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 fiftieth 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 steroid) and discharged from the hospital on December 9, 

1997. 

On December 11, 1997, Ms. Locane was given her second dose of the hepatitis B vaccine, as well as other 

vaccinations, without any adverse effects. Her Prednisone 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 petitioner’s weight velocity decreased prior to her 

Crohn’s diagnosis . . . . The special master explained that petitioner’s argument that her prevaccination 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 “relevant measure,” which is the “rate of change, not 

the absolute weight.” 

Id. The Special Master gave credit to Dr. Warner’s explanation that Ms. Locane’s treating doctors failed to diagnose 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 gastrointestinal symptoms was not out of the ordinary.1 Having 

 1 The Special Master also considered and rejected 

the expert opinion of Dr. Solny, another gastroenterologist. 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 aggravation 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 hepatitis B vaccination was not arbitrary or capricious. Furthermore, 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 thereafter 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 aggravation 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.” Broekelschen 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 petitioner 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 preponderance 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 determination 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 physicians 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 manifestation 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. Bellanti’s because of their different backgrounds and specialties 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 determining when a petitioner has met her burden of showing 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 showing of a proximate temporal relationship between vaccination and injury.” Id. Given the Special Master’s finding 

that the illness was present before the vaccine was administered, 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 significant 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 causation. 
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 concluded 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 flareup 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 & Human 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 Special Master’s denial of compensation under the Vaccine 

Act is affirmed. 

AFFIRMED 
13 LOCANE v. HHS

No costs.