Locane v. Secretary of Health & Human Services

United States Court of Appeals
for the Federal Circuit
__________________________
JENNIFER LOCANE,
Petitioner-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2011-5131
__________________________
Appeal from the United States Court of Federal
Claims in Case No.99-VV-589, Judge Christine O.C.
Miller.
__________________________
Decided: July 12, 2012
__________________________
CLIFFORD J. SHOEMAKER, Shoemaker & Associates, of
Vienna, Virginia, argued for petitioner-appellant.
MELONIE J. MCCALL, Trial Attorney, Torts Branch,
Civil Division, United States Department of Justice, of
Washington, DC, argued for respondent-appellee. Of
counsel on the brief were TONY WEST, Assistant Attorney
General, MARK W. ROGERS, Acting Director, VINCENT J.
MATANOSKI, Acting Deputy Director, and CATHARINE E.
REEVES, Assistant Director.
LOCANE v. HHS 2
__________________________
Before NEWMAN, PLAGER, and WALLACH, Circuit Judges.
WALLACH, Circuit Judge.
Ms. Jennifer Locane (“Ms. Locane”) filed a petition for
compensation under the National Childhood Vaccine
Injury Act (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 to -34
(2006), alleging that she suffered Crohn’s disease as a
direct result of hepatitis B vaccination. Special Master
Christian J. Moran denied the claim, finding Ms. Locane’s
disease began before her vaccination and finding that Ms.
Locane failed to prove by a preponderance of the evidence
that the vaccine caused or significantly aggravated her
disease. See Locane v. Sec’y of Health & Human Servs., 99
Fed. Cl. 715 (2011). Because the Court of Federal Claims
(“Claims Court”) correctly concluded that the Special
Master’s decision was not arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law, we
affirm.
BACKGROUND
I.
Ms. Locane was born on July 14, 1983. She was
adopted and does not know the medical history of her
biological family. Through age ten, Ms. Locane had
typical childhood illnesses and injuries and maintained an
average growth rate, with height and weight in the fifti-
eth percentile for children her age. However, in early
adolescence Ms. Locane’s growth rate began to diminish.
At thirteen she was in the twenty-fifth percentile for
height and fifteenth percentile for weight, and one year
later she fell to the tenth percentile for weight although
she remained in the twenty-fifth percentile for height.
3 LOCANE v. HHS
On August 29, 1997, her pediatrician, Dr. Tanis, did a
routine examination necessary for her participation in
high school athletics and administered the first of three
doses of hepatitis B vaccine. Within two weeks, Ms.
Locane suffered stomach cramps, loose stools, nausea, and
decreased appetite. Her discomfort persisted, and on
November 18, 1997, when Ms. Locane returned to see her
pediatrician she weighed four pounds less than she had in
August and was diagnosed with a virus. Ten days later,
Ms. Locane returned to her pediatrician because there
was blood in her stool and she had lost more weight. Dr.
Tanis concluded Ms. Locane had either Crohn’s disease or
ulcerative colitis and referred her to Dr. Tano, a pediatric
gastroenterologist.
Dr. Tano noted Ms. Locane’s weight placed her below
the fifth percentile for children her age. Dr. Tano opined
that Ms. Locane was suffering from inflammatory bowel
disease and recommended she go to the hospital. After a
series of tests that showed results “consistent with
Crohn’s disease,” she was prescribed Prednisone (a ster-
oid) and discharged from the hospital on December 9,
1997.
On December 11, 1997, Ms. Locane was given her sec-
ond dose of the hepatitis B vaccine, as well as other
vaccinations, without any adverse effects. Her Predni-
sone prescription was adjusted over the next few weeks as
her condition seemingly improved. Ms. Locane received
her third dose of the hepatitis B vaccine on February 6,
1998. Shortly thereafter her condition deteriorated. In
response, Dr. Tano increased her Prednisone prescription
on March 16, 1998.
