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No. 04-l128 V

(Filed Under Seal: April 1 8, 2016)

(Reissued: May 3. 20161.

UNPUBLISHED MAY - 3 20t6

U.S. COURT OF

FEDERAL CI-AIMS DARIUS AND TERESITA CANUTO.

on behalf of DAC,

Petitioners,

National Childhood Vaccine

Injury Act, 42 U.S.C. $ 300aa-1-34;

Motion for Review; Pro se

Petitioners

THE SECRETARY OF HEAI-TH AND

IJUMAN SERVICES,

Respondent.

Darius and Teresita Canuto, pro s€, petitioners.

Voris Edward Johnson, United States Department of Justice, Civil Division,

Washington, DC, for respondent.

OPINION AND ORDER

YOCK, Senior Judge.

This case comes before the court on petitioners' motion for review of Special

Master Hastings' decision, which denied the petitioners' claim for compensation under

the National Vaccine Injury Compensation Program. 42 U.S.C. $ 300aa-10 el seq

(2012 ed.). After thorough consideration of the entire record in this matter, the court will

deny petitioners' motion and aftlrm the special master's decision.

FACTUAL BACKGROUND

Special Master Hastings provided an exhaustive recitation of the facts in his

decision. Dec. at 8- 13. The court refers readers to that decision for a comprehensive

* This opinion originally was issued under seal on April 18,2016. The court afforded the parties an opportunity to

propose redactions in the opinion prior to its reissue. No such redactions wcre proposed.

FILED
discussion of the facts of this case. However, the court will provide a brief overview of

the case's most pertinent facts for the convenience ofthe reader.

Petitioners' son ("DAC") was born on July 17, 2000, in Bocaue, Philippines. Ex.

4 at 1 . His physicians noted that he was a "well baby" and in good health. Ex. 13 at 1.

He received several routine early childhood vaccines, including two doses ofa combined

diphtheria, tetanus, and whole-cell pertussis as well as a hepatitis B vaccine.r Ex. 13 at 1-

2.

Several months later, petitioners and their son relocated to Los Angeles,

Califomia, where DAC received additional vaccinations, including a vaccine for

diphtheria, tetanus, and acellular pertussis. Ex. I 5 at 1 -3. Around this time, DAC also

received vaccinations for haemophilus influenzae type b, measles, mumps, rubella, and

chickenpox.

Beginning at his one year checkup, on August 3,2001, DAC's physicians noted

signs of potential developmental delay. Ex. 17. During this visit DAC received a

vaccination for measles, mumps, and rubella. Over the next few months, DAC continued

to struggle with speech and language development and was diagnosed with severe to

profound expressive and receptive language disorder on October 30, 2003. Ex.34 at2.

At this point, DAC had a 40 word vocabulary and did not speak more than one word at a

time. Id.

On March 15,2004, DAC met with a developmental behavioral pediatrician, who

diagnosed him with autism. Ex. 39 at 4, At this stage, his linguistic skills tested at a

developmental age of 30.4 months and his chronological age was 44 months. DAC

displayed delayed language skills, difficulty interacting with peers, and limited play

skills. Ex. 39 at 3. In March of2006, a psychoeducational assessment ofDAC

confirmed his prior autism diagnosis. Ex. 53.

On July 6,2004, Darius and Teresita Canuto filed a short-form autism petition on

behalf of DAC. On December 18, 2015, the special master issued his decision, Canuto v.

Sec'y of Health & Human.9ervs., No. 04-l 128V, 2015 WL 9854939 (Fed' Cl. Sp. Mstr'

Dec. 1 8, 201 5), which denied petitioners' claim. Petitioners filed their motion for review

ofthe special master's decision on January 12,2016. ECF No. 61. The respondent filed

its response on February I1,2016. ECF No. 65.

I The special master noted that DAC's vaccination outside ofthe United States could potentially be fatal to petitioners'

claim. Dec at 19. Petitioners respond that this technical defect should be ignored because vaccines manufactued

outside ofthe United States are sometimes administered domestically. Pet'r's Memorandum ofObjections at 16-17.

Regardless, because the special master's decision does not rely on this issue, the court does not reach the question of

whether this potential defect would have required the denial ofpetitioners' claim.

