Court Opinion

ID: 613171
Source: CourtListenerOpinion
Date Created: 2011-09-06 15:17:42+00
Date Added: 2024-06-11T14:58:35.072555
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
              __________________________

               CHERYL LOMBARDI,
                Petitioner-Appellant,
                          v.
      SECRETARY OF HEALTH AND HUMAN
                 SERVICES,
             Respondent-Appellee.
              __________________________

                      2011-5004
              __________________________

    Appeal from the United States Court of Federal
Claims in Case No. 99-VV-523, Judge Marion Blank
Horn.
             ____________________________

              Decided: September 6, 2011
             ____________________________

   CLIFFORD J. SHOEMAKER, Shoemaker & Associates, of
Vienna, Virginia, argued for the petitioner-appellant.

    HEATHER L. PEARLMAN, Trial Attorney, Torts Branch,
Civil Division, United States Department of Justice, of
Washington, DC, argued for the respondent-appellee.
With her on the brief were TONY WEST, Assistant Attor-
ney General, TIMOTHY P. GARREN, Director, MARK W.
ROGERS, Deputy Director, and CATHARINE E. REEVES,
Assistant Director.
LOMBARDI   v. HHS                                         2

                __________________________

 Before RADER, Chief Judge, and LOURIE and O’MALLEY,
                    Circuit Judges.
  Opinion for the court filed by Circuit Judge LOURIE.
  Concurring opinion filed by Circuit Judge O’MALLEY.
LOURIE, Circuit Judge.
     Cheryl Lombardi appeals from the decision of the
United States Court of Federal Claims (“Claims Court”)
affirming the decision of a special master denying com-
pensation under the Vaccine Act for injuries that she
alleged were a result of receiving hepatitis B vaccinations.
Doe v. Sec’y of Dept. of Health & Human Servs., 94 Fed.
Cl. 597 (2010) (“Claims Court Op.”). Because we agree
with the Claims Court that the special master did not err
in concluding that Lombardi failed to prove by a prepon-
derance of the evidence that she suffered the alleged
injuries, we affirm.
                       BACKGROUND
    A. Facts of the Case
     The facts in this case are mostly undisputed.
Lombardi was born on October 17, 1946. She received the
first dose of the hepatitis B vaccine on April 1, 1997, and
the second dose on May 6, 1997. She suffered no immedi-
ate adverse reactions to those first two doses. On October
28, 1997, she received a third dose of the vaccine. Then,
on November 9, 1997, Lombardi visited a hospital emer-
gency room, complaining of right flank pain radiating into
her right chest. Various tests were performed, but the
evaluation failed to find a cause of her symptoms. She
was discharged the same day with a diagnosis of atypical
chest pain. Lombardi returned to the emergency room on
November 14, 1997, once again complaining of right flank
3                                          LOMBARDI   v. HHS

pain. The various tests that were performed on her
during that visit also failed to detect any identifiable
problems.
    On January 15, 1998, Lombardi sought treatment
from an internal medicine specialist, Dr. Michael
Conaway. Records from that visit document Lombardi’s
complaints of ongoing pain on her right side, as well as
weakness and fatigue.       Lombardi also informed Dr.
Conaway that she had experienced a weight gain of 40
pounds in the past five years. Dr. Conaway reviewed the
results of tests on blood drawn on January 13, 1998,
which indicated that petitioner had a positive antinuclear
antibody (“ANA”) rate. Dr. Conaway’s notes indicate that
Lombardi had a chest X-ray that showed some pleural
thickening and that he ordered additional tests to deter-
mine whether petitioner had systemic lupus erythemato-
sus (“SLE”). Those notes also indicate that Lombardi had
consulted Dr. Cordasco and was undergoing a work-up for
possible SLE.
    In February 1998, Dr. Teresa George, a rheumatolo-
gist, evaluated Lombardi for possible SLE, but found
nothing based on that examination. Instead, the doctor
noted that Lombardi had a history of joint pain which was
not associated with swelling. Dr. George wrote that
Lombardi denied having any skin rashes, hair loss, photo-
sensitivity, or changes in memory or concentration. Dr.
George also noted a higher ANA rate, but found all other
laboratory tests, including other serologies for diagnosing
SLE, were normal. She suspected that Lombardi “proba-
bly had a positive ANA in the past,” and concluded that
her right chest pain was of “unclear etiology” and that
there was not “enough evidence for systemic lupus ery-
thematosis [sic] or another autoimmune process at this
time.”
LOMBARDI   v. HHS                                       4

    In February and March 1998, Lombardi returned to
Dr. Conaway three times with complaints of right-sided
pain, nausea, and fatigue. After conducting a thorough
workup, Dr. Conaway wrote that he was “really at a loss
to explain both her pain and her fatigue at this point.”
After Lombardi’s third visit, Dr. Conaway referred her to
the Cleveland Clinic to obtain a more comprehensive
diagnostic evaluation.
     On March 16, 1998, Lombardi saw Dr. John Camp-
bell, a preventative medicine specialist at the Cleveland
Clinic. Dr. Campbell ordered blood tests, which revealed
that Lombardi had a vitamin B12 deficiency and an
elevated level of methylmalonic acid. He directed her to
have additional tests performed and to see a neurologist.
A radiology report from that time indicates that Lombardi
had decreased bone density, consistent with osteopenia of
her lumbar spine, and osteoporosis in her left hip. On one
of the physical evaluation forms entitled “impressions,”
Dr. Campbell’s notes state “post hepatitis B—fatigue,”
followed by an illegible word. On April 9, 1998, Lombardi
was examined by Dr. Patrick Sweeney, a neurologist at
the Cleveland Clinic, and Dr. Ian Lavery in the colorectal
surgery department. Dr. Lavery did not diagnose any
problems and Dr. Sweeney was doubtful that Lombardi
suffered from any neurologic problem, stating in his notes
that he “doubt[ed] neuro disease.” Following her return
from the other Cleveland Clinic physicians, Dr. Campbell
summarized his findings, based on their evaluations, as
“post vaccine syndrome.” Dr. Campbell’s recommendation
to Lombardi was that she take B12 and follow up with her
local physician.
    On April 23, 1998, Dr. Conaway assessed Lombardi
with chronic fatigue, expressing uncertainty as to
whether the mild vitamin B12 deficiency could explain
her symptoms. Lombardi reported that she could walk
5                                         LOMBARDI   v. HHS

