. Wright also cited to article by Eileen Shepard, titled, Injection technique 2:

administering drugs via the subcutaneous route, which provides multiple sites available for

subcutaneous injection. Pet. Ex. 17 at 1.7 The article explains that, “Recommended sites for

subcutaneous injection include the lateral aspects of the upper arm and thigh, and the umbilical

region of the abdomen. The back and lower loins can also be used.” Id. at 1. Importantly, the

article observes, “It is important to avoid inadvertently injecting the drug into muscle, as

intramuscular injection can affect drug absorption….” Id. The article describes that “a lifted

skinfold technique (pinching or bunching the skin) can be used to lift the subcutaneous layer

away from the underlying muscle….This method reduces the risk of inadvertent intramuscular

injection when undertaken correctly; however, releasing the skin too quickly before the injection

is completed or lifting it incorrectly can increase that risk.” Id. Dr. Wright asserted that the

7

Shepard, E., Injection technique 2: administering drugs via the subcutaneous route, 114 Nursing Times [online],

55-57 (2018). [Pet. Ex. 17].

10

“lateral aspect of the lower part of the upper arm” area identified in the Shepard article could

encroach on the subacromial space. Pet. Ex. 15 at 2.

Dr. Wright wrote that, “Both Dr. Adams’ clinical examination of [petitioner] and the

MRI findings support a conclusion that the injection was given in her shoulder area and not in

the triceps region. Pet. Ex. 15 at 2. He noted that petitioner exhibited generalized tenderness to

palpation near the deltoid insertion on the acromion, “which is directly over the posterior greater

tuberosity and infraspinatus insertion site.” Id. at 2. He also explained, “The MRI demonstrated

an abnormal signal in the infraspinatus tendon at its insertion along the bursal surface. This is

located directly underneath the deltoid, where [petitioner] felt tenderness.” Id. at 2-3.

Dr. Wright opined that the injection was most likely given in the green circled area on the

image of the posterior muscles of the upper arm (recreated below), which was “the most likely

explanation for her clinical presentation and her response to treatment. Id. at 3.

Finally, Dr. Wright responded to Dr. Abrams’ assertion that petitioner was overweight at

the time of receiving the vaccine, which would have lessened the risk of axillary nerve injury.

Pet. Ex. 15 at 2; see also Resp. Ex. A at 7. Dr. Wright stated that at the time of petitioner’s first

orthopedic consultation her BMI should be 25.8, according to the CDC BMI calculator.

Petitioner’s BMI was actually measured at 25.9 and Dr. Wright observed that the petitioner “was

only several weeks post-partum and breastfeeding, any excess weight was likely concentrated in

her abdominal area and breasts. This is not likely to be relevant to her shoulder anatomy.” Pet.

Ex. 15 at 2.

11

d. Respondent’s Expert Reports

Respondent submitted expert reports from Dr. Geoffrey D. Abrams, an orthopedic

surgeon. Respondent submitted Dr. Abrams first report on December 20, 2018. Resp. Ex. A

(ECF No. 28).

In responding to Dr. Sisto’s initial report, Dr. Abrams stated that there was no

documented evidence that petitioner experienced sensory or motor pathology of the axillary

nerve. Resp. Ex. A at 2. Dr. Abrams wrote, “In a typical axillary nerve injury, decreased

sensation about the lateral shoulder would be reported,” but petitioner’s treating orthopedist, Dr.

Adams’ “indicates that the left shoulder is neurovascularly intact,” which indicating no apparent

dysfunction in the axillary nerve sensory function. Id. at 2. Dr. Abrams also stated that neither

of petitioner’s MRIs demonstrated findings consistent with axillary neuropathy. Id.

Dr. Abrams stated that the recommended subcutaneous injection site for the MMR

vaccine “is the posterior triceps aspect of the upper arm.” Id. at 4. He argued that even if the

vaccine injection was not given at the recommended 45-degree angle, the depth of the axillary

nerve in the “more posterior location is even deeper than found on the lateral aspect of the

shoulder.” Id. He concluded his first report that “there is no objective evidence of injury to the

axillary nerve following petitioner’s receipt of the vaccine administration….it is with reasonable

medical certainty that the petitioner’s shoulder dysfunction is not related to injury of the axillary

nerve.” Id.

Dr. Abrams second report responded to Dr. Wright’s initial report. Resp. Ex. C at 1. He

states that “it is unlikely” that petitioner’s shoulder dysfunction was caused by a direct injection

of the vaccine into the subacromial space. Id.

Dr. Abrams re-stated that the “location of the injection for an MMR vaccine is in the

posterior triceps aspect of the upper arm. It is not possible to reach the subacromial space with

an injection given in this location.” Id. He also explained, “a subcutaneous injection is given at

a 45-degree angle, specifically to avoid penetration into the intra-muscular tissues. This makes

deep penetration of the needle even less likely.” Id. at 2. Dr. Abrams stated that the standard

needle length for an MMR vaccination is 5/8th” or 15.9 mm and even if the injection was given

improperly, “it would not be long enough to reach the subacromial space (or the more deeper

infraspinatus tendon…).” Id. Dr. Abrams cited to the article by Nakajima et al., which

examined intramuscular injection sites and proposed a new injection site for intramuscular

injections in the deltoid muscle. Resp. Ex. A, Tab 8 at 1 & 5.8 Dr. Abrams asserted that the

Nakajima article found that the subcutaneous thickness of females at the “typical injection site,

as measured by ultrasound ranged from 6-8 mm and that the thickness of the deltoid muscle at

this location ranged from approximately 15-20 mm.” Resp. Ex. C at 2. He argued that a needle

would have to traverse a minimum distance of approximately 21 mm to even reach the

subacromial space. Id.

8

Nakajima Y. et al., Establishing a new appropriate intramuscular injection site in the deltoid muscle, 13 Human

Vaccines & Immunotherapeutics 2123-2129 (2017). [Resp. Ex. A, Tab 8].

12

The Nakajima article examined the subcutaneous tissue thickness to “determine the

appropriate depth of needle insertion for intramuscular injection.” Id. at 2. The authors of the

study looked at the subcutaneous thickness at four different injection sites that have been

“recommended for safe and appropriate” intramuscular injection sites in the deltoid muscle. Id.

at 1. Subcutaneous thickness measured by ultrasound in females at the four different injection

sites ranged from 3.5 mm to 13.5 mm, with the thinnest subcutaneous layer found at the injection

site approximately 3 cm below the mid-acromion lateral border and the thickest subcutaneous

layer found at the injection site approximately 9 cm below the mid-acromion lateral border. Id.

at 4. The article also examined the thickness of the deltoid muscle to identify which injection

site is thick enough to insert the needle for an intramuscular injection. Id. at 3. The authors

found that the deltoid muscle in both male and female were thinnest at the injection site

approximately 3 to 5 cm below the mid-acromion lateral border and the deltoid muscle gradually

increased distally from the mid-acromion lateral border. Id. at 3-4.

Additionally, Dr. Abrams asserted that petitioner had an increased BMI, which would

“serve to further increase the distance the needle would have to traverse, making the claim of the

subacromial penetration even less likely.” Resp. Ex. C at 2. Dr. Abrams concluded, “the facts of

the case and the evidence within the medical record make it extremely unlikely that the petitioner

suffered a SIRVA related injury to her shoulder.” Id. at 3.

III. Petitioner’s Table Injury

a. Standard for Adjudication for a Table SIRVA

The QAI for SIRVA provides:

(10) Shoulder injury related to vaccine administration (“SIRVA”). SIRVA manifests as

shoulder pain and limited range of motion occurring after the administration of a vaccine

intended for intramuscular administration in the upper arm. These symptoms are thought

to occur as a result of unintended injection of vaccine antigen or trauma from the needle

into and around the underlying bursa of the shoulder resulting in an inflammatory

reaction. SIRVA is caused by an injury to musculoskeletal structures of the shoulder

(e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury an

abnormalities on neurological examination or nerve conduction studies (“NCS”) and/or

electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the

condition causing the neurological abnormality is not known). A vaccine recipient shall

be considered to have suffered a SRIVA 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 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

13

(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.).

42 C.F.R. § 100.3(c)(10)(i)-(iv).

b. Petitioner’s contentions

Petitioner contends that she has met her burden of proof for a Table SIRVA. Pet. Mot. at

7. Petitioner argues that the Vaccine Injury Table includes SIRVA as a Table Injury for the

MMR vaccine. Id. at 8. Specifically, petitioner argues that improper administration of the MMR

vaccine can satisfy the Criteria for a Table SIRVA. Id.

Petitioner argues that respondent’s position, “that MMR can, under no circumstances,

result in a table injury because it is meant for subcutaneous administration, rather than

intramuscular,” is inconsistent with the actual Vaccine Injury Table, which includes SIRVA as a

table injury for MMR. Id. at 8-9. Further, petitioner contends that the respondent is “advancing

an erroneous interpretation of the Vaccine Injury Table and its QAI for SIRVA.” Id. at 8.

