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

STEPHANIE ROSCOE
, as * PUBLISHED Representative of the Estate of * B. R
., deceased, * No. 11

- 206 V

* Petitioner, * Special Master Nora Beth Dorsey

*

v. * * Entitlement; Hepa titis A (“Hep A”) SECRETARY OF HEALTH * Vaccine; Tetanus

- Diphtheria

- Acellular AND HUMAN SERVICES, * Pertussis (“Tdap”) Vacc ine; Meningococcal

* (“ Menactra ”) Vaccine; Human Respondent. * Papillomavirus (“ HPV”) Vaccine ;
* Streptococcus P yogenes ; Death. * * * * * * * * * * * * * * *
Richard Gage
, Richard Gage, P.C., Cheyenne, WY , for petitioner

. Kyle Edward Pozza , U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ENTITLEMENT 1

I. INTRODUCTION

On April 4, 2011, Stephanie Roscoe (“petitioner”)
, as representative of the estate of B.R., deceased, filed a petition under the National Vaccine Injury Compensation Program (“Vaccine Act” or “the Program”), 42 U.S.C. § 300aa

- 10 et seq. (2012)

. 2 Petitioner a lleges that as a result

1 Because this Ruling contains a reasoned explanation for the action in this case, the undersigned is required to post it on the United States Court of Federal Claims’ website in accord ance with the E

- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Fe deral Management and Promotion of Electronic Government Services). This means the Ruling will be available to anyone with access to the Internet. In accordance with Vaccine Rule 18( b), petitioner has 14 days to identify and move to redact medical or othe r information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this defi nition, the undersigned will redact such material from public access.

2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99

- 660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa

- 10 to

- 34 (2012). All citations in this Ruling to in dividual sections of the Vaccine Act are to 42 U.S.C. § 300aa. 

# In the Unite d State s Court of Federal Claims

OFFICE OF S PECIAL M ASTERS Filed: June 8, 20202

petitioner is entitled to compensation

.
II. ISSUES IN AGREEMENT AND IN DISPUTE
The parties agree that B.R.’s death was “most likely caused by a gram

- positive bacteria, Streptococcus pyogenes [], that resulted in an infection in her hip, which led to septic shock that ultimately caused her death.” Resp

. Submission, filed Dec. 20, 2019, at 4 ( ECF No. 16 6) ; accord Petitioner’s (“Pet.”) Submission, fi le d Dec. 23, 2019, at 2 ( ECF No. 167 )

. They generally agree that there is a factual issue as to whether B.R. had a sore throat prior to her vaccin ations , and if so, the medical significance of her sore throat. R esp. Submission at 4; Pet. Submission at 2

. This issue will be addressed as part of the causation analysis related to Althen Prong Two

.

T h e issue in dispute is whether petitioner has establish ed by preponderant evidence that B.R.’s vaccinations adminis tered on March 31, 2009 were a substantial factor in causing her death

.
III. BACKGROUND

A. Procedural History
This case has a long and complicated procedural history. Petitioner filed her claim on Apr il 4, 2011 , and subsequently filed medical records and an expert report. See Petitioner’s Exhibits (“Pet. Exs.”) 1

- 6 . On November 18, 2011, respondent filed his Rule 4(c) Report, in which he recommended against compensation. Resp. Rept. at 2. R esponden t maintain ed that petitioner failed to provide a “sound and reliable” medical theory that supports the claim that B. R

. was injured and died as a result of the vaccination s. Id. at 1 1

.

3 Streptococcus pyogenes is “a ß

- hemolytic species [of Streptococcus] that comprises group A of the Lancefield classifica tion and is toxigenic and pyrogenic.” Streptococcus Pyogenes
, Dorland’s Med

. Dictionary Onli ne , https://www.dorlandsonline.com/dorland/definition? id=108772 (last visited May 27, 2020). Throughout this Ruling
, Streptococcus pyogenes may be abbreviated as S. pyogenes or simply as strep

. of receiving hepatitis A (“Hep A” ), tetanus-diphtheria-acellular pertussis (“ Tdap ”)
, meningococcal (“ Menact ra ”)
, and human papillomavirus (“HPV”) vaccines on Marc h 31, 2009, B.R

. suffere d fever, leg a nd bodily pa in, emotional and mental confusion and ang uish, and death. Petition a t 1 (ECF No. 1). Respondent argue d against c ompens ation, stating that “this case is not appropria te for c ompensation under the ter ms of the Vacc ine Act.” Respondent’s Report (“Resp. Rept.”) at 2 (ECF No. 16 ).

After c arefully analyzing and weighing the evidence pre sented in this case i n accordance with the applicable lega l standards, the unde rsigned finds that petitioner provided preponderant evidence th a t one or more of the vaccines B.R . rece ived cause d her to deve lop a Streptococcus pyogenes 3 infecti on that caused her dea th, which satisfies her burden of proof unde r Althen v. Secretary of Healt h & Human Services, 418 F .3d 1274, 1280 (Fed. Cir. 2005). Accordingly,3

4 The Vaccine Act provides, “[i]f a plaintiff has pending a c ivil action for a vaccine

- related injury or death, su ch person may not file a petition under [the Vaccine Act] for such injury or death.” § 11(a)(5)(B). It also provides that if “a civil action brought against a vaccine administrator or manufacturer for a vaccine

- related injury or death” results in an awar d of damages “under a judgment of a court or a settlement of such action, the person who brought such action may not file a petition under [the Vaccine Act] for such injury or death.” § 11(a)(7). On January 5, 2012, petitioner was ordered to file a suppl emental expe rt report to address the issues raised in respondent’s Rule 4 (c) Report. Order dated Jan. 5, 2012, at 1 (ECF No. 18). Petitioner sought and was granted several extensions of time within which to file the supplemental expert report, which was ultimately f ile d on January 15, 2013. Supplemental (“Suppl.”) Ex pert Rept., filed Jan. 15, 2013 (ECF No. 26). Respondent filed an expert report on April 10, 2013. Resp. Ex. A. An entitlement hearing w as sche duled for No vember 19 through 21, 2013. Prehearing (“ Pre hr’ g ”) Order dated May 14, 2013, at 1 (ECF No . 32). During sum mer 2013, the partie s engaged in settlement negotiations, and on August 22, 2013, the case w as referred to Special Master Moran fo r alternate dispute re solution (“ ADR ”) proceedings. Order dated Aug. 22, 2013, at 2 (E CF No. 38). The c ase did not proc eed to hearing but remained in ADR unti l February 201 4, at which time a 15-Week Stipulation Order wa s entered and an order removing the case fr om ADR wa s issued. See 15-Week Stipulation Orde r dated Fe b. 4, 2014 (ECF No. 44) ; Order dated Feb. 6, 2014 (ECF No . 45).
On July 8, 2014, a status conference wa s held by t he pre siding spe cial master to discuss petitioner’s counse l’s concerns about the sti pulation. Order dated July 8, 2014, at 1 (ECF No. 47). Petitioner’s counsel re ported that petitioner may h ave r eceived a se ttlement f or B.R.’s injury a nd death. 4 Id. Petitioner ha d been instructed not to disclose information about the settlement and the implications on the a greed upon stipulation relate d to the pre se nt claim. Id. Petitioner’s counsel wa s instructed to obtain more infor mation. Id.
On July 18, 2014, petitioner filed a copy of the complaint she file d in the S tate C ourt of Dougherty C ounty, State of Georgia, on April 1, 2011, against a n umber of individually n amed physicians, their employers, and Phoebe P utney Memorial Hospi tal (“Phoebe P utney” ) for medical negligence a nd the wr ongful death of B.R. Response to Court Order, filed July 18, 2014, at 2-20 (ECF No. 49). Petitioner also filed a n amende d complaint, which included affidavits of Dr. George Jerome S ha w, III a nd Dr. R obert Mills, setting for th alleged negligent acts committed by the physicia ns and nursing staf f a t Phoebe P utney. Id. at 2 1-36. Neither the complaint or the a mende d complaint state a ny a llegations based on the vaccines, against the person who administered the vaccines, or the manufactures of the va ccines. Subsequently, discovery depositi ons fro m petitioner’s Georgia civil c ase were file d. (ECF Nos. 55, 58-60).
On July 21, 2014, the special master iss ued a n Order to Show Cause wh y th e c ase shoul d not be dismissed because the petitioner had a p ending c ivil action when she file d her petition in this Court. Order da ted Sept. 25, 2014, at 3 (ECF No. 54). The iss ue wa s briefed, and the parties agreed tha t the controlling c ase w a s Schumacher v. Secretary of Health & Human Services, 2 F.3d 1128 ( Fed. Cir. 1993). Id. (citing P et. Brief in Support of Mutual Agree d upon Stipulation Approval and Opposition to Dismissal, filed Aug

. 22, 2014, at 3-4 (ECF No . 52); Resp. Reply to Pet. Response to the Order to Show Cause a nd Motion to Strike, filed Sept. 25, 2014, at 4 (ECF4

No. 53) ). In Schumacher, the Federal Circuit he ld that the Vaccine Act does not ba r a pe titioner from filing a v accine petition when her pending c ivil a ction is not against a vaccine manufacturer or vaccine a dministra tor. Id. ; Schumacher, 2 F .3d at 1133. Thus, the special master issued an order in which she rule d that the Vaccine Act di d not require dism issa l of the pe tition in this Court. Orde r dated Sept. 25, 2014, at 3. Respondent wa s given time to review new evidence, particularly the deposition testimony o f the ph ysicians who provided care t o B.R. as well a s the experts who gave testim ony in the State C o urt civil action in Georgia, and t o reevalua te his position as to the se ttlement agree ment. Id. at 4. After r eview of the ne w evidence
, respondent withdrew the se ttlement offe r and wished to proceed with litigation. Orde r da ted Feb. 20, 2015 (ECF No. 62 )

.
The spe cial master then reviewed the evidence, and issued an order providing he r impressions of the e vidence. See Order dated Mar. 25, 2015 , at 2-8 (ECF No. 63). She listed several options for the parties to take: (1) petitioner c an provide pa thology slides to the respondent’s expert for review ; (2) the parties can consider revisiting medi ation; and (3) if the parties could not informally resolve the c ase through settlement, they can proceed to a he aring. Id. at 8. The pa rties did not revisit mediation. Petitioner was ordered to file medic al literature, locate or file the culture r esults for B .R., a nd exchange the autopsy sli des so that experts for both parties could review them. Orde r date d Mar. 26, 2015, at 1 (ECF No. 64)

. Petitioner file d a supplemental expert report by D r. Harry S

. Latham, and respondent filed a suppl emental expert report by Dr . Sara Vargas. (ECF Nos. 67, 69).

The c ase wa s assigned to the unde rsigned on February 4, 2016, a nd an entitlement hearing wa s set for Ma rch 15 and 16, 2017. Notice of Reassignment da ted Feb. 4, 2016 (ECF No. 77); Prehr’g O rder dated Mar. 22, 2016 (ECF No. 81). On January 1 7, 2017, the undersigned held a status c onference to advise the parties that due to the c ontinuing re solution, the Office of Special Masters did not receive it s full budgetary allotment for 2017, and therefore, special masters did not have fund s to travel for he aring s. Order dated Ja n. 18, 2017, at 1 (ECF No. 82)

. Petitioner requested that the he aring b e r escheduled once the continuing re solution had ended, a nd requested that the he aring be h eld i n Albany
, Georgia so that petitioner a nd B.R.’s family c ould attend. Id. Alternative he aring da tes in June a nd August 2017 were discuss ed and provided to the pa rties. I d. The he aring was rescheduled for June 6 and 7, 2017. Prehr’g Order da ted Feb. 3, 2017 (ECF No. 84). The pa rties filed their re spective pre -hearing subm issions, and additional documents including medic al literature.
On June 2, 2017, petitioner’s counsel contacted the undersigned to reque st that the hearing se t for June 6 and 7, 2017 be re sche duled due to petitioner’s counsel’s medical emergency. Order date d June 5, 2017 (ECF No. 100). The entitle ment hearing w as cancelled and rescheduled for January 8 and 9, 2018. Id.; order dated Sept. 25, 2017 (ECF No. 106). At the pre-hearing status conference on December 1 9, 2017, counsel for p etitioner advised that he required further hospitalization due to his medical condition, and therefore, the hearing w as again postponed and rescheduled for M ay 21 and 22, 2018. Order dated Dec. 19, 2017 (ECF No. 109); order dated Jan. 31, 2018 (ECF No. 113). Petitioner’s coun sel was asked to consider associating with co- counsel. Order dated Dec. 19, 2017, at 1; orde r dated Jan. 31, 2018, at 1. Subsequently, the hearing se t for May 2018 was cancelled to allow petitioner’s counsel to associate counsel. Order da ted Feb. 13, 2018 (ECF No. 115).5

This matter is now ripe for adjudication.

