Williams-O'banion v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 08-743\/
Fiied; Ju1y25, 2014 RECEj‘V/}:_-
-‘UL 2 5 2014
RICHARD WILLIAMS-O’BANION, * U.S. CUURT OFFFEEE CLERK
* Special Master EHAL CLA!MS
* Hamilton-Fieldman
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Petitioner, * Decision on the Record; Insufficient
v, * Proof of Causation; Vaccine Act
* Entitlement; Denial of Compensation
SECRETARY OF HEALTH * Without Hearing; RCFC Rule S(d).
AND HUMAN SERVICES, *
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Respondent. *
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Richard Williams-O’Banion, Pr0 Se, Rancho Cordova, CA, Petitioner.
Lara Englund, United States Department of Justice, Washington, DC, for Respondent.
DECISIoN'
On October 20, 2008, Richard Williams-O’Banion ("Petitioner") filed a petition for
compensation under the National Vaccine lnjury Compensation Program ("the Prograrn"), 42
U.S.C. §300aa-l0 et seq. (2006),2 alleging that he suffered neurological injuries caused by
l The undersigned intends to post this Decision on the United States Court of Federal
Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, §
205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). As provided
by Vaccine Rule l8(b), each party has l4 days within which to file a motion for redaction "of
any information furnished by that party (l) that is trade secret or commercial or financial
information and is privileged or confidential, or (2) that are medical files and similar files the
disclosure of which would constitute a clearly unwarranted invasion of privacy." Vaccine Rule
l8(b). In the absence of such motion, the entire decision will be available to the public. Ia'.
w 2 The National Vaccine lnj,ury Compensation Program comprises Part 2 of the National
Childhood Vaccine lnjury Act of 1986, Pub. L. No. 99-660, lOO Stat. 3755, codified as amended,
42 U.S.C. §§30()aa-l() et seq. (2()06). Hereinafter, individual section references will be to 42
U.S.C. §300aa of the Vaccine Act.
receipt of an influenza ("flu") vaccination on October 28, 2005. Petition ("Pet") at l, ECF No. l.
For the reasons set forth below, the undersigned finds that the record does not support
entitlement to an award under the Program.
l
PROCEDURAL HISTORY
An initial Order was issued in the case on November l8, 2008. Order, ECF No. 4.
Petitioner was originally represented by the Homer, Conway & Chin-Caplan law tirm. Pet. at l.
Petitioner’s counsel filed a Motion to Withdraw as Attorney of Record on July 31, 2009.
l\/Iotion, ECF No. 19. During the next year, no filings were made in this case. However, on
August 5 , 20l0, Petitioner’s counsel filed a status report, outlining the status of the case.
Petitioner’s counsel stated that he had mailed Petitioner several letters, explaining why
Petitioner’s counsel would no longer remain on the case. Status Report at l, ECF No. 2l.
Petitioner’s counsel had additionally contacted another experienced Vaccine Program attorney to
see if she was interested in representing Petitioner, and on June 9, 20l 0, the attorney notified
Petitioner’s counsel that she was not interested in representing Petitioner. Id. at l-2. Petitioner’s
counsel then sent Petitioner a follow-up letter, asking him how he wished to proceed with the
case; the letter requested that Petitioner contact Petitioner’s counsel’s office "lz)osthaste." Ia’. at
2. Telephone messages were left for Petitioner on July 6th, l6th, and 30th, 20l0. Id. at 2. On
August 4, 2010, Petitioner’s counsel again called Petitioner. A message on the telephone
indicated that Petitioner’s telephone number had either changed or was disconnected. Id. at 2.
On September 7, 2010, the special master granted Petitioner’s counsel’s Motion to
Withdraw as Attorney of Record. Order, ECF No. 23. The special master ordered Petitioner to
inform the court of how he wished to proceed with his case by no later than February 7, 20l l.
Order, ECF No. 24. The special master’s order was returned to the court as undeliverable.
Notice, Jan. 4, 201 l, ECF No. 26.