only for about ten minutes before becoming exhausted.
Dr. Conaway also noted that Lombardi had “chronic right
lateral rib cage pain,” but was unable to determine a
cause of the pain. At the visit, Dr. Conaway referred
Lombardi to Dr. Elizabeth Hurst for a psychological
evaluation to investigate whether underlying depression
or trauma could account for her symptoms. There is no
record of Lombardi’s visit to Dr. Hurst.
     On May 1, 1998, Lombardi returned to Dr. Conaway
explaining that a friend had told her about a news report
suggesting that hepatitis B vaccine could lead to chronic
fatigue by causing rheumatologic problems. In his notes
from that visit, Dr. Conaway was doubtful of that diagno-
sis, noting that the “fact that I have seen no objective
signs of a rheumatologic condition and her [erythrocyte
sedimentation] rate has always been normal combined
with the fact that she has not responded in the past to
[non-steroidal anti-inflammatory drugs] and/or steroids
tend to push me away from that diagnosis.” Dr. Conaway
did however indicate that he was “unsure what to make of
her positive ANA.”
    In July 1998, Lombardi saw Dr. Andrew Campbell, a
specialist with experience evaluating chronic fatigue
syndrome due to the hepatitis B vaccine. Dr. Campbell
assessed her as having fatigue, chest pain, and polyneu-
ropathy. On another visit a few weeks later, Dr. Camp-
bell again diagnosed Lombardi as having fatigue and
polyneuropathy. He added the diagnosis of an adverse
reaction to a vaccine, and recommended a reassessment
in 90 days. Dr. Campbell’s notes from another visit three
weeks later stated that the decline in Lombardi’s health
was a direct result of her hepatitis B vaccination. Later,
in October 1998, Dr. Campbell indicated that she also
suffered from high cholesterol and prescribed vitamins,
including a vitamin B complex.
LOMBARDI   v. HHS                                        6

    On October 6, 1998, Lombardi visited Dr. Albert
Beraducci of Neurologic Associates, Inc., but there is no
diagnosis from that visit in the record. On October 30,
1998, she saw Dr. Joseph Plouffe, an infectious disease
specialist, who also found that specific antibodies to test
for SLE were negative. Dr. Plouffe concluded that peti-
tioner had a “[p]ossible immunologic process of question-
able etiology Hep B vaccine certainly possible.”
Throughout 1999, Lombardi continued to see Dr. Andrew
Campbell with little change in her condition. On Septem-
ber 24, 1999, petitioner again had a positive ANA test. In
late 1999, following another positive ANA test, Dr. Camp-
bell began intravenous immunoglobin treatment for
chronic inflammatory demyelinating polyneuropathy and
Lombardi remained on the treatment through at least
May 2000.
    In August and September 1999, Lombardi visited Dr.
Sandra Stewart–Pinkham, a pediatrician who assessed
that her problems were “best explained by an adverse
reaction to hepatitis B vaccine which contains 25 mcg of
mercury in each injection.” Dr. Stewart–Pinkham noted
that Lombardi’s problems “are identical to individuals
with chronic fatigue immune dysfunction, a disease of
unknown etiology.” Lombardi was evaluated by a derma-
tologist, Dr. Adam Hessel, in September 2001 for a recur-
rent episodic rash. A skin biopsy was performed on
March 7, 2002, after which petitioner was diagnosed with
Wells Syndrome. Dr. Hessel indicated that Wells Syn-
drome “could be seen in association with a vaccination
reaction” but that the “relationship is uncertain.” Dr.
Hessel later concluded that the rash was likely caused by
a reaction to toxic black mold found in her home.
    On June 18, 2004, a CT scan of Lombardi’s abdomen
indicated a tiny, unobtrusive stone in the upper portion of
the right kidney and an even smaller stone possibly in the
7                                          LOMBARDI   v. HHS

lower portion of the right kidney. The study was other-
wise normal. Urologist Dr. Bruce E. Woodworth stated
that based on the CT scan results, “one wonders if the
patient’s episodes of right flank pain may be due to pas-
sage of tiny calculi.” A radiographic examination of
Lombardi’s cervical spine taken on October 28, 2004,
showed multilevel degenerative disk disease with spondy-
losis and compression of the spinal cord at levels C5–6 to
the left and C6–7 to the right, associated with disc protru-
sions and foraminal stenoses. In a November 10, 2004,
Progress Note, Dr. Conaway assessed petitioner with “1.
Cervical disk degeneration [and] cervical spinal stenosis”
and “2. Chronic Fatigue Syndrome.” He referred her to a
chiropractor and an anesthesiologist for a steroid injec-
tion. During the pendency of this litigation, Lombardi
was also being treated by Dr. Kevin Schlessel, a rheuma-
tologist.
    Other pertinent details from Lombardi’s medical his-
tory include the fact that she became a vegetarian at the
age of 25, underwent a hysterectomy at the age of 31, and
had her appendix removed in her early 30s. At the age of
37, Lombardi had problems with her gallbladder and
subsequently underwent surgery for its removal. In
August 1990, her only child died under tragic and ex-
traordinary circumstances. At the time of vaccination,
Lombardi was employed at Abbott Laboratories, where
she packaged medical devices and worked with a chemical
called cyclohexane. Prior to working at Abbott, Lombardi
was employed at Ross Laboratories, where her duties
involved handling boxes contaminated with bodily fluids.
    B. Claims Court Proceedings
    On July 28, 1999, Lombardi filed a petition under 42
U.S.C. §§ 300aa-1, et seq. (2006) (“the Vaccine Act”)
seeking compensation for certain injuries that she
LOMBARDI   v. HHS                                         8