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STANDARDS

This court has jurisdiction to review a special master's decision in a Vaccine Act

case upon a properly filed petition for review. 42 U.S.C. $ 300aa-12(e)(l). The court

may set aside any of the special master's findings of fact or conclusions of law ifthose

determinations were "arbitrary, capricious, an abuse ofdiscretion, or otherwise not in

accordance with the law ." Id. at 12(e)(2)(B).

The court applies different standards to conclusions of law, findings of fact, and

discretionary rulings. Masias v. Sec'y of Health & Human Servs.,634 F.3d 1283, 1287-

88 (Fed. Cir. 2011)2; see also Munnv. Sec'y of Health & Human Servs.,970 F.2d 863,

87 1 no. 10 (Fed. Cir. 1992); Paffurd v. Sec'y of Health and Human Sens., 64 Fed. Cl. 19,

27 (2005), aff'd,451 F.3d 1352 (Fed. Cir. 2006). The court reviews conclusions oflaw

under the "not in accordance with the law" standard," findings of fact under the arbitrary

and capricious standard, and discretionary rulings under the "abuse of discretion"

standard. Saunders v. Sec'y of Health & Human Servs.,25 F.3d 1031, 1033 (Fed. Cir.

t994).

The arbitrary and capricious standard is "well understood to be the most

deferential [standard] possible." Munn,970F.2dat870. "Ifthe special master'has

considered the relevant evidence ofrecord, drawn plausible inferences and articulated a

rational basis for the decision, reversible error will be extremely difficult to

demonstrate."' Hibbardv. Sec'y of Health & Human Servs.,698 F.3d at 1363 (quoting

Hines on Behalf of Sevier v. Sec'y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed.

Cir. 1991)). "Congress assigned to a group of specialists, the Special Masters within the

Court of Federal Claims, the unenviable job of sorting through these painful cases and,

based upon their accumulated expertise in the field,judging the merits of the individual

cf aims." Deribeaw ex rel. Deribeaux v. Sec'y of Health & Human Servs.,717 F .3d

1363, 1366 (Fed. Cir. 2013) (quoting Hodges v. Sec'y of Health & Human,Servs.,9 F.3d

958, 961 (Fed. Cir. 1993) (internal citations omitted)). It is not the role of this court to

"reweigh the factual evidence," "assess whether the special master correctly evaluated the

evidence," or "examine the probative value of the evidence or the credibility of the

witnesses." Lampe v. Sec'y of Health & Human Servs.,219 F.3d 1357, 1360 (Fed. Cir.

2010).

2 "Under the Vaccine Act, lthe Circuit] review[s] a decision ofthe special master under the same standard as the

Court of Federal Claims." Masias,634 F.3d at 1287.

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DISCUSSION

Petitioners contend that the special master erred in rejecting their theory of

causation between vaccines3 and autism. To be successful, petitioners "must do more

than demonstrate a'plausible' or'possible' causal link between the vaccination and

injury." Il'.C. v. Sec'y of Health & Human Servs.,704 F.3d 1352, 1356 (Fed. Cir. 2013).

The statutory standard requires "a petitioner to demonstrate that the vaccine more likely

than not caused the condition alleged." LaLonde,746F.3d at 1339. In doing so, a

petitioner "must provide a reputable medical or scientific explanation" which is "legally

probable" if not "medically or scientifrcally certain." Moberly,592 F.3d at 1322 (citing

Knudson v. Sec'y of Health & Human.Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994)).

The special master analyzed petitioners' theory under the three-prong test for

causation in offtable claims,a as set forth in Althen v. Sec'y of Health & Human Servs.,

418 F.3d 1274, 1278 (Fed. Cir. 2005).5 Under Althen,petitioners must demonstrate by

preponderant evidence that vaccination brought about the alleged injury by providing: (l)

a medical theory causally connecting the vaccination and the injury; (2) a logical

sequence ofcause and effect showing that the vaccination was the reason for the injury;

and (3) a showing of a proximate temporal relationship between vaccination and injury.

Althen,4lS F,3d at 1278. If a petitioner satisfies this burden, they are entitled to recover

unless thc government dcmonstrates by a prcponderance ofthc cvidence that the injury

was in fact caused by unrelated factors. 1d

The special master determined that petitioners had not carried their burden, finding

that they had not satisfied any of the Althen test's three prongs. Dec. at26-27. Indeed,

the special master concluded that petition ers had "failed to present even a prima facie

case that any of DAC's vaccinations played any role in causing or aggravating his

autism." Dec. at 24 (emphasis included). The special master based his decision to a

considerable extent on the testimony and credibility of the parties' experts, but he also

discussed DAC's medical records and the testimony of his parents and other family

members describing DAC's condition.

