In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-1503V
Filed: January 23, 2017
Not to be Published.
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GINGER SMITH, *
*
Petitioner, *
*
v. * Motion for a Decision Dismissing
* Petition; influenza (“flu”) vaccine;
SECRETARY OF HEALTH * osteoarthritis; no expert.
AND HUMAN SERVICES, *
*
Respondent. *
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Wade H. Abed, II, Mankato, MN, for petitioner.
Robert P. Coleman, III, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION 1
On November 14, 2016, petitioner filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-10–34 (2012) (the “Vaccine Act”), alleging that influenza (“flu”)
vaccine administered in her left arm on November 19, 2013 caused her arthritis. Pet. pmbl. and ¶
12.
1
Because this unpublished decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this unpublished decision on the United States Court of Federal
Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). Vaccine Rule 18(b) states that
all decisions of the special masters will be made available to the public unless they contain trade secrets
or commercial or financial information that is privileged and confidential, or medical or similar
information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a
decision is filed, petitioner has 14 days to identify and move to redact such information prior to the
document’s disclosure. If the special master, upon review, agrees that the identified material fits within
the banned categories listed above, the special master shall redact such material from public access.
By “arthritis,” the undersigned assumes petitioner means osteoarthritis, 2 with which
doctors diagnosed her pre-vaccination. Her doctors have never diagnosed petitioner with
rheumatoid arthritis.
Because petitioner’s osteoarthritis preceded her flu vaccination of November 19, 2013,
petitioner would have to prove that flu vaccine not only significantly aggravated her left arm
osteoarthritis, but also that her left osteoarthritis was significantly worse than her pre-flu vaccine
left arm osteoarthritis.
On January 4, 2017, the undersigned issued an Order to Show Cause why this case should
not be dismissed. The undersigned suggested petitioner file a motion to dismiss under Vaccine
Rule 21(a)(1) by filing a notice of dismissal which would have resulted in an Order Concluding
Proceedings. The effect of an Order Concluding Proceedings is that judgment will not enter.
Vaccine Rule 21(a)(3).
On January 20, 2017, petitioner filed a Motion for a Decision Dismissing Petition under
the code for Motion to Voluntarily Dismiss pursuant to Rule 21(a). However, in petitioner’s last
paragraph, she states she intends to file a civil action and intends to elect to reject judgment.
Petitioner obviously was unaware that the effect of filing a motion to dismiss under Rule 21(a) is
to preclude the clerk of court’s filing a judgment under Rule 11(a). See Rule 21(a)(3). To protect
petitioner’s intent to file an election, therefore, the undersigned issues this decision dismissing the
case, rather than an Order Concluding Proceedings.
In petitioner’s Motion for a Decision Dismissing Petition, she states that an investigation
of the facts and science supporting her case has demonstrated to her that she will be unable to
prove that she is entitled to compensation in the Vaccine Program and, under these circumstances,
to proceed further would be unreasonable and would waste the resources of the court, respondent,
and the Vaccine Program. Mot. at ¶¶ 1, 2.
The undersigned GRANTS petitioner’s Motion for a Decision Dismissing Petition.
FACTS
Pre-vaccination records
Petitioner has had primary osteoarthritis of the knee since March 12, 2008. Med. recs.
Ex. 4, at 140.
2
Osteoarthritis is “a noninflammatory degenerative joint disease seen mainly in older persons,
characterized by degeneration of the articular cartilage, hypertrophy of bone at the margins, and changes
in the synovial membrane. It is accompanied by pain, usually after prolonged activity, and stiffness,
particularly in the morning or with inactivity.” Dorland’s Illustrated Medical Dictionary 1344 (32nd ed.
2012) (hereinafter, “Dorland’s”).
2
On March 7, 2013, RN Katie Lashway noted that petitioner needed transportation to get
to medical appointments and diabetes group visits because she was unable to ride the bus due to
her inability to walk the length of a city block without having to stop for rest due to pain in her
legs and joints. Med. recs. Ex. 3, at 26.