B. Summary of Relevant Facts

1. Medical Records

B.R . was born on September 4, 1997. Pet. Ex. 14 at 1. Prior to the March 31, 2009 vaccinations, she had no prior significant illnesses, no previous surgeries, and no hospitalizations since birth. Id. She did have the Sickle Cell Trait. Id

.
On March 31 , 2009, B.R. presented to her pediatrician’s office for her 11

- year well

- child vi sit. Pet. Ex. 14 at 3. She had no new complaints. Id. Her records show that she had no known drug allergies. Id. She was afebrile, pulse 90 and regular, and respiratory rate 22. Id. She was

5 For t he sake of accuracy and consistency, this Ruling refe rs to petitioner instead of petitioners throughout, reflecting that Stephanie Roscoe is the current and proper petitioner, although the petition was originally filed by both Frederick Parks and Stephanie Roscoe. On June 25, 2018, petitione r filed a mot ion to substitute counsel for Attorney Richard Gage. Motion to Substitute Attorney, filed June 25, 2018 (ECF No. 121). The mot ion was granted a nd a status conference was held on July 12, 2018 with new c ounsel. Order dated July 13, 2018 (ECF No. 122)

. Petitioner requested the opportunity to obtain an additional expert, whic h wa s granted, and petitione r was ordered to file the expert report by S eptember 11, 2018. Id. at 1-2. The medi cal records and other exhibits were refiled in proper format. See Pet. Exs. 12-41. A Vaccine Adverse Eve nt Reporting S ystem (“ VAERS ”) report was also filed. Pet. Ex. 42. After se veral motions for e xtension of time we re r eque sted a nd granted, petitioner filed the expert report of Dr. Douglas Miller on March 12, 2019. Pet. Ex. 43. Respondent filed his responsive re port on July 15, 2019. Resp. Ex. Z.
On December 24, 2019, petitione r filed a mot ion to amend the c ase c aption to re move the name of Frederick Pa rks as a pe titioner. Motion to Amend Caption, filed Dec. 24, 2019 (ECF No. 168). Letters of Administration dated October 4, 2013, naming Stephanie Michelle R oscoe as Administrator of the estate of B.R., were also filed. Pet. Ex. 45. The moti on amending the

case c apti on wa s gra nted on January 3, 2020. 5 Order dated Jan. 3, 2020 (ECF No . 171).
An entitlement hearing w as finally h eld on January 8, 2020 in Atlanta, Georgia. The petitioner attended the hearing but did not testify. See Transcript ( “Tr.” ) 3-4. Petitioner’s expert, Dr. Miller, and respondent’s expert, Dr. Vargas , testified. Tr . 3. After the he aring, respondent requested the opportunity to brief the d eposition testimony of physicians who testified in petitioner’s civil a ction, inclu ding Dr

. Latham, Dr. Mills, Dr. Mark Noe l Burns, and Dr. Belise Livingston-Burns, as well a s addre ss additional matters that arose during th e he aring. Resp. Status Rept., file d Jan. 22, 2020, at 1-2 (ECF No. 175 ). Respondent’s request wa s granted. Order dated Jan. 22, 2020 (ECF No. 176). Respondent’s post -hearing b rief was filed on February 24, 2020, and petitioner filed her post-hearing b rief on March 9, 2020. Re sp. Posthearing Brie f (“Posthr’g Br. ”) , file d Feb. 24, 2020 (E CF No. 181); Pet. Posthr’g B r., filed Mar. 9, 2020 (ECF No. 182).6

five fe et and three inche s tall and weighed 149 pounds. Id. He r BMI w a s 26.39. Id. Urine dip stick analysis w as normal and hemoglobin wa s normal at 11.8. Id. B.R. received the H ep A and HPV vaccines in her upper right arm and the Tdap and Menactra vaccines in her upper left arm. Id. a t 4.
On the following day, April 1, 2009, at 5:45 PM, B.R. was admitted to Phoebe P utney Emergency Department ( “ ED ” ) with complaints of hip pain and fever. Pet. Ex. 14 at 10. Triage assessment performed a t 6:00 PM revealed tha t B.R. ha d a fe ver of 102.9 °F, pulse of 115 per minute, and pain level of 10/10. Id. She w as noted to have be e n febrile with poor oral intake. Id. B.R.’s pa in began a t 3:30 AM, a nd was described as “affecting [ her] le f t iliac c rest and pelvis.” Id. a t 11. A history was obta ined from B.R.’s mother, petitione r. Id. B.R. had no history of cough, sore thr oat, runny nose , or ear pain. Id. Prior to her arrival, she ha d “ been play ful and normally a ctive.” Id. She did have hist ory of fever for the last few hours, with a maxim um temperature of 102 to 103, without c hills or sweats. Id. She h a d no nausea, vomiting, or diarrhea. Id.
A physical examination was performed by D r. Alfre d L. Woodard. Pet. Ex. 14 a t 12. B.R .’s nec k was supple with “[n]o significant adenopathy.” Id. Her throat was clear with no evidence o f inflammation. Id. Her tympanic m embranes were c lea r and there w ere no signs or symptoms of otitis media ( i.e. ear infection). Id. There w as no anterior or posterior lymphadenopathy. Id. She had unlabored respirations with good breath sounds, and “ [n]o audible ra les, ronchi [sic] , or wheezing.” Id. She did not c ough or have wh eezing durin g the examination, and she ha d no respiratory dist ress. Id. B.R. was “[m]oderately tende r to palpation over the lef

t anterior thigh” a nd he r skin wa s “clear with no lesions or rash.” Id. Diagnosis was feve r and pediatric vira l syndrome. Id. B.R. wa s g iven acetaminophen and ibuprof en. Id. Laboratory tests were performed including a c omplete blood count ( “ CBC ” ) with differential, urinalysis, and urine culture. Id. at 13. The diff erential portion of B .R.’s CBC wa s abnormal, with lymphocytes low a t 13.1% (nor mal 26.0-40.0) and monocy tes elevated at 12.6% (nor mal 1.0-9.0). Id. B.R.’s u rinalysis wa s normal. Id. The re sults of the urine culture were not reported back before B.R.’s discharge from the E D , but subsequently the report showe d less than 100,000 morphotype b acteria with no predominant organism. Id. at 18.
B.R. was discharged from the ED a t 8:47 PM by Dr. Woodard. Pe t. Ex. 14 at 14. Her temperature a t the ti me of discharge remained abnormal and her mothe r was advised to followup with her pe diatrician if B.R .’s symptoms worsened. Id. B.R .’s pain at the time of discha rge was 2/10. Id.
At 8:04 AM on April 3, 2009, B.R. was taken by her parents to the Palmyra Me dical Center ( “ Palmyra ” ) Em ergency R oom (“ER”) for f ever and pain in the left thigh, with nausea and vomiting, a nd a rash. Pe t. Ex. 14 a t 120. An “Emergency R oom Patient Sign -in Sheet Patie nt Information ” for m was completed and stated that B.R. had a “ [h]igh fever since Tues[day]. Extreme upper thigh pain. She ha d 4 vaccines on Tues[day]. Gagging Dehydrated .” Id. at 133. On the form’s list of signs a nd symptoms, B.R. wa s noted to have fe ver and fatigue. Id. She did not ha v e a c ough, shortness of breath, or close contact wit h a pe rson who had respiratory symptoms. Id.7

6 This report was interpreted as a contami nated specimen and not infection. See Tr. 56; Pet. Ex. 13 at 24.

7 Dr. Livingston’s history and physical examination was dictated on April 3, 2009, at 10:19 PM, and transcribed April 4, 2009, at 10:39 AM. Pet. Ex. 14 at 30. An initial assessme nt wa s performe d at 8:20 AM

. Pet. Ex

. a t 120. B.R. was noted to be in mild distress, with a n elevated heart rate of 147 and elevated temperature of 102.7 F. I d. H e r pain level wa s 6/10 and her pain wa s described a s aching. Id. She ha d no respiratory dist ress and breath sounds were n orma l. Id. She wa s seen b y D r. Da vid L. Kocherla who noted a rash on B.R.’s neck. Pet. Ex. 13 at 17. He ordered b lood and ur ine cultures, urinalysis, other laboratory studies, intravenous fluids, and a porta ble chest X-ray. Pet. Ex. 14 at 122. The urine c ulture

s howed “[m]ixed urogenital flora” with no grow th of a sig nificant sing le organism. 6 Pet. Ex. 13

a t 24. The chest X-ray impression was “[n]o evidence of frank pneumonia,” but “bronchitis or atypical pneumonia” could not be e xcluded. Id. at 27. Motrin, Tylenol #3 and Zofra n were administered. Pet. Ex. 14 at 121. Dr. Kocherl a’s diagnosis was post -vaccination reaction. Id. at 139. At 1:00 PM, Dr. Kocherla o rdered that B.R. be tra nsferred to Phoebe P utney for admission. Id.
B.R. was transported fro m Pa lmyra to Phoebe P utney by ambulance. Pet. Ex. 14 at 35. The a mbulance trip report sta tes B.R. “ is being tra nsferred . . . for follow up care . . . for a possible allergic r eaction to immunizations administered on 03/31/2009 ,” a nd “[B.R.] [ complains of] left hip pain ,” whic h she de scribe s “ as sharp and non radiating ” a nd “[r] ates pain as 10 on 1- 10 scale. ” Id.

After a rrival at Phoebe P utney , B.R. was seen by admitting ph ysician, Dr

. Belise Living ston. Pet. Ex. 14 at 27. Dr

. Livingston’s history of pr esent illness includes the fa ct that B.R

. received vaccinations four da ys prior to he r admissi on, B.R.’s history of fever and left hip pain, and B.R.’s sympto ms progress ed to the poi nt tha t “she began having marked difficulty ambulating.” Id. Dr

. Livingston noted that B.R. had a hist ory of borderline e levated blood pressure thou ght to be du e to her obe sity. Id. at 28. B.R. had no history of coug h, wheezing, trouble breathing, or respiratory dist ress. Id. Dr

. Livingston charte d, “ [t]he pa tient has ha d a
sore throa t off a nd on for the past week” and “ [s]he did have som e na usea with the sor e throat.” Id. Dr

. Living ston also included that “ [t]he mot her does report intermittent red rash that has

come a nd gone for the past 3 days.” Id.

Dr

. Living ston condu cted a physical examination, noting that B.R.’s oropharynx wa s “mildly inj ected.” Pe t. Ex. 14 at 28. 7 No significant adenopathy wa s present. Id. Respiratory sounds were clear bilaterally. Id. B.R. had tenderness of her left upper thigh and hip and she was unable to ambulate due to pain. Id. Dr

. Livingston did not se e a ny rashes or lesions a t the time of he r exam. Id. Consul ts were obtained fro m neurology and orthopedics. Id. at 29. The neurologist, D r. Ala n Little, found no evidence of ac ute neuropathy. Id. a t 29, 31-32. The orthopedist, Dr

. Thoma s M. Darden, noted that B.R. rece ived four va ccines, and his im pression

was “transient synovitis secondary to the vi ral load fr om the va ccine althou gh can not completely rule out the possi bility o f a bacterial sepsis of the j oint.” Id. at 33. An MR I was ordere d to evaluate fo r infection or septic joi nt. Id. at 34.8 2. Autops ies
Two autopsies were performed : the first was performed by Dr. Mark N . Burns, the Medical Director of the L aboratory and Pathologist at Phoebe Putney, and the second by Dr. Harry S. Latham, performed at the family’s request. See Pet. Ex. 14 at 83

- 84 ; Dr. Latham’s Autopsy Report (“Latham Autopsy”) , filed June 2, 2017 (ECF No. 98)

.

a. Autopsy by Dr. Mark N

. Burns
Dr. Burns performed the initial autopsy on April 7, 2009. Pet. Ex. 14 at 83. External examination revealed “prominate swelling of the left leg” with induration and discoloration of the left groin extending to the medial thig h and superiorly to t he iliac crest. Id. at 83

- 84. Bullae with serosanguinous fluid w ere present. Id. at 84. External genitalia was unremarkable and there was “ no palpable cervical, axillary, or inguinal lymphadenopathy .” Id. at 83.

Internal examination showed edema and hemorrhage, as well as “highly variable numbers of coccal bacteria” in the soft tissues of the left leg and thigh. Pet. Ex. 14 at 83 , 87

. The pleural (lung) surfaces were normal except some apical fibrous adhesions. Id. at 84. The cause of death The pre limin ary int erpretation of the MRI was edematous changes “note d within the muscular surrounding of the left hip compatible w it h myositis/rhabdomyolysis.” Pet. Ex. 14 at 29. An abscess was not se en. I d. D r. Living ston concluded tha t B.R.’s lab s were “ consistent with an acute inflammatory p rocess ” suggesting p ossible infectious myositis. Id. at 29-30. She ordere d a ra

pid stre p test, throa t culture, and influenza (“flu”) testing to rule out “likely c auses of infectious arthritis or myositis.” Id. at 30. The te sts were a ll negative. Id. at 66, 93. Dr. Livingston noted that the blood culture wa s still pending. Id. at 30. Dr

. Livingston stated that it was not c lear whe ther B.R.’s illness was related to her vaccinations. Id. at 58.
At 11:10 PM, the nursing staff re ce ived a c all fr om Palmyra r eporting that the blood cultures drawn earlier were posi tive, showing gram posit ive cocci in chains. Pe t. Ex. 14 a t 57, 71. D r. Living ston, was notified, a nd an antibiotic, ceftriaxone, wa s ordered. Id. a t 57, 71.
Throughout the early hou rs of April 4, 2009, B.R

. received medication fo r hip pain. See Pet. Ex. 14 at 71. At 1:25 AM, she wa s g iven morphine, at 5:10 AM, she wa s given Toradol, and at 6:45 AM, she wa s aga in given morphine. Id. At 6:45 AM, he r lef t hip was described as swollen, with bruising, and the skin was taunt. I d

. At 9:30 AM, B.R. wa s found unre sponsive but breathing. Id. a t 61- 6 2 . Dr

. Livingston arrived a nd a c ode wa s calle d. Id. at 62. B.R. was taken to the ED for emerge nt care because the ICU was full. Id. at 62, 81. B.R. progressively worsened and despite len gthy resuscitative e fforts, she died at 12:27 PM on April 4, 2009. Id. at 70, 81, 112-13.

A VAERS re port wa s filed on or a bout April 15
, 2009. Pet. Ex. 42. The re port contains

a sum mary of information that appears to have be en taken from B.R.’s medical records. See id.
On April 21, 2009, the d ea th certificate was signed by D r. Livingston, identifying necrotizing f

asciitis (Group A Streptococcus ) as the c ause o f death. Pet. Ex. 12.9

was “ n ecrotizing fasciitis (gram positive cocci) with septic shock.” Id

. at 8 3 (emphasis omitted)

. Tissue samples were taken from skin, lymph nodes, left perineal, groin, inguinal and hip, and spleen and liver. Id. at 87.

b. Autopsy by Dr. Harry S. Latham

Dr. Latham also concluded that necrotizing fasciitis due to gram positive cocci of the left upper leg, hip, and inguinal/groin area with septic shock was the cause of death. Latham Autopsy at 6. He described the external , internal, and microscopic findings r elative to the left leg and thigh similarly to those noted by Dr. Burns. See id. at 3, 6

. Unlike Dr. Burns, Dr. Latham performed a full autopsy to include all of the abdominal organs and brain. See id. at 4

- 5. Rele vant to the issues here, he described the lungs as “markedly edematous and congested” but did not describe any evidence of pneumonia. Id. at 4. Under pathological diagnosis, Dr. Latham note d,

S tatus post history of inoculations one day before onset of clinical sym p toms. No distinct point of origin for the introduction of the Group A Beta Hemolytic Streptococcus (Streptococcus Pyogenes) is found. However, wounds as minor as pin pricks, needle punctures, bruises , blisters or abrasions are as se rious as traumatic injury or surgical incision and can provide an opportunity for bacteria to enter the body.

Id. at 6 (emphasis omitted)

.
C. Deposition T estimony

As described above in the procedural history , petitioner filed a civil action against a number of defendants alleging medical malpracti ce arising out of the medical and nursing care provided to B.R. During the pendency of that action, a number of depositions were taken
, which were later filed in this matter. A brief summary of each deposition follows.

1. Stephanie Roscoe
Ms. Roscoe’s dep osition was taken on October 26, 2011. Resp. Ex. L at 1. She is the petitioner and mother of B.R. At the time of these events, she worked at Ryan’s Steakhouse. Id. at 13.
On Tuesday, March 31, 200 9, Ms. Roscoe had to work, so Mr. Parks took B.R. to th e doctor for her routine appointment and vaccinations. Resp. Ex. L at 14, 87. Prior to that doctor’s visit, B.R. had no complaints of pain, and did not have a stuffy nose, cough, sore throat
, or feve r. Id. at 31

- 32.

A t a pproximately 3:00 AM the morni ng after her vaccinations, April 1, 2009, B.R. woke her mother and complained of leg pain. Resp. Ex. L at 36

- 37. B.R. felt warm. Id. at 38. She did not have a runny nose, cough, or sore throat. Id

. at 35, 3 9 . Ms. Roscoe had to work that day. Id. at 39. When she got home from work, B.R. continued to complain of leg pain and her skin10 2. Frederick Parks

Mr. Parks is the father o f B.R. He gave his depositio n on October 26, 2011. Resp. Ex. K at 1. In April 2009, Mr. Parks worked at W.W. Construction Company, pouring asphalt and concrete for parking lots. Id. at 7.

