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OFFICE OF SPECIALMASTERS No. 04-1128V (To be published)



### * * * * ** * *** * * **** ** * * ** **** * * * DARIUS CANUTO and TERESITA CANUTO, Parents ofDAC,
Petitioners,
v.
SECRETARY OF HEAL TH AND HUMAN SERVICES, Respondent. 

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## * * * 

## * * * * * * * ** * *** * * * * * * * * * * * * * * * * * * * ** * * 

# FILED DEC 18 2015

OSM U

.S

. COURT OF FEDERAL CLAIMS

Filed: December 18, 2015

Vaccine Act Entitlement; Autism; DTP vaccine; DTaP vaccine; Decision without a Hearing.

Darius and Teresita Canuto, Panorama City, CA, prosepetitioners

. Lynn E. Ricciardella, US Departmentof Justice, Washington, DC,for respondent.



### DECISION

HASTINGS,SpecialMaster

This is an action in which the Petitioners, Darius and Teresita Canuto, seek an award under the National Vaccine Injury Compensation Program (hereinafter "theProgram" 1), on account ofa disorder oftheir son, DAC, known as an "autism spectrum disorder" ("ASD"), which they believe was caused by his receipt of, interalia, a series ofdiphtheria, pertussis, and tetanus ("DTP") vaccinations. 2 Forthe reasons set forth below, I concludethatPetitioners are not entitled to an award.

1The applicable statutory provisions defining the Program are found at 42 U.S.C

. § 300aa-l0 etseq. (2012 ed.). Hereinafter, for ease ofcitation, all "§" references will be to 42 U

.S

.C. (2012 ed.). At this time, I may also refer to the Act ofCongress that created the Program or the "Vaccine Act."

2 In fact, Petitioners at various times have pointed to a number ofDAC's vaccinations as allegedly being causal; however, as described in greater detail below, this Decision focuses primarily on DAC's DTP vaccines, because those are the only vaccinations addressed by Petitioners' expert in this case.I
THE APPLICABLE STATUTORY SCHEME
Underthe National Vaccine Injury CompensationProgram, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number offactual demonstrations, including showingthat an individual received a vaccination covered by the statute; received it inthe United States; suffered
a serious, long-standing injury; and has received no previous award or settlement on account of the injury. Finally and the key question in most cases underthe Program

- the petitionermust also establish a causal linkbetweenthe vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence ofwhat has been called a "Table Injury." That is, it may be shown thatthe vaccine recipient suffered an injury ofthe type enumerated inthe "Vaccine Injury Table," correspondingto the vaccination in question, within an applicable time period following the vaccination also specified in the Table. Ifso, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitledto compensation, unless it is affirmatively shown that the injury was causedby some factor otherthan the vaccination.§ 300aa-13(a)(l)(A); § 300aa-ll(c)(l)(C)(i); § 300aa-14(a); § 300aa-13(a)(l)(B).
In other cases, however, the vaccine recipient may have suffered an injury not ofthe type covered in the Vaccine Injury Table. In such instances, an alternative means exists to demonstrate entitlementto a Program award. That is, the petitioner may gain an award by showing that the recipient's injury was "caused-in-fact"by the vaccination in question. § 300aa13(a)(l)(B); § 300aa-1 l(c)(l)(C)(ii). ("Causation-in-fact" is also known as "actual causation.") In such a situation, the presumptions available underthe Vaccine Injury Table are inoperative. The burden is on the petitionerto introduce evidence demonstrating thatthe vaccination initially caused, or significantly aggravated, the injury in question. A/then v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines 

### v. HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of "causation-in-fact" must satisfy the "preponderance ofthe evidence" standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(l)(A); see alsoA/then, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must show that it is "moreprobable than not" that the vaccination initially caused or aggravated the injury. A/then, 418 F.3d at 1279. The petitioner need not show thatthe vaccination was the sole cause or eventhe predominant cause ofthe injury or aggravation, but must demonstrate that the vaccination was at least a "substantial factor" in causing or aggravating the condition, and was a "butfor" cause. Shyface 

### v. HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply "proofofa logical sequence ofcause and effect showingthatthe vaccination was the reason for the injury;" and the logical sequence must be supported by "reputable medical or scientific explanation, i.e., evidence in the form ofscientific studies or expert medical testimony."A/then, 418 F.3d at 1278; Grantv. HHS, 956F.2d 1144, 1148(Fed.Cir.1992).
TheA/then court also provided additional discussion ofthe "causation-in-fact" standard,
as follows: Concisely stated, Althen's burden is to showby preponderant evidencethatthe vaccination brought about her injury byproviding: (1) a medical theory causally connectingthe vaccination and the injury; (2) a logical sequence ofcause and effect showing that the vaccination was the reason for the injury; and (3) a

2showing ofproximatetemporal relationship between vaccination and injury. If Althen satisfies this burden, she is "entitledto recover unless the [government] shows, also by a preponderance ofthe evidence, that the injury was in fact caused by factors unrelated to the vaccine."
Al then, 418 F.3d at 1278 (citations omitted). TheAlthen court noted that a petitionerneed not necessarily supply evidence from medical literature supporting petitioner's causation contention,
so long as the petitioner supplies the medical opinion ofan expert. (Id. at 1279-80.) The court also indicated that, in finding causation, a Program fact-finder mayrely upon "circumstantial evidence," which the court found to be consistent with the "system created by Congress, in which close calls regarding causation are resolved in favor ofinjured claimants." 

### (Id. at 1280.)
SinceAlthen, the Federal Circuithas addressed the causation-in-fact standard in several additional rulings, which have affirmed the applicability oftheAl then test, and afforded further instruction for resolving causation-in-fact issues. In Capizzano v. HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006), the court cautionedProgram fact-finders against narrowly construingthe second element oftheAlthen test, confirmingthat circumstantial evidence and medical opinion, sometimes in the form ofnotations oftreating physicians in the vaccinee's medical records, may in a particular case be sufficientto satisfy that second element oftheAlthentest. BothPaffordv. HHS, 451F.3d1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir. 2007), discussed the issue ofwhich partybears the burden ofruling outpotential non-vaccine
causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue ofwhat evidence the special master may consider in decidingthe initial question ofwhether the petitionerhas met her causation burden. The issue ofthe temporal relationship between vaccination and the onset ofan alleged injury was further discussed in Locane v. HHS, 685 F.3d 1375 (Fed. Cir. 2012), and 

### WC 

### v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly 

### v. HHS, 592 F.3d 1315 (Fed. Cir. 2010), concludedthatthe "preponderance ofthe evidence" standard that applies to Vaccine Act cases is the same as the standard used in traditional tort cases, so that conclusive proofinvolving medical literature or epidemiology is not needed, but demonstration ofcausation mustbe more than "plausible" or "possible." BothAndreuv. HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Porter v. HHS, 663 F.3d 1242 (Fed. Cir. 2011), considered when a determination concerning an expert's credibility may reasonably affect the outcome ofa causation inquiry. Broekelschen v. HHS, 618 F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special masterto determine the reliability ofa diagnosis before analyzing the likelihood ofvaccine causation. Lombardi v. HHS, 656 F.3d 1343 (Fed. Cir. 2011), and Hibbardv. HHS, 698 F.3d 1355 (Fed. Cir. 2012), both again explored the importance ofassessing the accuracy ofthe diagnosis that supports a claimant's theory ofcausation. Doe II v. HHS, 601F.3d1349 (Fed. Cir. 2010) and Deribeaux v. HHS, 717 F.3d 1363 (Fed. Cir. 2013), both discuss the burden ofproofnecessary to establishthat a "factor unrelated" to a vaccine may have caused the alleged injury.
Another important aspect ofthe causation-in-factcase law under the Program concerns the factors that a special master should consider in evaluatingthe reliability ofexperttestimony and other scientific evidence relating to causation issues. In Daubertv. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court listed certainfactors that federal trial courts should utilize in evaluatingproposed experttestimony concerning scientific issues. In Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal Circuitruled that it is

3appropriate for special masters to utilize Daubert's factors as a framework for evaluating the reliability ofcausation-in-facttheories presented in Program cases.

II
BACKGROUND: THE OMNIBUS AUTISM PROCEEDING ("OAP")
This case is one ofmore than 5,400 cases filed under the Program in which petitioners alleged that conditions known as "autism"or "autism spectrum disorders" ("ASD")3 were caused by one or more vaccinations. A special proceeding known as the Omnibus Autism Proceeding ("OAP") was developed to manage these cases withinthe Office ofSpecial Masters ("OSM"). A detailed history ofthe controversy regarding vaccines and autism, along with a history ofthe development ofthe OAP, was set forth in the six entitlement decisions issued as "test cases" for two theories ofcausation litigated in the OAP (see cases cited below), and will only be summarized here.
A group called the Petitioners' Steering Committee ("PSC") was formed in 2002 by the many attorneys who represented Vaccine Actpetitioners who raised autism-related claims. About 180 attorneys participated in the PSC. Theirresponsibility was to develop any available evidence indicating that vaccines could contribute to causing autism, and eventually presentthat evidence in a series of"testcases," exploring the issue ofwhether vaccines could cause autism, and, ifso, in what circumstances. Ultimately, the PSC selected groups ofattorneys to present evidence in two different sets of"testcases" during many weeks oftrial in 2007 and 2008. In the six test cases, the PSC presentedtwo separate theories concerning the causation ofASDs. The first theory alleged that the measlesportion ofthe measles, mumps, rubella ("MMR") vaccine could cause ASDs. Thattheory was presented in three separate Programtest cases during several weeks oftrial in 2007. The second theory alleged that the mercury contained in thimerosal-containing vaccines could directly affect an infant's brain, thereby substantially contributing to the causation ofASD. That theory was presented in three additional test cases during several weeks oftrial in 2008.
Decisions in each ofthe three test cases pertainingto the PSC'sjirsttheory rejected the petitioners' causationtheories. Cedillo v. HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), a.ff'd, 89 Fed. Cl. 158 (2009), a.ff'd, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd, 88 Fed. Cl. 473 (2009), qff'd, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), qff'd, 88 Fed. Cl. 706 (2009).4 Decisions in each ofthe three "test cases" pertaining to the PSC's secondtheory also rejected the

3 "Autism Spectrum Disorder" is ageneral classification, which as of2010 included five different specific disorders: Autistic Disorder, Childhood Disintegrative Disorder, Asperger's Syndrome, Rett Syndrome, and Pervasive Developmental DisorderNot Otherwise Specified (PDD-NOS). King v. HHS, No. 03-584V, 2009 WL 892296 at *5 (Fed. Cl. Spec. Mstr. Feb. 12, 2010). The term "autism" is often utilized to encompass all ofthe types ofdisorders falling within the autism spectrum. (Id.) Irecognize that since the OAP test cases, the consensus description of ASDs, contained now in the "DSM-V" as opposed to the prior "DSM-IV," revises the prior subcategories ofASD set forth in the first sentence ofthis footnote. However, the DSM-V retains the same general description ofASDs.