claimed were a result of her hepatitis B vaccinations. The
petition did not identify any injuries, but claimed that she
had sought frequent medical treatment following the
vaccination. Subsequently, Lombardi focused her case
and offered expert opinions in support of claims that she
suffered from three different conditions that are not listed
on the Vaccine Injury Table—transverse myelitis, chronic
fatigue syndrome, and SLE.
    The case was assigned to a special master of the
Claims Court who conducted three evidentiary hearings.
Because Lombardi claimed off-Table injuries, she was
required to prove causation in fact.          See § 300aa-
11(c)(1)(C)(ii). Both parties retained medical experts, who
submitted reports and testified at the hearings regarding
Lombardi’s condition and whether the hepatitis B vaccine
caused her injuries. The government’s experts included
Dr. Thomas Leist, a neurologist, and Dr. Lawrence
Kagen, a rheumatologist. Lombardi also retained two
experts: Dr. Carlo Tornatore, a neurologist, and Dr.
Yehuda Shoenfeld, an immunologist and rheumatologist.
On December 1, 2006, at Dr. Tornatore’s request, an MRI
of Lombardi’s thoracic spine was performed. The condi-
tion stated in the resulting radiology report was “mild
atrophy of thoracic cord at mid thoracic levels: without
neurally compressive lesion or intrinsic focal cord lesion
depicted.”
    At the first hearing on November 1–2, 2007, Dr. Tor-
natore testified that Lombardi’s MRI indicated atrophy,
which in his opinion was caused by transverse myelitis
that he concluded resulted from the hepatitis B vaccine.
Dr. Leist offered his opinion that Lombardi suffered from
(1) a vitamin B12 deficiency; (2) an evolving, mixed colla-
gen vascular disorder; and (3) osteopenia, with degenera-
tive changes in her cervical spine. Dr. Leist rejected Dr.
Tornatore’s hypothesis that Lombardi suffered from
9                                          LOMBARDI   v. HHS

transverse myelitis as a result of the series of hepatitis B
vaccinations.
     At the second hearing, on April 9, 2008, Dr.
Shoenfeld, Lombardi’s expert, testified that Lombardi
suffered from chronic fatigue syndrome, which was a
“direct result” of the hepatitis B vaccine. Although not
stated in his expert report, Dr. Shoenfeld opined for the
first time at that hearing that Lombardi’s condition met
the diagnostic criteria for SLE, which he believed was also
caused by the hepatitis B vaccinations. Dr. Kagen, the
government’s expert, offered multiple possible diagnoses
for Lombardi’s condition, but did not comment as to
whether she suffered from chronic fatigue syndrome. Dr.
Kagen’s list of diagnoses included (1) a mixed connective
tissue disease with rheumatoid arthritis overlap, (2)
osteoarthritis with spinal cord and nerve root compres-
sion, (3) a nutritional deficit due to a lack of vitamin B12
in her diet, (4) an allergic reaction to mold, and (5) de-
pression.
    At the third hearing, on November 25, 2008, Dr.
Kagen testified that Lombardi did not meet the diagnosis
for SLE under the criteria set out by the American Col-
lege of Rheumatology (“ACR”). Dr. Shoenfeld reiterated
his diagnosis of SLE.
    On January 29, 2010, the special master published an
opinion denying Lombardi’s entitlement under the Vac-
cine Act. Doe 60 v. Sec’y of Health & Human Servs., No.
99-VV-523, 2010 WL 1506010 (Fed. Cl. Mar. 26, 2010)
(“Special Master Op.”). The special master conducted a
thorough analysis of all the tests performed on Lombardi,
and the opinions of the treating physicians as well as the
conflicting opinions of the testifying experts. See id. at
*12–33. The special master concluded that petitioner was
not entitled to compensation because she had “not estab-
LOMBARDI   v. HHS                                         10

lished that she suffers from any of the three conditions
that provide the basis for her experts’ opinions.” Id. at *1.
The special master stated that under our holding in
Althen v. Secretary of Health & Human Services, 418 F.3d
1274, 1278 (Fed. Cir. 2005), when a petitioner claims
compensation for an injury not listed on the Vaccine
Injury table, the petitioner must establish three elements,
the second being a logical sequence of cause and effect
showing that the vaccination was the reason for the
injury. However, because the special master found that
Lombardi had failed to establish that she suffered from
any specific injury, he found no need to determine
whether the claimed conditions were caused by vaccina-
tion under the second prong of Althen. Special Master Op.
at *12.
    With regard to transverse myelitis, the special master
concluded that Lombardi’s clinical presentation between
November 1997 and April 1998 was not consistent with
the signs and symptoms of transverse myelitis. Id. at *17.
He noted that her treating doctors, including her treating
neurologist, had never diagnosed her with transverse
myelitis and that the 2006 MRI, the only imaging study
done on Lombardi, did not counter the conclusions
reached by her treating doctors. Id.
    On Lombardi’s second claim, the special master ac-
knowledged that Lombardi had experienced some of the
symptoms attributable to chronic fatigue syndrome, but
also found a number of alternative causes for her fatigue,
including vitamin B12 and thiamine deficiency. Id. at
*24. Further, he noted that most of Lombardi’s treating
doctors did not diagnose her with chronic fatigue syn-
drome, a diagnosis that requires chronic fatigue plus
ancillary factors and the exclusion of other causes of the
fatigue. Id.
11                                        LOMBARDI   v. HHS

