Woodring v. Secretary of Health and Human Services ( 2016 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-896V
Filed: November 9, 2015
**************************** UNPUBLISHED
SCOTT WOODRING, *
* Chief Special Master Nora Beth Dorsey
Petitioner, *
* Entitlement; Ruling on the Record;
v. * Decision Without a Hearing; Lack of a
* Medical Opinion; Insufficient Proof of
* Causation; Acute Inflammatory
SECRETARY OF HEALTH * Demyelinating Polyneuropathy (“AIDP”);
AND HUMAN SERVICES, * Chronic Inflammatory Demyelinating
* Polyneuropathy (“CIDP”); Guillain-Barré
* Syndrome (“GBS”); Special Processing
* Unit (“SPU”)
****************************
Danielle Strait, Maglio Christopher and Toale, PA, (DC) Washington, DC, for petitioner.
Julia McInerny, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
On September 23, 2014, Scott Woodring filed a petition for compensation under
the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,2 [the
“Vaccine Act” or “Program”]. Petitioner alleges that he suffered “a severe neurological
injury, likely an inflammatory demyelinating neuropathy” after receiving the influenza
1 Because this unpublished decision contains a reasoned explanation for the action in
this case, the undersigned intends to post this decision on the website of the United
States Court of Federal Claims, in accordance with the E-Government Act of 2002 §
205, 44 U.S.C. § 3501 (2006). In accordance with the Vaccine Rules, each party has 14
days within which to request 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). Further,
consistent with the rule requirement, a motion for redaction must include a proposed
redacted ruling. If, upon review, the undersigned agrees that the identified material fits
within the requirements of that provision, such material will be deleted from public
access.
2National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755.
Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the
pertinent subparagraph of 42 U.S.C. § 300aa (2012).
vaccine on September 23, 2011. Petition at 1. Petitioner alleges that his injury was
“causally connected to an adverse reaction” to his vaccination. Petition at 2. The case
was assigned to the Special Processing Unit of the Office of Special Masters.
Under the Vaccine Act, compensation may not be awarded “based on the claims
of a petitioner alone, unsubstantiated by medical records or by medical opinion.”
§ 13(a)(1). Petitioner has failed to file the report of a medical expert, and the medical
records do not support petitioner’s claims. For the reasons discussed below, petitioner
has failed to demonstrate that he is entitled to compensation. The petition is dismissed
for insufficient proof.
I. Procedural History
Petitioner filed his petition without all relevant medical records due to the
impending expiration of the Vaccine Act’s statute of limitations.3 Petitioner filed the last
of his medical records on January 5, 2015, and the initial status conference was held
telephonically on January 23, 2015.
During the call, respondent’s counsel expressed concern regarding the length of
the time between vaccination and onset. See Order, issued Jan. 27, 2015, at 1.
Petitioner’s counsel indicated she was aware of the issue and requested additional time
for petitioner to file an affidavit and other documents to explain this lapse of time. See
id.
Instead of any additional proof, petitioner filed a motion for a decision on the
record pursuant to Vaccine Rule 8(d).4 In his motion, petitioner identified the exhibit and
page number of the medical records he believes support his claim and indicated that he
“considers the evidentiary record closed.” Motion for a Decision on the Record, filed
Mar. 4, 2015, at 1. He further indicated that he “will not proffer the opinion of a medical
expert and consequently elects not to pursue a formal causation hearing with expert
witness testimony.” Id. at 2.
Respondent filed her response approximately two months later. Respondent
argued that petitioner’s claim should not be compensated and instead, should be
dismissed. Response, filed May 15, 2015, at 1.
The matter is now ripe for adjudication.
3See Petition at 1 n.1. Petitioner included only his proof of vaccination with the petition.
See Exhibit 1.
4The Vaccine Rules, which can be found at Appendix B to the Rules of the Court of
Federal Claims (“RCFC”), govern all Vaccine Act proceedings. Vaccine Rule 1(a).
Under the Vaccine Rules, a special master may “decide a case on the basis of written
submissions without conducting an evidentiary hearing.” Vaccine Rule 8(d).
2
II. Medical History
There is little information regarding petitioner’s prior medical condition in the
medical records filed. Lab results from 2010 indicate petitioner’s cholesterol was high,
and he was prescribed medication. Exhibit 2 at 25. Later provided medical histories
indicate that he was a long time smoker. See, e.g., Exhibit 7 at 42.