4 The petitioners in Snyder did not appeal the decision ofthe U.S. Court ofFederal Claims.

4petitioners' causationtheories, and the petitioners in each ofthose three cases chose not to appeal. 

### Dwyer v. HHS, No. 03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 201 O); 

### King v. 

### HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar 12, 2010); 

### Meadv. 

### HHS, No. 03-215V, 2010 WL 892248 (Fed. CL Spec. Mstr. Mar. 12, 2010).
The "test case" decisions were comprehensive, analyzing in detail all ofthe evidence presented onboth sides. The three test case decisions concerningthe 

### PSC'sfirst theory (concerning the MMRvaccine) totaled more than 600 pages ofdetailed analysis, and were solidly affirmed in many more pages ofanalysis in three differentrulings by three different judges ofthe United States Court ofFederal Claims, and in two rulings by two separate panels of the United States Court ofAppeals for the Federal Circuit. The three special master decisions concerningthe PSC's

### secondtheory (concerning vaccinations containingthe preservative "thimerosal") were similarly comprehensive.
All told, the 11 lengthy written rulings by the special masters, thejudges ofthe U.S. Court ofFederal Claims, and the panels ofthe U.S. Court ofAppeals for the Federal Circuit 

### unanimously rejectedthe petitioners' claims, finding no persuasive evidence that eitherthe MMRvaccine orthimerosal-containing vaccines couldcontribute in any way to the causation of autism.Thus, the proceedings in the six "test cases" concluded in 2010. Thereafter, the Petitioners in this case, and the petitioners in other cases within the OAP, were instructed to decide howto proceed with their own claims. The vast majority ofthose autism petitioners elected eitherto withdrawtheir claims or, more commonly, to request that the special master presiding overtheir case decide their case on the writtenrecord, uniformly resulting in a decision rejecting the petitioner's claim for lack ofsupport. However, a small minority ofthe autism petitioners have electedto continue to pursue their cases, seeking other causationtheories and/or other expert witnesses. A few such cases have gone to trial before a special master, and in the
cases ofthis type decided thus far, all have resulted in rejection ofpetitioners' claims that vaccines played a role in causing their child's autism. 

### See, e.g., Blake v. HHS, No. 03-31V, 2014 WL 2769979 (Fed. CL Spec. Mstr. Vowell May 21, 2014) (autism not causedby MMR vaccination); 

### Henderson v. HHS, No. 09-616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Vowell Sept. 28, 2012) (autism not causedby pneumococcal vaccination); 

### Franklin v. HHS, No. 99- 855V, 2013 WL 3755954 (Fed. CL Spec. Mstr. Hastings May 16, 2013) (MMRand other vaccines found not to contribute to autism); 

### Coombs v. HHS, No. 08-818V, 2014 WL 1677584 (Fed. CL Spec. Mstr. Hastings Apr. 8, 2014) (autism not caused by MMRor Varivax vaccines); 

### Longv. HHS, No. 08-792V, 2015 WL 1011740 (Fed. Cl. Spec. Mstr. Hastings Feb. 19, 2015) (autism not caused by influenzavaccine); 

### Brookv. HHS, No. 04-405V, 2015 WL 3799646 (Fed. Cl. Spec. Mstr. Hastings May 14, 2015) (autism not caused by MMRor Varivax vaccines); 

### Holt
v. HHS, No. 05-136V, 2015 WL4381588 (Fed. Cl. Spec. Mstr. Vowell June 24, 2015) (autism not caused by Hepatitis B vaccine); 

### Lehner v. HHS, No. 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. Vowell July 22, 2015) (autism not caused by influenzavaccine); 

### Miller v. HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Vowell August 18, 2015) (ASD not causedby combination ofvaccines);

### Allen vHHS, No. 02-1237V, 2015 WL 6160215 (Spec. Mstr. Vowell Sept. 26, 2015) (autism not causedby MMRvaccination); 

### R.K. v. HHS (Spec. Mstr. Vowell Sept. 28, 2015) (not yet published) (autism not causedby influenzavaccine) (on appeal); 

### Hardy

5v. HHS, No. 08-108V, 2015 WL 7732603 (Fed. Cl. Spec. Mstr. Hastings Nov. 3, 2015) (autism not caused by several vaccines).
In addition, some causation autism claims have beenrejected without trial, at times over the petitioner's objection, in light ofthe failure ofthe petitionerto file plausible proofof vaccine-causation. See, e.g., Waddell v. HHS, No. 10-316V, 2012 WL 4829291 (Fed. Cl. Spec. Mstr. Campbell-Smith Sept. 19, 2012) (autism not causedby MMRvaccination); Bushnellv. HHS, No. 02-1648, 2015 WL 4099824 (Fed. Cl. Spec. Mstr. Hastings June 12, 2015) (autism not caused by multiple vaccines); Miller 

### v. HHS, No. 06-753V, (Fed. Cl. Spec. Mstr. Hastings Sept. 25, 2012) (autism not causedby DTaP orMMRvaccines); Fesanco 

### v. HHS, No. 02-l770V, 2010 WL 4955721 (Fed. Cl. Spec. Mstr. Hastings Nov. 9, 2010); Fresco 

### v. HHS, No. 06-469V, 2013 WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan. 7, 2013); Pietrucha 

### v. HHS, No. 00-269V, 2014 WL 4338058 (Fed. Cl. Spec. Mstr. Hastings Aug. 22, 2014). Judges ofthis court have affirmed the practice ofdismissal without trial in such a case. E.g., Fesanco 

### v. HHS, 99 Fed. Cl. 28 (Judge Braden affirming).
In none ofthe rulings sincethe test cases has a special master orjudge found any meritin
an allegation that any vaccine can contribute to causing autism.5



### III
PROCEDURAL HISTORY

On July 6, 2004, Darius and Teresita Canuto ("Petitioners"), actingprose, filed a ShortFormAutism Petition for Vaccine Compensation onbehalfoftheir son, DAC. After filing their petition, from August 2004 through August 2013, Petitioners were represented, at different times, by attorneys Clifford Shoemaker, Thao Ho, and Harry G. Potter. Petitioners' last attorney, Mr. Potter, withdrew as counsel in August 2013, and Petitioners have sincethen again been proceedingpro se. Subsequentto the filing oftheir petition, the case was stayed pendingthe outcome ofthe above-described OAP "test cases." (See Notice Regarding "Omnibus Autism Proceeding" dated 7/22/2004 (ECF No. 2).) On October4, 2004, Respondent filed a "Rule 4(c) Report" urging that compensation be denied. (ECF No. 6.)
After the proceedings in all ofthe OAP test cases became final, on January 30, 2013, I issued an order instructing the Petitioners to determine howthey wished to proceed inthis case. (See Order dated January 30, 2013 (ECF No. 16).) Aftertheir final attorney's motion to withdraw from the case was granted on August 22, 2013, I again issued to Petitioners orders

5 In Wright v. HHS, No. 12-423V, 2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21, 2015), Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a "Table Injury" after a vaccination. However, she stressed that she was not finding that the vaccinee's ASD in that case was "caused-in-fact" by the vaccination--to the contrary, she specifically found that the evidence in that case did not support a "causation-in-fact" claim, going
so far as to remark that the petitioners' "causation-in-fact" theory in that case was "absurd." 2015 WL 6665600, at* 2.

6instructing them to inform me ofhow they wished to proceed, and to file medical records pertainingto DAC ifthey wished to pursue their case. 

### (See Orders dated August 22 and 27, 2013, ECF Nos. 26, 27.) OnNovember 13, 2013, Petitioners filed Exhibits 1to 84, consisting chiefly ofDAC's medical records. (ECF No. 30.)

On January 2, 2014, Respondent filed a statement addressing whether this claim should proceed. (ECF No. 33.) Respondent statedthat Petitioners had not identifiedwhichvaccines injured DAC, or when the alleged injury began. (Id.) On January 24, 2014, Petitioners filed a response, addressing the first sign or symptom ofDAC's injury. (ECF No. 35.) Subsequently, on October 1, 2014, Petitioners filed, without exhibit numbers, both an expert report by Dr. Mark Levin, M.D. (herein after "Levin Report"), as well as his curriculum vitae (hereinafter "Levin CV"). (ECF No. 44.) On December 10, 2014, Respondent filed an expertreport by Dr. Max Wiznitzer, along with medical literature. (Exhibits A-F.)6

On December 19, 2014, Petitioners filed a documenttitled "Theory ofCausation." The document was divided into tenparts labeled Exhibits Ito IX, along with a final sectiontitled "Recapitulation."7

On January 7, 2015, I ordered Petitionersto file a written submission indicating whether they wished for me to issue a causation decision based onthe written record, or whetherthey would like to propose some otherprocedure. 

### (See my Inquiry to Petitioners, filed January 7, 2015 (ECF No. 49).) Petitioners subsequentlyrequested aruling onthe record, without an evidentiary hearing. 

### (See "Requestto Issue a Decision," filed January 15, 2015 (ECF No. 52).)

On April 2, 2015, Petitioners filed additional medical literature and inquired aboutthe status oftheir case. 8 (ECF No. 51.) On April 8, 2015, I issued an Orderrespondingto Petitioners' "Inquiry" ofApril 2, 2015. I noted that Ihad waited more than a decade for Petitioners to present evidenceto support their case, and would considerthe evidence they filed
on April 2. (ECF No. 53).

6 Respondent filed these materials on compact disc. Respondent's filing made on December 10, 2014, is incorrectly listed on the docket at ECF No. 48 as "Theory ofCausation for exhibits 1-9 on Compact Disc." The latter description, however, refers to Petitioners' filing ofDecember 19, 2014, for which there is no other docket entry.

7 The "Theory ofCausation" filing made by Petitioners on December 19, 2014, consists ofover 400 pages. Although the document does contain some pages from DAC's medical records, it mostly consists ofa collection of excerpts Petitioners copied from various sources (often Wikipedia) interspersed with Petitioners' own commentary regarding the alleged significance ofthe collected excerpts, mostly as they relate to further allegations regarding DAC and various aspects ofhis medical profile (e.g., blood type, genetic profile, etc.).

8 This filing included documents similar in nature to the ones filed on December 19, 2014, (see fn. 7, above) though much sho1ter at 62 pages. Itwas accompanied by about ten medical articles which Petitioners submitted in full, though without exhibit designation. The document itselfis dated March 31, 2015, though it was not received by the Court until April 2, 2015.