Petitioner argues that the introductory paragraph of SIRVA does four things: (1)

describes how SIRVA “manifests,” with shoulder pain and limited range of motion; (2) describes

how SIRVA “occur[s],” “from the unintended injection of vaccine antigen or trauma from the

needle into and around the underlying bursa of the shoulder….” (3) describes what SIRVA is

not; and (4) sets forth four criteria for “who shall be considered to have suffered SIRVA.” Id. at

10. Petitioner acknowledges that the introductory paragraph contains the phrase, “vaccines

intended for intramuscular administration,” but argues that it is “legally improper to read this

sentence in isolation and must be considered in context and harmonized with both the Table and

entire QAI. Id. Specifically, petitioner argues that the second sentence of the QAI SIRVA

paragraph, which provides, “unintended injection of vaccine antigen or trauma from the needle

into and around the underlying bursa” is not intended to exclude injuries where a vaccine should

have been administered subcutaneously, “but for whatever reason, were administered

intramuscularly.” Id.

Petitioner posits that the QAI acknowledges that SIRVA occurs when the vaccine is

inadvertently administered into the “tendons, ligaments, bursae, etc,” as opposed to the intended

muscle. Id. at 11. Petitioner suggests that, “The two sentences read together clearly contemplate

a scenario where the vaccine administrator (not the manufacturer), intends to place the injection

in one location, i.e. in a muscle, but inadvertently places it someplace else.” Id. (original

emphasis). Further, petitioner states, that the QAI does not explicitly exclude vaccines (to be

considered for a SIRVA) which have been designed by the manufacturer to be injected

subcutaneously, but instead are inadvertently injected intramuscularly, causing injury. Id.

Then petitioner argues that the introductory paragraph for SIRVA in the QAI would add a

fifth criteria to establish a SRIVA by requiring that a vaccine must have been intended for

intramuscular injection by the manufacturer. Id. at 11. Petitioner contends that if respondent had

intended to exclude vaccines intended for subcutaneous administration from SIRVA Table

14

injuries, respondent should have done so explicitly and not included SIRVA as a covered injury

for MMR in the Table itself. Id. at 11. To advance her argument, petitioner observes that the

first criteria in the SIRVA QAI does not actually require that the vaccine in question have been

intended for intramuscular administration, but only that the vaccine was actually administered

intramuscularly. Id. at 13 (emphasis added).

Petitioner also argues that the respondent’s position would “lead to an absurd result,” that

runs afoul of the principle of statutory interpretation that absurd results should be avoided. Id. at

11-12. Petitioner specifically cites to the Federal Circuit’s decision in Dupuch-Carron, where

the Court reiterated that, “[i]f a literal construction of the words of a statute be absurd, the act

must be so construed as to avoid the absurdity.” Dupuch-Carron v. Sec’y of Health & Hum.

Servs., 969 F.3d 1318, 1330 (Fed. Cir. 2020), cert denied, However, the Federal Circuit also

explained, “When construing a statutory term or phrase to avoid an absurd result, or when the

term or phrase is “ambiguous,” it “must be read in [its] context and with a view to [its] place in

the overall statutory scheme.” 969 F.3d at 1330 (citing Colonial Press Int’l, Inc. v. United

States, 788 F.3d 1350, 1357 (Fed. Cir. 2015); see also Wassenaar v. Office of Pers. Mgmt., 21

F.3d 1090, 1092 (Fed. Cir. 1994) (stating that “[a] reading of [a statute] which would lead to

absurd results is to be avoided when [it] can be given a reasonable application consistent with

[its] words and legislative purpose”).

Petitioner states that “under respondent’s proposed interpretation of the Table and QAI

for SIRVA, a vaccine petitioner, like the petitioner in the present case, who was injected

incorrectly in two separate ways, i.e. intramuscularly instead of subcutaneously, and, too deeply

into the deltoid muscle entering the bursa,” would have less chance of recovery for her alleged

vaccine injury than a person receiving an intramuscularly injection administered incorrectly. Pet.

Mem. at 12. The respondent’s position provides less protection to [a] more aggrieved petitioner

and respondent’s interpretation is inconsistent with the goals of the Vaccine Act. Id.

Finally, petitioner argues that she has satisfied the four enumerated SIRVA criteria

outlined in the QAI.9 Petitioner posits that the MMR vaccination she received was administered

incorrectly and it was injected intramuscularly, therefore, she meets the first criterion for a

SIRVA. Id. Petitioner also argues that she has demonstrated by preponderant evidence that the

onset of her pain began within 48 hours of vaccine administration. Id. at 13.

c. Respondent’s contentions

Respondent argues that petitioner has not established a Table injury because petitioner

received the June 8, 2016 MMR vaccine subcutaneously. Resp. Mem. at 5-6. Respondent states

that the language of the QAI defines a SIRVA as “shoulder pain and limited range of motion

occurring after the administration of a vaccine intended for intramuscular administration in the

upper arm. 42 C.F.R. 100.3(c)(10) (original emphasis). Resp. Mem. at 6. Respondent states

that the MMR vaccine “is a vaccination intended for subcutaneous administration,” and as such,

the petitioner’s claim fails to satisfy the language of the QAI. Further, respondent contends that

petitioner’s argument that her legal rights under the Vaccine Act are being deprived is erroneous

9

Respondent does not dispute that petitioner has met the (iii) and (iv) criterion of a Table SIRVA.

15

because petitioner is not being precluded from pursuing a causation-in-fact claim under the Act.

Id. at 7.

Respondent then argues that petitioner does not satisfy the Table SIRVA criteria’s onset

of pain occurring within 48 hours. Resp. Mem. at 7. Respondent contends that petitioner’s

failure to report her shoulder pain to her OB/GYN until June 20, 2016, approximately twelve

days after receiving the vaccination, is inconsistent with her affidavit that her pain began

immediately. Id. at 8. Respondent also argues that petitioner’s failure to mention her shoulder

pain on June 15, 2016 to her OB/GYN office, when they called petitioner to explain her

contraceptive benefits available under her insurance, is again evidence that petitioner’s onset of

left shoulder pain did not occur within forty-eight hours of vaccination. Id.

Respondent also suggests that some of petitioner’s contemporaneous medical records

contradict her affidavit. Id. at 9. Respondent states that a physical therapy note on June 4, 2016,

which provides, “She reports having a shot in the hospital which caused a lot of neck pain and

then a few days later her shoulder began getting stiff and she began having pain,” as

contradicting her affidavit, which provides that her left shoulder pain began the same evening as

the vaccination. Id. at 9; see Pet. Ex. 9 at ¶ 2. Citing to Reusser v. Sec’y of Health & Hum.

Servs., respondent posits that the written documentation recorded by the physical therapist is

more reliable than petitioner’s recollection of the events two years later. 28 Fed. Cl. 516, 523

(1993) (stating, “[W]ritten documentation recorded by a disinterested person at or soon after the

event at issue is generally more reliable than the recollection of a party to a lawsuit many years

later.”).

Respondent concludes that petitioner is not eligible for Table SIRVA presumption of

causation because she received a subcutaneous injection and the medical records do not

demonstrate onset of symptoms within the requisite time of forty-eight hours or less following

vaccination. Id. at 9.

d. Discussion of Petitioner’s Alleged Table Injury

The core issue between the parties is whether petitioner can claim a Table SIRVA for the

receipt of an MMR vaccine, which is only intended to be administered subcutaneously.

Petitioner argues that the inconsistency between the Table and the QAI creates a genuine

ambiguity, depriving her of her right under the Vaccine Act, to receive the presumption that the

vaccine in question caused her left shoulder injury. Pet. Mot. at 7-9.

The starting point for analyzing the respondent’s regulations begins if “there is [an]

express delegation of authority [by Congress] to an agency to elucidate a specific provision of

the statute by regulation. Chevron U.S.A., Inc., v. Nat’l Resources Defense Council, Inc., 467

U.S. 837, 843 (1984). When granting rulemaking power to agencies, Congress usually intends to

give them considerable latitude to interpret the ambiguous rules they issue. Kisor v. Wilkie, 139

S.Ct. 2400, 2412 (2019). Before concluding that a rule is genuinely ambiguous, a court must

exhaust all the “traditional tools” of construction. Kisor v. Wilkie, at 2415 (citing Chevron at 843

n.9). If a genuine ambiguity remains, moreover, the agency’s reading must still be reasonable.

139 S.Ct. at 2416; Thomas Jefferson Univ. v. Shalalala, 512 U.S. 504, 515 (1994). However, if

16

uncertainty does not exist, there is no plausible reason for Auer deference and “the regulation just

means what it means.” Kisor at 2415.

In this case, Congress has delegated authority to the respondent to promulgate regulations

to modify the Vaccine Injury Table. §300aa-14(c)(1). The respondent may add or remove

illnesses, disabilities, injuries and conditions for which compensation may be provided or change

the time period for which the first symptom or manifestation of the illness, disability, injury or

condition occurs. Id. at (c)(3). Additionally, Congress gave the respondent authority to revise

the Vaccine Injury Table to add vaccines to the Vaccine Injury Table for which the Centers for

Disease Control and Prevention (“CDC”) has recommended for the routine administration to

children and pregnant women. Id. at (e)(1)-(3).

