In the United States Court of Federal Claims

No. 13-611V

(Filed Under Seal: July 3, 2018)

(Reissued: July 18, 2018)1

*************************************

National Childhood Vaccine 

Injury Act; Review of Special 

Master’s Decision Granting 

Relief for Sudden Infant Death 

Syndrome; Application of 

Althen Test; Assessment of 

Expert Testimony. 

*

CHASE BOATMON and MAURINA 

CUPID, parents of J.B., deceased,

*

*

*

 Petitioners, *

*

v. *

SECRETARY OF

*

*

HEALTH AND HUMAN SERVICES, *

*

 Respondent. *

*

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Joseph Pepper, with whom was Ronald C. Homer, Conway Homer, P.C., Boston, 

Massachusetts, for Petitioners.

Thomas G. Ward, Deputy Assistant Attorney General, Torts Branch, Civil Division, with 

whom were Chad A. Readler, Acting Assistant Attorney General, C. Salvatore D’Alessio, 

Acting Director, Catharine E. Reeves, Deputy Director, Kathryn A. Robinette and Lara A. 

Englund, Trial Attorneys, Torts Branch, Civil Division, U.S. Department of Justice, 

Washington, D.C. for Respondent.

OPINION AND ORDER

WHEELER, Judge.

This vaccine case is before the Court on Respondent’s motion for review of the 

Special Master’s entitlement decision in Boatmon v. Sec’y of Health & Human Servs., No. 

13-611V, 2017 WL 3432329 (Fed. Cl. Spec. Mstr. July 10, 2017). The case focuses on the 

relationship, if any, between vaccines and Sudden Infant Death Syndrome (SIDS), a 

condition causing unexpected death, leaving families devastated and looking for answers. 

 

1 Pursuant to Rule 18(b) of the Court’s Vaccine Rules, this opinion and order was initially filed under seal. As 

required under the Rules, each party was afforded 14 days from the date of issue, until July 17, 2018, to object to the 

public disclosure of any information furnished by that party. Neither party submitted any proposed redactions.
2

The Special Master found that Petitioners Chase Boatmon and Maurina Cupid, the child’s 

parents, were entitled to compensation under the Vaccine Act because they had shown that 

vaccines were a substantial cause of their child J.B.’s SIDS-related death. The Court has 

carefully reviewed the parties’ briefs and the court record, and heard oral argument on June 

5, 2018. For the reasons explained, the Court finds as a matter of law that the Special 

Master erred in ruling for Petitioners, and in finding that Petitioners had met their burden 

of proof as established by applicable statutes and case law. The Court therefore grants the 

Respondent’s motion for review and reverses the Special Master’s entitlement decision 

below, vacating the judgment and dismissing the Petition. 

Background2

J.B. was born on April 7, 2011, four weeks premature but otherwise without notable 

health difficulties. He received his first hepatitis B vaccination at one week. At his twoweek well-baby visit J.B. appeared healthy, with normal growth and development. His 

subsequent well-baby visits were scheduled to account for the fact that he was born four 

weeks prematurely, and he had his two-month visit with his pediatrician around four

months after his birth, on July 22, 2011. He was noted to be a “well child” with normal 

growth and development, and received first diphtheria, tetanus and pertussis (DTaP), 

inactivated polio (IPV), pneumococcal conjugate (PCV), rotavirus, and hepatitis B (Hep 

B) vaccinations at that visit.

On September 2, 2011, J.B. had his four-month well baby visit, almost five months 

after his birth. The pediatrician described him as “healthy appearing and cooperative ...

well-nourished and well developed.” His chest and lungs were normal. He had no fever, 

nasal congestion, or cough. He met developmental milestones for a four-month old, and 

he was given his second round of vaccinations, again DTaP, IPV, PCV, rotavirus, and Hep 

B. His father stated in an affidavit that later in the day J.B. seemed quiet and withdrawn, 

and during the evening he had a fever. Early the next morning, at 4:00 a.m., his parents 

gave him Advil and he went to sleep on his back. When he woke up a few hours later, he 

was distant, very quiet, and would not eat. He began running a fever again and was given

more Advil at 8:00 a.m. In the early afternoon his father put him down for a nap on his 

back with his head to the right. His father then left the house and his mother checked on 

him twice. The second time, about 50 minutes after the start of his nap, his mother found 

that J.B. was unresponsive. She reported that he was on his right side with his head turned. 