Petitioner’s failure to respond to the September 7 order prompted the special master to
issue an Order to Show Cause, which instructed Petitioner to provide the court with a valid
address, telephone number, and a determination of how Petitioner wished to proceed with his
claim. Order, ECF No. 27. The mail was again returned to the court as undeliverable (Notice,
Apr. 8, 201 l, ECF No. 28); however, on May 9, 201 l, Petitioner submitted a current address to
the court and indicated that he wished to proceed as a pro se Petitioner. Response, ECF No. 29.
On September 9, 201 l, Respondent’s counsel filed a Rule 4(c) Report, stating that
"[t]here is no evidence in the record that petitioner’s neurological symptoms were caused by the
flu vaccine he received in October 2005." Report at 25, ECF No. 33. The special master ordered
Respondent to revise this Rule 4 (c) Report by putting all information into numbered paragraphs
condition or injury either falls within one of the "Table Injury" categories, or is shown by
medical records or a competent medical opinion to be vaccine-caused No such proof exists in
the record. Thus, this case is dismissed for insufficient proof. In the absence of a timely-
filed motion for review of this decision (see Appendix B to the Rules of the Court), the
Clerk shall enter judgment in accord with this decision.
IT IS SO ORDERED. _
Lisa D. IIarni!to11-Fie!dn1an
Special Master
ll
Order, ECF No. 37. Respondent’s counsel filed a revised Rule 4(c) Report on October 31, 201 l.
Report ECF No. 36.3
Eleven months later, Petitioner filed a Respense to Respondent’s Repoi't. Respotise, ECF
No. 45. Petitioner w'as thereafter ordered to file an expert report in pursuit ofhis claim. Order.
Aug. 24, 2010, ECF No. 46. Specit``ically, Petitioner was ordered to tile an expert report from his
treating physician, Dr. Williain R. Work. M.D., by no later than November 30, 2012. Order_.
ECF No. 50.
Petitioner did not file the letter of Dr. William R. Work, M.D. until February 19, 2013.
Notice, ECF No. 53. Upon reviewing Dr. Work"s letter_. the special master found that Dr. Work
did not conclude why or how Petitioner’s injury occurred, nor did Dr. Work explain the medical
records upon which he relied in asserting that Petitioner``s neurological symptoms began one day
following vaccination. The special lnaster submitted additional questions regarding Petitioner’s
claim to Dr. Work for further clarification.
The case was reassigned to the undersigned on March 18, 2013, pursuant to Vaccine Rule
3(d). Order, ECF No. 55 . Three months later, Petitioner filed Dr. Work``s Responses to the
court-ordered questionnaire. Response_. june 12. 2013, ECF No. 59. Dr. Work’s responses did
not provide evidence of a biological mechanism or scientific theory causally connecting
Petitioner’s vaccination with his injury, nor did Dr. Work``s answers provide any basis for his
conclusion concerning a date of onset one day following vaccination,
When questioned at a status conference, Petitioner failed to explain where evidence
existed in the record, denoting the onset of his symptoms one day following vaccination, EDR
Recording of Status Conference, Jul. 16, 2013, 2:16:21-2:18:50; Minute entry'_, .lul. 16, 2013.
Petitioner concluded, "[w]hat I have is the response to VAERSA' that I’ve sent and the notations
from my doctor [Dr. Work] stating the symptoms that immediately followed." Ia’. at 2:18:30-
2:20:00. The undersigned reiterated the concern that there were a number of visits to medical
providers in the period following vaccination, but no information in the record to show any
3 The undersigned has reviewed the extensive medical records filed in this case; however,
because Respondent’s Rule 4(c) Report contains a medical record summary that constitutes a
comprehensive summary of those extensive medical records, the undersigned does not herein
provide another such summary.