Prior to B.R.’s vaccinations on March 31, 2009, she did not c omplain of hip pain, sore thr oat, headache, pain, cough
, or runny nose. Resp. Ex. K at 14.
After receiving the vaccinations, B.R. complained that her arms were a bit sore. Resp. Ex. K at 13, 18. The next day, April 1, 2009, after Ms. Roscoe came home from work, B.R. complained t hat her leg hurt. Id. at 22. After B.R. was seen at the hospital that day, she had a limp. Id. at 27. On April 2, 2009, B.R. laid in her bed most of the day. Id. at 30. She complained of leg pain. Id. The next day, Apri l 3 , 2009
, Mr. Parks helped get B.R. in the car so that his wife could take her to the hospital. Id. at 37. Mr. Parks came to see his daughter at the hospital on April 3, and again on the morning of April 4. Id. at 40

- 42, 62.

3. Dr. Mark N. Burns

Dr. Bur ns attended the firs t two years of medical school at the University of South Dakota , then transferred and completed his medical training at Emory University

. Resp. Ex. Y at 5. He completed his residency in pathology at Emory, and then began practicing pa thology at Phoebe Pu tney in Albany, Georgia, where he worked until he retired. Id. at 5

- 6 . Dr. Burns is board certified in pathology. Id. at 6. In his capacity at the pathologist at Phoebe Putney, he was hot. Id. at 40-41. Ms. Roscoe took B.R. to the P hoebe P utney ED , where B.R. was seen by Dr. Woodard. Id. at 42-43. B.R. did not ha ve a cough, and did not c omplain of sore throa t, ear pain, or chills. Id. at 44. She did have na usea a nd wa s limping. Id. a t 44-46. Dr. Woodward diagnosed B.R. with a reaction to her vaccinations, and recommended Tylenol or Motrin for the fever. Id. at 47.

The ne xt day, April 2, 2009, Ms. Roscoe wor ked. Resp. Ex. L at 52. When she g ot home from wor k, B.R.’s limp was worse and it wa s more diff icult for h er to walk. Id. at 53-54. B.R. did not ha ve a ny c omplaints of runny nos e or cough. Id. at 54-55. About 6:00 AM the ne xt morning, April 3 , 2009, B.R. was really hot, in extreme pain, and unable to wa lk. Id. at 55-56. Ms. Roscoe took her to Palmyra. Id. at 57. Afte r being se en at Palmyra
, B.R. was transferred to Phoebe P utney b y ambulance. Id. At Phoebe P utney , B.R. was seen by D r

. Livingston and an orthopedist Dr . Darden, and an MRI was performed. Id. at 59-62.
After B.R. passed away
, Ms. Roscoe a nd Mr. Parks wanted to know wha t caused B.R.’s death and decided to pay for a full autopsy to be performed. Resp. Ex

. L a t 67.

I n addition to filing he r deposition from the c ivil case, Ms. Roscoe file d a n affidavit in which she a verred that B.R. did not ha ve a “ coug h or cold prior to receiving the vaccine shot s.” Pet. Ex. 37 at ¶ 13.11

worked in concer t with the medical examiner or coron er to perform autopsies to determine the cause of death. Id. at 8

- 9.
Dr. Burns testified that B.R. was the youngest patient with necrotizing fasciitis that he had ever seen

. Resp. Ex. Y at 16. After completing his evaluation and autopsy, Dr. Burns w as unable to determine the etiology of B.R.’s necrotizing fasciitis

. Id. at 16

- 17.

Dr. Burns defined necrotizing fasciitis as ,

a n uncommon infectious process that is rapid and life

- threatening and requires rapid surgical and antimicrobial intervention . The most common sites of infection are the lower extremities, including the groin and perineal regions. It’s a bacterial infectio n which is rapidly progressing. There’s generally a site of entrance, usually a wound of some sort or a natural occurring defect in one of the natural body barriers, such as the skin or the bowel or the urinary or genital tract. The most common organism identified as Strep pyogenes

. Resp. Ex. Y at 22. In a majority of cases, “there’s a clearly apparent site of entry, a wou nd, or an infectious process and localized infection that is readily apparent as the origin of the process.” Id. at 23.

Dr. Burns was not able to identify a site of entry for the bacteria that caused B.R.’s illness

. Resp. Ex. Y at 22

- 23 . When asked wh ether B.R.’s vaccinations had anything to do with her illness, Dr. Burns answered no
, that there was “no known scientific connection between such unrelated processes.” Id. at 23.

Dr. Burns did not do a full autopsy; he did not examine the brain, lungs , or heart. Resp. Ex. Y at 20. He did examine the perineal area and the external genitalia , which were

unrema rkable

. Id. at 72, 74. Further, there was no inguinal lymph adenopathy. Id. at 72.

4. Dr. Harry S. Latham

Dr. Latham attended medical school a t the University of North Carolina, and then began his residency in clinical and anatomical pathology in Palo Alto, California, and finished it at the Medical College of Virginia, in Richmond, Virginia. Resp. Ex. J. at 6. He started his practice in Burli ngton, North Carolina, and then moved to Union and Gaffney, South Carolina. Id. at 7

- 8

. He later moved to Cordele, Georgia, where he worked at Crisp Regional Medical Center. Id. at 8. He has performed approximately 1
, 600 autopsies over his 40

- year care er. Id. at 11

- 12

.
Dr. Latham testified that “ there was a very good likelihood that the vaccinations may have been the cause” of B.R.’s infection
, “[a] nd that was strictly because of time and effect of the event

. ” R esp. Ex. J. at 28. He explained tha t the cause of necrotizing fasciitis is not always known
, “ [i] t can be just a small prick and the bacteria get into the body.” Id

. at 28

- 29. Dr. Latham expounded on his opinions as follows:12

Id. at 29.
There was no area seen at autopsy t hat Dr. Latham was able to identif y as a site for the introdu ction of bacteria and no evidence of injury. Resp. Ex. J. at 30

- 31. Further, Dr. Latham testified that B.R. did not have strep throat. Id. at 3 5 , 37

.
When asked how long B.R. had the inf ection, Dr. Latham responded that the type of bacteria B.R. had causes sympto m s fairly quickly and that the pain she had the day after vaccination was caused by the infectio n. Resp. Ex. J. at 38

- 39.

5. Dr. Beli s e Livingston

- Burns

Dr. Livingston

- Burns 8 gave a deposition on June 25, 201 3. Resp. Ex. W at 1. She attend ed medical school at the University of Chicago, Pritzker School of Medicine, and did her residency in pediatrics at Emory University School of Medicine. Id. at 7. Dr. Liv ingston

- Burns practice d two years at a National Health Service clinic in Lake City, Florida , then joined the Albany Area Primary Health Care practice. Id. at 8.
Dr. Livingston

- Burns recalls that B.R.’s presentation on April 3, 2009, was concerning for G uilla i n

- B arr é syndrome ( “ GBS ” ) following vaccination or viral myositis, due to her di fficulty walking, leg weakness, and recent vaccines. Resp. Ex. W at 13

- 14 , 25

. Her ultimate diagnosis was necrotizing fasciitis and sepsis. Id. at 15. Necrotizing fasciitis was low on the list of differential diagnoses because B.R. had no open wounds a nd no history of trauma. Id. at 15

- 16. Dr. Livingston

- Burns documented that t here were no wounds or lesions noted on B.R.’s skin. Id. at 59.
Due to concern regarding GBS, Dr. Livingston

- Burns consulted Dr. Little, a neurologist. Resp. Ex. W at 31. After consultation, Dr. Little’s impression was septic versus inflammatory arthritis of the left hip, and he recommended a n orthopedic consult who ordered an MRI. Id. at 3 3

- 3 5 . The MRI showed edematous changes in the muscle adjacent to the left hip consi stent with myositis /

rhabdomyolysis with no evidence of absces s. Id. at 38. At that point, D r. Livingston

- Burns ordered an infectious disease consult. Id. at 39. She co nsidered a viral illness
, and ordered flu and strep testing, along with other lab stu dies. Id. at 43

- 44. The evening of

8 Dr. Livingston changed he r surname to Livingston

- Burns sometime between treating B.R. and giving her deposition. See Resp. Ex. W at 5, 7. The re a son I thou ght it might have b een the inoculations is simply be cause she g ot the inoculations the morning or maybe afternoon o f the 31 st of March a nd, within 12 hours or so, she wa s complaining of pain in her hip. And while it’s possible she g ot a n injury som ewhere e lse that introduce d the organisms into her body, likelihood, to me, is tha t it c ould have be e n from the inocula tions because e ither sterility wa sn’t obtaine d before th ey did the inj ection [s] and it wa s introduced

— because we ha ve ba cteria all ove r our bod y, including be ta Strep. And it just resides t here. Normally i t doesn’t cause p roblem s. But if it gets introduced int o a certain area whe re it c a n grow well, that’s when the problems occur.13

April 3, Dr. Livingston

- Burns was notified that B.R.’s blood culture was positive for gram

positive cocci in chains, and she suspected some type of Streptococcus, so she ordered antibiotics. Id. at 49

- 52.
Dr. Livings ton

- Burns did not offer any opinion as to the source of B.R. ’ s infection and necrotizing fasciitis. Resp. Ex. W at 12 4 . She believed that a report was filed regarding the B.R.’s vaccinations and the problems she had afterward , but she was not involved i n that process. Id. at 12 5

- 2 6

.

6. Dr. David Kocherla
Dr. Kocherla’s deposition was taken on September 5, 2012. Resp. Ex. X at 1. Dr. Kocherla attended medical school in India, and then took specialized training in general surgery, also in India. Id. a t 5

- 6

. He practiced general surgery in India and Iran, and then in 1994 came to the United States, where he completed a three year residency in internal medicine at Long Island Jewish Hospital in New York. Id. at 6

- 7. After completion of his residency, he moved to Albany, Georgia, where he joined a practice doing internal medicine, family practice, and emergency room care. Id. at 8. Subsequently, he joined Palmyra as a full

- time emergency medicine physician. Id. at 9.
Dr. Kocherla provided care to B .R. when she presented to the Palmyra ER on April 3, 2009. Resp. Ex. X at 23

- 24. Her chief complaints were fever, rash, inability to walk, polymyalgia, and polyarthralgia. Id. at 28

- 29. She had pain in the left hip, left knee, lower limb myalgia, and l ower leg weakness due to pain. Id. at 30

. B.R. also had a rash on her neck. Id. at 40, 42. Dr. Kocherla’s suspected that B.R. had sepsis and a septic joint due to the tenderness in her left hip and knee and fever. Id. at 37

- 43. He was aware that she had received four vaccinations four days before, and thought t he condition was related to vaccination, and questioned whether she had a rheumatological process. Id. at 42

- 43 . His diagnosis was “post

vaccination reaction,” a nd he ordered a sepsis work up

. Id. at 33

- 34, 37

- 43.

After Dr. Kocherla reviewed lab results, specifically the elevated sedimentation rate of 57, he thought that B.R. had sepsis or “post

- vaccination myopathy.” Resp. Ex. X at 53 , 56

- 58

. Dr. Kocherla c ited Up T o D ate “ [ u ] nder post

- vac cination reactions” as a resource providing information about a vaccination reaction that caused focal pain in the hip and thigh. Id

. at 54. After reviewing t he lab results, Dr. Kocherla’s diagnosis was “unexplained pain in the upper thigh” which could r epresent myopathy, a rheumatology problem, infection, abscess, sepsis, infected join t , infected tissues, and possibly bone infection. Id. at 58. His working diagnoses

w ere “post

- vaccination reaction, pol yarthralgia, [and] serum sickness.” 9 Id. Because B.R. had a rash , Dr. Kocherla also considered that B.R. might have “Still’s Disease or juvenile rheumatoid arthritis
, ” which presents with “rash, fever, and pain in the joints.” Id. at 71. He ordered tha t B.R. be transferred to Dr. Livingston at Phoebe P utney for pediatric care. Id. at 33

- 34, 49

- 50

.

9 Serum sickness is “a hypersensitivity reaction to the administration of foreign serum o r serum proteins characterized by fever, urticaria, a rthralgia, edema, and lymphadenopathy.” Serum Sickness
, Dorland’s Med

. Dictionary Online , https://www.dorlandsonline.com/dorland/ definition?id=106046 (last visited May 27, 2020).14 7. Dr. Robert W. Mills

Dr. Mill s ’ deposition was taken July 9, 2013. Pet. Ex. 18 at 1. He attended medical school and completed a residency in pediatrics at the Medical College of Ohio. Id. at 13

- 14

. He i s in private practice and the Medical Director at Mercy Children’s Hospital in Toledo, Ohio. Id. at 18.
Unlike the other physicians who gave a deposition , Dr. Mills did not pro vide any medical care to B.R .; i nstead, he was p laintiff ’ s expert in the medi cal malpractice case

. Dr. Mills submitted an expert affidavit, in which he testified that the nurses at Phoebe Putney violated the standard of care by failing to notify a physician on April 4, 2009 of B.R.’s vital signs at 12:00 midnight (BP 76/52, heart rate 140, and respiratory rate 36) and at 4:00 AM (BP 90/48, heart rate 140, and resp iratory rate 32). Pet. Ex. 15 at ¶¶ 7(o)

- 7(r), 10. Dr. Mill s’ affidavit was required under Georgia law to support a complaint for malpractice against the defendant
, Phoe be Putney. Pet. Ex. 18 at 32.
Dr. Mills’ deposition testimony generally focused o n his opinions as to the nursing care. Pet. Ex. 18 at 58. During his deposition, Dr. Mills was asked whether B.R.’s immunizations played any role in the development of h er illness , and h e testified that it was “highly, highly unlikely.” Id. at 45

- 46. D r. Mill s state d that since B.R. had the vaccinations in her arm, they

were unlikely to seed the infection in her leg. Id. at 46. He explained that in children
, infection

can seed through mucus membranes , or the nose, throat, or skin. Id. He also testified that little breaks, even tiny breaks in the skin, can seed infection and cause bacteremia. Id. He noted that B.R. had a history of a sore throat, but acknowledged th at her strep screen came back negative. Id. at 47. Dr. Mills also questioned whether minor muscle trauma from jogging (described in B.R.’s father’s deposition) may have incited the infection, but conceded that opinion was speculati ve

. Id.

