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.