She also stated that his nose and mouth were not covered.

J.B.’s mother called 911 and attempted CPR. A policeman arrived very quickly, 

about three minutes after the call, and finding that J.B. had no pulse or breath, began 

performing chest compressions until Emergency Services arrived. Efforts at resuscitation

 

2 Drawn from the Special Master’s Decision or where noted, from filed Exhibits.
3

were unsuccessful and J.B. was pronounced dead at the hospital on September 3, 2011, at 

4:01 p.m.

The medical examiner’s Report of Investigation includes a summary of a 

reenactment done by the Suffolk County Police Department with J.B.’s parents five days 

after his death. Med. Records at 3, Dkt. No. 6-9. Using a doll, the investigator noted that 

the father placed the doll on its back and put a blanket across the midsection. The autopsy 

report observed that photographs of the reenactment show a crib with soft blankets and a 

flat soft pillow. The autopsy found a “well nourished, well developed infant male” with 

no detected abnormalities that could cause death: “Given the absence of findings and the 

reported sleeping position in a child with no anatomic or microscopic significant findings, 

it is felt that the cause of his death is best classified as sudden infant death syndrome 

(SIDS).” 

Petitioners filed their vaccine petition on August 27, 2013, alleging that J.B.’s death 

was the result of the vaccinations he received the day before his death. Petitioners later

filed medical records and the expert report of Dr. Douglas Miller, a neuropathologist, 

together with the medical literature exhibits cited in his report. Respondent filed 

responsive expert reports of Dr. Brent Harris, a neuropathologist, and Dr. Christine 

McCusker, a pediatric immunologist, with medical literature, in opposition to Petitioner’s 

claims. The Special Master conducted an entitlement hearing at which all three experts 

testified on August 6 and 7, 2015. 

As noted by the Special Master, SIDS is defined as “the sudden death of an infant 

under one year of age which remains unexplained after a thorough case investigation, 

including performance of a complete autopsy, death scene investigation, and review of the 

clinical history.” SIDS occurs during sleep or transitions between sleep and waking, and

is the leading cause of infant mortality in the United States. Cardiorespiratory failure is 

emphasized. 

Medical researchers have attempted to understand the cause of such devastating 

deaths. Beginning in 1994, Dr. Hannah Kinney, a neuropathologist at Harvard, and her 

colleagues have developed and refined the “Triple Risk Model” as a hypothesis to explain 

the causes of SIDS. That model proposes that infants are at risk of SIDS when three factors 

occur simultaneously: the child (1) is in a critical development period, usually defined as

under six months old, (2) has an underlying vulnerability, and (3) encounters an externally 

caused stressor. 

As the research has developed into underlying vulnerabilities leading to SIDS, Dr. 

Kinney’s team and others have focused increasingly on brainstem abnormalities affecting 

response to cardiorespiratory difficulties. In this connection, the role of cytokines has been 

studied and debated, and was a key focus of the dispute in this case. Cytokines are 

“communication proteins” whereby “a signal is transmitted to the receptive cell inducing 
4

a response affecting behavior and function of the recipient cell.” McCusker Report at 2, 

Dkt. No. 30-1. The third factor, externally caused stressors, includes being placed in a 

prone or in a side sleeping position; found face-down or head covered; sleeping on an adult 

mattress, couch, or playpen; soft bedding; bed-sharing, and upper respiratory tract 

infection. Experts for both parties agreed that Dr. Kinney’s work has not included 

vaccinations among external stressors. The finding that SIDS infants were often in a facedown or prone position inspired the “Back-to-Sleep” campaign encouraging parents to 

place infants to sleep on their back, and this practice has reduced the incidence of SIDS by 

about 50 percent.3 Research continues to seek answers for the remaining fatalities.