On May 5, 2013, petitioner saw NP Carol A. Thiel for right biceps tendinitis. Id. at 32.
Petitioner had had right shoulder pain for almost one month. The right anterior upper arm pain
radiated to the deltoid area and above. She had been washing clothes the day before the pain
started. Id.
On May 14, 2013, petitioner saw Dr. Michael Mendoza for left shoulder pain, which she
described as the “worst pain ever.” Id. at 35. Petitioner pointed to the deltoid region of her left
shoulder as being painful with radiation of pain down her left arm. Id. The pain was 10 out of
10. Id. On physical examination, petitioner had limited flexion of her left arm compared to her
right arm. Id. at 36. She could move up to 100 degrees on her left, but up to 160 degrees on her
right. She had pain with abduction against force when isolating the deltoid and supraspinatus
muscles. Her rotator cuff tendinitis was improving but persistent. Id.
On May 31, 2013, petitioner saw Dr. Thomas L. Campbell, complaining of left arm pain.
Id. at 41. She had had some severe left arm pain, which might have been tendinitis, which now
resolved on ibuprofen. Id. at 42.
However, on June 24, 2013, petitioner started physical therapy for left shoulder pain,
whose onset she said was three months earlier. Med. recs. Ex. 4, at 143. She said she started a
new exercise program three months previously plus she also did a lot of housework. Id. She had
been disabled since 2005 and was previously a hairdresser. Id. at 144. The pain in her left
shoulder was lateral and anterior, sometimes extending to her wrist. It was aching and painful.
On a scale of 10, she rated her pain at 8. The symptoms worsened with reaching, lifting,
carrying, and overhead activity. Her left shoulder had forward flexion of 100 degrees and
abduction of 100 degrees. Id. P-T Mary Jane Bouley wrote petitioner’s findings were consistent
with a 56- year-old woman with adhesive capsulitis with pain, range of motion limitations,
strength limitations, and functional limitations. Id. at 145.
On June 5, 2013, petitioner saw Dr. Campbell, complaining of a recurrence of left arm
pain when she moved that arm or lifted things. Med. recs. Ex. 3, at 55. He diagnosed her with
rotator cuff tendinitis. Id. at 56.
Post-vaccination records
On November 19, 2013, petitioner received flu vaccine. Id. at 66.
3
On December 17, 2013, petitioner saw Dr. Campbell for allergic rhinitis, diabetes type II,
and benign essential hypertension. Id. at 69. She did not complain about her left arm.
On January 9, 2014, petitioner saw Dr. Elizabeth Loomis for sinusitis and benign
essential hypertension. Id. at 73. She did not complain about her left arm. On musculoskeletal
physical examination, petitioner had normal range of motion, without swelling or tenderness. Id.
at 74.
On January 28, 2014, petitioner saw Dr. Campbell for a sinus infection. Id. at 77. She
did not complain about her left arm.
On January 29, 2014, petitioner saw Dr. Stephen Lurie, complaining of nasal congestion
occasional bilateral epistaxis (nosebleed), and abdominal pain. Id. at 91. She did not complain
about her left arm.
On February 14, 2014, petitioner saw Dr. Thomas Gregg, complaining about left arm
pain that had lasted three months. Id. at 95. The pain was dull and in the biceps region. Id. On
physical examination, petitioner had pain on resisted external rotation of her left shoulder and
mild biceps tendon tenderness, but all other physical examination maneuvers were normal
without pain or tenderness. Id. at 96. He diagnosed her with muscle strain of her left biceps. Id.
(This is three months post-flu vaccination and petitioner’s complaint was restricted to her left
biceps, not her left shoulder. Her vaccination would have been administered in her deltoid, not
her biceps.)
On February 27, 2014, petitioner saw Dr. Campbell for various reasons, including
diabetes, gastroesophageal reflux, losing weight, left arm pain, and neck pain. Id. at 99-100.
