Porter v. Secretary of Health and Human Services

willfulness, Knight, infringement, and Depot Representa Amanda Personal tive Estate Claudia Likewise, affirm J. Rotoli- damages issues. we Barr, Deceased, Petitioner-Appellee, regarding court’s determinations claim inequitable construction and conduct. Its v. finding decision this case exceptional and Secretary of Health Human attorney

the award of fees is affirmed. Services, Respondent- Appellant. AFFIRMED 2010-5162, Nos. 2010-5163. United Appeals, States Court of DYK, Judge, concurring-in-part Circuit Circuit. Federal dissenting-in-part. 22, Nov. 2011. agree Although majority I with the Rehearing En Banc Denied Feb. 2012. respect construction, infringe- to claim Rehearing En banc Denied Feb. ment, conduct, inequitable damages, and willfulness, the legal framework for I

would Depot’s find that Home defense was unreasonable,

not objectively at least with

respect proposed to its claim construction top.” the term “table I respectfully

dissent majority’s contrary from the hold-

ing. I would Because hold that Mr. Powell prove objective

did not prong of the

willful infringement inquiry clear evidence,

convincing I would aside set

willfulness and the enhanced dam-

ages award.1 PORTER, Petitioner-Appellee,

Mona

SECRETARY OF HEALTH AND SERVICES,

HUMAN Re-

spondent-Appellant. majority 1. The states objective Maj. op. district court’s reasonableness. at 1237. adoption Depot’s of Home agree, construction in the but this does not indicate the con- preliminary injunction stage objectively does not show its struction is unreasonable either.

Sylvia Chin-Caplan, Conway, Homer & P.C., Boston, MA, Chin-Caplin, argued for petitioners-appellees. both On the brief was Ronald C. Homer. Damle,

Sarang Attorney, V. Appellate Staff, Division, Depart- Civil United States Justice, DC, ment of of Washington, ar- gued for him respondent-appellant. With West, Tony the brief were Assistant General, Attorney Bondy, and Thomas M. Attorney. RADER, petitioner is entitled to recover under the Judge, PROST

Before Chief O’MALLEY, Act. Judges. Vaccine Circuit Background by Circuit for court filed Opinion concurring-in- Opinion Judge PROST. part, dissenting-in-part filed Circuit before over- appeals present two us Judge O’MALLEY. first, lapping and factual issues. The legal 2010-5162, petition- case number concerns PROST, Judge. Circuit er Mona Porter. Ms. Porter was born on government appeals The combined 28, in September 1962. The first date her of the States Court of decision United history medical that has to this relevance Court”) (“Claims reversing Claims Federal 15, May day, case is 1991. On that Ms. denying a master’s decision Mona dermatologist prescribed minocy- Porter’s petitions and Claudia Rotoli’s for Porter’s Minocycline cline for Ms. Porter’s acne. under the National Vaccine compensation well-known in the literature cause AIH. to (“Vaccine Injury Compensation Program 1992, May 11, dermatologist On her indi- Act”), §§ -34. The U.S.C. 300aa-l cated should “finish mino- that she off’ her special master concluded that Ms. Porter cycline and then dosage discontinue treat- by a prove prepon- Ms. Rotoli did not and drug. ment with the hepatitis of the evidence that the derance July 8, 1992, On Ms. Porter received they B vaccine—which both received of B hepatitis first three doses in the doses 1990s—caused them to three a vaccine. also had liver function She (“AIH”). autoimmune The hepatitis suffer day. that Her function blood test liver Court, incorrectly applying Claims Andreu range. tests were within normal Ms. Services, Secretary Human Health & Porter’s dose was on second administered (Fed.Cir.2009), set aside the 7, August 1992. The record does not indi- entirety in their findings master’s any per- cate whether she had blood work that al- ground on the day. formed on Ms. Porter received by considering legedly erred 5, February her final dose on vaccine petitioners’ expert Having of the witness. performed A liver function test on March findings, rejected enzymes revealed her liver were ele- its own and Claims Court entered beyond range. vated well the normal that both Ms. Porter Ms. determined and repeated days liver function test was four for were entitled to recover their Rotoli comparable yiélded later results. and AIH under the Vaccine Act. We conclude Blood from this date indicated tests interpretation of the Claims Court’s B Ms. was immune to and Porter legally was and incon- Andreu erroneous A, B, or C. was not infected precedent. with this court’s We sistent 11, 1993, Ms. conclude On March Porter started further nauseated, yel- petitioners feeling itching, turning determination were and a was her compensation under the low. She visited doctor who not entitled arbitrary, capricious, employer’s colleague, but the office did Vaccine Act was not discretion, of this visit. Ms. Porter or otherwise not create record abuse such, Dr. Richard we next saw a gastroenterologist, accordance with law. As reverse visit, initial to affirm the Gilmore. At the Gilmore’s remand with instructions and that Ms. Porter suffered impression that neither was master’s determination 21, 1994, hepatitis of fever. On October her doc- from “acute undetermined that this is relat- etiology. possibility cough recommended that she take tor cannot He be excluded.” ed to her vaccine symptoms. for medicine these She body’s prescribed a minimize steroid given next dose addition- requested response, immune vaccine on November 1994. She visited work, The blood which was al blood work. approximately doctor two later her months 1, 1993, performed April was consistent on respi- prolonged upper to be treated for a of AIH. A function diagnosis with a liver bronchitis, ratory infection, conjunctiv- Ms. liver en- test showed that Porter’s began reported itis. She further that she above zymes had decreased but were still pain “right upper quadrant” to have her results, of these test light normal. 5, 1995, May May 1995. On Ms. Rotoli May performed liver biopsy was received her final dose and Dr. Gilmore pathologist 1993. The later, Four days vaccine. she donated being results as consistent interpreted the 19, 1995, May On blood. blood service with AIH. informed her that her donated blood con- AIH to affect Porter for continued Ms. tained elevated amount of a certain 4, years. August several additional On diagnostic some enzyme for forms of liver 1999, petition seeking compen- she filed a disease. sation See 42 under the Vaccine Act. sought Ms. Rotoli information about her seq. §§ et U.S.C. 300aa-l abnormal liver test results. Blood tests appeal, The second case 2010- number 25, May from had 1995 confirmed she 5163, petitioner Rotoli.1 concerns Claudia enzyme elevated liver levels. Ms. Rotoli 25, Ms. born January Rotoli was on diagnosed having hepatitis was un- case, pertinent As to this Ms. Rotoli’s med- origin. general a practi- known She saw 1984, ical history began a decade before 31, on May up. tioner 1995 for a follow she B hepatitis received the vaccine. doctor That noted that Ms. Rotoli had a 1990, February From to March 1984 Ms. hand, slight tremor in her and ordered rashes, Rotoli for skin shoul- was treated tests, addition, again additional blood which con- pain, anxiety. der and In severe anxiety Ms. Rotoli received treatment for firmed Ms. Rotoli’s liver function was symptoms and in 1994. depression Her subsequently not normal. She saw episodes included difficult speech, Katz, slow and 20, gastroenterologist, a on June vision, pains difficulty blurred chest and thought 1995. Dr. Katz that Ms. Rotoli Ultimately, thinking. she was treated at a might have either viral a illness or AIH hospital emergency Florida room for con- ordered and additional blood tests. The fusion, stuttering, difficulty. and speech test results were with a diagno- consistent Her at that included a examination time 29, 1995, sis of AIH. On June Ms. Rotoli scan, thyroid profile, CT head and blood a liver This biopsy. biopsy had showed count, all which were normal. chronic, Ms. Rotoli had active hepati- 10, 1994, tis with fibrosis moderate

On and necrosis. October Ms. Rotoli received on her results liver first Based blood test dose vaccine as later, well as a Dr. Katz days biopsy, diagnosed flu vaccine. Two she Ms. Rotoli as began experience coughing, congestion, having AIH to prescribed a steroid passed away 1. Ms. petitioner. Rotoli continue her after the Claims we to refer to as the simplicity, Court's in this decision case. For Koff) sys- disagreed, explaining and Dr. reaction of her immune man moderate does that “the evidence not show tem. B vaccine can cause autoimmune contin- problems health and other AIH Koff, only who offered the hepatitis.” Ms. In October plague Rotoli.