    With regard to Lombardi’s SLE claim, the special
master employed criteria issued by the ACR, requiring
that at least four of the eleven symptoms be met in order
for a diagnosis of SLE to be made. Id. at *25. The special
master concluded that Lombardi met only three. Id. at
*29. Moreover, he noted that from 1997 to 2007, none of
Lombardi’s numerous treating doctors had ever diagnosed
her as suffering from SLE, some of them even having
specifically investigated Lombardi for SLE. Id. In con-
clusion, the special master reasoned that while the an-
swer to what Lombardi suffered from was elusive, it was
not the government’s burden to provide that answer. Id.
at *31. The special master thus denied Lombardi’s peti-
tion for compensation under the Vaccine Act.
    Lombardi sought review of the special master’s deci-
sion in the Claims Court. The Claims Court affirmed the
special master’s decision, concluding that the special
master properly considered the entire record. Claims
Court Op., 94 Fed. Cl. at 624. The Claims Court con-
cluded that the special master was not arbitrary or capri-
cious in his decision and had laid out a detailed
assessment of whether petitioner had proven each diag-
nosis—transverse myelitis, chronic fatigue syndrome, and
SLE—for which she alleged entitlement to compensation.
Id. The Claims Court also concluded that the special
master had considered, and properly rejected, whether
Lombardi could recover under a medical theory of a non-
labeled, medical syndrome or symptomatology giving rise
to a non-identified autoimmune disease. Id. The Claims
Court noted that there was no agreement among
Lombardi’s expert witnesses, her treating physicians, or
in the underlying medical records, as to any injury, symp-
tomatology, or medical diagnosis from which Lombardi
suffered following her hepatitis B vaccinations. Id. The
court therefore held that such a record of divergent diag-
LOMBARDI   v. HHS                                         12

noses and symptoms could not support an analysis under
Althen. Id.
    Lombardi appeals the decision of the Court of Federal
Claims. We have jurisdiction pursuant to 42 U.S.C.
§ 300aa-12(f).
                        DISCUSSION
     We review an appeal from the Claims Court in a Vac-
cine Act case de novo, applying the same standard of
review as the Claims Court applied to its review of the
special master’s decision. Andreu v. Sec’y of Health &
Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009). We
owe no special deference to the Claims Court or the spe-
cial master on questions of law. Id. Whether the special
master applied the appropriate standard of causation is a
legal determination reviewed by this Court de novo under
the “not in accordance with law” standard. See Munn v.
Sec’y of Health & Human Servs., 970 F.2d 863, 870–73
(Fed. Cir. 1992). We uphold the special master’s findings
of fact unless they are arbitrary or capricious. Capizzano
v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1324
(Fed. Cir. 2006). “Thus, although we are reviewing as a
matter of law the decision of the Claims Court under a
non-deferential standard, we are in effect reviewing the
decision of the special master under the deferential arbi-
trary and capricious standard on factual issues.” Lampe
v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1369
(Fed. Cir. 2000).
    A petitioner seeking compensation under the Vaccine
Act must prove by a preponderance of the evidence that
the injury or death at issue was caused by a vaccine. 42
U.S.C. §§ 300aa-11(c)(1), -13(a)(1). If the claimed injury is
not listed in the Vaccine Injury Table (“off-Table injury”),
the petitioner may seek compensation by proving causa-
tion in fact. Moberly v. Sec’y of Health & Human Servs.,
13                                          LOMBARDI   v. HHS

592 F.3d 1315, 1321 (Fed. Cir. 2010); 42 U.S.C. § 300aa-
11(c)(1)(C)(ii). When a petitioner has suffered an off-
Table injury, we have established the following test for
showing causation in fact under the Vaccine Act:
     [The petitioner’s] burden is to show by preponder-
     ant evidence that the vaccination brought about
     her injury by providing: (1) a medical theory caus-
     ally 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, 418 F.3d at 1278. “[T]he function of a special
master is not to ‘diagnose’ vaccine-related injuries, but
instead to determine ‘based on the record evidence as a
whole and the totality of the case, whether it has been
shown by a preponderance of the evidence that a vaccine
caused the [petitioner’s] injury.’” Andreu, 569 F.3d at
1382 (quoting Knudsen v. Sec’y of Health & Human
Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)).
    Lombardi argues that she has demonstrated by a pre-
ponderance of the evidence that hepatitis B vaccination
caused her injuries. According to Lombardi, she was
denied compensation merely because her medical condi-
tion is complex and she suffers from more than one injury.
Lombardi contends that under the standard employed by
the special master and the Claims Court, she would have
to provide direct evidence of a single unwavering specific
diagnosis without the possibility of any other diagnosis in
order to succeed on her claim. She contends that the
special master and the Claims Court erred by failing to
analyze her condition under the Althen test merely be-
cause her treating doctors and experts suggested different
diagnoses. Lombardi argues that she proffered sufficient
LOMBARDI   v. HHS                                        14

evidence that she suffered from each of the three condi-
tions, transverse myelitis, chronic fatigue syndrome, and
SLE, thus requiring the special master to conduct a
causation analysis under Althen. Instead, Lombardi
continues, the special master improperly shifted to her
the government’s burden of proving that her condition
was unrelated to the vaccination.
     The government responds that the special master and
Claims Court applied the correct legal standard in review-
ing Lombardi’s case, and properly concluded that she had
failed to establish by a preponderance of the evidence that
she suffers from any of the three claimed diseases. Ac-
cording to the government, the special master did not
impose the government’s burden on her, or raise her
burden of proof to require absolute certainty as to each of
the diagnoses. Instead, the government contends, he
provided a sound rationale for his conclusions, detailing
why appellant’s experts failed to offer reliable evidence to
establish any prima facie case, and these factual findings
are entitled to significant deference under this court’s
precedent. The government further argues that there was
no need to evaluate Lombardi’s claim for causation under
Althen because she failed to show that she actually suffers
from the specific conditions that she alleges. According to
the government, it would be illogical for the special mas-
ter to assess whether or not the hepatitis B vaccine
caused those injuries when she has failed to prove that
she suffers from them.
    We agree with the government that the special mas-
ter properly denied Lombardi’s claim for compensation
under the Vaccine Act. Lombardi’s primary argument is
that she is entitled to recover once she proves by a pre-
ponderance of the evidence that the vaccine caused her
injury, and thus the special master was required to ana-
lyze causation. Instead of making that determination,
15                                         LOMBARDI   v. HHS

