In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 13-441V
Filed: August 18, 2014
************************* PUBLISHED
WILLIAM H. KENNEDY, JR., *
* Special Master
* Hamilton-Fieldman
*
Petitioner, * Vaccine Act Entitlement; Decision on the
v. * Record; Insufficient Proof of Causation;
* Denial of Compensation Without Hearing;
SECRETARY OF HEALTH * Vaccine Rule 8(d).
AND HUMAN SERVICES, *
*
Respondent. *
*************************
Russell W. Lewis, IV, Johnson Law Group, Nashville, TN, for Petitioner.
Glenn A. MacLeod, United States Department of Justice, Washington, DC, for Respondent.
DECISION1
On July 1, 2013, William H. Kennedy, Jr., (“Petitioner”) filed a petition for compensation
under the National Vaccine Injury Compensation Program (“the Program”), 42 U.S.C. §300aa-
10 et seq. (2006),2 alleging that he fainted and suffered facial injuries that were caused-in-fact by
receipt of an influenza (“flu”) vaccination on October 18, 2011. Petition (“Pet”) at 2, ECF No. 1.
For the reasons set forth below, the undersigned finds that the record does not support
entitlement to an award under the Program.
1
The undersigned intends to post this Decision on the United States Court of Federal
Claims’ 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 18(b), each party has 14 days within which to file a motion for redaction “of any
information furnished by that party (1) 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 18(b). In the
absence of such motion, the entire decision will be available to the public. Id.
2
The National Vaccine Injury Compensation Program comprises 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 et seq. (2006). Hereinafter, individual section references will be to 42
U.S.C. §300aa of the Vaccine Act.
1
I
PROCEDURAL HISTORY
This case was assigned to the undersigned on July 1, 2013. Notice, ECF No. 2. The
undersigned held an initial status conference in this case on July 24, 2013. Minute Entry, Jul. 24,
2013. After this status conference, the undersigned ordered Petitioner to file a Statement of
Completion or Status Report on or before September 4, 2013; Respondent’s Rule 4(c) Report
deadline was set for 42 days after Petitioner’s Statement of Completion. Order, ECF No. 6.
Petitioner failed to comply with these deadlines; therefore, on January 15, 2014, the undersigned
issued an Order to Show Cause, instructing Petitioner to show cause for that failure. Order, ECF
No. 8.
Petitioner filed a Response to the undersigned’s Order to Show Cause, stating that
Petitioner’s counsel had received electronic notifications in this case in his “spam” folder, and
therefore court orders were not detected until after the filing of the Order to Show Cause.
Response, ECF No. 10. Petitioner indicated in his Response that he still wished to continue with
his claim, and subsequently filed outstanding medical records on January 29, 2014. Response,
ECF No. 10; Records (Exs. 1-5), ECF No. 9. On April 10, 2014, the undersigned convened a
status conference with the parties, and Petitioner’s counsel “indicated that Petitioner’s retained
expert was no longer willing to participate in this case as the most recently filed medical records
did not support his theory of causation.” Order at 1, ECF No. 16. The undersigned thereafter
ordered Respondent’s counsel to file a Rule 4(c) Report by May 15, 2014, and Petitioner to file a
Motion for a Ruling on the Record by May 29, 2014. Id.
On May 9, 2014, Petitioner’s counsel filed an “Affidavit in Support of Claim.” Pet’r’s
Aff., ECF No. 17. Respondent’s counsel filed a Rule 4(c) Report on May 14, 2014, asserting that
this case is not appropriate for compensation. Report, ECF No. 18. Petitioner filed a Motion for
Judgment on the Administrative Record on June 6, 2014. Motion, ECF No. 19. Respondent’s
Response was filed on June 23, 2014. Response, ECF No. 20. This case is now ripe for a
decision on the record.