4 VAERS ("Vaccine Adverse Events Reporting System") is a database ereated, pursuant
to the Vaecine Act, by the FDA and the Centers for Disease Control and Prevention to receive
reports about adverse events which may be associated with vaccines. See Vaccine Adverse
Event Reporting System, uvcr."!c:hle at https::’fvaers.hhs.govfaboutfindex. See ctf.s'r) i\r'ctnce t-'. Sec ’y
c)_/``f!eu[th & Fltrmcrn S'ert’.s'., No.06-0T30V._ 2010 WL 3291896._ at *9 (l~'ed. Cl. Spec. Mstr. july
30, 2010) (discussing that VAERS is a surveillance system that accepts "'voltintarily submitted"
reports of events from manut``ztcturers, health care workers and patients_. and that the experiences
reported are unsolicited and reflect the reporting party’s concern of a possible relationship to
vaccination).
neurological injury until February of 2006. Id. During this status conference, the undersigned
also asked Petitioner if Dr. Work planned on filing anything else into the medical record in this
case. Petitioner stated that "[Dr. Work] was very stressed and is still very stressed out over the
letters . . . he tried to make himself as clear as possible as far as . . . his perception [or] any
doctor’s perception." Ia’. at 2:15:00-2:16:00. When questioned as to if Petitioner would be
retaining a medical expert in this case, Petitioner stated that he would not be retaining one. Ia'. at
2:2?':00-2:27:30. Respondent’s counsel then suggested that the next move in the case would be
for Respondent to file a Motion for Summary judgment since no expert report would be filed,
and Respondenl's counsel believed that the only evidence establishing vaccine causation
concerned timing, which is not sufficient under the law. Ia'. at 2:31:00-2:32:00. The undersigned
then explained the proposed filing procedure to Petitioner to see if he was amenable to
proceeding forward in this way; Petitioner consented to proceeding forward with the case in this
fashion because he wanted a resolution of this case. Ia'_ at 2:32:00-2:37:40.
The undersigned thereafter ordered Respondent to file a Motion for Summary Judgment,
Petitioner to file a Response to that l\/lotion, and Respondent to file a Reply. Order, ECF No. 6l.
Respondent’s Counsel filed a Motion for a Ruling on the Record on Augtlst l6, 2013. Motion,
ECF No. 62. On December 3, 2013, Petitioner filed his Response to Respondent’s Motion for a
Ruling on the Record. Notice, ECF No. 72. Respondent filed a Reply in support of the Motion
for a Ruling on the Record on January l4, 2()14. Reply, ECF No. 75. This case is now ripe for a
decision on the record.
II
DISCUSSION
To receive compensation under the Prograni. a petitioner must prove either: (1) that the
petitioner suffered a "'Table lnjtiry" -- i.e.._ an injury included in the vaccine Injtrry 'l``able --
corresponding to his vaccination. or (2) that the petitioner suffered an injury that was actually
caused by his vaccination. See 42 U.S.C. §§ _'SOOaa-IB(a)(I)(A) and BO{Jaa-l l(c_}(l). ``l``o
establish causation-in-fact, the petitioner must demonstrate by a preponderance of the evidence
that the vaccine was the cause of the injury. § _``)OUaa-lji(a)( 1 )(A). The petitioner is required to
e vaccine was "``not only |_``the] but-for cause of the injury but also a substantial factor
in bringing about the injury'." ll/[r)t')erly' v. Sec ``y r)j``l’~{ea!!h & i!z:)n.::n Servs., 592 F.Sd 1315, 1321
(Fed. Cir. 2010) (qttoting S'h},_'f£rce v. S'et' 'yr;yffleal£h & freeman .S'e.rv.r., 165 F.}d 134=1-. 1352-53
(Fed. Cir. 19‘\)9)). Purstlant to Rule S(d) ofthe Rules of the Court of Federal Clairns ("``RCFC"),
"‘[t]lie special master may decide a case on the basis ofwritten submissions without conducting
an evidentiary hearing." RCFC S(d).
prove that th
ln the serninal case of Althen v. .">``ecre£c:r_v rg)"¢‘)'ve Depcnrt:ne)z.'. r)j'fz'e.:':{th and Human
Servz``ce.s'. the federal Cireuit set forth a three-prong test used to determine whether a petitioner
has established a causal link between a vaccine and the claimed injury. See s1 Ilhien v. iSec ’y of
Health & Human Servs., 418 F.3d 1274, 1279 (Fed. Cir. 2()05). TheAlthen test requires the
petitioner to set forth: "(l) 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
4
inj ury; and (3) a showing of a proximate temporal relationship between vaccination and injury."