As in any statutory interpretation case, [the Court starts], of course with the statutory text,

and proceeds from the understanding that unless otherwise defined, statutory terms are generally

interpreted in accordance with their ordinary meaning. Sebelius v. Cloer, 569 U.S. 369, 376

(2013). Petitioner does not dispute that the QAI introductory paragraph for a SIRVA includes

the language “vaccines intended for intramuscular administration.” Pet. Mem. at 11; see also 42

C.F.R. § 100.3(c)(10). Nor does petitioner dispute that the MMR vaccine, at the current time she

received the vaccination, is not intended for intramuscular injection. Id. at 10. According to the

CDC’s Advisory Committee on Immunization Practices (“ACIP”), “routes of administration are

recommended by the manufacturer for each immunobiologic.” Court’s Exhibit 1 (“Ct. Ex.”).10

The AICP outlined the type of vaccine, dose and route of administration for each of the vaccines.

Id. at 11. The MMR vaccine’s route of administration is noted as “subcutaneous.” Id. Thus,

under the ordinary meaning of the phrase “vaccines intended for intramuscular administration,”

the MMR vaccine is excluded from QAI’s SIRVA definition at this time.

However, petitioner argues that the first sentence of the definition of SIRVA as provided

in the QAI cannot be read in isolation and “must be interpreted in context and harmonized with

both the Table and the entire QAI.” Pet. Mem. at 10. I agree with petitioner that looking at the

entire regulation as whole is instructive, as it is also dispositive.

When construing a statutory term or phrase to avoid an absurd result, or when the term or

phrase is “ambiguous,” it “must be read in [its] context and with a view to [its] place in the

overall statutory scheme. Colonial Press Int’l v. United States, 788 F.3d 1350, 1357 (Fed. Cir.

2015) (quoting Davis v. Mich. Dep’t of Treasury, 489 U.S. 803, 809 S.Ct. 1500 (1989).

Petitioner argues that the inclusion of SIRVA on the Table for the receipt of an MMR vaccine

and the language of the QAI creates an ambiguity that would lead to absurd results. However,

the Vaccine Injury Table is preceded by an introductory paragraph, which provides:

In accordance with Section 312(b) of the National Childhood Vaccine Injury Act of 1986,

title III of Public Law 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note and section

2114(c) of the Public Health Service Act, as amended (PHS Act) (42 U.S.C. 300aa-

14(c)), the following is a table of vaccines, the injuries, disabilities, illnesses, conditions,

and deaths resulting from the administration of such vaccines and the time period in

10

Vaccine Recommendations and Guidelines of the ACIP, https://www.cdc.gov/vaccines/hcp/acip-recs/general-

recs/administration html#t6_1

17

which the first symptom or manifestation of onset or of the significant aggravation of

such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine

administration for purposes of receiving compensation under the program…..Paragraph

(c) of this section sets forth the qualifications and aids to interpretations for the terms

used in the Table. Conditions and injuries that do not meet the terms of the qualifications

and aids to interpretation are not within the Table.

42 C.F.R. § 100.3(a) (emphasis added). This introductory paragraph makes it clear that the terms

defined in the qualifications and aids to interpretation outlined in paragraph (c) applies to the

illnesses, disability, injuries or conditions that are covered by the Table. Thus, the term SIRVA

as defined at 42 C.F.R. § 100.3(c)(10), which imposes a restriction that the vaccine be intended

for intramuscular administration, governs the Vaccine Injury Table section (a)(III)(C).

Finally, examining the history of the addition of SIRVA to the Vaccine Injury Table is

also instructive to determine whether the subcutaneous MMR vaccine was intended to qualify as

a Table SIRVA under the regulations.

Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on

the Vaccine Injury Table. See Vaccine Injury Table: Qualifications and aids to interpretation.

42 C.F.R. § 100.3(c)(10). However, the respondent began the rulemaking process to add SIRVA

to the Table two years prior.

On July 29, 2015, the respondent promulgated a Notice of Proposed Rule Making

(“NPRM”), to amend the Vaccine Injury Table by regulation. 80 F.R. 45132-01, 2015 WL

4538923 (July 29, 2015). Specifically, respondent proposed adding SIRVA to the Table,

describing it as, “an adverse event following vaccination thought to be related to the technique of

intramuscular percutaneous injection (the process where access to a muscle is obtained by using

a needle to puncture the skin) into an arm resulting in trauma from the needle and/or

unintentional injection of a vaccine into tissues and structures lying underneath the deltoid

muscle of the shoulder.” Id. at 45136. In the proposed rule, respondent stated, “As proposed the

proposed definition indicates, SIRVA is an injury related to the intramuscular injection of a

vaccine. Consequently, by definition, a Table injury of SIRVA will not result for those vaccine

that are not administered by intramuscular injection, including….subcutaneous MMR,

MMRV…” Id. (emphasis added).

Respondent further stated, “While the Secretary propose adding SIRVA to the Table for

MMR and Varicella vaccines, to meet the proposed QAI for SIRVA, the vaccine must be one

intended for intramuscular administration in the upper arm.” Id. (emphasis added). Respondent

acknowledged that there were no MMR or Varicella vaccines that are administered

intramuscularly at the time, but including SIRVA as a Table injury for those two vaccines (MMR

and Varicella) would not require a modification to the Table in the future, if such of those

vaccines became available to be administered intramuscularly. Id. The respondent further

acknowledged that the “disadvantage of this proposal could be confusion about whether a Table

injury for SIRVA may be satisfied for those vaccines, despite the QAI’s requirement that the

associated vaccine be intended for intramuscular administration.” Id. Respondent sought

18

feedback from the public specifically on the proposal to include SIRVA as Table injury for the

MMR and varicella vaccines. Id.

On January 19, 2017, the Secretary issued the final Rule amending the Vaccine Injury

Table. 82 F.R. 6294-01, 2017 WL 202456 (F.R). National Vaccine Injury Compensation

Program: Revisions to the Vaccine Injury Table (Jan. 19, 2017). In the final rule, respondent

published a summary of the comments regarding the NPRM, which included comments about

respondent’s proposal to include SIRVA as a Table injury for the MMR vaccines. Id. at *6297.

One commenter agreed with respondent’s proposal to add SIRVA as a Table injury for the MMR

and varicella vaccines “that are currently administered only by percutaneous injection in case an

intramuscular injection is available in the future,” but suggested that “the Table make clear that

SIRVA only pertains to intramuscular injection so there is no confusion with respect to vaccines

administered using a different method.” Id. In responding to the comment, respondent agreed

with the commenter that SIRVA should be an injury listed on the Table “for potential

formulations of MRM and varicella vaccines that are administered by intramuscular injection,”

but also declined to further clarify the Table, stating,

The QAI specifically states that SIRVA is a condition related to “administration

of a vaccine intended for intramuscular administration in the upper arm.” Thus,

the Secretary believes it is clear that to meet the definition of SIRVA in the QAI,

the vaccine administered must be one intended for intramuscular injection in the

upper arm.

Id. The respondent’s final rule ultimately added SIRVA as Table injury for the MMR and

varicella vaccines. See 42 C.F.R. §100.3(c)(10).

To some extent, the undersigned agrees with petitioner that having SIRVA listed as a

Table injury for vaccines that are not available for intramuscular injection (MMR and varicella)

at this time can lead to some confusion as to whether the administration of an MMR vaccination

can give rise to a covered Table SIRVA injury. The inclusion and the language in first SIRVA

criterion, “(i) No history of pain….prior to intramuscular vaccine administration,” does give rise

to some confusion and ambiguity, particularly when a claimant allege that the subcutaneous

vaccination was administered incorrectly, giving rise to a shoulder injury. However, as

discussed above, the NPRM and response to a commenter thereto, provides further clarification

that the inclusion of MMR on the table for SIRVA was merely prospective to account for a

possible future MMR vaccine that was intended for intramuscular administration. It was not

clear if in the course of rule making the possibility of improper intramuscular administration of a

vaccine intended for subcutaneous injection could give rise to a SIRVA injury.

Nevertheless, when all available sources of clarification of the Vaccine Injury Table and

QAI as applied to the MMR vaccine are utilized, it is apparent that the Secretary intended that

only vaccines intended for administration intramuscularly can give rise to a Table SIRVA injury.

Accordingly, the petitioner is not afforded the presumption of vaccine causation as a Table

claim.

19

IV. Petitioner’s Cause-in-Fact Claim

The finding above only forecloses petitioner’s Table SIRVA claim. In the alternative,

petitioner is alleging a cause-in-fact claim that the MMR vaccine, administered subcutaneously,

was the cause of her left shoulder pain. Pet. Mot. at 14.

A. Legal Standard

1. Finding of Fact

A special master must consider, but is not bound by, any diagnosis, conclusion,

judgment, test result, report, or summary concerning the nature, causation, and aggravation of

petitioner’s injury or illness that is contained in a medical record. Section 13(b)(1). “Medical

records, in general, warrant consideration as trustworthy evidence. The records contain

information supplied to or by health professionals to facilitate diagnosis and treatment of medical

conditions. With proper treatment hanging in the balance, accuracy has an extra premium.

These records are also generally contemporaneous to the medical events.” Curcuras v. Sec’y of

Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

Accordingly, where medical records are clear, consistent, and complete, they should be

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). However, this rule does not always

apply. In Lowrie, the special master wrote that “written records which are, themselves,

inconsistent, should be accorded less deference than those which are internally consistent.”

Lowrie, at *19.