ued to specialist hepatology, from Sjo- 1996, diagnosed further with was she provided peti- further testimony regarding following year, she gren’s disease. Regarding individual Ms. tioners’ cases. systemic erythe- lupus with diagnosed was Rotoli, he testified her June matosus, another autoimmune disorder. after biopsy (eight-and-a-half liver months diagnosed central she vaccination) exten- her first showed such lupus. filed Vaccine system She nervous that, experience, Ms. sive fibrosis his 4, 1999, seek- Program petition August predated had have her Rotoli’s for AIH and associ- compensation her ing Porter, Pertaining he vaccination. to Ms. injuries. ated problems that her liver were more opined by her likely minocycline caused use of —a II hepati- cause of AIH—than known cases, Porter’s and Ms. Rotoli’s Ms. B vaccine. tis other cases which along with several Porter’s denied Ms. alleged petitioners petitions, Ms. Rotoli’s alter providing them to from vaccine caused suffer denying petition native rationales for each assigned same were v. Sec’y er’s claim. Porter Health & of conduct a parties agreed in The 2006. Servs., 99-639V, No. Human 2008 WL The joint hearing for all of cases. these (Fed.Cl. 2008) 2, (“Special Oct. days heard of live testi- master five Op.”); Porter Master Rotoli of The separate two sessions. mony over 99-644V, Human Health & No. principally focused proceedings (Fed.Cl. 2008) WL 4483739 Oct. opinions government’s of the competing Op.”).2 Master After ex (“Special Rotoli Zweiman, im- Dr. Burton an experts, two length, amining Dr. Bellanti’s theories at Koff, spe- a munologist, Raymond and considering Dr. Zweiman’s and as well ex- hepatology, petitioners’ in cialist testimony, Dr. Koffs the special Bellanti, Joseph immunologist. pert, Dr. an that “none [Dr. Bellanti’s] concluded of hearing held over The first session was explanation a presents theories reliable days September 2007. The sec- three au hepatitis vaccine can cause how many two-day session held ond Master hepatitis.” Special toimmune Notably, pe- in March months later 2008. by Op. Accordingly, at *5. he found Porter offer from an titioners did not preponderance evidence both gastroenterology hepatology or expert petitioners had failed to establish a medi an to do being given opportunity despite theory causally connecting cal so. AIH. B vaccine to Id. at *15-16. addi tion, found hearing, expert specifically During petitioners’ (Dr. Bellanti) presented ap of theo- that Ms. Rotoli failed to establish a series temporal relationship between showing propriate that the ries directed light and AIH in of Dr. hepati- could cause her vaccinations B vaccine autoimmune (Dr. that her fibrosis government’s opinion Zwei- Koffs extensive experts tis. The only opinion to the Porter in these opinions master's in Porter and we cite 2. The substantially overlap. simplicity, For instances. Rotoli developed eight regarding could not have months. causation.” Id. at 81-82. Indi- Special cating Master Rotoli at *17-18. Be- master’s credibility “permeated analysis burden determinations his petitioners’ cause included estab- (1) claims,” petitioners’ theory the Claims Court lishing causally a medical con- set entirety aside the of the mas- necting injury; the vaccination and the ter’s factual (2) findings, specific rather than temporal proximate relationship adverse findings. Id. at 82. injury, between vaccination Althen v. Sews., Sec’y Health & Human Having discarded all of the mas- (Fed.Cir.2005), the special mas- ter’s fact because he made credi- that both petitioners ter concluded had bility assessments about Dr. Bellanti’s failed to demonstrate that.the B testimony, the Claims Court entered its inju- vaccine was the cause in fact of their own findings based on the record. The *18; ries. Id. Master Porter court credited Dr. Bellanti’s medical theo- Op. at *21. causally ries connecting vaccine to AIH and ruled that petitioners Although already he had concluded that had satisfied their respect burden with compensa- Ms. Porter was not entitled to this element of causation in fact. Id. at tion she because had not established cau- 83-88. As for timing of Ms. Rotoli’s fact, sation master also ad- injuries, the Claims Court found an ap- independent dressed an and wholly distinct propriate temporal relationship between denying reason for her claim. at *21- disease, the vaccine and the discounting government argued that an alter- opinion Koffs that Ms. Rotoli’s liver cause, i.e., native drug minocycline, biopsy demonstrated pre- that her AIH induced Ms. Porter’s AIH. dated receipt her vaccine sever- master found that a preponderance of the years. Instead, al the Claims Court cred- evidence established that it was more like- ited Ms. Rotoli’s theory alternative ly minocycline than not that caused substantial might “fibrosis be able to form Ms. Porter’s AIH. in as little as sixteen weeks.” Id. at 89. rejected Claims Court also the gov- Ill showing ernment’s that Ms. Porter’s AIH sought Petitioners review of the by was caused minocycline, instead credit- master’s decisions in their respective cases ing Dr. testimony Bellanti’s minocy- in the Claims Court. The Claims Court cline was not the cause because her symp- set aside the master’s factual find toms improve did not after discontinuing ings, reasoning that this court’s decision in drug. the Id. at 97-98. The court ulti- required Andreu that result. Rotoli v. mately concluded that petitioners both Sec’y Servs., Health & Human 89 Fed. of were entitled to compensation. 71, (2009). Cl. 80-82 The Claims Court After further proceedings concerning read Andreu to mean that a special master damages, judgment final was entered for may not credibility use determinations to petitioners and damages awarded. These reject petitioner’s a theory of causation. appeals jurisdiction followed. We have pur- Court, Id. at 82. The Claims based on 300aa-12(f). § suant to 42 U.S.C. that understanding law, of our case set aside master’s factual findings Discussion ground on the master had “erroneously used his assessment of Dr.

Bellanti’s credibility ... as a basis for We review de novo decisions of rejecting Dr. expert Bellanti’s the Claims arising Court under the Vac-

1249 Act, preponderance of of the evidence that the same standard applying cine by injury to its at issue was caused a vaccine. applied Court review as the Claims -13(a)(1). 300aa-ll(c)(l); §§ 42 U.S.C. master’s decision. of the review Act can Andreu, Causation under Vaccine be owe no 569 F.3d 1373. We ways. in one two shown of first meth spe or the to the Claims Court deference proving od of causation involves demon law. questions of We cial master strating petitioner sustained an fact of uphold injury in a association with vaccine listed they capricious. are or unless § Injury in the Vaccine Table. Id. 300aa- Sec’y v. Health & Human Broekelschen of ll(c)(l)(C)(i). cases, In such causation is (Fed.Cir.2010). 1339, Servs., F.3d 1345 618 “ Andreu, presumed. 569 F.3d at See ‘Thus, reviewing as a although we are Alternatively, complained-of injury if the of the matter of law the decision Claims Table, Injury not listed in the Vaccine standard, under a non-deferential Court petitioner may compensation by prov seek the decision of reviewing we are in effect ing Moberly in fact. v. Sec’y causation the deferential master under of Servs., 1315, Human Health & 592 F.3d factual capricious standard on is ” (Fed.Cir.2010); 42 1321 see also U.S.C. Sec’y Lombardi v. Health & sues.’ 300aa-ll(c)(l)(C)(ii). § Ms. Porter’s and (Fed. Servs., 1343, 656 F.3d 1350 Human petitions Ms. are based on Rotoli’s such Cir.2011) Lampe Sec’y v. (quoting injuries. “off-Table” Once causation is es Servs., 1357, 219 Health & Human F.3d tablished, petitioner is entitled to com (Fed.Cir.2000)). reweigh not 1369 We do pensation unless the can show evidence, whether the factual assess preponderance a evidence correctly evaluated the evi special master injury is due to factors unrelated to dence, probative value of or examine vaccine, i.e., an alternative cause. Doe the evidence or the of the wit Servs., Human Sec’y Health & 601 nesses —these are all matters within the (Fed.Cir.2010); F.3d see also Broekelschen, purview of the fact finder. 300aa-13(a)(l)(B). § U.S.C. (citing Munn v. 618 F.3d Health & Human petitioner When has suffered (Fed.Cir.1992)). Rather, long spe as injury, for apply off-Table we test es “ cial master’s of fact is ‘based on tablishing causation fact outlined in Al- wholly evidence in the record that [is] then: compelled uphold are implausible, we petitioner’s] by is to show burden [The arbitrary being as not or ca that the vaccina- preponderant evidence ” pricious.’ Sec’y v. Health & Cedillo of injury by brought provid- tion about her (Fed. Servs., 617 1338 Human F.3d (1) ing: theory causally a medical con- Cir.2010) (quoting Lampe, F.3d necting injury; and the the vaccination “ 1360). guess It is not our role to ‘second (2) logical sequence a of cause and effect fact-intensive con Master[’]s showing that the vaccination was the ‘in particularly clusions’ cases which the (3) injury; showing and a reason for of causation is in dis medical evidence relationship a proximate temporal of be- ” pute.’ (quoting Hodges injury. vaccination and tween 9 F.3d Health & Human 418 F.3d at 1278. function of a “[T]he (Fed.Cir.1993)). not vaccine- special ‘diagnose’ master is injuries, A related but instead to determine petitioner seeking compensation as a whole prove by Act must a ‘based on the record evidence under Vaccine case, injury it cline caused her and of the whether has totality and the capricious. preponderance of the shown been [peti- that a vaccine caused evidence ” II Lombardi, injury.’ 656 F.3d at tioner’s] 1382). Andreu, 569 F.3d at (quoting first consider whether We rejection Claims Court’s wholesale of the government contends appeal, On fact-finding master’s based his decision that the Claims Court’s threshold credibility legally use of assessments was master’s fact-find- to set aside erroneous. The Claims Court cited to this entirety was erroneous ing legally in its in support court’s decision Andreu of its consistently recog- court has because this case, ruling. explained In that we that a authority master’s to con- nized the the applica master cannot “cloak credibility expert sider and assess legal tion of an erroneous standard in the Act evaluating witnesses in Vaccine claims. determination, guise credibility of a notes that Claims thereby it from appellate shield review.” factfinding can issue its own based Court Andreu, 569 F.3d at 1379. The Claims only if the special on the record master’s here made no Court determination that arbitrary, underlying capri- decision was an applied master erroneous cious, discretion, an abuse of or otherwise Rather, legal standard. the Claims Court gov- accordance with the law. The read Andreu to mean that it is inappropri argues that the special ernment ate for a to consider a a full findings factual were based on petitioner’s expert’s credibility in evaluat amply reasoned consideration of the rec- ing petitioner’s showing of causation and that no proper ord evidence basis ex- fact. setting findings ists for those aside under reading The Claims Court’s of An the deferential standard of review. Indeed, dreu is incorrect. this court has Petitioners counter the Claims unambiguously explained mas correctly spe- Court determined that the expected ters are to consider the credibili impermissibly cial master had framed his' ty expert evaluating peti witnesses in rejection petitioners’ theory of cau- compensation tions for under the Vaccine credibility sation under the rubric of a Act. Recent decisions of this court subse determination to immunize himself from quent opinion to the Claims Court’s here appellate review. Petitioners contend that are instructive. In Moberly, we reiterated Andreu, legal this constitutes error under may that a not cloak the provides a basis for the Claims Court application legal erroneous standard to set aside the guise in the of a determination 300aa-12(e)(2)(B). § under 42 U.S.C. Pe- to shield it appellate from review. 592 they titioners further contend that met (discussing F.3d at 1325 Andreu by their establishing 1379). burden the three fac- clarify at went on to that this We required tors to show causation in fact master, special does not mean that “a as Finally, under Althen. Ms. Porter asserts case, the finder of fact in a Vaccine Act is that prima once she established her facie prohibited making credibility from deter case, the burden shifted to the regarding expert testimony.” minations to that show vaccine did Id. We indicated that as to “[assessments injury. argues reliability testimony not cause her She that the expert often special minocy- credibility master’s conclusion that turn on determinations” and indeed, required findings ex- ence those of fact are “[flinders entitled — as to the legal make determinations Vaccine Act and constitutes error. pected —to presented the evidence reliability of and, as to the credibil- appropriate,