Summary of Expert Testimony 

Petitioner’s Expert Dr. Miller

Petitioners’ expert, Dr. Douglas Miller, is a board-certified neuropathologist who 

has been practicing and teaching neuropathology at major U.S. medical centers for about 

thirty years. Miller Report at 2, Dkt. No. 21-1. He practices at the University of Missouri

School of Medicine and provides neuropathology consulting services including forensic 

autopsy services to counties throughout Missouri. He stated that he had reviewed a 

“considerable number of SIDS autopsies” in his career. After reviewing the medical 

records in this case, he concurred with the medical examiner’s finding that J.B.’s death was 

due to SIDS. He further opined, based on the evidentiary record and on medical literature 

submitted with his report, that it is “medically plausible” that J.B’s death was “related” to 

the vaccinations he received the day before his death, and that in fact the vaccinations “may 

represent a substantial contributing factor.” In his report he stated that he reached this 

conclusion from medical literature “suggesting a mechanism for SIDS involving cytokineinduced abnormalities of neurotransmitter function in the brainstem leading to respiratory 

arrest.” Id. at 2. While he noted that the autopsy in this case was “seriously deficient” 

because it failed to examine the part of the brain critical to his theory that J.B.’s brainstem 

was abnormally developed, he stated that “the setting is suspicious” for such a defect. Id.

at 7. Characterizing vaccinations as an external stressor under the Triple Risk Model, he 

argued that some literature shows that vaccines are “triggers for systemic cytokine release” 

and that the cytokines impair the response to breathing difficulties by a sleeping infant with 

an abnormal brainstem. Id. at 6.

Respondent’s Expert Dr. McCusker

Dr. Christine McCusker is Division Director of Pediatric Allergy, Immunology and 

Dermatology at Montreal Children’s Hospital, McGill University Health Center and is a 

pediatric immunologist and director of the Clinical Immunology Lab. McCusker CV, Dkt. 

No. 32-7. In her report, she reviewed the literature and disputed Dr. Miller’s opinion that 

 

3 Trachtenberg et al., Risk Factor Changes for Sudden Infant Death Syndrome After Initiation of Back-to-Sleep 

Campaign, 129 Pediatrics 630 (2012), Dkt. No. 31-4.
5

vaccinations played a substantial role in causing J.B.’s death by provoking release of 

destructive cytokines. McCusker Report, Dkt. No. 30-1. She argued that the cytokines

released as part of the immune response at the site of the inoculation are “transient and 

tightly regulated.” She further stated that cytokines have been shown to be expressed by 

cells of the brain and help maintain normal brain function. In a situation of distress such 

as that which occurs with SIDS, “it is reasonable to hypothesize” that “cytokines involved 

in neuroprotection would be released in an attempt to ‘save’ the system” rather than attack 

the system. Id. at 3. She also argued that increased cytokines would most likely promote

rather than inhibit arousal. She added that Dr. Kinney’s external stressors (part of the 

Triple Risk Model) such as sleeping position, bedding, and upper respiratory infection are 

related to interference with the mechanical ability to breathe, not to a neurochemical effect 

such as that posited by the Petitioner’s expert. Id. at 5. She also reviewed the

epidemiological literature specifically looking at SIDS and vaccination and found that 

“[m]ore recent well designed publications ... increase the strength of evidence against a 

causal association for SIDS and vaccines.” Id. at 8. Other case studies were also discussed

as not supportive of Petitioners’ arguments. She concluded from the literature that 

cytokines play an important role in sleep and arousal, and that they can induce fever as well 

as create more frequent arousal. She does not accept Petitioners’ claim that vaccineinduced cytokines reduce the capacity for arousal in brain-impaired infants leading to 

SIDS. Id.

Respondent’s Expert Dr. Harris

Dr. Brent Harris is an anatomic/neuropathologist (board-certified in both). Harris 

Report at 1, Dkt. No. 29-1. He has practiced in prominent academic medical centers and 

is currently an Attending Pathologist and Associate Professor in Neurology and Pathology 

and Director of Neuropathology at Georgetown University Medical Center. He is also a 

neuropathology consultant for the Washington, D.C. Chief Medical Examiner, the National 

Institutes of Health, Howard University Hospital, the Washington, D.C. Veterans 

Administration Hospital, and the American International Pathology Laboratory. In the last 

three years he reviewed more than 50 pediatric autopsies, the majority of which were SIDS 

cases. Harris Report, Dkt. No. 29-1. Dr. Harris reviewed the medical records and literature 

in this case and disagreed with Dr. Miller’s opinion that J.B’s death was linked to his 

vaccinations. Id. at 6. He saw no conclusive evidence “generally agreed upon in the 

medical community and in the medical literature” that links vaccination and SIDS. He 

stated that the Triple Risk Theory is “well-reasoned and generally accepted,” although it 

has yet to be proven, and also that it does not suggest a link with vaccinations. Id. Dr. 