The special master meticulously detailed this evidence, providing a comprehensive

and thorough analysis. Dec. at 8-13. Particularly, the special master gave weighty

consideration to DAC's medical records. The special master noted a conflict between

I Petitioners' allege that the measles-mumps-rubella, diphtheria-telanus-pertussis, diphtheria+etanus'acellular

pertussis, hepatitis B, and haemophilus influenzae type b vaccines, or some combination thereof, caused DAC's

autism.

a Autism is not listed on the Vaccine lnjury Table and, therefore, petitioners must demonstrate that the vaccines in

question were the cause-in-fact of DAC's injuries. $ 300aa-13(a)(l)(B); $ 300aa-1 1(c)(lXCXii).

t petitioners submitted a short-form autism petition. To the extent that petitioners allege other, non-autism-based

causation theories, those theories cannot be raised here because they were not alleged in the petition considered by the

special master.

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DAC's contemporaneous medical records and petitioners' testimony. Dec. at 12.

Although petitioners allege that DAC suffered from seizures, his contemporaneous

medical records showed no support for this claim. The special master found that this was

particularly troubling since petitioners contended that DAC suffered nine different

seizures over a three-year period. Id. (citingEx.2l at 2). The special master commented

that for DAC's pediatricians to "not recognize and not record a description of a seizure in

one instance would be unusual enough." 1d Ultimately, the special master concluded

that DAC's medical records provided the most credible evidence on DAC's symptoms,

noting that, where conflict exists, medical records are "frequently accordIed] more

weight" than conflicting subsequent testimony. 1d

The special master next considered the testimony from the parties' experts, Dr.

Max Wiznitzer, for respondent, and Dr. Mark Levin, for petitioners. Dec. at 20-28. The

special master began his analysis with a comparison of Dr. Wiznitzer's and Dr. Levin's

credentials. Dec. at 15. The special master found that Dr. Wiznitzer was very credible,

citing his specialty in pediatrics and developmental disorders and extensive history with

neurology and autism. /d. Conversely, the special master noted that Dr. Levin had

limited experience with autism and found that Dr. Levin's his specialty in the fields of

oncology and hematology lent his opinion less weight. The special master then turned to

Dr. Levin's theory connecting the DTP vaccine and autism. Dec. at 21.

Dr. Levin based his theory on the general rise ofautism rates in the United States

and the timing between vaccination and autism onset in DAC's specific case' Levin

Report at 3-4. The special master did not find Dr. Levin's theory credible, describing it

as "largely, if not entirely, unsupported speculation." Dec. at 21. The special master

found that Dr. Levin did not actually offer any scientific support for the notion that the

DTP vaccine can cause autism and concurred with Dr. Wiznitzer's observation that Dr.

Levin "offer[ed] no causal theory whatsoever." Id. (citing Ex. A at 6). The special

master also noted Dr. Levin's admission that this theory is debatable, finding Dr. Levin's

opinion "equivocal in addition to unsupported." Id. The special master concluded that

Dr. Levin's opinion on this point was ultimately "wholly unpersuasive regarding every

element necessary to proving causation-in-fact." Id.

The special master was similarly unpersuaded by Dr. Levin's opinion on whether

vaccines caused autism in DAC specifically. The special master found Dr' Levin's

opinion inadequate because it was "predicated entirely" on the alleged temporal

relationship between DAC's vaccinations and injury. As the special master noted, "a

temporal connection alone is not enough to demonstrate causation." Dec. at22 (quoting

LaLonde v. Sec'y of Health & Human Servs.,'146 F.3d 1334, 1341 (Fed. Cir. 2004)).

The special master was also troubled by Dr. Levin's confusion over the record.

Dec. at 22-23. The special master noted that "Dr. Levin's very limited discussion of

DAC's medical history was mistaken on the critical point of identifoing the type of

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vaccinations that DAC actually received." Dec. at22. The special master commented

that Dr. Levin's confusion resulted in an expert report that was "actually quite

incoherent." Dec. at 22-23.