7On August 7, 2015, Petitioners filed a documentthey titled "Focus ofReview." (ECF No. 57.) Attached to the document were manymorepages ofadditional materials.9

On September 11, 2015, Petitioners filed an additional inquiry requesting that their case be decided promptly. This request was titled as a "Requestto Issue a Final Decision." 10 (See Motion, September 11, 2015 (ECFNo. 58).)

IV
FACTS

A. Medicalrecords

DAC was delivered viacaesarean section onJuly 17, 2000, inBocaue, Philippines, after
a full-term pregnancy. (Ex. 4 at 1; Ex. 11, p. 1.) DAC vomited in the first hours oflife and showed mildjaundice. (Ex. 11, pp. 3-4.) He was discharged afterthree days. 

### (Id., p. 4.)

DAC's early pediatric carethrough his fifth month oflife was provided by Dr. Gonzales ofBocaue, Philippines. 11 (Ex. 13, p. 3.) Dr. Gonzales noted DAC to be a "wellbaby" during his pediatric visits on August 26, 2000, September 26, 2000, and October 25, 2000. 

### (Id., p. 1.) The only complaint identified by Dr. Gonzales was an early bout oflactose intolerance remedied by a switch to lactose-free formula. 

### (Id., p. 3.) Significantto this case, amongthe early childhood vaccines administeredby Dr. Gonzales were two doses of"Tritanrix" on September 26, 2000 andNovember 23, 2000. 

### (Id., pp. 1-2.) Dr. Gonzales identifiedthe Tritanrixvaccine
as a combined "DPT" (diphtheria, tetanus and whole-cell pertussis) and "Hep B" (hepatitis B) vaccine. 12 

### (Id., p. 1.) Subsequently, from January 2001 through March of2001, DAC was under the pediatric
care ofDr. TeresitaTan, in Los Angeles, California. (Ex. 15.) Duringthis periodhe was treated for a number ofillnesses, including an upperrespiratory infection on January 6, 2001, and

9 This filing includes excerpted pages from the prior filings referenced. It also includes many pages devoted to photographs ofholes in the walls and ceiling of, apparently, Petitioners' apartment. There is no explicit allegation thatthese photographs are in any way related to DAC's vaccine injury claim, nor any explanation ofhow they could berelevant to Petitioners' claim.

10 I am sorry that I was not able to file this Decision soonerthan Ihave, subsequentto Petitioners' "Requestto Issue
a Decision," filed on January 15, 2015. However, I must note that when Petitioners thereafter filed additional materials, apparently intended to supporttheircausation claim, on both April 2, 2015, on August 17, 2015, I was thereby required to review both ofthose sets ofadditional materials before issuingthis Decision.

11 The records provided for Dr. Gonzales (Ex. 13) appearto be an after-the-fact summary ofDr. Gonzales's treatment, written in October of2013; however, DAC's pediatric visits with Dr. Gonzales also appear to be recorded in a baby book maintained by petitioners. (Ex. 12.)

12 Dr. Gonzales's records also indicate that DAC received a dose of"BCG" (atype oftuberculosis vaccine), two doses of"OPV" (oral polio vaccine), and two doses of"Hib" (Haemophilus influenzatype B). (Ex. 13, pp. 1-2.)

8bronchitis on February 5, 2001. (Id., pp. 2-3.) On January 26, 2001, Dr. Tan administered a "Dtap" (diphtheria, tetanus, and acellular pertussis) 13 vaccine as well as an "IPV" (inactivated polio) vaccine, which was noted as his third dose. (Id., pp. 1, 3.) On March 30, 2001, Dr. Tan administered DAC'sthird dose ofHib vaccine. (Id., pp. 1, 5.)
Thereafter, DAC began seeing Dr. Gladys Hope Yerro for his pediatric carethrough the end of2002. (Exs. 16-20.) His first visit with Dr. Yerro was a sick visit on April 4, 2001, approximately five days after his March 30 Hib vaccination. (Ex. 16.) DACpresented withtwo days offever; he also had a cough and cold. (Id., p 1.) His symptoms were attributed to otitis media (ear infection). 14

Dr. Yerro next saw DAC on August 3, 2001, for a one-yearwell check-up. 15 (Ex. 17.) Her developmental notes indicatethat DAC was saying "Dada" and "Baba" and was cruising or walking with support, butthat he had poor weight gain and was "laggingbehind" on speech and language milestones. 16 (Id., pp. 1-2.) Dr. Yerro observedthat DAC was negative for vaccine reactions. (Id., p. 1.) He received MMRand varivax vaccinations at this visit. (Id., p. 2.)

DAC was seen again by Dr. Yerro on October 31, 2001, for acute gastroenteritis, and on November 19, 2001, for an upperrespiratory infection. (Exs. 18-19.) On December 3, 2001, DAC was seen with one week ofcoughing, three nights ofwaking, and constipation. (Ex. 20.) At 16 months ofage, Dr. Yerro noted that DAC's development was limited to one word, "daddy." (Id., p. 1.) Dr. Yerro wrote that DAC "needsto stim[ulate] verbally, advised should have [at] least 10-15 words." (Id., p. 2.) Atthis visit DAC also received Hib and DTaP vaccinations. (Id.) Dr. Yerro again recorded that DAC had not experienced any vaccine reactions. (Id., p. 1.)

Medical records for the years 2002 and 2003 are sparse. DAC wastested for tuberculosis in March of2002. (Ex. 24.) He received a Hepatitis A immunization onJuly 18, 2002, and was seen for acute gastroenteritis on July 30, 2002. (Exs. 25-26.) His vision and hearing were tested
on August 27, 2002, and he underwent a dental extraction under anesthesia in Decemberof2002. (Exs. 28-29.) None ofthese records address DAC's growth and development.

On July 7, 2003, DAC was evaluated for a preschool pre-admissionphysician'sreport. DAC was noted to have a "slight" developmental delay as well as "delayed speech." (Ex. 30, p.

13 Subsequent vaccination records which purported to "copy" DAC's prior vaccinations incorrectly identified this January 26, 2001 vaccination as being a "DPT" vaccine (Ex. 14; Ex. 27, pp. 1, 3); however, I accept Dr. Tan's record as accurate (see fn. 23, below).

14 In fact, the record says the impression is "om." This is a commonly used abbreviation for "otitis media." See, e.g., N.M. Davis, Medical Abbreviations: 32,000 Conveniences at the Expense ofCommunication and Safety (15th ed.), p. 239. Mrs. Canuto likewise confirmed that she understood DAC to have been diagnosed with otitis media at that visit. (Ex. 21, p. 2.)

15 DAC's vaccination record from Dr. Yerro indicates that DAC received a pneumococcal vaccine and a Hepatitis B vaccine on May 3, 2001 (Ex. 22; Ex. 14, pp. 1-2); however, no record for this visit was filed.

16 Significantly, DAC was raised in a bilingual home. Subsequentrecords indicate an increased effort to adjustto speaking English in the home when DAC was over 3 years old. (See, e.g., Ex. 39, p. I.)

91.) At that time, DAC also received his second Hepatitis Avaccination. (Id, p. 3; Ex. 31.) On September 17, 2003, DAC was treated for an upper respiratory infection. (Ex. 32.) Subsequently, a speech/language evaluation on October 30, 2003, indicated that "since infancy, the patienthas had no significant medical conditions. Withthe exception ofspeech and language development, the patient's early developmental milestones were within normal limits. The patient babbled as an infant, when he was not developing language by 2- 

### Yz years, his parents grew concerned. He has about 40 words in his expressive vocabulary and he does notuse 2-word combinations." (Ex. 34 at 1.) Moreover, on the Preschool Language Scale 3 (PLS-3), the auditory comprehension standard was 56, and expressive communication was 62. (Id.) DAC had the ability to initiate a game or social routine. (Id.) DAC was diagnosed with severe to profound expressive and receptive language disorder. (Id. at 2.) During a preschool assessment onJanuary 24, 2004, his teacher wrote that DAC was below 18 months on expressive and receptive language. (Ex. 35 at 2.) Additionally, he did not speak during the assessment, and his eye contact was fleeting. (Id. at 3.) OnFebruary 7, 2004, DAC had an Individualized Education Program (IEP), whichreported that he had attention deficit with speech and language delays. (Ex. 36 at 5.) His assessment stated "severe receptive and language delay will impacthis ability to assess language-based on activities ofthe preschool curriculum." (Id.)

On March 15, 2004, DAC was evaluatedby a developmental behavioral pediatrician, Nancy Brill, M.D. (Ex. 39 at 1.) Her history indicated that he smiled at five months, cooed at six months, and that by age three years and eight months he had attained a vocabulary ofabout sixty words. (Id.) By the time ofhis evaluation, DAC was beginning to form two-word phrases. (Id.) On the Gesell Developmental Testing, his developmental age was 30.4 months at the chronological age of44 months. (Id. at 3.) Dr. Brill diagnosed DAC with autism due to his delayed language skills, difficulty interacting with peers, and limited play skills. He also displayed repetitive behavior like tightening his fists and echo speech. (Id.) Subsequent genetic testing showed no chromosomal abnormality. (Ex. 40.) DAC laterhad a follow-up appointment with Dr. Brill at four years ofage onNovember 19, 2004. (Ex. 42.)

No medical records have been filed for the period from November of2004 until October of2005, otherthan records for twelve speechtherapy sessions from July through October of 2005. (Ex. 47.) Although DAC made some progress, his speech therapy was ended at his mother's request. 

### (Id., p. 7.) Upon discharge from speechtherapy, DAC still had a "severe" receptive and expressive language disorder. (Id.) DAC underwent a number ofeducational evaluations during this period as well. (Exs. 44-46, 48.) During his pediatric visit on October 19, 2005, DAC was noted to have had ahistory of autism and febrile seizures, with the "last one 1year ago." (Ex. 49 at 1.) He could count and spell. (Id.) DAC received occupational therapy at school. His mother declined vaccines because she remarked that they "makehim sick." (Id.)

In March of2006, DAC underwent apsychoeducational assessment at five years ofage to reevaluate his eligibly for special education services. (Ex. 53.) This assessment confirmedhis

10prior autism diagnosis. (Id., p. 11.) Mostofthe remaining records filed in this case pertainto further educational assessments or other academic reports. 

### (See Exs. 56, 59-61, 64-65, 67-72, 75, 77-83.) Petitioners also filed blood and urine test results from October 2006 from The Lord's Hospital in Bulacan, Philippines, for whichthere are not correlatingprogress notes or other records ofany medical visit. (Exs. 57-58.)