[a'. To establish entitlement to compensation under the Program, a petitioner is required to
establish each of the three prongs of Althen by a preponderance of the evidence. See ia'.
Specifically, under the first prong of Althen, petitioners must offer a scientific or medical
theory that answers in the affirmative the question "can the vaccine(s) at issue cause the type of
injury alleged?" See Payj”om’ v. Sec ’y of Health & Human Servs., No. 0l-0l 65\/, 2004 WL
1717359, at *4 (Fed. Cl. Spec. Mstr. July l6, 2004) (emphasis added). This may be
accomplished in a number of ways. Id "Reliability and plausibility of pathogenesis can be
bolstered by providing evidence that at least a sufficient minority in the medical community has
accepted the theory, so as to render it credible." Id. In addition, epidemiological studies and an
expert’s experience, while not dispositive, lend significant credence to the claim of reliability;
articles published in respected medical journals, which have been subjected to peer review, are
also persuasive. Ia'. However, publication “does not necessarily correlate with reliability,"
because "in some instances well-grounded but innovative theories will not have been published."
Daubert v. Merrell D0w Pharmaceutz``cals, Inc., 509 U.S. 579, 593-94 (1993).
ln addition to showing that the vaccine at issue can cause a particular injury, a petitioner
must also prove that the vaccine actually did cause the alleged injury in a particular case. See
Pq]j’orcz', 2004 WL 1717359, at *4 (emphasis added); Althen, 418 F.3d at l279. A petitioner does
not meet this obligation by showing a temporal association between the vaccination and the
injury; petitioner must explain how and why the injury occurred. Pafford, 2004 WL 1717359, at
*4.
While a temporal association alone is insufficient to establish causation under the third
prong of Althen, a petitioner must show that the timing of the injury fits with the causal theory.
See Althen, 418 F.3d at l278. F or example, if petitioner’s theory involves a process that takes
several days to develop after vaccination, an injury that occurred within a day of vaccination
would not be temporally consistent with that theory. Conversely, if the theory is one that
anticipates a rapid development of the reaction post-vaccination, the development of the alleged
injury weeks or months post-vaccination would not be consistent with that theory. The special
master cannot infer causation from temporal proximity alone. ln fact, it has been held, that
where a petitioner's expert views the temporal relationship as the "key" indicator of causation,
the claim must fail. See Thibaudeau v. Sec ’y ofHealth & Human Servs., 24 Cl. Ct. 400, 403
(Fed. Cl. Oct. 23, l99l); see also Grcmt v. Sec 'y ofHealth & Human Servs., 956 F.2d ll44
(Fed.Cir. 1992); Hasler v. Unz'ted States, 7l8 F.2d 202, 205 (6th Cir. 1983) (stating that
inoculation is not the cause of every event that occurs within a ten-day period following it).
A petitioner who demonstrates by a preponderance of the evidence that he suffered an
injury caused by vaccination is entitled to compensation, unless the respondent can demonstrate
by a preponderance of the evidence that the injury was caused by factors unrelated to the
vaccination. See Althen, 418 F.3d at 1278; Knudsen v. Sec ’y ofHealth & Human Servs., 35 F.3d
543,547(1¢@¢1_ Cir. 1994)_
ln this case, Petitioner sought redress for his injury under the Vaccine Act’s
compensatory provision for off-Table injuries. The undersigned examined Petitioner’s medical
records and did not find any evidence that satisfies the three elements of causation set forth
above. Petitioner has not proven that the influenza vaccination can cause or did cause his
alleged neurological injury. The undersigned will outline below why Petitioner failed to satisfy
all prongs of Althen and is not entitled to compensation under the Program.