The United States Court of Federal Claims has recognized that “medical records may be

incomplete or inaccurate.” Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 391

(1998). The Court later outlined four possible explanations for inconsistencies between

contemporaneously created medical records and later testimony: (1) a person’s failure to recount

to the medical professional everything that happened during the relevant time period; (2) the

medical professional’s failure to document everything reported to her or him; (3) a person’s

faulty recollection of the events when presenting testimony; or (4) a person’s purposeful

recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Human Servs., 110

Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014).

The Court has also said that medical records may be outweighed by testimony that is

given later in time that is “consistent, clear, cogent, and compelling.” Camery, 42 Fed. Cl. at 391

(citing Blutstein v. Sec’y of Health & Human Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed.

Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such testimony must

also be determined. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1379 (Fed. Cir.

2009); Bradley v. Sec’y of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

20

The special master is obligated to fully consider and compare the medical records,

testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110

Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health &

Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master’s

discretion to determine whether to afford greater weight to medical records or to other evidence,

such as oral testimony surrounding the events in question that was given at a later date, provided

that such determination is rational).

2. Causation

Petitioner is alleging that the MMR vaccine she received on June 8, 2016 was the cause-

in-fact of her left shoulder injury. Petitioner bears the burden of establishing actual causation.

To do so, she must “show by preponderant evidence that the vaccination brought about the injury

by providing 1) a medical theory connecting the vaccination and injury; 2) a logical sequence of

cause and effect showing that the vaccination was the reason for the injury; and 3) a showing of

proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of Health &

Hum. Servs., 418 F. 3d 1274, 1278 (Fed. Cir. 2005). There must be preponderant evidence for

each Althen prong. Caves v. Sec’y of Health & Hum. Servs., 100 Fed. Cl. 119, 132 (2011), aff.

per curiam, 463 Fed. Appx. 932 (Fed. Cir. 2012).

Under Althen prong one, the causation theory must relate to the injury alleged. Thus, a

petitioner must provide a “reputable” medical or scientific explanation that the vaccine received

can cause the type of injury alleged. Pafford, 451 F.3d at 1355-56. The theory must be based on

a “sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548. It must only

be “legally probable, not medically or scientifically certain.” Id. at 549. However, the theory

still must be based on a “sound and reliable medical or scientific explanation.” Id. at 548. The

Federal Circuit explained in Althen that “while [that petitioner’s claim] involves the possible link

between [tetanus toxoid] vaccination and central nervous system injury, a sequence hitherto

unproven in medicine, the purpose of the Vaccine Act’s preponderance standard is to allow the

finding of causation in a field bereft of complete and direct proof of how vaccines affect the

human body.” Althen, 418 F.3d at 1280 (emphasis added).

Under Althen prong two, petitioner must prove “a logical sequence of cause and effect

showing that the vaccination was the reason for [her] injury.” Althen, 418 F.3d at 1278. This

prong is sometimes referred to as the “did it cause” test; i.e. in this particular case, did the

vaccine(s) cause the alleged injury. Broekelschen, 618 F. 3d at 1345 (“Because causation is

relative to the injury, a petitioner must provide a reputable medical or scientific explanation that

pertains specifically to the petitioner’s case”). Temporal association alone is not evidence of

causation. See Grant v. Sec’y of Health & Hums. Servs., 9556 F.2d 1144, 1148 (Fed. Cir. 1992).

This sequence of cause and effect is usually supported by facts derived from petitioner’s medical

records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326;

Grant, 956 F.2d at 1148.

Althen prong three requires establishing a “proximate temporal relationship” between the

vaccination and the injury alleged. Althen at 1281. That term has equated to the phrase

“medically-acceptable temporal relationship.” Id. A petitioner must offer “preponderant proof

21

that the onset of symptoms occurred within a timeframe which, given the medical understanding

of the disorder’s etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of

Health & Hum. Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is

medically acceptable timeframe must align with the theory of how the relevant vaccine can cause

an injury (Althen prong one). Id. at 1352.

The preponderance of the evidence standard requires the petitioner to demonstrate that it

is “more likely than not” that the vaccine caused the injury. Moberly v. Sec’y of Health & Hum.

Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required.

Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). A petitioner

must demonstrate that the vaccine 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., 135 F.3d 1344, 1352-53 (Fed. Cir. 1999); Pafford v. Sec’y of

Health and Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006). Causation is determined on a

case-by-case basis, with “no hard and fast per se scientific or medical rules.” Knudsen v. Sec’y

of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). A fact-finder may rely upon

“circumstantial evidence” which is consistent with the “system created by Congress, in which

close calls regarding causation are resolved in favor of injured claimants.” Althen, 418 F. 3d at

1280.

The petitioner often presents expert testimony in support of his or her claim. Lampe v.

Sec’y of Health & Human Servs., 219 F.3d 1357, 1361 (Fed. Cir. 2000). Expert testimony in the

Vaccine Program is usually evaluated according to the factors set forth in Daubert v. Merrell

Dow Pharm., Inc., 509 U.S. 579, 594-96 (1993); see also Cedillo, 617 F.3d at 1339 (citing

Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir. 1999). A special

master may use the Daubert framework to evaluate the reliability of expert testimony, but expert

testimony need not meet each Daubert factor to be reliable. Boatmon v. Sec’y of Health &

Human Servs., 941 F.3d 1351 (Fed. Cir. 2019). The Daubert factors are “meant to be helpful,

not definitive,” and all factors “‘do not…necessarily apply even in every instance in which the

reliability of scientific testimony is challenged.’” Boatmon, 941 F. 3d at 1359 (citing Kumho

Tire Co. v. Carmichael, 526 U.S. 137, 151, 119 S. Ct. 1167, 143 L.Ed.2d 238 (1999). Thus, for

Vaccine Act claims, a “special master is entitled to require some indicia of reliability to support

the assertion of the expert witness.” Moberly at 1324. Where both sides offer expert testimony,

a special master’s decision may be “based on the credibility of the experts and the relative

persuasiveness of their competing theories.” Broekelschen v. Sec’y of Health & Human Servs.,

219 F.3d 1339, 1347 (Fed. Cir. 2010) (citing Lampe, 219 F.3d 1357 at 1362).

If the petitioner makes a prima facie case supporting vaccine causation-in-fact, the

burden shifts to respondent to show by a preponderance of the evidence that the injury is instead

due to factors unrelated to the administration of the vaccine. Deribeaux v. Sec’y of Health &

Human Servs., 717 F.3d 1363, 1367 (Fed. Cir. 2013) (citing § 13(a)(1)(B)). Respondent has the

burden of demonstrating that: “[A] factor unrelated to the vaccination is the more likely or

principal cause of injury alleged. Such a showing establishes that the factor unrelated, not the

vaccination, was ‘principally responsible’ for the injury. If the evidence or alternative cause is

seen in equipoise, then the government has failed in its burden of persuasion and compensation

must be awarded.” Knudsen, 35 F.3d at 551.

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B. Finding of Fact

In this case, there are two issues of fact to be resolved. The first is whether petitioner’s

MMR vaccine was inadvertently or erroneously administered intramuscularly in the shoulder

area as opposed to subcutaneously posterior to the triceps muscle. The second issue is the onset

of petitioner’s shoulder pain and dysfunction.

1. Site of Administration

a. Petitioner’s Arguments

Petitioner asserts that the MMR vaccine was inadvertently administered into her deltoid

muscle into her subacromial bursa. Pet. Mot. at 17-31. She argues that her statements in her

affidavit and to her treating physicians, in addition to, Dr. Wright’s statements, support that the

vaccine was mis-administered high into her upper left arm, instead of subcutaneously, as the

vaccine is intended to be administered. Id.

There is no doubt in the vaccination record that Baptist Medical Center ordered the MMR

vaccine for petitioner. Pet. Ex. 2 at 132. Additionally, the details of the order indicate the

amount of the vaccine to be given (0.5 ml) and that it is to be given subcutaneously. Id. Further,

the medication administration from Baptist Medical Center indicates that petitioner received the

MMR vaccine in her “left upper” arm. Id. at 200. However, this record does not provide any

further detail regarding the exact location of vaccine administration in her left upper arm or if it

was inadvertently administered into her muscle.

In her supplemental affidavit, petitioner provided additional detail regarding the location

of the vaccination. She stated, “Christy [my nurse], administered the shot at approximately 5:30

pm on June 8. It was given in the back of my upper left arm.” Pet. Ex. 9 at ¶ 3. Petitioner also

provided, “What I do remember physically about the shot was that, as I was waiting for my baby

and me to be discharged, I was lying on the hospital bed in my room….When the nurse came

into give me the shot, she had me sit up on the bed. She stood next to and over me to give the

injection. I felt the shot being given and it was on my upper arm toward the back.” Id. at ¶ 6.

The shot was itself was extremely painful immediately. Id. at ¶ 5.

Later, when petitioner went to see orthopedist, Dr. Michael Adams, petitioner described

that she received the MMR vaccine in her “lateral left shoulder,” providing a more specific

location to where she was injected. Pet. Ex. 4 at 43. When Dr. Adams examined petitioner’s left

shoulder, he noted, “Generalized tenderness to palpation about the deltoid girdle. Tender to

palpation over the bicipital groove.” Id. at 44. On April 26, 2017, at a follow-up appointment

with Dr. Adams for ongoing left shoulder pain, petitioner indicated that her pain was “posterior

in location.” Pet. Ex. 6 at 9. The physical examination revealed that petitioner had “tenderness

to palpation [on the] posterior rotator cuff.” Id. at 10.