them if Ill that evi- ity persons presenting of the Because the Claims Court did not of the Id. at 1326. Our discussion dence.” have a proper setting basis for aside the equally in is clear. issue Broekelschen special findings master’s of fact and substi case, recognized “[ejxpert we tuting findings, its own we turn now to the testimony very important often medical special in findings master’s order to assess Act on off-Table in Vaccine cases based they arbitrary capri whether were and actual injuries requiring proof of causa- findings cious. The master made Broekelschen, at tion.” on each of the three elements of the Al- again explained that “the mas- We fact, in then test for causation often times is based on the ter’s decision petitioners carry had failed to their burden credibility and the relative experts of the on each Althen factor. He also made find competing theo- persuasiveness of their “ ings regarding government’s evidence credibility findings and such ‘are ries” ” of alternative cause with respect Ms. virtually unchallengeable appeal.’ Porter’s AIH. To a prima establish facie 1361). at Final- (quoting Lampe, 219 F.3d case, the petitioners bear the burden of Doe, upheld in we master’s ly, all proving required three factors under findings arbitrary capri- as not and factual Althen. light of the “particularly cious parties’ respective to the

findings made as found no experts.” 601 F.3d 1351. We A disturbing for basis The special petition- master found that credibility findings experts, to those as carry ers had failed to their burden of that “the mas- again emphasized demonstrating theory causally “a medical unique position ter’s to see witnesses connecting” vaccine to testimony” and hear their makes “such test, required by the Althen ‘virtually ... unre- credibility assessments ” at 1278. Porter F.3d Master appeal.’ (quot- viewable on Id. at 1355-56 bottom, At petitioners at *15-16. do 1362). ing Lampe, 219 F.3d dispute applied cases, In the present proper legal evaluating standard their recognized experts that all three were Rather, arguments their relate claims. Dr. well-qualified, but found Zweiman’s entirely to the master’s evaluation per- to be more Koffs competing evidence and his ultimate in- than Dr. Bellanti’s in several suasive findings based on the evidence. experts’ opinions stances when the were hearing, At the both Dr. Zweiman and rejecting conflict. Rather than they Dr. Koff were unaware testified entirety, findings their any epidemiological scientific or evi- applied the def- Claims Court should have link hepati- dence of a causal between the capricious standard erential expert, B vaccine and AIH. Petitioners’ tis findings. of review to these Claims Bellanti, proffered number of theo- setting aside approach Court’s blanket hep- ries he claimed demonstrated ever determin- the factual without might B vaccine cause AIH. The were atitis ing whether the master examined each of these the- capricious failed to accord the defer- theory implicated Dr. fourth detail, weighing all of the Bellanti’s in great ones T-cells.” “dysfunction regulatory Id. by both sides. presented scientific evidence Regulatory responsible T-cells are *9-11. theory was based on Dr. Bellanti’s first suppressing against for immune reactions “molecu- biological known as a mechanism body’s Dr. the own tissues. Bellanti’s ex- ini- mimicry.” Id. at *6. Dr. Bellanti lar pert report posited suggest that “[s]tudies mimicry molecular as a tially described regulato- in the decrease number likely was “most to be theory he believed ability may ry expand T-cells and their an article presented valid.” Dr. Zweiman to autoimmune liver lead disease.” Id. reliability the of molecu- that undermined dysfunction *9. In the T-cell support of theory causally connect- mimicry lar as a Dr. theory, pointed Bellanti article B vaccine with AIH. Id. ing hepatitis the al., Longhi, Maria Serena et entitled theory at the Dr. Bellanti abandoned this “Impairment regulatory of CD4 + + CD25 hearing being after confronted with the disease,” liver T-cells autoimmune agreed (2004) (“Lon- He contrary research. Hepatology Journal of 31-37 mimicry article”). support article “doesn’t molecular ghi Id. at *10. Dr. Zweiman explana- ... another so we have seek that a T- agreed problem regulatory with may tion.” Id. be but cells associated with testified that it is unclear whether the AIH Dr. next two theories involved Bellanti’s dysfunction dysfunction or the causes “bystander “polyclonal acti- activation” AIH. causes the He further testified that vation,” Dr. respectively. Id. at *6-9. “nobody reported has ever whether or not Zweiman testified that there is no evidence hepatitis immunization induces alteration poly- B vaccine hepatitis induces immunoregulatory at *11. T-cells.” Id. A report clonal activation. Id. at *9. dispute Dr. Bellanti did not this assertion. Academy of the National of Sciences’ Insti- Id. master observed that none (“IOM”) likewise conclud- tute of Medicine linked the observation in ed that is no evidence “[t]here Longhi people article that AIH (in hepatitis antigen [hepatitis surface have a T-cell imbalance with the vaccine]) capable bystander activa- fact, B vaccine. Id. In he noted that Dr. non-specific tion ... or otherwise induces stopped own report Bellanti’s short of polyclonal activation.” The master identifying regu- vaccine as cause of favored, al- reports noted that IOM are latory dysfunction. spe- T-cell When though in the Pro- dispositive, Vaccine specifically cial asked Bellanti gram. presented Id. at *7. Dr. Bellanti no theory something whether his was “that response report, to the which had IOM B vaccine causes the T-cell testified, been nor filed before he did he regulatory deficiency,” Dr. Bellanti re- present any rebuttal articles. Id. When he “That ... sponded: isn’t known the article questioned he report, about the dis- simply deficiency patients referred to a it “opinion,” missed without further ar- it hepatitis. with autoimmune Whether ticulating any disagreement reason for his result, was the cause or the it isn’t report. Crediting with that Zwei- being it a preexist- clear.... would favor man mas- report, IOM deficiency, spec- ... that would ing but be biological ter found that neither of these ulative.” Id. at *10. In view of the testi- theory article, mechanisms constituted a reliable mony and the for explaining how the vaccine that Dr. Bellanti “could not connect found can B vaccine to his belief that an cause AIH. Id. at *8-9. diseases, au- mune a causal T-regulatory supporting in cells causes connec imbalance at *11. Accord- the vaccine AIH. hepatitis.” Id. tion between Id. toimmune that T- “A special rechallenge the master concluded *15. event occurs when a ingly, qualify as a medi- dysfunction patient does who had an adverse reaction to a cell connecting the vaccina- theory causally symptoms cal vaccine suffers worsened after injury. injection tion and the an additional of the vaccine.” Capizzano Health & Human additional ob- presented Dr. Bellanti two (Fed.Cir.2006). link support in of a causal be- servations recognized master that such an B vaccine and AIH. hepatitis tween persuasive event can be evidence that a that, First, hep- he contended because the causing vaccine is an adverse reaction. may B cause autoimmune atitis virus itself Master Porter at *15. Prob disease, hepatitis that the one can assume lematically, hearing, at the Dr. Bellanti did autoimmune dis- B vaccine can also cause any specific not cite literature re- about on a Relying ease. Id. at *12. review challenge with the B hepatitis vaccine nor England article in the New Journal of explain could he the basis for his assertion. Krawitt, by Dr. Edward a lead- Medicine acknowledged Id. The master ing researcher experts required produce are not litera underlying of Dr. rejected premise Althen; however, ture under Dr. Bellanti’s claim, i.e., B hepatitis virus Bellanti’s expert report stated that there were such AIH. Id. at *13. The Krawitt re- causes reports the literature. The mas article concluded that autoimmune view ter noted that “Dr. inability Bellanti’s hepati- had been associated with hepatitis prove implicated persua what he wrote his infections, hepatitis signifi- A and but tis C veracity.” siveness and his Id. at *15 n. 7. cantly, article did not mention a similar master also considered a 2005 B in- respect hepatitis with association Beran, ah, study by J. et the Central Id. Dr. Bellanti offered four arti- fection. European Journal of Public Health sub minimally support proposition cles that mitted Id. at *15. The Zweiman. hepatitis B virus can cause AIH. that the study reported people that the condition of subject in Id. Dr. Koff testified that preexisting AIH did not worsen after actually one of the articles had chronic B receiving hepatitis vaccine. The B, hepatitis not AIH. Id. at *12. He also study special master found Beran subject testified in another article contrary was further evidence to Dr. Bel C, likely had not AIH. Id. The regarding applicability lanti’s assertion remaining master found that rechallenge. articles, describing single both two case studies, any meaningful did not contain carefully considering After analysis about causation. Id. at *13. The theories, Bellanti’s numerous preponder- master found that “[a] master found each to be flawed and con regarding of the direct ance evidence ... presents cluded “none reliable virus contradicts assertion explanation of how the vaccine hepatitis.” it can cause autoimmune hepatitis.” can cause autoimmune Id. at Id. at *14. indicated, previously *5. As we “re have extremely