On September 23, 2011, petitioner’s hearing was evaluated due to a complaint of
tinnitus in his left ear for the previous six months. Exhibit 2 at 47. It was reported that
he suffered a hearing loss during childhood due to a fever. Id. The same day,
September 23, 2011, petitioner received the influenza vaccination alleged as causal.
Exhibits 1 and 5 (proof of vaccination).
Two months later on November 21, 2011, petitioner visited his primary care
provider, Dr. Cox, for his tinnitus and for follow-up regarding his high cholesterol.
Exhibit 2 at 97. It appears petitioner’s blood pressure also may have been elevated but
no other symptoms or complaints were noted.5
Petitioner first complained of moderate to severe back pain traveling down his
right leg to his foot on February 8, 2012 (138 days after vaccination). Exhibit 2 at 47.
He indicated he had been carrying equipment up and down stairs during the previous
week but denied any particular injury. Id. Dr. Cox ordered a lumbar MRI.6 Exhibit 2 at
55. Performed on February 20, 2012, the MRI showed a pinched nerve on petitioner’s
right side, and Dr. Cox ordered pain medication and physical therapy. Id. at 100.
Petitioner began physical therapy to address his injury (diagnosed as lumbar
nerve root compression) on March 2, 2012 at Cadillac Outpatient Rehabilitation
Services. Exhibit 4 at 292. In those records, his date of onset is listed as January 1,
2012 (100 days after vaccination). Id. Described as suffering pain, decreased core
strength, and limited range of motion, petitioner was prescribed therapy (to include
aquatherapy) and heat packs. Id. at 292-293.
Based on a referral from Dr. Cox, petitioner saw Dr. Zimmerman on March 26,
2012 to determine if surgery was warranted. Exhibit 6 at 9. According to Dr.
5 The medical record contains an entry which is difficult to read but appear to indicate
“elevated DBP,” most likely an abbreviation for elevated diastolic blood pressure.
Exhibit 2 at 97. Also, later medical records indicate a history of hypertension. See, e.g.,
Exhibit 2 at 42.
6“MRI” stands for magnetic resonance imaging. MRI technology uses a magnetic field
and radiofrequency signals to visualize internal structures of the body. See MOSBY’S
MANUAL OF DIAGNOSTIC AND LABORATORY TEST’S (“MOSBY’S”) at 1166 (4th ed. 2010).
3
Zimmerman’s records, petitioner’s symptoms began approximately six weeks prior to
that visit.7 Id.
At the visit on March 26, 2012, Dr. Zimmerman reviewed petitioner’s earlier MRI
and agreed with the radiologist that the small hernia noted was not compressive.
Exhibit 6 at 9. Observing that petitioner was suffering additional symptoms of weakness
and clumsiness, he described petitioner’s symptoms as “suggestive of myelopathy.” Id.
He speculated that petitioner may have suffered a disc rupture after his February 20,
2012 MRI. Id. He ordered additional MRIs which were performed on March 27, 2012.
Id.; see id. at 3-6 (results of March MRIs).
After reviewing the MRIs done March 27, 2012, Dr. Zimmerman remained
confused by petitioner’s symptoms. Exhibit 6 at 2. The results of the MRIs were normal
except for some bulging which Dr. Zimmerman assessed as minor and insignificant.
Referencing, for example, some clumsiness in petitioner’s hands, Dr. Zimmerman
theorized petitioner suffered a myelopathy or degenerative disease. Concluding he
could not help petitioner surgically, he recommended a neurology referral. Id.
On March 28, 2012, petitioner presented to the emergency room at Munson
Medical Center8 with complaints of increasing pain, heaviness, weakness, coldness in
his feet, and numbness in his fingers. Exhibit 7 at 393. He was admitted to the hospital
for observation and an MRI and EMG were ordered. Id. at 395.
An electrodiagnostic specialist, Dr. Richardson, reviewed the findings of
petitioner’s EMG and concluded he suffered from acute demyelinating polyneuropathy,
a presentation/variant of Guillain-Barré syndrome (“GBS”).9 Exhibit 7 at 416-418.
7Six weeks prior to the March 26, 2012 visit with Dr. Zimmerman would be February 14,
2012.
8 The medical records from Munson Medical Center indicate petitioner had seen a
neurologist, Dr. Syring, earlier that day who advised that he go to the emergency room
and recommended that he receive an MRI and EMG. See, e.g., Exhibit 7 at 400. “EMG”
stands for electromyogram which is used to evaluate patients with muscle weakness.