A. Althen Prong I
Under the first prong of Althen, Petitioner is required to set forth a reliable medical
theory, explaining how a particular vaccination can cause a particular injury. Althen, 418 F.3d at
1279. Scientific certainty is not required to establish causation under the Vaccine Act. Ia’. at
1280 (indicating that the purpose of the Vaccine Act’s preponderance of the evidence standard
"is to allow the finding of causation in a field bereft of complete and direct proof of how
vaccines affect the human body"). However, a causation theory accepted by a special master
must be supported by a "sound and reliable" medical or scientific explanation. Knudsen, 35 F.3d
at 548.
In this case, the evidence submitted by Petitioner consists of medical records, a letter
from Petitioner’s personal treating physician, Dr. William R. Work, M.D., Dr. Work’s responses
to Special Master Moran’s questionnaire, and a report from VAERS. None of this evidence
demonstrates a sound and reliable scientific theory connecting the influenza vaccination to
Petitioner’s neurological injury. The closest that Petitioner gets to establishing a causal theory is
through Dr. Work’s responses to a questionnaire, regarding the basis of Dr. Work’s opinion of
Petitioner’s claim. In response to the question about his own personal opinion as to the cause of
Petitioner’s polyneuropathy, Dr. Work stated:
There is no exact test that "proves" a vaccine polyneuropathy. You can test for
neuropathy and you can test for the extent of the neuropathy, but the cause of the
neuropathy can rarely ever be determined definitively. . . So my opinion that it is
a vaccine neuropathy is quite simple. . . . On October 28, 2005, [Petitioner] was
documented to have received an influenza vaccine (while undergoing the anti-
viral therapy) at Kaiser Perrnanente. His symptoms started the following day . . . .
[Since he] began having disabling symptoms the day following the influenza
vaccine and was later diagnosed with neuropathy and the symptoms that he has
are the same as those found on VAERS for people suffering with vaccine
polyneuropathy, then the simplest answer is the most likely one, i.e., [Petitioner’s]
polyneuropathy was from the influenza vaccine. . . .
Response (Ex. l) at 2, ECF No. 59.
This is an argument based solely on the temporal connection between Petitioner’s receipt
of the vaccine and the alleged onset of his neurological symptoms. lt offers no scientific
explanation for the alleged correlation between the influenza vaccine and polyneuropathy from
which Petitioner suffers. Absent a valid scientific theory connecting the influenza vaccination to
Petitioner’s inj ury, an asserted temporal association alone is insufficient to establish entitlement
to compensation under the Vaccine Program. Moberly, 592 F.3d at 1323. There can be no
assessment of whether the timing of an injury is consistent with a causal theory where no causal
theory is presented. While Dr. Work concludes that given the temporal association between
vaccination and alleged onset of injury, Petitioner’s injury was vaccine-caused, Dr. Work’s
opinion does not promulgate any medical, scientific, or biological mechanism by which an
influenza vaccination can cause a neurological injury. Dr. Work’s opinion focuses solely on the
temporal association between vaccination and injury in this case, which does not satisfy the first
prong of Althen.
Dr. Work’s reliance on VAER’s data to establish prong one of causation is also
misplaced. Although it is undisputed that Petitioner suffers from polyneuropathy, the reliability
of VAERS data has often been called into question under the Vaccine Program. See Analla v.
Sec ’y of Health & Human Servs., 70 Fed. Cl. 552, 558 (Fed. Cl. 2006) (discussing "concerns
about the reliability of VAERS data"); Ryman v. Sec y of Health & Human Servs., 65 Fed. Cl.
35, 40, 43 (Fed. Cl. 2005) (VAERS reports may be biased toward pre-existing notions of adverse
events); Capz``zzano v. Sec ’y of Health & Haman Servs., 63 Fed. Cl. 227, 231 (Fed. Cl. 2004)
(VAERS data has limited value due to the manner in which it is collectcd, the lack of
confirmation of the reported information, and the lack of any systematic analy'sis); Manvz``lle v.