Dr. Bellanti also asserted that versible error will be difficult to “reports in the literature” that where the there were demonstrate” B vaccine had caused a “re- “has considered the relevant evidence of record, plausible with autoim- drawn inferences and ar- challenge people event” analysis Dr. of Ms. findings the decision.” Koffs Ro- basis for ticulated a rational biopsy. toli’s liver Human Health & Hines (Fed.Cir.1991). 1518, 1528 F.2d explained that Ms. Rotoli’s liver Dr. Koff than biopsy, which was taken less nine reveals a special master’s decision The after she received her first dose of months of all of careful evaluation thorough and vaccine, exten- showed such records, tests, re- including the evidence that a liver damage sive she must have had literature, as well as the medical ports, and many years prior biopsy. for to the disease credibility. and their opinions experts’ master acknowl- Id. at *17. The weighed conflicting The training thirty years Dr. Koffs edged petitioners that and concluded evidence experience treating people with liver their burden of demon- not carried had Dr. Koff to disease. Id. *18. He found theory causally con- “a medical strating “quite quite persuasive” be certain and AIH. vaccine to necting” the testimony his that such extensive fibrosis reweigh not the factual court does This develop “cannot in nine months.” Id. the special or assess whether evidence any expert *17. Rotoli did not offer Ms. evidence, correctly evaluated Dr. hepatologist from a to rebut probative it examine the value of nor does analysis biopsy Koffs of her or his asser- credibility or the wit- the evidence damage could not have oc- tion are all matters within the nesses. These To off- curred the relevant timeframe. Broekelschen, fact finder. purview of the deficiency, set this Ms. Rotoli offered Lombardi, 1349; 656 F.3d at 618 F.3d at Huppertz Hans-Iko document- article Accordingly, master’s subject ing single study case of a who petitioners had failed determination AIH diagnosed following hepati- was with by preponderance in fact prove causation subject’s A liver tis infection. petitioner and that neither of the evidence fibrosis, and Rotoli ar- biopsy showed Ms. compensation under the was entitled to gued supports this fibrosis such arbitrary, capricious, not Vaccine Act was developed as hers could have over a short discretion, an abuse of or otherwise not provided time frame. Id. Dr. Koff an al- § accordance with law. U.S.C. 300aa- interpretation Huppertz ternative 12(e)(2)(B). study. subject He case testified study likely in that case had AIH before hepatitis According A. his infection Koff, the AIH caused the fibrosis but Putting aside the master’s until A was not discovered findings implicating Bellanti’s credibili evidence, In view of the infection. Id. ty, findings made master also finding that Ms. Rotoli’s that did not on the adverse rest began hepati- AIH before she received the in separate of Dr. Bellanti and were capri- tis B vaccine was not dependent denying petitioners’ reasons for cious. case, claims. Rotoli’s Ms. satisfy master found that she failed to by a

timing prong proven prepon of Althen because her AIH the had derance of the evidence that Ms. Porter’s predated her vaccinations. Master minocycline the cause longtime Rotoli at *17-18. These did use of credibility. AIH did not rest on Dr. involve Dr. Bellanti’s of her likewise Rather, Rather, credibility. lack of master based these Bellanti’s nocycline clearly undisputed wrong relied on the was “so as to be special master minocycline is known to cause arbitrary capricious.” fact that or Lampe, 219 F.3d records, Porter’s medical Ms. at 1367. testimony. Koffs Master Dr. sum, In we conclude that the Claims at *21-22. Ms. Porter’s medi- Porter legal Court committed error when it set indicated that dermatolo- “[a] cal records special findings aside the master’s of fact minocycline for Ms. Porter gist prescribed entirety their based on its erroneous 15, 1991,” early May prior to her as interpretation of Andreu. We further con- of the receipt of doses vaccine. special clude that the master’s determina- Dr. Id. at *21. Koff testified that Ms. petitioners tion that the were not entitled Porter’s records also indicated that Ms. compensation to under Vaccine Act minocycline again Porter took “on and off arbitrary, capricious, was not an abuse of at least 2002.” on again through Based discretion, or not in otherwise accordance records, his review of Ms. Porter’s with law. history Koff concluded that “the natural of autoimmune minocycline-induced Conclusion very seeing is much like we are Ms. judgment We reverse the of the Claims

Porter,” minocycline and that was the Court and remand with instructions to af- likely more cause of her condition. The firm special master’s determination also noted that one of special master Ms. petitioner neither is entitled to recov- treating Porter’s doctors had “discontinued er under the Vaccine Act. prescription minocycline her after Ms. reported hepatitis.” Porter that she had AND REMANDED REVERSED special

Id. at *22. The master found that action to “consistent with a belief that be O’MALLEY, Judge, coneurring- Circuit minocycline causing could Port- be Ms. in-part, dissenting-in-part. er’s liver troubles.” Id. I Although believe the trial court erred government’s showing To rebut in setting entirety special aside the cause, alternative Dr. Bellanti testified solely master’s based on his mis- “minocycline likely was not to be the determinations, “credibility” use of I can- Ms. cause of Porter’s because her agree majority’s with the decision improve condition did not when she ignore completely special im- stopped taking minocycline.” Id. proper use of those determinations. In noted, however, *21. The instances, several master’s reli- that the medical literature “contains more “credibility” ance on “demeanor” and example than one of cases in which the reject petitioner’s undoubtedly theories minocycline continued after the contrary was to this court’s case law. stopped.” Koff also testified addition, master’s unusual and “minocycline-induced disease does not expert’s relentless attacks on the truthful- invariably get you better when discontinue ness color the remainder of the drug.” opined you He further that “if analysis. master’s flawed intermittently keep taking [minocycline] endorse, majority cannot Porter, also as the years, over as in the case of Ms. does, find- going get it’s not better.” We cannot say ings legal and erroneous conclusions with master’s treatment conflicting finding respect evidence and his to Mona Porter’s claim. While our mi- that Ms. Porter’s AIH was caused review of masters’ decisions Vac- Keenan v. deferential, other Act cases. See it is not Vaccine cine Act cases Servs., 99- Sec’y & Human No. Health our standard of re- And stamp. rubber (Fed.Cl. 5, 561V, Apr. 2007 WL 1281592 masters to license for is not a view 2007); Bowes v. Health & Human a whim or literature on medical discount 481V, at *4 2006 WL explained As 01— legal standards. misapply 2006) (Fed.Cl. (finding Dr. Bellanti Sept. below, made because “Dr. Bellanti is part because persuasive ap- capricious findings arbitrary and excellent academic cre- physician with reject- legal standards plied erroneous experience spe- dentials and the medical claim, affirm the I would ing Ms. Porter’s immunolo- pediatrics cialities of [sic] of States Court of the United decision Indeed, familiar special one master gy.”). Court”) (“Claims Federal Claims prior with Dr. Bellanti from several cases I must dissent from Accordingly, claim. him, counterpart, and his be- described majority’s opinion. For portion of the any ing “as well-versed their fields as by majority, howev- stated the reasons experts hope two one could obtain.” er, independent are bases there because Keenan, 1231592, 2007 at *3. That WL claim, agree I Rotoli’s that bar Claudia special noting master found it “worth must that the decision of Claims Court received Dr. Bellanti’s the Court as to that claim. be reversed credibility.” Id. at *10. below, original three eight Of the cases I. joint settled before the majority’s by supplementing start $100,000 and one for hearings, two for history and procedural of the recitation $120,000. Sec’y See Zaskoda v. Health of unusual of the discussion Servs., (Fed.Cl. & Human No. 05-241V peti- five consolidated opinions these 29, 2007); May Sec’y v. Wadie Health & of eight petitioners, includ- Originally, tions. (Fed.Cl. Servs., Human No. 99-493V Jan. Rotoli,1 and Claudia filed ing Mona Porter 18, 2008); Hu- Kay Sec’y Health & of B vac- petitions alleging Servs., (Fed.Cl. 18, man 01-476V Jan. to suffer from autoim- cine caused them 2008). petitioners One of the whose case (“AIH”).2 All eight claims mune settled, Zaskoda, Jeffrey relied on Dr. Bel- assigned to the same master. were opinion support lanti’s his claim. Rotoli, along with Ms. Porter and Ms. remaining five cases were consoli- relied on the petitioners, several other purposes spe- dated for of trial before the expert, Joseph A. opinion of the same joint hearings, Following cial master. Bellanti, to their claims. support all of petitions— master denied immunologist Dr. Bellanti is an whose including Ms. Porter’s and Ms. Rotoli’s— have not qualifications and credentials petitioners failed to estab- opinion challenged, expert by preponderance been and whose lish of the evidence by by masters in that their AIH was caused accepted has been 11, passed away 2. AIH is a chronic liver disease in which an 1. Ms. Rotoli on November 2009, system 40, individual's immune attacks the indi age following the Claims at the foreign vidual’s liver as if it is a tissue. See daughter, Court’s decision in this case. Her Servs., Sec'y Rotoli v. Health & Human 89 Knight, appointed person- Amanda as the 71, (2009) (citing 2 Fed.Cl. 76 n. Michael P. estate, representative but we al of Ms. Rotoli’s Vogel, Hepatitis, Manns & Arndt Autoimmune petitioner as the for conti- refer Ms. Rotoli Therapy, Hepatology From Mechanisms to nuity clarity. 2, (2006)). Suppl. 1 S 132 No. Sec’y Porter v. Health & found that “Dr. Bellanti B vaccine. See Servs., 99-639V, No. 2008 WL lacked about Human when the autoim- 2008) (Fed.Cl. (“Special hepatitis began,” Oct. mune and that “his de- Op.’’); Rotoli v. suggested, Master Porter meanor when he testified at a 99-644V, minimum, Human No. Health & he lacked confidence in his (Fed.Cl. 2008) worst, Oct. 2008 WL statement” or his demeanor “[a]t (“Special Op.”). Master Rotoli With re- suggested that he was not truthful.” Spe- Porter, spect Op., to Ms. cial Master Rotoli at *17. found that met its also Many master’s comments AIH showing burden of that Ms. Porter’s appear in a nine page section of the cause, namely