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Petitioner’s expert, Dr. Wright, acknowledged that it would be difficult to identify the

exact location petitioner received the MMR vaccine, he opined that the injection was “most

likely” injected into the subacromial space. Pet. Ex. 15 at 1; Pet. Ex. 12 at 1. Dr. Wright noted

that petitioner exhibited generalized tenderness to palpation near the deltoid insertion on the

acromion which is directly over the posterior greater tuberosity and infraspinatus insertion site.

Pet. Ex. 15 at 2. He explained, “This is located directly underneath the deltoid, where

[petitioner] felt tenderness.” Id. Dr. Wright also noted that on petitioner’s MRI of her left

shoulder “demonstrated an abnormal signal in the infraspinatus tendon at its insertion along the

bursal surface.” Id. Based on what petitioner stated in her affidavit and the medical records, Dr.

Wright opined that it was likely petitioner received the injection in the deltoid muscle near its

insertion at the acromion, passing through the infraspinatus insertion site at the bursa, into the

subacromial bursa. Pet. Ex. 15 at 2-3; Pet. Mot. at 25. Dr. Wright provided a diagram depicting

where he believed petitioner received the MMR vaccine, re-created below:

Pet. Ex. 15 at 3. The green circle represents area in which Dr. Wright opined that petitioner

received the MMR injection.

Referencing the Bodor and Montalvo article, Dr. Wright stated that “an injection into the

subacromial space can be responsible for initiating a major inflammatory event in the

subacromial bursae resulting in persistent severe pain.” Pet. Ex. 12 at 1; Pet. Ex. 14 at 2. The

article highlights two case reports of shoulder dysfunction and pain following intramuscular

vaccination. Pet. Ex. 14. The authors hypothesized that vaccine was injected into the subdeltoid

bursa. Id. at 2. The authors explained that the subacromial bursa’s depth below the skin was

approximately 0.8 cm (8 mm) to 1.6 cm (16 mm) below the skin. Id. at 2. They wrote, “We

hypothesize that in both of our cases vaccine was injected into the subdeltoid bursa, causing a

robust local immune and inflammatory response. Given that the subdeltoid bursa is contiguous

with the subacromial bursa, this led to subacromial bursitis, bicipital tendonitis, and

inflammation of the shoulder capsule.” Id. at 2.

24

Petitioner argued that the skin and deltoid muscle at Dr. Wright’s proposed injection site

is thinner than at the proposed injection site by Dr. Abrams. Using the diagram below from the

Nakajima article, petitioner asserted that the Dr. Wright’s proposed injection site is the region

between b’ and 1/3 bb’. Pet. Mot. at 32.

Resp. Ex. A, Tab 8 at 24. Petitioner stated that, “The total thickness at 1/3 bb’ of skin is 5-6

mm…and of deltoid muscle is 9-13 mm thick….for a total range of 14-19 mm at that site.” Pet.

Mot. at 32; Resp. Ex. A, Tab 8 at 3-4. Petitioner asserted that, “Therefore, even if a 15.9 mm

needled intended for subcutaneous administration was used, it could indeed have reached the

bursa in the manner proposed by Dr. Wright.” Pet. Mot. at 32.

b. Respondent’s Arguments

Respondent contests that the “medical records reflect that the MMR vaccine was

administered subcutaneously in petitioner’s left arm,” which is consistent with the CDC

recommendation for subcutaneous injection of an MMR vaccine. Resp. Brief at 11.

Specifically, respondent states that petitioner described the vaccination site as “high on [the]

upper arm toward the back,” which is consistent with the proper injection site being in the

posterior triceps aspect of the upper arm. Id.

Respondent argued that Dr. Wright’s proposed injection site is not supported by the

record because petitioner did not state that the injection was given on her shoulder or

“completely on the back of her arm.” Resp. Brief at 12. Instead, respondent argued that

petitioner only stated that the vaccine was injected “towards” the back of her arm, which is

“consistent with the CDC recommendation for subcutaneous injection of an MMR vaccine in the

posterior triceps aspect of the upper arm.” Id. at 11.

25

Using the diagram from the Nakajima article (above), Dr. Abrams put the petitioner’s

injection site between ½ bb’ and 2/3 bb’ and respondent argued that “this region more closely

fits with petitioner’s description in her supplemental affidavit that the injection was high on her

upper arm-not on her shoulder.” Resp. Brief at 13 (original emphasis).

Dr. Abrams noted that the standard needle length for an MMR vaccination is 5/8” or 15.9

mm, which would make it difficult for the injection to reach the subacromial space. Resp. Ex. C

at 2. He stated that, “The subcutaneous (skin) thickness of females at the typical injection site, as

measured by ultrasound, range from 6-8 mm. In addition, the thickness of the deltoid muscle at

this location would have to traverse a minimum distance of approximately 21 mm to even reach

the subacromial space-and this was in a patient population significantly below the body mass

index of the petitioner.” Id. at 2. Respondent stated that the even if the needle was injected

“high in the upper aspect of the lateral arm, such as near site, 1/3 bb’ it is highly unlikely that the

needle passed into the structures behind the muscle due to the angle of administration.” Resp.

Brief at 14.

Dr. Abrams also asserted that a subcutaneous injection given at a 45-degree angle to

specifically “avoid penetration into the intra-muscular tissue.” Resp. Brief at 14; Resp. Ex. C at

2. Respondent argued that the way in which petitioner described the administering nurse

“standing over her” while injecting the vaccine supports proper administration angle of the

vaccine. Resp. Brief at 15. Respondent stated, “From a standing position over a patient, it

would be natural for the needle of the syringe to point downward at an angle towards the floor,

because of the way healthcare professionals hold a syringe between their fingers. Depressing the

syringe perfectly perpendicular to the patient’s arm while standing above the patient would

require holding the syringe in a very awkward manner. It is highly unlikely that this nurse

injected petitioner’s upper arm at the 90-degree angle required to reach the subacromial space,

while petitioner was sitting-down and the nurse was standing over her.” Id.

c. Conclusion regarding site administration

Petitioner has presented preponderant evidence that the June 8, 2016 MMR vaccine was

administered high on her left lateral shoulder in the deltoid muscle into the subacromial bursa.

Petitioner explained that she received the vaccination in her left “upper arm, towards the

back,” in her supplemental affidavit. Consistent with her affidavit, when petitioner presented to

orthopedist, Dr. Adams, she reported that her injection was into the “lateral left shoulder.” Pet.

Ex. 4 at 43. These two descriptions given by petitioner do not indicate that the vaccine was

administered in her triceps region as proposed by respondent, which is lower on the back of the

arm, but instead, both descriptions would put the injection site as being high towards the back of

her arm, closer to her shoulder.

Petitioner’s statement that the vaccine was administered on her “upper arm toward the

back,” is consistent with the physical examinations post-vaccination. For example, Adams noted

petitioner had, “Generalized tenderness to palpation about the deltoid girdle. Tender to palpation

over the bicipital groove.” Pet. Ex. 4 at 44. Petitioner also had “tenderness to palpation [on the]

posterior rotator cuff.” Pet. Ex. 6 at 10. During her first physical therapy evaluation on July 4,

26

2016, petitioner demonstrated tenderness on her biceps tendon long head, supraspinatus tendon

and the posterior cuff. Pet. Ex. 5 at 29.

Additionally, petitioner’s MRIs are also consistent with her description of where the

vaccine was injected into her left arm. The MRI taken on June 15, 2016 revealed the following,

“The infraspinatus tendon demonstrates abnormal increased T2 signal at its insertion.” Pet. Ex. 2

at 6. The impression of the radiologist was, “Partial thickness tear distal infraspinatus tendon at

its insertion along the bursal surface.” Id. Her follow-up MRI taken on April 21, 2017 showed

“abnormal bursal surface signal of the distal anterior supraspinatus adjacent to the footplate,”

and, “a tiny sliver of fluid in the subacromial subdeltoid bursa.” Pet. Ex. 6 at 13.

Petitioner’s description of the vaccination site being high towards the back of her upper

left arm, makes it more likely that the vaccine was administered in a manner that would have

been in or around the subacromial bursa, as suggested by Dr. Wright. The image below shows

the posterior view of the shoulder, recreated from the S. Atanasoff article, demonstrates the

relationship between the deltoid muscle, the subacromial bursa space to the supraspinatus

tendon.

Pet. Ex. 18 at 3.11 The Bodor article explained that the subacromial bursa extends from 3.0 cm to

6.0 cm beyond the lateral border of the acromion and that it lay anywhere from 0.8 cm (8 mm) to

1.6 cm (1.6 mm) below the skin surface. Pet. Ex. 14 at 2. At Dr. Wright’s proposed injection

site, it is conceivable that a 15.9 mm (or 1.59 cm) needle used for the MMR vaccine could

penetrate into the subacromial bursa, given its depth of 0.8 cm to 1.6 cm below the skin surface.