D. Affidavits fr om Family Members and Pastor Mary Whitley
Several affidavits were executed by family members and Pastor Mary Whitley. See Pet. Ex s . 33

- 40. Relevant to the causation issues addressed in this Ruling are statements about B.R.’s health prior to her vaccina tions and/or death. Brittany Parks, B.R.’s sister, lived in the same house and shared a bedroom with her sister. Pet. Ex. 38 at ¶ 5. She averred that she “did not observe or witness her sister having any complications with coughs or cold imme diately pri or to her death.” Id. at ¶ 8. Terry Roscoe, B.R.’s brother
, similar ly testified that “[ his ] sister never exhibited complications with colds or rash or the like prior to being administered the vaccine shots.” Pet. Ex. 39 at ¶ 7. Pastor Whitle y testified that prior to the vaccinations, B.R. “never complained about flu or cold or anything of that nature.” Pet. Ex. 40 at ¶ 6

.
E. Expert Reports
The experts agreed as to the cause of death, necrotizing fasciitis with septic shock due to a bacterial infection caused by Streptococcus pyogenes ; h owever, they disagree d as to how B.R. “came to be infected” with the bacteria. Resp. Ex. Z at 1 ; see also Pet. Ex. 43 at 6

- 8

. Dr. Miller opined that the source of bacteria was B.R.’s vaccination s , whereas Dr. Vargas op ined that it15

came from the throat , the genital tract, or an unknown origin

. Pet. Ex. 43 at 6

- 8; Resp. Ex. Z at 1

- 5

. Both experts reviewed the medical records, the autopsy report s , and the autopsy tissue slides. Pet. Ex. 43 at 1; R esp

. Ex. A at 1; Resp . Ex. M at 1

- 2. The medical records do not document redness, warmth
, or swelling at B.R.’s vaccination sites. Resp. Ex. A at 7

.

1. Petitioner

– Dr. Douglas Miller , M.D.

a. Background and Qualifications

Dr. Miller is a physician, certified in both neuropa thology and anatomic pathology by the American Board of Pathology. Pet. Ex. 43 at 1. He earned his B.A. from Williams College in Massachusetts in 1974. Pet. Ex. 44 at 1. He then attended University of Miami where h e earned both his M.D. and Ph.D. Id. Thereafter, Dr. Miller completed an anatomic pathology residency from 1980 to 1982 and a neuropathology residency from 1982 to 1984 at Massachusetts General Hospital. Id. Since 1984, he has spent his career in acade mic pathology. Pet. Ex. 43 at 1. Dr. Miller currently works as a Clinical Professor in the Department of Pathology & Anatomical Science s , Interim Chair of the Department of Pathology & Anatomical Science s, and the Pathology Residency Director at the Univ ersity of Missouri School of Medicine. Id. Throughout his career, he has served as a consultant to medical examiners requiring neuropathology subspecialty expertise. Id. at 1

- 2; Pet. Ex. 44 at 3. Dr. Miller serves on various committees and editorial re view boards and has authored or co

- aut hored almost 300 publications. Id. at 4

- 26.

b. Opinion

i. Althen Prong One
There are two tenets to Dr. Miller’s theory of causation. The first tenet is that Streptococcus pyo g enes is a well

- known cause of skin and other infection s . Pet. Ex. 43 at 7. Th is aspect of Dr. Miller’s theory is not in dispute.

The second tenet of Dr . Miller’s mechanism of causation is that S treptococcus pyogenes bacteria can be distributed through the blood stream to various body sites. Tr. 6 1 , 68

- 69 ; Pet. Ex. 43 at 7

- 8

. Th is mode of infection is referred to as hematogenous spread. Tr. 105

. Tissue with less perfusion that receive s less blood flow, like the fatty area of the thigh, can create a location for infection to set up, particularly in obese persons. Tr. 61. Bacte ria grows better in fatty areas tha n in other body tissue. Id. Dr. Miller opined that a bacterial infection can occur in a site remote from the place where the infection entered the body. Tr. 59

- 61 . Specifically
, he testified that in cases of hematogen ous spread of bacteria, an infection ca n occur at a remote site even if there are no symptoms of infection at the site where the bacteria entered the body. Tr. 67

- 70 , 91

.16

Dr. Miller also referenced an article filed by respondent, authored by Ian F. Cook

. 11 Tr. 63

- 65 (citing Resp. Ex. N )

. Cook review ed adverse infectious events that occurr ed after vaccination
, to emphas ize the importance of skin disinfection before administering vaccines . Tr. 65. Dr. Miller explained that bacteria can be introduced into the body through the skin via injection, and that is why it is important to sterilize the skin prior to vaccine injection. T r. 68

- 69, 85

. E ven proper disinfection technique does not completely sterilize the skin, and there is some chance for bacteria to be carried through the skin by a needle even if the person who administers the vaccine follows proper procedure. Tr. 86.

Cook reviewed data from a number of sources, including the VAERS database , Vaccine Safety Datalink ( “ VSD ” ) program, Korean, Italian
, and Canadian surveillance programs, Kaiser clinics, Medicare, and published reports in the medical literature. Resp. Ex. N at 2

- 3. He

r eported 1534 cases of sepsis 12 following vaccinations, noting that the majority (65.9%) were associated with cellulitis. 13 Id

. at 8.

T welve cases of necrotizing fasciitis were summarized in a Table in the Cook article : seven from the literature and five from the VAERS database

. Resp. Ex. N at 6

- 7 tbl. 5. One of the case reports in the table was from a paper authored by Thomas, 14 about a n 80

- year

- old patient wh o received t he flu vaccine in h er left upper arm. Id. at 6 tbl.5 (citing Resp. Ex. BB)

. Two da ys later, the patient presented with a blue discoloration of her left forearm, “blister

- like

10 Streptococcal and Enterococcal Inf ections , Merck Manual, https://www.merckmanuals.com/ professional/infectious

- diseases/gram

- positive

- cocci (last visited Sept. 11, 2013).

11 Ian F. Cook, Sepsis, Parenter al Vaccination and Skin Disinfection , 12 Hum. Vaccines & Immunotherapeutics 2546 (2016).

12 Cook defined sepsis as a systemic inflammatory response syndrome which occurs when infection is associated with organ dysfunction, hypoperfusion
, and/ or hypotensio n

. Resp. Ex. N at 8.

13 Cellulitis is defined as “an acute, infectious and expanding inflammatory condition of the skin.” Resp. Ex. N at 2.

14 M.G. Thomas, Clostridium Septicum Gas Gangrene Following Intramuscular Infection from an Influenza Vaccine B oo ster , 44 British J. Clinical Prac. 709 (1990). In support of his theory o f causation, Dr. Miller cited the Merck Manual, a guide book for physicians. T r. 58 (citing P et. Ex. 26). 10 With regard to necrotizing f asciitis due to Streptococcus pyogenes
, the Merck Manua l state s that “[i]noculation originates through the skin or bowel, and the defec t may b e sur gical, trivial, distant from the disease sit e, or occult, a s with colonic diver ticula or a n appendicea l abscess. ” Pe t. Ex. 26 at 4. Thus, the defect where the bacter ia enters the body can be trivi al, and Dr. Mille r emphasized that the site of bacteria e ntry may b e dist ant from the disease it c auses. Tr. 59-61.17 1) Male , age 72, had an influenza vaccine given in his left arm

. Id. at 9 tbl.7. He developed pain and swelling in his right wrist, arm, and left ankle. Id. Gr oup A strep was cultured from the right wrist. Id.

15 Clostridium septicum is defined as “a toxicogenic species commonly found in animal intestines and soil, causing diseases such as braxy and malignant edema; in humans it is sometimes associated with gas ga n grene.” Clostridium S epticum
, Dorland’s Med

. Dictionary Online , https://www.dorlandsonline.com/dorland/definition?id=65642 (last visited May 27, 2020).

16 Osteomyelitis is the “inflammation of bone caused by infection, usually by a pyogenic organism, alt hough any infectious agent may be involved.” Osteomyelitis
, Dorland’s Med

. Dictionary Online , https://www.dorlandsonline.com/dorland/ definition ?id=35862 (last visited May 27, 2020).

17 This is the British spelling of the word, hematogenous. For clarity , the English spelling will be

u sed throughout this R uling.

18 Dr. Miller defined hematogenous as “spread in the bloodstream.” Tr. 105.

19 Septic arthritis is an “infection of the joint.” Resp. Ex. N at 5. fluid collections” or bulla e, a nd a “ cold, pulseless lef t hand.” Tr. 64 (citing R esp. Ex. N at 6 tbl.5). The fluid in the lesions c ultured clostridium se pticum. 15 Id. (citing Resp. Ex. N at 6 tbl.5). Dr. Miller testifie d that based on the description provided in Cook, the inj ecti on site wa s the upper left deltoid musc le, and the “subsequent soft tissue infection wa s in the for earm and hand, without a dire ct conne ction to the va ccination site.” Tr. 64 -65. D r. Miller noted that th e infecti on was remote fr om the va ccine site. Tr. 65.

Cook also describe d ten cases of osteomyelitis 16 following va ccination. Resp. Ex. N at 5. Cook identified three mechanisms of infection sprea d: haematogenous 17 and contiguous spread with or without va scular insufficiency. Id. One c ase wa s due to hematogenous spread 18 afte r flu vaccination in the right arm of the patient. Id. at 5, 8 tbl.6. The pa tient’s c linical history w as notable for cellulitis in the rig ht arm and the p atient deve loped L3-4 vertebral osteomyelitis. Id. at 8 tbl.6. Dr. Miller e xplaine d that the mec hanism of hematoge nous spread of bacteria in the blood stream described in the pa tient in Cook’s article was the sa me “mode of spread” in B .R.’s case. Tr. 105.
Septic a rthritis 1 9 was another type of adverse infe ction occurring after vaccination reported by Cook. Resp. Ex . N a t 5, 9 tbl.7. Hematogenous sprea d wa s reporte d in four c ases of septic arthri ti s:18 2) Female, age 1 year, 1 month, had Hepatitis A a nd Varicella vaccinations in the left leg, and subsequently was unable to move her left elbow. Id. Aspirate of the left elbow was positive for Alcaligenes faecalis

. 20 Id. 3) Male, age unknown, had Hepatitis B vaccination in the left leg and developed pain and decreased movement in the left leg, and was diagnosed with septic arthritis of the left hip and ankle. Id. Blood cultures showed methicillin

susceptible Staphylococcus aureus 21 ( “ MSSA ” ), as did left ankle ulcer. Id. 4) Male, age 16, received the meni ngococcal and Tdap vaccines in his right arm, and developed methicillin

- resistant Staph ylococcus aureus ( “ MRSA ” ) bacteremia with left s acroiliac joint, and septic arthritis on bone scan and MRI. Id.

T here was no mention o f symptoms of infection at the site of vaccination in the four

cases described above, where the route of sp r ead was hematogenous

. See Resp. Ex. N at 9 tbl.7. Dr. Miller testified that the case involving the 16

- year

- old male who had a distant site infection illustrates his causal theor y . Tr. 110

- 11

. Dr. Miller also cited another article filed by respondent, authored by Stevens et al., 22 in support of his opin ions. Tr. 65

- 67 (citing Resp. Ex. Z, Tab 4 ) . The article describes patients who had severe G roup A S treptococcal infections. Tr. 66. Dr. Miller notes that “s ome of the patients did not have any documented portal of entry ,” explaining that these patient s had negative throat culture s and demonstrated no sign of injury to the skin

. Tr. 67. Of the patients with no evid ence of sk in infections, one had a “bacterial infection of the interior of the eye globe” or “ endophthalmitis .” Id. Dr. Miller opined that the patient with the eye infection had an infection from a source that was “clearly a distant site” and “ no detectable site o f entry.” Id. Therefore, Dr. Miller concluded that t he infection had “to be carried in the bloodstream.” Id.

ii. Althen Prong Two
The autopsy establishe d that B.R. had S treptococcus pyogenes , a bacteria that Dr. Miller opines is known to be present on hu man skin, and a known cause of human infections. Pet. Ex.

20 Alcaligenes faecalis is “a species isolate d from hospital environments and from blood, sputum, and urine specimens.” Alcaligenes F aecalis
, Dorland’s Med

. Dictionary Online
, https://www.dorlandsonline.com/ dorland/definition?id=55314 (last visited May 27, 2020).

21 Staphylococcus aureus is “a species comprising the yellow

- pigmented, coagulase

- posi tive pathogenic forms of [Staphylococcus]” that “causes serious suppurative inf ections and systemic disease, including impetigo bullosa, staphylococcal pneumonia, and staphylococcal scalded skin syndrome, and has developed resistance to nearly all classes of antibiotics.” Staphylococcus A ureus , Dorland’s Med

. Dictionary Online , http s://www.dorlandsonline.com/dorland/ definition?id=108211 (last visited May 27, 2020).

22 Dennis L. Stevens et al., Severe Group A Streptococcal Infections Associated with a Toxic Shock

- like Syndrome and Scarlet Fever Toxin A , 321 New Eng. J. Med. 1 (1989).19

23 Dr. Miller’s complete review of B.R.’s medical records will not be recounted in this section. For a more detailed summary of relevant facts, see supra Section III.B .1

. 43 at 7. Dr. Miller opine s that the “autopsy f indings are c onsistent with septic shoc k from an infection centered in the l eft hip region.” Id. at 4. According to Dr. Miller
, bacter ia got into th e bloodstream at the s ite of one of B.R.’s vaccinations, and once in the blood stream, traveled to the thigh, an area o f high fa t content. Tr. 69. Dr. Miller opines that there was no source of infection other than vaccination as evidenced by th e a utopsy

. Pet. Ex. 43 at 6.

Dr. Miller disa grees with respondent’s position that B.R. likely h ad strep throat, or other infection that caused he r necrotizing fasciitis and septic shoc k. Pet. Ex. 43 at 6. He opines that the clinical history do e s not provide evidence of any other source or site of infection. Id. At the hearing, Dr. Miller p ainstakingly reviewe d the me dical records in chronologic order to support his position that there wa s no evidence o f strep throat that could have b ee n the source of B.R.’s necrotizing f

asciitis. 23 See Tr. 13-57.

Dr. Miller be gan by stati ng that on March 31, 200 9, a t B.R. ’s well c hild visit, she had no complaints, her vital signs, lab tests, and urinalysis were no rmal, and there were no identifiable illnesses. Pet. Ex. 14 a t 3-4; Tr. 14. The onl y iss ue noted wa s B.R.’s weight. Tr. 14. Four vaccines were a dministered at this visit, two in each arm. Pet. Ex. 14 at 4; Tr. 15.
On April 1, 2009, B.R. was seen in the Phoebe P utney E D at 5:45 PM, complaining of hip pain a nd fever that began that morning at 3:30 AM. Pet. Ex. 14 at 10-12; Tr. 16. B.R. had no infectious disease risk fa ctors, no contacts with il lness, had been acting normally, was voiding urine, had no ear pa in, ha d no vomiting or diarrhea, felt hot, and was febrile for two -and-one-half hours. Tr. 17. B.R. denie d injury to the hip, and had a fever of 102 to 103. Id. ; P et. Ex. 14 at 11. There w as no history of cough, sore thro at, stuffy or runny nos e, chills, or swea ts, and her appetite was okay. Pe t. Ex. 14 at 11. A physica l exa m found B.R

. had no ear, nose, or throat abnormalities, her nec k was supple, she ha d no significant adenopathy (no e nlarged lymph nodes in her ne c k, face, or head), and her oropharynx (throa t) wa s clear with no inflammation or evidence o f otitis media (ear infection). Id. at 12; Tr. 18-19. She ha d g ood breath sounds, no labored breathing, no coughing, and no wheezing

. Pet. Ex. 14 at 12; Tr. 19. Lastly, her abdomen was soft with no palpable o r enlarged organs, she ha d good bowel sounds, she had “moderate tenderness to palpation over the left anterior thigh
, ” and her skin was clear with no

ra sh. Tr. 20; see Pet. Ex. 14 at 12.