A child "well visit" onAugust 15, 2008, notedthat DAC no longer was receiving speech therapy. (Ex. 63 at 2.) At thattime it was also noted that DAC's "teachers were concernedthat they were seeinghim have a 'tremor' towards the end ofthe school year." (Id.) Although DAC's parents at that time gave a history ofseizures from eightmonths to four years ofage, itwas noted ofthe tremor complaintthat "they have not seen this at home." (Id.) Itwas further noted in the medical record that "they say he used to do some hand flapping and shaking when younger but nothing in several years." (Id.) DAC'sphysician felt the shaking was a "behavioral action," but recommended a neurological follow up in light ofthe reported history ofseizures. (Id., p. 3.) Follow-up EEG testing on January 9, 2009, was interpreted as abnormal, showing "occasional right central/parietal sharps" suggestive of"anincreased risk offocal onset seizures." (Ex. 66, p. 2.) However, "clinical correlation" was recommended, and the history oftremor episodes was considered "poorly described." (Id., pp. 1-2.)

In June of2011, DAC underwent genomic testing for mitochondrial disorders. (Ex. 74.) The results were negative. (Ex. 74, p. 1.)

B. Parentalstatementsandaffidavit

In an affidavit, Mrs. Canuto averred that DAC had a fever, cough, and loss ofappetite, after his Hib vaccination ofMarch 30, 2001. (Ex.**21at~3.)** She said that onthe evening of April 3, 2001, she saw "forthe first time his arms, head, legsjerked, there was uncontrollable muscle spasm occurred in his body in an awake state." (Id. at

## if4.) Although she statedthat she didn'tknow it at the time, Mrs. Canuto alleged thatwhather son experienced was a seizure. (Id.,**~** 5.) Additionally, a narrative prepared by Petitioners for this claim stated that on March 30, 2001, after the Hib vaccination, DAC had a fever of 103.2 degrees for two days, and had "convulsions with a cough/ cold for aweek." (Ex. 41, p. 1.)

Ms. Canuto further averred in her affidavit that DAC had seizures on November 19, 2001, June 5, 2002, July 30, 2002, September 30, 2002, December 28, 2002, April 14, 2003, September 17, 2003, and September 5, 2004. (Ex. 21,**~if** 12-14.) Additionally, she statedthatthe seizure ofSeptember 5, 2004, was DAC's last. (Id.**at~** 14.)
Petitioners also submitted excerpts from a daily planning diary they maintained. (Ex. 84.) These pages indicate that Petitioners tracked DAC's medical appointments and some ofDAC's illnesses, includingrecording his various fevers. (Id.) Although somewhat difficultto read, I do not see any reference to seizures or seizure-like symptoms recorded in these entries. (Id.)

At least two ofthese alleged seizures, including the one that Petitioners link to DAC's Hib vaccination on March 30, 2001, coincide with illnesses for which DAC was treated by his pediatricians. In fact, Mrs. Canuto indicated in her affidavitthatthe seizure was the primary

11purpose ofDAC's April 4, 2001, appointmentwith Dr. Yerro. (Ex. 21,**~** 7.) Yet DAC's contemporaneous medical records do not indicate any report ofseizures or seizure-like symptoms at that time. (See, Exs. 16, 19.) As noted above, DAC's seizures were first addressed in the medical records on October 19, 2005. (Ex. 49, p. 1.) Atthat time, no specifics were indicated regarding onset or frequency, only that the last one occurred approximately a year prior. (Id.) A much later record in 2008 identified seizures beginning at eightmonths ofage, but this was simply a notation ofa parentalreportwhichwas offered, as with Mrs. Canuto's affidavit, years after the fact. (Ex. 63, p. 2.) Significantly, an evaluation in October of2003 reported that "since infancy, the patienthas had no significant medical conditions." (Ex. 34 at 1.)

Medical records "warrant consideration as trustworthy evidence." Cucuras v. Sec

### '.Y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed.Cir.1993). Accordingly, where subsequent testimony conflicts with contemporaneous medical records, special masters frequently accord
more weightto the medical records. See, e.g., Reusser v. Secy of Health & Human Servs., 28 Fed. Cl. 516, 523 (1993) ("[W]ritten documentationrecorded by a disinterested person at or soon afterthe event at issue is generally more reliable thanthe recollection ofa party to a lawsuit many years later."). To the extentthat DAC'scontemporaneous medical records showno report ofany seizures or seizure-like symptom, this suggests that Mrs. Canuto's much later affidavit should not be credited with regard to DAC's alleged seizures.

To be sure, I do note that Mrs. Canuto indicates that she did not know at the time that what she was describing was a seizure, describing it instead as uncontrollable muscle spasms including thejerking ofthe arms, head and legs. (Ex. 21, p. 1.) Moreover, later medical records do retroactivelyreference the history ofseizures thatMrs. Canuto alleges. In that regard, "it must be recognized that the absence ofa reference to a condition orcircumstance is much less significantthan a reference which negates the existence ofthe condition or circumstance. Since medical records typically record only a fraction ofall that occurs, the fact thatreference to an event is omitted from the medical records may not be very significant." Murphy v. HHS, 23 Cl. Ct. 726, 733 (Fed. Cl. 1991), ajf'd, 968 F.2d 1226 (Fed. Cir. 1992).

In balancing these considerations inthis case, I do notcreditMrs. Canuto'sreport of seizure activity occurring betweenApril of2001 and September of2004. That a pediatrician would not recognize and not record a description ofa seizure in one instance would be unusual enough. 17 In this case, however, Mrs. Canuto contends that DAC experienced seizures on nine separate occasions throughoutthatthree-plus year period. (Ex. 21, p. 2.) Yet I do notfind a single contemporaneous reference in DAC'smedical records to seizures, or any description of symptoms similarto the muscle spasms andjerkingthat Mrs. Canuto describes. This is particularly significant in that DAC's seizures allegedly occurred, on at leasttwo occasions, at or around the time ofpediatric sickvisits. Nor are these seizures reflected in Petitioners' owndiary entries which otherwise recorded DAC's illnesses, including the illness that allegedly triggered the first seizure, which was recorded only as "gotfever/cough." (Ex. 84, p. 2.) Moreover, the earliest reference to seizure activity inthe medical records in 2005, which is silentregardingthe

17 Despite not recognizing it as a seizure, Mrs. Canuto indicated that she did, in fact, report DAC's April 200I spasms to his pediatrician. (Ex. 22, p. 1.)

12onset ofthis seizure activity, post-dates the October 2003 evaluation whichincluded a report that DAC had had no serious medical issues since infancy.

Nor is the much later 2008 parental report ofearly childhood seizures persuasive corroboration. Atthat time DAC was evaluatedregarding "tremors" noted by his teachers. Although DAC'sparents at that time gave a history ofseizures from eight months to four years ofage, which report ultimately led to an abnormal EEG result, it was noted ofthe tremor complaintthat "they have not seen this athome." (Ex. 63, p. 2.) And indeed, Mrs. Canuto's affidavit does appear to treatthe alleged earlier seizures as distinct from later tremors. (Ex. 21, pp. 2-3.) Itwas further noted in the medical records that "they say he used to do some hand flapping and shaking when youngerbut nothing in several years." (Ex. 63, p. 2.) And, in any event, this report, like Mrs. Canuto's affidavit, came only years afterthe fact. Although DAC's medical records from 2005 and 2008, and particularlythe EEGresults, suggest that DAC may have experienced seizures during those years, they do notlend any support to Mrs. Canuto's contentionthat he was experiencing seizures from around eight months ofage to about four years ofage, let alone that seizures occurred on each ofthe specific dates alleged. Thus, I decline to accept as accurate Mrs. Canuto's after-the-factrecollection that DAC experienced seizures between April of2001 and September of2004. Herrecollection is not consistent with the contemporaneous medical records.


### C. Additional familystatements
Petitioners also submitted several statements by family members, specifically three aunts, describing observations they had made concerning DAC'sbehavior and development. Maria Concepcion C. Lim noted that on December 25, 2001, DAC was delayed in speech, walking, and understanding. (Ex. 21, p. 4.) Teresita C. Tibajia stated that she noticed that DAC was not developing like her own children. (Id., p. 5.) She noted thathe did notwalkuntil 17 months, and that he could not say her name, did not respond to his own name, used repetitive language, and could not converse with people. (Id.) Both aunts characterizedDAC as appearing "like any other child" at about five months ofage. (Id., pp. 4-5.) Virginia C. Cunanan stated that "Hehas
some uncontrolled behavior such as running straight when playing. He doesn'tpay attention when he is being called. He was very aloofand ignores the person who was talking to him." (Id., p. 6.) Ms. Cunanan's statementdid not address the onset ofthose behaviors. Although Ihave consideredthese statements, Ido not find them helpful in resolving this
case. None ofthe details recalled by these family members leaves eitherparty's theory more or less likely to be correct.

13

## v
SUMMARY OFEXPERTWITNESSES' QUALIFICATIONSAND OPINIONS

In this case, Petitioners presented an expertreport ofone medical expert; respondent also presented an expertreport ofone medical expert. At this point, Iwill briefly summarize boththe qualifications and the opinions ofthese expertwitnesses.


### A. Petitioners'expert, Dr. MarkLevin
1. Qualifications

Petitioners rely on the expertreport ofDr. Mark Levin. Dr. Levin attended Yeshiva University, earning a BachelorofArts degree in 1980. (Levin CV, p. 1.) He graduated from SUNY- Downstate Medical College in 1984 with a degree in medicine. (Id.) Duringhis postgraduate training, he was an intern and then resident in internal medicine atNew York Downtown Hospital in New York, NewYork from 1986-1987. He is licensed inNewYork (1990) and NewJersey (2000). (Id.) He was certified by the American Board oflnternal Medicine in 1987, and later certified in Oncology in 1989, and Hematology in 1990. 18 (Id.) Currently, he is the acting chiefofhematology and oncology at the University ofMedicine and Dentistry ofNewJersey- Newark. (Id. at 1.) He has authored 23 articles, several book chapters, and 10 abstracts, which are listed on his CV (Id. at 11-15.)


### 2. Summary of Dr. Levin'sopinion

Dr. Levin'sreport indicated that he believes that DAC's DTP vaccines caused him to suffer fever, seizures, and encephalitis, thereby causing autism. 19 (Levin Report, p.3.) He contended that the temporal relationship betweenthe first symptoms ofDAC's autism and the administration ofDTP vaccine is consistent with reports from literature.20 (Id.) He further contendedthat vaccine causation is supportedby the fact thatthere is an otherwise unexplained increase in autism rates in the United States. (Id.) Dr. Levin also cited unspecified court cases in which Pervasive Developmental Disorder ("PDD"), a condition on the autism spectrum, has allegedly been associated with vaccines, and in which individuals have been compensated inthis Program for injuries caused by DTP and DTaP vaccines. (Id., pp. 3-4.)

18 Dr. Levin's certification in Hematology is marked as "re-certification required" without any reference to recertification since 1990. (Id.)