Finally, respondent’s argument that petitioner was seated during the vaccine

administration and the administering nurse was standing makes it more likely that the vaccine

was administered in a downward angle, thus making it difficult to penetrate into the subacromial

bursa is not credible. The Atanasoff article explains, “…while patients are often seated for

vaccinations, the standing position of the provider administering the injection may also

contribute to injecting inadvertently high into the deltoid….Thus, concurrent seating positions

for both the administrator and the receiver may minimize the risk of the injection being too

11

Atanasoff, S. et al., Shoulder Injury Related to Vaccine Injury (SIRVA), 28 Vaccine 8049-8052 (2010). [Pet. Ex.

18].

27

high.” Pet. Ex. 18 at 4. In this case, petitioner stated that when she received the MMR

vaccination, she was seated on the bed and the administering nurse was standing above and

behind her. Pet. Ex. 9 at ¶¶ 3 and 9. Additionally, petitioner described the injection site was

“high” on her left arm. Pet. Ex. at ¶ 9. Given the seated position of the petitioner while

receiving the vaccine and that she described the site as being “high” towards the back of her left

arm, it is more likely that the administering nurse injected the vaccine high on the back of

petitioner’s left arm, penetrating into and around the subacromial bursa.

Consistent with the above, I find that petitioner has established by preponderant evidence

that the MMR vaccine she received was administered in the subacromial space, high on her left

arm. The administration appears to have been more consistent with an unintended intramuscular

administration, such that it penetrated into and around petitioner’s subacromial bursa.

2. Onset of Petitioner’s Pain

a. Respondent’s arguments

Respondent argues that the evidence does not demonstrate that petitioner experienced

shoulder pain or dysfunction within 48-hours of receiving the MMR vaccine. Resp. Brief at 7.

Respondent specifically argues that, “the contemporaneous medical records do not provide

independent evidence of onset within 48 hours of vaccination, and petitioner’s own statements

are insufficient to meet her burden.” Id. at 9. Respondent states that, “the contemporaneous

medical records reflect that she did not complain of shoulder pain until the June 20, 2016 phone

call to the office of her OB/GYN.” Id. at 8. Respondent states that petitioner had contacted her

OB/GYN’s office five days prior, on June 15, 2016 and did not complain of shoulder pain. Id.

Additionally, respondent argues that petitioner’s supplemental affidavit contradicts the medical

records. Resp. Brief at 8. Respondent states that petitioner stated in her supplemental affidavit

that on June 15, 2016 “her condition was so poor that she could not lift her arm or use it at all,”

however, petitioner waited an additional five days to seek medical treatment. Id.

Respondent also argues that petitioner’s description of onset of left shoulder pain in the

medical records fails to demonstrate that the pain began within 48 hours. Id. at 9. Respondent

notes that at a physical therapy appointment on July 4, 2016, petitioner reported that, “a shot in

the hospital…caused a lot of neck pain then a few days later her shoulder began getting stiff and

she began having pain.” Id. at 9. But later, in her affidavit, petitioner asserted that the neck pain

started after the shoulder pain.” Id. Respondent stated that this contradiction “calls into question

the reliability of petitioner’s supplemental affidavit.” Id. Respondent concluded that the medical

records do not demonstrate that petitioner’s onset of symptoms was within 48 hours or less

following the MMR vaccination. Id. at 10.

b. Petitioner’s arguments

Petitioner argues that the medical records and her affidavit support onset of her left

shoulder injury within 48 hours of receiving the MMR vaccination on June 8, 2016. Pet. Mot. at

32. Petitioner states that she called the OB/GYN office on June 20, 2016 and “the notes of the

call reflect that she stated that her arm was sore after the post-delivery vaccination.” Id. at 19;

28

Pet. Ex. 3 at 138. Petitioner also states that she told the same to her orthopedist, Dr. Adams at

the June 28, 2016 appointment, the record from which reported that “after they injected into her

lateral left shoulder, she began to have increased intense pain and range of motion problems.”

Id. at 20; Pet. Ex. 4 at 43. Additionally, petitioner asserts that at the same appointment, Dr.

Adams and petitioner appeared to have reviewed a website, which may have been the VICP or

the Table, and he wrote, “I do not think it is out of the realm of question that she had post-

injection stiffness and pain…” Id. at 21; Pet. Ex. 4 at 45.

Petitioner also asserts that her supplemental affidavit supports the onset of pain within 48

hours of receiving the vaccination. Petitioner explains in her affidavit that she felt excruciating

pain during the vaccination, so much that she nearly came off the bed. Pet. Mot. at 19; Pet. Ex. 9

at ¶ 1. Further, when petitioner called the office on June 20, 2016, the note reads, “Pt. calling

stating unable to move left arm. Pt. states sore after given shot in arm after delivery. Pt. states

now 2 weeks later unable to move warm at all.” Pet. Ex. 3 at 138.

Petitioner concluded that the evidentiary record documents that the onset of her shoulder

injury followed within 48 hours of the vaccination at issue, which is within a medically

appropriate proximate timeframe.

c. Conclusion regarding onset of petitioner’s should pain and dysfunction

Petitioner has demonstrated by preponderant evidence that the onset of her shoulder pain

occurred within 48 hours of her MMR vaccination on June 8, 2016.

The medical records demonstrate that petitioner consistently attributed the pain in her left

shoulder to the MMR vaccination on June 8, 2016. She called her OB/GYN on June 20, 2016

and reported that she was “unable to move her left arm,” and that her arm has been “sore after

given shot in arm after delivery,” and stated that her arm was “frozen.” Pet. Ex. 3 at 138.

Respondent argued that petitioner spoke to her OB/GYN’s office five days earlier, on June 15,

2016, but did not mention that her left arm was sore. Resp. Brief at 8. However, the records

from the call on June 15, 2016 indicate that the call was about petitioner’s health insurance

benefits covering a specific form of contraceptive. Pet. Ex. 3 at 63. Specifically, on June 9,

2016, the day following the vaccination, it was noted that, “Patient is interested in getting the

Mirena IUD inserted at her postpartum visit. Could you please check benefits and let her know

if it would be covered?” Id. On June 14, 2016, the note indicates that the OB/GYN office

checked petitioner’s health benefits and left a message with petitioner to call back. Id. Petitioner

called back on June 15, 2016 and spoke to Ms. Christina Catlett who noted, “Pt called back-

aware of benefits.” Id. It is clear from the OB/GYN’s internal messaging system, that the

purpose of the call was for checking benefits and not for the purposes of medical treatment.

As the Federal Circuit articulated in Kirby, there is no “presumption that medical records

are accurate and complete as to all the patient’s physical conditions.” Kirby v. Sec’y of Health &

Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). Following Kirby, a special master must

consider the context of a medical encounter before concluding that it constitutes evidence

regarding the absence of a condition. Hanna v. Sec’y of Health & Hum. Servs., No. 18-1455V,

2021 WL 3486248, at *14 (Fed. Cl. Spec. Mstr. July 15, 2021). In this case, the phone call

29

between the petitioner and the OB/GYN’s office on June 15, 2016 does not appear to constitute a

medical encounter, instead is appears to be focused on an administrative matter, rather than for

medical care. Further, in prior SIRVA cases it has been held that neither a delay in seeking

treatment in itself, nor a failure to report symptoms to a specialist or emergency room provider

prior to later seeking treatment, is necessarily dispositive of whether a petitioner’s shoulder pain

began within 48 hours of vaccination. See Forman-Franco v. Sec’y of Health & Hum. Servs.,

No. 15-1479V, 2018 WL 1835203 (Fed. Cl. Spec. Mstr. Feb. 21, 2018); Tenneson v. Sec’y of

Health & Hum. Servs., No 16-1664V, 2018 WL 3083140 (Fed. Cl. Spec. Mstr. Mar. 30, 2018),

mot. rev. denied 142 Fed. Cl. 329 (2019); Gurney v. Sec’y of Health & Hum. Servs., No 17-

481V, 2019 WL 2298790 (Fed. Cl. Mar. 19, 2019). As petitioner explained in her supplemental

affidavit, she has five children under the age of 13 and the delay in telling her medical provider

by 12 days is reasonable, given that she was caring for a newborn at the time, in addition to four

other children at home. Indeed, the reporting of her shoulder pain and inability to lift her arm

within 12 days of vaccination is far faster than many of the cases seen in this program.

Additionally, when petitioner had her first appointment with orthopedist. Dr. Adams, on

June 28, 2016, she once again attributed the onset to her left shoulder pain to the MMR

vaccination. Pet. Ex. 4 at 43. Under “History of Present Illness,” the note states, “[Petitioner]

notes that she gave birth three weeks ago and afterwards was offered the measles, mumps and

rubella vaccine. She states that after they injected into her lateral left shoulder, she began to

have increased intense pain and range of motion problems.” Id.

On July 4, 2016, petitioner had her first physical therapy evaluation. Pet. Ex. 5 at 28. At

this appointment under the “Subjective” section it states, “[Petitioner] states that the initial onset

occurred on 6/01/2016 when she [] reports she had a baby 4 weeks ago and reports insidious

onset of left shoulder pain. She reports she does not know why the pain started. She reports

having a shot in the hospital which caused a lot of neck pain and then a few days later her

shoulder began getting stiff and she began having pain.” Id. Respondent argued that this record

shows that petitioner had neck pain and then shoulder pain, which indicates that the shoulder

pain began after forty-eight hours after vaccine administration. Resp. Brief at 9. However, there

is no specific timeframe mentioned in this notation, except for a vague timeframe of “a few days

later.” Further, this notation is the only notation in the record that puts neck pain prior to the

onset of her shoulder pain, which she consistently attributed to the MMR vaccination. This

record was sufficiently vague and unclear as to dates of onset, date of delivery of the baby and

date of vaccination to raise questions about the care taken in questioning about and recording the

onset of pain. It is also the only record introducing this confusion, as when interviewed by an

orthopedist on June 28, 2016, six days prior to the physical therapy appointment, petitioner

unequivocally described the delivery of her baby three weeks before and the onset of pain after

they injected into her lateral left shoulder causing intense pain and range of motion problems.