Based on the c linical history and physical examination on April 1 , Dr. Miller c oncluded there wa s no evidence th at B.R. had strep throat. Tr. 20. Specifically
, he t estified that she ha d no inflammation in he r throat and no enlarged lymph nodes, which he finds typical fo r a p atient with strep throat. Id. Howeve r, Dr. Miller opined that there wa s evidence t hat B.R.’s leg w as infected on April 1 because she c omplained of p ain and her leg was tende r to palpation. Tr

. 20- 21.
Next, Dr. Miller recounted that B.R. was next seen by a physician on April 3, when she presented to the Palmyra ER with a high fever and “ [e] xtreme upper thigh pain.” Pet. Ex. 14 at 120, 133; Tr. 21. She was again noted to have no cough, no shortness of breath or difficulty20

24 A CDC monograph on Group A Strep and scarlet fever, filed as Respondent’s Exhibit Z, Tab 6, describes symptoms of str ep throat as very red, sore throat, fever, whitish coating on the tongue, and swollen glands in the neck, consistent with Dr. Miller’s tes timony on this point. Group A Streptococcal (GAS) Disease
, Ctrs. for Disease Control & Prevention, https://www.cdc.go v/groupastrep/diseases

- public/scarlet

- fever.html (last visited July 13, 2019). breathing
, no sore thro at, no close contact with anyone who had respiratory s ympt oms, and no contact with any pe rso n having a flu -like il lness. Pet. Ex. 14 at 133 ; Tr . 22. Physical exam revealed B.R

. was in mild distress. Pet. Ex. 14 a t 120; Tr. 23. She ha d normal breath sounds, an exam of her hea d, ea rs, eyes, nose, and throat was norma l, she ha d no history o f trauma
, and her skin was warm and intact with no breaks or lesions. Pet. Ex. 14 at 120; Tr

. 23-25. Based on the medical records from April 3, Dr. Miller concluded that there wa s no evidence that B.R. had strep throat. Tr. 26.

Dr. Miller testified that B.R. was transferre d fr om Palmyra to Phoebe P utney later that day and the a dmitting p ediatrician, Dr

. Livingston, documented a hist ory a nd physical exam. Tr. 27-28, 34; s ee Pet. Ex. 14 at 27-30. On exa m, B.R. ha d no nasal discharge, no cough, no wheezing
, a nd no trouble bre athing. Tr. 36. D r. Livingston stated, “[t]he pa tient has had a sor e throat off a nd on for the past week” and ha d “some nausea with the sore thr oat.” Pet. Ex. 14 at 28. B.R. had no pain on urination. Id. She h ad leg w eakness, worse pain in the left hip and thigh, a nd decrease d ambulation. Id. D r. Livingston also noted that B.R .’s mother reported that B.R. had a n “intermittent red rash that had c ome and gone for the past 3 days.” Id. Physical examination revealed B.R.’s oropharynx was “ mildly inj ected, ” there wa s “ [n]o significant adenopathy, ” and her lungs were clear. Id. Dr. Miller testified that the phrase “ mildly inj ected” suggests mi ld irritation or infla mmation. Tr. 38. Given the hist ory o f vomiting a t this point, Dr. Miller state d that the note a bout B.R. having a sor e throa t was possibly re lated to irritated mucus membranes from vomiting, but admitted that without more infor mation, the finding was difficult to interpret. Id.

The ne xt physica l exa m occurre d the morning of April 4, at 9:35 A.M. Tr. 39; s ee Pet. Ex. 14 at 61. At that time
, an exam revealed tha t B.R. had moist mucus membranes without inflammation, no coug h, a nd clea r lungs. Pet. Ex. 14 at 61.
In summary, Dr. Miller t estified that B.R. had five consecutive examinations of her throat: March 31, April 1
, April 3 , evening of April 3
, and the morning o f April 4. The note on April 3 from Phoebe P utney is the onl y ti me tha t any abnormality is seen and documented, and thus, it is inconsistent with all of the ot her contemporaneous entries. Tr. 37. Dr. Miller a lso explained that a c hild with acute strep throat would have a n inflamed throat, often with white follicles and exuda te. Tr. 40. Thus, the de scription by D r. Livingst on on April 3 of “mildly injected” i s not c onsistent with acute strep throat. 24 Id

. Further, the rapid strep test and throat culture done on the evening of April 3 were ne gative. Tr. 32. The thro at culture showe d no evidence o f a stre p organism. I d. Dr. Miller testif ied that the a ccuracy ra te of a ra pid strep test combined with a throat culture is 90-95% se nsitive. Tr. 32, 71. Thus, he concludes that there is no evi dence “at all” tha t B .R. had strep throat. Tr. 33.21

25 For the cases cited in Cook documenting a hematogenous sp read of infection, see supra Section III.E.1.b.i. Dr. Miller a lso disagreed with respondent’s suggestion that B.R. ha d pneumonia or bacterial bronchitis. Pet. Ex. 43 at 6. The lung ti ssue slides showed “marked congestion a nd

. . . intra-alveolar hemorrhage ,” a s well a s “c onsiderable desquamation of alveolar a nd bronchiolar lining c ells and alveolar macrophages, as a te rminal and autolytic phe nomenon, ” but there w as no pneumonia or indication of a prior inf ection of the lungs. Id. at 4-5. Dr. Mil ler disag rees with respo ndent’s expert, D r. Vargas, that lung ti ssue slide Q shows “early bron chopneumonia” because Dr. Varga s did not identify a ny evidence of “early bron chopneumonia” in the other three lung sli des. Id. at 5. The a reas of lung ti ssue identified as abnormal by D r. Varga s are, according to Dr. Miller, artifactual or te rminal findings. Id. at 6. Dr. Miller a lso referred to these findings a s “agonal,” which are changes that occur during d eath, and “autolysis,” or changes that occur when there is a delay in conducting a n autopsy. Tr. 195-96. To the extent that there we re any changes consistent with early pn eumo nia, Dr

. Miller opined they would be a c onsequence of B.R.’s septicemia
, and not a preceding in fection. Tr. 196. Dr. Miller a lso notes that B.R.’s records include man y sta tements that her lun gs were c lear, except a note close in time to her death, where she w as noted to be in mild respiratory dist ress. I d.

Dr. Miller state d that the pathologist s who performed the a utops ies did not opine that B.R.’s inf ection started in her throat. Tr. 51- 52. B.R.’s ur ine culture wa s a lso negative a nd not compatible with streptococcus. Tr. 56. Dr. Miller opined that there was no evidence o f a urin ary tract infection as the course of the infe ction in B.R.’s medical re cords. T r. 70. There w as no history of trauma, no other breaks in the skin. Tr. 7 2. There w as no reason for the treating physicians to culture the genital tract as there w ere no symptoms to suggest that was the source of infection. Tr. 91. D r. Miller concluded that other than her vaccinations, there is no other explanation as to the c ause of B.R .’s infection. Tr. 71.

Dr. Miller a greed that there was no evidence of a l ocal infection at the sit e of B.R.’s vaccinations. Tr. 91. H e point ed out that the Stevens article document ed a remote infe ctious complication (endophthalmitis) from an unknown site of entry. Tr. 89 (citing R esp. Ex. Z, Tab 4). Dr. Miller c onceded tha t in the cases of remote infe ctions cited in Cook, most had an infe ction at the inj ecti on site; however, there we re a lso cases cited in Cook that documented a hematogenous spread of infection, in the same manne r that Dr. Miller ’s asserts occurred in B.R.’s case , where the re was no infection described at the sit e of vaccination. Tr. 89-90, 107-11 (citing R esp. Ex. N at 9 tbl.7). 25

Consistent with the autopsies, Dr. Miller testified th at B.R.’s cause of death wa s necrotizing f

asciitis with septic shoc k, caused by Streptococcus pyogenes . Tr. 48-49. Dr. Miller explained that Streptococcus pyogenes is ubiquitous in the environment and on our ski n. Tr. 50. While soft tissue infections l ike B.R.’s are ve ry rare, they c an be f atal. Tr

. 51.
Dr. Miller testified that here, there was bacteria on the needle as it penetrated the skin, and the bacteria was deposited into the subcutaneous tissues, or “penetrate [d] a blood vessel,” thus getting into the bloodstream. Tr. 111. At the cellular level, Dr. Miller explained th at B.R.22 iii. Althen Prong Three

Dr. Miller testified that the onset of B.R.’s illness, the time frame between her vaccinations and thigh pain, was approximately 14 hours. Tr. 69

- 70. According to Dr. Miller, th is time frame was appropriate given his proposed mechan ism of causation. Tr. 70 . In support of his opinion as to onset, Dr. Miller cites a case described in the Stevens article, where a patient had a fulminant presentation within eight hours of presentat ion. Id. (citing Resp. Ex. Z, Tab 4 at 2). Dr. Miller opined that 14 hours was a sufficient time for bacteria to enter the bloodstream and seed an infection in the soft tissue and muscle of B.R.’s left hip. Tr. 96

- 97.

2. Petitioner

– Dr. Harry Latham
Petitioner filed four experts reports authored by Dr. Latham. See Pet. Ex s . 22

- 25. Dr. Latham was not called as a witness at the hearing.
In his first report, an affidavit, Dr. Latham provided a summary of B.R.’s medical records

. See Pet. Ex. 22 at ¶ 5. He then opined in a conclusory fashion that “there is no evidence to suggest a cause for [B.R.’s] symptoms and disorders other than the vaccinations; and, [B.R.’s] injuries and death five days later were related to the administration of her

. . . va c cinations. ” Pet. Ex. 22 at ¶ 6.
Dr. Latham provided four reasons for his causation opinion in his second report. The first reason was the onset of B.R.’s illness : the time frame between vaccination on March 31, 2009, at about 1:00 PM, and the onset of pain on April 1, at approximately 3:00 AM, indicates a “strong temporal association” which “speaks [ to ] cause and effect.” Pet

. Ex. 23 at 1. Second, B.R. received four vaccines, two in each arm. Id. Third, while Dr. Latham acknowledged that the “area affected by necrotizing fasciitis was not at the site of vaccination,” he noted that “necrotizing fasciitis has been documented to occur in areas away from the apparent point of

26 For a more detailed analysis of the facts in the autopsy reports t hat contribute to Dr. Miller’s opinion, see Pet. Ex. 43 at 3

- 6. had “transient bacteremia” a nd the bacteria that entered the bloodstream from the va ccination seeded the soft tissue of the hip and thigh. Tr. 103, 111. Then, she de ve loped an infection of the bloodstream and septic s hock as a fin al complication. Tr. 103-04. Dr. Miller sa id tha t Cook describes this as “metastatic
, ” mea ning that it spr eads from somewhere e lse. Tr. 104 -05.
In summary, Dr. Miller o pined that B.R. was previously he althy, but mildly obe se, and was “given a clean bill of he alth” on the day sh e re ceived four different injectable va ccinations. Pet. Ex. 43 at 8. Wit hin 15 hours, she had left hip pa in and fever. Id. She developed septicemia and septic shock, whic h caused her death. Id. She wa s diagnose d with a streptococcal infection. Tr. 97. She ha d no infection in her throa t. Id. There is no e vidence that she ha d evidence of genital infection. Id. She ha d four needle punctures that violated the ski n. Id. Autopsy did not show any sourc e for the bacteria. 26 Pet. Ex. 43 at 8. For all of these re asons , Dr. Miller concluded that bacter ia was introduced into the bloodstream by a va ccination, “a ra re but reporte d complication” o f vaccination admini ster ed by ne edle injection. Id. ; see a lso Tr. 96-97.23 3. Respondent

– Dr. Sara Vargas , M.D.

a. Background and Qualifications

Dr. Vargas is a doctor licensed to practice in Massa chusetts and board

- certified in anatomic pathology, clinical pathology, and pediatric pathology . Resp. Ex. A at 1. Dr. Vargas earned her A.B. from Harvard University in 1988 and her M.D. from University of Vermont College of Medicine in 1994. Resp. Ex. AA at 1. She then completed a residency in anatomic and clinical pathology at Brigham and Wome n’s Hospital and a fellowship in pediatric pathology at Children’s Hospital. Id. Since completing her residency and fellowship, Dr. Vargas has taught at Harvar d Medical School as an Instructor, Assistant Professor, and now Associate Professor and has als o worked as a staff pathologist at Children’s Hospital and Brigham and Women’s Hospital. Id. at 1

- 2; Resp. Ex. A at 2. Throughout h er career, s he has served on

27 Lymph is defined as fluid and cells, primarily lymphocytes, “collected from all parts of the body and returned to the blo od via the lymphatic system.” Lymph
, Dorland’s Med

. Dictionary Onl ine
, https://www.dorlandsonline.com/dorland/definition?id=28971 (last visited May 27, 2020). introduction of the bacteria.” Id. Fourth, he a sserts that bacter ia were c arried away from the point of introduction (vaccination) to a “ possibly more susce ptible area which has been traumatized” or has a “ compromised blood flow. ” Id.
In his third expert report, Dr

. Latham pr ovided a t heory e xplaining how vaccination in the

arm ca n cause n ecrotizing f asciitis in the hip. Pet. Ex. 24 at 1-2. Quoting the Merck Manual, he wrote “ [i]noculation originates through the ski n . . . and the defect may be s urgical, trivial, distant from the disea se s ite, or occult. ” Id. at 1 (quoting Pe t. Ex. 26 at 4). He gave examples of the mechanism. The fi rst example is tha t dental care c a n cause endocarditis, due to bacteria in the mouth traveling through the blood stream to a compromised heart valve. Id. Another example wa s sepsis caused by an infection in the bladde r or lun gs. Id. The thi rd example was lymphohematogenous 27 spread of bacteria “ from a distant source suc h as pneumonia or a r emote wound infection.” Id. a t 2. Dr

. Latham stated that S. pyogenes is normally found in the ski n and

ca n also be harbored in the re spiratory tra c t. Id. With regard to the facts here, he opin ed that the “injection of the vacc ine caused the break in the s kin which introduced the pathogenic or ganism into the bloodstream. This in turn, caused the necrotizing fasciitis.” Id. The ba cteria “ spread rapidly” onc e it e ntered the bod y. Id. It then infected the fa scia, “connective ba nds of tissue that surround muscles, nerves, fat, and blood vesse ls.” Id. Dr

. Latham described B.R.’s clinical

course a nd how it was consistent with his proposed theory. Id. at 2-3.