II.
Ms. Locane filed her petition in the Claims Court on
August 4, 1999, but development of the case was put on
LOCANE v. HHS 4
hold as the parties attempted to establish a mechanism
for cases involving the hepatitis B vaccine. A Special
Master was assigned to the case on February 8, 2006, and
expert testimony was heard on April 17, 2008.
Ms. Locane argued that the hepatitis B vaccine
caused her Crohn’s disease and/or caused significant
aggravation to her condition. Ms. Locane testified that
she had no intestinal problems before her August 1997
hepatitis B vaccination. She attributed the fact that she
had no reaction to the second vaccination in December
1997 to her high dosage of Prednisone at the time. Ms.
Locane described the consequences of her Crohn’s disease,
which included multiple protracted hospital visits
throughout college.
As a preliminary step, the Special Master held that it
was necessary to resolve when Ms. Locane’s Crohn’s
disease began. Ultimately, the Special Master concluded
that the preponderance of the evidence proved Ms. Locane
had Crohn’s disease before her August 1997 vaccination
and therefore the vaccination could not have caused her
Crohn’s disease.
Dr. Bellanti, Ms. Locane’s expert, is a professor of
immunology. Dr. Bellanti testified that there is a clear
temporal relationship between the hepatitis vaccination
and Ms. Locane’s development of Crohn’s disease, and
that theoretically a vaccination could cause Crohn’s
disease.
The Secretary of Health and Human Services’s expert,
Dr. Warner, is a clinical professor who specializes in
Crohn’s disease. Dr. Warner dismissed the temporal
relationship between receipt of the hepatitis B vaccine
and the diagnosis of Crohn’s disease as coincidental.
Instead, Dr. Warner pointed to Ms. Locane’s reduced
growth velocity, as evidenced in her growth charts, as an
5 LOCANE v. HHS
indication that she had Crohn’s disease prior to receiving
the hepatitis B vaccine. Dr. Warner explained that “[a]
reduction in growth velocity is commonly the first sign of
Crohn’s disease seen in the pediatric population, with
gastrointestinal symptoms manifesting at a later date.”
Locane, 99 Fed. Cl. at 721. On cross examination, Dr.
Bellanti recognized that “a decrease in growth velocity
may be the first sign of Crohn’s disease.” Id. at 722.
The Special Master deemed Dr. Warner’s testimony
more persuasive than Dr. Bellanti’s given the extent of
Dr. Warner’s experience and expertise with Crohn’s
disease and given that his testimony was consistent with
the medical literature:
The special master found that petitioner offered
“little response” to Dr. Warner’s opinion that peti-
tioner’s weight velocity decreased prior to her
Crohn’s diagnosis . . . . The special master ex-
plained that petitioner’s argument that her pre-
vaccination health was normal because she was a
petite child and lost only a few pounds from age of
eleven to thirteen was not supported by the “rele-
vant measure,” which is the “rate of change, not
the absolute weight.”
Id. The Special Master gave credit to Dr. Warner’s expla-
nation that Ms. Locane’s treating doctors failed to diag-
nose her Crohn’s disease until after the vaccinations
because it is easy to miss the subtle early symptoms. The
Special Master found that because the average delay in
diagnosis was 13.7 months, Ms. Locane’s 16 month lapse
between her growth velocity decreasing and her gastroin-
testinal symptoms was not out of the ordinary. 1 Having
1 The Special Master also considered and rejected
the expert opinion of Dr. Solny, another gastroenterolo-
gist. Dr. Solny’s first report was discounted because he
LOCANE v. HHS 6
found Ms. Locane’s disease began before her vaccination,
the Special Master held that the vaccine could not have
caused the disease and an analysis under Althen was
unnecessary. See Althen v. Sec’y of Health & Human
Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005) (summarizing
the elements necessary to show by preponderant evidence
that the vaccination brought about a petitioner’s injury).