19 Dr. Levin did not specifically identify which ofDAC's DTP vaccines he believed to be casual. In his summary of DAC's medical history, he noted that DAC received DTP vaccinations on September 26, 2000, November 23, 2000, and January 26, 2001. (Levin Report, p. 2.) The vaccination ofJanuary 26, 2001, however, was actually a DTaP vaccination and not a DTP vaccination as Dr. Levin stated in his report. (See fn. 21, below.)

20 Dr. Levin did not specify what literature he was referencing. Nor did he define or give a time frame for what he considered to be a temporal relationship. Moreover, since he did not identify which specific vaccine(s) out of DAC's series ofDTP vaccines he believed to be causal, he did not actually either explicitly or implicitly identify the actual period ofonset in DAC's own case.
14Ultimately, Dr. Levin opinedthat "I do notconsider the MMRvaccine to be causative in this case, since the first symptoms ofautism were noted on the same [date] that MMRwas administered. However, DTP appears to have caused fever, seizures and encephalitis in this case, which has beenrelated to later development ofautism." (Id, p. 4.) However, Dr. Levin did not explain or substantiate his contention that encephalitis "has beenrelated to later development ofautism." Nor did he describe what he considers to constitute the onset ofDAC's alleged encephalitis.

B. Respondent's expert, Dr. Max Wiznitzer
1. Qualifications Respondent relies on the expertreport ofDr. Max Wiznitzer. Dr. Wiznitzer attendedthe Northwestern University Honors Program and specialized in Medical Education, earning a Bachelor ofScience degree in Medicine in 1975. (Ex. B, p. 1.) Dr. Wiznitzer later graduated from Northwestern University Medical School in 1977 with a degree in medicine. (Id.) During his postgraduate training, Dr. Wiznitzer was aresident in pediatrics at the Children's Hospital Center in Cincinnati, Ohio from 1977 to 1980. (Id.) He also was a fellow in developmental disorders at the Cincinnati Center for Developmental Disorders from 1980 to 1981. (Id) He thereafter became a fellow in pediatric neurology at the Children's Hospital ofPhiladelphiafrom 1981 to 1984. (Id.)

Dr. Wiznitzer was certifiedby the American Board ofPediatrics in 1982, the American Board ofPsychiatry and Neurology in ChildNeurology in 1986, and the National Board of Medical Examiners in 1978. (Id., p. 5.) He has been licensed in Ohio (1979), Pennsylvania (1981), and New York (1984.) (Id.) Since 1986, Dr. Wiznitzer has rotated between Assistant Professor ofPediatrics, Neurology, and International Health at Case Western Reserve University. 

### (Id., p. 2.) He has also had a number ofhospital appointments, including most notably 19 years as either director or co-director ofthe Rainbow Autism Center at Rainbow Babies and Children's Hospital in Cleveland, Ohio. (Id., p. 3.)

Dr. Wiznitzer has also served on the editorial boards ofmanyjournals, including PediatricNeurology, Journal o.fChildNeurology, andLancetNeurology. (Id. at 6.) He has authored or co-authored 68 originaljournal articles, 11 book chapters, and 55 abstracts, which
are listed on his CV. (Id. at 13-23.)



### 2. Summaryof Dr. Wiznitzer's opinion

Dr. Wiznitzer asserted that DAC's clinical course is consistent with ASD, and that he displayed a "typical developmental trajectory" for a child with ASD. (Ex. A, pp. 5-6.) Specifically, Dr. Wiznitzer described a slow acquisition oflanguage skills, with a gradual appearance ofsocial differences, and no reported history ofregression. (Id.) Dr. Wiznitzer stated that there is no evidence in the contemporaneous medical records ofDAC having a seizure, acute encephalopathy, or encephalitis following any DTP vaccination. 

### (Id., p. 6.) He further noted that the medical records specifically note the absence ofany history ofvaccine reactions, on August 3, 2001, and December 3, 2001. (Id.)

15Dr. Wiznitzer also characterized Dr. Levin's theory as "speculative and without biological plausibility or scientific basis." (Id.) Dr. Wiznitzer noted that, in addition to finding
no support for his assertions in DAC'smedical records, Dr. Levin offered no mechanism of injury, and further that, in fact, Dr. Levin "offers no causal theory whatsoever." (Id.) Dr. Wiznitzer disputed Dr. Levin's assertion ofan association between autism and DTP, noting that the epidemiological evidence, to the contrary, favors rejection ofan association between autism and thimerosal-containing vaccines, which he indicated includes DTP vaccines. (Id.)

VI
ISSUES TO BE DECIDED Unfortunately, despite my order to do so (ECF No. 16), Petitioners never filed an amended petition for this case. Therefore, the only petition in the record is Petitioners' shortform Autism Petition. That Petition invokes the Master Autism Petition, whichin turn alleges that "the vaccinee in question has developed aneurodevelopmental disorder, consisting ofan Autism Spectrum Disorder or a similar disorder. This disorder was causedby ameasles-mumpsrubella (MMR) vaccination; by the 'thimerosal' ingredient in certain Diphtheria-TetanusPertussis (DTP), Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B, and Hemophilus InfluenzaType B (HIB) vaccinations; or by some combination ofthe two."
Nonetheless, as noted in the procedural history above, Petitioners have submitted unorthodox filings in this case containing expansive allegations regarding DAC, his vaccinations, and his alleged injury. Specifically, Petitioners' ExhibitIV identifies the following vaccinations as causal ofDAC's injury: Inactivated Polio Virus vaccine (IPV) and Diphtheria Tetanus and Acellular Pertussis vaccine (DTaP), both administered January 26, 2001; Haemophilus Influenzae B Conjugate vaccine (HIB3), administered March 30, 2001; Hepatitis A vaccine, administered March 30, 2001; and Measles, Mumps and Rubella live virus vaccine (MMR) and Varicellavirus vaccine, both administered August 3, 2001. (Ex. IV, p. 2.)
Petitioners' submissions also discuss many concepts related to a variety ofsubject areas, including, inter alia, metabolism, immuneresponse, allergy, inflammation, genetics and enzymology, which they believe are relevant to establishingthat these vaccines caused their son's autism. They do not, however, specify the exact nature ofDAC's alleged injury, referring instead to "DAC's ASD (Autism Spectrum Disorder) or otherinjury." (Ex. I, p. 3.)
However, the expert reportthat Petitioners subsequently filed in this case, in contrast to Petitioners' own expansive claims, opines onlythat DAC's series ofDTP vaccinations caused his injury. (Levin Report, pp. 2-3.) Dr. Levin explicitly opinedthat the MMRvaccine did not cause DAC's injury. (Id., p. 4.) Specifically, Dr. Levin opinedthat "DTP appears to have caused fever, seizures, and encephalitis in this case, which has beenrelated to later development ofautism." (Id., p. 4.)

As described in the following section ofthis Decision, Petitioners' own multiple submissions do not constitute substantial or persuasive evidence in this case. Nor do any of DAC's medical records suggestthat any ofhis vaccinations caused his autism. Therefore,

16notwithstanding the broad allegations containedin Petitioners' own submissions, the issue to be decided in this case is effectively limited to whether Petitioners have established it to be "more probable than not" that DAC'sDTP vaccinations caused an encephalitis or encephalopathy resulting in autism, as their medical expert opined. This is the only claim whichcan fairly be said to have been prosecutedthrough the submission ofminimal medical evidence. Respondent, through submission ofan expertreportby Dr. Max Wiznitzer, disputed that DAC's autism was caused by his DTP vaccinations, or any other vaccinations. (Ex. A, pp. 6-7.) Rather, Dr. Wiznitzer opined that DAC followed "anexpected developmental trajectory" for a child with ASD, and that there is no evidence ofencephalitis or encephalopathy. 

### (Id., p. 6.)

For the reasons described below, Ihave concluded that Petitioners have not presented a claim for which reliefcanbe granted underthe Vaccine Act, andthat, in any event, Petitioners' expert was utterly unpersuasive in his contentionthat DAC experienced a vaccine-caused injury.

VII
PETITIONERS' MULTIPLE SUBMISSIONS REGARDING THEIR THEORY OF CAUSATION
Before considering the expert opinions in this case, Iturn first to the multiple submissions providedby the Petitioners themselves, which were noted inthe procedural history above. This case is unique in that Petitioners have expended a great amount ofeffortin submittingmany hundreds ofpages ofexplanationregarding their ownpersonal views ofhow DAC's vaccinations might have causedhis injury. These submissions are a clear reflection of Petitioners' deep-seated convictionthat DAC's current condition is the result ofhis vaccinations. Nonetheless, Inote thatthe views expressed in these submissions do not constitute a medicalor expert opinion in support ofvaccine-causation. Theytherefore have very little evidentiary value, and are oflittle benefit in deciding this case.
The Vaccine Act states that "[t]he special master or court may not make such a finding [ofeligibility and compensation] based on the claims ofapetitioner alone, unsubstantiatedby medical records or by medical opinion."§ 300aa-13(a)(l). Obviously, these documents were created by Petitioners themselves, who have not demonstrated thatthey are qualified to offer medical opinions. 21 (See, e.g., Ex. I, pp. 2-3 (indicating thatthe "Theory ofCausation"

21 I do note that Mrs. Canuto's affidavit indicates that she is currently a nurse, though she does not identify her training or any ce1tifications. (Ex. 21, p. 1.) Norwould it seem that she has had a long career as a nurse. She averred that she did not have any medical background at the time ofthe alleged onset ofDAC's injury. (Id.) Indeed, DAC's birth certificate indicates that, at least as ofthat date, Mr. Canuto was a "businessman" and Mrs. Canuto was a "government employee." (Ex. 4.) There is nothing further in the record ofthis case to suggestthat either Mr. or Mrs. Canuto has any medical training. Although Mrs. Canuto's nursing background may have provided her with
some basic grasp ofmedical concepts and terminology, a nurse is generally not qualified to offer an opinion regardingthe causation ofmedical conditions, and the content ofPetitioners' submissions touches little, ifat all, on subjects actually related to nursing. Indeed, the asse1tions made in these submissions extend well beyond anything that could reasonably be considered within the training and experience ofa nurse. Moreover, even ifa nurse could be considered qualified to render a medical opinion in certain circumstances, there is nothing in therecord that

17document was prepared by petitionerTeresita Canuto).) Petitioners simply are not qualified to make the assertions contained in these documents regarding eitherthe significance ofDAC's own medical records or the various other materials cited. (See, e.g., Dickerson v. HHS, 35 Fed. Cl. 593 (1996), explaining that even in a Table Injury case, a medical opinion is still necessary to categorizethe reactions described by petitioner as actual symptoms or manifestations ofthe alleged injury.) These documents therefore do not constitute persuasive evidence, especially when weighed againstthe contrary opinion ofRespondent's pediatric neurologist, Dr. Wiznitzer.
Petitioners were advised multiple times that in order to succeed on their claim it would have to be supported by the opinion ofa medical doctor indicatingthat DAC's autism was, "more likely than not," causedby his vaccinations. (See, e.g., Scheduling Order, April 11, 2014 (ECF No. 36); Order, August 22, 2013 (ECF No. 26).) Petitionershave supplied a medical expert's report, from Dr. Levin, butthat expertreport only implicates DAC's series ofDTP vaccinations. (See Levin Report, generally.) Additionally, Dr. Levin'sreport does notoffer any supportto the diverse assertions made in Petitioners' own submissions. Whereas Dr. Levin cited the DTP vaccines as causal, Petitioners' submissions do not listthe DTP vaccines as causal, instead listing many other vaccines. (See, e.g., Ex. IV, p. 2.)