II
FACTUAL HISTORY
Petitioner received an influenza vaccination in his left deltoid on October 18, 2011, at a
Wal-Mart in Elizabethton, Tennessee. Pet. at 2. Petitioner averred that prior to receiving the
vaccination, he did not feel “ill or light-headed,” but afterward remained in the store for fifteen
minutes, as instructed by the vaccine administrator, and then “he stood up, took two steps, and
fainted.” Id. at 2.
2
When Petitioner fell, he struck his head on the concrete floor of the store. Id. Petitioner
lost one tooth and “chipped several others down to the nerve.” Id. Petitioner “had to have three
other teeth surgically removed.” Id. Petitioner sustained “five facial fractures which required his
jaw to be wired shut.” Id. Several “plates and screws were placed in his mandible during
surgery.” Id.
Immediately following Petitioner’s fall on October 18, 2011, Petitioner was transported
by ambulance to the Bristol Regional Emergency Room. The EMS Record indicates that
Petitioner’s fasting blood sugar taken by EMS personnel at the scene was “50,” and Petitioner
was described by EMS personnel as being “hypoglycemic.” 3 EMS Record at 2, Oct. 18, 2011,
filed Mar. 28, 2014. The ambulance record stated, “[p]atient’s vitals obtained along with blood
sugar level checked showing patient was hypoglycemic. Patient stated that he was diabetic and
had just taken his flu shot and approximately two minutes later patient passed out.” Id. Petitioner
was administered oral glucose in the ambulance. Id.
Upon admission to the Emergency Room, Petitioner’s medical history noted that
Petitioner was diabetic. Pet’r’s Wellmont Bristol Regional Medical Center Records at 3. It was
also noted that Petitioner had a history of falls within the last three months. Id. at 7. The medical
records indicated that Petitioner sustained injury to his head, neck and face. Id. at 3. On
examination at Bristol Regional Medical Center, Petitioner was noted to have suffered a
“comminuted nondisplaced fracture [] of the mandibular condyles bilaterally. Additionally, a
fracture through the anterior mandible is present extending into the right mandibular body.
There appears to be a fracture of the first molar . . .” Id. at 11-12.
Petitioner was transferred to Wellmont Holston Valley Medical Center to see a facial
trauma surgeon. Pet’r’s Wellmont Holston Valley Medical Center Records at 1. Dr. Testerman,
the attending physician, wrote that Petitioner became dizzy and fell while at Wal-Mart and was
“found to be hypoglycemic.” Id. at 5. Dr. Testerman additionally noted that “[i]t was felt that the
patient possibly became hypoglycemic and fainted, [] resulting in his injury.” Id.
A discharge summary from Bristol Regional Medical Center on October 22, 2011 stated
that Petitioner underwent a surgical procedure on October 20, 2011, and had an “[o]pen
reduction with internal fixation of his mandibular fracture.” Pet’r’s Wellmont Bristol Regional
Medical Center Records at 23.
Petitioner underwent another surgical procedure on October 27, 2011, where another
tooth was removed, and bars, screws, and wires were inserted in Petitioner’s mouth and face. Id.
at 31. Petitioner also had a subsequent surgery on December 22, 2011 for his remaining facial
injuries. Id. at 218. Petitioner noted in his affidavit that he still experiences pain and physical
disfigurement as a result of his fall on October 18, 2011. Pet’r’s Aff. at 4, ECF No. 17.
3
Hypoglycemia is defined as “an abnormally diminished concentration of glucose in the
blood, which may lead to tremulousness, cold sweat, piloerection, hypothermia, and headache;
when chronic and severe it may cause central nervous system manifestations that in rare cases
can even be fatal.” Dorland’s Illustrated Medical Dictionary 902 (32nd ed. 2012).