was caused an alternate opinion entitled “Additional Comments Re- drug minocycline. the acne Special Mas- Bellanti,” garding Dr. which he devoted at *21. ter Porter exclusively attacking to Dr. Bellanti’s pre- majority Although the makes no men- paredness veracity. and In addition to point, special opin- tion of this the master’s calling Dr. expert report Bellanti’s “mis- in ions these cases are remarkable for the accurate,” leading special and not mas- credibility, sheer number of references to ter included subsection about “Dr. Bel- demeanor, veracity. example, and For in Demeanor,” lanti’s in which he identified Dr. referring to Bellanti his Porter deci- ten during hearings instances in which sion, master used terms relat- uncomfortable,” Dr. “appear[ed] Bellanti ing credibility to a total of 31 times unsettled,” “appeared] “appear[ed] unfa- throughout 36-page opinion, including his miliar,” confidence,” or “lack[ed] was “be- “credibility” the words or “credible” a ing evasive.” Id. at *28-30. Based on times, combined 17 the word “demeanor” this, master drew what he be- times, eight “veracity” and the words and lieved was a “reasonable” inference that “truthfulness” a combined six times. The Dr. opinion Bellanti “was aware that his following passages are illustrative: “[t]his flawed, yet he provide chose to it evasive answer decreased Dr. Bellanti’s anyway.” at Id. *30. *15; credibility,” id. at evasive an- “[t]his opin- This section of the master’s Dr. swer decreased Bellanti’s ion with following: concludes question and calls into the truthfulness of *24; Here, report,” many Dr. Bellanti’s id. at lack questions “this so about the ba- statements, forthrightness lessens Dr. Bellanti’s sis for Dr. Bellanti’s con- *28; credibility.” report id. “Dr. Bellanti’s de- tained either his or testi- his during testimony strongly mony, meanor his rein- have led to a question about Dr. forces the doubts about Dr. Bellanti’s ve- veracity. professor Bellanti’s As a *29; author, racity,” published id. at consideration of “[a] Dr. Bellanti should report, testimony, appreciate Bellanti’s his the need for some evidence testifying signif- his demeanor while raises to substantiate his theories. Bel- just present any icant concerns not about Dr. Bellanti’s lanti failed to evidence that truthfulness,” persuasiveness persuasive support but also his was credible and decision, id. at In his his and opinions. *30.3 Rotoli statements Conse- noted, majority, Appendix 3. Like the cite to the Joint unless otherwise likewise refers to only opinion referring cite to the Porter when appendix submitted in connection with overlap to issues that between the appeal. Any master's two decisions in these cases. theory sup- expert witnesses’ medical opinion, as Dr. Bellanti’s quently, whole, any persuasiveness. weight epidemiological ported lacks Andreu, (quoting Id. 569 F.3d evidence.” added). Notably, although (emphasis 1379). for a master to no reason there is his under which the standard enunciate on to set The Claims Court went aside reviewed, be own decision will findings all of the that “[a] case announced this enter its own of fact and conclu- of an persuasiveness decision about pursuant law U.S.C. sions of virtually ap not reviewable on expert is 300aa-12(e)(2)(B). § Id. at 82.4 In a thor- (citing Bradley Id. at *3 peal.” ough analysis, the Claims Court found Human Health & petitioners, including favor of three (Fed.Cir.1993); Sword v. United Rotoli, Porter and Ms. and for the Ms. (1999)). States, 183, 188 44 Fed.Cl. to the other two respect pronouncement, Id. at 102. petitioners. however, motion upon did not hold true in the Claims for review of his decisions government appealed the Claims opinion addressing In a combined Court. awarding compensation decision Court’s cases, reversed all five the Claims Court respect petitioners. the three With to Ms. as to three of the de cases, gov- Porter’s and Ms. Rotoli’s credibility after that his cisions argues ernment that the Claims Court ran afoul of this court’s determinations incorrectly erred because it believed that Sec’y v. Health decision in Andreu & of special prohibited the master was from (Fed.Cir. Servs., Human 569 F.3d 1367 assessing credibility expert the of an wit- 2009). Sec’y Rotoli v. Health & See of government goes argue ness. The on to Servs., 71, Human 89 Fed.Cl. 80-82 that, special even if the master made im- (2009). the Claims Court Specifically, determinations, proper credibility any such that, “[j]ust special found as the master error was harmless because the Andreu, in the in did independent master’s decisions rested on erroneously these much of cases ‘cloaked’ grounds credibility. unrelated to The ma- rejection theory of of cau petitioners’ his and, therefore, jority agrees points on both ‘credibility’ the rubric of a sation under judgment reverses the of the Claims Court regarding determination [Dr. Bellanti].” and remands this matter with instructions (citation quo Id. at 80 and some internal to affirm the determina- omitted). finding, tation marks In so the tions. in in court relied on our decision Andreu respect majority, With due to the I can- that credibility which we stated determi not the the special nations “to the candor of endorse decision of are used assess witness, an a fact not evaluate whether master Ms. Porter’s case. For the rea- only concluding Campbell 4. This is not the time the Claims Court that Ms. had not met fact.”); has the of her set aside or rebuked this burden to establish causation Servs., particular special e.g., Campbell Dobrydnev Sec’y master. See v. Health & Human of 190, (2011) Sec’y (reversing spe- v. Health & Human 98 Fed.Cl. Fed.Cl. of (2009) ("Despite noting, among 383-84 mas- cial master and other criti- cisms, "[ejither attempt ter's to insulate decision from Master did his words, magic carefully purposeful- review the record or review the incantation of erroneously ly neglected highly relevant evi- court finds that he relied on an to discuss credibility petitioner’s] primary treating [the assessment of Dr. Brawer's as a dence from rejecting physician.”). basis for Brawer's below, majori- Moberly Secretary decision in I believe Health explained sons of Services, regarding case law and Human ty gives our recent (Fed.Cir.2010). unduly Moberly, an broad 1325-26 we credibility determinations overlooking explained errs in clarified Andreu and reading, and then master masters must make determinations about many places which evidence, reliability including expert demeanor or credi- improperly considered capricious testimony, credibility find- which “often turn on bility, made determinations, legal particularly stan- where ings, applied improper or claim, respect supporting With to Ms. Porter’s there is little evidence for the dard. overturning spe- expert’s opinion.” eiTors warrant Id. at 1326. also these We gen- explained even under our of fact are enti- “[flinders cial master’s decision indeed, expected make Accordingly, erous standard of review. determi- tled— —to reliability decision nations as to the would affirm the Claims Court’s the evidence and, presented appropriate, claim. to them as to Ms. Porter’s if credibility persons presenting added). Id. (emphasis evidence.” II. reading Moberly, on its Based as well majority first determines as statements two other cases in which incorrectly Court read Andreu to Claims concept we have endorsed the of a prohibited master is mean that determinations, making credibility making any from determina- majority finds that the Claims Court It analysis. tions in its causation is debat- in setting erred aside the interpreted Court able whether Claims findings. Majority Op. (citing Broek- creating prin- such an absolute Andreu as elschen v. Health & Human merely ciple, or whether it believed that Servs., 1339, (Fed.Cir.2010); F.3d 618 1347 credibility in the determinations this case Servs., Doe v. Health & Human improper they were because were used in of (Fed.Cir.2010)). 1349, 1351 F.3d attempt to mask master’s majority draws from these cases that “this accepting Even personal preferences. unambiguously explained court has that characterization, majority’s the Claims to expected masters are consider reading Court’s of Andreu is understanda- credibility expert of in evalu- witnesses ble, unambiguously that in given we stated for ating petitions compensation under the that decision that trial court makes a “[a] Majority Op. Vaccine Act.” credibility determination in order to assess witness, a the candor of fact not to evalu- disagree majority’s I with the character- expert ate whether an witness’ medical ization of our case law for two reasons. theory by iveight epide- supported is of First, explicit in statement Andreu Andreu, miological evidence.” 569 F.3d credibility that determinations are more added) (emphasis (citing Lampe at 1379 v. appropriate for fact witnesses than for ex- Sec’y Health & Human 219 F.3d perts vitality. must retain some The deci- (Fed.Cir.2000) J., (Plager, 1373-74 Moberly by three-judge pan- sion in was dissenting)). el, banc, and, sitting the court en case, course, matter, procedural in this not have dis- The Claims Court could Second, major- subsequent principle.5 did not have the our carded that benefit Moberly e.g., See v. IVAC 5. To the extent that conflicts sion would control. Johnston Andreu, (Fed.Cir.1989) panel Corp., holding of the earlier deci- called a holding of went so far as to draw what he ity in case overstates this inference” based on Bel- “special masters “reasonable by saying Moberly demeanor that Dr. Bellanti “was credibility lanti’s consider expected are flawed, yet he opinion Act aware that his in Vaccine cases. expert witnesses” added). anyway.” it Id. at *30. provide That chose to (emphasis Majority Op. error, Rather, says. legal the That constitutes even under Moberly not what is case law. explained post-Moberly our Moberly in panel reliabili- expected to consider masters are Given that the master made such credibility, partic- turns on ty, which often “inference” a universal demeanor-based a dearth of evidence there is ularly where knowingly that Dr. Bellanti offered a Moberly, expert’s opinion. supporting opinion, flawed it is difficult to review his Thus, in as we stated 592 F.3d at 1326. pervasive decision without the taint of this “if credibility can be considered Moberly, error, legal particularly light of his nu- words, In other the ma- appropriate.” “credibility” merous other assessments. jority our statements takes therefore, surprising, It is not permissible are experts assessments simply would discard the Claims Court interprets Act them Vaccine cases entirety findings their credibility assessments are ex- mean that findings and render its own the first law, invites, it That not the pected. tempta- I instance. While understand the tolerates, very mischief that or at least result, agree tion to reach that with the in these cases. occurred majority justify that our case law does not Nonetheless, approach. that blanket we Indeed, post-Moberly our decisions dem- overlook, does, majority cannot as the majority’s interpretation onstrate that the many places in which the Broekelschen, we ex- is erroneous. “credibility” “demeanor” or assessments that, general, when two pressly stated “[i]n improper. Considering legal those were witnesses, highly qualified, expert both errors, and the master’s other arbi- sup- of medical fact with dispute an issue trary capricious identified be- evidence, contradictory porting and it is low, application proper standard of immaterial whether one witness makes a review leads the same conclusion the appearance better on the stand.” 618 F.3d Claims Court reached. With back- added). case, In (emphasis at 1349 turn ground, now to merits of Ms. majority spe- excused the error of the Porter’s claim. (who cial master was same cases), present finding master as in the III. “[tjhough it was harmless even may improperly compensation have con- Because Ms. Porter seeks Greenberg’s injury, prove by sidered Dr. demeanor.” Id. for an off-table she must Here, hepatitis that the dispute preponderant there is no that Dr. Bellanti evidence by provid- AIH well-qualified, yet brought was vaccine about her “(1) ing: theory causally a medical con- nonetheless made extensive about (2) injury; body language. Special necting his demeanor and the vaccination and the sequence cause and effect logical Master Porter at *29-30. He even a of dicta, ("Where appear merely conflicting panel conflicting ... in and if not statements precedent, panel obligated our to re- is obligated law to follow the earlier case explain view the and reconcile or cases binding precedent”). which is the statements, possible. not if If reconcilable