Harris concluded that there were no pathological findings in J.B.’s medical records that 

indicate a vaccine related death. Id. at 7.
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The Althen Standards 

Petitioners seek recovery in this case for an “off-Table” injury, that is, an injury 

caused by a vaccine other than those injuries listed on the Vaccine Injury Table, 42 U.S.C. 

§ 300aa-14(a). In off-Table injuries, claimants must show causation in fact by a 

preponderance of the evidence. 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-13(a)(1)(A); 

see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 

2010). The U.S. Court of Appeals for the Federal Circuit summarized the claimant’s

evidentiary burden associated with off-Table cases in Althen v. Sec’y of Health & Human 

Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005), holding that the claimant must establish by 

preponderant evidence: 

(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 proximate temporal relationship between vaccination and injury. 

These three burden of proof factors are now commonly referred to as the three 

Althen prongs.

The Special Master’s Decision

The Special Master found in this case that Petitioners had established all three 

prongs required by the Althen test. With respect to Prong One, he first found that even 

though the autopsy did not examine J.B.’s brainstem, the infant must have had a defective 

brainstem because the Kinney studies had found such defects in about 75 percent of SIDS 

cases studied. Boatmon, 2017 WL 3432329, at *32. He went on to conclude that 

Petitioners had shown “a reasonable and reliable theory of vaccine causation” where 

cytokines produced by vaccination can act “as an extrinsic stressor in a baby with a 

brainstem deficit under the Triple Risk Model.” Id. at *38. As to Prong Two, requiring a 

“logical sequence of cause and effect” showing vaccination was the reason for J. B.’s death,

the Special Master dismissed as unlikely other possible external stressors such as formula 

feeding, side sleeping and soft bedding argued by Respondent’s expert as likely causes of 

his death. He then found that “[t]he cause and effect between the vaccines, the cytokines 

triggered by the vaccines, and their co-occurrence with other intrinsic and/or extrinsic risk 

factors in the presence of a defective or underdeveloped brainstem seems likely to have 

produced the perfect storm that resulted in J.B.’s death.” Id. at *41. The Special Master

also found that Petitioners had established the timeliness requirement of Prong Three. He 

reasoned that death on the day following vaccination was consistent with causation: 

“vaccine-induced cytokines are likely to be active in close proximity to the stimulating 

event.” Id. at *42. 
7

Standard for Review

This Court has jurisdiction to review decisions of the special masters in accordance 

with provisions of the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-12(e)(1)

- (2). Under those provisions, this Court will only set aside findings of fact or conclusions 

of law found to be “arbitrary, capricious, an abuse of discretion or otherwise not in 

accordance with law.” 42 U.S.C. § 300aa-12(e)(2)(B). With respect to findings of fact, 

the special masters have broad discretion to weigh evidence and make factual 

determinations. As to questions of law, the legal rulings made by a special master in 

connection with a vaccine claim are reviewed de novo, under a “not in accordance with the 

law” standard. Following this distinction, “[t]he allocation of the burdens of proof under 

the Vaccine Act is a legal issue subject to de novo review.” Heinzelman v. Sec’y of Health 

& Human Servs., 98 Fed. Cl. 808, 812 (2011); see also Whitney v. Sec’y of Health & 

Human Servs., 122 Fed. Cl. 297, 304-05 (2015). 

Discussion

In the Motion for Review, Respondent argues that the Special Master applied too 

low a standard when evaluating Petitioner’s burden of proof in this case. Respondent also

notes that in reaching his conclusions the Special Master ignored the decisions in four 

recent SIDS cases, in all of which the Special Masters rejected a similar if not identical 

theory presented by Dr. Miller, who testified on behalf of Petitioners using the same

medical literature presented in the instant case. Further, Respondent maintains that the 

Special Master impermissibly found, based on statistical evidence alone, that J.B. had a 

defective brainstem making him vulnerable to vaccines under the Special Master’s 

extension of the Triple Risk Theory.