Sec j/ ofHealth & Human Servs., 63 Fed. Cl. 482, 494 (Fed. Cl. 2004) (VAERS reports can be
filed by anyone, thus raising questions about the quantity and quality of the information
gathered). Therefore, VAERS data alone, without the opinion of a credible medical expert or
without medical records, is not proof of a causal connection.
Finally, under the Vaccine Act, lack of medical literature directly connecting vaccination
and injury is not dispositive with regard to establishing causation. Althen, 418 F.3d at 1280,' see
also Daubert, 509 U.S. at 593 (acknowledging that there are circumstances in which "well-
grounded but innovative theories will not have been published"). While published medical
literature linking vaccination to injury is thus not a necessary requirement under the first prong
of ./{££herz. it is one means of establishing or reinforcing a scientific explanation of causation.
l’c.y_‘}‘€)r¢!, 2004 WL 1717359, at *4. Here, Petitioner has neither promulgated a scientific theory
of causation. nor has Petitioner filed any medical literature linking the influenza vaccination to
his neurological injury. Without a theory, supportive medical records, or medical literature
postulating a theory, there is no evidence in the record that provides a theory of vaccine
causation under Althen Prong I. As such, Petitioner’s claim fails under the first prong of Althen.
B. Althen Prong II
Under the second prong of Althen, Petitioner is required to establish "a logical sequence
of cause and effect showing that the vaccination was the reason for the injury." Althen, 418 F.3d
at 1280; see Capz``zzano, 440 F.3d at 1327 ("There may well be circumstances Wh€ke it is found
that a vaccine can cause the injury at issue and where the injury was temporally proximate to the
vaccination, but it is illogical to conclude that the injury was actually caused by the vaccine.").
The Federal Circuit has also affirmed the notion that an expert opinion, connecting vaccination
with alleged vaccine-related injury_. is no better than the soundness of the reasons supporting it.
See Perrez``ra v. Sec ``y t)ff[ea.l£fi & f[urnc:n Se:'\.».v., 33 F.3d 1375 (Fed. C.ir. 1994). in this case,
Petitioner relies on lnedical records_. the report of his treating physician, Dr. Work. and VAERS
data to attempt to establish that logical nexus in this case.
Dr. Work’s letter states that the onset of Petitioner’s neurological symptoms began the
day after Petitioner received the flu vaccination. See Response (Ex. l) at 2, ECF No. 59. The
medical records, however, simply do not support this assertion. Despite the undersigned’s and
the previous special master’s numerous attempts to have either Petitioner or Dr. Work point out
the medical records that establish this one-day onset. no such records have ever been produced
Instead, the documented onset of Petitioner’s neurological symptoms occurred many months
after his October 28, 2005 vaccination. Onset of injury is not noted in the medical records until
February 2()06, when Dr. Charles C. Fang, M.D._. noted that Petitioner presented w'ith complaints
of "diffuse joint pains," "fatigue," and "achiness." Pet’r’s Ex. 2 at ll4, 116.
When questioned at a status conference about the onset issue, Petitioner failed to explain
this discrepancy EDR Recording ol"Status Conference, Jul. 16, 2013, 2:16:21-2:18:5(); Minute
entry._ Jul. [6, 20 l 3. When Petitioner was questioned about any record of neuropathy or fatigue
between the time of vaccination and his alleged onset of injury, Petitioner could point to no
record documenting such complaints; Petitioner only pointed to the VAERS report he submitted
and Dr. Work’s letter. EDR Recording of Status Conference, Jul. 16, 2{)13, 2:16:21-2:24:00;
l\/linute entry, Jul. 16, 2013. Petitioner concluded, "‘[w[hat l have is the response to VAERS that
l’ve sent and the notations from my doctor stating the symptoms that immediately fc)llowed." Id.
at 2:18:30-2:20:00. The undersigned reiterated the concern that Petitioner had several medical
appointments with several medical providers in the months following vaccination, and that none
of the records from those visits document neurological symptoms. Petitioner responded to the
undersigned on this point by stating, "[t]hey were trying to split up my symptoms individually
and would not comment on my symptoms as a whole until they were forced to by VAERS and
my insurance company." Id. at 2:25:50-2:25:54. Despite the undersigned``s attempts at eliciting
any evidence of the onset of injury one day following vaccination, the undersigned found no
such onset.