Lombardi continues, the special master and the Claims
Court were focused on deciding if she even suffered from
one of the three claimed conditions, thus requiring the
petitioner to prove a specific diagnosis. That, according to
Lombardi, imposed on her an improper burden of proving
a diagnosis with scientific certainty even before she could
prove causation under Althen. Lombardi’s arguments,
however, are unpersuasive in view of our recent prece-
dent.
    In Broekelschen v. Secretary of Health & Human Ser-
vices, 618 F.3d 1339 (Fed. Cir. 2010), we addressed the
same issue as that presented here. Dr. Broekelschen, the
petitioner in that case, suffered from symptoms that were
consistent with two different conditions—a vascular
condition and an inflammatory condition—which differ
significantly in their pathology. Id. at 1346. In ruling on
his petition for entitlement under the Vaccine Act, the
special master decided first to determine which injury Dr.
Broekelschen suffered from, and then proceeded to deter-
mine whether the vaccinations caused that injury. Id. at
1344. Dr. Broekelschen had claimed and presented
causation evidence on only one of those two conditions.
Because the special master made a factual determination
that the condition that Dr. Broekelschen actually suffered
from was not the one for which he had claimed or pre-
sented causation evidence, he denied the petition. Id. As
in this case, Dr. Broekelschen argued to us that the
special master erred by failing first to determine whether
Dr. Broekelschen had established a prima facie case that
the vaccine caused the condition that the petitioner had
alleged before determining that he actually suffered from
that illness. Id. at 1345. We rejected that argument,
explaining that the question of causation turned on which
injury the petitioner suffered. Id. at 1346. We deter-
mined that if the existence and nature of the injury itself
LOMBARDI   v. HHS                                          16

is in dispute, it is the special master’s duty to first deter-
mine which injury was best supported by the evidence
presented in the record before applying the Althen test to
determine causation of that injury. Id. That, we held, is
mandated by the Vaccine Act, which creates a cause of
action for persons suffering a “vaccine-related injury,” 42
U.S.C. § 300aa-11(a), “i.e., illness, disability, injury or
condition, [that] has to be more than just a symptom or
manifestation of an unknown injury,” Broekelschen, 618
F.3d at 1349. Thus, under Broekelschen, identification of
a petitioner’s injury is a prerequisite to an Althen analysis
of causation.
     Lombardi’s case, although unusual in that the identi-
fication of the injury and its nature is in dispute, is simi-
lar to Broekelschen.      As the special master noted,
Lombardi’s case is complicated by the fact that she al-
leged that she suffers from three different medical condi-
tions. It is further complicated by the fact that there was
little agreement as to her symptoms or the diagnosis of
her condition among her treating physicians or among the
experts. Special Master Op. at *12. The special master
pointed out that even the two experts that Lombardi
retained specifically for this litigation differ in their
opinions as to her “injury”—one of them diagnosed trans-
verse myelitis, and the other offered two alternatives,
chronic fatigue syndrome or SLE. Id. As the special
master correctly observed, Lombardi “has not argued that
the three conditions are so similar that doctors consider
them to be conditions along a spectrum of diseases.” Id.
at *7 n.7. In contrast, the government’s experts refuted
each of those diagnoses and proposed five other possible
conditions that Lombardi may have suffered from. In the
face of such extreme disagreement among well-qualified
medical experts, each of whom had evaluated the peti-
tioner, it was appropriate for the special master to first
17                                          LOMBARDI   v. HHS

determine what injury, if any, was supported by the
evidence presented in the record before applying the
Althen test to determine causation. Broekelschen, 618
F.3d at 1346. In the absence of a showing of the very
existence of any specific injury of which the petitioner
complains, the question of causation is not reached.
    Lombardi argues that by finding that she had failed to
prove the existence of any of her injuries, and therefore
declining to conduct an Althen analysis on any of her
alleged injuries, the special master penalized her for
alleging that she suffered from more than one injury.
Lombardi misstates the special master’s reasoning. The
special master did not require Lombardi to narrow the
number of alleged injuries to one. But the statute places
the burden on the petitioner to make a showing of at least
one defined and recognized injury. Here, the special
master merely found that Lombardi had failed to meet
her burden to show by a preponderance of the evidence
that she suffered from any medically recognized “injury,”
not merely a symptom or manifestation of an unknown
injury. See 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I) (requiring
that an off-Table injury petitioner must allege that he
“sustained, or had significantly aggravated, any illness,
disability, injury, or condition not set forth in the Vaccine
Injury Table but which was caused by a Vaccine referred
to in subparagraph (a)”). We therefore conclude that the
special master imposed the proper burden on Lombardi.
    Next, we review the special master’s findings on each
of Lombardi’s claims. In reaching his conclusions, the
special master thoroughly evaluated Lombardi’s medical
records as well as the medical opinions of several treating
physicians and experts. We afford these findings of fact
substantial deference. Hines v. Health & Human Servs.,
940 F.2d 1518, 1528 (Fed. Cir. 1991) (“If the special
master has considered the relevant evidence of record,
LOMBARDI   v. HHS                                       18