3
III
DISCUSSION
To receive compensation under the Program, a petitioner must prove either: (1) that the
petitioner suffered a “Table Injury” -- i.e., an injury included in the Vaccine Injury Table --
corresponding to his vaccination, or (2) that the petitioner suffered an injury that was actually
caused by his vaccination. See 42 U.S.C. §§ 300aa-13(a)(1)(A) and 300aa-11(c)(1). To
establish causation-in-fact, the petitioner must demonstrate by a preponderance of the evidence
that the vaccine was the cause of the injury. § 300aa-13(a)(1)(A). The petitioner is required to
prove that the vaccine was “not only [the] but-for cause of the injury but also a substantial factor
in bringing about the injury.” Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321
(Fed. Cir. 2010) (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53
(Fed. Cir. 1999)). Pursuant to Vaccine Rule 8(d), “[t]he special master may decide a case on the
basis of written submissions without conducting an evidentiary hearing.” See Vaccine Rule 8(d).
In the seminal case of Althen v. Secretary of the Department of Health and Human
Services, the Federal Circuit 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 Althen v. Sec’y of
Health & Human Servs., 418 F.3d 1274, 1279 (Fed. Cir. 2005). The Althen test requires the
petitioner to set forth: “(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. 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 id.
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 Pafford v. Sec’y of Health & Human Servs., No. 01-0165V, 2004 WL
1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 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. Id. 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 Dow Pharmaceuticals, Inc., 509 U.S. 579, 593–94 (1993).
In 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
Pafford, 2004 WL 1717359, at *4 (emphasis added); Althen, 418 F.3d at 1279. 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.
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 1278. For 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. In 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, e.g., Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144 (Fed.Cir. 1992);
Hasler v. United States, 718 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); Thibaudeau v. Sec’y of
Health & Human Servs., 24 Cl. Ct. 400, 403 (Fed. Cl. Oct. 23, 1991).
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 of Health & Human Servs., 35 F.3d
543, 547 (Fed. Cir. 1994).
In this case, Petitioner sought redress for his injury under the Vaccine Act’s
compensatory provision for off-Table injuries. The Petition alleges that Petitioner suffered facial
injuries as a result of fainting after receiving a trivalent influenza vaccination on October 18,
2011. Pet. at 2. The undersigned examined Petitioner’s medical records and did not find any
evidence that satisfies the three elements of causation set forth above. The undersigned
concludes that the medical records filed in this case provide preponderant evidence that
Petitioner’s fainting episode stemmed from his hypoglycemia, secondary to his Type 1 diabetes,
not his influenza vaccination. 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. Id. 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.
Petitioner has not provided a sound or reliable medical theory, causally connecting his
vaccination with his injury. Instead, Petitioner cites the close temporal proximity between
5
Petitioner’s fainting spell and the receipt of his influenza vaccine as evidence of a vaccine-
caused injury. Pet’r’s Motion at 1-4, ECF No. 19. Petitioner offers no scientific explanation for
the alleged correlation between the influenza vaccine and his fall. Absent a valid scientific
theory connecting the influenza vaccination to Petitioner’s injury, an asserted temporal
association alone is insufficient to establish entitlement to compensation under the Vaccine
Program. Moberly, 592 F.3d at 1323.
At one point in the case, Petitioner seemed prepared to offer expert testimony,
establishing a scientific theory under Althen prong one. However, during a status conference
convened on April 10, 2014, Petitioner’s counsel indicated that “Petitioner’s retained expert was
no longer willing to participate in this case as the most recently filed records did not support his
theory of causation.” Order, ECF No. 16. The undersigned asked Petitioner’s counsel whether
he was referring to the EMS record that indicated that Petitioner was a diabetic and that he was
hypoglycemic at the time he fainted, and Petitioner’s counsel affirmed that this was the issue. Id.
Without a credible medical expert, promulgating a sound and reliable medical theory of
causation, supportive medical records, or a sound and reliable medical theory itself, there is no
evidence in the record that provides any theory of vaccine causation sufficient to meet Althen
prong one. As such, Petitioner does not meet his burden 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 Capizzano, 440 F.3d at 1327 (“[t]here may well be circumstances where 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.”).