In sum, the special master weighed the opinions of Dr. Levin and Dr. Wiznitzer6

on petitioners' theory for causation and determined that the latter "was far more

persuasive." Dec. at24. The special master found that Dr. Wiznitzer "fully rebutted" Dr.

Levin's "very weak" opinion and that Dr. Wiznitzer was both better qualified and better

supported by the facts. Id. In the special master's view, Dr. Wiznitzer's opinion

provided "an explanation of DAC's condition that better accounts for DAC's complete

medical history." 1d

The special master's assessment of the experts, medical records, and other

evidence and conclusion that petitioners had failed to demonstrate a causal link between

DAC's vaccines and autism was not arbitrary or capricious. The record reflects that the

special master carefully and thoroughly weighed the evidence before him and determined

that petitioners had not provided a legally probable theory of causation-in-fact. The

special master appropriately evaluated the parties' expert witnesses' credibility, citing

their credentials, mastery of DAC's medical records, and ability to support their theories.

The court also notes that causation theories based on autism have been uniformly

rejected. An initial round oftest claims based on autism theories were brought and

denied as part of an omnibus proceeding. Cedillo v. Sec'y of Health & Human Servs.,

617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec'y of Health & Human,9ervs., 604 F.3d

1343 (Fed. Cir.20l0); Snyderv. Sec'y of Health & Human,lervs., 88 Fed. Cl. 706

(2009); Dwyer v. Sec'y of Health & Human Servs., No. 03-1202V , 2010 WL 892250

(Fed. Cl. Spec. Mstr. Mar.12,201); Kingv. Sec'y of Health & Human Servs., No. 03-

584V,2010 WL892296 (Fed. Cl. Spec. Mstr. Mar 12,2010); Meadv. Sec'y of Health &

Human Servs., No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12,2010).

Subsequently, special masters have rejected numerous claims based on autism.?

6 'l'he court notes that the petitioners, themselves, provided the special master with documenls purporting to

demonsfate a causal link between vaccines and autism. The special master found that petitioners were not qualified

to make assertions based on these submissions under 42 U.S.C. $ 300aa a13)(a)(l). In the altemative, the special

master found that Dr. Wiznitzer's contrary opinion was more persuasive.

7 See e.g.,Blake v. HHS, No. 03-31V, 2014 WL 2'169979 (Fed. Cl. Spec. Msfi. Vowell May 21, 2014); Henderson y.

HHS, No.09-616V,2012WL 5194060 (Fed. Cl. Spec. Mstr. Vowell Sept.28,20l2): Franklin v. HHS, No.99- 855V,

20 | 3 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16, 2013); Coombs v. HHS, No. 08-81 8V, 2014 WL 1677584

(Fed. Cl. Spec. Mstr. Hastings Apr. 8, 2014); Long v. HHS, No. 08-792V,2015 WL l0l 1740 (Fed. Cl. Spec. Msrr.

Hastings Feb. 19, 2015); Brook v. HHS, No. 04-405V, 2015 WL 3799646 (Fed. Cl. Spec. Mstr. Hastings May 14,

2015); Holt v. HHS, No. 05-136V, 2015 WL 4381588 (Fed. Cl. Spec. Mstr. Vowell June 24, 2015); Lehner v. HHS,

No, 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. Vowell July 22, 2015); Miller v. HHS, No. 02-235V, 2015

WL 5456093 (Fed. Cl. Spec. Mstr. Vowell August 18, 2015); Allen v HHS, No, 02-1237V,2015 WL 6160215 (Fed.

CI. Spec. Mstr. Vowell Sept.26,2015): R.K. v. HHS (Fed. Cl. Spec. Mstr. Vowell Sept. 28,20t5).

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It is not the role of this court to reconsider the "probative value of the evidence or

the credibility of the witnesses." Lampe,2l9 F.3d at 1360. Here, the special master "has

considered the relevant evidence ofrecord, drawn plausible inferences and articulated a

rational basis for the decision" and, therefore, the court will not disturb his decision in

this case. Hines,940 F.2d at 1528.

CONCLUSION

Accordingly, petitioners' MOTION for review is DENIED. The special master's

decision is affirmed. The Clerk is hereby directed to enter judgment according to the

special master's decision.

IT IS SO ORDERED.

Robert J. Yock

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