To the extentthat Petitioners' submissions cobbledtogether excerpts from medical literature, those articles have not been filed into the record ofthis case. Moreover, the excerpts are presented withouttheir full and proper context. I am therefore unable to assess the merits of any ofthe cited work. Further, it is quite likely that many, ifnot most, ofthe studies cited were not conducted with regard to determining apotential link betweenvaccinations and autism. To the extentthat Petitioners would seek to extend that work into anew and different context, such extension would have to be supported by expert medical opinion. Yet, despite the fact that Petitioners have indicated thatthey provided these materials to their expert, the theory of causationthey describe is far afield ofanything discussed or cited by Dr. Levin. Rather, the record suggests that Petitioners' own expert, by declining to include Petitioners' theories of causation in his report, effectively rejectedPetitioners' views regarding causation.

The same issue exists in regard to the ten medical articles which Petitioners did file in full. (See ECF No. 51.) Ihave reviewed all ofthese articles and I do not find them helpful in resolving this case. None ofthese articles were cited by Petitioners' expert, and all ofthe articles appear to me to be entirely irrelevantto Petitioners' claim.

Even considering Petitioners' submissions as evidence, I am compelledto note that, despite what appears to have been great effort on Petitioners' part, these submissions remain largely, ifnot entirely, incoherent, and are completely unpersuasive. Again, what Petitioners describe in these filings is far removed from anything addressed by their expert, and appears extremely implausible. Moreover, most ofthe assertions maderegarding DAC are not supported by the medical records, and are entirely speculative. Significantly, none ofDAC's medical records attribute his autism to any ofhis vaccinations.

actually substantiates Mrs. Canuto's nursing background or otherwise speaks to the extent and quality ofhertraining
or experience.

18This leaves Dr. Levin's rep01i, which implicates DAC's series ofDTPvaccines, as the only potentially viablepath for Petitioners to establishthattheir son's autism was, more likely than not, caused byhis vaccinations. Despite Petitioners' lengthy submissions, there is nothing in the evidentiary record offering any persuasive supp01ito any other claim.

VIII
ANY INJURY STEMMING FROM DAC'S DTP VACCINES MAY NOT BE COMPENSABLE AS A MATTEROF LAW, BECAUSE THEY WERE NOT ADMINISTERED IN THE U.S. Turning to Dr. Levin's report, a threshold issue presents itself, inthat Dr. Levin's opinion is restricted to DAC'sDTPvaccinations, which were administered inthe Philippines. (See Levin Report, p. 3; Ex. 13, pp. 1-3.) This may leave Petitioners without a compensable claim, because the Vaccine Act generally limits compensation to injuries resulting from vaccines received inthe United States or its territories. § 300aa-ll(c)(l)(B)(i)(I).

Dr. Levin's report indicatedthat "itis my opinionwithin a reasonable degree ofmedical certainty thatthe DTP vaccine caused [DAC] to develop and manifest autistic spectrum disorder." (Levin Report, p. 3.) He further opinedthat "I do not considerthe MMRvaccine to be causative inthis case, since the first symptoms ofautism were noted onthe same [day] that MMRwas administered. However, DTP appears to have caused fever, seizures, and encephalitis inthis case, whichhas been related to later development ofautism." (Id.)

This matter is unclear, however, since the statue containstwo exceptionsto the general rule that the Program covers only vaccinations administered in the U.S. See § 300aal l ( c)(1 )(B)(i)(II) and (III). Under subpart III ofthat statutory section, the Program does cover vaccinations received outside the U.S. or its territories if--

the vaccine was manufacturedby a vaccine manufacturer located in the United States, and [the vaccinee] returned to the United States not later than 6 months after the date ofthe vaccination.

In this case, from the filed records it is simply unknown whetherthe particularDTP vaccines that DAC received inthe Philippines were covered by the Program or not. Ifthey were not manufactured by a manufacturer located inthe United States, that would be a reason to deny Petitioners' claim, butthe matter is unclear.
Therefore, I will assume for purposes ofthis Decisionthat DAC'stwo DTP vaccines in question were coveredby the Program. Evenunderthat assumption, however, Petitioners' causation claimstill.fails, for reasons setforth below.

19IX

DR. LEVIN'S MISTKENASSUMPTION ABOUT DAC'S VACCINATION OFJANUARY 26, 2001 Significantly, I note that Dr. Levin**misident~fiedDAC's** vaccination ofJanuary 26, 2001,
as a DTP vaccination rather than a DTaP vaccination.22 This might allow for an inference that he intended to rest his opinion at least in part on that January 26 vaccination in additionto the two prior DTP vaccinations. The distinction is significant, because DAC's vaccination of January 26, 2001, was administered inthe United States.23

Dr. Levin, however, explicitly contrastedthe significance ofDTP and DTaP vaccines, indicatingthat "DTaP is now recommendedbecausethe rates ofall reactions following the DTaP vaccine are lowerthan withDTP." (Levin Report, p. 4.) He also stressed that DTP is no longer recommended in the United States. 

### (Id.) This suggests that, notwithstanding the fact that Dr. Levin's opinion erroneously identified DAC's DTaP vaccination ofJanuary 26, 2001, as a DTP vaccination, his decision to specify DTP, and only DTP, in his causation opinion, was deliberate. At no point did Dr. Levin actually opine that a

### DTaP vaccination, such as the one DAC actually received on January 26, 2001, could have caused DAC's condition, despite also acknowledging that DAC did subsequently receive a DTaP vaccination in December of2001.24

22 In his medical summary, Dr. Levin indicates that DAC received DTP vaccinations on September 26, 2000, November 23, 2000, and January 26, 2001. (Levin Report, p. 2.) He also indicates that DAC was later given a DTaP vaccination on December 3, 2001. (Id.) DAC's September and November DTP vaccinations are confirmed in the records ofDr. Ricardo Gonzales. (Ex. 13, pp. 1-3.) The third DTP dose identified by Dr. Levin, however, does not appear in Dr. Gonzales's records. Rather, it appears on a Yellow Card Vaccination Record subsequently created by Dr. Hope Yerro. (Ex. 14.) DAC's early vaccination entries were apparently hand-copied into that record, which indicates that DAC received a DTP dose on January 26, 2001. (Id.) The same entry was copied over to DAC's subsequentrecords with Kaiser Permanente. (Ex. 27, pp. 1, 3.) None ofthese copied records specifically identifies the source ofthis information. However, a chart note from Dr. Teresita Tan indicates that DAC was given a "Dtap" vaccination, not a DTP vaccination, in Dr. Tan's office on January 26, 2001. (Ex. 15, p. 2.). This is also confirmed in Dr. Tan's original immunization record. (Ex. 22.) Therefore, I accept Dr. Tan's original record, ratherthan the subsequent, copied notations ofDAC's vaccine record, as accurate. Thus, based on the medical records, I find that DAC was administered a DTaP vaccination, and not a DTP vaccination, on January 26, 2001.

23 As noted in footnote 22 above, Dr. Gonzales's records confirm that DAC received two doses ofDTP while under his care. Dr. Gonzales also confirmed that he cared for DAC in the Philippines (Ex. 13, p. 3). However, Dr. Teresita Tan, who administered DAC's DTaP vaccine in her office on January 26, 2001, practices in Los Angeles, California. (Ex. 15, p. 6.)

24 To the extent that Dr. Levin indicated that his opinion was based in part on the temporal relationship between DAC's DTP vaccines and the onset ofhis autism symptoms, he did not specify which vaccine or vaccines he was referring to, nor did he substantiate his claim that the timing is consistent with the medical literature as he claimed. Indeed, he did not even identify the expected time frame he was attempting to reference. Thus, this does not in itself indicate whether Dr. Levin intended to include the vaccination ofJanuary 26, 2001, in his opinion or not.

20

# x

DR. LEVIN'S EXPERT REPORT IS FACIALLY INADEQUATE
Next, assuming that the vaccinations thatDAC received in the Philippines were covered by the Program, Iwill nowturn to the substance ofDr. Levin's report. Even assuming, in addition, that Dr. Levin intended to attribute DAC's injury to both his two DTP vaccinations of late 2000 andhis DTP vaccination ofJanuary 26, 2001, Dr. Levin'sreport still suffers significant and numerous flaws. In short, it was wholly unpersuasive regarding every element necessary to proving causation-in-fact in this Program.
First, Dr. Levin's opinionregarding general causation (i.e., the capacity ofthe vaccine generallyto cause the type ofinjury DAC experienced) is incredibly cursory, and largely, ifnot entirely, unsupported speculation. His opinion that a causal relationship exists between DTP vaccinations and autism is limited to an alleged, butunexplained, temporal relationship between vaccination and onset in this case; an unspecified and unsubstantiated claim that thousands of autism cases have beenrelated to DTP vaccinations; and an allegedly unexplained increase in autism nationwide. (Levin Report, p. 3.) He did not actually offer any**scient~fic** supportfor the notion thatthe DTP vaccine can cause autism, in this orin any case. To the extentthat Dr. Levin posited a connectionbetween vaccine-induced encephalitis or encephalopathy and later autism, that alleged link was also completely unexplained and unsubstantiated. Indeed, Dr. Wiznitzer
was correct to note that Dr. Levin "offers no causal theory whatsoever." (Ex. A, p. 6.) Although Dr. Levin did provide a limited bibliography, he did not provide the underlying literature, nor did he link any ofthe cited work to his specific statements. And in any event, the cited articles themselves do not support Dr. Levin's contentions.25 Moreover, notwithstanding that he opined a "greaterthan 50% chance" ofa causal relationship, Dr. Levin acknowledged that the entire ideathat DTP vaccines can cause autism, and the possible causal mechanismby which it could happen, are boththe "subjectofa debate," leaving Dr. Levin's opinion equivocal in addition to beingunsupported. (Levin Report, p. 3.) Critically, support for the additional contention thatthe

### DTaP vaccination can cause autism, a contentionthat Dr. Levin offered implicitly at best, is even more limited. Indeed, Dr. Levin actually stressed that the DTaP vaccine is much saferthan the DTP vaccine. (Id.) His one-sentence "discussion" ofDTaP consists solely ofan unsubstantiated allegation of unspecified prior instances where compensation allegedly was awarded inthis Program for cases where the DTaP vaccine has led to encephalopathy.26 Yet, even accepting thatpremise at face

25 For example, Dr. Wiznitzernoted that at least one ofDr. Levin's citations was to an article regarding the measles virus. (Ex. A, p. 6.) Yet Dr. Levin specifically excluded the MMR vaccine, let alone the measles virus, from his opinion. (Levin Repo1t, p. 4.)