The test monitors the electrical activity of a muscle. MOSBY’S at 577-78.
9 GBS is a
Rapidly progressive ascending motor neuron paralysis of unknown
etiology, frequently seen after an enteric or respiratory infection. An
autoimmune mechanism following viral infection has been
postulated. It begins with parathesis of the feet. Followed by flaccid
paralysis of the entire lower limbs, ascending to the trunk, upper
limbs and face . . . . Variant forms include acute autonomic
neuropathy, Miller-Fisher yndrome, acute motor axonal neuropathy,
and acute motor-sensory axonal neuropathy.”
4
Petitioner reported that he had been suffering his symptoms for three weeks but had
been fatigued for several months. Id. at 416.
That same day, March 28, 2012, petitioner saw a neurologist, Dr. Lee, who
agreed with Dr. Richardson’s interpretation of the EMG results. Exhibit 7 at 419-21.
During the visit with Dr. Lee, petitioner and his wife reported flu-like symptoms which
began approximately a month before his symptoms (which would have been early
January 2012). Id. at 419. Dr. Lee recommended “full admission” and ordered a five
day course of IVIG.10 Exhibit 7 at 421. She indicated Dr. Salon would “assume
neurological coverage.” Id.
Dr. Salon monitored petitioner during his IVIG treatment, providing several
written updates regarding his progress. Exhibit 7 at 407-415. On March 30, 2012, Dr.
Salon agreed that petitioner suffered from AIDP,11 noting that petitioner’s spinal fluid
showed elevated protein levels. He reported that petitioner’s symptoms began as long
as eight weeks after “a likely viral illness.” Exhibit 7 at 413. Petitioner improved and
was transferred to the inpatient rehabilitation unit on April 3, 2012 after finishing IVIG
treatment. Id. at 405.
The medical records from petitioner’s inpatient physical therapy (from April 3-9,
2012) reflect a diagnosis of the AIDP variant of GBS. E.g., Exhibit 7 at 71, 76. The
records also reference the “24 hour flu-like syndrome” occurring one month prior to his
symptoms which were reported to Dr. Lee on March 28, 2012. Id. at 71. Petitioner was
discharged on April 9, 2012 (id. at 31) with instructions to continue outpatient physical
therapy (see Exhibit 4 at 207). On April 17, 2012, petitioner began physical therapy at
the same provider he visited in March 2012. Id. at 208. He underwent a second course
of IVIG in May 2012. See Exhibit 2 at 19-22.
On October 15, 2012, petitioner returned to his primary care provider, Dr. Cox,
complaining of weakness and soreness after a fall. Exhibit 2 at 39. Two months later,
he visited a different neurologist, Dr. Galinas, for a second opinion. Exhibit 3 at 65. He
complained of “weakness, poor balance and frequent falls.” Id. For the first time,
petitioner mentioned his vaccination when providing his medical history. He attributed
his illness to the influenza vaccination but mistakenly indicated he received the
vaccination in November 2011. Id. (Petitioner received the influenza vaccination on
September 23, 2011.)
DORLAND’S ILLUSTRATED MEDICAL DICTIONARY (32d ed. 2012) [“DORLAND’S”] at 1832.
10“IVIG” stands for intravenous immunoglobulin. Neil M. Davis, MEDICAL
ABBREVIATIONS, 15th Edition, at 178 (2011).
11“AIDP” stands for acute inflammatory demyelinating polyradiculoneuropathy. Neil M.
Davis, MEDICAL ABBREVIATIONS, 15th Edition, at 42 (2011). Polyradiculoneuropathy is
“any disease of the peripheral nerves and spinal nerve roots.” AIDP is a variant of GBS.
5
Dr. Galinas ordered an EMG, the results of which were abnormal. Exhibit 3 at
33. After reviewing the EMG results and noting petitioner’s history of AIDP with poor
recovery after IVIG treatment, Dr. Galinas diagnosed petitioner with chronic
inflammatory demyelinating polyneuropathy (“CIDP”).12 Id.
Petitioner returned to Dr. Galinas in early January 2013 for additional lab work.