Pet. Ex. 4 at 43.

Additionally, at her follow-up appointment with Dr. Adams on August 1, 2016, he noted

that petitioner’s left shoulder pain had been present for two months and stated, “It started after a

post-delivery vaccine and was severe in intensity and diffuse in nature associated with significant

decreased range of motion.” Id. at 22.

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Petitioner’s supplemental affidavit also supports onset of her left shoulder pain being

within 48 hours of receiving the MMR vaccination on June 8, 2016. She stated, “As I received

the shot, the pain was excruciating.” Pet. Ex. 9 at ¶ 4. She described the pain as “intense” and

“as if it was going into my bone.” Id. She also indicated that she could feel the pain even

though she had been given Percocet for after birth pain. Id. In her affidavit, she explained that

she was having terrible shoulder pain and then neck pain that radiated down to her shoulder. She

articulated that the neck pain started after the shoulder pain. Id. at ¶ 7. Petitioner’s statements

regarding the onset of her left shoulder pain in her supplemental affidavit do not contradict her

medical records and are quite consistent with those recorded by her orthopedist, Dr. Adams.

The evidence in the record as whole, supports petitioner’s position that the onset of her

shoulder pain began within 48 hours of receiving the MMR vaccine on June 8, 2016. The

twelve-day delay in treatment for her shoulder is consistent with the length of time of that many

other people seek care for shoulder pain following vaccination. See e.g. Smallwood v. Sec’y of

Health & Human Servs., No. 18-291V, 2020 WL 2954958, at *10 (Fed. Cl. Spec. Mstr. Apr. 29,

2020) (observing that it is “common for a SIRVA petitioner to delay treatment, thinking his/her

injury will resolve on its own.”); see also Hartman v. Sec’y of Health & Human Servs., No. 19-

1106V, 2021 WL 4823549, at *5 (Fed. Cl. Spec. Mstr. Sept. 14, 2021) (petitioner reported

shoulder pain less than one more after vaccination and repeatedly sought treatment to relieve her

pain and loss of function.).

Therefore, petitioner’s statements about the onset of her left shoulder pain occurring

within 48 hours of receiving the MMR vaccine on June 8, 2016 are consistent with the medical

records, which repeatedly note that petitioner attributed the onset of her pain to the vaccination at

issue in this case. As such, petitioner has demonstrated that her left shoulder pain occurred

within 48 hours of vaccination.

C. Causation

1. Althen prong one

Under Althen prong one, the causation theory must relate to the injury alleged. The

theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen, 35

F.3d at 548. It must only be “legally probable, not medically or scientifically certain.” Id. at 549.

However, the theory still must be based on a “sound and reliable medical or scientific

explanation.” Id. at 548. The Federal Circuit explained in Althen that “while [that petitioner’s

claim] involves the possible link between [tetanus toxoid] vaccination and central nervous

system injury, a sequence hitherto unproven in medicine, the purpose of the Vaccine Act’s

preponderance standard is to allow the finding of causation in a field bereft of complete and

direct proof of how vaccines affect the human body.” Althen, 418 F.3d at 1280 (emphasis added).

a. Petitioner’s arguments regarding Althen prong one

Petitioner’s expert, Dr. Wright opined that petitioner had a “direct injection into the

subacromial space and possibly into the infraspinatus,” which can “be responsible for initiating a

major inflammatory event in the subacromial bursae resulting in persistent severe pain.” Pet. Ex.

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12 at 1. He acknowledged that he did not know the exact location of petitioner’s injection, but

found it likely that she had received the injection in the subacromial space and possibly in the

infraspinatus, based on her positive response to the steroid injection and the edema found on her

MRI. Pet. Ex. 15 at 1.

Dr. Wright cited to the Bodor and Montalvo article which describes two case reports of

individuals who experienced shoulder pain and weakness following vaccinations. Pet. Ex. 14.12

The authors hypothesized that the vaccines were injected into the subdeltoid bursa causing a

robust local immune and inflammatory response in the structures of the shoulder. Id. at 2. They

explained that the inflammatory response in the subdeltoid bursa led to subacromial bursitis,

bicipital tendonitis, and inflammation of the shoulder capsule. Id.

Petitioner also cited to the Atanasoff et al. article, which describes the mechanism of a

SIRVA. Pet. Ex. 18. Petitioner argues that the mechanism of injury described in the Atanasoff

article has been accepted by this Court, and respondent, as sound and reliable. Specifically, the

article provides:

If…a vaccine is inadvertently injected into the synovial space of the shoulder (bursa or

joint), pre-existing antibody in the synovial tissues, present as a result of earlier naturally

occurring infection or vaccination, may lead to a more prolonged inflammatory response.

Pet. Ex. 18 at 3. The authors further explained, “….the rapid onset of pain with limited range of

motion following vaccination…is consistent with a robust and prolonged immune response

within already-sensitized shoulder structures following injection of antigenic substance into the

subacromial bursa or the area around the rotator cuff tendon.” Id. Importantly, the authors of

Atanasoff et al. observed, “Given that 62% of our cases were overweight or obese based upon

BMI and that no case was considered underweight, needle length alone may not have been the

cause of injection into tissues other than the deltoid.” Id. at 4. They also noted that, “the

standing position of the provider administering the injection may also contribute to injecting

inadvertently high into the deltoid….Thus, concurrent seating positions for both the administer

and the receiver may minimize the risk of the injection being “too high.” Id.

Petitioner summarized Dr. Wright’s theory as, “an injection in the deltoid muscle, near its

insertion at the acromion, passing through infraspinatus insertion site at the bursa, into the

subacromial bursa, can cause a shoulder injury.” Pet. Mot. at 17; Pet. Ex. 15 at 2.

b. Respondent’s arguments regarding Althen prong one

Respondent’s expert, Dr. Abrams, does not disagree with Dr. Wright’s explanation of the

SIRVA mechanism. Instead, he asserts, “The location of the injection for an MMR vaccine is in

the posterior triceps aspect of the upper arm. It is not possible to reach the subacromial space

with an injection given in this location.” Resp. Ex. C at 1.

He notes that he MMR vaccine is administered subcutaneously, which, with proper

technique is given at a 45-degree angle in order to avoid penetration into the intra-muscular

12

Bodor, M. & Montalvo, E., Vaccination-related shoulder dysfunction, 25 Vaccine 585-587 (2007). [Pet. Ex. 14].

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tissues. Id. He states that the needle length for administering an MMR vaccine is not long

enough to reach the subacromial space or the infraspinatus tendon. Id. Dr. Abrams argues that

the petitioner’s increased BMI would increase the distance the needle has to traverse to penetrate

the subacromial space, decreasing the likelihood of “inadvertent vaccine needle penetration into

the subacromial space.” Id.

Respondent, in the response brief to petitioner’s motion, does not question Dr. Wright’s

proposed mechanism, but instead argues that Dr. Wright’s “theory is dependent…on an assumed

site of injection and the manner of injection unsupported by the evidence in this case.” Resp.

Brief at 11.

c. Discussion and conclusion of Althen prong one

Petitioner has established a sound and reliable theory to explain how the MMR vaccine,

when administered incorrectly, can be inserted into the synovial space of the shoulder, causing a

shoulder injury related to vaccine administration. The mechanism for a SIRVA injury is well

described in medical literature filed in this case. Both the Atanasoff and Bodor articles support a

causal association between vaccination and shoulder dysfunction.

As discussed above, the authors of the Atanasoff article specifically opined that if a

vaccine “is inadvertently injected into the synovial space of the shoulder (bursa or joint), pre-

existing antibodies in the synovial tissues, present as a result of earlier naturally occurring

infection or vaccination, may lead to a more prolonged inflammatory response.” Pet. Ex. 18 at 3.

Further, the authors of Atanasoff indicated that a person’s body weight or needle length did not

appear to have an effect on whether the vaccine antigen was injected into tissues other than the

deltoid muscle. Id. at 4. While respondent argued that the needle used for MMR vaccination is

only 15.8 mm, the Bodor article demonstrated that the subacromial bursa sits between 6 mm and

13 mm below the skin’s surface, making it accessible with a 15.8 mm needle length.

Additionally, the Nakajima article explained that the subcutaneous thickness at the proposed

injection site 1/3 bb’ (which corresponds with Dr. Wright’s proposed injection site) was between

3.5 mm to 6.3 mm and the thickness of the deltoid muscle range from 9.0 mm to about 12 mm.

Resp. Ex. A, Tab 8 at 2.