The Special Master then determined that Ms. Locane
failed to show by a preponderance of the evidence that she
was entitled to compensation under the significant aggra-
vation theory because the course of her disease was not
affected by the vaccination. The Special Master found
that flare-ups in symptoms are part of the normal course
of the disease, that Ms. Locane did not have an adverse
reaction to the second vaccination dose, and that she
experienced flare-ups throughout college that were not
preceded by a hepatitis B vaccination. Therefore, the
Special Master found Ms. Locane did not show that her
condition was worse than it would have been but for the
vaccination.
On review, the Claims Court affirmed, concluding
that the Special Master’s factual finding that the onset of
Ms. Locane’s Crohn’s disease occurred prior to her hepati-
tis B vaccination was not arbitrary or capricious. Fur-
thermore, the Claims Court held that failure to conduct
an analysis under Althen after determining that the
preponderance of evidence showed the illness predates the
vaccination was not an abuse of discretion. Finally, the
had mistakenly assumed that Ms. Locane received her
first hepatitis B vaccination in 1994 and sometime there-
after her growth velocity slowed. Dr. Solny’s second
report failed to address the change in Ms. Locane’s growth
curve and failed to address Dr. Warner’s opinion that Ms.
Locane suffered from Crohn’s disease prior to her August
1997 vaccination.
7 LOCANE v. HHS
Claims Court held that the Special Master’s factual
finding that Ms. Locane failed to prove significant aggra-
vation was not arbitrary or capricious.
Ms. Locane timely appealed to this court. We have
jurisdiction over this appeal pursuant to 42 U.S.C.
§ 300aa-12(f).
DISCUSSION
“We review an appeal from the Court of Federal
Claims in a Vaccine Act case de novo, applying the same
standard of review as the Court of Federal Claims applied
to its review of the special master’s decision.” Broekel-
schen v. Sec’y of Health & Human Servs., 618 F.3d 1339,
1345 (Fed. Cir. 2010). We give no deference to the Claims
Court’s or Special Master’s determinations of law, but
uphold the Special Master’s findings of fact unless they
are arbitrary or capricious. Id.To receive compensation under the Vaccine Act a peti-
tioner must prove by a preponderance of the evidence that
the injury at issue was caused by a vaccine. 42 U.S.C.
§ 300aa-13(a)(1). Causation is presumed if a petitioner
can show that she sustained an injury in association with
a vaccine listed in the Vaccine Injury Table. 42 U.S.C.
§ 300aa-11(c)(1)(C)(i); Andreu v. Sec’y of Health & Human
Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009). If the injury
is not listed in the Vaccine Injury Table, a petitioner must
prove actual causation or causation in fact by a prepon-
derance of the evidence. 42 U.S.C. § 300aa-11(c)(1)(C)(ii);
Moberly v. Sec’y of Health & Human Servs., 592 F.3d
1315, 1321 (Fed. Cir. 2010). There is a three prong test to
demonstrate causation in fact “by preponderant evidence”;
the petitioner must provide: “(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
LOCANE v. HHS 8
proximate temporal relationship between vaccination and
injury.” Althen, 418 F.3d at 1278. Upon demonstration of
causation a petitioner is entitled to compensation unless
the respondent “can show by a preponderance of the
evidence that the injury is due to factors unrelated to the
vaccine.” Broekelschen, 618 F.3d at 1342; see 42 U.S.C.
§ 300aa-13(a)(1)(B). Additionally, a petitioner can receive
compensation if a vaccination “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” the Vaccine Injury Table. 42 U.S.C.
§ 300aa-11(c)(1)(C)(ii)(I). Significant aggravation is
defined as “any change for the worse in a preexisting
condition which results in markedly greater disability,
pain, or illness accompanied by substantial deterioration
of health.” 42 U.S.C. § 300aa-33(4).
I.