In his third a nd fourth reports, Dr

. Latham addresse d responde nt’s assertions that B.R.’ s necrotizing f

asciitis was caused from either strep throat or vaginal infection. Pet. Ex. 24 at 3-4; Pet. Ex. 25 at 1-2. Dr

. Latham opined that if B.R. had strep throat, she would have ha d a posi tive throat culture, a nd an “inflamed oropharynx.” Pet. Ex. 24 at 3; see a lso Pet. Ex. 25 at 2. He a lso disagreed that B.R.’s necrotizing fa sciitis was caused by v aginal infection since urine c ultures did not show streptococcal infection and there w as no evidence o f vag inal discharge. Pet. Ex. 24 at 3.24

various committees and editorial boards and joined numerous professional societies

. Resp. Ex. AA at 3

- 5. Dr. Vargas has authored or co

- authored almost 200 publications. Id. at 17

- 36

.

b. Opinion

i. Althen Prong One

Dr. Vargas does not disagree with Dr. M iller’s general theory of causation, but disagrees with his specific opinion that bacteria from a vaccination site can cause necrotizing fasciitis if there is no infection at the vaccination site. Tr. 189

- 90

. Where the source of infection is the skin, Dr . Vargas does not believe that bacteria can proliferate and cause infection if the vaccination site is clean and without infection. Tr. 190. In the alternative, if the source of infection is from another ar ea of the body that is colonized with strep, the n an infection at the site is not required for the bacteria to travel to a distant site and cause infection. Tr. 193.

Like Dr. Miller
, Dr. Varg as testified that necrotizing fasciitis is “a rapidly moving bacterial infection involving deep soft tissue. ” Tr. 128. She stated that i n approximately fifty percent of cases , the source of the bacteria is not known

. Tr. 128, 193

- 94. The i nfection that causes necrotizing fasciitis ca n come from sources other than skin

. Tr. 128

- 29. Strep b acteria

“ c an c olon ize surfaces that are contiguous with the outside world ” like the throat and female genital tract. Tr. 128; see also Resp. Ex. Z at 1

- 2. Dr. Vargas opined that there can also be hematogenous translocation 28 of strep “ from the throat in the presence or abs ence of symptomatic pharyngitis to a site of blunt trauma or muscle strain.” Tr. 130 (quoting Resp. Ex. Z, Tab 2 at 5)

. 29

Dr. Vargas agreed that the skin can be the source of bacteria in necrotizing fasciitis. Tr. 130

. However, t o a ttribute necrotizi ng fasciitis to a vaccine given at a distant site, Dr. Vargas feels it would be important to see an infection at the point of entry or site of vaccination. Tr. 130

- 31. She agreed that vaccinations can introduce bacteria that cause necrotizing fasciitis, but the bacteria can also come from somewhere else because there is no known source in over half of the cases of necrotizing fasciitis. Tr. 133. Dr. Vargas also agreed that bacteria can travel to distant sites. Tr. 135. She testified that bacteria can travel when large amounts of it are seeded in the bloodstream. Id.
In support of her opinion that in order for vaccination to cause a distant site infection, there must first be an infect i on at the vaccination site , Dr. Vargas referenced the Cook articl e

. Tr. 13 6

- 3 7 ; Resp. Ex. Z at 3 . Dr. Vargas explained that in cases of infectious abscess es post

vaccination , there is a description of an a bscess or infection at the site of vaccine injection. Tr.

28 Dr. Vargas defined translocation as the “way by which bacteria get into the bloodstream.” Tr. 188

.

29 Michael E. Pichichero, Complications of Streptococcal Tons illopharyngitis , UpToDate, https://www.uptodate.com/contents/complications

- of

- streptococcal

- tonsillopharyngitis (last updated Mar. 22, 2019).25

30 The phrase “invasive infection” was used in an Up T oDate article authored by Stevens and Kaplan and filed by resp ondent as Resp ondent’s Ex hibit G. See Dennis L. Stevens & Sheldon L. Kaplan, Group A Streptococcal (Streptococcus Pyogenes) Bacteremia in Children , UpToDate, https://www.uptodate.com/contents/ group

- a

- streptococcal

- streptococcus

- pyogenes

- bacteremia

in

- chil dren (last updated June 23, 2012). They define invasive infections to include “bacteremia, pneumonia, osteomyelitis, septic arthritis,” necrotizing fasciitis, “or any other infection associate d with the isolation of [strep] from a normally sterile body si te.” Resp. Ex. G at 1.

31 After the hearing, respondent filed the Thomas article. Resp. Ex. BB. In it, the author states that the patient received a flu vaccine in the left upper arm. Id. at 1. One day later, she developed some discomfort at her vac cination site. Id. Other t han the reference to discomfort, there is no description of infection or cellulitis at the site of vaccination. See id. at 1

- 2.

32 Joseph M. Bellapianta, Necrotizing Fasciitis , 17 J. Am. Acad. Orthopaedic Surgeons 174 (2009).

33 Dennis L. Stevens & Larry M. Baddour, Necrotizing Soft Tissue Infections , UpToDate, https://www.uptodate.com/contents/necrotizing

- soft

- tissue

- infections (last updated Feb. 28, 2013). 138-40 ; see Resp. Ex. N. at 4-5 tbl.4. Dr. Vargas noted that she wa s “unable to find a single reference in the medic al literature in which any a uthor eve r attributed an invasive bacterial infection to vaccination when there was no evident cellulitis occurring at the va ccination site itself. ” 3 0 Resp. Ex. Z a t 3; see a lso Tr. 147.
With regard to the necrotizing fa sciiti s cases summarize d by C ook in Table 5 , Dr. Vargas di d not see “ any e vidence of any inj ection site that staye d clea n a nd yet had an infection at a distant site attributed to it.” Tr. 144. Ther e w as one c aveat: Dr. Vargas was unable to read the Thomas article listed in Table 5, and the description of that case stud y w as too ambiguous for h er to confirm that there w as no infection at the sit e of va ccination. 31 Tr. 144-45.

I n response to the Merc k Manual reference cite d by petitioner, Dr. Vargas testified that the examples used in that tex t were c ases where a n infe ction had “set up” and then the “ infection travel[ed] to a distant site, ” which is different tha n a sit uation where b acteria c omes f rom “a clean site.” Tr. 146 -47.
Dr. Vargas cited several articles to support her opinions. In a n article by Bellapianta, et al., 32 the authors state, “ [n] ecrotizing f asciitis typically follows an injury to the invol ved site.” Resp. Ex. D at 1. The authors also state that “[ n]ecrotizing fa sciitis has been associated with . . . injection sites. ” Id. “ Although the skin is the most common portal of entry, in 45% of cases, no definitive a ccess point can be foun d. ” Id. a t 2. One of the risk factors for the illness is obesity, although half of cases occur in healthy pe rsons. Id.

Another article c ited by Dr. Vargas wa s a surve y article by S tevens a nd Baddour. 33 Resp. Ex. F. The a uthors sta te that strep “ may loc alize to the e xact site of muscle inj ury due to26 ii. Althen Prong Tw o
Dr. Vargas opined that in B.R.’s case, the bacteria that c aused necrotizing fasciitis was introduced by a source other than vaccination. Tr. 168 ; Resp. Ex. A at 7. She stated that there is “no evidence that [B.R.’s] vaccination site

. . . ever showed any evidence of infection” and “there is no known case of nec rotizing fasciitis due to a medical injection in which the fasciitis occurred without involving the injected area.” Resp. Ex. M at 4. She further opin e d that “ the more common and mo re probable causes of bacterial seeding of the groin fascia” include stre p throat,

“ direc t spread from a nearby genital infection,” and unknown or idiopathic. Resp. Ex. A at 8

. She states that idiopathic cases are “well

- known” but “poorly understood.” I d.
In her first expert report, Dr. Vargas opined strep throat was likel y. Resp. Ex. A at 7. In her suppl e mental expert report, Dr. Vargas agreed with the testimony by Dr. Mills, when he “pointed to the throat as one of the possible sources of bacterial seeding.” Resp. Ex. M at 2. At

34 Respondent cited an article by Varricchio et al., which explains tha t “VAERS are not formal

case reports, but rather nonstandardized descriptions of symptoms and signs temporally associated with a vaccination or vaccinations. The information in a report is not necessarily complete, nor is it verified in most cases.” Frederick Varricchio et al., Und erstanding Vaccine Safety Information from the Vaccine Adverse Event Reporting System , 23 Pediatric Infectious Disease J. 287, 288 (2004) (filed as Resp. Ex. R). increased surface expression of the vimentin, ” a pr otein, which binds the bacter ia. Id. at 2. In cases with no clear entry point, the infection likely occurs due to hematogenous translocation of strep “ from the thro at (asymptomatic or symptomatic pha ryngitis) to a site of blunt trauma or muscle stra in. ” Id. at 3.
On cross-examination, Dr. Vargas agreed that strep can move through the body to remote locations from where it e nters. Tr. 174-75. She also agreed that while stre p is likely to be found in warm moist areas, it c an be foun d anywhere on the body. Tr. 174. The bacter ia “ uses multiple tissues, including [] blood , to spread. ” Tr. 175. Dr. Vargas specifically agreed that a puncture c an introduce b acteria into the bod y. Id.

Whe n questioned about the s eptic arthrit is case s summarized by Cook in Table 7, Dr. Varga s agreed that patients one, two, and four ha d infections at locati ons distant from vaccination. Tr. 178- 79. She a lso agreed that Cook did not de scribe any inf ection at the sit e of injection in these thre e c ases. Id. Dr. Vargas stated that the VAERS report s of these thre e c ases were not filed, so there is no additional information about the site of injection. 34 Tr. 193.

Dr. Vargas testified tha t “septic a rthritis is . . . just li ke ne crotizing fa sciitis, it pre sents, and we don’ t know why

. Many, many c ases, we s ay it got there throu gh the bloods tream, but we don’t know.” Tr. 183. In general, D r. Vargas, explained that hematogenous is defined as “spread through the bloodstream.” Tr. 184. She t estified that when there i s no evidence o f contiguous infection, or direct contaminati on, “the n you have to invoke a hematogenous source.” Tr. 183.27

35 Ellen R. Wald, Approach to Diagnosis of Acute Infectious Pharyngitis in Children and Adol escents , UpToDate, http://www.uptodate.com/contents/approach

- to

- diagnosis

- of

- acute

infectious

- pharyngitis

- inchildren

- and

- adolescents (last updated June 2, 2015). the hearing, Dr. Varga s testified that the medical records state that B.R. had a sore throa t and “mildly inj ected” throa t, which supports her opinion that the strep bacteria could have c ome fr om the throat. Tr. 154-57. D r. Vargas asserts that B.R.’s sore throa t had occurred “off a nd on for a week” p rior to her tr ansfer to Phoebe P utney on April 3, and thus, it pre ceded her vaccination. Resp. Ex. Z a t 2.
According to Dr

. Vargas
, B.R.’s n egative rapid strep test a nd negative throat culture do not “ rule out ” the possibility o f S. pyogenes in the throat. Resp. Ex. M at 5. She notes that

“ throat culture s are kno wn to miss 5 -10% of S. pyogenes infection[s] .” Id. When asked about the accuracy o f the r apid stre p test and throat culture, Dr

. Vargas agreed with Dr. Miller’s testimony th at the tests were 90% accurate, stati ng Dr. Miller wa s “not too far off.” Tr. 171. Respondent filed a medic al article by W ald 35 which confirm ed the veracity o f Dr . Miller’s opini on. Resp. Ex. M, Tab 7 at 5. Wa ld observes that “[w]hen performe d properly, the

se nsitivity of [a] throat culture is 90 to 95 perce nt for [g roup A strep] .” Id.

The re ference in B.R .’s medica l record to a r a sh was significant to Dr. Vargas. She testified that “ a r ash is a common manifestation of strep pyogenes infection. ” Tr. 156. She noted the re cords indicate on April 4 that a r ash had been present off and on for three days. Resp. Ex. Z a t 3 (citing Pet. Ex. 14 at 28, 59). Dr. Vargas opined that rashes in patients with strep throat are ofte n seen one to two days after the onse t of bacterial infection. I d

. She state d that “[t]he c haracterist ic rash occurring in the setting of group A strep infection is termed scarlet fever.” Id. She fu rther o pined that in patients with scarlet fever, the most c ommon site for bloodstream infection (sepsis) is the pharynx (thr oat). Id.
On cross-examination, Dr. Vargas was questioned a bout B.R.’s medica l record entries related to the pr esence of a ra sh on physical examination. On March 31 and April 1 , no rash was noted on examination. Pe t. Ex. 14 at 3-4, 10-12. On April 3, Dr. Kocherla noted a ra sh on B.R.’s neck. Pet. Ex. 13 at 17; R esp. Ex. X at 40. Dr. Vargas agreed that if the infection started in B.R.’s leg on April 1 , then one c ould attribute a rash present on April 2 or 3 to the infection in B.R.’s leg. Tr. 174.

Nex t, Dr. Vargas testifie d a bout the autopsy, specifically h er review of one m icroscopic slide of lung ti ssue. She opined tha t lung tissue slide Q show ed inflammatory cells and intra alveolar macrophages. Tr. 160-63. Dr. Vargas described a n area with “mucopurulent material in alveolar spaces.” Tr. 163. She e xplained that these finding s indicated “possible e arly bronchopneumonia .” Resp. Ex. M at 2; see a lso Resp. Ex. Z a t 3-4. Dr. Vargas stated t he se findings “fit [ ] very well with bacter ia coming do wn from the upper respiratory t ract, down into the lungs.” Tr. 164. However, she explained th at it “doesn’t have to be strep” that cause d the finding se en in the lung s lide; “ [o]ther ba cteria could have done thi s, but i t fits, you know, that it could have be en strep.” Id. Dr. Varga s c onceded that the finding on the lung sli de was no t unique to, or diagnost ic o f , strep throa t. Tr. 185.28 iii. Alt h en Prong Three
Dr. Vargas testified that a 14 hour onset s eemed to o short a period of time for transient bacteremia to occur from a vaccine injection, and for the bacteria to travel to a distant site and multiply . Tr. 190

- 91. Dr. Vargas opined that onset would not “be less than 24 hours.” Tr. 190. She did not cite any source to support her onset opinion.

R espondent filed several articles address ing onset. In Stevens, the authors st udied 20 cases of Group A Streptococcal soft tissue infection. Resp. Ex. Z, Tab 4 at 2. One patient had

36 Dr. Vargas testified that she did not review the actual chest X

- ray, only the report. Tr. 186. More im portantly
, Dr. Vargas conceded that the findings were “ very common in any death, any hospi tal dea th that [she] se e[s] .” Tr. 185. Dr. Vargas testified that it is common for patients to get pneumonia whe n they are v ery il l. Id. Further, she state d that when patie nts get septic, it is “common to start getting the proteinaceous exudate into the lung . It’s the lung’s way of reacting.” Id.