1261 prongs improper credibility vaccination was the rea- showing that the determina- (3) tions, injury; showing of a arbitrary findings, son for the or ap- erroneous relationship between proximate temporal below, plications explained of law. As injury.” Sec’y Althen v. vaccination and petitioners demonstrated a theory medical of Servs., 1274, Health & Human 418 F.3d causally connecting B vaccine (Fed.Cir.2005). A petitioner 1278 sat- AIH, that, namely to because the isfies this burden is “entitled to recover AIH, B virus itself can cause it is more shows, [government] by unless the also likely than not that the B vaccine evidence, preponderance injury of can cause AIH. Ms. Porter also satisfied fact caused factors unrelated to the second and third Althen prongs be- Sec’y the vaccine.” Knudsen v. Health enzyme cause tests revealed that her liver (Fed. Servs., & Human 35 F.3d spiked shortly levels after receiving her Cir.1994) (alteration (citation original) dose, third B vaccine an indica- omitted). tion of which the unrebutted evi- medically dence showed was a causation, appropriate establishing a petitioner’s timeframe for the inju- occurrence of such explanation only medical or scientific need Finally, ries. “legally probable, medically be or sci- failed to entifically Moberly, certain.” 592 F.3d at meet its burden of proving that Ms. Port- Knudsen, (quoting at minocycline F.3d 548- er’s use of more likely than 49). A petitioner required pro- is not not caused AIH her because Ms. Porter’s epidemiologic vide medical literature or AIH improve did not after discontinuing linking injury, studies the vaccine to the minocycline, use of a known characteristic impermissibly peti- would raise drug-induced hepatitis. As explained in preclude tioner’s below, burden the use of more detail circumstantial permitted evidence under findings as to each of these fail issues Act compensation program. the Vaccine generous survive even our standard of re- Andreu, 1378; Althen, 569 F.3d at 418 view. petitioner required