26 For both DTP and DTaP vaccinations, "encephalopathy or encephalitis" constitutes a Table Injury ifit occurs within 72 hours ofvaccination. (42 C.F.R. § 100.3(a).) Critically, however, Table Injuries carry apresumption of causation only when the injury fits the statutory definition and when onset falls within the prescribed period. In the instant case, however, there is no interpretation ofthe record that could establish DAC's injury as a Table Injury encephalopathy or encephalitis. Dr. Levin also did not adequately address the timing ofthe encephalopathy he claims to have occurred (he failed to specify its onset and also failed to identify a specific vaccine as causal). To the

21value, Dr. Levin did not even attemptto address, let alone persuasively address, the supposed further link between encephalopathy and autism. Instead, he stated only that some children have "moderate reactions" to vaccination, such as fever, crying, and seizure. He did not, however, offer any explanation for how such areaction couldultimately leadto autism.27 (Levin Report, p. 4.)
Moreover, Dr. Levin's discussion ofspecific causation (i.e., the ideathat DAC's vaccines actually didcause his own injury) is equally unpersuasive. In fact, Dr. Levin's causal opinion is predicated entirely on the alleged presence ofa temporal relationship betweenvaccination and injury. This alone leaves the opinion inadequate. (See, e.g., Lalonde v. HHS, 746 F.3d 1334, 1341 (Fed. Cir. 2014)(holding that "thebasis for Ms. LaLonde's petitionreduces to atemporal relationship betweenthe administration ofthe DTaP vaccine and M.L.'s focal brain injuries. As
we have stated before, atemporal correlation alone is not enoughto demonstrate causation"); see alsoAlthen, 418 F.3d at 1278 ("Althoughprobative, neither a mere showing ofa proximate temporal relationship between vaccination and injury, nor a simplistic elimination ofother potential causes ofthe injury suffices, without more, to meetthe burden ofshowing actual causation").) Yet, even Dr. Levin's opinionregarding that alleged temporal relationship is itself deeply flawed.

As noted above, Dr. Levin's very limited discussion ofDAC's medical history was mistaken on the critical point ofidentifying the type ofvaccinations that DAC actually received. Mistaking DAC's vaccination ofJanuary 26, 2001, as a DTP rather than a DTaP vaccination is particularly glaring in light ofDr. Levin's clear distinction regarding the relative safety ofthose two differenttypes ofvaccinations, and his contentionthatthe DTP vaccinations were causal. The mistake also highlights the report's overall vagueness. 28

extentthat Dr. Levin spoke ofany "first symptom," it was in regard to DAC's autism, not any supposed encephalopathy or encephalitis, and onset was pegged at around August 3, 2001. (Levin Report, p. 2.) Petitioners also alleged thatthe first symptom ofDAC's injury arose around the time ofhis first birthday on July 17, 2001, roughly 6 months following his then-most-recent DTaP vaccination. (ECF No. 35.) Although petitioners alleged that DAC experienced a seizure on April 3, 2001 (Ex. 21), this too was months after any ofDAC'sprior DTP or DTaP vaccinations and, in any event, the existence ofthat alleged seizure is not supportedbythe medical records. (See Section IV(B) above.) Therefore, absent a Table presumption, it was incumbent upon Dr. Levin to establish that DTaP vaccines can, in fact, cause the type ofinjury DAC allegedly sustained. In and ofitself, and particularly in light ofthe potential for a causal presumption under the Vaccine Injury Table, the fact that prior claims have been paid does not establish causation in this case.

27 As discussed in footnote 5, above, in Wright v. HHS, No. 12-423V, 2015 WL 6665600 (Fed. Cl. Spec. Mstr. Sept. 21, 2015), Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a "Table lnjwy encephalopathy" after a vaccination. Special Master Vowell stressed, however, that she was notmaking ajudicial determination that the child's autism was vaccine-caused. 2015 WL 6665660 at* 30.

28 The mistake is understandable to some degree. As noted in footnote 22 above, there are some records that suggest thatthe vaccination ofJanuary 26, 2001, was aDTP vaccination. Indeed, Inote that Dr. Wiznitzer made the same mistake. (See Ex. A, p. 1.) Nonetheless, the distinction was merely incidental in Dr. Wiznitzer's report, whereas it
was central to Dr. Levin's opinion. Had Dr. Levin's report included an appropriate level ofspecificity, the error likely would have presented itselfto him. And even ifnot, at least Dr. Levin's intention would have been clear. As it stands, however, Dr. Levin's report does not even adequately identify which vaccines he considers to be causal.

22Dr. Levinreported that DACreceived a series ofthree DTP vaccines (one ofwhich he erroneously identified), and then opined generally thatcausation canbe inferred bythe temporal relationship betweenthe onset ofautism and the "administrations ofDTP vaccine." (Levin Report, p. 3.) That is, thoughrelying entirely on a temporal connection, Dr. Levin failed to even distinguish amongthe three vaccines (one ofwhich wasn'teven DTP) despite the fact thatthey
were administered months apart. Moreover, although he contendedthat the claimedtemporal relationship is consistent withthe relevantmedical literature, he completely failed to cite any supporting literature, or evenremark onwhat time frame this unspecified literature establishes. And finally, despite seemingto imply that whatDAC actually experiencedwas a "brain inflammation/encephalopathy,"whichin turn later ledto autism (id at 3-4), Dr. Levin discussed only the onset ofDAC's autism, and did not specifically address the timing ofany symptomthat could be an indication ofbrain inflammation, encephalopathy, orencephalitis. Confusingly, to the extentthat Dr. Levin opinedthat "DTP appears to have caused fever, seizures and encephalitis in this case" (Levin Repmi, p. 4), his summary ofDAC's medical history actually seems to linkthe onset ofthose alleged symptoms to DAC's Hib vaccination of March 30, 2001, and notto any ofhis DTP orDTaP vaccinations (Levin Report, p. 2). 29 Thus, it is noteven clearhoworwhy Dr. Levinposits a temporal relationship betweenthe DTP vaccinations and DAC's ASD.
Forthese reasons, Dr. Levin'sreport is actually quite incoherent. Infact, despite the fact thatDr. Levin clearly statedthat he believes DTPvaccinations to be causal, by allegedly causing
an encephalopathy/encephalitis that inturn causedDAC's autism, I am unable to detectfrom his report whatDr. Levin actuallybelieves the time ofonset ofthe alleged encephalopathy to be, let alone determine whether such a time frame conformsto any relevantmedical literature.
Moreover, regardless ofwhich vaccine is placed atissue, ifDr. Levin is relying upon an alleged seizure by DAC, the existence ofsuch a seizure occurring at any time soon after his DPT
orDTaP vaccinations is not supported by the medical records. As addressed above in Section IV(B) ofthis Decision, there is no mention inthe medical records ofthe seizuresthatMrs. Canuto alleged. (Ex. 16, p 1.)
Thus, even lookingto the substance ofDr. Levin'sreport, it still fails to offer any substantial suppotito the proposition that DAC's ASD was causedby any vaccine at all, let alone being caused by a Program-coveredvaccine, such as his DTaP vaccination ofJanuary 2001.

29 Despite this, Dr. Levin apparently opted notto opine that DAC's Hib vaccine

- a Program-covered vaccine was the cause ofDAC's injury. (Nor is there any persuasive evidence in the record that DAC's Hib vaccine injured him in any way.)

23XI
RESPONDENT'S EXPERT WAS FARMORE QUALIFIED, AND FULLY REBUTTED DR. LEVIN'S REPORT

For all the reasons above, Ihave concluded that Petitioners have.failedto present even a primafacie case that any ofDAC'svaccinations played any role in causing or aggravating his autism. Thus, the burden ofproofnever shifted to respondent. Nonetheless I further note that Respondent's expert, Dr. Wiznitizer, was far more persuasive than Dr. Levin. Dr. Wiznitzer's opinion in this case fully rebutted Dr. Levin's opinion, which as described above, was very weak in itself. Dr. Witzniter's opinion carried greater weight than Dr. Levin'sboth because he is better qualified to offer an opinionregarding DAC's neurologic status, including his autism diagnosis, and because his report is more detailed, more coherent, and better supported by the facts and the literature.
Whereas Dr. Levin is a specialistin oncology and hematology (Levin Report, p. 1 ), two fields unrelated to the instant case, Dr. Wiznitzer is a pediatric neurologistwith extensive experience diagnosing autism spectrum disorders, including nearly two decades as director ofthe Rainbow Autism Center (Ex. B, pp. 1-3). Dr. Levin's experience with autism, in contrast, is limited to three years ofspecial education advocacy during which he claims to have learned much aboutpervasive developmental disorder (PDD). (Levin Report, p. 1.) Moreover, Dr. Wiznitzer's body ofpeer-reviewed articles includes papers on subjects relatedto autism as well
as encephalitis and encephalopathy. (Ex. B, pp. 13-19.) Dr. Levin'spublished works, on the other hand, all pertain to subjects completelyunrelated to any ofthe issues presented bythe instant case. (Levin CV, pp. 5-10.) Dr. Wiznitzer's opiniontherefore carries greater weight. He is far better qualified to speak, not only to the course and onset ofDAC's autism, but also to the question ofwhether DAC experienced an encephalitis or encephalopathy. Moreover, Dr. Wiznitzer further buttressed his opinion with supporting medical literature.30

In any event, Dr. Wizniter's summary ofDAC'smedical history is much more detailed, and his opinionthat the onset ofDAC's autism was unrelated to his vaccinations tracks that history much more closely than does Dr. Levin's opinion. Specifically, Dr. Wiznitzer concluded that DAC "has a developmental history with no reported regression ofskills. Rather, he displayed a slow acquisition ofskills with a gradual appearance ofsocial differences." (Ex. A, pp. 5-6.) Dr. Wiznitzer cited multiple instances in the medical records where DAC's speech delay was noted, not as a regression, but as a failure to obtain significant language development in the first instance, with concerns first being noted at around two years ofage. Citing medical literature directly on point, Dr. Wiznitzer concluded thatthis was atypical developmental trajectory for children with ASD.31 (Ex. A, p. 6.)