The Atanasoff article also indicates that the standing position of the vaccine administrator

over a seated patient “may also contribute to injecting inadvertently high.” Pet. Ex. 18 at 4. In

this case, petitioner stated that she was sitting on a bed and the nurse who administered the

vaccine “stood next to and over me to give the injection.” Pet. Ex. 9 at ¶ 6. Petitioner described

the location as being “high on my upper arm towards the back.” Id. Petitioner’s statements that

the vaccine administrator was standing while she was seated and it was administered “high” on

her left upper arm, makes it more likely that the MMR vaccine was mis-administered into her

subacromial bursa, leading to an inflammatory event resulting in persistent pain and movement

dysfunction. The description of tenderness in the shoulder girdle and bicipital groove are also

consistent with a high administration point where the deltoid muscle is thinnest.

Further, petitioner was diagnosed with left shoulder bursitis, a diagnosis consistent with

other SIRVA cases in the program. Kraus v. Sec’y of Health & Human Servs., No. 17-2001V,

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2021 WL 4705177 (Fed. Cl. Spec. Mstr. Sept. 2, 2021) (petitioner diagnosed with right shoulder

bursitis following a flu vaccination); Lang v. Sec’y of Health & Human Servs., No. 17-996V,

2020 WL 7873272, at *3 (Fed. Cl. Spec. Mstr. Dec. 11, 2020) (petitioner was diagnosed with

bursitis following flu vaccination); Schoonover v. Sec’y of Health & Human Servs. No. 16-1324,

2019 WL 1040642, at *5 (Fed. Cl. Spec. Mstr. Jan. 30, 2019).

Petitioner has presented a reputable scientific theory based on a sound and reliable

medical explanation, demonstrating that the MMR vaccine, when administered improperly, can

cause a shoulder pain and dysfunction, thus satisfying Althen prong one.

2. Althen prong two

Under Althen prong two, petitioner must prove “a logical sequence of cause and effect

showing that the vaccination was the reason for [her] injury.” Althen, 418 F.3d at 1278. This

prong is sometimes referred to as the “did it cause” test; i.e. in this particular case, did the

vaccine(s) cause the alleged injury. Broekelschen, 618 F. 3d at 1345 (“Because causation is

relative to the injury, a petitioner must provide a reputable medical or scientific explanation that

pertains specifically to the petitioner’s case”). Temporal association alone is not evidence of

causation. See Grant v. Sec’y of Health & Hum. Servs., 9556 F.2d 1144, 1148 (Fed. Cir. 1992).

This sequence of cause and effect is usually supported by facts derived from petitioner’s medical

records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326;

Grant, 956 F.2d at 1148. Treating physicians are likely to be in the best position to determine

whether a logical sequence of cause and effect show[s] that the vaccination was the reason for

the injury. Paluck v. Sec’y of Health & Hum. Servs., 786 F.3d 1373, 1385 (Fed. Cir. 2015)

(quoting Andreu, 569 F.3d 1375).

Prior to the receiving the MMR vaccine, petitioner did not experience any left shoulder

pain or dysfunction. Petitioner received the MMR vaccine on June 8, 2016 and immediately felt

pain, which led to a reduction in shoulder mobility. Consistent with the finding above that the

MMR vaccination was mis-administered into petitioner’s deltoid muscle penetrating into her

bursa, the medical history relating to petitioner’s left shoulder pain and dysfunction following the

vaccination at issue demonstrates a logical sequence of cause and effect showing that the

vaccination was the reason for her injury.

On June 20, 2016, petitioner reported to her OB/GYN that she received a shot after the

delivery of her child, and she was “unable to move her left arm.” Pet. Ex. 3 at 138. Petitioner

described her arm as “frozen.” Id. The MRI of petitioner’s left shoulder showed a 50% tear of

the infraspinatus tendon at its insertion along the bursal surface. Pet. Ex. 2 at 6. While it is

unclear if petitioner’s partial thickness tear was caused by the MMR vaccination, the rapid onset

of pain and shoulder dysfunction following the vaccination is consistent with the medical

literature describing SIRVAs. The Atanasoff article explains that common conditions such as

“impingement syndrome, rotator cuff tear, biceps tendonitis, osteoarthritis and adhesive

capsulitis….may cause no symptoms until provoked by trauma or other events.” Pet. Ex. 18 at 3.

The authors of Atanasoff noted, “some of the MRI findings in our case series, such as rotator

cuff tears, may have been present prior to vaccination and became symptomatic as a result of

vaccination-associated synovial pain.” Id. at 3.

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After the MRI, petitioner sought treatment from orthopedist, Dr. Adams. Pet. Ex. 4 at 43.

At her first appointment, petitioner explained that she received the MMR vaccine into her

“lateral left shoulder” and she began to have “intense pain and range of motion problems.” Id.

Her physical exam revealed restricted active range of motion in her left shoulder, generalized

tenderness to palpation near the deltoid girdle and over the bicipital groove. Id. at 44. Petitioner

was diagnosed with left shoulder joint pain and left partial acute rotator cuff tear. Id. at 45.

Dr. Adams opined that her left shoulder pain could have been related to her MMR vaccination,

stating, “I do not think it is out of the realm of question that she had post-injection stiffness and

pain.” Pet. Ex. 4 at 45.

Petitioner received a steroid injection in her left shoulder and actively participated in

physical therapy. Pet. Ex. 4 at 25; Pet. Ex. 5 at 4-32. When she returned to Dr. Adams on

August 1, 2016 following six weeks of physical therapy, petitioner noted decreased pain in her

shoulder, but the pain began to increase as intensity in physical therapy increased. Pet. Ex. 4 at

22. Dr. Adams did not recommend another steroid injection, but recommended that she finish

out physical therapy and then begin a home exercise regime. Id. at 4. Dr. Adams also wrote in

petitioner’s medical record, “We did review some scientific evidence of post vaccine injection

rotator cuff tear when placed in the wrong place. It does appear at this time though, that she is

healing appropriately.” Id. at 23.

Petitioner had a repeat MRI on April 21, 2017, which showed abnormal bursal surface

signal of supraspinatus tendon and a “tiny” amount of fluid in the subacromial subdeltoid bursa.

Pet. Ex. 6 at 13.

When petitioner returned to Dr. Adams in April 2017, petitioner reported that her left

shoulder pain was persistent and described it as, “posterior in location, dull and burning quality

and moderate in severity.” Pet. Ex. 6 at 9. On physical exam, petitioner demonstrated full range

of motion “with painful arc from 80-120 degree of flexion and abduction,” and she demonstrated

one out of two impingement signs. Id. at 10. Dr. Adams reviewed the most recent MRI and

noted that petitioner had “mild abnormal signal on the bursal side of the anterior supraspinatus,”

and opined that it represented a “partial tear,” and that she had persistent tenosynovitis in the

proximal biceps tendon, consistent with the 2016 MRI. Id. at 9-10. Petitioner was diagnosed

with left shoulder joint pain, left partial chronic rotator cuff tear, and left shoulder bursitis. Id. at

11.

Finally, petitioner’s expert, Dr. Wright opined, “[petitioner] sustained an injection site

injury to her left shoulder due to the MMR vaccine injection on 6/8/2016. There was no pre-

existing history of pain in the left shoulder, the pain started immediately after the injection, and

persisted at least 10 months.” Pet. Ex. 12 at 1.

Dr. Abrams’ argument rests entirely on the theory that the MMR vaccine was

administered correctly in accord with the directions of the CDC. It is difficult to conceive of a

subcutaneously injected vaccination into the subcutaneous fat above the triceps muscle causing a

SIRVA injury. However, the evidence particular to this case strongly suggests that the

vaccination was not properly administered with the nurse standing next to and above the seated

35

patient, giving the injection high in the shoulder, where the muscle is thinnest and the

documented new onset pain occurred.

Therefore, petitioner’s medical records and supporting opinion by Dr. Wright,

demonstrates that the MMR vaccination administered on June 8, 2016 was the cause of her left

shoulder pain and dysfunction. As such, petitioner has provided preponderant evidence to satisfy

Althen prong two.

3. Althen prong three

Under Althen Prong Three, petitioner must establish a “medically acceptable temporal

relationship” between the vaccination and the injury alleged. Althen, 418 F.3d at 1281.

Both respondent and petitioner in this case postulate that the appropriate medically

acceptable timeframe between vaccination and the injury alleged is 48 hours. Resp. Brief at 7;

Pet. Mot. at 32. However, they disagree as to whether the onset of petitioner’s injury occurred

within 48 hours. Respondent argued that petitioner “failed to show by a preponderance of the

evidence that her shoulder pain began within 48 hours of receiving the vaccine.” Resp. Brief at

16. Petitioner argued that the evidentiary records, including petitioner’s medical records and

affidavits, demonstrate that onset of petitioner’s shoulder injury followed within 48 hours of the

vaccination at issue, which “fits the postulated time frame elucidated in the applicable medical

literature (and the Table).” Pet. Mot. at 32.

Consistent with the finding above regarding the onset of petitioner’s left shoulder pain

and dysfunction, petitioner has provided preponderant evidence to satisfy Althen prong three.

V. Conclusion

In accordance with the above, I dismiss petitioner’s Table SIRVA claim, but find that she

has established by preponderant evidence that she is entitled to compensation, demonstrating that

the MMR vaccination administered on June 8, 2016 was the cause-in-fact of her left shoulder

pain and dysfunction. A separate damages order will be issued.

IT IS SO ORDERED.

s/Thomas L. Gowen

Thomas L. Gowen

Special Master

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