F.3d 1280. Nor is a “general acceptance to demonstrate a A. the scientific or medical communities.” Capizzano Health & Human respect prong With the first of Al- (Fed.Cir.2006). 440 F.3d then, it we have stated would be purpose of the pre- “[T]he Vaccine Act’s inconsistent with the Vaccine Act’s com- ponderance standard is to allow the pensation program require “to identifica- complete of causation a field bereft of proof specific biological tion and mecha- proof and direct of how vaccines affect the Knudsen, nisms.” 549. Even a body,” possible human if the link even possible link between a vaccine and an injury between the vaccine and the is injury proven, that has not been and in Althen, unproven.” “hitherto 418 F.3d an proof, which there is absence of direct 1280. Under the vaccine compensation Althen, is sufficient. 418 F.3d at In 1280. system by Congress, created “close calls case, petitioners this advanced several the- regarding causation are resolved favor causally ories B connecting hepatitis injured (citing claimants.” Id. Knud- AIH, only vaccine to one which is neces- 549). sen, 35 F.3d at minimum, sary satisfy prong. this At a case, that, In special hep- this master based his the evidence showed because the AIH, decision as to each of the three B can it Althen atitis virus itself cause is 49); B 440 F.3d at 1325. Accord- hepatitis Capizzano, that the likely than not more special to the extent master ingly, AIH. can cause vaccine on whether the causal connection focused rejected Dr. Bellan- master special The B virus and AIH “is hepatitis between the found there was no he theory ti’s because legal the correct known” rather than on underlying premise i.e., for the support — standard, special applied B can cause virus itself hepatitis that the impermissibly petition- strict burden on so, however, special doing AIH. In setting That error alone warrants ers.6 heightened to a Dr. Bellanti master held findings. aside his report, In expert his point. burden on this that “infection with Dr. Bellanti stated master’s error In addition to the cause autoim- B virus is known to heightened to a bur- holding petitioners (“J.A.”) Appendix Joint hepatitis.” mune den, factual onto Dr. special master latched 123. The capricious. sup- also are “is that the causation Bellanti’s statement port of his assertion that the disproving more on known” and focused AIH, Dr. Bellanti relied virus could cause than precise statement Dr. Bellanti’s on a medical textbook entitled The Auto- standard, legal which applying the correct (Noel R. and Ian immune Diseases Rose theory “known.” require does not to be ed.1998). eds., Mackay, R. 3d Indeed, in his “Additional Com- “appears found that this textbook Bellanti,” Regarding ments Dr. Bellanti’s assertion.” supports [sic] that, “[ajlthough Dr. Bellanti master found at *12. He also Special Op. Master Porter known,’ preponderance fact states this ‘is “[n]ormally, a textbook would noted indicates that Dr. Bellan- of the evidence for a statement.” Id. at be a reliable basis was in error.” Mas- ti’s statement *24. added); Op. (emphasis ter Porter at *23 master, however, (noting *12 lack of took the see also id. at extraordinary step discounting unequiv- report citations in the “seems inconsistent in a textbook based on the that Dr. Bellanti asserts ‘is ocal statements fact ”). it fact that the articles which the textbook known.’ But is irrelevant whether correct the link is cites are dated in 1989 and 1984.7 Even Dr. Bellanti is remarkable, “known”; inquiry whether a more master dis- the relevant articles, supports counted one of the which was preponderance of the evidence German, medically written in because he found that theory, this whether or not it is B, AIH, a accepted in the scien- it involved chronic not generally certain or testimony from community. Moberly, tific 592 F.3d at that was based on See Knudsen, admittedly a witness who could even (quoting 548- point. Spe- Although support edition to his See master also concluded fourth (”[T]o preponderance does not that a of the evidence n. 6 cial Master Porter at *12 support that the B virus can cause implying extent that Dr. Zweiman is applying presumably the correct stan- Mackay edition of Rose and textbook third dard, separate it is difficult to this statement and that the fourth edition elim- is out-of-date improper master’s otherwise from the virus, any hepatitis inates mention of the legal burden. respondent should have submitted the corre- chapter sponding chapter, from the fourth government’s expert, Zwei- 7. The Dr. Burton edition.”). There is no indication that the man, relying criticized Dr. Bellanti for on the did not cite these same fourth edition also the third edition of this textbook instead of edition, and 1984. introduce the articles from 1989 fourth but he failed to a Specifically, study read the article. ed case about a child with both B, AIH testimony govern- hepatitis which master cited the authors Koff, Raymond “strengthens possibility for his said expert, hepa- ment’s that may in the German titis B virus act patient trigger also as a “[t]he for B, this study actually hepatitis had chronic not rare autoimmune disease Val- [AIH].” Nobili, al., at *12. But erio hepatitis.” autoimmune Id. et Co-occurrence Chron- only Hepatitis one of ic Dr. Koff testified about Virus and Auto- Infection article, in the Hepatitis Young four cases discussed and he immune in a Senegalese Girl, he Eur. admitted that reached his conclusion J. Gastroenterol Hepatol., (2006) (the article”). text in going through “without Ger- 927-29 “Nobili that, man.” J.A. 1005. He then stated Although master found that other three need more information “[t]he supported these articles Dr. Bellanti’s the- (empha- about. I need a translation.” ory, master discounted them added).8 sis I can conceive of nothing they because he felt lacked a meaningful arbitrary than rejecting more medical lit- causation analysis. that, He also found erature, textbook, cited a medical based they studies, because single involved case not, testimony on the of a who witness did “ruling possible out a coincidence impos- is not, and could read the text of the litera- Special sible.” Master Porter at *13. ture. Even our deferential review does rejecting In persuasiveness of these conclusion, permit such a and I cannot studies, master relied on the agree majority with the repre- this testimony of government’s expert, thorough sents “a and careful evaluation of Zweiman, despite the fact that Dr. Zwei- all Majority Op. of the evidence.” 1254. man testified that he require would “suit- able epidemiologic evidence” before ac- textbook, In addition to this which on its cepting theory the hepatitis B supported face Dr. Bellanti’s medical theo- vaccine can cause AIH. J.A. 586. Dr. ry, Dr. Bellanti also relied on two other Zweiman’s proof, strict standard of howev- that, according articles to the mas- er, is in direct conflict with our case law. ter, support “seem to offer some modest (“[Re- Capizzano, See 440 F.3d at 1325 for his assertion.” Master Porter quiring epidemiologic ... studies ... atOp. *12. One article described the case Althen.”). contrary to what we said study 26-year of a man old who received a vaccine, Twinrix which is vaccine for The special master then credited an arti- B, both A and by re- cle written a Dr. Krawitt against to find in an pre- sulted acute exacerbation of his petitioners. describing potential causes existing al., AIH. Csepregi, See Antal et explained for the article Acute Exacerbation Hep- convincing Autoimmune most evidence of viral infections Twinix, 11 leading atitis Induced World to AIH J. “is related to the hepatitis (2005) (the Gastroenterol, Krawitt, 4114-4116 “Cse- viruses.” See Hep- Autoimmune article”). atitis, pregi (2006) The second article report- Eng. 354 N J. Med. 54-66 going 8. Portions of Dr. people Koff's also reflect we are to be inundated with general against finding problems claims, bias who will make and I think it would vaccine, as he is concerned set.”). good precedent not be inviting about a flood of claimants. See Roto- question master did not Dr. Koff's admitted ("But li J.A. 977 what worries me the most is evaluating testimony, apparent- bias when his accept if we this notion that B vac- ly reserving all assessments for Dr. cine, extraordinary safety which has this rec- Bellanti alone. ord, induce, cause, whatever, aggravate, can added). statements, article”) the fact that Dr. Dr. Krawitt’s (emphasis (the “Krawitt Krawitt, that anyone the field for or article on its face of the Although the text link matter, possible of a is not aware theory, the Dr. Bellanti’s actually supports injury and an does not a vaccine between beyond the text to looked special master a matter finding a of causation as preclude types of studies significance find (al- Althen, 418 F.3d at 1280 of law. See that support state- in footnotes cited even if the lowing of causation in- ment, of three studies which consisted and the link between the vaccine possible hepati- A or hepatitis volving patients injury unproven”); is “hitherto Gass viruses. tis C cf. Servs., Inc., Hotel Marriott to credit master’s decision The Cir.2009) (6th C.J., dissenting) (Boggs, and Mac- over Rose the Krawitt article (“Of course, the absence of evidence is not article, textbook, Csepregi kay absence.”). as evidence of the same capricious. article is Nobili short, discredited First, article does not even the Krawitt (in on part a medical textbook based testi- and, B hepatitis virus directly address mony from a witness who could not read may that supports hepatitis anything, if articles) underlying and two one of the generally it refers a cause because be Dr. theo- supporting case studies Bellanti’s AIH. causing hepatitis “the viruses” Instead, against petition- ry. he found omitting that special master concluded on an article that on its face also er based “intentional,” but that con- hepatitis was theory by placing Dr. Bellanti’s supports any Put sim- support. is devoid of clusion weight imagined on an omission. great “omitted”; rather nothing was ply, that the putting Even aside article makes blanket statement Krawitt petition- on imposed improper an burden may cause that “the viruses” to show what “is known” about causa- ers in a footnote then cites three studies tion, these warrant reversal. support the article to at the end of in- Although these studies proposition. important peti- It is to remember that a viruses, A and C required produce volve medical tioner is not an there was “omission” suggesting definitively linking literature the vaccine to Althen, a conclusion that was “intentional” reads injury. 418 F.3d at 1280. Cir- simply into the article that is absent. appropriate cumstantial evidence is both causation, and sufficient to demonstrate only support for his including the link between a vaccine where testimony govern- conclusion is the injury previously and an unknown and Koff, Dr. who said he expert, ment’s supporting without direct evidence causa- hearing Dr. Krawitt between ses- spoke to Here, dispute tion. there can be no learned in these out-of-court dis- sions and petitioners’ evidence meets stan- that Dr. Krawitt is not aware of cussions dard, and the master’s reliance on causing B virus autoimmune is, most, an alternative article that silent Master Porter hepatitis. Special of his au- scope on the issue exceeds the Court, I “deeply *14. Like the Claims am thority. particularly given true This is Rotoli, suspicious” of these discussions. master dismissed Bel- n. If the 89 Fed.Cl. at 86 entirety through in its opinion lanti’s Krawitt, it should had from of his “demeanor.” improper assessment directly rely- it rather than presented have I am sensitive to our standard of out-of-court discussions be- While ing belated i.e., not to re- accepting that this court is hearing sessions. Even tween review —

1265 majority The special undisputed or assess the mas- recites weigh evidence evidence, showing strikingly we also are facts close connec- ter’s evaluation affirm a master’s tion between the dates of Ms. Porter’s required to hepatitis B and the wholly implausible. Be- vaccine doses date of findings that are showing in her findings master’s this blood tests abnormal liver cause the level, A Majority Op. I would find that the function. few rise to that case A prong points emphasizing. the first are worth blood petitioners have satisfied day test taken the same Ms. Porter re- Althen. ceived her first dose vaccine, which was two also months after B. she was ordered to finish off and discontin- government does not focus on the The drug minocycline, ue use of the revealed prongs Althen second and third —which that her liver functions were normal. sequence of cause and logical relate to the months, Over the next seven Ms. Porter temporal proximity effect and the be- received her second and third doses of the injury arguing the vaccine and tween —in vaccine. Less than one month independent grounds unrelated to receiving after her third dose of the vac- re- credibility support master’s cine, Ms. Porter’s blood tests showed that claim. jection Appel- of Ms. Porter’s See enzymes her liver were elevated well be- (“In case, spe- Br. 10 Porter’s lant’s yond range. the normal Three tests with- primarily cial master based his decision days the next 17 all revealed the same separate independent on two and ratio- enzyme elevated liver During levels. nales,” identifying Althen prong one time, began nauseated, Ms. Porter feeling minocycline). cause of alternative yellow. itching, turning Later blood Likewise, majority’s findings sup- biopsy work and a liver both revealed re- port master do not address sults consistent with AIH. prongs. perhaps good these There is two Dr. Bellanti testified that a reasonable that, reason for as the expect develop time to AIH to following a points these are findings perhaps on hepatitis B vaccination is between Here, egregious of his decisions. most days. expert report, In his he conclud- to an master held Ms. Porter temporal relationship ed be- “[t]he unreasonably by requiring strict burden tween her immunizations and the onset of identify specific her to date of the ” symptoms medically appropriate.... disease, onset of her rather than a medi- undisputed J.A. 126. The facts this case timeframe, cally appropriate to demon- fully support opinion. Dr. Bellanti’s relationship strate a between her vaccine blood test run on the date of Ms. Porter’s time, injury. and her At the same first B vaccine showed normal recognized master himself levels, enzyme liver and a blood test taken particulars of Ms. Porter’s AIH made days after Ms. third hepatitis Porter’s specific finding virtually impossi- such a B vaccine dose revealed elevated liver en- on ble. Based this unreasonable stan- zymes. 24-day period squarely fits This dard, rejected Dr. Bel- day within Dr. Bellanti’s 14 to 40 time- testimony being lanti’s unrebutted too frame. “vague.” point this must be overturned because There is no indication the record that they government challenged are not accordance with our well- this it, any law. or to contradict established offered evidence rely any identify specific not on Ms. Porter to date of special master did and the disease, reject to Dr. Bellanti’s contrary special evidence onset for her which the Rather, special the theory on this issue. acknowledged nearly impossi- master was testimony Dr. Bellanti’s found that ble, master special the master held Ms. Porter to faulted Dr. Bellanti be- “vague” and was unreasonably high Using an standard. the date of “simply does not know cause he improper reject standard to Dr. Bel- this at Special Op. Master Porter *16- onset.” testimony unrebutted errone- lanti’s was time, however, special the 17. At the same ous, special findings and the master’s that “Dr. acknowledged Bellanti’s master issue should be set aside. this justified the knowledge is because lack of prevents anyone information available C. began.” the disease establishing from when * 17 n. He also found that “deter- Id. at 8. Porter has all three Because Ms. met Ms. Porter’s autoim- mining the onset of prongs, Althen she has established causa- difficult, impossi- mune is if Althen, tion. at 418 F.3d 1278. There- ble, to the disease’s insidious onset.” due fore, compensation she is entitled to unless added). Nonetheless, (emphasis *17 Id. at government can preponderant show required master Ms. Porter to evidence that her AIH is due factors “date” her AIH specific establish the be- Althen, unrelated to the vaccine. 418 F.3d that, gan, finding she does not estab- “[i]f 1278; § at see also 42 U.S.C. 300aa- she began, lish the date her disease cannot 13(a)(1)(B). The special master found between a vaccina- establish the interval met proving its burden of of her tion and the onset disease.” Id. minocycline that Ms. of Porter’s use added) Sec’y (emphasis (citing Pafford of likely more than not the cause of her Servs., Health & Human 451 F.3d finding majority that the affirms. The (Fed.Cir.2006)). point again master’s on this plainly decision is erroneous, is for the three independent It in our erroneous. is well-established below, reasons discussed be must re- proximate temporal case law that the rela- versed. tionship injury between the vaccine and First, contrary majority’s to the state- only “medically accept- within a must be ment that the master did not make de Bazan v. able” timeframe. See of credibility determinations to reach his con- 539 F.3d