30 Although Dr. Levin did provide a briefbibliography, he failed to provide any ofthe supporting literature and also failed to offer any citations to that literature to supporthis specific statements. Dr. Wiznitzer, on the other hand, both provided the supporting literature, and directly cited to it to support his assertions.

31 Specifically, Dr. Wiznitzer cited and submitted the following: Johnson, et al., Identification andevalulation of children with autism spectrum disorders, Pediatrics 2007; 120: 1183-1215, and Ozonoff, et al., The onset of autism: patterns of**~ymptom** emergence in thefirstyears of life, Autism Res. 2008; 1:320-328.

24Dr. Wiznitzer also noted the absence ofany indication in the contemporaneous medical records that DAC ever experienced an encephalopathy or encephalitis. (Ex. A, p. 6.) Specifically, he correctly observedthatthere is no contemporaneous medical recordreporting any seizure activity (see Section IV(B) above), and no subsequent course ortreatment consistent with such a concern. (Id.) He also noted that, in fact, DAC'smedical records from August 3, 2001, and December 3, 2001, specifically documentparental reports ofthe absence ofany prior vaccine reactions. 32 (Id., p. 6; see also Ex. 17, p. 1and Ex. 20, p. 1.)

For all these reasons, I find that Respondent's expert submissionwas much more persuasive than Petitioners' submission. Dr. Wiznitzerfully rebutted Dr. Levin's opinion, providing an explanation ofDAC's conditionthat better accounts for DAC's complete medical history. 33

XII
PETITIONERS HAVE FAILED THE ALTHEN TEST
As noted above, in its ruling inAlthen, the U.S. Court ofAppeals for the Federal Circuit discussed the "causation-in-fact" issue in Vaccine Act cases. The court stated as follows: Concisely stated, Althen's burden is to showbypreponderant evidencethat the vaccinationbrought abouther injury by providing: (1) a medical theory causally connectingthe vaccination and the injury; (2) a logical sequence ofcause and effect showingthatthe vaccination was the reason for the injury; and (3) a showing ofaproximate temporal relationship betweenthe vaccination and injury. IfAlthen satisfies this burden, she is "entitledto recoverunless the [government] shows, also by apreponderance ofthe evidence, thatthe injury was in fact caused by factors unrelated to the vaccine."
Althen, 418 F.3d 1274, 1278 (Fed. Cir. 2005)(citations omitted). In the pages above, ofcourse, I have already set forth in detail my analysis in rejecting Petitioners' "causation-in-fact"theory in this case. In this part ofmy Decision, then, I will briefly explainhowthat analysis fits specifically within the three parts oftheAl then test, enumerated in the first sentence ofthe

32 Subsequently, on October 19, 2004, Mrs. Canuto declined vaccinations, because she believedthatthey made DAC sick. (Ex. 49, p. 2.)

33 Although Dr. Wiznitzer opined that DAC's condition is explained as autism, which is in essence idiopathic, I stress that the burden ofproofdid not shift to respondentto prove an alternate cause. Rather, I find Dr. Wiznitzer's opinion to be an effective challenge to Dr. Levin's opinion ofvaccine causation. That is, I am considering respondent's evidence relative to Petitioners' case-in-chief. (See, e.g., deBazan v. HHS, 539 F.3d 1347, 1353-54 (Fed. Cir. 2008)("The government, like any defendant, is permitted to offer evidence to demonstrate the inadequacy ofthe petitioner's evidence on a requisite element ofthe petitioner's case in-chief

... Here, the government's evidence did not concern any factors unrelated to the vaccine. Rather, Dr. Sriram's testimony bore directly on whether the medical evidence supported concludingthatthe vaccine could be the cause-in-fact, which is clearly part ofthe petitioner's case-in-chief.") (emphasis original).)

25Althen excerpt set forth above. The short answer is that Ifind that Petitioners' theory in this case clearly does not satisfy theA!then test.


### A. Relationship betweenA/thenProngs 1and2

One interpretive issue with theA/thentest concerns the relationship betweenthe first two elements ofthat test. The first two prongs oftheAl then test, as noted above, are thatthe petitioners must provide "(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence ofcause and effect showing thatthe vaccination was the reason for the injury." Initially, it is not absolutely clearhow the two prongs differ from each other. That is, on their faces, each ofthe two prongs seems to require a demonstration ofa "causal" connectionbetweenthe "vaccination" and "the injury." However, a number ofProgram opinions have concluded that these first two elements reflectthe analytical distinction that has been described as the "cancause" vs. "did cause" distinction. That is, in many Program opinions issued prior toAlthen involving "causation-in-fact" issues, special masters orjudges stated that a petitionermust demonstrate (1) thatthe type ofvaccination in question can cause the type of injury in question, and also (2) that theparticularvaccination received by the specific vaccinee didcause the vaccinee's own injury. See, e.g., Kuperus v. HHS, 2003 WL 22912885, at *8 (Fed. Cl. Spec. Mstr. Oct. 23, 2003); Helms v. HHS, 2002 WL 31441212, at *18 n. 42 (Fed. Cl. Spec. Mstr. Aug. 8, 2002). Thus, a number of judges and special masters ofthis court have concluded that Prong 1ofAlthen is the "can cause" requirement, and Prong 2 ofA/then is the "did cause" requirement. See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-73 (2008); Nussman v. HHS, 83 Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL 2296047, at *24 (Fed. Cl. Spec. Mstr. July 20, 2007); Zeller v. HHS, 2008 WL 3845155, at *25 (Fed. Cl. Spec. Mstr. July 30, 2008). And, most importantly, the Federal Circuit confirmed that interpretation in Pafford, ruling explicitly that the "can it?/did it?" test, used by the special master in that case, was equivalentto the first two prongs oftheAlthentest. Paffordv. HHS, 451 F.3d at 1352, 1355-56 (Fed. Cir. 2006). Thus, interpreting the first two prongs ofA/then as specified in Pafford, under Prong 1ofA/then
a petitionermust demonstrate that the type ofvaccination in question can cause the type of condition in question; and under Prong 2 ofAlthenthe petitioner mustthen demonstrate thatthe particular vaccination did cause the particular condition ofthe vaccinee in question.
Moreover, there canbe no doubt whatsoever thattheAlthentest ultimately requires that,
as an overall matter, apetitionermust demonstrate that it is "moreprobable than not" thatthe particular vaccine was a substantial contributing factor in causing the particular injury in question. That is clear from the statute itself, which states that the elements ofapetitioner's case mustbe establishedby a "preponderance ofthe evidence."§ 300aa-13(a)(l)(A). And, whatever is the precise meaning ofProngs 1and 2 ofAlthen, in this case the overall evidence falls far short ofdemonstrating that it is "moreprobable than not" that any ofthe vaccines that DAC received contributed to the causation ofDAC'stragic neurodevelopmental disorder.



### B. Petitioners havenotestablishedProng 1 of A/then in this case. As explained above, under Prong 1ofA/then apetitionermust provide a medical theory demonstrating that the type ofvaccine in question can cause the type ofcondition in question. Here, Petitioners did not even minimally supporttheirtheory that the type ofinjury DAC experienced could have beenvaccine-caused. Although Petitionersthemselves submitted

26extensive writings regarding theirtheory ofcausation, Ihave not found those filings to be persuasive evidence in this case for the reasons described above, leaving only Dr. Levin's opinion. Dr. Levin's opinion, in turn, focused on non-U.S. vaccinations that may not evenbe coveredby this Program. Moreover, he left his assertions completely unsupported. Even assuming that all ofthe vaccinations to which Dr. Levin points were coveredby the Program, and granting Dr. Levin his unsupported assumptionregarding the alleged causal relationship between DTP/DTaP vaccinations and encephalopathy/encephalitis, he completely failed to address how those injuries could ultimately manifest as autism. Thus, Petitioners' claim fails underA/then Prong 1.


### C. Petitioners have failed to establish Prong2 of Alt/ten in this case.
Under Prong 2, the Petitioners need to showthat it is "moreprobable than not" that one ofDAC's vaccinations didcause DAC'sown condition. Butthis they have failed to do, for all of the reasons detailed above. In terms ofestablishing causation in DAC's case in particular, Dr. Levin relied entirely on an alleged temporal connectionbetweenDAC's vaccination and his injury. This alone leaves Dr. Levin's opinion inadequate, because no suchtemporal association has been demonstrated. Dr. Levin completely failed to substantiatethis assertion. He did not explain what he considered the time ofonset to be in this case. Nor did he explain more generally what he considered amedically acceptable time frame for the onset ofthe type of injury at issue. Additionally, to the extentthatDr. Levin believed DAC's autism was actually the result ofan encephalitis/encephalopathy evidencedby fever and seizure, his opinion was silentregarding the onset ofthat alleged encephalopathy/encephalitis, speaking only to the onset ofDAC'sautism. Further, his summary ofDAC's medical history, confusingly, mentioned a seizure only in connection with DAC's Hib vaccine, which Dr. Levin did notopine to be causal. But in any event, I decline to creditthe allegation ofa seizure even at thattime, because it was not corroboratedby the medical records. Thus, for all these reasons, Petitioners have failed to establish Prong 2 ofA!then in this case.34



### D. Petitioners have failedto establish Prong3 of Alt/ten in this case.
Since Ihave explained why Petitioners have failed to satisfy the.first and secondprongs ofA/then, Ineed not discuss why Petitioners' case also fails to satisfy the thirdprong, under which Petitioners must show a proximate temporal relationship between vaccination and injury. However, Iwill note againthat Dr. Levin utterly failed to establish either the period ofonset in DAC's case spec{fically, or the medically accepted time frame for such a conditiongenerally.



### E. This is nota close case.
As noted above, inAlthenthe Federal Circuit indicated thatthe Vaccine Act involves a "system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants." 418 F.3d at 1280. Accordingly, Inote here thatthis case ultimately is nota

34 To clarify, Petitioners have failed to show that DAC's autism was either initially causedby any ofhis vaccinations, or was aggravated in any way by his vaccinations.

27close case. For all the reasons set forth above, Ifound that Dr. Levin's theory was notat all persuasive, while Respondent's expertwasfar more persuasive.

XIII

CONCLUSION
The record ofthis case demonstrates plainly that DAC and his family have beenthrough
a tragic ordeal, and Ihave great sympathy for the family. However, Imust decide this case not on sentiment, but by analyzing the evidence. Congress designed the Programto compensate only the families ofthose individuals whose injuries or deaths canbe linked causally, eitherby a Table Injury presumption orby apreponderance of"causation-in-fact" evidence, to a listed vaccine. Inthis case, the evidence advanced by the Petitioners has fallen far short of demonstrating such a link. Accordingly, I conclude thatthe Petitioners in this case are not entitled to a Program award on DAC'sbehalf.35

35 In the absence ofa timely-filed motion for review ofthis Decision, the Clerk ofthe Court shall enterjudgment accordingly.

28