She said her neck and shoulder pain were the “worst pain ever”. Id. at 100. Dr. Campbell noted
that petitioner’s left arm pain had been occurring the prior one to two weeks from the triceps into
the left biceps. Id. He reflected she had left arm pain in spring 2013 when she had a shoulder
injection in May 2013 that was helpful. She denied any injury in the area. Id. Dr. Campbell’s
assessment was her left arm pain was likely musculoskeletal. Id. at 106.
On April 23, 2014, petitioner went for a P-T evaluation with P-T Danielle Blankenship.
Med. recs. Ex. 4, at 161. Petitioner told P-T Blankenship that there was no specific cause for her
left upper arm pain. Its onset was over a year previously. The pain started in her shoulder and
then went down her wrist to her hand. It then went into her left axilla. She had been exercising,
but was afraid to keep exercising for fear it might cause further pain to her left arm. The pain
was aching, sharp, and constant. It was in all aspects of her left arm and shoulder, including the
left scapular muscles. She had decreased range of motion. It hurt at night, when she reached
overhead to the side or behind her back, or when she lifted. Id.
On April 30, 2014, petitioner returned to P-T and felt her pain improved. Id. at 192. She
had received a cortisone injection to her left shoulder since her last P-T. Id. at 205.
4
On May 29, 2014, petitioner saw Dr. Campbell for a variety of reasons including pain in
her left shoulder. Med. recs. Ex. 3, at 115. She went to an orthopedist in Brockport who
diagnosed her with arthritis of her shoulder and gave her a steroid injection which helped
somewhat. Id. at 116. She was undergoing physical therapy, which helped. Id.
On August 1, 2014, petitioner saw PA Colleen McTammany for a follow up to her left
elbow and shoulder pain. Med. recs. Ex. 4, at 232. A cortisone injection in the lateral
epicondylitis the prior time helped her pain significantly. Now she complained of an occasional
ache in her forearm. She had 5 out of 5 strength in her shoulder, elbow, and wrist. The
assessment was lateral epicondylitis. Id.
On November 14, 2014, petitioner returned to PA McTammany for follow up. Id. at 258.
She had forearm pain that day and felt a popping and pain in her neck. There was no known
injury. PA McTammany reviewed petitioner’s MRI of her shoulder in 2010. X-ray revealed
petitioner had glenohumeral joint arthritis with a spur. Id.
On December 1, 2014, petitioner saw Dr. Donna G. Ferrero, complaining of chronic, left-
sided shoulder pain following a flu shot in 2013. Id. at 272-73. This was over one year since she
had the flu vaccination and it was the first time petitioner told a doctor that her shoulder pain
followed a flu vaccination. Petitioner told Dr. Ferrero that her symptoms had progressed so that
she now had left-sided neck pain and wrist pain. Id. at 273. Doctors had diagnosed her with
rotator cuff tendinitis, lateral epicondylitis, and wrist sprain. Physical therapy did not help. Id.
On December 11, 2014, petitioner underwent a physical assessment with OTD Dana
Emery during which petitioner made less than optimal effort with grip and pinch testing. Id. at
326. If petitioner had given full effort, a bell curve would have resulted from grip testing in all
five positions. However, petitioner’s readings were nearly identical across all positions,
indicating poor effort. Petitioner reported inability to use her left arm due to pain, although she
was able to get down into the bottom of a tub and out of it without assistance. Petitioner also
reported independence in feeding, including cutting meat, and independence in grooming,
including opening containers. OTD Emery noted that these findings were not consistent with
grip and pinch strength testing. Id.
On January 9, 2015, petitioner saw NP Lori Conway with numerous complaints,
including left arm pain, which she related to her flu vaccination on November 19, 2013. Med.
recs. Ex. 3, at 121-22. Petitioner said she remembered the vaccination was very painful. Id. at
122. However, NP Conway noted that petitioner’s MRI in 2010 showed problems with her
rotator cuff. Moreover, there were recent x-rays showing petitioner had arthritis and a bone spur.