Exhibit 8 at 27. At that visit, Dr. Galinas advised him to undergo another course of IVIG
and increase his nightly dose of gabapentin. Id. at 28. After finishing IVIG treatment,
petitioner reported some improvement in his numbness but Dr. Galinas questioned the
benefit of the IVIG treatment. Id. at 25-26. Dr. Galinas prescribed prednisone,
outpatient therapies, and a home exercise program in March 2013. Id. at 24. Petitioner
reported much improvement in numbness, tingling, and strength in May 2013. Id. at 21.
He continued his outpatient physical therapy until March 10, 2014. See Exhibit 4 at 5.
At that time, it was noted that petitioner had returned to exercising at a local fitness
center and could climb stairs independently. He was instructed to continue his exercise
program at home. Id. at 16.
III. Applicable Legal Standards
Under the Vaccine Act, petitioner may prevail on his claim if the vaccinee for
whom he seeks compensation has “sustained, or endured the significant aggravation of
any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the
Table). § 11(c)(1)(C)(i). The most recent version of the Table, which can be found at
42 C.F.R. § 100.3, identifies the vaccines covered under the Program, the
corresponding injuries, and the time period in which the particular injuries must occur
after vaccination. § 14(a). If petitioner establishes that the vaccinee has suffered a
“Table Injury,” causation is presumed.
If, however, the vaccinee suffered an injury that either is not listed in the Table or
did not occur within the prescribed time frame, petitioner must prove that the
administered vaccine caused injury to receive Program compensation on behalf of the
vaccinee. § 11(c)(1)(C)(ii) and (iii). In such circumstances, petitioner asserts a “non-
Table or [an] off-Table” claim and to prevail, petitioner must prove his claim by
preponderant evidence. § 13(a)(1)(A). This standard is “one of . . . simple
12 CIDP is
a slowly progressive, autoimmune type of demyelinating
polyneuropathy characterized by a progressive weakness and
impaired sensory function in the limbs and enlargement of the
peripheral nerves, usually with elevated protein in the cerebrospinal
fluid. It occurs most commonly in young adults, particularly males,
and is related to [GBS]. Presenting symptoms often include tingling
or numbness of the digits, weakness of the limbs, hyporeflexia or
areflexia, fatigue, and abnormal sensations.
DORLAND’S at 1491.
6
preponderance, or ‘more probable than not’ causation.” Althen v. Sec’y of Health &
Human Servs., 418 F.3d 1274, 1279-80 (Fed. Cir. 2005) (referencing Hellebrand v.
Sec’y of Health & Human Servs., 999 F.2d 1565, 1572-73 (Fed. Cir. 1993). The
Federal Circuit has held that to establish an off-Table injury, petitioners must “prove . . .
that the vaccine was not only a but-for cause of the injury but also a substantial factor in
bringing about the injury.” Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344,
1351 (Fed. Cir 1999). Id. at 1352. The received vaccine, however, need not be the
predominant cause of the injury. Id. at 1351.
The Circuit Court has indicated that petitioner “must show ‘a medical theory
causally connecting the vaccination and the injury’” to establish that the vaccine was a
substantial factor in bringing about the injury. Shyface, 165 F.3d at 1352-53 (quoting
Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992)). The
Circuit Court added that "[t]here must be a ‘logical sequence of cause and effect
showing that the vaccination was the reason for the injury.’” Id. The Federal Circuit
subsequently reiterated these requirements in its Althen decision. See 418 F.3d at
1278. Althen requires a petitioner
to show by preponderant evidence that the vaccination
brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a
logical sequence of cause and effect showing that the
vaccination was the reason for the injury; and (3) a showing
of a proximate temporal relationship between vaccination
and injury.
Id. All three prongs of Althen must be satisfied. Id. Close calls regarding causation
must be resolved in favor of the petitioner. Id. at 1280.
Petitioner is not required to eliminate alternative causes when establishing his
prima facie case. Doe 11 v. Sec’y Health & Human Servs., 601 F.3d 1349, 1357-58
(Fed. Cir. 2010); de Bazan v. Sec’y, Health & Human Servs., 539 F.3d 1347, 1352 (Fed.
Cir. 2008). To support an argument regarding causation, petitioner may, however,
introduce evidence of the lack of an alternative cause. Walther v. Sec’y, Health &
Human Servs., 485 F.3d 1146, 1149-50 (Fed. Cir. 2007). Respondent also may
introduce evidence of the lack of an alternative cause to rebut evidence regarding
causation. Doe 11, 601 F.3d at 1358; de Bazan, 639 F.3d at 1353.