I n addition t o the lung ti ssue slide
, Dr. Vargas believes that B.R .’s che st X-ray 36 showed “opacities in the lun g fie lds,” that looked like “very early bron chopneumonia.” Tr. 165. She testified that the re was no “frank” or “obvious pn eumonia” but they c ould not “exclude bronchitis or an atypica l pneumonia.” Tr. 188 . Based on the che st X-ray
, Dr. Varga s believes the change s she sa w in lung ti ssue occurre d before B .R. became critically il l. Tr. 186. She explained that portable c he st X-rays, like the one here, are mor e diff icult to interpret than standard che st X-rays with two views. Tr. 188. Dr. Varga s said that the ra diologist s aw a “ slight prominence of the interstit ial markings in the infrahilar regions, ” which she interpre ted as

“ bronchitis and a n early bronchopneumonia.” Tr. 187. Howeve r, the ra diologist who interpreted B.R.’s porta

ble che st X-ray stated, “ N o evidence of frank pneumonia

. Cannot exclude bronchitis or atypical pneumonia .” Pet. Ex. 13 at 27 . The radiologist did not diag nosis B.R

. with bronchitis or early bron chopneumonia. See id.
Dr. Vargas filed a several artic les that specifically s upport her opinion that the source of B.R.’s strep infection was the throa t, including the Stevens and Baddour article. See Resp. Ex. F. The a uthors state tha t “ [i]n cases with no clea r portal of entry, the pathogenesis of infection likely c onsists of hematogenous translocation of [ Group A Streptococcus ] fr om the throa t . . . to

a sit e of blunt trauma or muscle stra in.” Id. at 3.
In the UpToDate artic le by S tevens and Kaplan, the a uthors agreed that “among pa tients with scarlet fever, the ph arynx is the most c ommon source of bloodstream [Group A Streptococcus ].” Re sp. Ex. G at 3. However, they noted tha t “[ t]he lea st common source of bacteremia in children has been the lower respiratory tr act. When bacteremic [ Group A Streptococcal ] pne umonia oc curs, it usually is associated with prior viral infections, particularly influenza.” Id. They also state that “[ t]he most fr equent source of [Gr oup A Streptococcal ] bacteremia in children is the skin,” incited by cellulitis , minor trauma, and varicella inf ections. Id. at 2.29

IV. DISCUSSION

A. Standards for A djudication
The Vaccine Act was established to compensate vaccine

- related injuries and deaths. § 10(a). “Congress designed the Vaccine Program to supplement the state law civil tort system as a simple, fair and expeditious means for com pensating vaccine

- related injured persons. The Program was established to award ‘vaccine

- injured persons quickly, easily, and with certainty and generosity.’” Rooks v. Sec’y of Health & Human Servs. , 35 Fed . Cl. 1, 7 (1996) (quoting H.R. Rep. No. 908 at 3, reprinted in 1986 U.S.C.C.A.N. at 6287, 6344).
Petitioner’s burden of proof is by a preponderance of the evidence. § 13(a)(1). The preponderance standard requires a petitioner to demonstrate that it is more likely than not that the vaccine at issue caused the injury. Moberly v. Sec’y of Health & Human Servs. , 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010). Proof of medical certainty is not required. Bunting v. Sec’y of Health & Human Servs. , 931 F.2d 867, 873 (Fed. Cir. 1991). In particular
, petitioner must prove that the vaccine was “not only [the] but

- for cause of the injury but also a substantial factor in bringing about the injury.” Moberly , 592 F.3d at 1321 (quoting Shyface v. Sec’y of Health & Human Servs. , 165 F.3d 1344, 1352

- 53 (Fed. Cir. 1999)); see also Pafford v. Sec’y of Health & Human Servs. , 451 F.3d 1352, 1355 (Fed. Cir. 2006). A petitioner who satisfies this burden is entitled to compensation unless respondent can prove, by a preponderance of the evidence, that

37 Rajoo Thapa et al., Necrotizing Fasciitis Following BCG Vaccination , 48 Indian Pediatrics 235 (2011).

38 BCG stands for “Bacille

- Calmette

- Guérin.” Resp. Ex. H at 1. BCG is a vaccine for tuberculosis. Tuberculosis (TB): BCG Vaccine Fact S heet
, Ctr s. for Disease Control & Prevention
, https://www.cdc.gov/tb/publications/factsheets/prevention/bcg.htm (last reviewed May 4, 2016).

39 Tang Chi Thuong et al., An Outbreak of Severe Infections with Community

- Acquired MRSA Carrying the Panton

- Valentine Leuko cidin Following V accination , 2 PLoS ONE e822 (2007).

40 The vaccines included H epatitis B (“HBV”), Measles, Mumps, Rubella (“MMR”), and varicella. Resp. Ex. O at 3. “fulminant myositis eight hour s after presentation.” Id. In Thapa et al., 37 the authors present ed a
cas e report of an infant who deve loped necrotizing fasciitis following a BCG 38 vaccination. Resp. Ex. H at 1. The infa nt had symptoms of infection 18 hours after vacc ination. Id.

The a uthors of Thuong
, et al. 3 9 summarize da ta of nine children who developed severe Staphylococcus aureus infections following v accination. 40 Resp. Ex

. O at. 1. Three children had

a s ystemic syndrome c onsistent with toxic shock syndrome. Id. at 2. F our of the c hildren had skin and soft tissue infe ctions, including one with necrotizing f asciitis. Id. All of the ski n and soft tissue infections occurred at the v accination site. Id. In seven of the n ine children, onset of symptoms occurred in a range of nine to 14 hours. Id. at 3.30

the vaccinee’s injury is “due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B).

B. Factual Issues
A petitioner must prove, by a preponderance of the evidence, the factual circumstances surrounding her claim. § 13(a)(1)(A). To resolve factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical record s and testimony. See Burns v. Sec’y of Health & Human Servs.
, 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining th at a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records). Contemporaneous medic al records are presumed to be accurate. See Cucuras v. Sec’y of Health & Human Servs. , 993 F.2d 1525, 1528 (F ed. Cir. 1993). To overcome the presumptive accuracy of medical records, a petitioner may present testimony which is “consistent, clear, cogent, and compelling.” Sanchez v. Sec’y of Health & Human Servs. , No. 11

– 685V, 2013 WL 1880825, at *3 (Fed. Cl. Spe c. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Human Servs. , No. 90

– 2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 19 98)).
There are situations in which compelling testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of Health & Human Servs. , 69 Fed. Cl. 775, 779 (2006) (“[L]ike any no rm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking.”); Lowrie v. Sec’y of Health & Human Servs. , No. 03

– 1585V, 2005 WL 6117475, at *1 9 (Fed. Cl. Spec. Mstr. Dec. 12, 2005) (“[W]ritten records which are, themselves, inconsistent, should be acco rded less deference than those which are internally consistent.” (quoting Murphy v. Sec’y of Health & Human Servs. , 23 Cl. Ct. 726, 733 (1991), af f’d per curiam , 968 F.2d 1226 (Fed. Cir. 1992) ) ). Ultimately, a determination regarding a witness’s credibili ty is needed when determining the weight that such testimony should be afforded. Andreu v. Sec’y of Health & Human Servs. , 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Human Servs. , 991 F.2d 1570, 1575 (Fed. Cir. 1993).
Despite the weight afforded medical records, special masters are not bound rigidly by those records in determining onset of a petition er’s symptoms. Valenzuela v. Sec’y of Health & Human Servs. , No. 90

– 1002V, 1991 WL 182241, at *3 (Fed. Cl. Spec. Mstr. Aug. 30, 1991) ; see also Eng v. Sec’y of Health & Human Servs. , No. 90

– 1754V, 1994 WL 67704, at *3 (Fed. Cl. Spec. Mstr. Feb. 18, 1994) (Section 13(b)(2) “must be construed so as to give effect also to § 13(b)(1) which directs the special master or court to consider the medical records (reports, diagnosis, conclusions, medical judgment, test reports, etc.), but does not require the special master or court to be bound by them”).

C. Causation
To receive compensation through the Progra m, petitioner must prove either (1) that B. R

. suffered a “Table Injury”

— i.e., an injury listed on the Vaccine Injury Table

— corresponding to a vaccine that s he rec eived, or (2) that B. R . suffered an injury that was actually caused by a31

D. Causation Analysis

1. Althen Prong One

Under Althen Pro ng One, petitioner must set forth a medical theory explaining how the received vaccine could have caused the sustained injury. Andreu , 569 F.3d at 1375; Pafford , 451 vaccination. See §§ 11(c)(1), 13(a)(1)(A) ; Capizzano v. Sec’ y of Healt h & Human Servs., 440 F.3d 1317, 1319-20 (Fed. C ir. 2006). Because p etitioner does not a llege tha t B.R . suffered a Ta ble Injury, she must pr ove that a vacc ine B.R . rece ived caused her injury. To do so, she must establish, by pr eponderant eviden ce : (1) a medic al theory causally c onnecting the vacc ine and B .R .’s in jury (“ Althen Prong On e”); (2) a lo gical sequence of cause a nd effect showing that the

vacc ine was the reason f

or B.R .’s injury ( “ Althen Prong Tw o”); and (3) a s howing of a proximate temporal relationship between the vaccine a nd B.R .’s injury (“ Althen Pron g Th ree”). § 13(a)(1 ); Althen, 418 F .3d at 1278.

The c ausation theory must re late to the in jury a lleged. The petitioner must prov ide a sound and reliable medical or scientific e xplanation that pertains specifically to this case, although the explanation need only be “ legally pro bable, not medically or scientifically c ertain.” Knudsen v. Sec’y o f Health & Huma n Servs. , 35 F.3d 543, 548-49 (Fed. Cir. 1994). Petitioner cannot establish entitlement to compensation based solely on her assertions; rather, a v accine claim must be supported either by medic a l records or by the opini on of a m edical doctor. § 13(a)(1). In determining whether pe titioner is entitled to compensation, the special master shall consider all mate rial in the record, including “ any

. . . conclusion, [or] medi cal judgment . . . which is contained in the re c ord regarding . . . causation.” § 13(b)(1)(A). The unde rsigned must weigh the subm itted evidence and the testimon y o f the pa rtie s’ proffered experts and rule in petitioner’s fa vor when the e vidence we ighs i n her favor. See Moberly, 592 F.3d at 1325-26 (“Finders of f

act are e ntitled— indeed, expected

— to make de terminations as to the re liability of the evidence pre sented to them and, if appropriate, a s to the c redibility o f the pe rsons presenting that evidence.” ); Althen
, 418 F.3d at 1280 (noting that “close calls” a re re solved in petitioner’s favor).
“Expert medical testimony which merely expresses the possibility

— not the prob ability

— of the oc currence of a c ompensable injury is insufficient, by it self, to substantiate the c laim that such an injury oc curred.” LaC our v. Sec ’ y o f Health & Huma n Servs., No. 90

– 316V, 1991 WL 66579, at *5 (Fed. Cl. Spec. Mstr. Apr. 15, 1991); accord Burns v. Sec ’ y of Health & Human Servs., No. 90

– 953V, 1992 WL 3 65410, at *6 (Fed. Cl. Spec. Mstr. Nov. 6, 1992)
, aff ’ d , 3 F.3d 415 (Fed. Cir. 1993)

. The F ederal Circuit ha s likewise made c lear that the mere possibility of a link between a v accination and a pe titioner ’ s injury is not suff icient to satisfy the preponderance standa rd. Moberly , 592 F.3d at 1322 (emphasizing that “proof of a ‘pla usible’ or ‘possible’ causal link between the vacc ine and the injury ” do es not e quate to proof o f causati on by a preponderance of the e vidence ); Waterman v. Sec ’ y o f Health & Huma n Servs., 123 Fed. Cl. 564, 573-74 (2 015) (denying pe titioner ’ s mot ion for re view and noting tha t a possible c ausal link was not suff

icient to meet the pre ponderance stan dard)

. While c ertainty is by no means required,

a possi ble mechanism do es not rise to the leve l of preponderance

. Id. ; see also De B azan v. Sec ’ y of Health & Human Servs., 539 F.3d 1347, 1351 (Fed. Cir. 2008).32

F.3d at 1355-56. Petitioner ’ s theory o f causation need not be medically o r scientifically c ertain, but it must be infor

med by a “sound and reliable” medical or scientific explanation. Boatm on v. Sec’y of Health & Human Servs. , 941 F.3d 1351, 1359 (Fed. Cir. 2019); see a lso Knudsen, 35 F.3d at 548; Veryzer v. Sec’y of Healt h & Huma n Servs. , 98 Fed. Cl. 214, 223 (2 011) (noting that special master s are b ound by both § 13(b)(1) and Vaccine Rule 8(b) (1) to consider only evidence th at is both “relevant” a nd “reliable”). If pe titioner relies upon a medical opinion to support her theory, the basis f or the opini on and the re liability o f that basis must be considered in the determination of how much weight to afford the off ered opinion. See Broekelschen v. Sec’y of Healt h & Huma n Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) ( “The sp ecial master’s decision often times is based on the credibility of the e xperts and the relative pe rsuasiveness of their c ompeting th eories.” ); Perreira v. Sec’y of Health & Hum an Servs. , 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (stating t hat an “expert opinion is no better th an the soundness of the reasons supporting it ” (c iting Fehrs v. United States, 620 F.2d 255, 265 (Ct. Cl. 1980)) ).
Petitioner cannot prevail with just an opinion that since ther e is no othe r factor to explain B.R.’s infection but the va ccines, the v accin es must have be en the cause. However, this case involves more than that assertion. Both Dr. Miller a nd Dr

. Vargas
, as well as Cook and other authors of the medic al literature file d in this matter, agree that there is streptococca l bacteria on the skin. They agree that an injection ca n serve a s a porta l of entry for the bacteria to enter the tissues and blood stream. They agree that this mechanism of action

— hematogenous spread through the blood stream

— can cause se psis a nd other rare, adverse
, and even fatal, infections. They agree that these inva sive infections can occur in sites distant to the portal of e ntry. For example, in osteomyelitis, the infection occurs in the bone. In septic arthritis, the infection occurs in the joint. In the case o f endophthalm it is, the infection occurs in the e ye. This causal mechanism, recognized by the experts and authors of relevant medical literature, is thus, sound and reliable.
Respondent, however, adds an additional requirement to the causal mechanism as it relates to the f

acts and circumstances presented here. Responde nt argues that a patient must have an infection at the portal of e nt ry

— here
, the site o f vaccination

— in order for there to be spread of that bacteria by the bloodstrea m to a remote sit e. None of the medic al articles filed by e ither party address that narrow iss ue. The a rticles provide a brie f summary of the fac ts about each

case r e port. Some of the articles describe the local condition of the skin where the portal of entry is the ski n. The take away from the medical literature relevant here is that injecti ons, including vaccinations given by inj ection penetrating the skin, can pro vide a porta l of e ntry for ba cteria to sprea d via the bloodstream to other sites.
Dr. Vargas agreed that the mec hanis m of h ematogenous sprea d is the s a me for septic arthritis as it is for necrotizing fa sciitis. Likewise, Cook did not dra w distinctions in the mechanism of hematoge nous bacterial sprea d, a s applied to septic a rthritis, osteomyelitis, or necrotizing f

asciit is . Certainly, the case r eports specific to necrotizing fa sciitis occurring after

vacc ination may h ave included infor mation suggesting there m ay ha ve b een sig ns of infection at the site of vaccination or injection. However, th is was not univer sal. Further, the c ase r e ports of invasive infe ctions caused by strep bacteria, including ba cteremia, osteomyelitis, and septic arthritis, often omitted a de scription of the va ccine or infection site. None of the a uthors of the releva nt articles stated an opini on like tha t held by Dr . Varga s, specifically that there must be33

infection at the vaccine site for a remote infection to occur. T hus, it would be erroneous for the undersigned to impose the equivalent of a “condition precedent” to a causal mechanism where phy sicians who have studied and authored medical reports on the subject did not do so. Accordingly, t he undersigned finds that petitioner has set forth a sound and reliable medical theory, satisfying Althen Prong One.