Ms. Locane argues that the Special Master’s determi-
nation that the onset of her Crohn’s disease occurred prior
to her first hepatitis B vaccination was arbitrary and
capricious. Ms. Locane asserts that her treating physi-
cians took no notice of her weight prior to her vaccination,
that her significant weight loss occurred after August
1997, and that prior to that time “there was no manifesta-
tion of symptoms that justified a diagnosis of Crohn’s.”
Ms. Locane contends that Dr. Warner’s explanation is
equivocal, that the medical records and actions of her
treating doctors demonstrate the onset of her Crohn’s
disease came after her vaccination, and that any close
calls should be resolved in her favor, and therefore, denial
of her claim was arbitrary and capricious. 2
2 Specifically, Ms. Locane objects to the significance
placed on Dr. Warner’s testimony that she had fallen “off
of the growth curve” prior to her vaccination when her
9 LOCANE v. HHS
“Expert medical testimony is often very important in
Vaccine Act cases based on off-Table injuries . . . . The
special master’s decision often times is based on the
credibility of the experts and the relative persuasiveness
of their competing theories.” Broekelschen, 618 F.3d at
1347; see Lampe v. Sec’y of Health & Human Servs., 219
F.3d 1357, 1362 (Fed. Cir. 2000) (we give deference to the
Special Master’s factual findings, which are “virtually
unchallengeable on appeal”). The Special Master found
Dr. Warner’s testimony more persuasive than Dr. Bel-
lanti’s because of their different backgrounds and special-
ties and because the medical literature supports Dr.
Warner’s theory. Locane, 99 Fed. Cl. at 721-22. We find
nothing arbitrary or capricious about the Special Master’s
determination that Dr. Warner’s testimony was more
persuasive than Dr. Bellanti’s testimony. Accordingly, we
affirm the Claims Court’s decision to uphold the Special
Master’s finding that the onset of Ms. Locane’s illness
began prior to her hepatitis B vaccination. See Hodges v.
Sec’y of Dep’t of Health & Human Servs., 9 F.3d 958, 961
(Fed. Cir. 1993) (noting the reviewing court’s purpose “is
not to second guess the Special Master[’s] fact-intensive
conclusions; the standard of review is uniquely deferential
for what is essentially a judicial process”).
II.
weight loss was insubstantial until after August 1997.
Also, Ms. Locane argues that her weight loss did not
reach the range the medical literature cites as an early
manifestation of the disease (4.52 kg to 22.6 kg) until
after her first hepatitis B vaccination. Furthermore, Ms.
Locane notes that no one was concerned about the initial
decreases in growth velocity, that none of her treating
doctors identified the onset as prior to her vaccination,
and that one of her doctors even filed a Vaccine Adverse
Event Reporting System report indicating a “suspected
reaction” to the vaccination.
LOCANE v. HHS 10
Ms. Locane also contends that the Special Master
erred in failing to conduct an analysis under Althen. She
avers that she has met her burden of proving causation by
presenting a medical theory that causally connects the
vaccination and the injury, by demonstrating a medically
appropriate temporal association between the vaccination
and the onset of her illness, and by establishing a logical
sequence of cause and effect.
In Althen, this court enunciated the standard for de-
termining when a petitioner has met her burden of show-
ing by preponderant evidence that the vaccine caused the
injury. Althen, 418 F.3d at 1278. The three-prong test is
intended to evaluate whether the vaccine actually caused
the injury. To prove causation in fact “by preponderant
evidence” a petitioner must demonstrate: “(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 show-
ing of a proximate temporal relationship between vaccina-
tion and injury.” Id. Given the Special Master’s finding
that the illness was present before the vaccine was ad-
ministered, logically, the vaccine could not have caused
the illness. The Althen inquiry is inapplicable. 3 Accord-
3 This court has previously discussed instances
where it is appropriate for the Special Master to first
determine an injury before applying the Althen test. In
Broekelschen the court held “it was appropriate for the
special master to initially determine which injury Dr.