Once petitioner has established a prima facie case, the burden shifts to
respondent to show by preponderant evidence that petitioner’s injury was “due to
factors unrelated to the administration of the vaccine.” § 13(a)(1); see also DeBazan,
639 F.3d at 1352-54; Walther, 486 F.3d at 1150.
7
IV. Analysis of Petitioner’s Claim
Petitioner alleges that the influenza vaccination he received on September 23,
2011 caused him to suffer a demyelinating polyneuropathy later diagnosed as CIDP.
Motion for a Decision on the Record at 1. To support his claim, petitioner relies solely
on the medical records filed and arguments made in his petition and motion.
Respondent opposes compensation in this case arguing that petitioner has not
established that he suffered the injury claimed and even if he had, has not proved
causation. Response at 6. She maintains petitioner has failed to satisfy any of the
Althen prongs. Id. at 7-8.
The undersigned finds petitioner has provided evidence sufficient to establish
that he suffered the alleged injury (demyelinating polyneuropathy later diagnosed as
CIDP) but has failed to prove causation. Specifically, petitioner has failed to satisfy all
three Althen prongs. He has not provided sufficient evidence to establish a medical
theory of causation, a logical sequence of cause, and effect showing the vaccination
caused his injury and a proximal temporal relationship between vaccination and injury.
1. The Alleged Injury
Although his primary care physician, Dr. Cox, initially though petitioner’s back
pain was due to a compressed nerve, in March 2012, Dr. Zimmerman questioned this
diagnosis. An EMG was administered to petitioner in March 2012, the results of which
were consistent with AIDP, a variant of GBS. After that date, none of petitioner’s
treating physicians questioned his diagnosis, and he received treatment consistent with
that diagnosis. Petitioner did not respond well to IVIG treatment and was later deemed
to have CIDP.
2. Causation
The Secretary has proposed adding the injury of GBS following receipt of
seasonal influenza vaccines to the Vaccine Injury Table. See National Vaccine Injury
Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45,132-01
(July 29, 2015) (to be codified at 42 C.F.R. pt. 100). As described by the Secretary, this
change would apply to GBS which presents as AIDP when the petitioner’s first symptom
or onset occurs within 3 to 42 days after vaccination. Id. at 45,145-46.
Nevertheless, this change has not been finalized and even if it were, petitioner’s
onset occurred more than 42 days after vaccination. Thus, petitioner must prove
causation in this case. He must satisfy all three Althen prongs.
a. A Medical Theory Causally Connecting Vaccine and Injury.
To satisfy the first Althen prong, petitioner must show that the vaccine in question
can cause the injury alleged. See Pafford v. Sec’y, Health & Human Servs., No. 01-
165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff’d, 64 Fed. Cl. 19
(2005), aff’d, 451 F.3d 1352 (Fed. Cir. 2006). Petitioner must offer a medical theory
8
which is reputable and reliable. See, e.g., Pafford v. Sec’y, Health & Human Servs.,
451 F.3d 1352, 1355 (reputable); Moberly v. Sec’y, Health & Human Servs., 592 F.3d
1315, 1324 (Fed. Cir. 2010) (reliable). Petitioner must prove this prong by preponderant
evidence. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1350 (Fed.
Cir. 2010).
Petitioner has not filed the report of a medical expert or offered a medical theory.
He has not established that the influenza vaccine can cause CIDP.
Although the Secretary has proposed adding GBS to the Vaccine Injury Table,
she indicates that the “scientific evidence is inadequate to accept or reject a causal
relationship between seasonal influenza vaccines and GBS.” Revisions to the Vaccine
Injury Table, 80 Fed. Reg. at 45,135. She bases her recommendation on studies
showing a causal connection between earlier strains of the seasonal influenza
vaccination but asserts “there is no evidence demonstrating that current formulations of
the seasonal influenza vaccine can cause GBS.” Id. at 45,146. Moreover, here
petitioner has been diagnosed with CIDP, and that injury is not identified as an injury on
the proposed Table changes. In fact, CIDP is specifically excluded. Id. at 45,145.
Petitioner has failed to provide a medical theory causally connecting the
influenza vacation to his injury. He has failed to satisfy the first Althen prong.
b. A Logical Sequence of Cause and Effect
To satisfy the second Althen prong, petitioner must prove that the vaccine he
received did cause his injury. Pafford, 2004 WL 1717359, at *4. He must provide
preponderant evidence of causation. See Capizzano v. Sec’y of Health & Human
Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006). Opinions of a treating physician who
determines a vaccination caused the petitioner’s injury should be considered when
determining if petitioner has met his burden of proof under the second Althen prong.