drawn plausible inferences and articulated a rational
basis for the decision, reversible error will be extremely
difficult to demonstrate.”). We address each in turn.
    A. Transverse Myelitis
     Lombardi argues that Dr. Tornatore’s testimony con-
cerning his diagnosis of transverse myelitis after review-
ing Lombardi’s MRI, combined with the medical literature
that he submitted to support his diagnosis, should have
sufficed to demonstrate by a preponderance of the evi-
dence that she had transverse myelitis. The special
master, however, articulated several reasons for rejecting
that diagnosis. First, the special master properly recog-
nized the special value that we have placed on the opin-
ions of treating physicians. Special Master Op. at *13
(citing Capizzano, 440 F.3d at 1326). The special master
noted that the neurologist and rheumatologist treating
Lombardi shortly after the vaccines were administered,
namely, Dr. Sweeney, who conducted a complete neuro-
logical exam, and Dr. George, who performed a compre-
hensive evaluation, did not diagnose transverse myelitis.
Id. at *14 (noting also that the “idea that petitioner
suffers from transverse myelitis originated in this litiga-
tion”). The special master found that even Dr. Tornatore
did not arrive at that diagnosis after reviewing medical
records. Instead, Dr. Tornatore suggested that Lombardi
undergo an MRI of her spine, reasoning that “if the MRI
reveals a demyelinating lesion of the thoracic spine, . . .
the etiology of her flank pain and its association with the
hepatitis B vaccination would be clarified.” Id. The MRI,
however, failed to reveal a lesion, and showed only “mild
atrophy of the thoracic cord.” Yet, Dr. Tornatore found
that result sufficient to diagnose transverse myelitis and
further to connect it to Lombardi’s symptoms nine years
earlier. Id. at *15. It was not arbitrary or capricious for
the special master to have rejected that expert testimony.
19                                         LOMBARDI   v. HHS

See Moberly, 592 F.3d at 1324. Moreover, the special
master explained that Lombardi seems to have had none
of the typical problems associated with transverse mye-
litis, such as numbness, weakness, sensory abnormalities,
and problems with the bowel and bladder. Special Master
Op. at *16. The special master’s finding that many of
Lombardi’s complaints did not match the symptoms of
transverse myelitis was not arbitrary or capricious. We
thus affirm the special master’s conclusion that Lombardi
failed to establish that she suffered from transverse
myelitis.
     B. Chronic Fatigue Syndrome
    Lombardi argues that the special master improperly
rejected evidence, including medical records, showing that
her treating physicians, Drs. Campbell and Stewart-
Pinkham, diagnosed her with post-hepatitis B fatigue,
and testimony from her expert, Dr. Shoenfeld, that she
met at least four of the eight diagnostic criteria for
chronic fatigue syndrome. We disagree. The special
master explained that chronic fatigue syndrome is a
diagnosis of exclusion, and should be made only after
other chronically fatiguing conditions have been ruled out.
Id. at *18 (citing the Journal of Clinical Investigation).
Dr. Kagen testified that there were at least two alterna-
tive explanations for Lombardi’s fatigue—vitamin B12
deficiency and osteoarthritis—that precluded the diagno-
sis of chronic fatigue syndrome. Id. at *19. There is also
support in Lombardi’s extensive medical records for a
finding that she may have suffered from both of those
conditions. Moreover, the special master found support in
the cited medical literature that those two conditions
could also explain some of her symptoms such as fatigue
as well as joint and muscle pain.
LOMBARDI   v. HHS                                        20

    In addition, the special master meticulously reviewed
Lombardi’s medical records to determine if any of her
treating physicians had actually diagnosed her with
chronic fatigue syndrome. He paid special attention to
any “fatigue” reference in Lombardi’s treating physician’s
statements, but concluded that they did not amount to
preponderant evidence of chronic fatigue syndrome. Id. at
*23–24. In doing so, he explained in detail his reasoning
for rejecting each of the references as an actual diagnosis
of that medical condition. Id.
    The special master’s decision on Lombardi’s claim for
chronic fatigue syndrome required reconciling conflicting
testimony from opposing experts. He found the opinions
of Dr. Leist and Dr. Kagen to be persuasive, but not Dr.
Shoenfeld’s. Id. at *20. We conclude that the special
master reasonably weighed the evidence before him and
that his decision on Lombardi’s claim of chronic fatigue
syndrome was well within the discretion granted to
special masters under the vaccine program. See Andreu,
569 F.3d at 1379; see also Munn, 970 F.2d at 871 (We do
not “reweigh the factual evidence, or . . . assess whether
the special master correctly evaluated the evidence . . . or
the credibility of the witnesses.”).
    C. SLE
    Lombardi argues that the special master imposed an
improper burden by employing the criteria developed by
the American College of Rheumatologists for a diagnosis
of SLE and requiring her to prove that she met at least
four of the eleven criteria before such a diagnosis can be
made. Lombardi contends that that requirement reflects
a diagnosis of SLE with 96 percent certainty, and her
burden under the Vaccine Act cannot be that high. Even
so, Lombardi argues, Dr. Shoenfeld extensively detailed
the presence of more than four of the required criteria; yet
21                                           LOMBARDI   v. HHS

the special master improperly discredited that opinion
and arbitrarily denied Lombardi’s claim.
     We agree with the government that the special mas-
ter’s decision here was reasonable. First, we find no error
in the special master’s decision to analyze Lombardi’s
claim under the ACR’s criteria. Those criteria are gener-
ally accepted in the medical community for diagnosing
SLE, and Lombardi’s own expert referenced them in
analyzing her condition. The special master properly
decided that her burden of showing that she suffers from
SLE would have been satisfied if Lombardi could have
demonstrated that she met the ACR’s criteria for a diag-
nosis of SLE. See Moberly, 592 F.3d at 1322 (A petitioner
needs to “provide a reputable medical or scientific expla-
nation that pertains specifically to the petitioner’s case.”).
    The special master noted that the SLE claim was
raised for the first time more than eight years after
Lombardi’s initial petition was filed. Special Master Op.
at *24.      Following her hepatitis B vaccinations,
Lombardi’s treating physicians actively investigated
whether she suffered from SLE, but in the ten years that
ensued, no doctor ever diagnosed her with that disease.
On the contrary, two of her treating physicians affirma-
tively ruled out that diagnosis. Id. at *29. Yet, at a late
stage of this litigation, Lombardi’s expert Dr. Shoenfeld
diagnosed her with SLE, contending that she met at least
five of the ACR’s criteria. The special master independ-
ently evaluated whether Lombardi met each of the eleven
criteria. Id. at *25-29. The special master rejected Dr.
Shoenfeld’s characterization of Lombardi’s upper lip rash
as a malar rash, one of the eleven criteria. Id. at *25.
Likewise, the special master rejected Dr. Shoenfeld’s
conclusion that Lombardi’s joint pain, or arthralgia,
demonstrated that she had arthritis, another ACR crite-
rion. Id. at *27. He also rejected Dr. Shoenfeld’s testi-
LOMBARDI   v. HHS                                        22