Broekelschen suffered before applying the Althen test.”
Broekelschen, 618 F.3d at 1349. In Althen this court
stated that “[a]lthough probative, neither a mere showing
of a proximate temporal relationship between vaccination
and injury, nor a simplistic elimination of other potential
causes of the injury suffices, without more, [to] meet the
burden of showing actual causation.” Althen, 418 F.3d at
1278. In the case at hand, the appearance of symptoms
11 LOCANE v. HHS
ing to 42 U.S.C. § 300aa-13(a)(1)(B) compensation should
only be awarded if on the record as a whole “there is not a
preponderance of the evidence that the illness . . . is due
to factors unrelated to the administration of the vaccine . .
. .” As the Claims Court explained, “[n]owhere in the
statutory scheme or Federal Circuit precedent emerges a
requirement that the special master conduct a causation
analysis once the special master has determined that a
preponderance of the evidence shows that the onset of the
illness predates the vaccination.” Locane, 99 Fed. Cl. at
729.
III.
In the alternative, Ms. Locane argues that if “contrary
to all evidence” the court upholds the finding that her
Crohn’s disease was preexisting, then the course of her
disease was significantly aggravated by her hepatitis B
vaccinations. Ms. Locane notes that “there is not a single
expected course of Crohn’s disease,” and prior to the
vaccination she had no other symptoms except for some
mild weight fluctuations and the illness “did not in any
way impact her life.” Ms. Locane acknowledges that there
is no known cause of Crohn’s disease, but posits numerous
plausible theories “along with a demonstrated striking
temporal association of onset, or in the instance of signifi-
cant aggravation, flare-ups following vaccination within a
medically appropriate time-frame.”
The Special Master held that “a preponderance of the
evidence demonstrates that [Ms. Locane’s] course was
consistent with Crohn’s disease and was not affected by
the hepatitis B vaccination.” Locane, 99 Fed. Cl. at 731.
The testimony was unclear as to whether Crohn’s has a
specific pattern or normal course. The Special Master
after vaccination does not necessitate a finding of causa-
tion.
LOCANE v. HHS 12
credited Dr. Warner’s testimony that it was typical for
young people to experience flare-ups with Crohn’s disease
like those Ms. Locane experienced and found Ms. Locane’s
expert evidence did not persuasively show the vaccination
made her symptoms worse. Id. The Special Master con-
cluded that “something other than the hepatitis B vaccine
cause[d] [Ms. Locane] to suffer worse symptoms of
Crohn’s disease” given that she did not experience a flare-
up after the second vaccination and she experienced
similar flare-ups that were not preceded by a vaccination
dose. Id. at 732. Ultimately, the Special Master found
that the preponderance of the evidence showed that the
course of Ms. Locane’s condition was not inconsistent with
the disease generally and not affected by the vaccinations.
Id. at 733. Because the Special Master “considered the
relevant evidence of record, [drew] plausible inferences
and articulated a rational basis for the decision,” the
decision was not arbitrary or capricious. Hines v. Sec’y of
Dep’t of Health & Human Servs., 940 F.2d 1518, 1528
(Fed. Cir. 1991). Ms. Locane was given ample opportunity
to develop her significant aggravation claim but ‘“failed to
present persuasive evidence that separates [her] problems
from an expected course of Crohn’s disease.’” Locane, 99
Fed. Cl. at 731 (quoting Locane v. Sec’y of Health & Hu-
man Servs., No. 99-589V (Fed. Cl. Spec. Mstr. Feb. 17,
2011)). It is not the role of this court to relitigate claims
that have already been adjudicated. Accordingly, we
affirm the Claims Court’s decision that Ms. Locane failed
to prove significant aggravation.
CONCLUSION
The decision of the Claims Court upholding the Spe-
cial Master’s denial of compensation under the Vaccine
Act is affirmed.
AFFIRMED
13 LOCANE v. HHS
No costs.