Health & Human issue, clusions on this master (Fed.Cir.2008) (stating that the stan- expressly improperly assessed Dr. requires proof that “preponderant dard Bellanti’s demeanor in evaluating evi- occurred within a symptoms onset minocy- dence about Ms. Porter’s use which, given timeframe for the medical Specifically, determining cline. that Dr. it understanding etiology, of the disorder’s Bellanti’s demeanor reinforced doubts causation”); medically acceptable to infer credibility, Althen, about his (referring at to a 418 F.3d “appeared] noted that Dr. Bellanti uncom- “medically-acceptable temporal relation- asserting history fortable when that the Indeed, ship”). to which the even case Ms. Porter’s autoimmune shows special his conclu- support cites vaccine, not the mino- “medically acceptable sion refers to a time cycline, caused her disease.” Mas- frame for the onset of the disease follow- vaccination,” one ten ing specific not a ter Porter *30. This was date. Pafford, findings master used to draw By requiring issue, misplacing that Dr. Bellan- burden on this the “reasonable inference” contrary master’s decision is opinion. a flawed to the deliberately ti offered statutory law, scheme and to our case generally it is Given our statement majority error that the overlooks. rely on demeanor to dis- inappropriate quali- of an otherwise count the Finally, Broekelschen, 618 F.3d at expert, fied must set aside because he a be used clear master’s evaluation of Dr. the evaluating double-standard when whether question again demeanor on this Bellanti’s government the met its burden of demon- ran afoul of our case law. strating minocycline that was the alterna- tive cause of Ms. Porter’s AIH. We have

Second, erroneously explained that “the standards that apply to on Porter to dis- placed the burden Ms. petitioner’s proof of actual causation an prove minocycline that was alternative fact in off-table cases should be the same cause, placing rather than the burden on that apply government’s as those to the prove to its case affirma- government proof of alternative actual causation in tively. Although agreed both sides Knudsen, fact.” 35 F.3d at Despite Dr. Bel- minocycline hepatitis, can cause rule, this master held Ms. Port- opined minocycline lanti did not cause higher govern- er to a standard than the Porter’s AIH because her condition Ms. ment on identical issues in specific two stopped taking improve did not when she findings. minocycline, drug-in- a characteristic of supported by duced that is medi- First, although master found supporting cal literature. facts that Dr. inability identify Bellanti’s theory undisputed. Spe- Bellanti’s are See specific inju- date of onset for Ms. Porter’s (“The Op. at *21 factual claim, cial Master Porter ry fatal to was her he excused the predicate opinion for Dr. Bellanti’s is accu- government exacting from this standard. using Porter mino- rate. Ms. discontinued govern- When he considered whether the time, cycline. hep- After this Ms. Porter’s impossible showing ment made the same improve.”). atitis not Dr. Bellanti make, did also that Dr. Bellanti spe- could not only hepati- stated that rare eases does that, summarily cial master found “[t]he persist window, tis and become chronic after dis- temporal despite the inherent un- drug. continuance of the certainty stating when the hepatitis be- gan, appropriate.” Master evidence, In it light of this should have *22. finding Porter This is in stark government’s been the burden to show finding contrast to his on the same issue exception that Ms. Porter was the rare that, does not establish “[i]f [Ms. Porter] rule that an general individual’s condi- began, the date her disease she cannot improve stopping tion will after use of the interval establish the between a vaccina- drug. flipped But the tion and the onset of her disease.” Id. at Porter, by placing it on Ms. fault- burden government *17. There is no evidence the why ing explaining Dr. Bellanti for not Ms. the date Ms. Porter’s established disease Porter was not one of the rare cases. See began, yet failing was not fatal to the Dr. Bellanti (“Although id. was asked to ability government’s to show an alternative why Porter was not one of explain Ms. cause, as it was to Ms. Porter. cases, these rare he failed to answer the addition, no basis for distin- master also con- question provided significance single case stud- guishing Ms. Porter’s case from other sidered literature.”). reported By supporting government’s position in the ies cases rests on summarily discounting single independent grounds case are while supported proper scope Dr. Bellanti’s theo- within the of his discretion. studies that Here, ry Specifically, of causation. in the medical litera- examples on that Ms. Rotoli failed to meet the third

relied prong ture an individual’s contin- Althen where based Ms. Rotoli’s liver minocycline use of stopping ued after biopsy capricious. is not AIH more that Ms. Porter’s show Koff testified that Ms. Rotoli’s liver biopsy by minocycline. than cause likely stage showed such advanced of fibrosis significant, these not- special master found that she must have had the disease for ing “special masters are not to dis- many years, only biopsy but the was taken statistically that a possibility count the eight months after her dose first actually particular in a hand, rare event occurred B hepatitis vaccine. On the other case.” Id. at *21. Bellanti sub- When Dr. Bellanti opine did fibrosis theory his that support mitted articles seen on Ms. Rotoli’s liver could have devel- can cause virus itself oped eight in as little as months. Based however, rejected evidence, these on this master was they single case studies because were pre- within his to find that “[a] discretion studies, “ruling possible that out a such ponderance of the evidence establishes impossible.” coincidence is *13. Ms. Rotoli’s autoimmune be- master, therefore, treated the gan long before she received the government’s examples “statistically vaccine.” Master Rotoli actually therefore, rare occurred” but I, event[s] [that] agree majority *17. with the examples found that Ms. Porter’s were that the Claims Court’s decision should be *13, mere “coincidence.” Id. at 21. Ap- reversed as to Ms. claim.9 Rotoli’s plying different standards to the identical

types by of evidence offered Ms. Porter V. is, explanation and the without definition, arbitrary capricious. If reasons, foregoing For the I although is to mean anything standard short of agree majority with the as to Ms. Rotoli’s discretion, unfettered master’s claim, I would affirm the Claims Court point decision on this cannot stand. claim, respect Ms. Porter’s compensation. she is entitled to I

IV. join cannot majority endorsing Despite inappropri- pervasive master’s errors in his assessments, ate credibility “credibility” assessments, find- and “demeanor” ings, application legal of erroneous legal applied erroneous standards he cases, steps standards his decisions in these I at several analysis, his and his agree majority with the the special evaluating parties’ double standard in rejection claim respective Accordingly, Ms. Rotoli’s evidence. I re- truthful.”). despite though reach this conclusion that he was not Even inappropriate credibility master's assessments special master’s demeanor assessments were ("Dr. prong. of Dr. Bellanti as to this See id. indeed, glaringly so—the evidence error^— Bellanti lacked about when the au- biopsy, of Ms. Rotoli’s liver and Dr. Koff’s began.... toimmune Dr. Bellanti’s testimony interpreting biopsy, were inde- suggested, demeanor when he testified at a pendently support sufficient to minimum, that he lacked confidence in his master’s conclusion. worst, suggested statement. At demeanor his portion of the dissent as to that spectfully

majority opinion.

Case Details

Case Name: Porter v. Secretary of Health and Human Services

Court Name: Court of Appeals for the Federal Circuit

Date Published: Nov 22, 2011

Citation: 663 F.3d 1242

Docket Number: 19-2011

Court Abbreviation: Fed. Cir.