mony that Lombardi suffered from a neurologic disorder
even though she did not experience any seizures or psy-
chosis. Id. at *28. In each of those determinations, the
special master relied upon the definitions as provided by
the ACR. We find that decision to be rational and con-
clude that the special master’s decision was legally sup-
ported in ruling that, at best, Lombardi fulfilled only
three of the eleven criteria for a diagnosis of SLE, thereby
not satisfying the diagnostic requirement for SLE.
    Lombardi relies heavily on the opinion of her treating
rheumatologist, Dr. Schlessel, who submitted a letter to
the special master and who, Lombardi contends, is now
treating her for SLE. Dr. Schlessel’s short letter, how-
ever, appears to be written for the purpose of this litiga-
tion and his statement on Lombardi’s condition is
conclusory: “Please be advised that [Lombardi] has a
number of complaints. Her laboratory tests will be con-
sistent with a diagnosis of systemic lupus erythematosus.”
No “laboratory tests” were ever provided to the special
master and there is no evidence in the record that they
even exist. Moreover, Dr. Schlessel’s statement appears
to predict what Lombardi’s test will reveal, rather than
state an actual diagnosis of SLE. We do not fault the
special master for rejecting such unreliable evidence. Cf.
Moberly, 592 F.3d at 1324 (“[T]he special master is enti-
tled to require some indicia of reliability to support the
assertion of the expert witness.”). We conclude that the
special master’s finding that Lombardi had not shown by
a preponderance of the evidence that she suffered from
SLE was not arbitrary or capricious.
    Lastly, we reject Lombardi’s argument that, given his
record, the special master in this case was biased against
petitioners, and that we should not permit him to “shield
his actions from appellate review.” In support of her
argument, Lombardi cites scores of unrelated decisions
23                                         LOMBARDI   v. HHS

rendered by the special master assigned to this case. We
conclude that those decisions are irrelevant to the case
before us and that Lombardi’s allegations against the
special master are misplaced. There is a difference be-
tween disagreement with a special master’s fact findings
and an accusation that he is biased against petitioners.
We have stated before that special masters of the Claims
Court have “the unenviable job of sorting through these
painful cases and . . . judging the merits of the individual
claims.” Hodges v. Health & Human Servs., 9 F.3d 958,
961 (Fed. Cir. 1993). The special master spent significant
effort in deciding Lombardi’s case, holding three separate
hearings, analyzing Lombardi’s extensive medical record,
resolving conflicting expert opinions, and reviewing a
gamut of evidentiary materials submitted by both parties
to rule on multiple factual and legal issues in a signifi-
cantly difficult case. The Claims Court affirmed his
judgment, holding his factual findings to be reasonable
and his conclusions in accordance with the law. We agree
with the Claims Court. Contrary to Lombardi’s assertion,
the special master did not “cloak the application of an
erroneous legal standard in the guise of a credibility
determination, and thereby shield it from appellate
review.” Andreu, 569 F.3d at 1374.
    To the extent that Lombardi urges us to independ-
ently evaluate the facts of this case to decide whether she
suffers from any of the medical conditions that she al-
leges, we are not at liberty to do so. The special master’s
opinion in this case was well reasoned and put forth a
thorough analysis of each of Lombardi’s claims. We
cannot second guess the special master’s fact conclusions.
Hodges, 9 F.3d at 961 (“The statute makes clear that, on
review, the Court of Federal Claims is not to second guess
the Special Master’s fact-intensive conclusions.”).
LOMBARDI    v. HHS                                       24

    This is an unfortunate case. Lombardi obviously had
a multitude of symptoms of illness. Whether any of them
was caused by hepatitis B vaccine we do not know. But,
having carefully reviewed Lombardi’s arguments and the
record in this case, we conclude that the special master’s
determination that Lombardi had failed to prove by a
preponderance of evidence that she suffered from any of
the three claimed medical conditions and that she is
entitled to compensation under the Vaccine Act was not
“arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law.”          42 U.S.C. § 300aa-
12(e)(2)(B); Hines, 940 F.2d at 1524.
                       CONCLUSION
   We have considered Lombardi’s remaining arguments
and do not find them persuasive. Accordingly, the judg-
ment of the Claims Court is
                      AFFIRMED.
                          COSTS
No Costs.
  United States Court of Appeals
      for the Federal Circuit
               __________________________

                 CHERYL LOMBARDI,
                  Petitioner-Appellant,
                            v.
      SECRETARY OF HEALTH AND HUMAN
                 SERVICES,
             Respondent-Appellee.
               __________________________

                       2011-5004
               __________________________

    Appeal from the United States Court of Federal
Claims in Case No. 99-VV-523, Judge Marion Blank
Horn.
              __________________________