The four decisions by three different Special Masters addressing the question of 

vaccine causation in SIDS deaths were issued in 2015 and 2016. See Jewell v. Sec’y of

Health & Human Servs., No. 11-138V, 2016 WL 5404165 (Fed. Cl. Spec. Mstr. Aug. 29, 

2016); Copenhaver v. Sec’y of Health & Human Servs., No. 13-1002V, 2016 WL 3456436 

(Fed. Cl. Spec. Mstr. May 31, 2016), review denied, 129 Fed. Cl. 176 (2016); Lord v. Sec’y 

of Health & Human Servs. No. 12-255V, 2016 WL 806818 (Fed. Cl. Spec. Mstr. Feb. 9, 

2016); Cozart v. Sec’y of Health & Human Servs., No. 00-590V, 2015 WL 6746616 (Fed. 

Cl. Spec. Mstr. Oct. 15, 2015, review denied, 126 Fed. Cl. 488 (2016). These cases 

uniformly found that the evidence presented by Dr. Miller to prove his theory of vaccine 

causation was not persuasive. For example, in Copenhaver, the Special Master found 

Respondent’s expert, Dr. McCusker, to be a “superb witness” and better qualified to 

discuss cytokines because of her cytokine research, her expertise in immunology, and her 

status as a board-certified pediatrician. Copenhaver, 2016 WL 3456436, at *11,*13. He 

also found that none of the medical articles submitted “reliably demonstrate that vaccines 

increase the risk of SIDS.” Id. at *3. And he found that Petitioners improperly used 

assumptions rather than facts to fill gaps in knowledge about their case. Id. at *16. 
8

Similarly, in Cozart a different Special Master found Petitioners had failed to prove a 

“sound and reliable” medical theory as required by Althen Prong One because they did not 

show how the Triple Risk Model relates to vaccines. They also could not point to any other 

medical professionals aside from their own two experts, who shared their opinion about 

vaccines and SIDS. Id. at *17. In their response to Respondent’s Motion for Review in 

the present case, Petitioners were not able to cite a single Vaccine Program opinion finding 

that vaccinations had caused SIDS. 

A Special Master is not bound to follow the opinions of other Special Masters; 

however, when issuing an opinion extending vaccine causation to previously uncharted 

areas, a clear explanation would be expected, if not critical. The Special Master here made 

no acknowledgement of the other cases reaching opposite conclusions and made no attempt 

to distinguish the instant case from any of the others. Here, even though extension of the 

Triple Risk Theory to vaccine causation has not been advanced by Dr. Kinney or her 

colleagues, nor has it been accepted by any other medical authorities outside those 

testifying in the Vaccine Program, the Special Master describes Petitioners’ theory to be 

“reasonable and persuasive.” Boatmon, 2017 WL 3432329, at *40. 

This departure from the conclusions of other Special Masters can only be explained 

by improper application of the standard of proof required in vaccine cases. While scientific 

certainty is not required to establish causation under the Vaccine Act, the theory must be 

supported by a “sound and reliable” medical or scientific explanation. Knudsen v. Sec’y 

of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). In Moberly, 592 F.3d at 

1322, the Federal Circuit noted that a Petitioner must provide a “reputable medical or 

scientific explanation” for causation, and that this standard requires more than mere 

“plausibility,” which is “not the statutory standard.” In the case at bar, the theory embraced

by the Special Master has not been accepted by any other experts in the field of SIDS 

research. The Moberly Court cited with approval the standards for assessing expert 

reliability set forth in Daubert v. Merrell Dow Pharm., Inc,, 509 U.S. 579 (1993). Among 

the Daubert considerations is whether the theory at issue has been subjected to peer review

and publication. Id. at 593. With respect to Petitioners’ burden of proof, the Special Master 

in this case has applied a standard so low as to constitute clear error. 

Loss of a child in a sudden and seemingly senseless manner can only be described 

as heartbreaking. For this reason research to find clear answers must continue, and 

premature unsupported conclusions cannot be relied upon. In this case, having found that

Petitioners failed to satisfy Althen Prong One, the Court also finds that they have not 

presented a persuasive basis for finding that the vaccinations caused J.B.’s death, as 

required under Althen Prong Two. For this reason, the Court hereby GRANTS the motion 

for review, REVERSES the ruling on entitlement, and VACATES the decision of the 

Special Master. The Clerk is directed to dismiss the Petition and to enter Judgment for 

Respondent.
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IT IS SO ORDERED.

s/Thomas C. Wheeler

THOMAS C. WHEELER

Judge