Dr. Work stated that the basis for his statement regarding the onset of symptoms one day
after Petitioner received the influenza vaccination came from Dr. Work’s examination of the
medical records from Kaiser, and the letter from Dr. Charles Fang, dated June l3, 2006. Dr.
Work acknowledged that Dr. Fang attributed all of Petitioner’s neuropathy symptoms to hepatitis
C, but Dr. Work disagreed with that attribution Ratlter._ Dr. Work asserted that Petitioner was
able to work full-time without any impairment at his job as a loan officer up until the day the
influenza vaccine was administered (October 28, 2005). after which Petitioner was excused from
work from November l, 2005, to June l3, 2006. Response (Ex. l) at 2-3. ECF l\lo. 59. Despite
Dr. Work’s assertion on this point, there is no evidence in the record showing that Petitioner’s
time-0 ft`` work slips indicated that he was not working due to neurological symptoms. lf this is
the only evidence (Petitioner’s time~oft`` work slips) that Dr. Work has to evaluate the onset of
Petitioner"s injury. then his assessment is speculative at best. Speculation does not amount to
proofol`` causation by a preponderance of the evidence.
The report of Dr. Work does little more than establish that Petitioner had a neurological
injury of unknown etiology. Response._ ECF No. 59. Dr. Work states that the basis for his
opinion regarding Petitioner"s polyneuropatliy diagnosis \vas from the records of Dr. Michael
O’Brien and Dr. Barry Mann. Response (Ex. l) at 3. ECF No. 59. Dr. Work stated that both sets
of records included nerve conduction testing and both reported a polyneuropathy of unknown
etiology. Ia'. Dr. Work maintained that it is simply the juxtaposition of the vaccine and the onset
of symptoms combined with the nerve testing that "leads one to more likely than not conclude
that Mr. O’Banion’s polyneuropathy was caused by the intl uenza vaccine." !t'!. As discussed
earlier, this is a temporal connection not a causal one. "[N]eitlier a mere showing cfa proximate
listic elimination of other potential
temporal relationship between vaccine and injury, nor a simp
causes of the injury suffices, without more, to meet the burden of showing actual causation."'
Moberly, 592 F.3d at 1323-34 (citing Althen, 418 F.3d at 1278).
The fact that at the time Petitioner was seeking treatment for his neurological
sy~'mptoms, several of Petitioner’s doctors, and Petitioner himself at tirnes, attributed his
symptoms to hepatitis C or to his treatment for that condition_. also does not support
Petitioner``s argument that his condition was caused by the vaccine. See, e.g.. Pet’r``s i~",x. 2
at ll~’-l_. ll6, l |7-19_. 127-28; Pet’r’s Ex. 5 at 13; Pet’r’s Ex. 9 at IO-ll; Pet’r’s Ex. l0 at
l; Pet’r"s Ex. 19 at 46_. 5 l , 53; Pet’r’s Ex. 20 at 94-96; 207-10; see also Curcuras v. Sec ’y
r.y;"fi'et'.'!.'fi & Ht:rnan S'er'vs'._, 993 I````.Zd 1525 (Fed. Cir. 1993) (medical records created
contemporaneously with the events they describe are presumed to be accurate; a person
seeking treatment will report symptoms and other relevant information accurately and
completely to facilitate receiving appropriate treatment).
Finally_. Petitioner relied heavily on the VAERS data he submitted in this case to establish
a causal link between his vaccination and injury. As the undersigned has previously discussed,
the reliability of VAERS data has often been called into question under the Vaccine Program.