O’MALLEY, Circuit Judge, concurring.
    Because the majority correctly applies the standard
set forth in Broekelschen v. Secretary of Health & Human
Services, 618 F.3d 1339 (Fed. Cir. 2010), and because we
are bound by this court’s precedent, I concur in the judg-
ment of the court. I write separately, however, to ques-
tion whether Broekelschen articulates the appropriate
standard, particularly since it marks a departure from
this court’s prior holding in Althen v. Secretary of Health
& Human Services, 418 F.3d 1274 (Fed. Cir. 2005).
    In Althen, this court explained that a claimant seek-
ing compensation for an off-Table injury must show that
LOMBARDI v. HHS                                          2

the “vaccination caused her malady.” 418 F.3d at 1278.
Specifically, the court set forth the following three-part
test for causation:
   [The petitioner’s] burden is to show by preponder-
   ant evidence that the vaccination brought about
   her injury by providing: (1) a medical theory caus-
   ally 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 rela-
   tionship between vaccination and injury.
Id. A claimant who satisfies this burden is entitled to
compensation unless the government can prove, by a
preponderance of the evidence, that the claimant’s injury
is due to factors unrelated to the vaccine. Id.
    In Broekelschen, the court added an additional hurdle
not contemplated in Althen. Specifically, the court held
that, where the parties dispute the existence and nature
of the injury, the special master must first determine
which injury is best supported by the evidence before
applying the Althen test to determine whether the vaccine
caused that injury. Broekelschen, 618 F.3d at 1346. After
Broekelschen, therefore, “identifying the injury is a pre-
requisite to the [causation] analysis.” Id.
    Judge Mayer, who wrote the unanimous opinion in Al-
then, dissented in Broekelschen on grounds that the
majority’s approach of “first assigning a diagnosis to [the
petitioner’s] symptoms before applying the Althen test, is
not supported by statute, caselaw, or logic, and its effect
was to impermissibly heighten [the petitioner’s] burden.”
Broekelschen, 618 F.3d at 1352. As Judge Mayer ex-
plained, the Vaccine Act does not “narrowly limit[] its
application to known injuries.” Id. Instead, by its terms,
the Vaccine Act: (1) creates a cause of action for persons
3                                           LOMBARDI v. HHS

suffering from a “vaccine-related injury or death”; and
(2) broadly defines “vaccine-related injury or death” to
include “an illness, injury, condition, or death.” See 42
U.S.C. § 300aa-11(c); 42 U.S.C. § 300aa-33(5).
     According to the majority in Broekelschen, “[m]edical
recognition of the injury claimed is critical and by defini-
tion a ‘vaccine-related injury,’ i.e., illness, disability,
injury or condition, has to be more than just a symptom or
manifestation of an unknown injury.” 618 F.3d at 1349.
In effect, the majority in Broekelschen suggests that a
claimant must prove that she has received a firm diagno-
sis of a specific disease or disorder before the methodology
of Althen is to be applied. And, the majority in Broekel-
schen, as the majority here, makes clear that where there
is a question as to the precise nature of the injury, the
special master virtually has free reign to choose from
among the possible diagnoses. I disagree with these
requirements.
    By statute, an off-Table petitioner, such as Lombardi,
must allege only that she “sustained, or had significantly
aggravated, any illness, disability, injury, or condition not
set forth in the Vaccine Injury Table but which was
caused by a Vaccine.” 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I).
Although the claimant must show that the vaccine caused
an “illness, disability, injury, or condition,” nothing in the
statutory language requires a clear diagnosis. Indeed, the
breadth and variety of the phrases chosen to describe the
possible harms cognizable under the Act implies that no
such requirement should be read into the statute. Given
the absence of a diagnosis requirement, I agree with
Judge Mayer that, even where there is no “definitively
diagnosed injury,” a petitioner “may experience an illness
or disability that, with the proper showing of causation,
can meet the criteria for a vaccine-related injury under
the Vaccine Act.” See Broekelschen, 618 F.3d at 1352.
LOMBARDI v. HHS                                           4

     The majority in Broekelschen emphasized that this
situation, where the exact nature of the injury is disputed,
is “atypical” and “unusual.” 618 F.3d at 1349. Similarly,
the special master here stated that Lombardi’s case is
“unusual” because: (1) “doctors have not reached any
consensus about what condition affects her now, or af-
fected her in 1997-98”; and (2) her “treating doctors have
not diagnosed her with one condition consistently.” Doe
60 v. Sec’y of Health & Human Servs., No. 99-VV-523,
2010 WL 1506010, *7 (Fed. Cl. Mar. 26, 2010). As Judge
Mayer noted in his dissent, however, every case is unique,
and it is not difficult to imagine cases such as this, where
medical examiners agree that something is wrong with an
individual but either disagree as to the exact diagnosis or
simply arrive at different, non-conflicting diagnoses.
Importantly, nothing in the terms of the Vaccine Act
requires a petitioner to show agreement among experts as
to a specific diagnosis.
    Broekelschen marks an unwarranted departure from
this court’s decision in Althen and provides a mechanism
for special masters to shortcut the causation analysis in
instances where the alleged injuries can support multiple
diagnoses. As long as the respondent suggests an alter-
nate diagnosis, the special master can effectively render
his own diagnosis and deny compensation without ever
shifting the burden to the government to show, by a
preponderance of the evidence, that other factors unre-
lated to the vaccine caused the injury. As this court has
recognized, however, the purpose of the Vaccine Act “was
to establish a compensation program under which awards
could be made to vaccine-injured persons ‘quickly, easily,
and with certainty and generosity.’” Shyface v. Sec’y of
Heath & Human Servs., 165 F.3d 1344, 1351 (Fed. Cir.
1999) (quoting H.R. Rep. No. 99-908, 99th Cong., 2d Sess.
(1986), reprinted in 1986 U.S.C.C.A.N. 6344). Because
5                                         LOMBARDI v. HHS

Broekelschen creates an additional prerequisite to recov-
ery and impermissibly increases a petitioner’s burden, I
believe its holding contravenes the purpose of the Vaccine
Act and is inconsistent with both the statutory language
and our prior decision in Althen.
    Accordingly, although I agree that the decision in this
case is correct in light of Broekelschen, and therefore
concur in the court’s judgment, I question whether that
case articulates the correct standard. For the reasons
discussed above, I believe we should revisit or signifi-
cantly limit our decision in Broekelschen.