See id. Any diagnosis, conclusion, or medical judgment contained in the record should
be considered when determining if compensation is appropriate. § 13(b)(1).
Petitioner has not provided evidence that the influenza vaccination he received
on September 23, 2011 caused his injury. None of petitioner’s treating doctors
attributed his condition to the vaccination he received, and petitioner was unable to
obtain a medical opinion supporting causation from his treating doctors or another
expert. A review of the medical records filed revealed that none of petitioner’s treating
physician’s offered any opinion as to the cause of his illness.
The only evidence regarding causation is found in medical histories provided by
petitioner and his wife. In the majority of those medical histories, they did not link
petitioner’s injury to his vaccination but rather a flu-like illness suffered approximately
one month prior to onset. See, e.g., Exhibit 7 at 419. It was not until ten months after
onset and more than a year after vaccination that petitioner first mentioned any
relationship between his influenza vaccination and his injury. When doing so, he
misstated the vaccination date, indicating it was two months later and thus, closer in
time to his onset. See Exhibit 3 at 65 (history provided to Dr. Galinas in December
9
2012). Prior to that time, petitioner and his wife linked his injury only to a flu-like illness
they indicated he suffered in January 2012.
Moreover, as other special masters have observed, there is a difference between
a medical history provided by petitioner and reported in his medical records and a
statement regarding causation offered by the treating physician. See, e.g., Caves v.
Sec’y, Health & Human Servs., 2010 WL 5557542, at *20 (Fed. Cl. Spec. Mstr. Nov. 29,
2010).
For all these reason, petitioner has not established a logical sequence of cause
and effect showing that the vaccination was the reason for the injury. He has failed to
satisfy the second Althen prong.
c. A Proximate Temporal Relationship between Vaccination and Injury
The third Althen prong requires that petitioner provide preponderant evidence
that the first symptom or onset of his injury “occurred within a timeframe for which . . . it
is medically acceptable to infer causation-in-fact.” de Bazan, 539 F.3d at 1352.
Petitioner must show that his injury did not occur too soon or too long after vaccination.
Id.
The medical records show that petitioner’s first symptom or onset most likely
occurred in late January or early February 2012 more than four months after his
September 23, 2011 vaccination.13 The earliest possible onset would be January 1,
2012 which is still 100 days after vaccination, and this date appears only in the records
from petitioner’s February 2012 physical therapy. See Exhibit 4 at 292.
The Secretary’s proposal to add the injury of GBS after receiving the influenza
vaccine includes a timeframe for onset between 3 to 42 days. Revisions to the Vaccine
Injury Table, 80 Fed. Reg. at 45,146. In petitioner’s case, 42 days after vaccination
would be November 4, 2011. The fact that the Secretary has proposed this time frame
does not mean that a petitioner may not obtain compensation for a claim involving a
later onset (even one that is substantially later) but the petitioner must provide evidence
establishing that the later onset is medically acceptable to infer causation.
In petitioner’s case, even based on the earliest date of onset (January 1, 2012),
the time between vaccination and onset is at least 100 days (more than twice the length
of time set forth in the proposed table change), and petitioner has provided no evidence
that an onset occurring that long after vaccination is medically acceptable to infer
causation. Petitioner has failed to provide evidence of a proximate temporal
relationship between vaccination and injury, and thus, has failed to fulfill the
requirements of the third Althen prong.
13See, e.g., Exhibit 2 at 45. When he first complained of back pain on February 8,
2012, petitioner indicated the pain’s duration was one week. This statement identifies
petitioner’s first symptom or onset as occurring on February 1, 2012.
10
V. Conclusion
Petitioner has failed to offer the opinion of a medical expert, and the medical
records filed do not support his allegations. He has failed to demonstrate that his injury
was caused the vaccination he received. Specifically, petitioner has failed to satisfy the
requirements of the Althen prongs.
This case is not a close call. Petitioner has failed to establish that he is entitled
to compensation under the Vaccine Act. This case is dismissed for insufficient
proof.
The clerk of the court is directed to enter judgment in accordance with this
decision.14
IT IS SO ORDERED.
s/Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
14 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party
filing a notice renouncing the right to seek review.
11