In this case, the evidence submitted by Petitioner consists of his affidavit and the
submission of Petitioner’s medical records, which Petitioner alleges show that his facial and
dental injuries, sustained after fainting, were caused-in-fact by his receipt of an influenza
vaccination on October 18, 2011. The undersigned finds no such causal relationship between
Petitioner’s injury and vaccination.
Petitioner received the influenza vaccination on October 18, 2011. Pet. at 1. Petitioner
was transported by ambulance the same day to the Bristol Regional Hospital Emergency Room
after fainting and sustaining facial injuries. The ambulance record states:
[p]atient’s vitals obtained along with blood sugar level checked showing patient
was hypoglycemic. Patient stated he was diabetic, and had just taken his flu shot
and approximately two minutes later patient passed out.
EMS Medical Record at 2. A fasting blood sugar taken by EMS personnel at the scene was 50,
and Petitioner was described by EMS personnel as “hypoglycemic.” Id. Petitioner was then
administered oral glucose in the ambulance. Id.
6
Petitioner’s attending physician at Holston Valley Medical Center, Dr. Testerman,
affirmed that Petitioner became dizzy and fell while at Wal-Mart and was “found to be
hypoglycemic.” Pet’r’s Wellmont Holston Valley Medical Center Records at 5. Dr. Testerman
additionally noted that “[i]t was felt that the patient possibly became hypoglycemic and fainted,
[] resulting in his injury.” Id. Dr. Testerman’s notes make no mention of the vaccine as a possible
cause of Petitioner’s fainting episode.
The undersigned does not doubt that Petitioner carefully monitors his blood sugar levels,
eats regularly, and administers himself insulin appropriately. Pet’r’s Ex. 17 at 1. That does not
change the fact that when the EMS personnel responded to the Wal-Mart because Petitioner had
fainted, they found Petitioner’s blood sugar to be very low; they described Petitioner as
“hypoglycemic,” with a blood sugar level of 50. EMS Medical Record at 2. Petitioner’s
retained expert declined to participate in this case when he learned of the information set forth in
these treatment records (suggesting the significance of such facts). Order, ECF No. 16. Based
on the evidence provided in the medical records in this case, the undersigned finds that
Petitioner’s fall stemmed from his hypoglycemia as a result of his low blood sugar, not his
influenza vaccination. Under prong two of Althen, Petitioner must provide preponderant
evidence that his vaccination did cause his alleged injury. In this case, Petitioner has failed to
meet his burden. Since Petitioner has provided no evidence that his influenza vaccine did cause
his resulting injuries, through either 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 that comports with Petitioner’s prong one
theory of causation. Althen, 418 F.3d at 1279. Petitioner submitted records that purport to
establish a temporal association between when Petitioner received the influenza vaccination and
the timing of this fainting spell, resulting in Petitioner’s facial and dental injuries. As previously
discussed, however, though the events of vaccine receipt and subsequent injury occur in close
temporal proximity, Petitioner has provided no theory against which to evaluate the temporal
nexus of his claim. In the absence of that nexus, Petitioner’s claim fails under the third prong of
Althen.
IV
CONCLUSION
Under the Act, a petitioner may not be given a Program award based solely on the
petitioner’s claims alone. Rather, the petition must be supported by either medical records or by
the opinion of a competent physician. § 13(a)(1). In this case, because there are insufficient
medical records supporting Petitioner’s claim, a medical expert opinion must be offered in
support, establishing a sound and reliable medical theory, linking vaccination to injury, and
7
demonstrating a logical sequence of cause and effect between said vaccination and injury.
Petitioner has offered no such opinion.
The undersigned is sympathetic to the fact that Petitioner suffers from facial injuries.
However, under the law, the undersigned can authorize compensation only if a medical 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.
s/Lisa D. Hamilton-Fieldman
Lisa D. Hamilton-Fieldman
Special Master
8
Kennedy Jr. v. Secretary of Health and Human Services
Combined Opinion