On physical examination, petitioner had left arm pain and tenderness over the shoulder, biceps,
and triceps. Id. NP Conway commented that she “again reiterated that I did not think this was
related to her influenza vaccine.” Id. at 123.
5
On March 23, 2015, petitioner saw Dr. Campbell, complaining of ongoing pain in her left
shoulder. Id. at 130. A recent MRI showed significant arthritis of her left shoulder. Id.
On March 30, 2015, Dr. Jonathan C. Gabel wrote that imaging of petitioner’s left
shoulder showed: (1) mild left supraspinatus tendinopathy with superimposed partial-thickness
articular surface tear; (2) moderate infraspinatus tendinopathy, and moderate tendinopathy of the
intra-articular portion of the long head of the biceps tendon; and (3) severe glenohumeral joint
osteoarthritis, degeneration/tearing of the labrum, and small glenohumeral joint effusion with
debris vs. synovitis. Med. recs. Ex. 4, at 91. His assessment was degenerative joint disease of
the left shoulder. His suggestion was to repeat the cortisone injection and P-T. Petitioner might
eventually require arthroplasty. 3 Id.
On November 9, 2015, Dr. Natercia Rodrigues wrote that petitioner injured herself
moving her mother. Med. recs. Ex. 3, at 188. Petitioner’s mother had been in and out of the
hospital for congestive heart failure. Petitioner took care of her while she was in the hospital,
helping her mother with washing herself and moving around. Petitioner reported she had back
pain generalized to her left side. Petitioner had to push manually the footrest of her mother’s
recliner down into her chair and, when she did this, petitioner felt pain on her left shoulder and
left side down into her back. She felt as if she pulled a muscle. Petitioner had known left
shoulder osteoarthritis and doctors instructed her not to do any lifting with her left shoulder. She
got a steroid shot every three to four months. Petitioner was getting an aide to help her mother.
Id.
On November 24, 2015, petitioner saw Dr. Assunta Ritieni for left shoulder pain of two
months, and left rib pain after trying to lift her mother. Id. at 192. She also complained of
aching and worsening with lifting her arm and coughing. Id.
On January 7, 2016, petitioner saw Dr. Campbell who noted that petitioner was recently
evaluated for her left shoulder pain and was found to have a rotator cuff tear with significant
tendinopathy. Id. at 198. On physical examination, she had a very tender left rotator cuff with
limited range of motion of her shoulder. Id. at 199.
On March 21, 2016, MRI evaluation of petitioner’s left shoulder concluded: (1) mild left
supraspinatus tendinopathy with superimposed partial-thickness articular surface tear; (2)
moderate infraspinatus tendinopathy and moderate tendinopathy of the intra-articular portion of
the long head of the biceps tendon; and (3) severe glenohumeral joint osteoarthritis,
degeneration/tearing of the labrum, and small glenohumeral joint effusion with debris vs.
synovitis. Med. recs. Ex. 4, at 125. The diagnosis was left glenohumeral arthritis, partial tear of
left rotator cuff, and left shoulder pain. This diagnosis was consistent with arthritis and partial
rotator cuff tear. Id.
3
Arthroplasty is “plastic surgery of a joint.” Dorland’s at 158.
6
DISCUSSION
To satisfy her burden of proving causation in fact, petitioner must prove by preponderant
evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical
sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y
of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion
in Grant v. Sec’y of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992):
A persuasive medical theory is demonstrated by “proof of a logical
sequence of cause and effect showing that the vaccination was the
reason for the injury[,]” the logical sequence being supported by
“reputable medical or scientific explanation[,]” i.e., “evidence in
the form of scientific studies or expert medical testimony[.]”
418 F.3d at 1278.
Petitioner must show not only that but for flu vaccine, she would not have osteoarthritis,
but also that flu vaccine was a substantial factor in bringing about her osteoarthritis. Shyface v.
Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
Here, however, petitioner had osteoarthritis before her flu vaccination in 2013. Therefore,
she would have to prove that the 2013 flu vaccine significantly aggravated her pre-existing
osteoarthritis. The Vaccine Act defines “significant aggravation” in 42 U.S.C. § 300aa-33(4) as
“any change for the worse in a preexisting condition which results in markedly greater disability,
pain, or illness accompanied by substantial deterioration of health.”
The medical records show that flu vaccine did not significantly aggravate petitioner’s
preexisting osteoarthritis. It took petitioner three months after vaccination even to mention that
her left arm hurt and, when she did complain to her doctors, she said what hurt was her left
biceps, not her shoulder. For months, she could not give treating doctors and physical therapists a
cause for her pain. She related her left arm osteoarthritis to the left arm osteoarthritis that Dr.
Campbell diagnosed in May 2013. Only in December 2014, more than one year after flu
vaccination, did she even mention that her left arm had been hurting her since the 2013 flu
vaccination, but in light of the earlier records, this December 2014 statement is not credible.
There was one significant aggravator of her left shoulder pain--when she moved her mother’s
position when her mother had congestive heart failure and was in the hospital, petitioner seriously
aggravated her preexisting left arm osteoarthritis.
Osteoarthritis is generally a disease of the elderly resulting in degeneration of joints.
Beyond the fact that petitioner has struggled since 2008 with knee osteoarthritis, she has
periodically had problems with both her left and right shoulders, even complaining that the pain
in her left shoulder pre-vaccination was the “worst ever.”
7
Flu vaccination can occasionally be administered too high up, i.e., in the shoulder itself
rather than in the deltoid. But if that had happened to petitioner, she would have had immense
pain that sent her to the doctor or an emergency room within days of vaccination. That did not
happen. Petitioner is frequently at a doctor’s office for her diabetes, morbid obesity,
osteoarthritis, sinusitis, gastroesophageal reflux, abdominal pain, and other illnesses. Her first
post-vaccinal complaint about her left arm occurred three months after vaccination and she
complained about her left biceps. The biceps is not the location of a vaccination. It is not near the
shoulder.
Moreover, none of petitioner’s treating doctors opined that the 2013 flu vaccination
caused or significantly aggravated petitioner’s osteoarthritis. Nurse practitioner Lori Conway
reiterated her opinion that petitioner’s left arm pain had nothing to do with her flu vaccination.
The Federal Circuit in Capizzano emphasized that the special masters are to evaluate
seriously the opinions of petitioner’s treating doctors since “treating physicians are likely to be in
the best position to determine whether a logical sequence of cause and effect show[s] that the
vaccination was the reason for the injury.” 440 F.3d at 1326. See also Broekelschen v. Sec’y of
HHS, 618 F.3d 1339, 1347 (Fed. Cir. 2010); Andreu v. Sec’y of HHS, 569 F.3d 1367, 1375
(Fed. Cir. 2009).
The undersigned cannot rule in petitioner’s favor based solely on her allegations
“unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-13(a)(1). The
medical records do not substantiate flu vaccine causing petitioner any reaction much less that she
had significant left arm pain subsequent to it or increased osteoarthritis because of it. Petitioner
did not file an expert medical opinion in support of her allegation that flu vaccine caused her
arthritis. The undersigned GRANTS petitioner’s Motion for a Decision Dismissing Petition. The
undersigned cancels the first telephonic status conference scheduled in this case on Tuesday,
February 7, 2017, at 12:00 p.m. (EST).
CONCLUSION
This petition is DISMISSED. In the absence of a motion for review filed pursuant to
RCFC Appendix B, the clerk of the court is directed to enter judgment herewith. 4
IT IS SO ORDERED.
January 23, 2017 s/Laura D. Millman
DATE Laura D. Millman
Special Master
4
Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
8