See Capizzano, 63 Fed. Cl. at 213 1 (VAERS data has limited value due to the manner in which it
is collected, the lack of confirmation ofthe reported infonnation, and the lack of any systematic
analysis); il/!cznw``lle, 63 Fed. Cl. at 494 (VAERS reports can be filed by anyone, thus raising
questions about the quantity and quality ofthe information gathered); Rynzc'.'n, 65 Fed. Cl. at 4(},
43 (_VAERS reports may be biased toward pre-existing notions ofadverse events``); Anc:!!t':, 70
Fed. Cl. at 558 (discussing "‘concerns about the reliability of\/AERS data"). VAERS data alone,
without the opinion of a credible medical expert and medical records, atternpting to make a
rational causal connection between that data and the vaccine and injury alleged is not proof of a
causal connection. Here, VAERS data cannot be used to demonstrate a logical sequence of
cause and effect between Petitioner’s influenza vaccination and neurological injury._ absent direct
evidence in the medical record to establish such a connection.
Since Petitioner has provided no evidence that his influenza vaccine did cause his
neurological injury, through the medical records or the opinion of a credible medical expert,
Petitioner’s claim fails under the second prong of Althen.
C. Althen Prong III
Under the third prong of Althen, Petitioner is required to show that there was a proximate
temporal relationship between vaccination and injury. Althen, 418 F .3d at l279. Petitioner
submitted records that purport to establish a temporal association between when Petitioner
received the influenza vaccination and the onset of his neurological injury. Petitioner, however,
has not shown a proximate, temporal relationship between the vaccination and alleged injury.
since it is not clear when the onset of Petitioner’s symptoms first began. Petitioner first
complained of"brain fog" in February 2006 (Pet"r’s Ex. 2 at 1l4, 116``)_; his first complaint of
weakness and difficulty walking w'as in March 2006 (l’et’r’s Ex. 2 at 120-22); and his first
complaint of numbness and ting,litig vvas in May 2006 (Pet``r``s Ex. 2 at 128-31). These incidents
took place many months after his October 2005 v'accination.
Additionally, when discussing his medical history, Petitioner stated multiple times in the
record that some of his alleged symptoms had started years prior to vaccination. See Pet’r’s EX.
2 at 5-8, 136-37, l4l-43; Pet’r’s Ex. 5 at 13; Pet’r’s Ex. 19 at 46-48, 5l, 53; Pet’r’s Ex. 20 at 94-
96, 207-l0. The process for finding facts in the Vaceine Pr-ogram begins with analyzing the
medical records. 42 U.S.C § 300aa-l l(c)(2). Medieal records that are created
contemporaneously with the events they describe are presumed to be accurate. See Curcuras,
993 F.2d at 1528. Petitioner’s history of neurological symptoms, :as noted in the medical
records, pre-date vaccination This fact alone does little to bolster Petitioner``s claim tliat onset
symptomatology began one day following receipt of the influenza vaccination. See Pet’r’s Ex. 2
at 5-8, 136-31 141-43; Pet``r’s Ex. 5 at l3; Pet’r’s Ex. 19 at 46-48, 5l, 53; Pet’r’s Ex. 20 at 94-
96, 207-l0.
Finally, as previously discussed, whether the neurological issues Petitioner attributed to
the vaccine began one day after the vaccine or several months after the vaccine is in some ways
irrelevant. Petitioner has provided no theory against which to evaluate the temporal nexus of
onset. ln the absence of that nexus, Petitioner’s claim fails under the third prong of Althen.
III
CONCLUSION
Under the Act, a petitioner may not be given a Pro gram award based solely on a
petitioncr"s claims zilone. Ratlier. the petition must be supported by either medical records or by
the opinion ot``a competent physieiari. § 13{``*¢1)(1). in this case, because there are instit``ticient
niedical records supporting Petitioner’s claim, a medical expert opinion must be offered in
support_. establishing a biological theory linking vaccination to alleged inj ury, and denionstrating
a logical sequence ot`` cause and effect between said vaeciiiatioii and iiijury. Petitioner, lio\,vever,
has not offered a credible or persuasive expert opinion
The undersigned is sympathetic to the fact that Petitioner suffers from neurological
inj uries. However, under the law, the undersigned can authorize compensation only if a medical
l0