2. Althen Prong Two

Under Althen Prong Tw o, petitioner must prove by a preponderance of the evidence that there is a “ logical sequence of cause and effect showing that the vaccination was the reason for the injury.” Capizzano , 440 F.3d at 1324 (quoting Althen , 418 F.3d at 1278). “Petitioner mus t show that the vaccine was the ‘but for’ cause of the harm . . . or in other words, that the vaccine was the ‘reason for the injury.’” Pafford , 451 F.3d at 1356 (internal citations omitted).
In evaluating whether this prong is satisfied, the opinions and views of the vaccinee’s treating physicians are entitled to some weight. Andreu , 569 F.3d at 1367; Capizzano , 440 F.3d at 1326 (“[M]edical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in t he best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.’” (quoting Althen
, 418 F.3d at 1280 ) ). Medical records are generally viewed as trustworthy evidence, since they are

c reated contemporaneously with the treatment of the vaccinee. Cucuras , 993 F.2d at 1528. The petitioner need not make a specific type of evidentiary showing, i.e., “epidemiologic studies, rechallenge, the presence of pathological markers or genetic predis position, or general acceptance in the scientific or medical communit ies to establish a logical sequence of cause and effect.” Capizzano , 440 F.3d at 1325. Instead, petitioner may satisfy her burden by presenting circumstantial evidence and reliable medi cal opinions. Id. at 1325

- 26.

Petitioner has demonstrated that admi nistration of vaccines can lead to remote site infections, including necrotizing fasciitis and septic shock, through hematogenous spread of bacteria and thus
, satisfied Althen Prong One. Petitioner has also shown causation specific to this case

— that B.R.’ s vaccinations lead to her necrotizing fasciitis and septic shock, consequently causing her death. There is preponderant evidence to establish a “logical sequence of cause and effect sho wing that the vaccination was the reason for the injury.” Capizzano
, 440 F.3d at 1324 (quoting Althen , 418 F.3d at 1278).

Th ere are three reasons for this finding. First, B.R.’s clinical course and autopsy a re consist e nt with the mechanism proposed by Dr. Miller . Second, there is insufficient evidence to support a fin ding that B.R. had strep throat, early pneumonia, or a urogenital source of infection. And third, this finding is consistent with the medical records and testimony of treating physicians
, Dr. Kocherla and Dr. Darden , and pathologist
, Dr. Latham.

a. Clinical Course and Autopsy
B.R. was healthy, although mildly obese, on the day that she received four vaccinations by injection

— four needle punctures of the skin . Within 15 hours, she had le ft hip pain and fever. A throat culture was negative for strep , b ut a blood culture revealed strep in her blood. She34

B.R.’s course. Twelve of the 20 patients had bacteremia, and of these patients , six died. Id. at 4. Of the se six, three died within 36 hours of hospital admission. Id. Nineteen patients had shock on admission to the hospital or shortly thereafter. Id.

b. B.R. Did Not Have Strep Throat, Pneumonia, or a Urogenital Source of Infection

Based on the medical records, results of the throat culture, autops ies
, expert reports and testimo ny, and the totality of facts and circumstance s , the undersigned finds that B.R. did not have strep throat, pneu m o n ia, or a urogenital source of infection that caused her necrotizing fasciitis and septic shock

.
While the records include a reference to s ore throat and a description that B.R.’s throat was “mildly injected,” this evidence is insufficient to establish that B.R. had strep throat given the weight of the evidence against such a finding . The most compelling evid ence was B.R.’s negative throat c ulture. When performed properly, the literature and experts agreed that this test has an accuracy rate of 90

- 95%

. See Tr. 32, 71, 171. There is no evidence that B.R.’s throat culture was performed improperly. The negative results establish that it is v ery unlikely that she had strep throat or that the bacteria that seeded her necrotizing fasciitis came from the throat

.
The consecutive physical examinations of B.R. conducted by different doctors over a five

- day period provide more evidence that B.R. d id not have strep throat. The physicians who performed these exams did not document evidence of the usual c haracteristics of strep throat
, which include inflamed appearance , often with white follicles or exudate. B.R. did not have adenopathy or enlarged lymph nodes in the neck area suggestive of a th r oat infection. N one of B.R.’s treating physicians diagnosed her with strep throat . A ddit ionally, the two pathologists who performed autopsies did not attribute her infection to strep throat. developed septicemia a nd septic shoc k, which caused her death. There is no e vidence th at she had a genital infection. The a utopsies did not show any sourc e for the bacteria. Fo r these reasons, Dr

. Miller concluded that bacteria wa s introduced into the bloodstream by a va ccination, “a ra re but reporte d complication” of vacc ination administered by ne edle inj ection. Pet. Ex. 43 at 8; see also Tr. 96-97.
Through the e xpert report and testimony of D r. Miller, petitioner established by preponderant evidence th at B.R. developed transient bacteremia

— that is, bacter ia entered the bloodstream from vaccination, which seeded the s oft tissue of the hip and thigh. The autopsy established that B.R. ha d S. pyogene s , a ba cteria k nown to be pre sent on the ski n and a known cause of infection. The autopsy findin gs were c onsistent with septic shoc k and an infection in tissue of the left thig h and hip. B.R. developed necrotizing fa sciitis, infection of the bloodstream, and septic s hock which caused her death.

Moreove r, B.R.’s clinical c ourse w as consistent with the c ase r eports in the medical literature file d in this case. In Stevens, the a uthors studied 20 cases of Group A Streptococcal soft tissue infection. Resp. Ex. Z, Tab 4 a t 1. Abrupt onset with severe pa in was the common presentation. Id. at 2. One pa tient had “fulminant myositis eight hours after presentation.” Id. I n addition to onset, the c linical course of several of the pa tients was similar in time frame to35

There is als o insufficient evidence to support respondent’s position that B.R. may ha ve had early pn eumonia or bronchopneumonia. There is no doc umentation that B.R. had a cough, wheezing, or respiratory distress, and until she became critically il l on April 4, she ha d no respiratory dist ress. Medical records establish that o n her admission to Phoebe P utney on April 3, B.R

. had no history of coug h, wheezing, trouble bre athing, or respiratory distress. Lung sounds were clear bilaterally. B.R. was not dia gnosed with pneumonia b y any o f the doc tors who examined he r on March 31, April 1, April 3, or April 4. The two pathologists who performe d autopsies also did not diag nose pne umonia.
Dr. Vargas opined that one lung ti ssue slide (slide Q) ma y ha ve sho wn findings that indicated “possible early bronchopneumonia.” Resp. Ex. M at 2; see a lso Resp. Ex. Z a t 3-4. However, opinions based on possibilities are insuff icient to establish causation. See, e.g., Moberly, 592 F.3d at 1322 ; De B azan, 539 F .3d at 1351 ; Burns, 1992 WL 3 65410, at *6 ; LaCour
, 1991 WL 66579 , at *5.

Furthe r, Dr. Varga s conceded that the findings on lung sli de Q, are “ ve ry c ommon in . . . any hospi tal death, ” a s it is common for patients to get pneumonia whe re th ey are v ery il l. Tr. 185. Assuming thi s wa s true for B.R
., if she did have pneumonia, it would have oc curred after she be came ve ry il l on A pril 4, and therefore, it w ould not ha ve c aused the infection that manifested as hip pain on Apr il 1.
With regard to Dr. Vargas ’ opinion that B.R.’s che st X-ray showe d very early bronchopneumonia, th at opinion was based, in part, on he r review a nd opin ion of one lung sli de. For the r easons explained above, the undersigned doe s not find Dr. Vargas’ opinion about the lung sli de to be persuasive evidence th at B.R.’s infection was caused by pne umonia . Moreover, the unde rsigned finds the opini on of the interpreting radiologist to be the most re liable evidence as to the re sults of the X -ray, and that opinion did not include the finding o f pne umonia.
Lastly, t here is no e vidence to support a c onclusion that B.R.’s infection originate d from

a uro genital source. The medical records do not document that B.R. ever complained of urogenital sympt oms. Her urinalysis wa s normal. He r urine culture did not show bacterial infection. B.R. was not d iagnose d with urogenita l infection by any tre ating physician. On autopsy , external genitalia was unremarkable a nd there w as no inguinal lymphadenopathy. The pathologists did not make a ny findin gs consi stent with urogenital infection, or attribute B .R.’s infection to a urogenital source.
In summary, there is either no evidence o r insufficient evidence to show that the sourc e of B.R.’s infection was due to a ny source other th an her vaccinations. As to Dr. Vargas’ position that the cause w as idiopathic or un known, that might be a viable opti on but for the fact that B.R. had four injections of her ski n, and the breach of the ski n, even when the skin is properly cleaned, is known to be associated with remote inf ections, caused by h ematogenous spread. The undersigned cannot ignore the fact of B.R.’s vaccinations, and the re sulting po rtal of entry that each injection created, so a s to entertain a suggestion that they did not pla y a role , and thus conclude that the cause h ere w as idiopathic.36 c. T reating P hysicians 41

Several of B.R.’s treating physicians records offer ed evidence supportiv e of vaccine causation . On April 3, Dr. Kocherla’s diagnosis was post

- vaccination reaction . He ordered a sepsis workup , including blood cultures that revealed S. pyogenes . In his deposition, Dr. Kocherla testified that he believed that B.R. had sepsis or post

- vaccination myopathy , and he was correct. The blood cultures revealed that B.R. had S. pyogenes sepsis.

O rthopedist Dr. Darden examined B.R. after her transfer to Phoebe Putney. His impression was transient synovitis secondary to viral load from vaccines and possible bacterial sepsis of the joint. Testing of the joint was not performed, so it is not known whether B.R. had a septic joint

. Regardless, based on the literature filed in this case, a septic joint caused by bacteria occurs du e to the same mechanism of action propounded by Dr. Miller.
The pathologists were split on the issue of vaccine causation. In his autopsy, Dr. Burns d id not express an opinion as to vaccine causation, but in his deposition , he testified that B.R. ’ s vaccinations had nothing to do with her illness. On the other hand, Dr. Latham opined that the vaccines may have caused B.R.’s illness based on the fact tha t she had S. pyogenes , which is known to be present on the body, and that th e illness can be caused by a skin prick
, or in this case vaccination.
On the whole, the undersigned finds the records and opinions of Drs. Kocherla, Darden, and Latham provide su pport for vaccine causation
, and when combined with the other evidence

summa rized above
, add to the weight of the evidence in favor of petitioner

. The undersigned found petitioner ’s Althen Prong One theory sound and reliable, and now finds petitioner, b y preponderant evidence, has shown that the v accin ations were the source of the bacteria that caused B. R.’s infection and death

. According ly , petitioner has satisfied Althen Prong Two.

3. Althen Prong Three

Althen Prong Three r equires petitioner to establ ish a “proximate temporal relationship” between the vaccination and the injury alleged. Althen , 418 F.3d at 1281. That term has been equated to mean a “medically acceptable temporal relationship.” Id. The petitioner must offer “preponderant proof that the onset of symptoms occurred within a timeframe which, given the medical understanding of the disease’s etiology, it is medically acceptable to infer causation

- in

fact.” De Bazan , 539 F.3d at 1352. The exp lanation for what is a medically acceptable tim e frame must also coincide with the theory of how the relevant vaccine can cause the injury alleged (under Althen Prong One). Id. ; Koehn v. Sec’y of Health & Human Servs. , 773 F.3d 1239, 1243

41 The undersigned has considered the opinions and testimony of all of the physicians who se depositions w ere filed in this matter but gives more weight to the opinions and testimon y of those who treated B.R. and created contemporaneous medical records. Thus, the opinion of Dr. Mills, who was not a treating physician nor an expert in this matt er, was afforded less weight.37

(Fed. Cir. 2014) ; Shapiro v. Sec’y of Health & Human Servs. , 10 1 Fed. Cl. 532, 542 (2011), recons. den’d after remand , 105 Fed. Cl. 353 (2012), aff’d mem.
, 503 F. App ’ x 952 (Fed. Cir. 2013).
The undersigned find s p etitioner has provided preponderant evidence of a proxima te temporal relationship between B.R.’s vac cina tion s and the first manifestation of the infection which led to her death . Dr. Miller and Dr. Vargas agree that the time frame between B.R.’s vaccinations and the onset of her infection, marked by hip and thi gh pain, was approximately 14 hours. Dr. Mille r opined that 14 hours was appropriate, and cite d to the case report published by Steven s. Dr. Vargas testified that 14 hours seemed too short, but did not cite any literature or other evidence to support her testimony on this point. The articles cited b y respondent provided eight cases where onset was in the range of nine to 18 hours

. See Resp. Ex. H at 1 (discussing patient with symptoms of infection 18 hours post

- vaccination ); Resp. Ex. O at 3 ( describ ing seven children who had onset ranging from nine to 14 hours ) . Given the case reports described in the literature, and the lack of other evidence, the undersigned finds the petitioner’s evidence as to onset more credible and persuasive.

E. Alterna tive Causation
Because the undersigned concludes that pe titioner ha s established a prima facie case, petitioner is entitled to compensation unless respondent can put forth preponderant evidence “that [ B. R

. ’s] injury was in fact caused by factors unrelated to the vaccine.” Whitecotton v. Sec’y of Health & Human Servs. , 17 F.3d 374 (Fed. Cir. 1994), rev’d on other grou nds sub

nom. , Shalala v. Whitecotton , 514 U.S. 268 (1995); see also Walther v. Sec’y of Health & Human Servs.
, 485 F.3d 1146, 1151 (Fed. Cir. 2007). As discussed above in the analysis related to Al then Prong Two , the undersigned found the respondent faile d to establish evidence to show that B.R.’s infection was caused by a source other than her vaccinations. Thus, respondent did not prove by a preponderance of evidence that B. R .’s injury is “due to factors unrelated to the administration of the vaccine.” § 13(a)(1)(B).

V. CONCLUSION
This is a very tragic case. The undersigned extends her sympathy to the petitioner and family of B.R. for their loss. The undersigned’s decision, however, is not base d on sympathy, but based on the evidence. For the reasons discussed above, the undersigned finds that petitioner has established by preponderant evidence that she is entitled to compensation. A separate damages order will issue.

IT IS SO ORDERED.

s/ Nora Beth Dorsey Nora Beth Dorsey Special Master